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Code · REGISTER · 2007-09-20 · Environmental Protection Agency (EPA) · Rules and Regulations

Rules and Regulations. Final rule

50,922 words·~231 min read·/register/2007/09/20/07-4663

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 5001-06-M ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R03-OAR-2007-0450; FRL-8469-4] Approval and Promulgation of Air Quality Implementation Plans; Delaware; Amendments to the Open Burning Regulation AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. SUMMARY: EPA is approving a State Implementation Plan
(SIP)revision submitted by the State of Delaware. This SIP revision pertains to the amendments of Delaware's open burning regulation. EPA is approving this SIP revision in accordance with the Clean Air Act. DATES: *Effective Date:* This final rule is effective on October 22, 2007. ADDRESSES: EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2007-0450. All documents in the docket are listed in the *www.regulations.gov* Web site. Although listed in the electronic docket, some information is not publicly available, i.e., confidential business information
(CBI)or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through *www.regulations.gov* or in hard copy for public inspection during normal business hours at the Air Protection Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal are available at the Delaware Department of Natural Resources & Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover, Delaware 19903. FOR FURTHER INFORMATION CONTACT: Rose Quinto,
(215)814-2182, or by e-mail at *quinto.rose@epa.gov.* SUPPLEMENTARY INFORMATION: I. Background On June 21, 2007 (72 FR 34207), EPA published a notice of proposed rulemaking
(NPR)for the State of Delaware. The NPR proposed approval of Delaware's open burning regulation (Regulation No. 1113). The formal SIP revision was submitted by the Delaware Department of Natural Resources and Environmental Control (DNREC) on May 2, 2007. Other specific requirements of Delaware's open burning regulation and the rationale for EPA's proposed action are explained in the NPR and will not be restated here. No public comments were received on the NPR. II. Final Action EPA is approving Regulation No. 1113—Open Burning as a revision to the Delaware SIP. This SIP revision was submitted on May 2, 2007. III. Statutory and Executive Order Reviews A. General Requirements Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 *et seq.* ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal requirement, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it approves a state rule implementing a Federal standard. In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 *et seq.* ). B. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U.S.C. 801 *et seq.* , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the **Federal Register** . This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2). C. Petitions for Judicial Review Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2007. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action, pertaining to Delaware's amendments to the open burning regulation, may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) List of Subjects in 40 CFR Part 52 Environmental protection, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds. Dated: September 6, 2007. William T. Wisniewski, Acting Regional Administrator, Region III. 40 CFR part 52 is amended as follows: PART 52—[AMENDED] 1. The authority citation for part 52 continues to read as follows: Authority: 42 U.S.C. 7401 *et seq.* Subpart I—Delaware 2. In § 52.420, the table in paragraph
(c)is amended by revising the title and entries for Regulation No. 13—Open Burning to read as follows: § 52.420 Identification of plan.
(c)* * * EPA-Approved Regulations in the Delaware SIP State citation Title/subject State effective date EPA approval date Additional explanation * * * * * * * Regulation 1113 Open Burning (Formerly Regulation 13) Section 1.0 Purpose 04/11/07 09/20/07 [Insert page number where the document begins] Section 2.0 Applicability 04/11/07 09/20/07 [Insert page number where the document begins] Section 3.0 Definitions 04/11/07 09/20/07 [Insert page number where the document begins] Section 4.0 Prohibitions and Related Provisions 04/11/07 09/20/07 [Insert page number where the document begins] Section 5.0 Season and Time Restrictions 04/11/07 09/20/07 [Insert page number where the document begins] Section 6.0 Allowable Open Burning 04/11/07 09/20/07 [Insert page number where the document begins] Section 7.0 Exemptions 04/11/07 09/20/07 [Insert page number where the document begins] * * * * * * * 7 [FR Doc. E7-18352 Filed 9-19-07; 8:45 am] BILLING CODE 6560-50-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-2882; MB Docket No. 05-67; RM-11116, RM-11342] Radio Broadcasting Services; Clinton, Fishers, Indianapolis, and Lawrence, IN AGENCY: Federal Communications Commission. ACTION: Final rule; dismissal. SUMMARY: This *Report and Order* dismisses two Counterproposals as unacceptable for consideration. In addition, this *Report and Order* upgrades Channel 230A, Station WWFT (FM), Fishers, Indiana, to Channel 230B1, reallots Channel 230B1 from Fishers to Lawrence, Indiana, as Lawrence's first local aural transmission service, and modifies Station WWFT (FM)'s license accordingly. In order to maintain local service at Fishers, the *Report and Order* reallots Channel 238B, Station WFMS (FM), from Indianapolis to Fishers, Indiana, and modifies Station WFMS (FM)'s license accordingly. To accommodate the reallotment of Channel 230B1 to Lawrence, the *Report and Order* substitutes Channel 229A for Channel 230A at Station WPFR-FM. Clinton, Indiana, and modifies Station WPFR-FM's license accordingly. The Media Bureau's Consolidated Database System
(CDBS)reflects these changes. ADDRESSES: Federal Communications Commission; 445 Twelfth Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: R. Barthen Gorman, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's *Report and Order,* MB Docket No. 05-67, adopted June 27, 2007, and released June 29, 2007. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *http://www.BCPIWEB.com* . The Commission will not send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A), because Section 73.202(b) of the Commission's Rules has not been amended. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-18500 Filed 9-19-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-3478; MB Docket No. 05-245; RM-111264, RM-11357] Radio Broadcasting Services; Animas, NM; Corona de Tucson, AZ; Lordsburg, NM; Sierra Vista, Tanque Verde and Vail, AZ; and Virden, NM AGENCY: Federal Communications Commission ACTION: Final rule. SUMMARY: In response to the Counterproposal filed by Cochise Broadcasting, LLC and Desert West Air Ranchers Corporation, this document reallots Channel 267C3 from Corona de Tucson to Tanque Verde, Arizona, and modifies the license of Station KKYZ to specify Tanque Verde as the community of license. To continue local service at Corona de Tucson, it reallots Channel 253A from Vail, Arizona, to Corona de Tucson, and modifies the Station KRDX license to specify Corona de Tucson as the community of license. To replace local service at Vail, it substitutes Channel 279A for Channel 279C1 at Lordsburg, New Mexico, reallots Channel 279A to Vail, and modifies the outstanding construction permit (File No. BNPH-20050609ABD) to specify operation on Channel 279A at Vail. Finally, it allots Channel 279C1 to Animas, New Mexico, and Channel 228C1 to Virden, New Mexico, as first local services. The reference coordinates for the Channel 267C3 allotment at Tanque Verde, Arizona, are 32-19-59 and 110-45-19. The reference coordinates for the Channel 253A allotment at Corona de Tucson, Arizona, are 32-55-39 and 110-37-57. The reference coordinates for the Channel 279A allotment at Vail, Arizona, are 31-58-16 and 110-35-59. The reference coordinates for the Channel 279C1 allotment at Animas, New Mexico, are 31-56-50 and 108-28-45. The reference coordinates for the Channel 228C1 allotment at Virden, New Mexico, are 32-24-12 and 108-53-59. With this action, this proceeding is terminated. DATES: Effective September 20, 2007. FOR FURTHER INFORMATION CONTACT: Robert Hayne, Media Bureau
(202)418-2177. SUPPLEMENTARY INFORMATION: This is a synopsis of the *Report and Order* in MB Docket No. 05-245, adopted July 30, 2007, and released July 31, 2007. The full text of this decision is available for inspection and copying during normal business hours in the FCC Reference Information Center at Portals II, CY-A257, 445 12th Street, SW., Washington, DC 20554. The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copying and Printing, Inc. 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *http://www.BCPIWEB.com* . The Commission will send a copy of this *Report and Order* in a report to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A). List of Subjects in 47 CFR Part 73 Radio, Radio broadcasting. As stated in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows: PART 73—RADIO BROADCAST SERVICES 1. The authority citation for part 73 continues to read as follows: Authority: 47 U.S.C. 154, 303, 334, 336. § 73.202(b) [Amended] 2. Section 73.202(b), the Table of FM Allotments under New Mexico, is amended by adding Animas, Channel 279C1 and by adding Virden, Channel 228C1. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-18499 Filed 9-19-07; 8:45 am] BILLING CODE 6712-01-P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 [DA 07-2196; MB Docket No. 05-263; RM-11269] Radio Broadcasting Services; Church Rock and Grants, NM AGENCY: Federal Communications Commission. ACTION: Final rule; dismissal. SUMMARY: This Report and Order dismisses two Counterproposals as unacceptable for consideration. In addition, this *Report and Order* reallots Channel 279C0, Station KYVA-FM, from Grants, New Mexico, to Church Rock, New Mexico, and modifies the license of Station KYVA-FM accordingly. The foregoing change of community provides the first local aural transmission service to Church Rock. The Media Bureau's Consolidated Database System
(CDBS)reflects these changes. ADDRESSES: Federal Communications Commission, 445 Twelfth Street, SW., Washington, DC 20554. FOR FURTHER INFORMATION CONTACT: R. Barthen Gorman, Media Bureau,
(202)418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's *Report and Order* in MB Docket No. 05-263, adopted May 23, 2007, and released May 25, 2007. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center at Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., Portals II, 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone 1-800-378-3160 or *http://www.BCPIWEB.com.* The Commission will not send a copy of this *Report and Order* in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, *see* 5 U.S.C. 801(a)(1)(A), because Section 73.202(b) of the Commission's Rules has not been amended. Federal Communications Commission. John A. Karousos, Assistant Chief, Audio Division, Media Bureau. [FR Doc. E7-18495 Filed 9-19-07; 8:45 am] BILLING CODE 6712-01-P DEPARTMENT OF TRANSPORTATION Federal Transit Administration 49 CFR Part 661 [Docket No. FTA-2005-23082] RIN 2132-AA90 Buy America Requirements; End Product Analysis and Waiver Procedures AGENCY: Federal Transit Administration (FTA), DOT. ACTION: Final rule. SUMMARY: The Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) requires the Federal Transit Administration (FTA or the Agency) to make certain changes to the Buy America requirements. This Final Rule creates a new publication process for public interest waivers to provide an opportunity for public comment; clarifies Buy America requirements with respect to microprocessor waivers; issues new provisions to permit post-award waivers; clarifies the definition of “end products” with regards to components, subcomponents, and major systems, and provides a representative list of end products; clarifies the requirements for final assembly of rolling stock and provides representative examples of rolling stock components; expands FTA's list of communications, train control, and traction power equipment; and updates debarment and suspension provisions to bring them into conformity with statutory amendments made by SAFETEA-LU. EFFECTIVE DATE: The effective date of this publication is October 22, 2007. FOR FURTHER INFORMATION CONTACT: Richard Wong, Office of the Chief Counsel, Federal Transit Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590,
(202)366-4011 or *Richard.Wong@dot.gov.* SUPPLEMENTARY INFORMATION: I. Background On November 28, 2005, the Federal Transit Administration
(FTA)published a Notice of Proposed Rulemaking
(NPRM)in the **Federal Register** (70 FR 71246) that discussed several proposals mandated by SAFETEA-LU (Pub L. 109-59, August 10, 2005), and proposed to provide further clarification of existing FTA decisions on Buy America. Due to the complexity of many Buy America issues addressed in the NPRM and the divergence of opinion in important areas, FTA issued a final rule that addressed fewer subjects than addressed in the NPRM. (71 FR 14112, Mar. 21, 2006.) These more routine topics covered in the final rule included:
(1)Administrative review;
(2)the definition of “negotiated procurement;”
(3)the definition of “contractor;”
(4)repeal of the general waiver for Chrysler vans;
(5)certification under negotiated procurements;
(6)pre-award and post-award review of rolling stock purchases; and
(7)miscellaneous corrections and clarifications to the Buy America regulations. The Second Notice of Proposed Rulemaking (SNPRM) (71 FR 69412, Nov. 30, 2006) addressed six issues identified in the original NPRM but not covered in the initial final rule:
(1)A publication process for public interest waivers to provide an opportunity for public comment;
(2)a clarification of Buy America requirements with respect to microprocessor waivers;
(3)new provisions to permit post-award waivers;
(4)clarifications in the definition of “end products” with regards to
(a)components and subcomponents,
(b)major systems, and
(c)a representative list of end products;
(5)a clarification of the requirements for final assembly of rolling stock and a list of representative examples of rolling stock items;
(6)expanding FTA's list of eligible communications, train control, and traction power equipment; and added a technical correction; and, an update of the debarment and suspension provisions to bring them into conformity with statutory amendments made by SAFETEA-LU. 1. Published Justification for Public Interest Waivers In the first NPRM, FTA proposed amending 49 CFR 661.7(b) to implement the SAFETEA-LU requirement that FTA publish justifications for public interest waivers in the **Federal Register** and provide for notice and comment. The NPRM proposed to continue the current practice of posting all public interest waiver requests on FTA's Buy America Web site for public review and comment, with the additional step of publishing FTA's proposed approvals in the **Federal Register** for additional comment. After a thorough review of the comments received in response to the NPRM, which were discussed at length in the SNPRM, FTA believed that SAFETEA-LU intended a four-step process:
(1)Publish the incoming public interest waiver request on FTA's Web site for public review and comment;
(2)publish FTA's proposed approvals and FTA's justification in the **Federal Register** for formal notice and comment;
(3)issue a formal written decision to the applicant; and
(4)post copies of the formal decision on FTA's Web site. A. Comments Received FTA received six comments in response to the SNPRM. All supported an expedited approach. Most supported the 30-day timeframe proposed in the SNPRM, although one commented that providing fair public notice was more essential than a rapid turnaround. Two commenters urged FTA to publish both the incoming request and the proposed determination in the **Federal Register** . Several commenters complained that monitoring both FTA's Web site and the Federal Register Web site on a daily basis for potential waiver petitions was unduly burdensome. One commenter to both the NPRM and SNPRM suggested that FTA not limit publication of decisions to approvals of waiver petitions. The commenter noted that lessons learned from disapprovals lead to a better understanding and application of the Buy America requirements. B. FTA Response FTA believes that a dual **Federal Register** publication process for both incoming requests and proposed determinations would be slow and cumbersome, jeopardizing FTA's ability to maintain a 30-day processing time. FTA believes that publication of incoming requests on FTA's Buy America Web site with simultaneous notice to trade associations such as the American Public Transportation Association
(APTA)and the Community Transportation Association of America
(CTAA)provides interested parties with adequate notice and opportunity to comment, and that formal publication of FTA's proposed determination and justification in the **Federal Register** meets SAFETEA-LU's notice and comment requirements. As explained in the NPRM and SNPRM, FTA believes the plain language of SAFETEA-LU and its legislative history expressly requires FTA to issue a written justification and to publish it in the **Federal Register** , and only in instances where the justification supports a waiver request. *See* 49 U.S.C. 5323(j)(3); *see also* H.R. Conf. Rep. No. 109-203, at 952 (2005). However, FTA agrees with the commenter who asked FTA to also publish denial letters, and FTA will publish both approval and denial letters on its Web site, as FTA believes that researchers and potential applicants will find both documents useful. With regards to the concern that monitoring both FTA's Web site and the **Federal Register** for public interest waivers will be unduly burdensome, FTA has made improvements to its Web site whereby interested parties can subscribe to be notified whenever a new item is published on a specific FTA webpage, including FTA's table of its **Federal Register** publications. FTA believes that this proactive notification system will reduce, if not eliminate, the need to constantly monitor both FTA's Web site and the **Federal Register** for waiver petitions and determination letters. Accordingly, FTA believes the following process meets the requirements specified in SAFETEA-LU:
(1)Post notification of the public interest waiver request on FTA's Web site and solicit comments on the request;
(2)based on the comments received, prepare a justification that explains the rationale for approving or denying a waiver request;
(3)publish the justification in the **Federal Register** for notice and comment within a reasonable time; and
(4)publish the final decision on FTA's Web site regarding the waiver request, based on comments received in response to the published justification. It should be noted that upon review of the formal comments received in response to the publication of the proposed determination and justification in the **Federal Register** , FTA may ultimately determine that a waiver is *not* in the public interest, and deny the request, despite FTA's initial determination. FTA believes that this methodology would create a total processing time of about 30 calendar days. 2. Microcomputer/Microprocessor Waivers In the SNPRM, FTA requested comment on its proposal to implement the SAFETEA-LU requirement to “clarify” that any waiver of the Buy America requirements for a microprocessor, computer, or microcomputer, applies “only to a device used solely for the purpose of processing or storing data” and does not extend to the product or device containing a microprocessor, computer, or microcomputer. A. Comments Received FTA received nine comments on this issue, many of which echoed identical comments submitted in response to the initial NPRM, proposing the exclusion of input/output devices and software. Other commenters voiced objections to the current methodology of considering the cost of the microcomputer/microprocessor as domestic content for purposes of meeting the 60% domestic content requirement, suggesting that the cost of the exempted item should be excluded from the sum of the end product's domestic and non-domestic content. On the other hand, several commenters stressed that existing regulatory practices must be continued to avoid significant disruption in the industry, emphasizing that FTA was directed to “clarify” its existing Buy America interpretations with regard to microcomputers and microprocessors, without changing the current regulatory regime. B. FTA Response In FTA's attempt to clarify that the waiver applied to devices “used solely for the purpose of processing or storing data,” commenters misinterpreted this effort to mean that “input/output” facilities and software should now be excluded from the waiver's coverage. Such is not the case. Although the current version of the general waiver at 49 CFR 661.7, Appendix A, does not include the term “input/output” facility, FTA has interpreted the waiver to include software (“microcomputer equipment, *including software,* of foreign origin can be procured by grantees.”) (Emphasis added.) In addition, the inclusion of input/output devices under the waiver provision was used in a previous definition of a microcomputer. See 50 FR 18760, May 2, 1985 (“A basic microcomputer includes a microprocessor, storage, and *input/output facility,* which may or may not be on one chip.”) (Emphasis added.) FTA agrees with commenters that Congress did not intend for FTA to change its current regulatory treatment of microcomputer equipment. See H.R. Conf. Rep. No. 109-203, at 952
(2005)(“In directing the Secretary to issue new regulations regarding microprocessors, computers, or microcomputers, there is no intent to change the existing regulatory treatment of software or of microcomputer equipment.”) Because SAFETEA-LU directed FTA to “clarify,” not alter current regulatory policy, FTA will continue to allow both software and input/output devices to be covered under the microcomputer/microprocessor waiver, provided that the waiver is limited to the device used solely for the processing or storing data. Consistent with prior FTA rulemakings and letters of determination, the waiver does not extend to an entire product or device merely because it contains a microprocessor or microcomputer, such as a laptop computer, video display monitor, farecard reader, or similar piece of hardware or equipment. 3. Post-Award Waivers FTA sought comment in the first NPRM on its proposal to create a post-award non-availability waiver. Under FTA's current regulation, a bidder or offeror that certifies compliance with Buy America is “bound by its original certification” and “is not eligible for a waiver of those requirements.” 49 CFR 661.13(c). The NPRM's proposed language would allow grantees to request a non-availability waiver after contract award where a bidder or offeror had originally certified compliance with the Buy America requirements, but can no longer comply with its certification and contractual obligations due to commercial impossibility or impracticability. In the SNPRM, FTA revised the provisions in the first NPRM based on responses from commenters who recommended that in the interest of consistency, FTA use the existing process for non-availability waivers set forth in 49 CFR 661.7(c). In addition, commenters suggested that FTA include a “good faith” element in its deliberations. FTA agreed and the SNPRM proposed that a grantee, when making a request for a post-award waiver, should provide specific evidence of a contractor's good faith when justifying the post-award waiver. This evidence would include information about the origin of the product or materials, invoices, or other relevant solicitation documents as requested and that the item to be procured cannot now be obtained domestically due to commercial impossibility or practicability. Additionally, when determining whether conditions exist to grant a post-award waiver, the SNPRM stated that FTA would consider all appropriate factors on a case-by-case basis. A. Comments Received FTA received four comments on the revised language. Two commenters, one a large public transit agency and one a system manufacturer concurred with the SNPRM's revised approach. The third commenter, a large transit agency, expressed concerns about validating the credibility of its supplier or contractor and the sufficiency of the evidence that needed to be submitted to FTA as part of the waiver request. The transit agency was concerned that it could be placed in a conflict of interest position or subjected to litigation if had to advocate on behalf of a given vendor. The fourth commenter, a large trade association representing transit agencies and their vendors and suppliers, opined that the consideration of other bidders or offerors should have no consideration in FTA's evaluation of post-award non-availability requests, believing that a frustrated second-lowest bidder could hold a transit agency “economic hostage” to a frustrated competitor who had obtained limited remaining domestic supplies through exclusive distribution agreement or other arrangement. According to the trade association, the situation would result in significant cost increases as the transit agency would be forced to terminate its contract with the initial contractor with no effective competition to ensure reasonable pricing. B. FTA Response FTA believes that the language set forth in the SNPRM forms a reasonable approach. With regard to proving supplier or contractor credibility, a transit agency may reasonably rely upon a contractor's representation, as making a knowingly false claim in a Federally-funded procurement could subject a perjurious contractor to Federal criminal statutes and possible debarment from future contracting opportunities. With regard to the sufficiency of the evidence, the SNPRM stated that FTA will consider all factors on a case-by-cases basis. If FTA believes that the document submitted by a grantee or its contractor is insufficient, inadequate, or suspect, FTA may request additional information to determine whether there is sufficient evidence to justify granting a waiver. With regard to the concerns of the third commenter that submitting a waiver request would raise conflict-of-interest issues, FTA believes that submitting a post-award waiver request would not constitute advocacy on behalf of a given vendor, but rather, constitutes advocacy on behalf of the transit agency itself, which would be forced into reopening a bid or otherwise encounter performance delays without a post-award waiver. FTA does not agree with the comments from the fourth commenter that the status of other bidders should be excluded from consideration. The Buy America status of other responsive bidders, including losing bidders, is materially relevant, particularly where the winning bidder is seeking to substitute non-domestic materials for domestic ones. The intent of Buy America is to safeguard American jobs by requiring that steel, iron, and manufactured goods used in an FTA-funded project are produced in the United States—not to protect a particular contractor or supplier against the vagaries of the marketplace. In deciding whether to grant a post-award waiver, therefore, FTA will consider the status of other bidders or offerors who are Buy America compliant and can furnish domestic material or products on an FTA-funded project. Concluding otherwise would violate the legislative intent of Buy America. With regard to the commenter's concern that a losing bidder offering American-made products could hold the purchaser economic hostage and charge extortionary rates, FTA acknowledges that it has the authority to grant a cost-differential waiver if the price of acquiring a domestic product would increase the cost of the overall contract to the transit agency by more than 25 percent. Because the SNPRM stated that FTA would consider “all appropriate factors on a case-by-case basis” in deciding whether to grant a post-award waiver, FTA believes it would be appropriate to take the reasonableness of any cost differential into account when deciding whether to grant a waiver request. Whether the 25 percent cost differential would apply to the cost of the non-available domestic product or to the cost of the overall contract is a factor FTA would consider on a case-by-case basis, depending upon the significance of the product to the overall contract. 4. “End Products” SAFETEA-LU directed FTA to define the term “end product,” and in defining the term, FTA is to “address the procurement of systems under the definition to ensure that major system procurements are not used to circumvent the Buy America requirements.” In addition, SAFETEA-LU directed FTA to develop a list of representative end products that are subject to Buy America requirements. 4a. Defining “End Product” Under a Shift and Non-Shift Approach FTA's initial NPRM sought comments on two alternative definitions of the term “end product.” The first proposed definition came from FTA's current, long-standing practice whereby the end product is the deliverable item specified by the grantee in the third party contract. Under this “shifting” methodology, the same item could be an end-product, a component, or a subcomponent, depending upon the deliverable specified in the third party contract, with applicable Buy America requirements attaching based on an item's characterization. Applying this shifting approach, FTA's first proposed definition stated: “End product means any item subject to 49 U.S.C. 5323(j) that is to be acquired by a grantee, as specified in the overall project contract.” FTA's second proposal was to base the definition of “end product” on that found in the Federal Acquisition Regulation
(FAR)at 48 CFR part 25 implementing the Buy American Act, 41 U.S.C. 10a-10d. Under this definition, end products do not shift and components and subcomponents retain their designation. FTA's second proposed definition for this “non-shift approach” stated: “End product means any article, material, supply, or system, whether manufactured or unmanufactured, that is acquired for public use under a federally funded third party contract.” To that point, FTA created a list of representative end products that was included in the SNPRM. Based on its analysis and review of the comments received in response to the first NPRM, FTA concurred with the majority of commenters who recommended that FTA adopt the second “non-shift” proposal in the SNPRM, finding that such an approach would
(1)foster reasonable predictability and stability in the transit business community,
(2)enable offerors and bidders to price proposals more accurately, and
(3)allow transit agencies to obtain better prices. Several commenters opposed the NPRM's “non-shift” approach, stating that keeping track of aftermarket rolling stock parts would not only prove to be an impossible burden for grantees, it would also discourage parts suppliers from developing an aftermarket support structure within the United States, potentially increasing the lead time for the purchase of replacement parts. These concerns were based on the assumption that FTA would treat replacement parts under the rolling stock standard ( *i.e.* , where sixty percent of the subcomponents of a component, by cost, must be domestic, but forty percent may be foreign-sourced). To address the concerns of these commenters, the SNPRM proposed to treat rolling stock replacement parts under the simpler “manufactured products” standard in 49 CFR 661.5, which requires that a component be manufactured domestically, without the need to document the origin of each of its subcomponents. As FTA's Buy America regulation currently states, a component of a manufactured product “is considered of U.S. origin if it is manufactured in the United States, regardless of the origin of its subcomponents.” 49 CFR 661.5(d)(2). The SNPRM's proposal to apply the “manufactured product” standard to replacement parts is very different from the current regulation that applies the rolling stock standard to such parts. Under the current regulation, a component of rolling stock, in order to be Buy America-compliant, must consist of at least 60% domestic subcomponents. A rolling stock component, if purchased later as a replacement part, shifts upwards to become an “end product” and its subcomponents shift to become “components” and must consist of 100% domestic, even if the original subcomponent was part of the vehicle's allowable 40% non-domestic content. The SNPRM proposed that replacement components would retain their characterization as “components” throughout the life of the vehicle and their replacements would not shift upwards to become “end products.” In addition, replacement components would be subject to the “manufactured products” standard with regard to the origin of its subcomponents. By applying the “manufactured products” standard to replacement components, suppliers would still be required to manufacture replacement components in the United States, thereby preserving a domestic manufacturing base while at the same time recognizing the global marketplace with regard to the procurement of subcomponents. In addition, applying the “manufactured products” test to the acquisition of replacement components relieves manufacturers and buyers of the burden of documenting country-of-origin records for an endless number of possible subcomponents, so long as the component itself is manufactured in the United States. FTA believed the SNPRM's approach provided limited relief from current practices and was not likely to disrupt the supply industry. A more significant change in the SNPRM pertained to the replacement of subcomponents. Under the current regulation, if a purchaser replaces rolling stock subcomponents, those replacement parts also shift upwards to become “end products” ( *i.e.* , the item must be American-made). The SNPRM proposed that replacement parts would be subject to the same Buy America requirements that applied to the original part—subcomponents would not shift upwards to become “end products” but would instead remain “subcomponents” throughout the life of the vehicle. Albeit such a rule might lead to an increase in the level of foreign-sourced replacement parts, FTA believed that the benefits of consistency, stability, and favorable price structures in the transit industry and would outweigh any disadvantages to domestic suppliers. A. Comments Received The four parties who submitted comments on this issue represented a broad cross-section of docket commenters—one of the nation's largest public transit agencies, a manufacturer of an integrated fare collection system, a manufacturer of rolling stock, and a large industry trade association. All four endorsed FTA's proposal. The SNPRM, the trade association noted, “will provide the market predictability the transit industry needs to maintain stability and reasonable pricing,” adding that permanently fixing the status of a part as components or sub-components for all future purposes would allow agencies to procure proven replacement parts without non-productive recordkeeping The transit agency expressed similar concerns that maintaining records of rolling stock end products, components, and end products throughout the service life of the vehicle would have been an “unbearable burden.” The fare collection system manufacturer concurred without additional comment, while the rolling stock manufacturer stressed that components “should always be manufactured in the U.S. regardless of whether the component was purchased as part of an end product or separately as a service part for an end product.” B. FTA Response Based on the comments received, FTA is adopting the SNPRM's non-shift approach. Under the current regulation, a procurement for a replacement part, whether the part was previously classified as a component or a sub-component, is treated as a procurement for an “end product.” Under the new approach, procurements for replacement parts, whether components or subcomponents of the original end product, would retain their characterization and the requirements applicable to manufactured products would apply. This new approach would apply consistently to the procurement of replacement parts for rolling stock as well as to manufactured products. This approach to replacement parts is supported by the trade association's comments that the SNPRM's approach would “provide the market predictability the transit industry needs to maintain stability and reasonable pricing,” and that “fixing their status as components or sub-components for all future purposes will allow agencies to procure replacement parts without non-productive record keeping.” For rolling stock components, FTA recognizes that the illustrative list of “typical” rolling stock components in Appendices B and C to 49 CFR 661.11 will assist procurement officers in identifying components. For manufactured products, the contract or the bid proposal would govern the hierarchy of components and subcomponents. In addition, the classification of “components” and “subcomponents” would not only apply to the procurement of items purchased as part of the vehicle's original equipment, but would apply consistently to the same item if purchased as an aftermarket accessory. To illustrate, under the present regulation, a bicycle rack is treated as a “component” if specified in a contract for the purchase of a new bus, but is treated as an “end product” if subsequently purchased as an aftermarket accessory or as part of a vehicle rehabilitation or retrofit. FTA believes that the same Buy America rules should apply regardless of when the bicycle rack is purchased, *i.e.