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Code · REGISTER · 2007-09-20 · Drug Enforcement Administration (DEA), Justice · Proposed Rules

Proposed Rules. Notice of Proposed Rulemaking

17,405 words·~79 min read·/register/2007/09/20/07-4652

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

BILLING CODE 4160-01-S DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1301 [Docket No. DEA-275P] RIN 1117-AA99 Changes to Patient Limitation for Dispensing or Prescribing Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment by Qualified Individual Practitioners AGENCY: Drug Enforcement Administration (DEA), Justice. ACTION: Notice of Proposed Rulemaking. SUMMARY: The Drug Enforcement Administration
(DEA)is proposing to conform its regulations to recent statutory amendments to the Controlled Substances Act that changed certain patient limitations for practitioners who dispense or prescribe certain narcotic drugs for maintenance or detoxification treatment. DATES: Written comments must be postmarked, and electronic comments must be sent, on or before November 19, 2007. ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-275” on all written and electronic correspondence. Written comments being sent via regular mail should be sent to the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Attention: DEA **Federal Register** Representative/ODL. Written comments sent via express mail should be sent to DEA Headquarters, Attention: DEA **Federal Register** Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301. Comments may be sent directly to DEA electronically by sending an electronic message to *dea.diversion.policy@usdoj.gov.* Comments may also be sent electronically through *http://www.regulations.gov* using the electronic comment form provided on that site. An electronic copy of this document is also available at the *http://www.regulations.gov* Web site. DEA will accept attachments to electronic comments in Microsoft word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept any file formats other than those specifically listed here. *Posting of Public Comments:* Please note that all comments received are considered part of the public record and made available for public inspection online at *http://www.regulations.gov* and in the Drug Enforcement Administration's public docket. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted. If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted online or made available in the public docket. Personal identifying information and confidential business information identified and located as set forth above will be redacted and posted online and placed in the Drug Enforcement Administration's public docket file. If you wish to inspect the agency's public docket file in person by appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph. FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone
(202)307-7297. SUPPLEMENTARY INFORMATION: Overview On August 2, 2005, the President signed amendments to the Controlled Substances Act to increase the patient limitation on prescribing drug addiction treatments by qualified medical practitioners in group practices from 30 patients for each group to 30 patients for each qualified practitioner in a group (Pub. L. 109-56; 119 Stat. 591) (21 U.S.C. 823(g)(2)). On December 29, 2006, the President signed amendments to the Controlled Substances Act to permit certain qualifying physicians to dispense and prescribe Schedule III, IV, and V narcotic controlled substances approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment to up to 100 patients at any one time, after the practitioner submits to the Secretary of Health and Human Services a notification of the practitioner's need and intent to treat the increased number of patients. The amendment was made as part of the Office of National Drug Control Policy Reauthorization Act of 2006 (ONDCPRA) (§ 1102 of Pub. L. 109-469, 120 Stat. 3502). This Notice of Proposed Rulemaking
(NPRM)would conform DEA regulations to Pub. L. 109-56 by removing the requirement in 21 CFR 1301.28(b)(iv) that limits to 30 the number of patients that could receive maintenance or detoxification treatment through a group practice. This change means that each qualifying practitioner whether working individually or in a group practice may offer maintenance and detoxification treatment to 30 patients at any one time. This NPRM would also conform DEA regulations to § 1102 of Pub. L. 109-469 by permitting certain qualifying physicians to treat up to 100 patients. To qualify to treat the additional patients, not sooner than one year after the practitioner submitted the initial notification, the practitioner must submit a second notification to the Secretary of Health and Human Services of the need and intent of the practitioner to treat up to 100 patients. Further, the practitioner must be a “qualifying physician” under 21 U.S.C. 823(g)(2)(G) and must have the capacity to refer the patients to whom the individual practitioner will provide narcotic drugs or combinations of narcotic drugs for appropriate counseling and other appropriate ancillary services (21 CFR 1301.28(b)(1)(i) and (ii)). These proposed amendments would not change the requirement that each practitioner must first qualify to prescribe and dispense these medications for maintenance and detoxification treatment, or must be prescribing these approved substances using the “good faith” exception, found within current regulations at 21 CFR 1301.28(e). Background On October 17, 2000, Congress passed the Drug Addiction Treatment Act of 2000 (DATA), amending the Controlled Substances Act
(CSA)(21 U.S.C. § 801 *et seq.* ) to establish “waiver authority for physicians who dispense or prescribe certain narcotic drugs for maintenance treatment or detoxification treatment” (Pub. L. 106-310, title XXXV; 114 Stat. 1222, codified at 21 U.S.C. 823(g)(2)). Prior to DATA, the Controlled Substances Act and DEA regulations required practitioners who wanted to conduct maintenance or detoxification treatment using narcotic controlled drugs to be registered as a Narcotic Treatment Program
(NTP)in addition to the practitioner's individual registration. The separate NTP registration authorized the practitioner to dispense or administer, but not prescribe, narcotic drugs. With passage of DATA, DEA published a NPRM (68 FR 37429; June 24, 2003) proposing to amend the regulations affecting maintenance and detoxification treatment for narcotic treatment by establishing an exemption from the separate registration requirement. After consideration of the comments received on the NPRM, DEA published a Final Rule on June 23, 2005 (70 FR 36338). The June 23, 2005, Final Rule permitted the following:
(1)Qualifying physicians to dispense and prescribe Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.