* , a bicycle rack will be treated as a component and must comply with the manufactured products standard. This approach will lead to consistency in the manufacturing of components and will greatly simplify the procurement process for transit agencies and their suppliers. In the NPRM, FTA considered an approach that would have permitted the replacement of non-domestic components and subcomponents with identical products of non-domestic manufacture. But due to comments from transit agencies that maintaining country-of-origins records for every component and subcomponent throughout a vehicle's useful service life was too great of a recordkeeping burden, FTA is not adopting this approach. FTA believes that the benefits of the non-shift approach to the procurement of replacement parts outweigh any potential impact on replacement parts manufacturers. FTA finds it noteworthy that despite publication of the SNPRM and a request for data in the February public meeting, FTA received no comments to the docket from domestic suppliers of replacement subcomponents that quantified any adverse economic effects, particularly since the SNPRM would have subjected them to potential foreign competition. FTA believes that adopting the non-shift approach will benefit transit agencies in their direct procurement of replacement parts, and lead to additional cost-savings to transit agencies and component manufacturers in the procurement of subcomponents. The non-shift approach will also provide consistency and stability with regard to the identity of components and subcomponents, eliminating the distinctions between the procurement of rolling stock and manufactured product replacement parts, and different procurement standards for replacement parts and aftermarket products. Transit agencies will be able to procure replacement parts from the original part manufacturers, purchasing agents will find it easier to determine the applicable Buy America rules when attempting to procure replacement parts, and opening the market to foreign and domestic sources will guarantee favorable price structures in the transit industry and cost savings to the American taxpayer. 4b. “System” as an “End Product” SAFETEA-LU requires that “the procurement of systems” be addressed “to ensure that major system procurements are not used to circumvent the Buy America requirements.” The NPRM sought comment on whether FTA should continue its longstanding practice of including “systems” as definable end products. Furthermore, FTA sought comment on a proposed definition of “system” which was based on the “functional test” for interconnected systems from the Harmonized Tariff Schedule of the United States (HTSUS), 19 U.S.C. 1202, heading 8474, used in customs law. The NPRM proposed to define “system” as “a machine, product, or device, or a combination of such equipment, consisting of individual components, whether separate or interconnected by piping, transmission devices, electrical cables or circuitry, or by other devices, which are intended to contribute together to a clearly defined function.” Although many commenters expressed concerns that manufacturers could potentially abuse the definition of “system” to incorporate a large degree of non-domestic subcomponents into a single “end product” procurement, a majority of commenters encouraged FTA to continue its longstanding practice of including a “system” as a definable end product. Furthermore, FTA noted that SAFETEA-LU only required FTA to develop a rule to “ensure that major system procurements are not used to circumvent the Buy America requirements,” and did not expressly seek to prohibit the designation of systems as end products. Rather, SAFETEA-LU instructed FTA to develop a rule that would cure potential abuses, without eliminating system procurements or drastically changing FTA's long-standing Buy America practices. FTA received many comments offering alternatives to the NPRM's proposed definition of “system.” Some commenters suggested FTA should consider whether performance warranties apply to an integrated system; whether products perform on an integrated basis with other products in a system, or are operated independently of associated products in the system; or whether transit agencies routinely procure a product separately (other than as replacement or spare parts). Based on these comments, FTA rewrote the SNPRM's definition of “system” to incorporate these criteria. A. Comments Received Five commenters responded to FTA's proposal. Four were generally appreciative of FTA's approach, while one, a transit vehicle manufacturer, found the concept “confusing and unnecessary,” and urged a more concise definition and a full listing of end products. A large transit agency supported FTA's definition, proposing that FTA add a “minimum set of components and interconnections” factor to the criteria. A large industry trade association, while appreciative of FTA's efforts, commented that the SNPRM “fails to provide necessary guidance to the industry” and stated that the list of characteristics should be expanded, lest the absence of one characteristic be seen as determinative. The commenter added that the definition should address what types of systems would not be eligible for consideration as end products. A manufacturer of a fare collection system responded to the trade association's comments, stating that the trade association's members were unable to achieve consensus on this issue and that because the trade association was unable to propose clear product-specific categories as an alternative definition to FTA's approach, FTA should instead use principles in performing its analysis. B. FTA Response Based on the comments received and on SAFETEA-LU's statutory language and legislative history, FTA is retaining the SNPRM's definition of a “system” and will add the term “system” to the definition of “end product.” FTA believes the definition proposed in the SNPRM and the new illustrative criteria will protect against the bundling of unrelated independent products into a “super system” that would undermine the principles of Buy America. Most importantly, as FTA explained in the SNPRM, FTA is willing to carefully review major system procurements to determine whether an integrated system actually exists, and, if so, which items constitute the system. This review process will further serve to avoid the circumvention of Buy America requirements. FTA believes a fare collection system, in toto, meets the definition of an “end product.” FTA reached this conclusion in a 1994 and 2002 decision involving the Massachusetts Bay Transportation Authority (MBTA), and a 1995 decision involving the Tri-County Metropolitan District of Oregon. In these three decisions FTA cited 49 CFR § 661.11(s) in defining “end product” as any item procured by a grantee as specified in the overall project contract. Furthermore, FTA believes that the fare collection system at issue in its 2002 determination would have met the SNPRM's definition of “system:” the warranty clause referred to a single end product, *i.e.* , an automated fare collection system; the automated fare collection system was the subject of a single procurement whereby the manufactured “end product” was functionally different than that which would have resulted from a mere assembly of elements or materials; and most importantly, the individual parts performed on an integrated basis with other parts of the system. Under FTA's Buy America current methodology, if a purported end product is too large, *i.e.* , composed of what FTA traditionally considers as separate “end products” such as structures, vehicles, fare collection equipment, etc., FTA will break it down into separate end products. FTA's willingness to do this in previous requests to evaluate the characterization of a turnkey rail project as a “system” should allay the fears of commenters that an end product system could be so large, and incorporate so many different levels of equipment such as stations, track, vehicles, fare collection equipment, etc., that Buy America requirements could be circumvented. FTA remains aware that a single large-scale procurement could conceivably contain multiple end products, each of which must independently meet the requirements of Buy America. But at the same time FTA also recognizes that various elements may be integrated into a single system. FTA is aware of the developing trend towards systems procurements and the potential circumvention of Buy America requirements, and will therefore exercise heightened scrutiny in this area, using the new criteria. FTA notes, however, that the criteria are illustrative rather than determinative, and that lacking one of the criteria would not necessarily result in the automatic disqualification of a “system.” 4c. Representative List of End Products SAFETEA-LU directed FTA to develop a “representative list” of end products. FTA sought comment on a proposed list of representative end products in the first NPRM, and as FTA explained then, the proposed list was not meant to be all-inclusive, instead describing general “representative” categories of end products consistent with the legislation. A. Comments Received FTA received five comments on this issue. Of these, two commenters concurred with FTA's approach. One commenter stated that FTA's proposed representative list was “too abbreviated and inconsistent,” recommending that FTA issue a more extensive or comprehensive list and subjecting that list for public comment before publishing it as a Final Rule. Another commenter representing a coalition of manufacturers provided a list of end products that it believed should be added to the representative list, stating that products identified on the list should retain their status as end products, even if incorporated into a new system. One commenter, an elevator manufacturer, sought clarification that the adjective “mobile” in the representative list of manufactured products applied to lifts, hoists, and elevators that were movable and not part of a facility's permanent infrastructure. B. FTA Response FTA agrees with the commenters who recommended FTA implement a “representative” list of end products for two reasons: First, SAFETEA-LU directed the Secretary to “develop a list of *representative* items that are subject to the Buy America requirements” (emphasis added). By use of the term “representative” rather than “comprehensive,” FTA believes that Congress did not intend that the list be exhaustive. Second, FTA agrees that it would be unrealistic and unnecessary to develop a comprehensive list and keep it constantly updated as some commenters suggested. FTA believes it is impractical to attempt to produce an exhaustive comprehensive list of every conceivable end product, component, and subcomponent in the transit industry. The comprehensive lists offered by commenters to the NPRM and SNPRM, which were often very lengthy, highly detailed, and seldom uniform, illustrate the difficulty of creating such a list. One commenter stated that the suggested lists of end products were not based upon the development of reasonable governing principles, but rather, “by parochial interests that are focused literally on a product by product basis.” That commenter recommended that FTA design its regulations around principles that can be fairly and impartially applied on a consistent basis in a technologically complex and constantly evolving environment. FTA believes that a more practical approach is to issue a representative list that is not meant to be all-inclusive and to rely upon basic governing principles to address future deliberations. An example of this practical approach are the representative lists of typical bus and rail car components found in Appendices B and C to 49 CFR 661.11. Manufactured products not enumerated on those component lists can be analyzed within the context of other items on those lists, using governing principles. FTA's representative list of “end products” is similarly reflective of the broad scope of transit procurements and new end products can be similarly assessed. With regard to the applicability of the term “mobile,” FTA intended for it to apply to all portable or moveable lifts, hoists, and elevators. FTA did not intend that permanently affixed lifts, hoists, and elevators would be considered as “end products.” Rather, they will continue to be considered components of the larger facility, which itself could constitute the “end product.” 5. Definition of “Final Assembly” In the first NPRM, FTA sought comment on its proposal to amend the definition of “final assembly” in 49 CFR part 661 for rolling stock procurements by incorporating the minimum requirements for final assembly as outlined in FTA's March 18, 1997, Dear Colleague letter, C-97-03, which Congress implemented through section 3035 of the Transportation Equity Act for the 21st Century (TEA-21) (Pub. L. 105-178). Several commenters recommended several changes to the NPRM's proposed definition, suggesting that it be made consistent with the descriptions of incorporation and final assembly for rail cars and buses in 49 CFR 661.11(b) and (c). FTA concurred with these commenters, agreeing that the definition of final assembly should refer back to 49 CFR 661.11(b) and
(c)for the bus and rail car components that must be incorporated into the end product at the final assembly location. FTA also agreed with a commenter who recommended that language from the March 18, 1997, Dear Colleague letter regarding FTA determinations of compliance be added to the “final assembly” provisions. A. Comments Received Although two transit agencies concurred with FTA's approach without providing substantive comments, the proposal was opposed by five rolling stock manufacturers, a large industry trade association, a consortium of suppliers, and a consultant, all of whom submitted lengthy comments to the SNPRM describing their opposition. These commenters pointed out that the Dear Colleague letter has been successfully implemented for the past ten years, and that any changes could create confusion for manufacturers and grantees. One commenter noted that the Dear Colleague letter reflected extensive input from industry participants. Vehicle manufacturers stated that they had made long-term operational and investment decisions based on existing law and guidance, and changing policy would be “extremely onerous and harmful to manufacturers that currently comply with existing laws.” Another commenter warned that adoption of the SNPRM's language would have “unintended consequences” on an “already fragile bus industry.” Finally, commenters pointed out that the Dear Colleague letter's definition of “final assembly” had been acknowledged and memorialized by Congress in section 3035 of TEA-21, and Congress did not indicate any direction for FTA to alter the current definition of final assembly. B. FTA Response FTA finds the commenters persuasive. Not only does the Dear Colleague letter reflect widespread industry understanding of the final assembly process, it is a long-standing precedent that reflects industry input and consensus and has been recognized by Congress as an acceptable standard. Therefore, FTA is withdrawing the proposed language in the SNPRM and will instead continue to implement the terms of the March 18, 1997, Dear Colleague letter, with a few minor additions to reflect industry practices that have taken effect after the 1997 Dear Colleague letter was issued, such as the construction of bus shells and the installation of locomotive engines in passenger railcars. 6. Communication, Train Control, and Traction Power Equipment FTA sought comment on three substantive proposals to the Buy America requirements for rolling stock components in the NPRM. In the first of these proposals, FTA sought comment on whether it should continue to find that the items of communication equipment listed in 49 CFR 661.11 include wayside equipment, *i.e.* , communication equipment that is not in or on a vehicle, but on the adjacent tracks or right-of-way. FTA also sought comment on whether the items of train control, communication, and traction power equipment listed in 49 CFR 661.11(t), (u), and
(v)should be deleted and whether any new items should be added to these lists to reflect new technology. Finally, FTA sought comment on whether the term “communication equipment” should be limited to equipment whose primary function is communication “with or between people” or whether it should be expanded to include a “machine-to-machine” interface. Based on comments received in response to the NPRM, FTA determined that the rolling stock requirements for communications equipment would continue to apply to wayside equipment. One commenter recommended deleting several items from the proposed lists of train control, communication, and traction power equipment, but several more commenters suggested the addition of items to the lists, which was reflected in the SNPRM. With regard to the expansion of the term “communication equipment” to include machine-to-machine interactions, FTA noted in the SNPRM that modern communication networks frequently support both capabilities ( *i.e.* , human to human interaction and machine-to-machine interface) and it would be difficult in those situations to determine which components of the communication equipment was supporting one purpose or the other. Moreover, FTA's review of prior Buy America decisions involving communication equipment supported these conclusions and FTA declined to make such a distinction in the SNPRM. However, the SNPRM stated that FTA will continue to carefully scrutinize, on a case-by-case basis, whether technology may properly be characterized as “communication equipment” within the meaning of the rolling stock provisions of 49 U.S.C. 5323(j) and 49 CFR 661.11. A. Comments Received Two of the three commenters to the SNPRM concurred with FTA's approach. One commenter, a large transit agency, believed that further modification was necessary to reflect current technology and practices—namely, that propulsion systems and cab display should be added to the list of traction power equipment. B. FTA Response FTA notes that several commenters recommended that aluminum composite conducting rail, otherwise known as Bimetallic Power Transmission
(BPTS)Equipment, which is a combination of an aluminum conductor and a stainless steel abrasion-resistant cap, be added to the list of traction power equipment in 49 CFR 661.11(v). However, FTA's current regulation at 49 CFR 661.11(w) states that “[t]he power or third rail is not considered traction power equipment and is thus subject to the requirements of 49 U.S.C. 5323(j) and the requirements of 49 CFR 661.5.” FTA believes that these recommendations go beyond the scope of the present rulemaking. Currently, all power or third rails, regardless of whether made primarily from aluminum, steel, or some other material, is excluded from the definition of “traction power equipment” and instead is subject to 49 CFR 661.5. If the rail is made of steel or iron, the product must comply with 49 CFR 661.5(c). If BPTS third rail is not made primarily of steel, it would be treated as a manufactured product under 49 CFR 661.5(d). In order to provide a competitive and level playing field, FTA is interpreting the commenters' recommendations as a request to classify power or third rails as traction power equipment, whether made of steel, aluminum, or some other material. This would require a Congressional action to exclude steel and iron contact rail from the domestic manufacturing requirements of 661.5(c), which is beyond FTA's authority in this rulemaking. 7. Statutory Update The SNPRM proposed to amend the debarment and suspension provisions in 49 CFR 661.18 to incorporate a reference to SAFETEA-LU, replacing the existing reference to the Intermodal Surface Transportation Efficient Act of 1991 (ISTEA). A. Comments Received Commenters were unanimous in their support of the amendment. B. FTA Response FTA is adopting the amendment without change. FTA is also amending the statutory references to section 165 of the Surface Transportation Assistance Act of 1982 in 49 CFR 661.6 and 661.12 and replacing them with references to the current Buy America requirements at 49 U.S.C. 5323(j). In addition, FTA is amending the title of 49 Part 661 to remove the reference to the Surface Transportation Assistance Act of 1982 so that the title will simply read, “Buy America Requirements.” II. Regulatory Analyses and Notices A. Statutory/Legal Authority for This Rulemaking This final rule is authorized under SAFETEA-LU (Pub. L. 109-59), which amended Section 5323(j) and
(m)of Title 49, United States Code and required FTA to revise its regulations with respect to Buy America requirements. B. Executive Order 12866 and DOT Regulatory Policies and Procedures This final rule is a nonsignificant regulatory action under section 3(f) of Executive Order 12866 and, therefore, was not reviewed by the Office of Management and Budget. This final rule is also nonsignificant under the Regulatory Policies and Procedures of the Department of Transportation (44 FR 11034, Feb. 26, 1979). This final rule imposes no new compliance costs on the regulated industry; it merely clarifies terms existing in the Buy America regulations and adds terms consistent with SAFETEA-LU. C. Executive Order 13132 This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). This final rule does not include any regulation that has substantial direct effects on the States, the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply. D. Executive Order 13175 This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this final rule does not have tribal implications and does not impose direct compliance costs, the funding and consultation requirements of Executive Order 13175 do not apply. E. Regulatory Flexibility Act and Executive Order 13272 The Regulatory Flexibility Act (5 U.S.C. 601-611) requires each agency to analyze regulations and proposals to assess their impact on small businesses and other small entities to determine whether the rule or proposal will have a significant economic impact on a substantial number of small entities. This final rule imposes no significant new costs on small entities, and in fact, is expected to reduce costs by eliminating specific recordkeeping burdens. Therefore, FTA certifies that this proposal does not require further analysis under the Regulatory Flexibility Act. F. Unfunded Mandates Reform Act of 1995 This final rule does not propose unfunded mandates under the Unfunded Mandates Reform Act of 1995. If the proposals are adopted into a final rule, it will not result in costs of $100 million or more (adjusted annually for inflation), in the aggregate, to any of the following: State, local, or Native American tribal governments, or the private sector. G. Paperwork Reduction Act This final rule proposes no new information collection requirements. H. Regulation Identifier Number
(RIN)A regulation identifier number
(RIN)is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document may be used to cross-reference this action with the Unified Agenda. I. Environmental Assessment The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321-4347), requires Federal agencies to consider the consequences of major Federal actions and prepare a detailed statement on actions significantly affecting the quality of the human environment. There are no significant environmental impacts associated with this final rule. J. Privacy Act Anyone is able to search the electronic form for all comments received into any of our dockets by the name of the individual submitting the comments (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit *http://dms.dot.gov* . List of Subjects in 49 CFR Part 661 Grant programs—transportation, Public transportation, Reporting and recordkeeping requirements. Accordingly, for the reasons described in the preamble, part 661 of the Code of Federal Regulations is amended as follows: PART 661—BUY AMERICA REQUIREMENTS 1. The authority citation for part 661 is amended to read as follows: Authority: 49 U.S.C. 5323(j) (formerly sec. 165 of the Surface Transportation Assistance Act of 1982 (Pub. L. 97-424); as amended by sec. 337, Pub. L. 100-17; sec. 1048, Pub. L. 102-240; sec. 3020(b), Pub. L. 105-178; and sec. 3023(i) and (k), Pub. L. 109-59); 49 CFR 1.51. 2. The heading for part 661 is revised to read as set forth above. § 661.1 [Amended]. 3. Amend § 661.1 by removing “Federal Mass Transit Act of 1964, as amended” and adding in its place “49 U.S.C. 5323(j)”. 4. Revise § 661.3 to read as follows: § 661.3 Definitions. As used in this part: *Act* means the Federal Public Transportation Law (49 U.S.C. Chapter 53). *Administrator* means the Administrator of FTA, or designee. *Component* means any article, material, or supply, whether manufactured or unmanufactured, that is directly incorporated into the end product at the final assembly location. *Contractor* means a party to a third party contract other than the grantee. *End product* means any vehicle, structure, product, article, material, supply, or system, which directly incorporates constituent components at the final assembly location, that is acquired for public use under a federally-funded third-party contract, and which is ready to provide its intended end function or use without any further manufacturing or assembly change(s). A list of representative end products is included at Appendix A to this section. *FTA* means the Federal Transit Administration. *Grantee* means any entity that is a recipient of FTA funds. *Manufactured product* means an item produced as a result of the manufacturing process. *Manufacturing process* means the application of processes to alter the form or function of materials or of elements of the product in a manner adding value and transforming those materials or elements so that they represent a new end product functionally different from that which would result from mere assembly of the elements or materials. *Negotiated procurement* means a contract awarded using other than sealed bidding procedures. *Rolling stock* means transit vehicles such as buses, vans, cars, railcars, locomotives, trolley cars and buses, and ferry boats, as well as vehicles used for support services. *System* means a machine, product, or device, or a combination of such equipment, consisting of individual components, whether separate or interconnected by piping, transmission devices, electrical cables or circuitry, or by other devices, which are intended to contribute together to a clearly defined function. Factors to consider in determining whether a system constitutes an end product include: Whether performance warranties apply to an integrated system (regardless of whether components are separately warranteed); whether products perform on an integrated basis with other products in a system, or are operated independently of associated products in the system; or whether transit agencies routinely procure a product separately (other than as replacement or spare parts). *United States* means the several States, the Commonwealth of Puerto Rico, the District of Columbia, Guam, American Samoa, the U.S. Virgin Islands, and the Commonwealth of the Northern Mariana Islands. Appendix A to § 661.3—End Products The following is a list of representative end products that are subject to the requirements of Buy America. This list is representative, not exhaustive.
(1)*Rolling stock end products:* All individual items identified as rolling stock in § 661.3 ( *e.g.* , buses, vans, cars, railcars, locomotives, trolley cars and buses, ferry boats, as well as vehicles used for support services); train control, communication, and traction power equipment that meets the definition of end product at § 661.3 ( *e.g.* , a communication or traction power system).
(2)* Steel and iron end products:* Items made primarily of steel or iron such as structures, bridges, and track work, including running rail, contact rail, and turnouts.
(3)*Manufactured end products:* Infrastructure projects not made primarily of steel or iron, including structures (terminals, depots, garages, and bus shelters), ties and ballast; contact rail not made primarily of steel or iron; fare collection systems; computers; information systems; security systems; data processing systems; and mobile lifts, hoists, and elevators. § 661.6 [Amended] 5. Amend § 661.6 as follows: a. Remove “Certificate of Compliance With Section 165(a)” and add in its place “Certificate of Compliance with Buy America Requirements” and remove “section 165(a) of the Surface Transportation Assistance Act of 1982, as amended” and add in its place “49 U.S.C. 5323(j)(1)”. b. Remove “Certificate for Non-Compliance with Section 165(a)” and add in its place “Certificate of Non-Compliance with Buy America Requirements”, remove “section 165(a) of the Surface Transportation Assistance Act of 1982, as amended” and add in its place “49 U.S.C. 5323(j)”, and remove “section 165(b)(2) or (b)(4) of the Surface Transportation Assistance Act of 1982” and add in its place “49 U.S.C. 5323(j)(2)”. 6. Amend § 661.7 as follows: a. In paragraph (a), remove “Section 165(b) of the Act” and add in its place “Section 5323(j)(2) of Title 49 United States Code” and remove “section 165(a)” and add in its place “49 U.S.C. 5323(j)(1)”. b. Revise paragraph (b); c. Amend paragraph
(c)by removing “section 165(b)(2) of the Act” and adding in its place “49 U.S.C. 5323(j)(2)” and removing “section 165(a)” and adding in its place “49 U.S.C. 5323(j)”; d. Add a new paragraph (c)(3); e. Amend paragraph
(e)by removing “section 165(b) of the Act” and adding in its place “49 U.S.C. 5323(j)(2)”; f. Amend paragraph
(f)by removing “section 165(b)(3) of the Act” and adding in its place “49 U.S.C. 5323(j)(2)(C)”; and g. Amend Appendix A to § 661.7 by removing paragraphs
(b)and
(c)and adding new paragraph (b). The revisions and addition read as follows: § 661.7 Waivers.
(b)Under the provision of 49 U.S.C. 5323(j)(2)(A), the Administrator may waive the general requirements of 49 U.S.C. 5323(j)(1) if the Administrator finds that their application would be inconsistent with the public interest. In determining whether the conditions exist to grant this public interest waiver, the Administrator will consider all appropriate factors on a case-by-case basis, unless a general exception is specifically set out in this part. When granting a public interest waiver, the Administrator shall issue a detailed written statement justifying why the waiver is in the public interest. The Administrator shall publish this justification in the **Federal Register** , providing the public with a reasonable time for notice and comment of not more than seven calendar days.
(c)* * *
(3)After contract award, the Administrator may grant a non-availability waiver under this paragraph, in any case in which a bidder or offeror originally certified compliance with the Buy America requirements in good faith, but can no longer comply with its certification. The Administrator will grant a non-availability waiver only if the grantee provides sufficient evidence that the original certification was made in good faith and that the item to be procured cannot now be obtained domestically due to commercial impossibility or impracticability. In determining whether the conditions exist to grant a post-award non-availability waiver, the Administrator will consider all appropriate factors on a case-by-case basis. Appendix A to § 661.7—General Waivers
(b)Under the provisions of § 661.7
(b)and
(c)of this part, a general public interest waiver from the Buy America requirements applies to microprocessors, computers, microcomputers, or software, or other such devices, which are used solely for the purpose of processing or storing data. This general waiver does not extend to a product or device which merely contains a microprocessor or microcomputer and is not used solely for the purpose of processing or storing data. 7. Amend § 661.9(a) by removing “section 165(b)(3) of the Act” and “section 165(b)(3)” and adding in their place “49 U.S.C. 5323(j)(2)(C)”. 8. Amend § 661.11 as follows: a. Remove and reserve paragraph (s). b. Add paragraphs (t)(14) through (t)(22), (u)(18) through (u)(30), and (v)(28) through (30); c. Amend Appendix B by adding “Car body shells” before “Engines”; d. Amend Appendix C by adding “engines” after “Car shells” and remove “doors, door actuators, and controls,” and add in its place “doors, door actuators and controls, wheelchair lifts and ramps to make the vehicle accessible to persons with disabilities,”; and e. Add a new Appendix D. The additions read as follows: § 661.11 Rolling stock procurements.
(t)* * *
(14)Cab Signaling;
(15)ATO Equipment;
(16)ATP Equipment;
(17)Wayside Transponders;
(18)Trip Stop Equipment;
(19)Wayside Magnets;
(20)Speed Measuring Devices;
(21)Car Axle Counters;
(22)Communication Based Train Control (CBTC).
(u)* * *
(18)Antennas;
(19)Wireless Telemetry Equipment;
(20)Passenger Information Displays;
(21)Communications Control Units;
(22)Communication Control Heads;
(23)Wireless Intercar Transceivers;
(24)Multiplexers;
(25)SCADA Systems;
(26)LED Arrays;
(27)Screen Displays such as LEDs and LCDs for communication systems;
(28)Fiber-optic transmission equipment;
(29)Fiber-optic transmission equipment;
(30)Frame or cell based multiplexing equipment; 13) Communication system network elements.
(v)* * *
(28)Propulsion Control Systems;
(29)Surge Arrestors;
(30)Protective Relaying. Appendix D to § 661.11—Minimum Requirements for Final Assembly
(a)*Rail Cars:* In the case of the manufacture of a new, remanufactured, or overhauled rail car, final assembly would typically include, as a minimum, installation and interconnection of the typical Rail Car Components listed in § 661.11, Appendix C, including but not limited to the following items: car bodies or shells, chassis, carbody wiring, car-borne power plants or power pick-up equipment, energy management and storage devices, articulation equipment, propulsion control equipment, propulsion cooling equipment, friction brake equipment, energy sources for auxiliary equipment and controls, heating and air conditioning equipment, interior and exterior lighting equipment, coupler equipment and coupler control system, communications equipment, pneumatic systems, electrical systems, door and door control systems, passenger seats, passenger interiors, cab interiors, destination signs, wheelchair lifts (or other equipment required to make the vehicle accessible to persons with disabilities), motors, wheels, axles, gear boxes or integrated motor/gear units, suspensions, and truck frames. Final Assembly activities shall also include the inspection and verification of all installation and interconnection work; and the in-plant testing of the rail car to verify all functions. In the case of articulated vehicles, the interconnection of the car bodies or shells shall be included as work to be performed by the manufacturer as part of vehicle delivery.
(b)*Buses:* In the case of a new, remanufactured, or overhauled bus, final assembly would typically include, at a minimum, the installation and interconnection of the typical Bus Components listed in § 661.11, Appendix B, including but not limited to the following items: car bodies or shells, the engine and transmission (drive train), axles, energy management and storage devices, articulation equipment, propulsion control system, chassis, and wheels, cooling system, and braking systems; the installation and interconnection of the heating and air conditioning equipment; the installation of pneumatic system and the electrical system, door systems, passenger seats, passenger grab rails, destination signs, wheelchair lifts or ramps and other equipment required to make the vehicle accessible to persons with disabilities, and road testing. Final Assembly activities shall also include final inspection, repairs and preparation of the vehicles for delivery. In the case of articulated vehicles, the interconnection of the car bodies or shells shall be included as work to be performed by the manufacturer as part of vehicle delivery.
(c)If a manufacturer's final assembly processes do not include all the activities that are typically considered the minimum requirements, it can request a Federal Transit Administration
(FTA)determination of compliance. FTA will review these requests on a case-by-case basis to determine compliance with Buy America. § 661.12 [Amended] 9. Amend § 661.12 as follows: a. Remove “Certificate of Compliance With Section 165(b)(3)” and add in its place “Certificate of Compliance with Buy America Rolling Stock Requirements” and remove “section 165(b)(3) of the Surface Transportation Assistance Act of 1982, as amended” and add in its place “49 U.S.C. 5323(j)” and b. Remove “Certificate for Non-Compliance with Section 165(b)(3)” and add in its place “Certificate of Non-Compliance with Buy America Rolling Stock Requirements”; remove “section 165(b)(3) of the Surface Transportation Assistance Act of 1982, as amended” and add in its place “49 U.S.C. 5323(j)”; and remove “section 165(b)(2) or (b)(4) of the Surface Transportation Assistance Act of 1982” and add in its place “49 U.S.C. 5323(j)(2)(C)”. § 661.18 [Amended] 10. Amend the introductory text by removing “the Intermodal Surface Transportation Efficiency Act of 1991” and adding in its place “the Federal Public Transportation Act of 2005”. James S. Simpson, Administrator. [FR Doc. E7-18355 Filed 9-19-07; 8:45 am] BILLING CODE 4910-57-P 72 182 Thursday, September 20, 2007 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-29249; Directorate Identifier 2007-NM-112-AD] RIN 2120-AA64 Airworthiness Directives; Airbus Model A318, A319, A320, and A321 Series Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for the products listed above. This proposed AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: After a push back from the gate, an A320-200 aircraft was preparing to initiate taxi, when a NLG (nose landing gear) uncommanded retraction occurred, and then the aircraft abruptly hit the ground. * * * Untimely unlocking and/or retraction of the NLG, while on the ground, could cause injury to ground personnel and significant structural damage to the airplane. The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI. DATES: We must receive comments on this proposed AD by October 22, 2007. ADDRESSES: You may send comments by any of the following methods: • *DOT Docket Web Site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Fax:*
(202)493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* Room W12-140 on the ground floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. • *Federal eRulemaking Portal: http://www.regulations.gov* . Follow the instructions for submitting comments. Examining the AD Docket You may examine the AD docket on the Internet at *http://dms.dot.gov* ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Tim Dulin, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-2141; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-29249; Directorate Identifier 2007-NM-112-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments. We will post all comments we receive, without change, to *http://dms.dot.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2007-0065R1, dated June 12, 2007 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states: After push back from the gate, an A320-200 aircraft was preparing to initiate taxi, when a NLG (nose landing gear) uncommanded retraction occurred, and then the aircraft abruptly hit the ground. Investigations revealed that the retract condition is caused by a combination of a faulty MLG (main landing gear) proximity switch, a power interruption to LGCIUs (Landing Gear Control and Interface Units) and an internal hydraulic leak through the LG (landing gear) selector valve 40GA. The internal hydraulic leak through the LG selector valve 40GA was due to a broken seal in one of the end cap chambers for the valve spool. As a corrective action, a duplicate inspection (DI or DI-BE) for these valves has been introduced in production, and the Component Maintenance Manual
(CMM)has been revised. Untimely unlocking and/or retraction of the NLG, while on the ground, could cause injury to ground personnel and significant structural damage to the aircraft. This Airworthiness Directive
(AD)mandates the inspections of the LG selector valve 40GA and the LG door selector valve 41GA, to identify a possible hydraulic leak. The corrective action includes replacing the LG selector valve 40GA and/or the LG door selector valve 41GA if necessary. You may obtain further information by examining the MCAI in the AD docket. Relevant Service Information Airbus has issued Service Bulletin A320-32-1290, Revision 01, dated November 10, 2006. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI. FAA's Determination and Requirements of This Proposed AD This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD. Costs of Compliance Based on the service information, we estimate that this proposed AD would affect about 653 products of U.S. registry. We also estimate that it would take about 7 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $365,680, or $560 per product. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **Airbus:** Docket No. FAA-2007-29249; Directorate Identifier 2007-NM-112-AD. Comments Due Date
(a)We must receive comments by October 22, 2007. Affected ADs
(b)None. Applicability
(c)This AD applies to Airbus Model A318, A319, A320, and A321 series airplanes, certificated in any category, except those identified in paragraphs (c)(1) and (c)(2) of this AD.
(1)Manufacturer serial numbers
(MSNs)2389, 2392, 2393, 2396, 2398, 2403, 2405, 2407, 2409, 2410, 2411, 2413 through 2439, 2441, and MSNs above 2441, on which no replacement of the landing gear
(LG)selector valve 40GA or the LG door selector valve 41GA has been performed since aircraft delivery from Airbus.
(2)Aircraft on which LG selector valve 40GA and LG door selector valve 41GA have been stamped to indicate that a duplicate inspection has been done. If the duplicate inspection has been done, the amendment plates on the valves will be stamped with letters “DI” or “DI-BE.” Subject
(d)Air Transport Association
(ATA)of America Code 32: Landing Gear. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: After push back from the gate, an A320-200 aircraft was preparing to initiate taxi, when a NLG (nose landing gear) uncommanded retraction occurred, and then the aircraft abruptly hit the ground. Investigations revealed that the retract condition is caused by a combination of a faulty MLG (main landing gear) proximity switch, a power interruption to LGCIUs (Landing Gear Control and Interface Units) and an internal hydraulic leak through the LG (landing gear) selector valve 40GA. The internal hydraulic leak through the LG selector valve 40GA was due to a broken seal in one of the end cap chambers for the valve spool. As a corrective action, a duplicate inspection (DI or DI-BE) for these valves has been introduced in production, and the Component Maintenance Manual
(CMM)has been revised. Untimely unlocking and/or retraction of the NLG, while on the ground, could cause injury to ground personnel and significant structural damage to the aircraft. This Airworthiness Directive
(AD)mandates the inspections of the LG selector valve 40GA and the LG door selector valve 41GA, to identify a possible hydraulic leak. The corrective action includes replacing the LG selector valve 40GA and/or the LG door selector valve 41GA if necessary. Actions and Compliance
(f)Unless already done, do the following actions.
(1)For aircraft that have accumulated up to and including 20,000 total flight cycles as of the effective date of this AD: Within 4,500 flight cycles after the effective date of this AD, but not exceeding 20,800 total flight cycles, inspect for hydraulic leaking of the LG selector valve 40GA and the LG door selector valve 41GA and replace if necessary the LG selector valve 40GA and the LG door selector valve 41GA before further flight in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-32-1290, Revision 01, dated November 10, 2006.
(2)For aircraft that have accumulated over 20,000 total flight cycles as of the effective date of this AD: Within 800 flight cycles after the effective date of this AD, inspect for hydraulic leaking of the LG selector valve 40GA and the LG door selector valve 41GA and replace if necessary the LG selector valve 40GA and the LG door selector valve 41GA before further flight in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-32-1290, Revision 01, dated November 10, 2006.
(3)For all airplanes: Repeat the inspection specified in paragraph (f)(1) or (f)(2) of this AD, as applicable, thereafter at intervals not to exceed 20,000 flight cycles, or 89 months, whichever occurs first, and replace if necessary (i.e., if any leakage is found) the LG selector valve 40GA and the LG door selector valve 41GA before further flight, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-32-1290, Revision 01, dated November 10, 2006.
(4)For all airplanes: From the effective date of this AD, the installation of LG selector valve 40GA or LG door selector valve 41GA, that do not have the duplicate inspection “DI” or “DI-BE” recorded on their amendment plates, is possible provided that it is inspected within 800 flight cycles after installation, in accordance with the instructions given in Airbus Service Bulletin A320-32-1290, Revision 01, dated November 10, 2006. Repeat the inspection thereafter as given in paragraph (f)(3) of this AD.
(5)Actions done before the effective date of this AD in accordance with Airbus Service Bulletin A320-32-1290, dated May 2, 2006, are acceptable for compliance with the corresponding actions of this AD. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: No differences. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs)* : The Manager, International Branch, Transport Airplane Directorate, ANM-116, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Tim Dulin, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-2141; fax
(425)227-1149. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act, the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to MCAI EASA Airworthiness Directive 2007-0065R1, dated June 12, 2007, and Airbus Service Bulletin A320-32-1290, Revision 01, dated November 10, 2006, for related information. Issued in Renton, Washington, on September 10, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-18540 Filed 9-19-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-29259; Directorate Identifier 2007-NM-195-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 767 Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to supersede an existing airworthiness directive
(AD)that applies to all Boeing Model 767 airplanes. The existing AD currently requires repetitive measurements of the rudder and elevator freeplay, repetitive lubrications of rudder and elevator components, and related investigative/corrective actions if necessary. This proposed AD would instead require revised repetitive measurements of the rudder freeplay and the elevator freeplay for each of the power control actuators
(PCAs)that move the rudder and elevator, corrective and related investigative actions if necessary, and repetitive lubrications of the rudder and elevator components. For some airplanes, this proposed AD would also require related concurrent actions. This proposed AD results from reports of freeplay-induced vibration of the rudder and the elevator. The potential for vibration of the control surface should be avoided because the point of transition from vibration to divergent flutter is unknown. We are proposing this AD to prevent excessive vibration of the airframe during flight, which could result in loss of control of the airplane. DATES: We must receive comments on this proposed AD by October 22, 2007. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • *DOT Docket Web site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Fax:*
(202)493-2251. • *Hand Delivery:* Room W12-140 on the ground floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207, for service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Tamara Anderson, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6421; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “Docket No. FAA-2007-29259; Directorate Identifier 2007-NM-195-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov,* including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or may can visit *http://dms.dot.gov.* Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov,* or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Operations office (telephone
(800)647-5527) is located on the ground level of the West Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion On May 17, 2006, we issued AD 2006-11-12, amendment 39-14616 (71 FR 30272, May 26, 2006), for all Boeing Model 767 airplanes. That AD requires repetitive measurements of the rudder and elevator freeplay, repetitive lubrication of rudder and elevator components, and related investigative/corrective actions if necessary. That AD resulted from reports of freeplay-induced vibration of the rudder and the elevator. We issued that AD to prevent excessive vibration of the airframe during flight, which could result in loss of control of the airplane. Actions Since Existing AD Was Issued Since we issued AD 2006-11-12, we have learned that the procedures in Boeing Special Attention Service Bulletins 767-27-0197 and 767-27-0198, both dated October 27, 2005 (referred to in the existing AD as the appropriate sources of service information for accomplishing the actions required by that AD), yielded false-positive results for the measurements of the rudder and elevator freeplay. The service bulletin instructions for measuring the freeplay also did not include information on certain prior or concurrent actions to be performed on certain airplanes. Therefore, we have determined that the requirements of AD 2006-11-12 do not adequately address the identified unsafe condition. Other Relevant Rulemaking On February 21, 2001, we issued AD 2001-04-09, amendment 39-12128 (66 FR 13227, March 5, 2001). That AD requires repetitively testing the elevator control system to determine if an elevator power control actuator
(PCA)is rigged incorrectly due to yielded or failed shear rivets in a bellcrank assembly, and follow-on actions, if necessary. That AD refers to Boeing Alert Service Bulletins 767-27A0168 and 767-27A0169, both dated November 21, 2000, as the applicable sources of service information. Boeing Alert Service Bulletins 767-27A0168 and 767-27A0169 are referred to in this proposed AD as sources of service information for accomplishing concurrent actions on certain airplanes. This proposed AD would not affect any of the requirements of AD 2001-04-09. Relevant Service Information We have reviewed Boeing Special Attention Service Bulletins 767-27-0197, Revision 1, dated July 19, 2007 (for Model 767-200, -300, and -300F series airplanes); and 767-27-0198, Revision 1, dated July 19, 2007 (for Model 767-400ER series airplanes). The service bulletins describe improved procedures for repetitive measurements of the rudder freeplay and the elevator freeplay for each of the PCAs that move the rudder and elevator. For freeplay that exceeds certain specified limits, the service bulletins describe procedures for doing applicable related corrective and related investigative actions. Corrective and related investigative actions include repairing or replacing all applicable affected parts if necessary, and repeating the freeplay measurement, until the freeplay is within acceptable limits. Affected parts may include worn or loose hanger links, reaction links, PCA rod ends, and trunnion connections that contribute to the freeplay. The service bulletins also describe procedures and repetitive intervals for repetitive lubrication of the rudder and elevator components that are the same as those described in the original issues of the service bulletins. For certain Model 767-200, -300, and -300F series airplanes, Boeing Special Attention Service Bulletin 767-27-0197, Revision 1, specifies prior or concurrent accomplishment of Boeing Alert Service Bulletin 767-27A0168, dated November 21, 2000, which describes, among other actions, procedures for inspecting the elevator bellcranks for any shear rivets that are broken or yielded. For certain Model 767-400ER series airplanes, Boeing Special Attention Service Bulletin 767-27-0198, Revision 1, specifies prior or concurrent accomplishment of Boeing Alert Service Bulletin 767-27A0169, dated November 21, 2000, which describes, among other actions, procedures for inspecting the elevator bellcranks for any shear rivets that are broken or yielded. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. FAA's Determination and Requirements of the Proposed AD We have evaluated all pertinent information and identified an unsafe condition that is likely to develop on other airplanes of the same type design. For this reason, we are proposing this AD, which would supersede AD 2006-11-12. This proposed AD would require accomplishing the actions specified in the special attention service bulletins described previously, except as discussed under “Differences Between the Proposed AD and the Special Attention Service Bulletins.” Differences Between the Proposed AD and the Special Attention Service Bulletins Although Revision 1 of Boeing Special Attention Service Bulletins 767-27-0197 and 767-27-0198 recommends accomplishing the initial rudder and elevator freeplay measurements within 18 months after the date on the service bulletins, the proposed AD would require a compliance time of 12 months after the effective date of the AD. We have determined that 18 months would not address the identified unsafe condition soon enough to ensure an adequate level of safety for the affected fleet. In developing an appropriate compliance time for this proposed AD, we considered the degree of urgency associated with the subject unsafe condition, and the possibility that this proposed AD could extend the compliance time for airplanes on which the measurements required in AD 2006-11-12 have not been accomplished. In light of these factors, we find that 12 months represents an appropriate interval of time for affected airplanes to continue to operate without compromising safety. This difference has been coordinated with Boeing. Costs of Compliance There are about 979 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this proposed AD. No parts are necessary to accomplish any action. Estimated Costs Action Work hours Average labor rate per hour Cost per airplane Number of U.S.-registered airplanes Fleet cost Freeplay measurement 30 $80 $2,400, per measurement cycle 423 $1,015,200, per measurement cycle. Lubrication 27 $80 $2,160, per lubrication cycle 423 $913,680, per lubrication cycle. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by removing amendment 39-14616 (71 FR 30272, May 26, 2006) and adding the following new airworthiness directive (AD): **Boeing:** Docket No. FAA-2007-29259; Directorate Identifier 2007-NM-195-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by October 22, 2007. Affected ADs
(b)This AD supersedes AD 2006-11-12. Applicability
(c)This AD applies to all Boeing Model 767-200, -300, -300F, and -400ER series airplanes, certificated in any category. Unsafe Condition
(d)This AD results from reports of freeplay-induced vibration of the rudder and the elevator. The potential for vibration of the control surface should be avoided because the point of transition from vibration to divergent flutter is unknown. We are issuing this AD to prevent excessive vibration of the airframe during flight, which could result in loss of control of the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Service Bulletin References
(f)The term “service bulletin,” as used in this AD, means the Accomplishment Instructions and Appendices A, B, and C of the following service bulletins, as applicable:
(1)For Model 767-200, -300, and -300F series airplanes: Boeing Special Attention Service Bulletin 767-27-0197, Revision 1, dated July 19, 2007; and
(2)For Model 767-400ER series airplanes: Boeing Special Attention Service Bulletin 767-27-0198, Revision 1, dated July 19, 2007. Repetitive Measurements
(g)At the latest of the compliance times specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD, as applicable: Measure the rudder and elevator freeplay. Repeat the measurement thereafter at intervals not to exceed 12,000 flight hours or 36 months, whichever occurs first. Do all actions required by this paragraph in accordance with the service bulletin.
(1)Within 12 months after the effective date of this AD.
(2)Within 36 months since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness.
(3)For the elevator freeplay measurement: Within 12,000 flight hours or within 36 months after the last elevator freeplay inspection accomplished in accordance with Boeing Special Attention Service Bulletin 767-27-0197 or 767-27-0198, both dated October 27, 2005, as applicable, whichever occurs first. Related Investigative and Corrective Actions
(h)If any measurement found during the measurement required by paragraph
(g)of this AD exceeds any applicable limit specified in the service bulletin: Before further flight, do the applicable related investigative and corrective actions in accordance with the service bulletin. Initial Lubrication
(i)At the latest of the compliance times specified in paragraphs (i)(1), (i)(2), and (i)(3) of this AD, as applicable: Lubricate the rudder and elevator components specified in the service bulletin. Do all actions required by this paragraph in accordance with the service bulletin.
(1)Within 9 months after the effective date of this AD, or within 9 months since the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness; whichever occurs later.
(2)For airplanes on which BMS 3-33 grease is not already in use prior to the time the lubrication task is being accomplished: Within 3,000 flight hours or 9 months after the last lubrication accomplished in accordance with the service bulletin or Boeing Special Attention Service Bulletin 767-27-0197 or 767-27-0198, both dated October 27, 2005, whichever occurs first.
(3)For airplanes on which BMS 3-33 grease is already in use prior to the time the lubrication task is being accomplished: Within 6,000 flight hours or 18 months after the last lubrication accomplished in accordance with the service bulletin or Boeing Special Attention Service Bulletin 767-27-0197 or 767-27-0198, both dated October 27, 2005, whichever occurs first. Repetitive Lubrication
(j)Repeat the lubrication required in paragraph
(i)of this AD at the applicable interval specified in paragraph (j)(1) or (j)(2) of this AD.
(1)For airplanes on which BMS 3-33 grease is not already in use prior to the time the lubrication task is being accomplished: At intervals not to exceed 3,000 flight hours or 9 months, whichever occurs first.
(2)For airplanes on which BMS 3-33 grease is already in use prior to the time the lubrication task is being accomplished: At intervals not to exceed 6,000 flight hours or 18 months, whichever occurs first. Repetitive Prior or Concurrent Inspection
(k)For airplanes specified in paragraphs (k)(1) and (k)(2) of this AD: Prior to or concurrently with the accomplishment of each elevator freeplay measurement specified in paragraph
(g)of this AD, do all applicable actions required by AD 2001-04-09.
(1)Group 1, configuration 2, airplanes as identified in Boeing Special Attention Service Bulletin 767-27-0197, Revision 1, dated July 19, 2007.
(2)Group 1, configuration 1, airplanes as identified in Boeing Special Attention Service Bulletin 767-27-0198, Revision 1, dated July 19, 2007. Alternative Methods of Compliance (AMOCs) (l)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(3)An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4)AMOCs approved previously in accordance with AD 2006-11-12 are approved as AMOCs for the corresponding provisions of this AD.
(5)AMOCs approved previously in accordance with AD 2001-04-09, are approved as AMOCs for the corresponding provisions of paragraph
(k)of this AD. Issued in Renton, Washington, on September 13, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-18544 Filed 9-19-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-29257; Directorate Identifier 2007-NM-144-AD] RIN 2120-AA64 Airworthiness Directives; Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive
(AD)for certain Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This proposed AD would require repetitive detailed inspections for cracking of the left side and right side frame and reinforcement angles at fuselage station
(FS)640 between stringer 9 and stringer 12, and corrective actions if necessary. This proposed AD results from reports that cracks have been discovered on the frame and reinforcement angles at FS 640. We are proposing this AD to detect and correct cracking of the frame, which could lead to failure of the fuselage structure and possible loss of the airplane. DATES: We must receive comments on this proposed AD by October 22, 2007. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • *DOT Docket Web site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Government-wide rulemaking Web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Fax:*
(202)493-2251. • *Hand Delivery:* Room W12-140 on the ground floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Bombardier, Inc., Canadair, Aerospace Group, P.O. Box 6087, Station Centre-ville, Montreal, Quebec H3C 3G9, Canada, for service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Pong K. Lee, Aerospace Engineer, Airframe and Propulsion Branch, ANE-171, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone
(516)228-7324; fax
(516)794-5531. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2007-29257; Directorate Identifier 2007-NM-144-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that Web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov.* Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov* , or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Operations office (telephone
(800)647-5527) is located on the ground level of the West Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, notified us that an unsafe condition may exist on certain Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. TCCA advises that cracks have been discovered on the frame and reinforcement angles at fuselage station
(FS)640 on a number of CRJ (Canadair Regional Jet) airplanes. This condition, if not corrected, could result in failure of the fuselage structure and possible loss of the airplane. Relevant Service Information Bombardier has issued Alert Service Bulletin 601R-53-061, Revision E, dated December 7, 2006. The alert service bulletin describes procedures for doing repetitive detailed visual inspections for cracking of the frame at fuselage station
(FS)640 between stringer 9 and stringer 12 (Part A of the Accomplishment Instructions) and, if necessary, corrective actions as follows: • Repair as described in Part A of the Accomplishment Instructions; • Install a modification, including related investigative and corrective actions; or • Contact Bombardier for repair instructions. The related investigative and corrective actions of the modification (Part C of the Accomplishment Instructions) include cutting out a section of the flange frame at FS640 then doing a liquid penetrant or eddy current inspection for cracking of the skin doubler, and contacting Bombardier for repair instructions. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. TCCA mandated the service information and issued Canadian airworthiness directive CF-2003-12, dated May 7, 2003, to ensure the continued airworthiness of these airplanes in Canada. FAA's Determination and Requirements of the Proposed AD These airplanes are manufactured in Canada and are type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, TCCA has kept the FAA informed of the situation described above. We have examined TCCA's findings, evaluated all pertinent information, and determined that we need to issue an AD for airplanes of this type design that are certificated for operation in the United States. Therefore, we are proposing this AD, which would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between the Proposed AD and Bombardier Alert Service Bulletin/Canadian Airworthiness Directive.” Differences Between the Proposed AD and Bombardier Alert Service Bulletin/Canadian Airworthiness Directive The Canadian airworthiness directive specifies that Bombardier Alert Service Bulletin 601R-53-061, Revision B, dated February 20, 2003, or later revisions, must be used to do all described inspections and actions. However, we have determined that Revision E, dated December 7, 2006, of the alert service bulletin no longer contains certain actions described by Revision B. Therefore, this proposed AD would require doing all actions in accordance with Alert Service Bulletin 601R-53-061, Revision E, dated December 7, 2006. This difference has been coordinated with TCCA. In this proposed AD, the “detailed visual inspection” specified in the Bombardier alert service bulletin and Canadian airworthiness directive is referred to as a “detailed inspection.” We have included the definition for a detailed inspection in a note in the proposed AD. The Bombardier alert service bulletin and Canadian airworthiness directive specify to contact Bombardier for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions using a method approved by the FAA or TCCA (or its delegated agent). In light of the type of repair that would be required to address the unsafe condition, and consistent with existing bilateral airworthiness agreements, we have determined that, for this proposed AD, a repair approved by the FAA or TCCA (or its delegated agent) would be acceptable for compliance with this proposed AD. Although the Accomplishment Instructions of the alert service bulletin describe procedures for submitting certain information to the manufacturer, this proposed AD would not require that action. Interim Action We consider this proposed AD interim action. If final action is later identified, we might consider further rulemaking then. Costs of Compliance This proposed AD would affect about 739 airplanes of U.S. registry. The proposed inspection would take about 2 work hours per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the proposed AD for U.S. operators is $118,240, or $160 per airplane, per inspection cycle. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **Bombardier, Inc. (Formerly Canadair):** Docket No. FAA-2007-29257; Directorate Identifier 2007-NM-144-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by November 5, 2007. Affected ADs
(b)None. Applicability
(c)This AD applies to Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes, certificated in any category; as identified in Bombardier Alert Service Bulletin 601R-53-061, Revision E, dated December 7, 2006. Unsafe Condition
(d)This AD results from reports that cracks have been discovered on the frame and reinforcement angles at fuselage station
(FS)640. Failure of this frame could degrade the structural integrity of the airplane. We are issuing this AD to detect and correct cracking of the frame, which could lead to failure of the fuselage structure and possible loss of the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Service Bulletin Reference
(f)The term “service bulletin,” as used in this AD, means the Accomplishment Instructions of Bombardier Alert Service Bulletin 601R-53-061, Revision E, dated December 7, 2006. Detailed Inspection
(g)Before the accumulation of 8,600 total flight cycles or within 1,100 flight cycles after the effective date of this AD, whichever occurs later: Perform a detailed inspection to detect cracking of the left side and right side frames and reinforcement angles at FS640 between stringer 9 and stringer 12, in accordance with Part A of the Accomplishment Instructions of the service bulletin. Note 1: For the purposes of this AD, a detailed inspection is: “An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirror, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.” Repetitive Inspection and Corrective Action
(h)If no crack is found during the inspection required by paragraph
(g)of this AD: Repeat the detailed inspection thereafter at intervals not to exceed 1,100 flight cycles, until the frame modification described in paragraph (i)(2) of this AD has been done.
(i)If any crack is found during the inspection required by paragraph
(g)of this AD: Before further flight, repair the crack in accordance with paragraph (i)(1), (i)(2), or (i)(3) of this AD, as applicable.
(1)For any crack found in the frame at the stringer 9 cut-out only, repair in accordance with Part A of the Accomplishment Instructions of the service bulletin.
(2)For any crack found in the frame reinforcement doubler only: Do the frame modification (including related investigative and corrective actions) described in Part C of the Accomplishment Instructions of the service bulletin, except where the alert service bulletin specifies to contact the manufacturer for repair instructions, repair the crack using a method approved by either the Manager, New York Aircraft Certification Office (ACO), FAA; or Transport Canada Civil Aviation
(TCCA)(or its delegated agent); then do the detailed inspection required by paragraph
(j)of this AD.