(2)Narcotic-dependent patients to have one-on-one consultations with a practitioner in a private practice setting.
(3)Pharmacies to fill prescriptions for Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.
(4)Practitioners to offer maintenance and detoxification treatment with Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment to no more than 30 patients in their private practices without having a second registration as a NTP. The exemption and other amendments established by the Final Rule apply to individual practitioners working in traditional NTPs as well as any other practice setting. The rule does not affect the existing prohibition against prescribing any Schedule II narcotic controlled drugs for maintenance or detoxification treatment. Under the provisions of DATA implementing regulations as codified in 21 CFR 1301.28(b)(1)(iii) and (iv), the 30-patient limitation applied equally to individual practices and to group practices (i.e., 30 patients per group), severely limiting the number of patients that could be treated by physicians in group practices. Pursuant to Pub. L. 109-56 effective on August 2, 2005, and § 1102 of Pub. L. 109-469 effective on December 29, 2006, this NPRM would make conforming changes to DEA's regulations at 21 CFR 1301.28(b)(1)(iii) and (iv). Specifically, paragraph (b)(1)(iii) is proposed to be amended to permit the treatment of up to 100 patients by a qualifying practitioner if the necessary criteria are met and notification is submitted to the Secretary of Health and Human Services. Further, paragraph (b)(1)(iii) is proposed to be amended by removing the phrase “Where the individual practitioner is not a member of a group practice,” since there is no longer a distinction between practitioners in group practices and those practicing independently. Finally, paragraph (b)(1)(iv) is proposed to be deleted to remove language regarding members of group practices. Relevant to the change regarding the treatment of up to 100 patients, the Director of the Center for Substance Abuse Treatment in the Department of Health and Human Services issued a letter announcing the statutory change as follows: Under ONDCPRA (effective December 29, 2006), physicians who meet the following criteria may notify the Secretary of Health and Human Services
(HHS)of their need and intent to treat up to 100 patients at any time:
(1)The physician must currently be qualified under DATA 2000;
(2)at least one year must have elapsed since the physician submitted the initial notification for authorization;
(3)the physician must certify their capacity to refer patients for appropriate counseling and other appropriate ancillary services; and
(4)the physician must certify that the total number of patients at any one time will not exceed the applicable number. DEA emphasizes that practitioners must meet these HHS criteria before prescribing a Schedule III, IV, or V controlled substance for narcotic maintenance or detoxification treatment to more than 30 patients at any one time. Regulatory Certifications Regulatory Flexibility Act The Deputy Assistant Administrator, Office of Diversion Control, has reviewed this regulation and hereby certifies that it has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 601-612) and that it will not have a significant economic impact on a substantial number of small entities. This NPRM would relieve a restriction on practitioners desiring to treat narcotic dependent patients by removing the 30 patient limit for group practices and by permitting certain qualifying physicians to treat up to 100 patients after certain criteria are met. Thus the changes would provide greater access to care for patients due to increased patient limits. Executive Order 12866 The Deputy Assistant Administrator further certifies that this rule has been drafted in accordance with the principles in Executive Order 12866 § 1(b). It has been determined that this is a significant regulatory action and, therefore, this action has been reviewed by the Office of Management and Budget. This rule will not impose additional costs on practitioners as it simply increases the number of patients that a practitioner may treat for narcotic dependence. As previously noted, this change would provide greater access to care for patients due to the increased patient limits. Executive Order 12988 This rule meets the applicable standards set forth in §§ 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform. Executive Order 13132 This rule does not preempt or modify any provision of State law; nor does it impose enforcement responsibilities on any State; nor does it diminish the power of any State to enforce its own laws. Accordingly, this rulemaking does not have Federalism implications warranting the application of Executive Order 13132. Unfunded Mandates Reform Act of 1995 This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $120,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995. Congressional Review Act This rule is not a major rule as defined by § 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act). This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign based companies in domestic and export markets. List of Subjects in 21 CFR Part 1301 Administrative practice and procedure, Drug traffic control, Security measures. For the reasons set out above, 21 CFR part 1301 is proposed to be amended as follows: PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES 1. The authority citation for part 1301 continues to read as follows: Authority: 21 U.S.C. §§ 821, 822, 823, 824, 871(b), 875, 877, 886a, 951, 952, 953, 956, 957. 2. § 1301.28 is proposed to be amended by revising paragraph (b)(1)(iii) and removing paragraph (b)(1)(iv) to read as follows: § 1301.28 Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. (b)(1) * * *
(iii)The total number of patients to whom the individual practitioner will provide narcotic drugs or combinations of narcotic drugs under this section will not exceed 30 at any one time unless, not sooner than 1 year after the date on which the practitioner submitted the initial notification to the Secretary of Health and Human Services, the practitioner submits a second notification to the Secretary of the need and intent of the practitioner to treat up to 100 patients. A second notification under this subparagraph shall contain the certifications required by subparagraphs
(i)and