(3)For any crack found in areas of the inspection zone described in paragraph
(g)of this AD other than those described in paragraphs (i)(1) and (i)(2) of this AD: Repair the crack using a method approved by either the Manager, New York ACO, FAA; or TCCA (or its delegated agent). Repetitive Inspection After Frame Modification
(j)Within 12,000 flight cycles after doing the modification described in paragraph (i)(2) of this AD, do the detailed inspection required by paragraph
(g)of this AD. Repeat the detailed inspection thereafter at intervals not to exceed 1,100 flight cycles. No Reporting Requirement
(k)Although the alert service bulletin referred to in this AD specifies to submit certain information to the manufacturer, this AD does not include that requirement. Alternative Methods of Compliance (AMOCs) (l)(1) The Manager, New York ACO, FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO. Related Information
(m)Canadian airworthiness directive CF-2003-12, dated May 7, 2003, also addresses the subject of this AD. Issued in Renton, Washington, on September 12, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-18539 Filed 9-19-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-29255; Directorate Identifier 2007-NM-085-AD] RIN 2120-AA64 Airworthiness Directives; Boeing Model 737-100, -200, -200C, -300, -400, and -500 Series Airplanes AGENCY: Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: The FAA proposes to adopt a new airworthiness directive
(AD)for certain Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. This proposed AD would require doing repetitive internal eddy current and detailed inspections to detect cracked stringer tie clips; doing applicable corrective and related investigative actions, if necessary; and measuring the fastener spacing and the edge margin; as applicable. As a temporary alternative to doing the actions described previously, this proposed AD would require repetitive external general visual inspections of the skin and lap joints for cracks and evidence of overload resulting from cracked stringer tie clips, and applicable corrective actions if necessary. This proposed AD results from a report of several cracked stringer tie clips. We are proposing this AD to prevent multiple cracked stringer tie clips and damaged skin and frames, which could lead to the skin and frame structure developing cracks and consequent decompression of the airplane. DATES: We must receive comments on this proposed AD by November 5, 2007. ADDRESSES: Use one of the following addresses to submit comments on this proposed AD. • *DOT Docket Web site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Government-wide rulemaking web site:* Go to *http://www.regulations.gov* and follow the instructions for sending your comments electronically. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Fax:*
(202)493-2251. • *Hand Delivery:* Room W12-140 on the ground floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Contact Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-2207, for the service information identified in this proposed AD. FOR FURTHER INFORMATION CONTACT: Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)917-6447; fax
(425)917-6590. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to submit any relevant written data, views, or arguments regarding this proposed AD. Send your comments to an address listed in the ADDRESSES section. Include the docket number “FAA-2007-29255; Directorate Identifier 2007-NM-085-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. We will post all comments we receive, without change, to *http://dms.dot.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this proposed AD. Using the search function of that web site, anyone can find and read the comments in any of our dockets, including the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the **Federal Register** published on April 11, 2000 (65 FR 19477-78), or you may visit *http://dms.dot.gov.* Examining the Docket You may examine the AD docket on the Internet at *http://dms.dot.gov* , or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Operations office (telephone
(800)647-5527) is located on the ground level of the West Building at the DOT street address stated in the ADDRESSES section. Comments will be available in the AD docket shortly after the Docket Management System receives them. Discussion We have received a report of 15 cracked stringer tie clips in the crown skin area between station
(STA)500B and STA 907 between stringer
(S)10L and S-10R, on a Boeing Model 737 airplane. The airplane had accumulated total 31,415 flight cycles. This airplane had three adjacent cracked clips at two consecutive body station frames (six clips total). The six stringer tie clips were cracked along the joint common to the stringer. The six total stringer tie clips were the same formed bonded stringer tie clips that were installed as terminating action in accordance with Boeing Service Bulletin 737-53-1085, Revision 1, dated May 10, 1990. Stringer tie clip cracking along the joint common to the stringer occurs primarily as a result of cyclic loading associated with cabin pressure and flight loads. If three adjacent stringer tie clips on one frame crack, it could result in an inability of the fuselage frame structure to support operating loads. This could result in local skin buckling and deformation of the skin and frame. Multiple cracked stringer tie clips and damaged skin and frames, if not corrected, could lead to the skin and frame structure developing cracks, which could result in decompression of the airplane. Other Relevant Rulemaking We previously issued AD 93-08-04, amendment 39-8551 (58 FR 25546, April 27, 1993), for certain Boeing Model 737-100, -200, and -200C series airplanes. That AD requires structural inspections of older airplanes and is part of the Aging Airplane Service Bulletin Structural Modification and Inspection Program. Boeing Service Bulletin 737-53-1085, Revision 1, is one of several service bulletins required by that AD. This proposed AD would affect the requirements of AD 93-08-04 pertaining to Boeing Service Bulletin 737-53-1085, Revision 1. We previously issued AD 2002-07-08, amendment 39-12702 (67 FR 17917, April 12, 2002), applicable to certain Boeing Model 737-200, -200C, -300, -400, and -500 series airplanes. That AD requires repetitive inspections to find cracking of the lower skin at the lower row of fasteners in the lap joints of the fuselage, and repair of cracking found. That AD also requires modification of the fuselage lap joints at certain locations, which constitutes terminating action for certain repetitive inspections. This proposed AD would not affect the current requirements of AD 2002-07-08. Relevant Service Information We have reviewed Boeing Special Attention Service Bulletin 737-53-1268, dated August 25, 2006. This service bulletin supersedes Boeing Service Bulletin 737-53-1085, Revision 1. The service bulletin describes one required inspection and one temporary alternative inspection. Inspection A, the one required inspection, involves the following: • Doing repetitive internal eddy current and detailed inspections to detect cracked stringer tie clips. The inspection area is from STA 559 to STA 887, STA 360 to STA 540, and STA 907. The inspections from STA 559 to STA 887 are identical to those specified in Boeing Service Bulletin 737-53-1085, Revision 1. If the terminating action was done in accordance with Boeing Service Bulletin 737-53-1085, the inspections need to be restarted in accordance with Boeing Special Attention Service Bulletin 737-53-1268. • Doing applicable corrective and related investigative actions, if necessary. The corrective actions include replacing any cracked stringer tie clip with a new clip, contacting Boeing for repair instructions, and repairing any damaged lap joints; as applicable. The related investigative actions include doing an internal detailed inspection to detect damaged or deformed skin and frame and to detect damaged lap joints, and doing internal eddy current inspections to detect cracked lap joints; as applicable. • Measuring the fastener spacing and the edge margin; as applicable. The initial compliance time for Inspection A is before the accumulation of 25,000 or 35,000 total flight cycles (as applicable), or within 2 or 3 years (as applicable) after the date of the service bulletin, whichever occurs later. The repeat interval for Inspection A is 15,000 or 20,000 flight cycles (as applicable). Inspection B, which is a temporary alternative to doing Inspection A, involves the following: • Doing repetitive external general visual inspections of the skin and lap joints for cracks and evidence of overload resulting from cracked stringer tie clips, and • Doing applicable corrective actions if necessary. The corrective actions include contacting Boeing for repair instructions, and repairing any cracked or damaged lap joint and skin. For Inspection B, the threshold for the initial compliance times ranges between 37,500 and 47,500 total flight cycles, and the grace period for the initial compliance times is 25,000 flight cycles or 6 or 12 months, depending on the number of flight cycles on the airplane. Inspection B must be done before exceeding an inspection period ranging from 5,000 to 50,000 total flight cycles. The repeat interval for Inspection B is 2,500 flight cycles. The service bulletin also describes procedures for an optional eddy current inspection to detect damaged stringer tie clips and replacement of any cracked clip with a new clip. The optional inspection can be done in addition to and at the same time as Inspection A described previously. The optional inspection will detect damaged stringer clips earlier than the detailed inspection, which may prevent future costly repairs. Accomplishing the actions specified in the service information is intended to adequately address the unsafe condition. The service bulletin refers to Boeing Service Bulletin 737-53A1177, Revision 6, dated May 31, 2001, as an additional source of service information for doing an internal eddy current inspection of the lap joint for certain airplane configurations. FAA's Determination and Requirements of the Proposed AD We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other airplanes of this same type design. For this reason, we are proposing this AD, which would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between the Proposed AD and Service Information.” Differences Between the Proposed AD and Service Information The service information specifies to contact the manufacturer for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions in one of the following ways: • Using a method that we approve; or • Using data that meet the certification basis of the airplane, and that have been approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization whom we have authorized to make those findings. Costs of Compliance There are about 2,685 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this proposed AD. Estimated Costs Action Work hours 1 Average labor rate per hour Cost per airplane 1 Number of U.S.-registered airplanes Fleet cost 1 Inspection A Between 40 and 103 $80 Between $3,200 and $8,240, per inspection cycle 787 Between $2,518,400 and $6,484,880, per inspection cycle. Inspection B (temporary alternative to Inspection A) Between 2 and 109 80 Between $160 and $8,720 787 Between $125,920 and $6,862,640, per inspection cycle. 1 Depending on the airplane configuration. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The Federal Aviation Administration
(FAA)amends § 39.13 by adding the following new airworthiness directive (AD): **Boeing:** Docket No. FAA-2007-29255; Directorate Identifier 2007-NM-085-AD. Comments Due Date
(a)The FAA must receive comments on this AD action by November 5, 2007. Affected ADs
(b)AD 93-08-04, amendment 39-8551. Applicability
(c)This AD applies to Boeing Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, certificated in any category; as identified in Boeing Service Bulletin 737-53-1268, dated August 25, 2006. Unsafe Condition
(d)This AD results from a report of several cracked stringer tie clips. We are issuing this AD to prevent multiple cracked stringer tie clips and damaged skin and frames, which could lead to the skin and frame structure developing cracks and consequent decompression of the airplane. Compliance
(e)You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done. Service Bulletin References
(f)The term “the service bulletin,” as used in this AD, means the Accomplishment Instructions of Boeing Service Bulletin 737-53-1268, dated August 25, 2006. Inspection A: Required Internal Inspections, Applicable Corrective and Related Investigative Actions, and Measurement
(g)Do repetitive internal eddy current and detailed inspections to detect cracked stringer tie clips; do applicable corrective and related investigative actions, if necessary; and measure the fastener spacing and the edge margin; as applicable. Do all applicable actions at the applicable compliance times and repeat intervals identified in tables 2 through 8 inclusive of paragraph 1.E., “Compliance,” of the service bulletin; except as provided by paragraphs (i), (j), and
(k)of this AD. Do all applicable actions in accordance with the Accomplishment Instructions of the service bulletin, except as provided by paragraph
(m)of this AD. Note 1: The service bulletin refers to Boeing Service Bulletin 737-53A1177, Revision 6, dated May 31, 2001, as an additional source of service information for doing an internal eddy current inspection of the lap joint for certain airplane configurations. Inspection B: Temporary Alternative External Inspections and Corrective Actions
(h)As a temporary alternative to doing the actions required by paragraph
(g)of this AD, do repetitive external general visual inspections of the skin and lap joints for cracks and evidence of overload resulting from cracked stringer tie clips, and applicable corrective actions if necessary. Do all applicable actions at the applicable compliance times and repeat intervals identified in tables 9 through 12 inclusive of paragraph 1.E., “Compliance,” of the service bulletin, but not to exceed the flight cycles in the “Inspection Period Allowed” column of the tables; except as provided by paragraphs
(i)and
(l)of this AD. Do all applicable actions in accordance with the Accomplishment Instructions of the service bulletin, except as provided by paragraph
(m)of this AD. Note 2: The eddy current inspection along the stringer tie clip radius to detect damage and replacement, as applicable, specified in paragraph 3.B.5. of the Accomplishment Instructions of the service bulletin are not required by this AD. The actions are optional and can be done in addition to and at the same time as the actions required by paragraph
(g)of this AD. Exceptions to Service Information
(i)Where the service bulletin specifies a compliance time after the date of the service bulletin, this AD requires compliance within the specified compliance time after the effective date of this AD.
(j)For Model 737-100, -200, and -200C series airplanes, on which Boeing Service Bulletin 737-53-1085, Revision 1, dated May 10, 1990, has not been done in accordance with AD 93-08-04: As of the effective date of this AD, do the applicable inspections from STA 559 to STA 887 in accordance with paragraph
(g)of this AD, at the applicable compliance times specified in paragraph
(b)of AD 93-08-04.
(k)In the first row of tables 5 and 6 of paragraph 1.E., “Compliance,” of the service bulletin, where the service bulletin specifies a compliance time of before 25,000 total airplane flight cycles, this AD requires a compliance time of before the accumulation of 25,000 total flight cycles, or within 2 years after the effective date of this AD, whichever occurs later.
(l)Where the service bulletin specifies no starting point (e.g., “after the date on the service bulletin”) for a grace period, this AD requires compliance within the specified grace period after the effective date of this AD.
(m)Where the service bulletin specifies to contact Boeing for appropriate action: Before further flight, repair the discrepancy using a method approved in accordance with the procedures specified in paragraph
(o)of this AD. Certain Actions End Certain Requirements of AD 93-08-04
(n)Accomplishment of the internal eddy current and detailed inspections for STA 559 to STA 887 in accordance with paragraph
(g)of this AD constitutes compliance with the inspections required by paragraph
(a)of AD 93-08-04, as it pertains to Boeing Service Bulletin 737-53-1085, Revision 1, dated May 10, 1990. Accomplishment of the internal eddy current and detailed inspections does not terminate the remaining requirements of AD 93-08-04, as it applies to other service bulletins. Operators are required to continue to inspect and/or modify per the other service bulletins listed in that AD. Alternative Methods of Compliance (AMOCs) (o)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested in accordance with the procedures found in 14 CFR 39.19.
(2)To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(3)An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD. Issued in Renton, Washington, on September 12, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-18554 Filed 9-19-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2007-29256; Directorate Identifier 2007-NM-137-AD] RIN 2120-AA64 Airworthiness Directives; Fokker Model F.28 Mark 0070 and 0100 Airplanes AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: We propose to adopt a new airworthiness directive
(AD)for the products listed above. This proposed AD results from mandatory continuing airworthiness information
(MCAI)originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: Two events have been reported of Fokker 100 (F.28 Mk.0100) aircraft, where the Nose Landing Gear
(NLG)failed to extend in the normal mode and problems were experienced to open the NLG doors, almost preventing extension of the NLG in the emergency (alternate) mode. Subsequent investigation and tests have shown that the friction of the bearing in the roller of the NLG Door Uplock Bracket Assembly is high, causing increased resistance in the mechanical system that unlocks the NLG doors. This condition, if not corrected, may result in a NLG up landing, which is considered a hazardous event. The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI. DATES: We must receive comments on this proposed AD by October 22, 2007. ADDRESSES: You may send comments by any of the following methods: • *DOT Docket Web Site:* Go to *http://dms.dot.gov* and follow the instructions for sending your comments electronically. • *Fax:*
(202)493-2251. • *Mail:* U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* Room W12-140 on the ground floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. • *Federal eRulemaking Portal:* *http://www.regulations.gov* . Follow the instructions for submitting comments. Examining the AD Docket You may examine the AD docket on the Internet at *http://dms.dot.gov* ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone
(800)647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer, International Branch, ANM-116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-1137; fax
(425)227-1149. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2007-29256; Directorate Identifier 2007-NM-137-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments. We will post all comments we receive, without change, to *http://dms.dot.gov* , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. Discussion The Civil Aviation Authority—The Netherlands (CAA-NL), which is the aviation authority for the Netherlands, has issued Dutch Airworthiness Directive NL-2006-004, dated February 28, 2006 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states: Two events have been reported of Fokker 100 (F.28 Mk.0100) aircraft, where the Nose Landing Gear
(NLG)failed to extend in the normal mode and problems were experienced to open the NLG doors, almost preventing extension of the NLG in the emergency (alternate) mode. Subsequent investigation and tests have shown that the friction of the bearing in the roller of the NLG Door Uplock Bracket Assembly is high, causing increased resistance in the mechanical system that unlocks the NLG doors. This condition, if not corrected, may result in a NLG up landing, which is considered a hazardous event. Since a potentially unsafe condition has been identified that may exist or develop on aircraft of the same type design, this Airworthiness Directive requires the introduction of an improved roller in the NLG Door Uplock Bracket Assembly. You may obtain further information by examining the MCAI in the AD docket. Relevant Service Information Fokker Services B.V. has issued Service Bulletin SBF100-32-143, dated February 15, 2006, and Component Service Bulletin D76501-32-17, dated February 15, 2006. The actions described in this service information (replacing the roller in the uplock bracket) are intended to correct the unsafe condition identified in the MCAI. FAA's Determination and Requirements of This Proposed AD This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design. Differences Between This AD and the MCAI or Service Information We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information. We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD. Costs of Compliance Based on the service information, we estimate that this proposed AD would affect about 13 products of U.S. registry. We also estimate that it would take about 5 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Required parts would cost about $135 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $6,955, or $535 per product. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Findings We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify this proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. The FAA amends § 39.13 by adding the following new AD: **Fokker Services B.V.:** Docket No. FAA-2007-29256; Directorate Identifier 2007-NM-137-AD. Comments Due Date
(a)We must receive comments by October 22, 2007. Affected ADs
(b)None. Applicability
(c)This AD applies to Fokker Model F.28 Mark 0070 and 0100 airplanes, certificated in any category, all serial numbers. Subject
(d)Air Transport Association
(ATA)of America Code 32: Landing gear. Reason
(e)The mandatory continuing airworthiness information
(MCAI)states: Two events have been reported of Fokker 100 (F.28 Mk.0100) aircraft, where the Nose Landing Gear
(NLG)failed to extend in the normal mode and problems were experienced to open the NLG doors, almost preventing extension of the NLG in the emergency (alternate) mode. Subsequent investigation and tests have shown that the friction of the bearing in the roller of the NLG Door Uplock Bracket Assembly is high, causing increased resistance in the mechanical system that unlocks the NLG doors. This condition, if not corrected, may result in a NLG up landing, which is considered a hazardous event. Since a potentially unsafe condition has been identified that may exist or develop on aircraft of the same type design, this Airworthiness Directive requires the introduction of an improved roller in the NLG Door Uplock Bracket Assembly. Actions and Compliance
(f)Unless already done, do the following actions.
(1)Within 4,000 flight hours after the effective date of this AD, modify the NLG Door Uplock Bracket Assembly, in accordance with the Accomplishment Instructions of Fokker Service Bulletin SBF100-32-143, dated February 15, 2006.
(2)As of 18 months after the effective date of this AD, no spare NLG Door Uplock Bracket Assembly may be installed as a replacement part unless it has been modified in accordance with the Accomplishment Instructions of Fokker Component Service Bulletin D76501-32-17, dated February 15, 2006. FAA AD Differences Note: This AD differs from the MCAI and/or service information as follows: No difference. Other FAA AD Provisions
(g)The following provisions also apply to this AD:
(1)*Alternative Methods of Compliance (AMOCs):* The Manager, International Branch, ANM-116, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Tom Rodriguez, Aerospace Engineer, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425)227-1137; fax
(425)227-1149. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector
(PI)in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2)*Airworthy Product:* For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3)*Reporting Requirements:* For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act, the Office of Management and Budget
(OMB)has approved the information collection requirements and has assigned OMB Control Number 2120-0056. Related Information
(h)Refer to MCAI Dutch Airworthiness Directive NL-2006-004, dated February 28, 2006, Fokker Service Bulletin SBF100-32-143, dated February 15, 2006, and Fokker Component Service Bulletin D76501-32-17, dated February 15, 2006, for related information. Issued in Renton, Washington, on September 12, 2007. Ali Bahrami, Manager, Transport Airplane Directorate, Aircraft Certification Service. [FR Doc. E7-18553 Filed 9-19-07; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 2 [Docket No. 2007N-0262] RIN 0910-AF92 Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine) AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration (FDA), after consultation with the Environmental Protection Agency (EPA), is proposing to amend FDA's regulation on the use of ozone-depleting substances
(ODSs)in self-pressurized containers to remove the essential-use designation for epinephrine used in oral pressurized metered-dose inhalers (MDIs). FDA has tentatively concluded that there are no substantial technical barriers to formulating epinephrine as a product that does not release ODSs, and therefore epinephrine would no longer be an essential use of ODSs. If the essential-use designation is removed, epinephrine MDIs containing an ODS could not be marketed after a suitable transition period. We will hold an open public meeting on the essential use of epinephrine on a date to be announced later. DATES: Submit written or electronic comments by November 19, 2007. ADDRESSES: You may submit comments, identified by Docket No. 2007N-0262 and/or RIN number 0910-AF92, by any of the following methods: *Electronic Submissions* Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described previously in the ADDRESSES portion of this document under *Electronic Submissions* . *Instructions* : All submissions received must include the agency name and Docket No(s). and Regulatory Information Number
(RIN)(if a RIN number has been assigned) for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents, comments, a transcript of, and material submitted for, the joint meeting of the Nonprescription Drugs and Pulmonary-Allergy Drugs Advisory Committee held on January 24, 2006, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket number(s), found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell or Martha Nguyen, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041. SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. CFCs B. Regulation of ODSs 1. The 1978 Rules 2. The Montreal Protocol 3. The 1990 Amendments to the Clean Air Act 4. EPA's Implementing Regulations 5. FDA's 2002 Regulation II. Criteria III. Effective Date IV. 2006 NDAC/PADAC Meeting V. Epinephrine A. Do Substantial Technical Barriers Exist to Formulating Epinephrine Products Without ODSs? B. Do OTC Epinephrine MDIs Provide an Otherwise Unavailable Public Health Benefit? 1. Does Epinephrine Provide a Greater Therapeutic Benefit Than Similar Adrenergic Bronchodilators? 2. Does OTC Marketing of Epinephrine MDIs Provide an Important Public Health Benefit? 3. Conclusions on the Public Health Benefits of OTC Epinephrine MDIs C. Does Use of OTC Epinephrine MDIs Release Cumulatively Significant Amounts of ODSs Into the Atmosphere or is the Release Warranted in View of the Otherwise Unavailable Important Public Health Benefit? D. Conclusions VI. Environmental Impact VII. Analysis of Impacts A. Introduction B. Need for Regulation and the Objective of This Rule C. Background 1. CFCs and Stratospheric Ozone 2. The Montreal Protocol 3. Benefits of the Montreal Protocol 4. Characteristics of Asthma 5. Current U.S. Market for OTC Epinephrine MDIs D. Benefits and Costs of the Proposed Rule 1. Baseline Conditions 2. Benefits of the Proposed Rule 3. Costs of the Proposed Rule and Alternatives 4. Effects on Medicaid and Medicare E. Alternative Phase-Out Dates F. Sensitivity Analyses G. Conclusion VIII. Regulatory Flexibility Analysis IX. The Paperwork Reduction Act of 1995 X. Federalism XI. Request for Comments XII. References I. Background A. CFCs Chlorofluorocarbons
(CFCs)are organic compounds that contain carbon, chlorine, and fluorine atoms. CFCs were first used commercially in the early 1930s as a replacement for hazardous materials then used in refrigeration, such as sulfur dioxide and ammonia. Subsequently, CFCs were found to have a large number of uses, including as solvents and as propellants in self-pressurized aerosol products, such as MDIs. CFCs are very stable in the troposphere, the lowest part of the atmosphere. They move to the stratosphere, a region that begins about 10 to 16 kilometers
(km)(6 to 10 miles) above Earth's surface and extends up to about 50 km (31 miles) altitude. Within the stratosphere, there is a zone about 15 to 40 km (10 to 25 miles) above the Earth's surface in which ozone is relatively highly concentrated. This zone in the stratosphere is generally called the ozone layer. Once in the stratosphere, CFCs are gradually broken down by strong ultraviolet light, releasing chlorine atoms that then deplete stratospheric ozone. Depletion of stratospheric ozone by CFCs and other ODSs allows more ultraviolet-B (UV-B) radiation to reach the Earth's surface, where it increases skin cancers and cataracts, and damages some marine organisms, plants, and plastics. B. Regulation of ODSs The link between CFCs and the depletion of stratospheric ozone was discovered in the mid-1970s. Since 1978, the U.S. Government has pursued a vigorous and consistent policy, through the enactment of laws and regulations, of limiting the production, use, and importation of ODSs, including CFCs. 1. The 1978 Rules In the **Federal Register** of March 17, 1978 (43 FR 11301 at 11318), FDA and EPA published rules banning, with a few exceptions, the use of CFCs as propellants in aerosol containers. These rules were issued under authority of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321 *et seq.* ) and the Toxic Substances Control Act (15 U.S.C. 2601 *et seq.* ), respectively. FDA's rule (the 1978 rule) was codified as § 2.125 (21 CFR 2.125). These rules issued by FDA and EPA had been preceded by rules issued by FDA and the Consumer Product Safety Commission requiring products that contain CFC propellants to bear environmental warning statements on their labeling (42 FR 22018, April 29, 1977; 42 FR 42780, August 24, 1977). The 1978 rule prohibited the use of CFCs as propellants in self-pressurized containers in any food, drug, medical device, or cosmetic. As originally published, the rule listed five essential uses exempt from the ban. The third listed essential use was for “[m]etered-dose adrenergic bronchodilator human drugs for oral inhalation.” This use describes epinephrine MDIs. The 1978 rule provided criteria for adding new essential uses, and several uses were added to the list, the last one in 1996. The 1978 rule did not provide any mechanism for removing essential uses from the list as alternative products were developed or CFC-containing products were removed from the market. The absence of a removal procedure came to be viewed as a deficiency in the 1978 rule, and was addressed in a later rulemaking, discussed in section I.B.5 of this document. 2. The Montreal Protocol On January 1, 1989, the United States became a Party to the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol) (September 16, 1987, 26 I.L.M. 1541 (1987)), available at *http://www.unep.org/ozone/pdfs/Montreal-Protocol2000.pdf* . 1 The United States played a leading role in the negotiation of the Montreal Protocol, believing that internationally coordinated control of ODSs would best protect both the U.S. and global public health and the environment from potential adverse effects of depletion of stratospheric ozone. Currently, there are 191 Parties to this treaty. 2 When it joined the treaty, the United States committed to reducing production and consumption of certain CFCs to 50 percent of 1986 levels by 1998 (Article 2(4) of the Montreal Protocol). It also agreed to accept an “adjustment” procedure, by which, following assessment of the existing control measures, the Parties could adjust the scope, amount, and timing of those control measures for substances already subject to the Montreal Protocol. As the evidence regarding the impact of ODSs on the ozone layer became stronger, the Parties used this adjustment procedure to accelerate the phase-out of ODSs. At the fourth Meeting of the Parties to the Montreal Protocol, held at Copenhagen in November 1992, the Parties adjusted Article 2 of the Montreal Protocol to eliminate the production and importation of CFCs by January 1, 1996, by Parties that are developed countries (Decision IV/2). 3 The adjustment also indicated that it would apply, “save to the extent that the Parties decide to permit the level of production or consumption that is necessary to satisfy uses agreed by them to be essential” (Article 2A(4)). 1 FDA has verified all Web site addresses cited in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document has published in the **Federal Register** . 2 The summary descriptions of the Montreal Protocol and decisions of Parties to the Montreal Protocol contained in this document are presented here to help you understand the background of the action we are taking. These descriptions are not intended to be formal statements of policy regarding the Montreal Protocol. Decisions by the Parties to the Montreal Protocol are cited in this document in the conventional format of “Decision IV/2,” which refers to the second decision recorded in the Report of the Fourth Meeting of the Parties to the Montreal Protocol on Substances That Deplete the Ozone Layer. Reports of Meetings of the Parties to the Montreal Protocol may be found on the United Nations Environment Programme's Web site at *http://ozone.unep.org/Meeting_Documents/mop/index.shtml* . 3 Production of CFCs in economically less-developed countries is being phased out and is scheduled to end by January 1, 2010. See Article 2A of the Montreal Protocol. One of the most important essential uses of CFCs under the Montreal Protocol is their use in MDIs for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The decision on whether the use of CFCs in MDIs is “essential” for purposes of the Montreal Protocol turns on whether “(1) It is necessary for the health, safety, or is critical for the functioning of society (encompassing cultural and intellectual aspects) and
(2)there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health” (Decision IV/25). Each request and any subsequent exemption is for only 1 year's duration (Decision V/18). Since 1994, the United States and some other Parties to the Montreal Protocol have annually requested, and been granted, essential-use exemptions for the production or importation of CFCs for their use in MDIs for the treatment of asthma and COPD (see, among others, Decisions VI/9 and VII/28). The exemptions have been consistent with the criteria established by the Parties, which make the grant of an exemption contingent on a finding that the use for which the exemption is being requested is essential for health, safety, or the functioning of society, and that there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of health or the environment (Decision IV/25). Phasing out the use of CFCs in MDIs for the treatment of asthma and COPD has been an issue of particular interest to the Parties to the Montreal Protocol. Several decisions of the Parties have dealt with the transition to CFC-free MDIs, including the following decisions: • Decision VIII/10 stated that the Parties that are developed countries would take various actions to promote industry's participation in a smooth and efficient transition away from CFC-based MDIs (San Jose, Costa Rica, 1996). • Decision IX/19 required the Parties that are developed countries to present an initial national or regional transition strategy by January 31, 1999 (Montreal, Canada, 1997). • Decision XII/2 elaborated on the content of national or regional transition strategies required under Decision IX/19 and indicated that any MDI for the treatment of asthma or COPD approved for marketing after 2000 would not be an “essential use” unless it met the criteria laid out by the Parties for essential uses (Ouagadougou, Burkina Faso, 2000). • Decision XIV/5 requested that each Party report annually the quantities of CFC and non-CFC MDIs and dry-powder inhalers
(DPIs)sold or distributed within its borders and the approval and marketing status of non-CFC MDIs and DPIs. Decision XIV/5 also noted “with concern the slow transition to CFC-free metered-dose inhalers in some Parties” (Rome, Italy, 2002). • Decision XV/5 stated that, at the 17th Meeting of the Parties (in December 2005) or thereafter, no essential uses of CFCs will be authorized for Parties that are developed countries, unless the Party requesting the essential-use allocation has submitted an action plan for MDIs for which the sole active ingredient is albuterol. Among other items, the action plan should include a specific date by which the Party plans to cease requesting essential-use allocations of CFCs for albuterol MDIs to be sold or distributed in developed countries 4 (Nairobi, Kenya, 2003). 4 Our obligation under XV/5 was met by our final rule eliminating the essential use status of albuterol (70 FR 17168, April 4, 2005). • Decision XVII/5 stated that Parties that are developed counties should provide a date to the Ozone Secretariat 5 before the 18th Meeting of the Parties (October 30 to November 3, 2006) by which time a regulation or regulations will have been proposed to determine whether MDIs, other than those that have albuterol as the only active ingredient, are nonessential (Dakar, Senegal, 2005). 5 The Ozone Secretariat is the Secretariat for the Montreal Protocol and the Vienna Convention for the Protection of the Ozone Layer (the Vienna Convention) (March 22, 1985, 26 I.L.M. 1529 (1985)), available at *http://hq.unep.org/ozone/pdfs/viennaconvention2002.pdf* . Based at the United Nations Environment Programme
(UNEP)offices in Nairobi, Kenya, the Secretariat functions in accordance with Article 7 of the Vienna Convention and Article 12 of the Montreal Protocol. The main duties of the Secretariat include the following: • Arranging for and servicing the Conference of the Parties, Meetings of the Parties, their Committees, the Bureaux, Working Groups, and Assessment Panels; • Arranging for the implementation of decisions resulting from these meetings; • Monitoring the implementation of the Vienna Convention and the Montreal Protocol; • Reporting to the Meetings of the Parties and to the Implementation Committee; • Representing the Convention and the Protocol; and • Receiving and analyzing data and information from the Parties on the production and consumption of ODSs. 3. The 1990 Amendments to the Clean Air Act In 1990, Congress amended the Clean Air Act to, among other things, better protect stratospheric ozone (Public Law No. 101-549, November 15, 1990) (the 1990 amendments). The 1990 amendments were drafted to complement, and be consistent with, our obligations under the Montreal Protocol (see section 614 of the Clean Air Act (42 U.S.C. 7671m)). Section 614(b) of the Clean Air Act provides that, in the case of a conflict between any provision of the Clean Air Act and any provision of the Montreal Protocol, the more stringent provision will govern. Section 604 of the Clean Air Act requires the phase-out of the production of CFCs by 2000 (42 U.S.C. 7671c), 6 while section 610 of the Clean Air Act (42 U.S.C. 7671i) required EPA to issue regulations banning the sale or distribution in interstate commerce of nonessential products containing CFCs. Sections 604 and 610 provide exceptions for “medical devices.” Section 601(8) (42 U.S.C. 7671(8)) of the Clean Air Act defines “medical device” as: any device (as defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), diagnostic product, drug (as defined in the Federal Food, Drug, and Cosmetic Act), or drug delivery system-
(A)if such device, product, drug, or drug delivery system utilizes a class I or class II substance for which no safe and effective alternative has been developed, and where necessary, approved by the Commissioner [of Food and Drugs]; and
(B)if such device, product, drug, or drug delivery system, has, after notice and opportunity for public comment, been approved and determined to be essential by the Commissioner [of Food and Drugs] in consultation with the Administrator [of EPA]. 6 In conformance with Decision IV/2, EPA issued regulations accelerating the complete phase-out of CFCs, with exceptions for essential uses, to January 1, 1996 (58 FR 65018, December 10, 1993). 4. EPA's Implementing Regulations EPA regulations implementing the Montreal Protocol and the stratospheric ozone protection provisions of the 1990 amendments are codified in part 82 of title 40 of the Code of Federal Regulations (40 CFR part 82). (See 40 CFR 82.1 for a statement of intent.) Like the 1990 amendments, EPA's implementing regulations contain two separate prohibitions, one on the production and import of CFCs (subpart A of 40 CFR part 82) and the other on the sale or distribution of products containing CFCs (40 CFR 82.66). The prohibition on production and import of CFCs contains an exception for essential uses and, more specifically, for essential MDIs. The definition of essential MDI at 40 CFR 82.3 requires that the MDI be intended for the treatment of asthma or COPD, be essential under the Montreal Protocol, and if the MDI is for sale in the United States, be approved by FDA and listed as essential in FDA's regulations at § 2.125 (21 CFR 2.125). The prohibition on the sale of products containing CFCs includes a specific prohibition on aerosol products and other pressurized dispensers. The aerosol product ban contains an exception for medical devices listed in § 2.125(e). The term “medical device” is used with the same meaning it was given in the 1990 amendments and includes drugs as well as medical devices. 5. FDA's 2002 Regulation In the 1990s, we decided that § 2.125 required revision to better reflect our obligations under the Montreal Protocol, the 1990 amendments, and EPA's regulations, and to encourage the development of ozone-friendly alternatives to medical products containing CFCs. In particular, as acceptable alternatives that did not contain CFCs or other ODSs came on the market, there was a need to provide a mechanism for removing essential uses from the list in § 2.125(e). In the **Federal Register** of March 6, 1997 (62 FR 10242), we published an advance notice of proposed rulemaking (the 1997 ANPRM) in which we outlined our then-current thinking on the content of an appropriate rule regarding ODSs in products FDA regulates. We received almost 10,000 comments on the 1997 ANPRM. In response to the comments, we revised our approach and drafted a proposed rule published in the **Federal Register** of September 1, 1999 (64 FR 47719) (the 1999 proposed rule). We received 22 comments on the 1999 proposed rule. After minor revisions in response to these comments, we published a final rule in the **Federal Register** of July 24, 2002 (67 FR 48370) (the 2002 final rule) (corrected in 67 FR 49396, July 30, 2002, and 67 FR 58678, September 17, 2002). The 2002 final rule listed as a separate essential use each active moiety 7 marketed under the 1978 rule as essential uses for metered-dose steroid human drugs for oral inhalation and metered-dose adrenergic bronchodilator human drugs for oral inhalation; eliminated the essential-use designations in § 2.125(e) for metered-dose steroid human drugs for nasal inhalation and for products that were no longer marketed; set new standards to determine when a new essential-use designation should be added to § 2.125; and set standards to determine whether the use of an ODS in a medical product remains essential. 7 Section 314.108(a) (21 CFR 314.108(a)) defines “active moiety” as the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance. When describing the various essential uses, we will generally refer to the active moiety, for example, albuterol, as opposed to the active ingredient, which, using the same example, would be albuterol sulfate. When discussing particular indications and other material from the approved labeling of a drug product, we will generally use the brand name of the product, which, using the same example would be PROVENTIL HFA (among others). In describing material from treatises, journals, and other non-FDA approved publications, we will generally follow the usage in the original publication. II. Criteria Among other changes, the 2002 final rule, in revised § 2.125(g)(2), establishes a standard for removing an essential-use designation for any drug after January 1, 2005, that would apply to a drug for which there is no acceptable non-ODS alternative with the same active moiety. The process for removing the essential-use designation for such a drug must include a consultation with a relevant advisory committee and an open public meeting, in addition to a proposed rule and a final rule. The criterion established for removing the essential use in such circumstances is that it no longer meets the criteria specified in revised § 2.125(f) for adding a new essential use (§ 2.125(g)(2)). The criteria in § 2.125(f) are: “(i) Substantial technical barriers exist to formulating the product without ODSs;
(ii)The product will provide an unavailable important public health benefit; and
(iii)Use of the product does not release cumulatively significant amounts of ODSs into the atmosphere or the release is warranted in view of the unavailable important public health benefit.” The three criteria in § 2.25(f)(1) are linked by the word “and”. Because the three criteria are linked by “and” (as opposed to “or”), failure to meet any single criterion satisfies the threshold under the regulation for determining that the use is not essential. We discussed these criteria in the preamble to the 1999 proposed rule. A key point in our discussion of technical barriers was: Generally, FDA intends the term “technical barriers” to refer to difficulties encountered in chemistry and manufacturing. A petitioner would have to establish that it evaluated all available alternative technologies and explain in detail why each alternative was unusable to demonstrate that substantial technical barriers exist (1999 proposed rule at 47721). In applying the “technical barriers” criterion, we will be looking at the results of reformulation efforts for similar products, as well as statements made about the manufacturer's particular efforts to reformulate their product or products. Similarly, in discussing what is “an unavailable important public health benefit,” we said: The agency intends to give the phrase “unavailable important public health benefit” a markedly different construction from the [phrase used in the 1978 rule] “substantial health benefit.” A petitioner should show that the use of an ODS would save lives, significantly reduce or prevent an important morbidity, or significantly increase patient quality of life to support a claim of important public health benefit (1999 proposed rule at 47722). In determining whether a drug product provides an otherwise unavailable important public health benefit, our primary focus is on the availability of non-ODS products that provide equivalent therapeutic benefits for patients who are currently using the CFC MDIs. If therapeutic alternatives exist for everyone using the CFC MDI, we would then determine that the CFC MDI does not provide an otherwise unavailable important public health benefit. In the case of epinephrine MDIs, the fact that they are marketed over-the-counter (OTC), while the therapeutic alternatives for epinephrine MDIs are prescription drugs, makes the analysis of whether everyone is adequately served by the therapeutic alternatives more complicated. Under the third criterion, the threshold for removing the essential use designation is satisfied unless we find either:
(1)The use of the product does not release cumulatively significant amounts of ODSs into the atmosphere; or
(2)the release, although cumulatively significant, is warranted in view of the otherwise unavailable important public health benefit that the use of the drug product provides. In evaluating whether continuing the essential-use designation of an MDI would result in the product releasing significant quantities of ODSs, in light of past policy statements (2002 final rule p. 48380) and the current state of the phase-out of ODSs, the release of CFCs from epinephrine MDIs is currently significant and as the phase-out of ODSs continues throughout the world, the significance of the quantities of CFCs released by epinephrine MDIs will increase. In applying the first part of the third criterion, we are guided by previous policy statements. The United States evaluated the environmental effect of eliminating the use of all CFCs in an environmental impact statement in the 1970s (see 43 FR 11301, March 17, 1978). As part of that evaluation, FDA concluded that the continued use of CFCs in medical products posed an unreasonable risk of long-term biological and climatic impacts (see Docket No. 1996N-0057 formerly 96N-0057). Congress later enacted provisions of the Clean Air Act that codified the decision to fully phase out the use of CFCs over time (see 42 U.S.C. 7671 *et seq.* (enacted November 15, 1990)). We note that the environmental impact of individual uses of nonessential CFCs must not be evaluated independently, but rather must be evaluated in the context of the overall use of CFCs. Cumulative impacts can result from individually minor, but collectively significant, actions that take place over a period of time (40 CFR 1508.7). Significance cannot be avoided by breaking an action down into small components (40 CFR 1508.27(b)(7)). Currently, MDIs for the treatment of asthma and COPD are the only legal use for newly produced or imported CFCs (see 71 FR 58504 (October 4, 2006)). Although it may appear to some that the CFCs released from MDIs represent insignificant quantities of ODSs, and therefore should be exempt, the elimination of CFC use in MDIs is one of the final steps in the overall phase-out of CFC use. The release of ODSs from some of the MDIs may be relatively small compared to total quantities that were released 2 or 3 decades ago, but if each use that resulted in the release of relatively small quantities of ODSs were provided an exemption, the cumulative effect would be to prevent the elimination of ODS releasing products. This would prevent the full phase-out envisioned by the Clean Air Act and the Montreal Protocol. Therefore, we tentatively conclude that the release of ODSs from epinephrine MDIs is cumulatively significant. Given this proposed finding that the first part of the third criterion is not satisfied, the threshold for the removal of the essential-use designation for epinephrine under § 2.125(f)(1)(iii) is met if we also find that the second part of the third criterion is not satisfied: it provides an otherwise unavailable important public health benefit which warrants the cumulatively significant release of the ODS. As noted previously, because the three criteria in § 2.125(f)(1) are linked by the word “and,” failure to meet any single criterion may result in a determination that the use is not essential. Accordingly, if we find that the product fails to provide an otherwise unavailable important health benefit (criterion two), this would meet the threshold under the regulation for a finding that the use of the product is not essential, and we would not necessarily need to reach the last step under the third criterion (balancing the important health benefit against the release of the ODS to determine if the release is warranted). Assuming, however that we do analyze the third criterion, then, because of our tentative conclusion that the release of ODSs from epinephrine MDIs is cumulatively significant, we would need to conduct the balancing inquiry under the second part of the third criterion. We will discuss our tentative conclusions on how the second part of the third criterion applies to OTC epinephrine MDIs in section V.C of this document. The criteria in § 2.125(g)(2) (which refers to those found in § 2.125(f)(1)) that we are using in this rulemaking are different from those in § 2.125(g)(3) and (g)(4). Section 2.125(g)(2) specifically addresses the situation where there is no marketed non-ODS product containing the active moiety listed as an essential use, while § 2.125(g)(3) and (g)(4) apply to situations where there is at least one marketed non-ODS product with the listed active moiety. Section 2.125(g)(2) permits FDA to remove an essential use even if a current essential-use active moiety is not reformulated, provided that sufficient alternative products exist to meet the needs of patients, because the essential use would no longer provide an otherwise unavailable important health benefit. Therefore, the analysis we use here is not identical to the analysis we used under § 2.125(g)(4) in the recent rulemaking to remove the essential use for albuterol (70 FR 17168, April 4, 2005). However, the basic concern of protecting the public health underlies all of the criteria. Therefore, our analyses are similar, and we have found it useful to borrow concepts from the more specific provisions of § 2.125(g)(3) and (g)(4) to help give more structure to our analysis under the broader language of § 2.125(f)(1). III. Effective Date We are proposing that any rule finalizing the removal of the essential use for OTC epinephrine MDIs have an effective date of December 31, 2010. Because there are therapeutic alternatives which are marketed as prescription drugs, in determining the appropriate effective date for this rulemaking, we will consider both:
(1)Whether adequate time exists to provide patient education for users of OTC epinephrine MDIs, particularly those who do not consult doctors, pharmacists, and other health care professionals; and
(2)whether adequate production capacity and supplies are available to meet the new, presumably increased, demand for the therapeutic alternatives once OTC epinephrine MDIs are no longer sold. Patient education for any transition away from OTC epinephrine MDIs presents unique concerns. Much of the thinking about patient education on the transition from CFC MDIs has focused on the dissemination of information through physicians, pharmacists, and other health care professionals. This information could be given orally by health care professionals, or the information could be available in the professionals' offices or pharmacies for patients to read. Because epinephrine MDIs are sold OTC, many purchasers will not interact with a health care provider. New avenues of communication will have to be opened to reach all OTC epinephrine MDI users. Many OTC epinephrine MDI users may need to be provided information to help them select a physician. Some OTC epinephrine MDI users who face economic barriers to appropriate health care may need even more time to find and avail themselves of free or low-cost health care and prescription drug programs (see section V.B.2.b of this document). These factors have led us to believe that a transition away from OTC epinephrine MDIs may be more difficult than transitions in which patients change from one prescription drug to another prescription drug, and accordingly that any effective date for such a rulemaking should provide for a longer transition period than the transition period for the recently published proposed rule to eliminate the essential-use designation for MDIs containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil (72 FR 32030, June 11, 2007). We have, therefore, tentatively concluded that the December 31, 2010, effective date would be appropriate for a final rule removing the essential-use designation for OTC epinephrine MDIs. We invite comment on the proposed effective date of December 31, 2010, as well as possible alternative effective dates, such as December 31, 2011 or 2012. In determining an appropriate effective date, we have kept in mind that albuterol MDIs that use the hydrofluoroalkane HFA-134a
(HFA)as a propellant are a primary therapeutic alternative to OTC epinephrine MDIs, because both drugs are in the same therapeutic class (short-acting inhaled beta-agonist bronchodilators), albuterol is the only member of the class available in an HFA MDI, and no members of the class are available as a DPI. 8 Sales of OTC epinephrine MDIs have totaled approximately 4.5 million MDIs a year. We are confident that there will be adequate supplies of albuterol HFA MDIs to meet the needs of all users of albuterol CFC MDIs by December 31, 2008 (the date on which albuterol MDIs will no longer be designated an essential use). 9 Although we have limited data on production increases above current demand for 2009, 2010, and later, we believe that by December 31, 2010, albuterol HFA production will be able to meet any increased demand caused by this rulemaking. This proposed effective date is 1 year later than the effective date that we proposed in the recently published proposed rule to eliminate the essential-use designation for MDIs containing flunisolide, triamcinolone, metaproterenol, pirbuterol, albuterol and ipratropium in combination, cromolyn, and nedocromil (72 FR 32030, June 11, 2007). As we said in that proposed rule, many of the patients using some of those drugs would switch to albuterol HFA inhalers. We believe that the additional time required for the needed patient education on alternatives to OTC epinephrine MDIs will also provide additional time to scale up production of albuterol HFA MDIs. This additional time should provide greater assurance that there will be adequate supplies of albuterol HFA MDIs for all patients who use them. We specifically invite comments from manufacturers of albuterol HFA MDIs on this issue. 8 Neither HFA MDIs nor DPIs release ODSs. HFA MDIs and DPIs are generally considered to be the non-ODS drug products that are most comparable to CFC MDIs in terms of portability and ease of use. 9 Current information indicates that production of albuterol HFA MDIs will be adequate to meet the current demand for albuterol MDIs much earlier than December 31, 2008. In proposing a December 31, 2010, effective date, we expect that 2010 would be a transition year characterized by declining production of OTC epinephrine MDIs. If a December 31, 2010, effective date is established by this rulemaking, we anticipate that other administrative actions taken by EPA and FDA would reflect the concept of 2010 being a transition year. The sale of remaining stocks of CFC MDIs by manufacturers, wholesalers, and retailers was a consideration in setting the effective date of the albuterol rule (70 FR 17168, 17179, April 4, 2005). We believe that this consideration is appropriate for this rulemaking also. In evaluating the period of time needed to sell remaining stocks of OTC epinephrine MDIs, a factor that must be considered is the expiration dating for the relevant products. Both PRIMATENE MIST and the OTC epinephrine MDIs made by Armstrong Pharmaceuticals, Inc. (Armstrong) have expiration dates set at 24 months after manufacture. Drug products are not generally sold right up to the expiration date. Drugs are generally sold well before the expiration date, allowing the purchasers a significant amount of time to use the drug before it reaches its expiration date; therefore, we believe that all OTC epinephrine MDIs manufactured prior to publication of a final rule based on this proposal should be sold by December 31, 2010. We are tentatively proposing a December 31, 2010, effective date based on our preliminary assumption that there will not be an inhaled epinephrine OTC drug product that does not contain ODSs on the market in the foreseeable future. We strongly urge interested individuals to submit detailed information on whether inhaled-epinephrine will be available in a non-ODS formulation and when a non-ODS inhaled epinephrine product can reasonably be expected to be on the market. We also specifically request comment on whether publishing a final rule or the effective date of any such rule should be affected by the additional information that we receive concerning the availability of an inhaled epinephrine OTC drug product that does not contain ODSs. IV. 2006 NDAC/PADAC Meeting Section 2.125(g)(2) requires that we consult an advisory committee before we remove an essential-use designation when there is no non-ODS product with the same active moiety. We consulted the Nonprescription Drug Advisory Committee
(NDAC)and the Pulmonary-Allergy Drugs Advisory Committee (PADAC) on the essential-use status of OTC MDIs containing epinephrine at a joint committee meeting held on January 24, 2006 (NDAC/PADAC meeting). 10 Presentations were made by representatives of Wyeth Consumer Health (Wyeth), two patient advocacy and public policy groups, and physician organizations. Seven of the joint committee members recommended that epinephrine be retained as an essential use, while eleven members recommended that the essential-use designation be removed. The opinions expressed by the NDAC and PADAC (NDAC/PADAC) members and other participants in the NDAC/PADAC meeting will be discussed below. 10 The transcript of the NCPAC/PADAC meeting, slides used in presentations made at the joint meeting, and written material presented to the committees for the meeting may be found at *http://www.fda.gov/ohrms/dockets/ac/cder06.html* . This NDAC/PADAC meeting should not be confused with the open public meeting on the essential-use status of OTC MDIs containing epinephrine we will be holding in the near future. We will publish a notice for that meeting in the **Federal Register** shortly. V. Epinephrine Epinephrine is a short-acting adrenergic bronchodilator used in the treatment of asthma. A new drug application
(NDA)for OTC epinephrine MDIs was approved in 1956. Epinephrine was included in the 1978 rule under the provision designating “[m]etered-dose adrenergic bronchodilator human drugs for oral inhalation” as an essential use. Approved NDAs for OTC epinephrine MDIs are currently held by Wyeth and Armstrong, (a subsidiary of Amphastar Pharmaceuticals, Inc.). Wyeth markets their OTC epinephrine MDIs as PRIMATENE MIST, while Armstrong labels their product as “house brands” for certain retail pharmacies. Epinephrine MDIs are the only MDIs for treatment of asthma (or any other disease) that are approved for OTC use. 11 Customers do not need a prescription from a health care provider to purchase OTC epinephrine MDIs. Wyeth presented data at the NDAC/PADAC meeting estimating that 2 to 3 million people with asthma use OTC epinephrine MDIs (meeting transcript p. 51, Wyeth slide 19). Based on the 2005 National Health Interview Survey (NHIS), the Centers for Disease Control and Prevention's National Center for Health Statistics
(NCHS)has estimated that 7.7 percent of the U.S. population currently has asthma (Ref. 1). Using an estimate of the U.S. population of 300 million, 12 we can estimate that approximately 23 million people in the United States currently have asthma. 11 The OTC monograph for Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products permits OTC marketing of epinephrine in a hand-held rubber nebulizer for use in the treatment of asthma (21 CFR part 341). While this product did not use CFCs, all of the information available to us shows that such products are no longer marketed. The OTC monograph for Cold, Cough, Allergy, Bronchodilator, and Antiashtmatic Drug Products permits OTC marketing of oral dosage forms of ephedrine. Ephedrine is not available in an MDI. In addition, OTC ephedrine products have a slower onset of action than epinephrine MDIs, and therefore they cannot be considered a suitable alternative to OTC epinephrine MDIs. 12 The U.S. Census' estimate of the U.S. Population was 299,948,296 as of October 10, 2006, 1804 GMT, with an estimated net increase in the population of 1 person every 11 seconds. See *http://www.census.gov/population/www/popclockus.html* . Epinephrine is also an active ingredient in many other drug products. It is used in a self-injectable dosage form for treatment of severe allergic reactions. EPIPEN is an example of epinephrine in this dosage form. Epinephrine is also available OTC as a solution for use in an electrically powered nebulizer for the treatment of asthma. This rulemaking will not affect the availability of these non-MDI drug products. A. Do Substantial Technical Barriers Exist to Formulating Epinephrine Products Without ODSs? As we said in the 2002 final rule, we intend the term “technical barriers” to refer to difficulties encountered in chemistry and manufacturing. To demonstrate that substantial technical barriers exist, it will have to be established that all available alternative technologies have been evaluated and why each alternative is unusable (2002 final rule at 48373). Wyeth did not present any significant data on technical barriers to formulating an inhaled epinephrine product without ODSs at the NDAC/PADAC meeting. At the NDAC/PADAC meeting, Wyeth said that they had been trying to reformulate or outsource their product for over a decade and mentioned unacceptable prototypes, but they mentioned that a significant difficulty in reformulation was avoiding designs that would infringe patents held by 3M Co.
(3M)and GlaxoSmithKline
(GSK)(meeting transcript, pp. 86-88). It should be kept in mind that patent licenses and contract manufacturing by patent holders have been very frequently used during the current transition away from CFC MDIs. An example of this is 3M's manufacture of, and patent licensing for, albuterol HFA MDIs. 3M holds patents on HFA MDI technology and it also manufactures PROVENTIL HFA (albuterol) MDIs for sale by Schering Corporation (Schering). Ivax Corp. has licensed HFA MDI technology patents from 3M and manufactures PROAIR HFA (albuterol) MDIs. We have not been presented with any evidence that Wyeth could not obtain patent licenses or arrange for contract manufacturing by a patent holder. At least nine different active moieties have been formulated as HFA MDIs for the treatment of asthma and COPD in the United States and abroad. 13 HFA MDIs have been formulated with both suspensions and solutions. Albuterol and levalbuterol are close chemical analogs of epinephrine. Given the chemical similarity between them and the success with reformulating albuterol (as albuterol sulfate in PROAIR HFA, PROVENTIL HFA, and VENTOLIN HFA) and levalbuterol (as levalbuterol tartrate in XOPENEX), there appears to be no technical reason why epinephrine cannot be successfully reformulated into an HFA MDI. Wyeth said at the NDAC/PADAC meeting that early attempts to formulate an epinephrine HFA MDI were characterized by higher pressures and quantities of alcohol that provided unacceptable sensations to users of the product, including an unpleasant taste of alcohol 14 (Wyeth briefing material, p. 1-7; meeting transcript, p. 87). These do not seem to represent technical barriers; rather they seem to be the type of problems routinely encountered in the development of a new product that require prototypes to be reengineered. Indeed, Wyeth did not seem to truly believe that there were technical barriers to development of an epinephrine HFA MDI, predicting that they would have a product developed and clinically tested by 2011, and attributing their earlier difficulties to a lack of in-house expertise (Wyeth briefing material, p. 1-7). FDA has had experience with several firms reformulating products from ODS containing MDIs to non-ODS products. Based on our experience with those reformulation efforts, it seems highly unlikely that a non-ODS inhaled epinephrine drug product will be developed and clinically tested until well after 2011. As we mentioned before, we are particularly interested in receiving comment on current efforts on developing non-ODS inhaled epinephrine drug products that would be suitable for OTC sale, including any discernible impediments to such efforts. 13 The nine moieties formulated as HFA MDIs are albuterol, beclomethasone, budesonide, fenoterol, fluticasone, flunisolide, formoterol, ipratropium, and salmeterol. While a salmeterol DPI (SEREVENT) has been approved in the United States, salmeterol HFA MDIs have only been approved overseas. There are no approved fenoterol or formoterol products in the United States, but fenoterol HFA MDIs and formoterol HFA MDIs have been approved in several foreign countries. 14 PRIMATENE MIST contains 35 percent alcohol and other MDIs also contain alcohol. Wyeth did not reveal the amount of alcohol in their prototype or explain why the amount of alcohol could not be reduced or the taste otherwise minimized. Wyeth said that an epinephrine DPI was not a viable alternative to the epinephrine MDI, but without any elaboration (Wyeth briefing material, p. 1-7). The DPI has proven to be a very successful dosage form. At least nine different moieties have been formulated as DPIs for treatment of asthma and COPD in the United States or overseas. 15 Alkermes, Inc., developed a large dose epinephrine DPI for investigations into using an epinephrine DPI for treatment of anaphylaxis. While this product has not been approved by FDA and it is not intended for the treatment of asthma, it does show that epinephrine can be formulated into a DPI (Refs. 2 and 3). 15 The nine moieties formulated as DPIs are albuterol, beclomethasone, budesonide, fluticasone, formoterol, mometasone, salmeterol, terbutaline, and tiotropium. While albuterol HFA MDIs have been approved in the United States, albuterol DPIs are not currently marketed in the United States, but are approved overseas. A terbutaline CFC MDI and other terbutaline products have been approved in the United States, but terbutaline DPIs have only been approved overseas. There are no approved formoterol products in the United States, but formoterol DPIs have been approved in several foreign countries. Thus, all of the evidence before us indicates that epinephrine can be formulated into a drug product that does not release ODSs. The facts presented by Wyeth at the NDAC/PADAC meeting did not indicate that there are technical barriers to the development of a non-ODS epinephrine product, despite the conclusions that Wyeth presented at the meeting. However, as noted previously, we are especially interested in receiving public comment concerning any such technical barriers that may exist. B. Do OTC Epinephrine MDIs Provide an Otherwise Unavailable Important Public Health Benefit? Because we have reached a tentative conclusion that there are no substantial technical barriers to formulating epinephrine into a non-ODS product, we do not believe it is necessary at this time to reach a conclusion on the public health benefits of OTC epinephrine MDIs. However, this issue was discussed at length at the NDAC/PADAC meeting and we are keenly interested in the potential public health benefits of having epinephrine MDIs available OTC. We will evaluate and weigh those public health benefits before issuing any final rule on the essential-use designation for epinephrine. Accordingly, we will discuss some of the questions on which we would be particularly interested in receiving comments that would be relevant in reaching a conclusion on the public health benefits of OTC epinephrine MDIs. 1. Does Epinephrine Provide a Greater Therapeutic Benefit Than Similar Adrenergic Bronchodilators? During the last several years, four prescription HFA MDIs with two different forms of albuterol have come onto the market: • Albuterol sulfate MDI (PROAIR HFA); • Albuterol sulfate MDI (PROVENTIL HFA); • Albuterol sulfate MDI (VENTOLIN HFA); and • Levalbuterol tartrate MDI (XOPENEX HFA). These products use HFA as a replacement for ODSs, which does not affect stratospheric ozone. Albuterol and epinephrine are both adrenergic bronchodilators. Albuterol MDIs are therapeutic alternatives to OTC epinephrine MDIs and are, by far, the most widely prescribed short-acting bronchodilators. To determine whether epinephrine provides an otherwise unavailable important public health benefit, we should compare OTC epinephrine MDIs to albuterol HFA MDIs. The labeled indication for the OTC epinephrine MDIs is “for temporary relief of occasional symptoms of mild asthma.” The comparable labeled indication for the albuterol HFA MDIs is “for treatment or prevention of bronchospasm with reversible obstructive airway disease.” OTC epinephrine MDIs and three of the albuterol HFA MDIs are indicated for adults and children 4 years of age and older. 