(ii)of this paragraph. The Secretary of Health and Human Services may promulgate regulations to change the total number of patients. Dated: September 13, 2007. Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control. [FR Doc. E7-18531 Filed 9-19-07; 8:45 am] BILLING CODE 4410-09-P DEPARTMENT OF TRANSPORTATION Federal Highway Administration 23 CFR Part 950 [FHWA Docket No. FHWA-06-23597] RIN 2125-AF07 Interoperability Requirements, Standards, or Performance Specifications for Automated Toll Collection Systems AGENCY: Federal Highway Administration (FHWA); DOT. ACTION: Notice of proposed rulemaking (NPRM); request for comments. SUMMARY: As required under section 1604(b)(6) of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), this proposed rule specifies the interoperability requirements for automated toll collection systems for the facilities that are tolled under any of the tolling programs contained in section 1604 of SAFETEA-LU. Specifically, this notice proposes to require facilities operating with authority under section 1604 of SAFETEA-LU to use electronic toll collection systems and for these systems to address their interoperability with other toll facilities. Although a nationwide interoperability standard has not yet been established, this proposed rule seeks to accelerate progress toward achieving nationwide interoperability by requiring these facilities to upgrade their electronic toll collection systems to the national standards whenever adopted. This document also provides notice of public meetings on this proposed regulation. DATES: The public meeting will be held on Thursday, October 11, 2007, from 1:30 p.m. to 5 p.m., at the U.S. Department of Transportation headquarters conference center. Comments must be received on or before November 19, 2007. Late-filed comments will be considered to the extent practicable, but the FHWA may issue a final rule at any time after the close of the comment period. ADDRESSES: The October 11, 2007, public meeting will be held at the U.S. Department of Transportation headquarters conference center, 1200 New Jersey Avenue, SE., Washington, DC 20590. Mail or hand deliver comments to the U.S. Department of Transportation, Dockets Management Facility, Room PL-401, 1200 New Jersey Avenue, SE., Washington, DC 20590, or submit electronically at *http://dmses.dot.gov/submit* or fax comments to
(202)493-2251. Alternatively, comments may be submitted to the Federal eRulemaking portal at *http://www.regulations.gov* . All comments should include the docket number that appears in the heading of this document. All comments received will be available for examination and copying at the above address from 9 a.m. to 5 p.m., e.t., Monday through Friday, except Federal holidays. Those desiring notification of receipt of comments must include a self-addressed, stamped postcard or you may print the acknowledgment page that appears after submitting comments electronically. Anyone is able to search the electronic form of all comments in any one of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, or labor union). You may review the 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.* FOR FURTHER INFORMATION CONTACT: For technical questions or information about this notice of proposed rulemaking, contact Mr. Robert Rupert, FHWA Office of Operations,
(202)366-2194. For legal questions, please contact Mr. Michael Harkins, Attorney Advisor, FHWA Office of the Chief Counsel,
(202)366-4928, Federal Highway Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590. Office hours for the FHWA are from 7:45 a.m. to 4:15 p.m., e.t., Monday through Friday, except Federal holidays. SUPPLEMENTARY INFORMATION: Electronic Access and Filing You may submit or retrieve comments online through the Document Management System
(DMS)at: *http://dmses.dot.gov/submit* . Electronic submission and retrieval help and guidelines are available under the help section of the Web site. Alternatively, internet users may access all comments received by the DOT Docket Facility by using the universal resource locator
(URL)*http://dms.dot.gov* . It is available 24 hours each day, 365 days each year. Please follow the instructions. An electronic copy of this document may also be downloaded by accessing the Office of the Federal Register's home page at: *http://www.archives.gov* or the Government Printing Office's Web page at *http://www.gpoaccess.gov/nara.* Introduction Section 1604 of SAFETEA-LU (Pub. L. 109-59, 119 Stat. 1144) includes provisions related to tolling of highways and facilities. Specifically, section 1604 establishes or amends three tolling programs:
(1)The Value Pricing Pilot Program;
(2)the Express Lanes Demonstration Program; and
(3)the Interstate System Construction Toll Pilot Program. For each toll program under this section, section 1604(b)(6) requires the Secretary of Transportation to promulgate a final rule specifying requirements, standards, or performance specifications for automated toll collection systems. Section 1604(b)(6) also requires that in developing the final rule to maximize the interoperability of electronic collection systems, the Secretary shall maximize to the extent practicable three other areas:
(1)Accelerate progress toward the national goal of achieving a nationwide interoperable electronic toll collection system;
(2)Take into account the use of noncash electronic technology currently deployed within an appropriate geographical area of travel and the noncash electronic technology likely to be in use within the next five years; and
(3)Minimize additional costs and maximize convenience to users of toll facility and to the toll facility owner or operator. Background States are increasingly turning to tolling as a means of supplementing traditional methods of roadway financing and enhancing transportation mobility. The electronic collection of these tolls, which began in the mid 1980s, has grown dramatically over the past 25 years and is expected to grow even more over the next decade. The percentage of toll lanes capable of using electronic toll collection has grown from 36% in 1997 to nearly 80% in 2005. 1 According to a June 2006 report from the United States Government Accountability Office, 23 States have plans to build toll road facilities, including 7 States that are planning their first toll roads. 2 1 U.S. DOT Intelligent Transportation Systems Joint Program Office, ITS Deployment Statistics Web site, *http://www.itsdeployment.its.dot.gov/Trendsgraph.asp?comp=ETC;* 2006. 2 U.S. Government Accountability Office, Report number GAO-06-554, “Highway Finance: States’ Expanding Use of Tolling Illustrates Diverse Challenges and Strategies” June 2006; *http://www.gao.gov/new.items/d06554.pdf.