16 The labeled indications for the albuterol HFA MDIs cover all patients described in the labeled indication for OTC epinephrine MDIs. 16 PROAIR HFA is indicated for adults and children 12 years of age and older. Clinical data presented by a representative of Wyeth at the NDAC/PADAC meeting indicated that OTC epinephrine MDIs may be slightly quicker to onset of action than albuterol MDIs, but they have a significantly shorter duration of action (Wyeth briefing statement at p. 1-9). The slightly quicker onset of action may explain why some people with asthma describe OTC epinephrine MDI as working better than prescription drugs. The slightly quicker onset of action is a pharmacodynamic assessment, but there are no clinical data to support a conclusion that this perceived quicker relief provided by epinephrine leads to better outcomes. Therefore, we do not believe that this represents a “otherwise unavailable important public health benefit.” Wyeth presented another study of the treatment of nocturnal asthma that concluded that OTC epinephrine MDIs can “achieve the same benefit as albuterol” MDIs (Ref. 4, p. 533). 17 However, as pointed out by NDAC/PADAC members, the frequency of doses of epinephrine used in this study were several times the amount approved in labeling (this was also true, but to a smaller degree, for albuterol in this study). 18 Further, this was a limited study with only eight subjects completing the evaluations. These elements made the utility of this study for purposes of this rulemaking very questionable, and even if these questions were ignored, the study shows, at best, that epinephrine is roughly as effective as, but not more effective than, albuterol. 17 The author of the study report did not appear to view the study as supporting the OTC use of epinephrine MDIs, stating that the results of the study do not imply that it is safe for people with asthma to self-medicate without physician intervention and that results of the study indicate that nonprescription epinephrine presents the same risk of delaying patients from seeking medical care as other beta-agonists. The report concluded with a statement that a larger study is required before epinephrine can be recommended as rescue therapy when a prescription beta <sup>2</sup> -agonist MDI is not accessible (Ref. 3). 18 The author of the study report recognized that the large number of actuations might be impractical (Ref. 43). In the United States, the generally recognized standard of care for asthma is set forth in the National Heart, Lung, and Blood Institute's Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma (EPR-2) (Ref. 5). 19 The National Heart, Lung, and Blood Institute is one of the National Institutes of Health. In the 2002 update to EPR-2 (Ref. 6), we find the latest updates to the standard. 19 The Guidelines represent best practices and are recognized as the clinical standard of care for treatment of asthma. See, e.g., *http://www.asthmanow.net/care.html* ; *http://www.colorado.gov/bestpractices/index.html* ; *http://www.doh.wa.gov/CFH/asthma/publications/plan/health-care.pdf* . In several points in Wyeth's written, oral, and visual presentation for the NDAC/PADAC meeting, it was stated that use of epinephrine was consistent with the National Heart, Lung and Blood Institute's asthma treatment guidelines (Ref. 5) (frequently called the second Expert Panel Report or EPR-2), issued as part of the National Asthma Education and Prevention Program. 20 The EPR-2, as updated, is widely seen as representing the generally recognized standard of care for asthma in the United States. 21 Wyeth stated in its written materials that epinephrine is not mentioned specifically in the EPR-2 (Wyeth briefing material, p. 1-8; meeting transcript, pp. 50-51; Wyeth slide 18). FDA disagrees with these statements. The 2002 update to the EPR-2 states that “[n]onselective agents (i.e., epinephrine, isoproterenol, metaproterenol) are not recommended due to their potential for excessive cardiac stimulation, especially in high doses” (Ref. 6, p. 120). While recognizing the possibility that the concerns expressed in the EPR-2 about cardiovascular risk may be overstated (see Refs. 4 and 9), we do not need to reach a conclusion on the relative cardiovascular risk of the use of epinephrine compared to the use of albuterol. FDA is unaware of any evidence comparing epinephrine and albuterol at recommended doses indicating that the cardiovascular safety of epinephrine is better than that of albuterol. 20 EPR-2 was updated in 2002 (Ref. 6) (EPR—Update 2002). References to outside publications or any other statements of fact or opinion in this document concerning a drug product are not intended to be equivalent to statements in labeling approved under section 505 of the act (21 U.S.C. 355) and part 314 of FDA regulations (21 CFR part 314). 21 The EPR-2 is very similar to other published standards of care (See the *Australian Asthma Management Handbook: 2002* (Ref. 7) and the “Canadian Asthma Consensus Report, 1999” (Ref. 8). A voting consultant with NDAC characterized the OTC epinephrine MDI as an “inferior medicine” (meeting transcript, p. 181). She admitted there was an absence of good data on the safety and efficacy of OTC epinephrine MDIs. Her opinions were shared by many members of the committees. NDAC/PADAC members who recommended that the essential use for OTC epinephrine MDIs be retained did not state that epinephrine was safer or more effective than albuterol. The evidence before us indicates that epinephrine is not safer or more effective than albuterol. The EPR-2 recommends against epinephrine's use. The consensus opinion at the NDAC/PADAC meeting was that OTC epinephrine MDIs presented no significant therapeutic advantage over albuterol MDIs. This leads us to tentatively conclude that OTC epinephrine MDIs do not provide a clinical benefit that is otherwise unavailable. If we intended to draw a conclusion about the public health benefits of OTC epinephrine MDIs, and if OTC epinephrine MDIs were prescription drugs, as albuterol HFA MDIs are, our analysis would be nearly complete. However, the epinephrine MDIs, PRIMATENE MIST and the Armstrong products, are the only MDIs for treatment of asthma that are marketed OTC. We, therefore, have to examine more questions on the possible public health benefits of the continued OTC marketing of epinephrine CFC MDIs. 2. Does OTC Marketing of Epinephrine MDIs Provide an Important Public Health Benefit? Our discussion on the public health benefit of OTC marketing of epinephrine is largely informed by the data presented and the opinions expressed at the NDAC/PADAC meeting. a. *Is patient convenience an important public health benefit* ? Wyeth asserted at the NDAC/PADAC meeting that the convenience of patients having an OTC MDI for asthma provides an “important public health benefit” (meeting transcript, p. 66). Having this OTC product available would allow patients who run out of their prescribed medication and cannot get a refill authorization from their physician to go to the local store and purchase OTC epinephrine MDI. Wyeth presented data from a survey they had conducted indicating that one-third of OTC epinephrine MDI users use it as their sole asthma medication, while two-thirds use it in addition to prescription drugs. The survey indicated that 55 percent of people with asthma who solely use OTC epinephrine MDIs for their asthma said that the OTC product is “easier and quicker to obtain.” Fifty-eight percent of asthma patients who use both prescription drugs and OTC epinephrine MDIs say they purchase the OTC MDI when they either “run out of my prescription medication” or “have an asthma attack and I don't have my prescription with me” (Wyeth slide 36). Maintaining current valid prescriptions and supplies of prescribed drugs is a regular and sometimes onerous, but necessary, task for many patients with chronic diseases. It would certainly be more convenient for all of these patients if some sort of therapeutic alternative were available OTC. However, there are no OTC remedies for most serious diseases. Of note, patients with anaphylaxis to bee stings or peanuts can face sudden, life-threatening attacks if exposed to their relevant triggers. Yet epinephrine autoinjectors, such as EPIPEN, are not OTC products because of considerations that include the proper evaluation and treatment of such patients. No evidence has been presented to us, in the course of this rulemaking, to indicate how asthma differs from other serious diseases in a way that warrants having an OTC treatment available. These facts would support a conclusion that any added convenience of OTC availability of epinephrine for patients who have been prescribed drugs for the treatment of asthma, such as albuterol MDIs, does not provide an “important public health benefit.” b. *Do OTC epinephrine MDIs provide an important health benefit for people who have poor access to adequate health care* ? Wyeth and several members of NDAC and PADAC have stated that a significant number of people with asthma do not have adequate access to health care, and a significant number of these people with asthma use OTC epinephrine MDIs. To examine the public health benefit of OTC marketing of epinephrine MDIs we must examine
(1)The number of people with asthma who use epinephrine because of inadequate access to health care providers able to diagnose asthma and prescribe treatments other than epinephrine, and
(2)the extent that OTC epinephrine benefits these people. We are particularly interested in the public health benefits that may be provided to this population by having epinephrine MDIs available OTC. Any final conclusion we reach on the essential-use designation of epinephrine could be affected by data on the public-health benefit contained in comments submitted in response to this proposed rule. Wyeth presented information at the NDAC/PADAC meeting from their 2005 survey indicating that 22 percent of people with asthma did not have health insurance (Wyeth slide 31). Statistics from NCHS (Ref. 10) indicate that slightly less than 14.1 percent of the general population does not have health insurance. While the difference between 14.1 percent and 22 percent is not significant for purposes of this document, 22 it may be true that the percentage of people with asthma who are uninsured is higher than that of the general population. Wyeth also presented data indicating that 27 percent of people with asthma do not have health insurance that provides prescription drug benefits (Wyeth slide 31). However, lack of insurance does not necessarily equate to poverty and financial barriers to adequate health care. Approximately 18 percent of uninsured Americans have household incomes of $75,000 or more, and another 17 percent have household incomes of $50,000 to $74,999 (Ref. 11). 22 The reason we say that the difference is not significant for purposes of this document is that so many of the numbers discussed represent such broad estimates that the difference between 14 percent and 22 percent would not affect any conclusion. We are acutely aware that for the individuals and families involved, absence of health insurance is very significant. Other barriers to health care exist, such as lack of sick leave, transportation, and child care. However, we do not have any data that would be useful in determining how these barriers affect people with asthma and their use of OTC epinephrine MDIs. There is very little data about how barriers to health care affect use of OTC epinephrine MDIs. According to data provided by Wyeth, roughly two-thirds of OTC epinephrine MDI users use the MDIs in addition to prescription drugs, while one-third solely use OTC epinephrine MDIs (Wyeth slide 32). As discussed in section V.B.2.b of this document, a majority of the two-thirds of OTC epinephrine MDI users who also use prescription drugs do so for reasons of convenience. However, because the two-thirds of OTC epinephrine MDI users who also use prescription drugs apparently have adequate access to health care, we will focus, for this part of the document, on the one-third of OTC epinephrine MDI users who solely use OTC epinephrine MDIs. We have very little data on why patients use OTC epinephrine MDIs instead of prescribed drugs. At the NDAC/PADAC meeting Wyeth presented data from their 2005 Internet survey of people with asthma (Wyeth slide 35). The data are summarized in table 1 as follows: **Table 1.—Most Frequent Reasons Cited by Sole OTC Epinephrine MDI Users** “Easier and quicker to obtain” 55 percent “More reasonably priced” 41 percent “I don't have health insurance” 25 percent “I don't want to go to a doctor” 25 percent “I don't have a doctor” 21 percent “OTC drugs work better for me” 11 percent The basis for the “more reasonably priced” response in the survey is unclear. While the perception of a percentage of the survey participants may have been that OTC epinephrine was less costly, an accurate determination of the relative price of the OTC product compared to the prescription substitutes would require a complex analysis which could not be embodied in an informal Internet opinion survey. For example, it is not clear how respondents calculated the retail price of the prescription drug products that they compared to OTC epinephrine, if they were comparing comparable drug products, or the degree to which they factored health insurance co-payments or the availability of patient assistance programs into their price comparison. It is also unclear if the respondents viewed the cost of a visit to a physician to obtain a prescription as a part of the price of a prescription drug. Because it is not clear what this response actually means, it contributes little to our analysis of the possible public health benefits of epinephrine. As discussed at length at the NDAC/PADAC meeting, the response in the survey that “OTC drugs work better for my asthma” is not supported by adequate and well-controlled studies. The responses that may best inform an attempt to reach a low-end estimate of the percentage of people who solely use OTC epinephrine MDIs who do so because of barriers to health care are “I don't have health insurance” (25 percent), “I don't want to go to a doctor” (25 percent), and “I don't have a doctor” (21 percent). Those stating absence of health insurance are describing a potential barrier to health care. The other two statements are more ambiguous. “I don't want to go to a doctor” may be an expression of a general aversion to going to doctors, it may be a manifestation of a desire not to confront a potentially serious illness, or it also may reflect that an asthmatic may not wish to go to a doctor because of lack of insurance or other barriers to health care. “I don't have a doctor,” may be similar to “I don't want to go to a doctor,” or it may reflect a person who has not yet chosen a doctor, because of a recent arrival in a locality or because the person has stopped seeing a previous doctor. The survey participants were permitted to select more than one reason for solely using an OTC epinephrine MDI. While we know that participants gave more than one answer (the sum of the answers is 178 percent), we do not know how the responses overlapped with each other. We will assume, for now, that the 25 percent responding “I don't have health insurance” represents users of OTC epinephrine who do so because of barriers to health care. We realize that this may underrepresent those people with asthma whose responses of “I don't want to go to a doctor,” and “I don't have a doctor” also reflected a barrier to health care. However, any underestimation may be counterbalanced by other factors, such as: • Approximately 18 percent of uninsured Americans have household incomes of $75,000 or more, and another 17 percent have household incomes of $50,000 to $74,999 (Ref. 11). While uninsured, these people would not necessarily face barriers to health care. • According to Wyeth's 2005 Internet survey, 28 percent of people with asthma who solely use OTC epinephrine MDIs have visited a doctor in the previous year for treatment of asthma; these patients presumably have access to health care. We do not know how these two points relate to the numbers from Wyeth's 2005 Internet survey giving the reasons that people with asthma purchase OTC epinephrine MDIs. As was frequently noted at the NDAC/PADAC meeting, the debate over the essential-use status of epinephrine is hobbled by a paucity of data, and we note here that we are especially interested in receiving public comments and any available data concerning this issue. The fact that this is an Internet survey, and that we know little about how the survey was conducted, raises questions about its reliability. However, in the absence of better data, we estimate that 25 percent of people with asthma who solely use OTC epinephrine MDIs for treatment of asthma do so because of barriers to health care. Since two-thirds of people who use OTC epinephrine MDIs also use prescription drugs to treat their asthma, somewhat less than 9 percent of all people with asthma using OTC epinephrine MDIs do so because of barriers to health care. These figures appear to be the best low-end estimate we can derive from the limited data we have before us. Referring to their 2005 Internet survey, Wyeth stated that 60 percent of people with asthma solely using OTC epinephrine MDIs replied that they had a “prescription medication coverage plan” (Wyeth slide 33). This figure is lower than the 66 percent who replied that they had insurance covering physicians visits. This means that approximately 40 percent of OTC epinephrine MDI users who solely use the product did not have prescription drug coverage. This seems a reasonable high-end estimate of the percentage of people with asthma solely using OTC epinephrine MDIs who do so because of barriers to health care. This estimate is over-inclusive because it includes people with asthma whose income would mean that absence of insurance does not present a barrier to health care and patients with asthma that have access to free or low-priced drugs through doctor's samples or free and low-priced drug programs. The fact that lack of insurance coverage for prescription drugs does not perfectly reflect barriers to health care is shown by the fact, according to Wyeth's 2005 survey, that 19 percent of asthma patients who solely use prescription drugs do not have insurance coverage for prescription drugs. While it is over-inclusive for some groups, the higher figure may do a better job of capturing people who face other poorly quantified barriers to health care, such as lack of sick leave, transportation, or child care. We have arrived at an estimate that between 25 percent and 40 percent of people with asthma who solely use OTC epinephrine MDIs, and therefore between 9 percent and 14 percent of all people with asthma that use OTC epinephrine MDIs, do so because of barriers to health care. We have also estimated that 1.7 to 2.3 million people with asthma use OTC epinephrine MDIs. This estimate is based on data provided by Wyeth at the NDAC/PADAC meeting, although Wyeth reached a different conclusion based on the same numbers. 23 Applying our estimate that between 9 percent and 14 percent of all people with asthma who use OTC epinephrine MDIs do so because of barriers to health care to our estimate that 1.7 to 2.3 million people with asthma use OTC epinephrine MDIs, we arrive at an estimate that between 150,000 and 320,000 people with asthma who use OTC epinephrine MDIs do so because of barriers to health care. At the NDAC/PADAC meeting, a representative for several Hispanic-American health policy organizations presented information about the high incidence of asthma among Hispanic-Americans and African-Americans (meeting transcript, pp. 162 to 169). The representative opposed removing epinephrine's essential-use designation, stating that it would have a serious adverse impact on people with asthma who face barriers to health care, and that this impact would be disproportionately felt by Hispanic-Americans. 23 At the NDAC/PADAC meeting Wyeth presented estimates that 15 to 20 percent of adults with asthma use OTC epinephrine (Wyeth slide 32). Applying these percentages to the number of adults who have asthma, they estimated that 2 to 3 million people use OTC epinephrine MDIs at any given time. Wyeth appears to have made a mistake. If we look at the 1993 ACNielsen study (Wyeth slide 29) where the study population was adults, it appears that Wyeth compared the number of respondents who reported using an OTC asthma drug
(557)to the number of respondents who reported having an asthma incident in the previous 12 months (2,713). If we divide 557 by 2,713, we get 0.205 or 20 percent. The number of adults who have asthma is substantially higher than the number who have had an asthma incident in the previous 12 months; for 2004 the numbers are 14.4 million and 7.7 million respectively (Ref. 35). Applying 15 to 20 percent to the number of adults with asthma would result in a significant inflation of the number of OTC epinephrine MDI users. Applying 15 to 20 percent to the number of adults who have had an asthma incident in the previous 12 months gives us an estimate of 1.7 to 2.3 million people using OTC epinephrine MDIs. We believe that this estimate is more accurate than the 2 to 3 million estimate. According to the 2002 NHIS (Ref. 12), 7.2 percent of Non-Hispanic Whites in the United States had asthma, while the prevalence of asthma in Non-Hispanic Blacks was 9.5 percent and the corresponding figure for Non-Hispanic American Indians was 9.9 percent. The incidence of asthma among all Hispanics in the United States (4.9 percent) was lower than the incidence for the general population (7.2 percent), but the rate for Puerto Ricans was markedly higher at 13.1 percent. The National Health Care Disparities Report (Ref. 13) (2005 NHCDR) (which was mentioned by the speaker), indicates that Hispanic-Americans have significantly worse access to health care in terms of numbers of uninsured persons (Ref. 13, p. 92) having a usual source of care (a facility where one regularly receives care) (Ref. 13, p. 94), and having a usual primary care provider (a doctor or nurse from whom one regularly receives care) (Ref. 13, p. 95). Other portions of the 2005 NHCDR provide information about asthma counseling in community health centers (Ref. 13, p. 135) and hospital admissions for pediatric asthma (Ref. 13, p. 150). None of the data in the 2005 NHDCR refer directly to the use of OTC epinephrine MDIs, so drawing specific conclusions from the 2005 NHCDR is difficult and subjective. Results from the National Cooperative Inner City Asthma Study (NCICAS) were referred to at the NDAC/PADAC meeting. NCICAS was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). NCICAS studied a treatment strategy for children with asthma living in inner-city census tracts where at least 20 percent of the population was below federal poverty guidelines. The study was conducted in eight study units located in seven cities across the United States. Wyeth presented information from a report from NCICAS, showing that 53 percent of the participants in the study reported difficulties in obtaining short term care for their children's asthma (Ref. 14). Ninety-three percent of the families studied in NCICAS were insured, largely by Medicaid, and while 50 percent of the families studied had to pay for health care (presumably a co-payment for most of the families), only 8 percent reported “care costs too much” as a barrier to health care. The intervention studied in the NCICAS was described as effective by one of the lead investigators (Ref. 15). Failure to refill prescriptions for asthma drugs was mentioned by Wyeth at the NDAC/PADAC meeting (meeting transcript, p. 113). Another report from NCICAS shows that 16 percent of caregivers reported not having a prescription filled for the child with asthma for whom they were caring (Ref. 16). This number compares favorably with compliance rates found in the general population. 24 People do not always have prescriptions filled or take their medicine, regardless of income or health insurance. 24 See Refs. 17 and 18. The various studies used different methods of measuring non-compliance, so direct numeric comparisons are not possible. Dr. Carolyn Kercsmar, who participated in the NCICAS and is a member of PADAC, responded to Wyeth's description of the data from the NCICAS by saying, “* * *[the children with asthma and the caregiver's] access were problems and didn't prevent them, it just hindered their care, and it was not just for acute care. It was for problems in accessing chronic care. Also, in that study, the vast majority of the patients had medication prescribed including albuterol as part of that study.* * *” (meeting transcript, p. 141). The NCICAS data do not show that the availability of OTC epinephrine is needed for adequate treatment of asthma in poor inner-city areas. While recognizing that the patient population studied was largely insured, we believe that comparable health care access options for low-income, non-insured patients are widely available. Programs that offer free or low-cost drugs, such as Schering's “SP Cares program” (see *www.schering-plough.com/schering_plough/corp/sp_cares.jsp* ), and organizations that provide more comprehensive health care free or at low-cost, such as Communicare in South Carolina or the Puget Sound Neighborhood Health Centers in Washington, should be able to help lower economic barriers to access for people with asthma who use OTC epinephrine MDIs. Although we do not believe that all of the people currently using OTC epinephrine MDIs due to economic barriers to health care can or will avail themselves of these programs, we do believe that these programs are widely available, and that they can provide adequate alternatives to OTC epinephrine MDIs for many people with asthma. This should minimize some of the adverse impacts that may result from the absence of OTC epinephrine MDIs. In looking at the issue of OTC epinephrine MDIs as an alternative for people with asthma who face barriers to health care, it should be kept in mind that the retail price of OTC epinephrine MDIs is also a barrier to health care. In comparing the price of OTC epinephrine to that of its alternatives, we must keep in mind that OTC epinephrine MDIs, which cost approximately $13 per inhaler (meeting transcript, p. 127), are not available through any low-cost drug plans. Prescription drugs obtained through these programs can be substantially less expensive than OTC epinephrine MDIs. To give one example, an eligible person obtaining VENTOLIN HFA (albuterol MDI) through GSK's “Bridges to Access” program would make a $10 co-payment for a 60-day supply of the drug; after 60 days no further co-payment is required (see *http://bridgestoaccess.gsk.com/index.html* ). OTC epinephrine MDIs are more expensive than prescription drugs for people who can and do avail themselves of low-cost drug programs such as “SP Cares” and “Bridges to Access.” A public speaker representing an asthma education and advocacy organization before the NDAC/PADAC meeting said that the longer duration of effect of albuterol and levalbuterol (and other newer prescription drugs that do not release ODSs) means that, while these drug are more expensive per MDI and per dose, they may be cheaper than OTC epinephrine MDIs when the price is calculated for each hour of relief (meeting transcript, pp. 159-160). While a drug's duration of action can affect the cost to a patient (or other payor) for therapy with the drug, we do not have the comparative clinical data to confirm the assertion made by the speaker. We believe that a small population of people with asthma who face barriers to health care may derive some benefit from having epinephrine MDIs available OTC. We also believe that utilization of programs providing low-cost or free prescription drugs may reduce, but not eliminate, the number of people with asthma facing barriers to health care who depend on OTC epinephrine MDIs. We are keenly interested in, and request comments on, the public health effect and costs that may result from the removal of OTC epinephrine MDIs from the market and how these programs may reduce any adverse impact on the public health. We will take under consideration and weigh carefully the potential consequences identified in public comments before issuing any final rule. In assessing the public health benefits of OTC epinephrine MDIs, the benefits of having the drug available OTC must be balanced against the potential risks, if any. c. *Do risks of self-treatment of asthma outweigh the public health benefits that OTC epinephrine MDIs may provide* ? Much of the discussion at the NDAC/PADAC meeting focused on the issue of whether the risks of self-treatment of asthma outweigh the public health benefits that OTC epinephrine MDIs may provide. This issue could affect any decision we make on the essential-use status of OTC epinephrine MDIs. Accordingly, we will discuss some of the points raised at the NDAC/PADAC meeting and other information we feel may be relevant, and request comment on these issues to the extent that they apply to OTC epinephrine MDIs as an essential use of ODSs. i. *Misdiagnosis of asthma* . OTC epinephrine MDIs are only indicated for mild intermittent asthma. The approved labeling for OTC epinephrine MDIs states that the drug should only be used after a doctor has diagnosed asthma. This is because asthma can be a difficult disease to diagnose, even for physicians (Ref. 19). COPD, vocal chord dysfunction, heart disease, and many other illnesses can be misdiagnosed as asthma (see Ref. 5, p. 22). The results of a study presented by Wyeth at the NDAC/PADAC meeting indicated that 92 percent of those surveyed who solely use OTC epinephrine MDI stated that they had been diagnosed with asthma by a doctor (Wyeth slide 23, citing Ref. 20). We do not have data on how recently the diagnoses were made or on the current accuracy of the diagnoses. The study did state that only 47 percent of those who solely use OTC epinephrine MDIs currently had a primary caregiver for management of asthma (Ref. 20, p. 989), which would seem to indicate that at least some of the diagnoses were not particularly recent. The Internet survey presented by Wyeth at the NDAC/PADAC meeting indicates that 8 percent of purchasers of OTC epinephrine MDIs have not been diagnosed with asthma by a physician, and 28 percent of those who solely use OTC epinephrine MDI reported that they visited a doctor's office in the past year for treatment of their asthma (Wyeth slide 33). This would imply that 72 percent of people who solely use OTC epinephrine MDI had not seen a doctor in the past year for diagnosis and treatment of their asthma. Asthma is a variable disease that can either lessen or worsen in severity over time. A person previously diagnosed with asthma may be asymptomatic for long periods of time. A diagnosis of asthma and, more important, an evaluation of its severity made at some point in the past may no longer be accurate. Currently, follow-up visits are recommended at 1- to 6-month intervals after an initial diagnosis of asthma (EPR-2, Ref. 5, p. 87). A previous diagnosis of asthma does not necessarily mean that an individual's current asthma-like symptoms are caused by asthma, or that the individual's asthma is of the same severity as originally diagnosed. The likelihood of the previous diagnosis accurately reflecting the patient's current status would seemingly have to decrease the older the diagnosis and evaluation is. A study referred to by Wyeth at the NDAC/PADAC meeting said that “self assessment of asthma severity may not be ‘on target,’ especially among individuals who self-medicate their illness with nonprescription bronchodilators” (Ref. 20, p. 992). It should be kept in mind that this was said about a group in which 92 percent had reported having been diagnosed by a physician as having asthma. This study was relatively small and, while potentially informative, it cannot be viewed as conclusive at this time. There are some additional data available on the potential misdiagnosis of the severity of asthma by purchasers of OTC epinephrine MDIs. Wyeth presented data at the NDAC/PADAC meeting that 76 percent of OTC epinephrine MDI purchasers bought one or two OTC epinephrine MDIs a year. This indicates that 24 percent of purchasers bought three or more OTC epinephrine MDIs each year. A Wyeth web page ( *http://www.primatene.com/faq/answers.asp#puffs* ) says that each 15 milliliters
(mL)vial should deliver 270 puffs and the 22.5 mL of PRIMATENE MIST vial should deliver 405 puffs. The 15 ml vial is the most popular size of PRIMATENE MIST (meeting transcript, p. 127). The 15 mL size is also the size manufactured for sale as house brands by Armstrong. If we look at three 15 mL MDIs used over a year-long period, we see that they would provide 16 puffs a week, a level of use that would indicate asthma incidents that are so frequent or severe that it no longer should be characterized mild intermittent asthma. We realize that some of the 24 percent of people who solely use OTC epinephrine MDIs and purchase three or more MDIs in a year may not be using all of the contents of the OTC epinephrine MDIs they purchase. They may be replacing lost MDIs or purchasing extra MDIs to keep at work or in a gym bag. It also should be noted that the use of two 22.5 mL vials a year also provides 16 puffs a week, again indicating a level of use that would not be associated with mild intermittent asthma. There is other evidence that purchasers of OTC bronchodilators were unable to correctly diagnose the severity of their asthma. A study was conducted in Australia of purchasers of albuterol (or salbutamol, as it is known in Australia and most of the rest of the world), a bronchodilator that was available both with and without a prescription in the State of New South Wales (Ref. 21). In that study, 95 percent of the surveyed purchasers who usually or always purchased albuterol without a prescription were undertreated for their asthma according to a relevant standard of care. We have not formed an opinion on the applicability of the study to the questions involved in this rulemaking. We realize that the study involved a different drug (albuterol), in a different country (Australia), and that the study is over 13 years old. However, we also recognize that the study may represent some of the better data currently available on the question of self-diagnosis of asthma by the purchasers of OTC bronchodilators. The evidence seems to suggest that many OTC epinephrine MDI purchasers are buying the drug based either on self-diagnosis or on an out-of-date physician's diagnosis. The issue of the accuracy of the diagnosis of asthma upon which a purchase of an OTC epinephrine MDI is made is very important in reaching a determination on the public health benefits of having the drug available OTC. While some evidence suggests that many purchasers of OTC epinephrine MDIs are doing so based on an inaccurate diagnosis of the severity of their asthma, we have not reached a conclusion on that evidence's weight and significance. ii. *Undertreatment of asthma* . Undertreatment of asthma can cause more frequent symptoms and attacks, missed work and school, activity limitations, a decline in lung health and function and, possibly, death (Ref. 9). As mentioned earlier, in the United States, the generally recognized standard of care for asthma is set forth in the EPR-2 (Ref. 5). In the 2002 update to EPR-2 (Ref. 6) we find the latest updates to the standard. Asthma is divided into four classes of severity, which correspond to treatment “steps.” More severe classes of asthma are defined by greater frequency of symptoms during the day and night, lower peak expiratory flow
(PEF)and forced expiratory volume in 1 second