* As the toll industry has grown, toll agencies have used a variety of toll devices manufactured by various competitive companies. This resulted in islands of unique proprietary toll devices throughout the country. The early electronic toll collection systems used a variety of electronic and radio communications technologies to identify accountholders as they traveled through toll collection lanes and then charge the appropriate toll against the appropriate account. There was little interoperability among the systems, and users had to establish multiple accounts and obtain multiple radio devices in order to use electronic toll collection on different toll facilities. The various toll agencies in the New York City area recognized the need to allow their users to move among their facilities with a common electronic toll collection technology and formed the Inter Agency Group (IAG). The IAG established a common accounting system that would enable users to set up an account with one toll collection agency that would be useable across multiple toll facilities. In the early 1990s, the IAG coined the term “E-ZPass” as a service mark for its common electronic toll collection system, and selected a vendor that all participating agencies would use for electronic tolling applications. The IAG and E-ZPass have grown to include 21 agencies in the mid-Atlantic, northeast, and Illinois. Similar efforts to regionalize electronic toll collection took place in Florida and California, resulting in common toll collection technologies for those areas. As of 2005, there were about 20 million electronic toll customers across the country. The largest concentrations of electronic toll customers are on the east coast, with about 17 million users, and on the west coast, with over 2 million users. Existing Noncash Electronic Toll Collection Technologies Currently, the electronic toll collection systems in any given geographic region typically use similar techniques, but are not interoperable from region to region. These existing toll facilities use a communications technology known as Dedicated Short Range Communications (DSRC). DSRC is a short range microwave radio that is capable of communication with the roadside while a vehicle is moving at highway speeds. Currently, all DSRC devices used for electronic toll collection operate in the unlicensed 902 Megahertz
(MHz)to 928 MHz band of the radio frequency spectrum. Tolls can be collected from motorists through a device called a “transponder,” which is about the size of a compact disk or a pocket calculator and is installed in a motorist's car or truck. The transponder communicates via DSRC with a “reader” installed over or near the lane of travel. The reader communicates with the appropriate financial accounting system and the motorist's toll account is debited for the proper toll amount without the need for stopping at a toll plaza. Although the future will bring new entrants and new innovation, the electronic toll collection market has evolved in recent years such that there are essentially three de-facto “standards” employed in large numbers.
(1)The E-ZPass toll device is employed on virtually all of the toll roads in the mid-Atlantic, northeast coast, and Illinois with approximately 14 million users. This is a proprietary device whose intellectual property rights are owned by Mark IV Industries of Toronto, Canada. There are also other proprietary toll collection technologies used by smaller numbers of systems and users in Texas, Georgia, and Florida.
(2)The California Title 21 Electronic Toll Collection standard is used on the west coast with approximately 2 million users. This California specification is an “open” standard and currently there are two manufacturers, Transcore and Sirit.
(3)The American Society of Testing Materials
(ASTM)V6 standard is used by the trucking industry for the electronic clearance of commercial vehicles by both Help Inc.'s Prepass system and by the I-75 Coalition NorPass system. This is an open standard currently manufactured by Raytheon and Mark IV. National Interoperability None of these de-facto standards are interoperable with one another. In an attempt to achieve interoperability in 1996 and 1997, the DOT encouraged and supported the development of a single standard for electronic toll collection. The ASTM established a standards committee; however, the companies in the toll market at that time could not agree on a single standard that would allow national interoperability. During that same time frame, the DOT pursued the examination of a new frequency for DSRC devices that could be licensed and thus used for a variety of transportation applications including electronic toll collection. In 1997, the Intelligent Transportation Society of America (ITS America), acting on behalf of the transportation industry, filed a petition with the Federal Communications Commission
(FCC)requesting the allocation of 75 MHz of spectrum at 5.85 Gigahertz
(GHz)to 5.925 GHz. This allocation was granted by the FCC in late 1999, and is licensed for public safety and private applications. As a result of the FCC's action, the DOT initiated the support of the development of a new set of standards for DSRC at 5.9 GHz. (“5.9 GHz” is the term used to refer to the spectrum between 5.85 GHz and 5.925 GHz.) The standards are being developed under the auspices of the Institute of Electrical and Electronic Engineers (IEEE). All of the current toll device manufacturers in the United States are participating in the development of these open standards and have agreed upon the electronic communications technology to be employed. In addition, the DOT is sponsoring the development of prototype DSRC equipment to implement the standards under development. The four manufacturers of electronic toll collection equipment in the United States as of 2005—Mark IV, Raytheon, Sirit, and Transcore—united to form the DSRC Industry Consortium to conduct this development. The current DSRC program is conducting tests of prototype equipment and these open standards for technical feasibility. However, even if the technical communications standards are interoperable technologically, more must be done to ensure interoperability for electronic toll collection. Specifically, interoperability also requires “back-office” interoperability, i.e., properly identifying and accounting for electronic toll collection tags. The IAG provides this integrated accounting service for its members through its E-ZPass application. True national interoperability will require greater exchange of accounting and fiscal information among toll authorities and their financial agents. OmniAir, an independent, not-for-profit trade association created as a result of the International Bridge, Tunnel and Turnpike Association's (IBTTA) 5.9 GHz DSRC Next Generation Task Force, has developed a draft electronic toll collection requirements document and is developing a national interoperability specification for electronic payment services. Toll agencies that adopt the OmniAir specifications will be positioned to provide interoperable services for all toll users. Development and approval of an open technical communications standard will be a significant step toward nationally interoperable electronic toll collection services. The adoption of an approved open standard by the DOT for use on all Federal-aid projects and other projects receiving tolling authority from the DOT will help to accelerate progress toward national interoperability. Any interoperability test for electronic toll collection would need to include not only the electronic communications, but also the accounting compatibility necessary to allow motorists to use various toll facilities without requiring multiple accounts. Toll plazas and barriers reduce a facility's throughput of vehicles, resulting in traffic congestion and its associated hazards as the demand and volume of vehicles increases. Electronic tolling helps to mitigate congestion by eliminating the bottlenecks caused by toll plazas and barriers. For example, in 1995, researchers compared vehicle throughput on lanes with manual toll collections versus electronic toll collection on the Tappan Zee Bridge in New York. The manual collection lane accommodated up to 400-450 vehicles per hour while an electronic lane peaked at 1000 vehicles per hour. 3 Also, in another example, the E-ZPass electronic toll collection system saved commuters approximately 2.1 million hours of delay on the New Jersey Turnpike in 2000. 4 Electronic tolling may also address vehicle safety and property damage concerns associated with toll barriers. The FHWA solicits comments from States, toll authorities, or other groups that may have conducted studies to analyze the effects of electronic tolling on safety and property damage. 3 Lennon, L. “Tappan Zee Bridge E-ZPass System Traffic and Environmental Studies,” Paper presented at the 64th ITE Annual Meeting: 1995. ITS Benefits Database Link: *http:www.itsbenefits.its.dot.gov/its/benecost.nsf/0/BFFD6D277991A8C385269610051E2BE.* 4 Operational and Traffic Benefits of E-ZPass to the New Jersey Turnpike, Prepared by the Wilbur Smith Associates for the New Jersey Turnpike Authority, New Jersey: August 2001. ITS Benefits Database Link: *http://www.itsbenefits.its.dot.gov/its/benecost.nsf/0/78B2ACEBB79ED67785256AC0006E29ED.* DOT Outreach Efforts In preparing this NPRM, the FHWA met with representatives of the IBTTA to gather technical information and insight on its members' current state-of-practice for electronic toll collection. In addition, IBTTA shared information about activities it has been conducting related to interoperability, including establishing OmniAir as an independent, not-for-profit trade association addressing 5.9 GHz and interoperability. General Discussion of the Proposal This proposal is intended to comply with the mandate of section 1604(b)(6) of SAFETEA-LU to promulgate a final rule specifying the requirements, standards, or performance specifications for automated toll collection systems implemented under section 1604. Although the ultimate goal of 1604(b)(6) of SAFETEA-LU is to achieve a nationwide interoperable electronic toll collection system, the Department does not believe that it can effectively establish a national standard at this time. As explained above, the DSRC program is conducting tests of prototype equipment and open standards for technical feasibility. These new standards, when published, may form the basis of a future rulemaking that would establish the standards for a nationwide interoperable electronic toll collection system. However, with respect to this proposal, the Department believes that requiring toll agencies to take interoperability issues into consideration in developing its toll collections systems will address the objective of the statute to accelerate progress toward the goal of nationwide interoperability in the best way possible at the present time. As such, the FHWA proposes to require that the toll collection agency for any facility operating pursuant to authority under section 1604 of SAFETEA-LU consult with the FHWA regarding its proposed method for electronic toll collection, and explain how the toll collection technique achieves the highest reasonable degree of interoperability possible with other facilities. The selection and explanation should consider not only current toll collection technologies but also emerging technologies and standards that may come into use. Additionally, this proposal would require toll agencies to develop reasonable methods to enable vehicle operators that are not enrolled in an interoperable toll collection program to use the toll facility. Agencies that operate tolling facilities that rely exclusively on electronic toll collection must address how they would accommodate users that have not enrolled in a compatible accounting system that provides for the collection of toll fees for use of the facility. Lastly, the FHWA recognizes that privacy issues may arise in connection with the implementation, operation, and enforcement of electronic toll collection systems, largely as a result of toll tags being linked to an individual's account with a toll agency or transportation authority or through alternative accommodations. In order to mitigate this concern, this rulemaking proposes to require toll agencies to develop, implement, and make publicly available privacy policies designed to protect against the inappropriate, unnecessary, or unauthorized disclosure of any data that may be collected regarding a user's use of an electronic toll collection system. These policies would not be subject to Departmental approval, however. The Department solicits comments related to the methods or means by which privacy concerns can be balanced with the environmental and congestion reducing advantages of electronic tolling. This NPRM applies only to the tolling programs authorized under section 1604 of SAFETEA-LU. The authority to toll under a section 1604 program will be granted on a case-by-case basis and in accordance with the criteria listed in statute and this regulation. In consideration of the above discussion, the FHWA requests comments on the following questions:
(1)How should a national electronic toll collection standard be pursued?
(2)What aspects of electronic toll collection should be standardized?
(3)How critical is the timing for establishing a national electronic toll collection standard?
(4)How should the national standard incorporate current technologies and functions?
(5)How should the national standard allow for changes in technologies over time?