(FEV1)(both are measurements of how well a patient can exhale using the greatest effort), and higher variability in PEF measurements over the course of a day. As the severity of a patient's asthma increases, treatment becomes more aggressive: For mild persistent asthma, daily use of an inhaled corticosteroid (available only by prescription) is recommended; if the patient has moderate persistent asthma, higher doses of inhaled corticosteroids and/or inhaled corticosteroids with a long-acting beta-agonist are recommended; and for severe persistent asthma, still higher doses of inhaled corticosteroids are recommended in conjunction with a long-acting bronchodilator (available only by prescription). If a patient's asthma becomes more severe, treatment should become more aggressive, and if the asthma is well controlled, a physician should generally try to reduce the quantity of drugs being taken in order to provide good control with the minimum quantity of drugs. This approach is characterized as a “stepwise approach for managing asthma” (EPR 2002 Update, Ref. 6, Appendix A-1). No daily medication is recommended for mild intermittent asthma, but the EPR-2 recommends the use of a short-acting inhaled beta <sup>2</sup> -agonist bronchodilator, as needed to treat the occasional bronchospasm. Albuterol is a short-acting inhaled beta <sup>2</sup> -agonist bronchodilator and albuterol MDIs are the most widely prescribed “rescue inhalers” in the United States. The EPR-2 does not recommend nonselective short-acting beta-agonist bronchodilators as rescue inhalers, but rather they recommend use of an inhaled short-acting beta <sup>2</sup> selective agonist. Beta-receptors are adrenergic sites in the autonomic nervous system in which physiological responses occur when agents, in this case beta-agonists, are bound to the receptor. Activation of beta-receptors causes various reactions, including relaxation of the bronchial muscles and an increase in the rate and force of cardiac contraction. The beta-receptors are subdivided into beta <sup>1</sup> , located primarily in the heart and intestinal smooth muscle, and beta <sup>2</sup> , more localized to bronchial, vascular, and uterine smooth muscles. Epinephrine is a non-selective beta-agonist which affects both the beta <sup>1</sup> and beta <sup>2</sup> -receptors so that it affects both heart and bronchial smooth muscles (as well as the intestinal, vascular, and uterine smooth muscles). Beta <sup>2</sup> selective agonists, such as albuterol, have less of an effect on the heart than beta <sup>1</sup> and non-selective beta-agonists have. Epinephrine's lack of selectivity has caused concerns about its effect on the heart, but the limited data we have before us do not indicate that use of OTC epinephrine MDIs is associated with a greater risk of significant adverse cardiovascular events. The question of undertreatment of asthma for purchasers of OTC epinephrine MDIs is not confined to people with asthma who solely or primarily use OTC epinephrine MDIs. The level of usage of short-acting beta <sup>2</sup> -agonists is a factor that should be monitored by physicians treating asthma patients (EPR-2, Ref. 6, p. 35). Increased usage may often indicate the need for treatment being stepped up, while decreased usage may indicate that treatment could be stepped down. The availability of OTC epinephrine MDIs allows patients to purchase a short-acting beta-agonist without a prescription. It seems possible that this may deny important information to the health care provider as to the accurate assessment of a patient's use of rescue inhalers. We are unaware of any data that directly address this issue. iii. *Patient education* . Patient education is generally regarded as a key component to successful asthma treatment. The EPR-2 says, “[E]ducation for an active partnership with patients remains the cornerstone of asthma management and should be carried out by health care providers delivering asthma care. Education should start at the time of asthma diagnosis and be integrated into every step of clinical asthma care” (Ref. 5, p. 5). Elements of patient education can include providing information about how asthma affects the lungs, the difference between short-acting rescue medications and control medications, the importance of using control medication as prescribed, important environmental control measures that may need to be considered, such as removing asthma triggers from the patient's home, the tracking of severity of the patient's asthma, and proper use of an MDI. The proper use of an MDI is an important factor in proper treatment of asthma. This issue was mentioned but not discussed at the NDAC/PADAC meeting (meeting transcript, p. 139). Improper use of an MDI can result in a reduction of the dose delivery by 50 percent or more (Ref. 22). A study in children and adolescents showed less than 25 percent used their MDIs correctly (Ref. 23), and a study in adults showed similar results (Ref. 24). Further, the last study showed that inadequate English language literacy is associated with poor use of MDIs. The importance of patient education may be a significant issue in any discussion of the risks and benefits of self-treatment of asthma. iv. *Effects of undertreatment* . While the cost of treatment for poor and medically underserved populations was frequently mentioned at the NDAC/PADAC meeting, much less was said about the effects and costs of undertreatment. A recent study of urban pediatric patients, who were predominantly from poor and minority households, showed that an increased use of corticosteroids in pediatric patients (in accordance with the guidelines in EPR-2) resulted in fewer hospitalizations, emergency department visits, and outpatient visits (Ref. 25). The importance of prompt appropriate treatment of asthma is reinforced by studies suggesting that delaying treatment with inhaled corticosteroids decreases the effectiveness of the inhaled corticosteroids once treatment begins (Refs. 26 and 27). Studies also indicate that regular use of beta-agonist bronchodilators may reduce the person with asthma's response to subsequent beta-agonist administration (Ref. 28). This tolerance could mean that patients who regularly use OTC epinephrine MDIs may be placed in a position where their occasional use of a beta <sup>2</sup> -agonist, as part of a course of treatment using inhaled corticosteroids as a control medication, may not be as effective for these patients as might otherwise be possible. The effects of undertreatment of asthma may be a key issue in any discussion of the risks and benefits of self-treatment of asthma. One public speaker did say that “a delay in the early introduction of prescription anti-inflammatory asthma therapy could lead to the development of irreversible lung damage” (meeting transcript, p. 171). We do not find his statement to be persuasive. The use of inhaled steroids was not shown to prevent damage to the lungs in several studies (Refs. 29, 30, and 31), and the evidence supporting the speaker's statement about “irreversible lung damage” is limited and not conclusive (Ref. 32). Any disagreement on the issue of permanent lung damage should not be allowed to obscure the fact that proper use of inhaled steroids significantly reduces asthma morbidity. 3. Conclusions on the Public Health Benefits of OTC Epinephrine MDIs We believe that epinephrine does not have any clinical advantages over albuterol HFA MDIs and that patient convenience for patients that have not kept their asthma drugs prescriptions current or do not have the prescribed drug product with them is not an important public health benefit. We have not reached a conclusion on the risks and benefits of continuing to have epinephrine available OTC for people with asthma who face barriers to obtaining appropriate health care, and therefore we cannot reach a conclusion on whether the use of OTC epinephrine MDIs provides an important health benefit. We specifically request comments on the expected costs and public health effects to individuals with asthma if OTC epinephrine MDIs were removed from the market without a similar product being available OTC. While our tentative conclusion that epinephrine is no longer an essential use is based primarily on the conclusion we have drawn regarding technical barriers to producing the epinephrine in a non-ODS formulation, we will evaluate the public-health effects of removal of OTC epinephrine from the market, and any final conclusions we reach on the essential-use designation of epinephrine may be significantly influenced by data received in comments on the public-health issues raised by this proposal. C. Does Use of OTC Epinephrine MDIs Release Cumulatively Significant Amounts of ODSs Into the Atmosphere or is the Release Warranted in View Of The Otherwise Unavailable Important Public Health Benefit? The use of CFCs in MDIs for the treatment of asthma and COPD is the only legal use in the United States of newly manufactured CFCs. The quantity of CFCs used in OTC epinephrine MDIs is a significant portion of the total quantity of newly manufactured CFCs used, and therefore eventually released, in the United States. The size of the portion will increase as other MDIs containing CFCs are removed from the market. As we discussed in part II of this document, the release of CFCs from MDIs is cumulatively significant. Because we have not reached a conclusion on the public health benefits of OTC epinephrine MDIs, we cannot reach a conclusion on whether the release of CFC ODSs is warranted in view of the public health benefits. D. Conclusions We have tentatively concluded the following: • The pharmaceutical industry has had success in formulating similar moieties without ODSs. In particular, HFA MDIs containing albuterol, a close chemical analog of epinephrine, have been approved by FDA. We have no evidence to suggest that formulating epinephrine in a product that does not release ODSs poses unique technical challenges. Therefore, we tentatively conclude that no substantial technical barriers exist to formulating an epinephrine inhaler without ODSs. • The release of ODSs into the atmosphere from OTC epinephrine MDIs is cumulatively significant. We have not reached a conclusion on whether the use of OTC epinephrine MDIs provides an unavailable important public health benefit or whether the release of ODSs from OTC epinephrine MDIs is warranted in view of the otherwise unavailable public health benefit. However, as we discussed in part II of this document, if a use fails to meet any one of the three criteria in § 2.125(f), FDA may elect to go through rulemaking to remove its essential-use designation. We have therefore tentatively concluded that oral pressurized MDIs containing epinephrine are no longer an essential use of ODSs and should be removed from the list of essential uses in § 2.125(e). As noted throughout the preamble, we are keenly interested in receiving public comments and any available data concerning technical barriers to developing an epinephrine inhaler without ODSs, the status of any ongoing efforts to develop such a product, and the public health effects and costs of removing epinephrine MDIs from the market prior to a similar product being available OTC. Any final conclusions that we reach on the essential-use designation of epinephrine may be significantly influenced by such comments. VI. Environmental Impact We have carefully considered the potential environmental effects of this action. We have tentatively concluded that the action will not have a significant adverse impact on the human environment, and that an environmental impact statement is not required. Our initial finding of no significant impact and the evidence supporting that finding, contained in a draft environmental assessment, may be seen in the Division of Dockets Management (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday. We invite comments on the draft environmental assessment. Comments on the draft environmental assessment may be submitted in the same way as comments on this document (see DATES ). VII. Analysis of Impacts A. Introduction FDA has examined the impacts of the proposed rule under Executive Order 12866 the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law No. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this proposed rule is a significant regulatory action as defined by the Executive order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The agency does not believe that the proposed rule would have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current
(2005)Implicit Price Deflator for the Gross Domestic Product. This proposed rule may result in a 1-year expenditure that would meet or exceed this amount. The Congressional Review Act requires that regulations that have been identified as being major must be submitted to Congress before taking effect. This rule is major under the Congressional Review Act. This proposed rule would prohibit sales of OTC epinephrine CFC MDIs in interstate commerce after December 31, 2010, forcing users to either self-medicate with less effective therapies (see section VII.D.3.a), or to visit a physician and get a prescription for an alternative drug product such as albuterol. Because OTC epinephrine CFC MDIs are widely regarded by physicians and people with asthma as the most effective relief medication for asthma available OTC, if users of these MDIs choose to self-medicate, they will be more likely to require hospitalization or an emergency department visit. Alternatively, if they choose to see a physician to obtain a prescription for albuterol, the OTC epinephrine CFC MDI users, or their insurers, will have to pay more, not only for visits to the physician, but also for more expensive drugs. More physician visits, however, may lead current OTC epinephrine MDI users to increase their use of prescription control medication, such as inhaled corticosteroids, which should decrease their likelihood of both asthma attacks and hospital visits. We have no data suggesting whether current OTC epinephrine MDI users are more likely to self-medicate or to visit a physician and get an albuterol MDI prescription once OTC epinephrine MDIs are no longer available. We therefore focus on scenarios where, if OTC epinephrine MDIs are no longer available, all current OTC epinephrine MDI users either self-medicate with other products such as herbal supplements, caffeine, and OTC ephedrine or visit a physician to obtain, and fill, prescriptions for albuterol MDIs. These extreme scenarios offer plausible bounds for estimating the costs and benefits resulting from this proposed rule and regulatory alternatives. CFCs available for production of OTC epinephrine MDIs may be exhausted prior to the effective date of this proposed rule if the United States was unable to obtain an essential-use allocation for CFCs under the Montreal Protocol for use in OTC epinephrine MDIs for 2010 (see Ref. 33, p. 59). If so, this proposed rule may not have any significant impacts. To the extent that CFCs for production of OTC epinephrine MDIs remain available, we estimate this proposed rule will have the impacts summarized in the following table. **Table 2.—Summary of Annual Quantifiable Effects of the Proposed Rule, Assuming CFCs for Production of OTC Epinephrine MDIs Remain Available** Increased Health care Expenditure, in 2006 Dollars Increased Emergency Department Visits for Asthma Increased Hospitalizations for Asthma Reduced CFC Emissions from Phase-Out (tonnes) If current OTC epinephrine MDI users self-medicate $360 million to $1.0 billion 0 to 440,000 40,000 to 120,000 70 If current OTC epinephrine MDI users visit their physician for prescription albuterol (excluding controller medication) $170 million to $340 million 70 We are unable to estimate quantitatively the reductions in skin cancers, cataracts, and environmental harm that may result from the reduction in CFC emissions by roughly 70 tonnes during these years. Although we cannot estimate quantitatively the public health effects of the phase-out, based on a qualitative assessment, the agency concludes that the benefits of this regulation justify its costs. We state the need for the regulation and its objective in section VII.B of this document. Section VII.C of this document provides background on CFC depletion of stratospheric ozone, the Montreal Protocol, the OTC epinephrine MDI market, and the health conditions that epinephrine is used to treat. We analyze the benefits and costs of the rule, including effects on government outlays, in section VII.D of this document. We assess alternative dates in section VII.E of this document, and discuss sensitivity analysis in section VII.F of this document. We present an analysis of the effects on small business in a regulatory flexibility analysis in section VIII of this document. We discuss our conclusions in section VII.H of this document. B. Need for Regulation and the Objective of This Rule This proposed regulation responds to U.S. obligations under the Montreal Protocol, as well as the requirements of the Clean Air Act. The Montreal Protocol itself recognizes that the regulation of ODSs is necessary because private markets are very unlikely to preserve levels of stratospheric ozone sufficient to protect the public health. In private markets, individual users of CFC MDIs have no significant private incentive to switch to non-ozone-depleting products because under current regulations the environmental and health costs of ozone-depleting products are external to users. Moreover, should MDI users voluntarily internalize these costs by switching to alternative products, they would not receive the benefits of their actions. Each user would bear all of the costs and virtually none of the benefits of such a switch, as the environmental and health benefits would tend to be distributed globally and occur decades in the future. Thus, the outcome of an unregulated private market would be the continued use of CFC MDIs, even if the social value of reducing emissions were clearly much greater than the price premium for non-ozone-depleting therapies. One of the objectives of this proposed rule is to respond to the obligations under the Montreal Protocol requiring the United States to reduce atmospheric emissions of ODSs, specifically CFCs. CFCs and other ODSs deplete the stratospheric ozone that protects the Earth from ultraviolet solar radiation. We are proposing to end the essential-use designation for ODSs used in MDIs containing epinephrine because we have tentatively concluded that no substantial technical barriers exist to formulating epinephrine in a product that does not release ODSs (see section V.A of this document). Removing this essential-use designation will reduce emissions that deplete stratospheric ozone. C. Background 1. CFCs and Stratospheric Ozone During the 1970s, scientists became aware of a relationship between the level of stratospheric ozone and industrial use of CFCs. Ozone (O <sup>3</sup> ), which causes respiratory problems when it occurs in elevated concentrations near the ground, shields the Earth from potentially harmful solar radiation when it is in the stratosphere. Excessive exposure to solar radiation is associated with adverse health effects, such as skin cancer and cataracts, as well as adverse environmental effects. Emissions of CFCs and other ODSs reduce stratospheric ozone concentrations through a catalytic reaction, thereby allowing more solar radiation to reach the Earth's surface. Because of this effect and its consequences, environmental scientists from the United States and other countries advocate ending all uses of these chemicals. 2. The Montreal Protocol The international effort to craft a coordinated response to the global environmental problem of stratospheric ozone depletion culminated in the Montreal Protocol, an international agreement to regulate and reduce production of ODSs. The Montreal Protocol is described in section I.B.2 of this document. One hundred and ninety-one countries have now ratified the Montreal Protocol, and the overall usage of CFCs has been dramatically reduced. In 1986, global consumption of CFCs totaled about 1.1 million tonnes, and by 2004, total annual production had been reduced to 70,000 tonnes (Ref. 34). This decline amounts to more than a 90-percent decrease in production and is a key measure of the success of the Montreal Protocol. Within the United States, use of ODSs, and CFCs in particular, has fallen sharply—production and importation of CFCs is less than 1 percent of 1989 production and importation (Ref. 34). A relevant aspect of the Montreal Protocol is that production of CFCs in any year by any country is generally banned after the phase-out date unless the Parties to the Montreal Protocol agree to designate the use for which the CFCs are produced as “essential” and approve a quantity for that use. Each year, each Party nominates the amount of CFCs needed for each essential use and provides the reason such use is essential. Agreement on both the essentiality and the amount of CFCs needed for each nominated use has been reached by consensus at the annual Meeting of the Parties. 3. Benefits of the Montreal Protocol EPA has generated a series of estimates of the environmental and public health benefits of the Montreal Protocol (Ref. 35). The benefits include reductions of hundreds of millions of nonfatal skin cancers, 6 million fewer fatalities due to skin cancer, and 27.5 million cataracts avoided between 1990 and 2165 if the Montreal Protocol were fully implemented. EPA estimates the value of these and related benefits to equal $4.3 trillion in present value when discounted at 2 percent over the period of 175 years. This amount is equivalent to about $6 trillion after adjusting for inflation between 1990 and 2004. This estimate includes all benefits of total global ODS emission reductions expected from the Montreal Protocol and is based on reductions from a baseline scenario in which ODS emissions would continue to grow for decades but for the Montreal Protocol. 4. Characteristics of Asthma OTC epinephrine MDIs are used to treat asthma, a chronic respiratory disease characterized by episodes or attacks of bronchospasm on top of chronic airway inflammation. These attacks can vary from mild to life-threatening and involve shortness of breath, wheezing, cough, or a combination of symptoms. Many factors, including allergens, exercise, and viral infections may trigger an asthma attack. Early release data from the first 6 months of the 2006 NHIS indicate that 8.0 percent of people in the United States have asthma (Ref. 36, fig. 15.5). The prevalence of asthma decreases with age, with the prevalence being 9.5 percent for children ages 0 to 14, compared to 7.8 percent for persons ages 15 to 34, and 7.4 percent for adults ages 35 and over (Ref. 36, fig. 15.5). The early release data from the first 6 months of the 2006 NHIS also indicate 4.2 percent of Americans had an asthma episode in the previous 12 months, with 5.5 percent of children under age 14, 3.6 percent of persons ages 15 to 34, and 4.0 percent of adults over age 35 reporting episodes (Ref. 36, fig. 15.2). According to data from the National Ambulatory Medical Care Survey, in 2004 there were about 15 million outpatient asthma visits to physician offices and hospital clinics and 1.8 million emergency department visits (Ref. 37, table 19). According to data from the National Center for Health Statistics: National Hospital Discharge Survey, there were 497,000 hospital admissions for asthma in 2004 (Ref. 37, table 12) and 4,099 mortalities in 2003 (Ref. 37, table 1). The estimated direct medical cost of asthma (hospital services, physician care, and medications) was $11.5 billion in 2004 (Ref. 37, table 20). We estimate that OTC epinephrine MDI users make roughly 280,000 to 370,000 visits to emergency departments and require roughly 75,000 to 100,000 hospitalizations annually. We know of no data or study suggesting OTC epinephrine MDI users differ from other people with asthma in their risk of requiring emergency department visits or hospitalizations. In a published study of 601 people with asthma (Ref. 38), the authors did not find any evidence that epinephrine users are more likely to visit emergency departments or to require hospitalization than people with asthma who do not use epinephrine. On the other hand, we know of no data suggesting that OTC epinephrine MDI users are less likely to visit emergency departments or require hospitalization. As described in section V.B.2.b of this document, we estimate that 1.7 to 2.3 million people with asthma use OTC epinephrine MDIs. Assuming 1.7 to 2.3 million people with asthma are OTC epinephrine MDI users, and that they require emergency department visits and hospitalization in proportion to their share of the population, OTC epinephrine MDI users account for roughly 280,000 to 370,000 emergency department visits annually [15 percent of 1.8 million = 280,000; 20 percent of 1.8 million = 370,000] and 75,000 to 100,000 hospitalizations annually [15 percent of 497,000 = 75,000; 20 percent of 497,000 = 100,000]. 25 25 The 15 to 20 percent figures were derived, in part, from comparing the number of purchasers of OTC epinephrine MDIs to the number of adults suffering an asthma incident in the previous 12 months. While the prevalence of asthma (the percent of the population diagnosed with asthma) has been increasing in recent years, CDC reports that the incidence of asthma (the rate of new diagnoses) has remained fairly constant since 1997 (Ref. 39). Non-Hispanic Blacks, children under 17 years old, and females have higher incidence rates than the general population and also are more likely to have had an attack of asthma in the previous 12 months. The CDC notes that although increases have occurred in the numbers and rates of physician office visits, hospital outpatient visits, and emergency department visits, these increases are accounted for by the increase in prevalence. The CDC also notes that asthma mortality and asthma hospitalization rates were declining and stated that these downward trends might indicate early successes by asthma intervention programs. 5. Current U.S. Market for OTC Epinephrine MDIs We estimate that 1.7 million to 2.3 million consumers purchase roughly 4.5 million OTC epinephrine MDIs in the United States each year, at an average price of $13.29 per MDI. Based on data from ACNielsen for the 52 weeks ending September 9, 2006 (Ref. 40), we estimate 3.5 million OTC epinephrine MDIs are sold in the United States annually, excluding sales through Wal-Mart Stores, Inc. (Wal-Mart). 26 Wyeth estimates roughly 25 percent of OTC medications such as PRIMATENE MIST, a branded OTC epinephrine MDI product, are sold through Wal-Mart annually (Wyeth slide 32), implying a total market of roughly 4.5 million OTC epinephrine MDIs sold annually. This is equivalent to 1.3 billion inhalations per year, or 146 million days of therapy (at 9 inhalations per day, the highest recommended long-term dose). 26 Retail sales data from drug stores and supermarkets provided by ACNielsen do not include retail sales data from Wal-Mart because Wal-Mart does not participate in ACNielsen surveys. Based on ACNielsen data (Ref. 40) for the 52 weeks ending September 9, 2006, adjusted for sales through Wal-Mart, we estimate OTC epinephrine MDI sales amount to roughly $60 million in the United States annually and the average U.S. retail price of OTC epinephrine MDIs is $13.29, equivalent to roughly $0.41 per day of therapy. According to American Lung Association reports derived from the National Center for Health Statistics' 2004 NHIS (Ref. 37, table 10), 11.6 million individuals reported having had an asthma attack in the last 12 months. According to Wyeth Pharmaceuticals (Wyeth slide 32), 15 to 20 percent of adults with asthma that have had an asthma attack in the previous 12 months use OTC epinephrine MDIs. As we discussed in section V.B.2.b of this document, we estimate that 1.7 to 2.3 million people with asthma use OTC epinephrine MDIs. Each of these users, on average, purchases roughly 1.9 to 2.6 OTC epinephrine MDIs each year [4.5 million MDIs ÷ 1.7 million users = 2.6 MDIs per user per year; 4.5 million MDIs ÷ 2.3 million users = 1.9 MDIs per user per year]. We estimate 600,000 to 1.3 million OTC epinephrine MDI users do not regularly use prescription asthma products. According to Wyeth Pharmaceuticals, somewhere between 43 percent (Wyeth slide 33) and two-thirds (Wyeth slide 32) of OTC epinephrine MDI users also use prescription drugs for treatment of their asthma. This implies that 600,000 to 1.3 million OTC epinephrine MDI users do not use prescription asthma medicine [1,752,653 x .33 = 578,375; 2,336,871 x .57 = 1,332,016]. D. Benefits and Costs of the Proposed Rule We estimate the benefits and costs of government action relative to a baseline scenario that, in this case, is a description of the production, use, and access to OTC epinephrine MDIs in the absence of a final rule based on this proposed rule. In this section we first describe such a baseline, and then present our analysis of the benefits of the rulemaking. We also present an analysis of the most plausible regulatory alternatives, given the Montreal Protocol. Next, we turn to the costs of the rulemaking and to an analysis of the effects on the Medicare and Medicaid programs. 1. Baseline Conditions We developed baseline estimates of future conditions to assess the economic effects of prohibiting marketing of OTC epinephrine MDIs after December 31, 2010. It is standard practice to use, as a baseline, the state of the world without the rulemaking in question, or where the rulemaking implements a legislative requirement, the world without the statute. For this proposed rule, we make the baseline assumption that it is questionable if the United States would be able to obtain an essential-use allocation for CFCs for the manufacture of OTC epinephrine MDIs under the Montreal Protocol for 2010. 27 To the extent that new CFCs for production of OTC epinephrine MDIs remain available past that date, we estimate this rulemaking will have quantifiable impacts as summarized in table 2. If CFCs for the production of OTC epinephrine MDIs are no longer available by the end of 2010, this rule will have no impact. 27 Even if there is no essential-use allocation under the Montreal Protocol for the year 2010, production of epinephrine CFC MDIs would likely continue well into the year with manufacturers using preexisting stocks of CFCs. 2. Benefits of the Proposed Rule The benefits of a final rule based on this proposed rule include environmental and public health improvements from protecting stratospheric ozone by reducing CFC emissions by roughly 70 tonnes annually. Benefits also include expectations of increased returns on investments in environmentally friendly technology, reduced risk of unexpected disruption of supply of OTC epinephrine MDIs, and continued international cooperation to comply with the spirit of the Montreal Protocol, thereby potentially reducing future emissions of ODSs throughout the world. Failure to finalize this proposed rule may lead the Parties to the Montreal Protocol to consider restrictions on access to the CFCs required to manufacture these OTC epinephrine MDIs products, which could create the risk of removal of these products from the market. a. *Reduced CFC emissions* . Withdrawal of OTC epinephrine MDIs from the market will reduce CFC emissions by approximately 70 tonnes per year. Current CFC inventories are substantial. Nominations for new CFC production are generally approved by the Parties to the Montreal Protocol 2 years in advance. The proposed rule would ban marketing of OTC epinephrine CFC MDIs after December 31, 2010. There is some uncertainty with respect to the amount of inventory that will be available in the future, but the United States' ability to obtain an essential-use allocation for CFCs for the manufacture of OTC epinephrine MDIs in 2010 is questionable. In an evaluation of its program to administer the Clean Air Act, EPA has estimated that the benefits of controlling ODSs under the Montreal Protocol are the equivalent of $6 trillion in 2004 dollars. However, EPA's report provides no information on the total quantities of reduced emissions or the incremental value per tonne of reduced emissions. EPA derived its benefits estimates from a baseline that included continued increases in emissions in the absence of the Montreal Protocol. We have searched for authoritative scientific research that quantifies the marginal economic benefit of incremental emission reductions under the Montreal Protocol, but have found none conducted during the last 10 years. As a result, we are unable to quantify the environmental and human health benefits of reduced emissions from this regulation. Such benefits, in any event, were included in EPA's earlier estimate of benefits. The reduction of CFC emissions associated with removing OTC epinephrine CFC MDIs from the U.S. market represents only a fraction of 1 percent of total global CFC emissions. Current allocations of CFCs for OTC epinephrine MDIs account for less than 0.1 percent of the total 1986 global production of CFCs (Ref. 41). Furthermore, current U.S. CFC emissions from MDIs represent a much smaller, but unknown share of the total emissions reduction associated with EPA's estimate of $6 trillion in benefits, because that estimate reflects future emissions growth that has not occurred. If a final rule removing the essential-use designation of OTC epinephrine MDIs takes effect before CFCs cease to be available, the proposed rule may account for some small part of the benefits estimated by EPA. However, we are unable to assess or quantify specific reductions in future skin cancers and cataracts associated with the reduced emissions that might be associated with this proposed rule or the regulatory alternatives. b. *Returns on investment in environmentally-friendly technology* . Establishing a phase-out date prior to the expiration of patents on HFA MDI technology and other aerosolized drug technology that does not use ODSs rewards the developers of the ozone-safe technologies. In particular, such a phase-out date would validate expectations that the government will protect incentives to research and develop ozone-safe technologies. Newly developed technologies to avoid ODS emissions have resulted in more environmentally “friendly” air conditioners, refrigerants, solvents, and propellants, but only after significant investments. Several manufacturers have claimed development costs that total between $250 million and $400 million to develop HFA MDIs and new propellant-free devices for the global market (Ref. 42). These investments have resulted in several innovative products in addition to HFA MDIs. For example, breath-activated delivery systems, dose counters, DPIs, and mini-nebulizers have also been successfully marketed. c. *International cooperation* . The advantages of selecting a date that maintains international cooperation are substantial because the Montreal Protocol, like most international environmental treaties, relies primarily on a system of national self-enforcement, although it also includes a mechanism to address noncompliance. In addition, compliance with the Montreal Protocol's directives is subject to differences in national implementation procedures. Economically less-developed nations, which have slower phase-out schedules than developed nations, have emphasized that progress in eliminating ODSs in developing nations is affected by observed progress of developed nations, such as the United States. If we had adopted a later phase-out date, other Parties could attempt to delay their own control measures. 