(6)What are the personal privacy aspects of a national electronic toll collection standard and the technologies that may be used to achieve it? Section-by-Section Discussion of the Proposal Section 950.1 Purpose This section states that the proposed regulations establish interoperability requirements, standards, and performance specifications for facilities that are granted tolling authority by any program authorized under section 1604 of SAFETEA-LU. Section 950.3 Definitions The specific terms that have special significance to agencies or facilities that are subject to these proposed regulations are defined in this section. Section 950.5 Requirement To Use Electronic Toll Collection Technology This section establishes the proposed requirement that all facilities that are granted tolling authority by any program under section 1604 of SAFETEA-LU must use electronic toll collection systems as the method for collecting tolls from vehicle operators unless the toll agency can demonstrate to the FHWA that some other method is either more economically efficient or will result in a safer operating conditions for the facility. However, since section 1604(b)(5) of SAFETEA-LU requires exclusive electronic toll collection for the Express Lanes Demonstration Program, the FHWA is not authorized to grant an exception to the electronic toll collection requirement for facilities granted toll authority under section 1604(b) of SAFETEA-LU. This rule further requires toll agencies to make reasonable accommodations to allow potential users who may not be enrolled in the applicable toll collection program to use the facility. Since subsection 1604(b)(6)(A) states that the interoperability rule be applied for “automated toll collection systems implemented under this section,” which includes subsections 1604(a), 1604(b), and 1604(c), this proposed interoperability requirement would apply the mandatory use of electronic toll collection to all the programs authorized under section 1604. Additionally, this section clarifies that a toll agency may use cash payment methods, such as toll booths, in areas that are not located in the toll facility's lanes of travel if the location and use of such methods do not create unsafe operating conditions on the toll facility. Additionally, this rule would require toll agencies to develop and implement privacy policies to safeguard the disclosure of any data that may be collected concerning any user of a toll facility operating pursuant to authority under a 1604 toll program. The FHWA specifically requests comments on the privacy implications of this rule and potential measures that could be taken to ensure that these privacy interests are protected. Section 950.7 Interoperability Requirements This section establishes the proposed requirements for interoperability among electronic tolling systems for agencies or facilities that are granted tolling authority by any program authorized under section 1604 of SAFETEA-LU. Because of the differences that may arise in defining the potential users of a facility while maintaining interoperability, the FHWA requests comments on whether these proposed regulations allow for toll agencies to use different technologies. In section 950.7(a), we propose to require the toll agency having jurisdiction over a facility that is tolled pursuant to any of the tolling programs under section 1604 of SAFETEA-LU to: identify the projected users of the facility; and identify the predominant electronic toll collection systems likely utilized by the users of the facility. In section 950.7(b), we propose to require the toll agency to receive the FHWA's concurrence on its selection of the facility's electronic toll collection system. In section 950.7(c), we propose to require, in order to receive the FHWA's concurrence, the toll agency to demonstrate to the FHWA how the selected toll collection system achieves the highest reasonable degree of interoperability possible with other toll facilities. Additionally, the toll agency must explain, as provided at section 1604(b)(6)(B)(ii) of SAFETEA-LU, how the toll collection system takes into account the use of noncash electronic technology currently deployed within an appropriate geographic area of travel, as defined by the toll agency, and identify the noncash electronic technology likely to be in use within the next five years in that area. The facility's electronic toll collection system's design must include the communications requirements between roadside equipment and electronic toll transponders, as well as accounting compatibility requirements in order to ensure that users of the toll facilities are properly identified and tolls are charged to the appropriate account of the user. In section 950.7(d), we propose to require all electronic toll collection systems on any facility that is tolled pursuant to any of the tolling programs under section 1604 of SAFETEA-LU to upgrade to the nationwide interoperability standards if established in a future rulemaking by the FHWA. As explained above, this proposed rule seeks to accelerate progress toward nationwide interoperability by requiring any facility that is tolled pursuant to authority from any of the toll programs at section 1604 of SAFETEA-LU to upgrade its electronic toll collection system to operate under any nationwide standard subsequently established. In section 950.7(e), we propose to exempt all toll facilities that are currently being tolled under the Value Pricing Pilot Program from this proposed rule. The value pricing program was originally established in the section 1012(b) of the Intermodal Surface Transportation Efficiency Act of 1991 (Pub. L. 102-240). Thus, applying this rule to electronic toll collection systems that are already operational may be burdensome. However, any change to the facility's toll collection system after the effective date of the final rule would be subject to the regulations proposed in this rule. Section 950.9 Enforcement This section discusses remedial actions for agencies or facilities that fail to comply with the proposed requirements in section 950.7. We propose to suspend the tolling authority of any facility that does not comply with the requirements of this rule. However, we would be able to extend the tolling authority for any such facility if the applicable toll agency demonstrates that it is taking the necessary steps to come into compliance with the regulations. Public Meeting The public meeting will be held on Thursday, October 11, 2007, at the U.S. Department of Transportation headquarters conference center. The meeting will be held from 1:30 p.m. to 5 p.m. Rulemaking Analyses and Notices All comments received before the close of business on the comment closing date indicated above will be considered and will be available for examination in the docket at the above address. Comments received before, during, and after the comment closing date will be filed in the docket and will be considered to the extent practicable. In addition to late comments, the FHWA will also continue to file relevant information in the docket as it becomes available, and interested persons should continue to examine the docket for new material. A final rule may be published at any time after close of the comment period. Executive Order 12866 (Regulatory Planning and Review) and DOT Regulatory Policies and Procedures The FHWA has determined preliminarily that this action would be a significant regulatory action within the meaning of Executive Order 12866 and would be significant within the meaning of Department of Transportation regulatory policies and procedures. This action is considered significant because of the substantial State and local government and public interest in the requirements for automated toll collection systems. This rulemaking proposes interoperability requirements, standards, and performance specifications for toll projects initiated under section 1604 of SAFETEA-LU that use electronic toll collection. Section 1604 of SAFETEA-LU establishes or amends three tolling programs:
(1)The Value Pricing Pilot Program, which has a maximum of 15 cooperative agreements;
(2)the Express Lanes Demonstration Program, which has a maximum of 15 tolling projects; and
(3)the Interstate System Construction Toll Pilot Program, which has a maximum of 3 tolling projects. This rulemaking only establishes conditions on a Federal grant of authority for toll programs under section 1604 and does not require a State to impose tolls on any particular facility nor mandate how a State or toll authority operates, maintains or enforces its tolling program. It is anticipated that the economic costs of this rulemaking would be minimal while the benefits could be significant. These proposed changes are not anticipated to adversely affect, in a material way, any sector of the economy. Since this proposed rule only applies to new projects initiated under section 1604 of SAFETEA-LU, no significant encumbrances are added to the project's design or implementation. Interoperability will afford potential reductions in implementation and operating costs in several ways for both the implementing agencies and the public. First, it will allow the leveraging of existing resources, specifically the toll transponders that are being used by vehicle operators. By designing for interoperability, the new electronic toll collection project will not need to distribute as many toll transponders as it would if it designed a unique toll collection system. The public users will not need to purchase or fund additional devices and accounts. Second, the operating cost for an electronic toll lane is less than one-tenth that of a standard lane. A 1997 report indicated that the Oklahoma Turnpike Authority spent approximately $16,000 per year on the operational cost of an electronic toll collection lane. In contrast, the Authority spent approximately $176,000 per year to operate a manual toll collection lane. Third, there are also environmental savings as noted above. Finally, increasing access to electronic toll lanes will decrease time spent waiting to pay tolls. For example, attended toll collection facilities can process approximately 300 vehicles per hour, or 12 seconds per vehicle. Dedicated electronic toll collection facilities can process approximately 1,200 vehicles per hour, or 3 seconds per vehicle. 5 Using a conservative estimate for a queue of 4 vehicles for processing per lane, the delay for not using electronic toll collection equals 36 seconds. During peak periods, queues would be longer and delays increased. When multiplied by the number of transactions, these time savings can be considerable based on the value of $15+ per hour that an average person in the United States earns. While the total savings are dependant on how many new systems are built, they could be considerable. Costs would be dependent on the methods that are instituted to collect payments. For example, it may take longer to pay using a lane that allows for multiple types of payment as opposed to lanes dedicated to electronic toll collection or barrier-free collection techniques. However, the Department believes that these differences would be minimal or more than offset by the delays caused by current systems. The Department seeks comments on these issues from both government entities and the public. 5 Tollways Volume 2, Number 3, by IBTTA, 2005; The Path to Open Road Tolling, by Timothy O. Gallagher and Harold W. Worrall, pgs. 11-21. Therefore, this proposed rulemaking will result in only minimal costs to those affected. In addition, these changes would not interfere with any action taken or planned by another agency and would not materially alter the budgetary impact of any entitlements, grants, user fees, or loan programs. Consequently, a full regulatory evaluation is not required. Regulatory Flexibility Act In compliance with the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612) the FHWA has evaluated the effects of this proposed action on small entities and has determined that the proposed action would not have a significant economic impact on a substantial number of small entities. This rulemaking does not change the roles or responsibilities of small entities in electronic toll collection projects. The rulemaking neither improves nor worsens small entities opportunities to participate in electronic toll collection projects, so results in no economic affect on the small entities. For these reasons, the FHWA certifies that this action would not have a significant economic impact on a substantial number of small entities. Unfunded Mandates Reform Act of 1995 This proposed rule would not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48). This proposed rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $128.1 million or more in any one year (2 U.S.C. 1532). Further, in compliance with the Unfunded Mandates Reform Act of 1995, the FHWA will evaluate any regulatory action that might be proposed in subsequent stages of the proceeding to assess the effects on State, local, and tribal governments and the private sector. Additionally, the definition of “Federal Mandate” in the Unfunded Mandates Reform Act excludes financial assistance of the type in which State, local, or tribal governments have authority to adjust their participation in the program in accordance with changes made to the program by the Federal Government. The Federal-aid highway program permits this type of flexibility. This rulemaking only establishes conditions on a Federal grant of authority for toll programs under section 1604 and does not require a State, public authority, or private entity designated by a State, to impose tolls on any particular facility nor mandates how a State or toll authority operates, maintains or enforces its tolling program. Executive Order 13132 (Federalism Assessment) This proposed action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, and the FHWA has determined that this proposed action would not have sufficient federalism implications to warrant consultation with the States. The FHWA has also determined that this proposed action would not preempt any State law or State regulation or affect the States' ability to discharge traditional State governmental functions. Executive Order 12372 (Intergovernmental Review) Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program. Accordingly, the FHWA solicits comments on this issue. Paperwork Reduction Act Under the Paperwork Reduction Act of 1995