3. Costs of the Proposed Rule and Alternatives The costs of removing OTC epinephrine MDIs from the market include the costs of increased physician visits, increased use of more expensive reliever MDIs, and potential increases in the use of controller medications, visits to emergency departments, and hospitalizations. Because we cannot predict whether OTC epinephrine MDI users will self-medicate or go to a physician for a prescription reliever once OTC epinephrine MDIs are removed from the market, we quantify the costs for two extreme cases. In the first case, OTC epinephrine MDI users not already seeing a physician self-medicate, while those who already see a physician switch from OTC epinephrine MDIs to albuterol HFA MDIs. In the second case, all OTC epinephrine MDI users visit their physician and switch to albuterol HFA MDIs. We propose these two cases as reasonable bounds for the expected cost of removing OTC epinephrine MDIs from the market. a. *Self-medication* . If all OTC epinephrine MDI users who do not already see a physician for asthma were to self-medicate once OTC epinephrine MDIs were no longer available, and those who do see a physician were to increase their albuterol use, we estimate this rulemaking would result in $360 million to $1.0 billion in increased spending annually. This spending includes $280 million to $1.0 billion resulting from increased hospitalizations and emergency department visits, and roughly $30 million to $80 million in increased spending on more expensive medicines. Under the assumption of self-medication, we estimate that removing OTC epinephrine MDIs from the market would result in 40,000 to 120,000 more hospitalizations for asthma annually, and up to 440,000 more asthma-related emergency department visits each year. These estimates, based on calculations throughout this section, do not capture the decreased quality of life of OTC epinephrine MDI users, lost productivity, or the cost of alternative therapies, such as herbal remedies, caffeine and OTC ephedrine. The authors of a published study found that people with asthma who self-medicate with herbal products and caffeine, the most common forms of self medication, are at increased risk of requiring an emergency department visit or hospitalization (Ref. 38). They found that those using herbal treatments are 2.5 times as likely to require hospitalization, and that those who use caffeine to treat asthma are 3.1 times as likely as other people with asthma to require both an emergency department visit and hospitalization. We estimate that OTC epinephrine MDI users who do not use prescription medicine for their asthma make roughly 100,000 to 200,000 emergency department visits and require roughly 25,000 to 50,000 hospitalizations. We estimate OTC epinephrine MDI users make roughly 280,000 to 370,000 emergency department visits and require about 75,000 to 100,000 hospitalizations annually, as described in section VII.C.4 of this document. We estimate somewhere between 43 percent and two-thirds of OTC epinephrine MDI users do not use prescription medicine for their asthma, as discussed in section 6. Assuming that OTC epinephrine MDI users who do not use prescription medicine for asthma do not differ in their rates of hospitalization and emergency department visits from those who do use prescription medicine for asthma, we estimate that OTC epinephrine MDI users who do not use prescription medicine for asthma make 100,000 to 200,000 emergency department visits and require 25,000 to 55,000 hospitalizations annually [275,700 emergency department visits x 1/3 = 91,900 emergency department visits; 367,600 emergency department visits x (1 - .43) = 209,532 emergency department visits; 74,550 hospitalizations x 1/3 = 24,850 hospitalizations; 99,400 hospitalizations x (1 - .43) = 56,658 hospitalizations]. If current OTC epinephrine MDI users who do not use prescription medicine for asthma were to self-medicate with herbal treatments, and those self-medicating with herbal treatments face 2.5 times the risk of a hospitalization, this would imply a lower bound increase of roughly 40,000 hospitalizations [24,850 hospitalizations x (2.5 - 1) = 37,275]. As an upper bound, if all OTC epinephrine MDI users were to self-medicate with caffeine, emergency department visits would increase by roughly 440,000 [209,532 emergency department visits x (3.1 - 1) = 440,017] and hospitalizations would increase by roughly 120,000 [56,658 hospitalizations x (3.1 - 1) = 118,983]. We do not have data that will allow us to estimate increases in hospitalizations and emergency department visits for patients using other forms of self-medication, such as OTC ephedrine. We request comments that would provide information allowing us to address this issue. We estimate the 2006 cost of an emergency department visit for asthma at roughly $300 and the cost of hospitalization for asthma at roughly $7500. Based on data from the 2004 National Hospital Discharge Survey, the American Lung Association estimates the 497,000 hospitalizations for asthma cost roughly $3.6 billion in inpatient care and physician services, equivalent to roughly $7,300 per hospitalization (Ref. 37). The 1.8 million emergency department visits for asthma cost about $518 million, equivalent to roughly $280 per visit. Adjusting these figures for inflation according to the CPI for medical care, we estimate that the average hospitalization for asthma would cost roughly $7,500 and the average emergency department visit for asthma would cost roughly $300 in 2006. Based on these estimates, if current OTC epinephrine MDI users who do not currently use prescription medicine were to self-medicate, the result would be costs of roughly $280 million [37,275 hospitalizations x $7,565.84 = $282,016,770] to $1.0 billion annually [(118,982 hospitalizations x $7,565.84) + (440,017 emergency department visits x $294.17) = $1,029,639,003]. Assuming current OTC epinephrine MDI users who do use prescription medicine for asthma increase their use of albuterol HFA MDIs without requiring more frequent physician visits, we estimate that they will pay roughly $30 million to $80 million more for medicine each year. As discussed in section 6, somewhere between 43 percent and two-thirds of OTC epinephrine MDI users also use prescription medicine for their asthma. Assuming current OTC epinephrine MDI users who also use prescription medicines for their asthma use roughly the same number of OTC epinephrine MDIs per year as those who do not, we estimate dual users use roughly 2 million to 3 million OTC epinephrine MDIs annually [4,486,104 MDIs x 0.43 = 1,929,025; 4,486,104 MDIs x 2/3 = 2,990,736 MDIs]. As discussed in the following section, we estimate an albuterol HFA MDI will cost between $16 and $25 more than an OTC epinephrine MDI, and that one albuterol MDI is roughly equivalent to one OTC epinephrine MDI. The lower priced albuterol MDIs are currently being withdrawn from the market, and will not be available at the time of the proposed effective date of this rule (see 70 FR 71685). The higher price for albuterol HFA MDIs implies that if OTC epinephrine MDI users who also use prescription medicine for their asthma were to increase their use of albuterol HFA MDIs when OTC epinephrine MDIs are no longer available, they and their insurers would spend roughly $30 million to $80 million more per year for medicine [1,929,025 MDIs x $16.08 per MDI = $31,022,023; 2,990,736 MDIs x $25.15 per MDI = $76,418,426]. In total, self-medication by OTC epinephrine-only MDI users and increased albuterol use by those already using prescription medicine would result in increased spending of $360 million to $1.0 billion annually [$282,016,770 + $76,418,426 = $358,435,196; $1,029,639,003 + $31,022,023 = $1,060,661,026]. b. *Increased physician visits and albuterol use* . If, as a result of the removal of OTC epinephrine MDIs from the market, all current OTC epinephrine MDI users were to seek out prescription albuterol HFA MDIs through increasing the frequency of physician visits, we estimate that this scenario would result in roughly $170 million to $340 million in increased health care spending, including $100 million to $225 million in economic costs through an increase in visits to physicians and $72 million to $114 million in increased spending on prescription albuterol. We estimate that if current epinephrine users who do not use prescription medicine for their asthma make one additional physician visit per year to enable them to switch from OTC epinephrine MDIs to albuterol MDIs, the result would be roughly 600,000 to 1.3 million additional physician visits annually. This estimate stems directly from the estimate presented in section 6 that there are roughly 600,000 to 1.3 million epinephrine users who do not use prescription medicine for their asthma. These estimates assume that OTC epinephrine MDI users who do use prescription medicine for their asthma, and therefore already make regular physician visits, are able to increase their albuterol use without increasing the frequency of those visits. We estimate the 2006 cost of a physician visit for asthma to be roughly $170. Based on 2004 data from the National Ambulatory Medical Care Survey, the American Lung Association estimates that 1.5 million physician visits and non-emergency outpatient hospital visits for asthma cost roughly $2.4 billion, equivalent to roughly $160 per physician visit. Adjusting these figures for inflation according to the CPI for medical care, we estimate that a physician visit for asthma would cost roughly $170 per visit in 2006. An increase of 600,000 to 1.3 million physician visits each year would therefore cost roughly $100 million to $225 million annually [584,217.75 visits x $168.966 per visit = $98,712,936; 1,332,016.47 visits x $168.966 per visit = $225,065,495]. These estimates do not take into account the value of the time patients spend visiting their physicians. If all current OTC epinephrine MDI users were to switch to prescription albuterol HFA MDIs, we estimate the result to be roughly $70 million to $115 million in increased spending on medicine. We estimate that it will take roughly one albuterol HFA MDI to replace each OTC epinephrine MDI removed from the market. OTC epinephrine MDIs contain roughly 270, 405, or 540 inhalations, depending on the size of the MDI. Based on ACNielsen data for the 52 weeks ending September 9, 2006 (Ref. 40), we estimate that the average OTC epinephrine MDI contained 293 inhalations, equivalent to 32.6 days of therapy, assuming OTC epinephrine MDI users use, but do not exceed, the long term maximum recommended dose of 9 inhalations per day. The usual dosage of albuterol HFA MDIs is 8 to 12 inhalations per day, and albuterol HFA MDIs contain 200 inhalations, implying that each MDI contains 17 to 25 days of therapy per MDI. Allowing for the greater therapeutic effectiveness of albuterol compared to epinephrine, we estimate it will take roughly one albuterol HFA MDI to replace each OTC epinephrine MDI removed from the market. Based on ACNielsen data from the 52 weeks ending September 9, 2006 (Ref. 40), we estimate the average retail price of an OTC epinephrine MDI to be $13.29. Based on average retail sales prices across all payer types for the first half of 2004, the average albuterol HFA MDI cost $39.42 (Ref. 43). This estimate does not reflect less expensive albuterol HFA MDIs introduced to the market since that time. Some market analysts also predict that albuterol HFA MDI prices will decline up to 20 percent as the market switches away from albuterol CFC MDIs and large payers use their market power to drive down prices (Ref. 44). Taking these factors into consideration, we estimate the average retail price of an albuterol HFA MDI is $30 or more, a price increase of roughly $16 to $25 per MDI. If current OTC epinephrine MDI users must purchase one albuterol MDI for each OTC epinephrine MDI they currently purchase, total expenditures by current OTC epinephrine MDI users and their insurers would increase roughly $70 million to $115 million [4,486,104 MDIs x $16.08 per MDI = $72,134,239; 4,486,104 MDIs x $25.55per MDI = $114,627,640]. If, instead of self-medicating, OTC epinephrine MDI users go to the physician and increase their use of albuterol HFA MDIs, we estimate increased spending of roughly $170 million to $340 million dollars annually [$98,712,936 for physician visits + $72,134,239 for medicine (albuterol) = $170,857,175; $225,065,495 in physician visits + $114,627,640 in medicines = $339,693,135]. These estimated expenditures would decrease dramatically if generic albuterol HFA MDIs were to be introduced to the market. Patents listed in “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) for albuterol HFA MDIs expire in 2010 and 2017, making those possible dates for generic entry. Of course, unforeseen introduction of alternative therapies could reduce these expected increases in expenditures. These increased expenditures represent, to some extent, transfers from consumers and third-party payers, including the Federal Government and State governments, to pharmaceutical manufacturers, patent holders, and other residual claimants. However, to some extent, these increased expenditures represent purchases of products that are more costly to manufacture and bring to market, and, therefore, would be social costs. We are unable to estimate the fraction of those increased expenditures on drugs that constitute social costs. c. *Controller medication* . We estimate that the cost to current OTC epinephrine MDI users of filling additional prescriptions for controller medications would, on average, exceed the potential direct cost savings from reducing hospitalizations and emergency department visits by more than $280 per current OTC epinephrine MDI user. In a study of almost 50,000 asthma patients (Ref. 45), the authors found that patients with low adherence to controller medication have significantly higher risk (odds ratio of 1.72) of emergency department visits or of hospitalization relative to patients with moderate or high adherence. The study found that patients receiving high daily doses of controller medication had the lowest risk (odds ratio of .37) of emergency department visits or of hospitalization. As discussed in section VII.D.3.a of this document, we estimate OTC epinephrine MDI users who do not use prescription medicines make roughly 100,000 to 200,000 emergency department visits and require about 25,000 to 55,000 hospitalizations annually. If they all were to visit their physicians, receive prescriptions for a controller medication, fill them, and use the medication, based on the results of the study of almost 50,000 asthma patients, we estimate 20 to 40 percent of these emergency department visits and hospitalizations could be avoided, equivalent to roughly 20,000 to 80,000 fewer emergency department visits [20 percent of 91,900 is 18,380; 40 percent of 209,532 is 83,813] and 5,000 to 10,000 fewer hospitalizations [20 percent of 24,850 is 4,970; 40 percent of 56,658 is 11,332]. Assuming the average cost for an emergency department visit for asthma is about $300 and the average cost of a hospitalization for asthma is roughly $7,500, as discussed in section D.3.a of this document, this would reduce health care costs by roughly $40 million to $100 million annually [($294.17 per visit x 18,380) + ($7565.84 per hospitalization x 4,970) = $41,236,000; ($294.14 per visit x 83,813) + ($7565.84 per hospitalization x 11,332) = $105,837,600]. This cost is roughly $70 to $80 per current OTC epinephrine MDI user per year [$41,236,000 / 584,218 OTC epinephrine only MDI users = $70.58; $105,837,600 / 1,332,016 OTC epinephrine only MDI users = $79.46]. We looked at a range of CFC-free controller medications such as FLOVENT HFA, ASMANEX TWISTHALER, PULMICORT TURBOHALER, and QVAR, and found the wholesale price of the smallest dose of the least expensive medication to be roughly $1.00 per day of therapy, 28 equivalent to roughly $370 per patient year of therapy. On average, the cost of increasing the use of controller medication among current OTC epinephrine MDI users who do not currently use prescription medicine would exceed the benefits, in terms of decreased emergency department visits and hospitalizations, by over $280 per person per year. This number would be lower if a greater fraction of people with asthma at high risk of emergency department visits were to begin using controller medication on a regular basis, and higher if a greater fraction of low risk people with asthma were to begin using controller medication on a regular basis. These estimates do not take into account the impact of asthma attacks on individuals' quality of life and productivity. 28 Analysis completed by FDA based on information provided by IMS Health, IMS National Sales Perspective (TM), 2005, extracted March 2006. 4. Effects on Medicaid and Medicare As a result of the removal of OTC epinephrine CFC MDIs from the market, we estimate State and Federal Medicaid spending will increase $35 million to $250 million annually and that Federal Medicare spending, together with private spending by Medicare beneficiaries, will increase $20 million to $250 million annually. Some OTC epinephrine MDI users may be eligible for both Medicare and Medicaid. To the extent this population is large, these estimates overstate potential spending increases from this proposed rule by counting these individuals twice: once in Medicaid estimates and once in Medicare estimates. We are unable to estimate the size of the population of OTC epinephrine MDI users eligible for both programs. a. *Medicaid* . We estimate that 20 to 25 percent of the costs of the removal of OTC epinephrine MDIs from the market will be born by State and Federal Medicaid programs, equivalent to $70 million to $250 million annually if Medicaid-eligible OTC epinephrine MDI users who do not use prescription medicine for their asthma were to self-medicate upon implementation of this proposed rule, and equivalent to $35 million to $85 million annually if Medicaid-eligible OTC epinephrine MDI users were to visit their physicians to obtain and fill prescriptions to enable them to switch to albuterol. Assuming epinephrine users with insurance, including Medicaid, are more likely to visit a doctor, and less likely to self-medicate, the costs of this proposed rule are more likely to fall in the $35 million to $85 million range. According to proprietary surveys conducted by or for Wyeth between 1993 and 1994 (Wyeth slide 31), 27 percent to 33 percent of OTC epinephrine MDI users had incomes of less than $20,000 at the time the surveys were conducted. A 2005 Internet survey conducted by Wyeth found that 20 percent of OTC epinephrine MDI users had incomes of less than $25,000. Eligibility for Medicaid varies by State but is generally tied to the Federal poverty guidelines (Ref. 46). The 2006 Federal poverty guidelines establish a poverty threshold of $20,000 in annual income for a family of four (Ref. 47). Accordingly, if we assume 20 percent to 25 percent of OTC epinephrine MDI users are eligible for Medicaid, if Medicaid-eligible OTC epinephrine MDI users who do not use prescription medicine were to self-medicate, and if those who do self-medicate were to switch to albuterol, Federal Medicaid spending would increase roughly $70 million to $250 million annually [20 percent of $360 million = $72 million; 25 percent of 1 billion = $250 million]. If all current epinephrine users eligible for Medicaid were to instead visit their physicians and use prescription albuterol, we estimate that Federal Medicaid spending would increase by $35 million to $85 million dollars annually [20 percent of $170,857,175 = $34,171,435; 25 percent of $339,693,135 = $84,923,284]. These estimates exclude costs that may result from increased prescribing of controller medications, and do not take into account the impact of asthma attacks on individuals' quality of life and productivity. b. *Medicare* . We estimate 10 percent to 25 percent of the costs of the removal of OTC epinephrine MDIs from the market will be paid by Federal Medicare spending and by Medicare beneficiaries. If all Medicare-eligible OTC epinephrine MDI users were to self-medicate upon implementation of this proposed rule, Federal Medicare spending and spending by Medicare beneficiaries would increase roughly $40 million to $250 million dollars annually. Alternatively, if all Medicare-eligible OTC epinephrine MDI users were to visit their doctors to obtain and fill prescriptions for albuterol, Federal Medicare spending and spending by Medicare beneficiaries would increase roughly $20 to $85 million annually. Assuming epinephrine users with insurance, including Medicare, are more likely to visit a doctor, and less likely to self-medicate, the costs of this proposed rule are more likely to fall in the $20 million to $85 million range. According to proprietary surveys conducted by or for Wyeth between 1993 and 2005 (Wyeth slide 31), 16 percent to 33 percent of OTC epinephrine MDI users are over the age of 55, implying the percentage of epinephrine users over the age of 65, and therefore eligible for Medicare, must be lower. Accordingly, if we assume 10 percent to 25 percent of OTC epinephrine MDI users are over the age of 65, Medicare spending and private spending by Medicare beneficiaries would increase $40 million to $250 million annually if all Medicare-eligible OTC epinephrine MDI users were to self-medicate [10 percent of $360 million = $36 million; 25 percent of $1.0 billion = $250 million], and by $20 million to $85 million annually if they were all to visit their physicians for prescription albuterol [10 percent of $170,857,125 = $17 million; 25 percent of $339,693,135 = 84,923,284]. These estimates exclude costs that may result from increased prescribing of controller medications, and do not take into account the impact of asthma attacks on individuals' quality of life and productivity. E. Alternative Phase-Out Dates The alternatives we considered included the following phase-out dates: 1. December 31, 2008; 2. December 31, 2009; 3. December 31, 2010 (the proposed rule). Spending per year does not differ among the regulatory alternatives. The only difference among the alternatives is how long the estimated costs shown in table 2 of this document would accrue. At some time in the near future, the unavailability of CFCs—not the proposed rule or an alternative—may lead to removal of OTC epinephrine from the marketplace. Our current belief is that bulk CFCs are likely to be unavailable in 2010 (see section VII.A), so the costs for the first alternative would be the present value of the annual costs for 2 years, 2008-2009, and the cost for the second alternative would be the present value of the costs for 1 year, 2009. The third alternative, which is the proposed rule, would have no quantifiable costs or benefits. We invite comments on these projections and on the costs and benefits of any other possible alternative effective dates, such as December 31, 2011 or 2012. F. Sensitivity Analyses The estimated costs summarized in table 2 incorporate a range of estimates about the price increases consumers and other payers will face, the size of the affected market, and the consequences of consumers' response to the removal of OTC epinephrine MDIs from the market. This represents the full range of uncertainty for the estimated effects of this proposed rule. The full range incorporates the ranges of estimates for the individual uncertain variables in the analysis. In each section of the document, we show the ranges associated with each major uncertain variable, taking into account the possibility that in response to the removal of OTC epinephrine MDIs from the market, OTC epinephrine MDI users who do not currently use prescription medicines will either self-medicate or visit a physician to get an albuterol prescription. The estimated increases in emergency department visits and hospitalizations depend upon a range of estimates of the percentage of people with asthma that use OTC epinephrine MDIs (15 to 20 percent) and the fraction of OTC epinephrine MDI users that do not use prescription medicines and are therefore more likely to self-medicate (somewhere between 33 and 57 percent), as well as the rate we estimate hospitalizations and emergency department visits will increase among this population (2.5 to 3.1 times). Similarly, estimates of the impact of the removal of OTC epinephrine MDIs from the market on public and private spending depends on whether or not OTC epinephrine MDI users self-medicate, the above estimates on increased hospitalizations and emergency department visits, and the cost of those visits. A range of estimates of the percentage of adults with asthma that use OTC epinephrine MDIs (15 to 20 percent) and the fraction of OTC epinephrine MDI users that do not use prescription medicine for their asthma (somewhere between 33 and 57 percent), in addition to the overall size of the OTC epinephrine MDI market, determines the number of additional physician visits these users will require to switch from OTC epinephrine MDIs to albuterol MDIs. Estimated increases in spending on medicine depend on the size of the OTC epinephrine MDI market, and the price premium current OTC epinephrine MDI users can expect to pay for their medicine, roughly $16 to $25 per MDI. G. Conclusion Limits in available data prevent us from quantifying the costs and benefits of the proposed rule and weighing them in comparable terms. The benefits of international cooperation to reduce ODS emissions are potentially enormous but difficult to attribute to any of the small steps, such as this rulemaking, that make such cooperation effective. As discussed above in detail, the benefits of the removal of OTC epinephrine MDIs from the market include environmental and public health improvements from protecting stratospheric ozone by reducing CFC emissions. Benefits also include expectations of increased returns on investments in environmentally friendly technology, reduced risk of unexpected disruption of supply of CFC MDIs, and continued international cooperation to comply with the spirit of the Montreal Protocol, thereby potentially reducing future emissions of ODSs throughout the world. The removal of OTC epinephrine MDIs from the market could potentially cost public and private consumers of OTC epinephrine MDIs hundreds of millions of dollars annually, and increase hospitalizations and emergency department visits for asthma significantly. If CFCs cease to be available for OTC epinephrine MDIs before the effective date of a final rule removing the essential-use designation of OTC epinephrine MDIs, however, this proposed rule would have no benefits or costs. We specifically request comments on the costs and benefits of this proposed rule. VIII. Regulatory Flexibility Analysis The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because known current producers are not small entities and the likelihood that the proposed rule will not impose compliance costs, the agency does not believe that this proposed rule would have a significant economic impact on a substantial number of small entities. FDA requests comment on this issue. IX. The Paperwork Reduction Act of 1995 We have tentatively concluded that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. X. Federalism We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have tentatively determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Consequently, we do not currently plan to prepare a federalism summary impact statement for this rulemaking procedure. We invite comments on the federalism implications of this proposed rule. XI. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written comments regarding this proposal. Submit a single copy of electronic comments or two copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. An upcoming public meeting on the essential-use status of OTC MDIs containing epinephrine will provide an additional opportunity for public comment. We will provide details on the meeting in a notice published in the **Federal Register** in the near future. XII. References The following references have been placed on display in the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the Web site addresses, but we are not responsible for subsequent changes to the Web site after this document publishes in the **Federal Register** . 29 29 FDA has verified all Web site addresses cited in this document, but FDA is not responsible for any subsequent changes to the Web sites after this document has published in the **Federal Register** . 1. National Center for Health Statistics, “Early Release of Selected Estimates Based on Data From the 2005 National Health Interview Survey,” figure 15.4, available at *http://www.cdc.gov/nchs/data/nhis/earlyrelease/200606_15.pdf* . 2. Alkermes, Inc., press release, dated March 22, 2004, available at *http://www.alkermes.com/newsroom/showArticle.aspx?id=267* . 3. Fu, K. et al., “Air®-Epinephrine: Inhalation Therapy for the Emergency Self-Treatment of Anaphylaxis,” *Journal of Aerosol Medicine* , Vol. 16(2):190, June 2003. 4. Hendeles, L. et al., “Response to Nonprescription Epinephrine Inhaler During Nocturnal Asthma,” *Annals of Allergy, Asthma, and Immunology* , 95:530, December 2005. 5. National Heart, Lung, and Blood Institute, “Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma,” NIH publication No. 97-4051, July 1997. 6. National Heart, Lung, and Blood Institute, “Expert Panel Report: Update on Selected Topics 2002: Guidelines for the Diagnosis and Management of Asthma,” NIH publication No. 02-5074, June 2003. 7. National Asthma Council Australia Ltd., “Asthma Management Handbook: 2002,” Melbourne:2002. 8. Boulet, J. P. et al., “Canadian Asthma Consensus Report, 1999,” *Canadian Medical Association Journal* , 161(11 Supp.):S1, November 30, 1999. 9. Dickinson, B. D. et al., “Safety of Over-the-Counter Inhalers for Asthma: Report of the Council on Scientific Affairs,” *Chest* , 118(2):522, August 2000. 10. Cohen, R. A. and M. E. Martinez, “Health Insurance Coverage: Estimates from the National Health Interview Survey, 2005,” National Center for Health Statistics, June 2006, available at *http://www.cdc.gov/nchs/data/nhis/earlyrelease/insur200606.pdf* . 11. U.S. Census Bureau, “Table HI01. Health Insurance Coverage Status and Type of Coverage by Selected Characteristics: 2004: All Races,” available at *http://pubdb3.census.gov/macro/032005/health/h01_001.htm* . 12. National Center for Health Statistics, “Asthma Prevalence, Health Care Use and Mortality, 2002,” fig. 1, available at *http://www.cdc.gov/nchs/products/pubs/pubd/hestats/asthma/asthma.htm* . 13. Agency for Health Quality and Research, 2005 National Healthcare Disparities Report, AHQR publication 06-0017, December 2005, available at *http://www.ahrq.gov/qual/nhdr05/nhdr05.htm* . 14. Crain, E. F. et al., “Reported Difficulties in Access to Quality Care for Children with Asthma in the Inner City,” *Archives of Pediatric and Adolescent Medicine* ,” 152:333, April 1998. 15. Evans, R. et al., “A Randomized Clinical Trial to Reduce Asthma Morbidity Among Inner-City Children: Results of the National Cooperative Inner-City Asthma Study,” *Journal of Pediatrics* , 135(3):332, September 1999. 16. Bauman, L. J. et al., “Relationship of Adherence to Pediatric Asthma Morbidity Among Inner-City Children,” *Pediatrics* , 110(1):1, June 2006. 17. Bender, B. et al. “Measurement of Children's Asthma Medication Adherence by Self Report, Mother Report, Canister Weight, and Doser CT,” *Annals of Allergy, Asthma, and Immunology* , 85:416, November 2000. 18. Erickson S. R. et al., “Compliance From Self-Reported versus Pharmacy Claims Data With Metered-Dose Inhalers,” *The Annals of Pharmacotherapy* , 35(9): 997, September 2001. 19. Joyce, D. P., K. R. Chapman, and S. Kesten, “Prior Diagnosis and Treatment of Patients with Normal Results of Methocholine Challenge and Unexplained Respiratory Symptoms,” *Chest* , 109(3):697, March 1996. 20. Kuschner, W. G. et al. “Nonprescription Bronchodilator Medication Use in Asthma,” *Chest* , 112(4):987, October 1997. 21. Gibson, P., “Association Between Availability of Non-Prescription β <sup>2</sup> Agonist Inhalers and Undertreatment of Asthma,” *British Medical Journal* , 306:1514, June 5, 1993. 22. Giraud, V., and N. Roche, “Misuse of Corticosteroid Metered-Dose Inhaler Is Associated With Decreased Asthma Stability,” *European Respiratory Journal* , 19:246, 2002. 23. Scarfone, R. J. et al., “Demonstrated Use of Metered-Dose Inhalers and Peak Flow Meters by Children and Adolescents with Acute Exacerbations,” *Archives of Pediatric and Adolescent Medicine* ,” 156:378, April 2002. 24. Williams, M. V., “Inadequate Literacy Is a Barrier to Asthma Knowledge and Self-Care,” *Chest* , 114(4):1008, October 1998. 25. Cloutier, M. et al., “Use of Asthma Guidelines by Primary Care Providers to Reduce Hospitalizations and Emergency Department Visits in Poor, Minority, Urban Children,” *Journal of Pediatrics* , 146:591, May 2005. 26. Overbeek, S. E. et al., “Is Delayed Introduction of Inhaled Corticosteroids Harmful in Patients With Obstructive Airways Disease (Asthma and COPD)?” *Chest* , 110(1):35, July 1996. 27. Selroos, O. et al., “Effect of Early vs Late Intervention With Inhaled Corticosteroids in Asthma,” *Chest* , 108(5):1228, November 1995. 28. Salpeter, S. R., T. M. Ormiston, and E. E. Salpeter, “Meta-Analysis: Respiratory Tolerance to Regular β <sup>2</sup> Agonist Use in Patients with Asthma,” *Annals of Internal Medicine* , 140(10):802, May 18, 2004. 29. Szefler, S. et al., “Long-Term Effects of Budesonide or Nedocromil in Children With Asthma,” *New England Journal of Medicine* , 343:1054, October 12, 2000. 30. Guilbert, T. et al., “Long-Term Inhaled Corticosteroids in Pre-School Children at High Risk for Asthma,” New England Journal of Medicine, 354:1985, May 11, 2006. 31. Bisgard, H. et al., “Intermittent Inhaled Corticosteroids in Infants with Episodic Wheezing,” *New England Journal of Medicine* , 354:1998, May 11, 2006. 32. Bousquet, J. et al., “Asthma: From Bronchoconstriction to Airways Inflammation and Remodeling,” *American Journal of Respiratory and Critical Care Medicine* , 161:1720, 2000. 33. United Nations Environmental Programme, 2006 Assessment Report of the Technology and Economic Assessment Panel, 2006. 34. United Nations Environmental Programme, Production and Consumption of Ozone-Depleting Substances: 1986-2004, 2005. 35. U.S. Environmental Protection Agency, “The Benefits and Costs of the Clean Air Act: 1990-2010,” ( *http://www.epa.gov/air/sect812/copy99.html* ) November 1999. 36. National Center for Health Statistics, “Early Release of Selected Estimates Based on Data From the January-September 2006 National Health Interview Survey” March 28, 2007, available at *http://www.cdc.gov/nchs/about/major/nhis/released200703.htm#15* . 37. American Lung Association, “Trends in Asthma Morbidity and Mortality,” Epidemiology & Statistics Unit, Research and Scientific Affairs, July 2006. 38. Blanc, P. D. et al., “Use of Herbal Products, Coffee or Black Tea, and Over-the-Counter Medications as Self-Treatments Among Adults with Asthma,” *Journal of Allergy and Clinical Immunology* , 100:(6\1) 789, December 1997. 39. Mannino, D. M. et al., “Surveillance for Asthma—United States, 1980-1999,” *Morbidity and Mortality Weekly Report* , 51(SS01):1-13, March 29, 2002. 40. Analysis completed by FDA based on retail sales data from drug stores and supermarkets provided by ACNielsen for the 52 weeks ending September 9, 2006. 41. U.S. Environmental Protection Agency, final rule, “Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2006,” 71 FR 58504, October 4, 2006. 42. Rozek, R. P., and E. R. Bishko, “Economics Issues Raised in the FDA's Proposed Rule on Removing the Essential-Use Designation for Albuterol MDIs,” National Economic Research Associates, August 13, 2004 (FDA Docket No. 2003P-0029/C25). 43. Analysis completed by FDA based on prescription data provided by IMS Health, National Prescription Audit, 2004; IMS Health, IMS MIDAS (TM), Q1/2004-Q2/2004. 44. Gal, A., and N. R. Chari, “TEVA, SEPR: SGP to Phase Out CFC Albuterol Production by Early 2007; TEVA and SEPR Likely to Benefit,” report prepared for Sanford C. Bernstein & Co., LLC (New York), October 17, 2006. 45. Berger, W. E. et al., “The Utility of the Health Plan Employer Data and Information Set (HEDIS) Asthma Measure to Predict Asthma-Related Outcomes,” *Annals of Allergy, Asthma and Immunology* , 93:538, December 2004. 46. Centers for Medicare and Medicaid Services, *Medicaid at-a-Glance 2005: A Medicaid Information Source* , available at *http://www.cms.hhs.gov/MedicaidEligibility/downloads/MedGlance05.pdf* . 47. Department of Health and Human Services, notice, “Annual Update of the HHS Poverty Guidelines,” 71 FR 3848, January 24, 2006. List of Subjects in 21 CFR Part 2 Administrative practice and procedure, Cosmetics, Devices, Drugs, Foods. cc Therefore, under the Federal Food, Drug, and Cosmetic Act, the Clean Air Act, and under authority delegated to the Commissioner of Food and Drugs, after consultation with the Administrator of the Environmental Protection Agency, it is proposed that 21 CFR part 2 be amended as follows: PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS 1. The authority citation for 21 CFR part 2 continues to read as follows: Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342, 343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 7671 *et seq.* § 2.125 [Amended] 2. In § 2.125, remove and reserve paragraph (e)(2)(v). Dated: February 5, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. Editorial note: This document was received at the Office of the Federal Register on September 17, 2007. [FR Doc. 07-4663 Filed 9-17-07; 12:01 pm]
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  • 40 CFR 52
  • Pub. L. 104-4
  • 47 CFR 73
  • 49 CFR 661
  • Pub. L. 109-59
  • 49 CFR 661.7(b)
  • 49 CFR 661.7
  • 49 CFR 661.13(c)
  • 49 CFR 661.7(c)
  • 48 CFR 25
  • 41 USC 10a-10d
  • 49 CFR 661.5
  • 49 CFR 661.5(d)(2)
  • 49 CFR 661.11
  • 49 CFR 661.11(s)
  • Pub. L. 105-178
  • 49 CFR 661.11(b)
  • 49 CFR 661.11(t)
  • 49 CFR 661.11(v)
  • 49 CFR 661.11(w)
  • 49 CFR 661.5(c)
  • 49 CFR 661.5(d)
  • 49 CFR 661.18
  • 49 CFR 661.6
  • 5 USC 601-611
  • 42 USC 4321-4347
  • Pub. L. 97-424
  • Pub. L. 100-17
  • Pub. L. 102-240
  • 49 CFR 1.51
  • 14 CFR 39
  • 21 CFR 2
  • Pub. L. 101-549
  • 40 CFR 82
  • 40 CFR 82.1
  • 40 CFR 82.66
  • 40 CFR 82.3
  • 40 CFR 1508.7
  • 40 CFR 1508.27(b)(7)
  • 21 CFR 341
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