(PRA)(44 U.S.C. 3501, *et seq.* ), Federal agencies must obtain approval from the Office of Management and Budget
(OMB)for each collection of information they conduct, sponsor, or require through regulations. The FHWA has determined that this proposal does not contain collection of information requirements for the purposes of the PRA. National Environmental Policy Act The agency has analyzed this proposed action for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321) and has determined that this proposed action would not have any effect on the quality of the environment. Executive Order 12630 (Taking of Private Property) The FHWA has analyzed this proposed rule under Executive Order 12630, Governmental Actions and Interface with Constitutionally Protected Property Rights. The FHWA does not anticipate that this proposed action would affect a taking of private property or otherwise have taking implications under Executive Order 12630. Executive Order 12988 (Civil Justice Reform) This action meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. Executive Order 13045 (Protection of Children) We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. The FHWA certifies that this proposed action would not cause any environmental risk to health or safety that might disproportionately affect children. Executive Order 13175 (Tribal Consultation) The FHWA has analyzed this action under Executive Order 13175, dated November 6, 2000, and believes that the proposed action would not have substantial direct effects on one or more Indian tribes; would not impose substantial direct compliance costs on Indian tribal governments; and would not preempt tribal laws. The proposed rulemaking addresses interoperability requirements, standards, or performance specifications for toll projects initiated under section 1604 of SAFETEA-LU that use electronic toll collection and would not impose any direct compliance requirements on Indian tribal governments. Executive Order 13211 (Energy Effects) We have analyzed this action under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use dated May 18, 2001. We have determined that this is not a significant energy action under that order since it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required. Regulation Identification Number A regulation identification 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 contained in the heading of this document can be used to cross reference this action with the Unified Agenda. List of Subjects in 23 CFR Part 950 Communications equipment, Electronic products, Highways and roads, Motor vehicles, Radio, Telecommunication, Transportation. Issued on: September 12, 2007. J. Richard Capka, Federal Highway Administrator. In consideration of the foregoing, the FHWA proposes to add a new part 950 to title 23, Code of Federal Regulations, to read as follows: PART 950—ELECTRONIC TOLL COLLECTION Sec. 950.1 Purpose. 950.3 Definitions. 950.5 Requirement to use electronic toll collection technology. 950.7 Interoperability requirements. 950.9 Enforcement. Authority: 23 U.S.C. 109, 315; sec. 1604(b)(5) and (b)(6), Pub. L. 109-59, 119 Stat. 1144; 49 CFR 1.48. § 950.1 Purpose. The purpose of this part is to establish interoperability requirements, standards, and performance specifications for toll facilities that are tolled under section 1604 of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) (Pub. L. 109-59; 119 Stat. 1144) that use electronic toll collection. § 950.3 Definitions. *1604 toll program* refers to any of the tolling programs authorized under section 1604 of SAFETEA-LU. These programs include the Value Pricing Pilot Program, the Express Lanes Demonstration Program, and the Interstate System Construction Toll Pilot Program. *Dedicated short-range communications* means a microwave radio that is capable of short-range communication with the roadside while a vehicle is moving at highway speeds. *Electronic toll collection* means the ability for vehicle operators to pay tolls without stopping their vehicles through the use of dedicated short-range communications between onboard vehicle and roadside devices. *Toll agency* means the relevant public or private entity or entities to which toll authority has been granted for a facility under a 1604 toll program. § 950.5 Requirement to use electronic toll collection technology.
(a)Any toll agency operating a toll facility pursuant to authority under a 1604 toll program shall use an electronic toll collection system as the method for collecting tolls from vehicle operators for the use of the facility unless the toll agency can demonstrate to the FHWA that some other method is either more economically efficient or will make the facility operate more safely. If a facility is collecting tolls pursuant to section 1604(b) of SAFETEA-LU, the toll agency shall only use electronic toll collection systems. Nothing in this subsection shall prevent a toll agency from using cash payment methods, such as toll booths, in areas that are not located in the toll facility's lanes of travel if the location and use of such methods do not create unsafe operating conditions on the toll facility.
(b)A toll agency using electronic toll collection technology must develop and implement reasonable methods to enable vehicle operators that are not enrolled in a toll collection program that is interoperable with the toll collection system of the relevant toll facility to use the facility.
(c)A toll agency using electronic toll collection technology must develop, implement, and make publicly available privacy policies to safeguard the disclosure of any data that may be collected through such technology concerning any user of a toll facility operating pursuant to authority under a 1604 toll program, but is not required to submit such policies to FHWA for approval. § 950.7 Interoperability requirements.
(a)For any toll facility operating pursuant to authority under a 1604 toll program, the toll agency shall—
(1)Identify the projected users of the facility; and
(2)Identify the predominant toll collection systems likely utilized by the users of the facility.
(b)Based on the identification conducted under subsection (a), the toll agency shall receive the FHWA's concurrence on the proposal for the facility's toll collection system's standards and design.
(c)In requesting the FHWA's concurrence, the toll agency shall demonstrate to the FHWA that the selected toll collection system and technology achieves the highest reasonable degree of interoperability possible with other toll facilities. The toll agency shall also explain to the FHWA how the toll collection system takes into account the use of noncash electronic technology currently deployed within an appropriate geographic area of travel (as defined by the toll agency) and identify the noncash electronic technology likely to be in use within the next five years in that area. The facility's toll collection system's design shall include the communications requirements between roadside equipment and toll transponders, as well as accounting compatibility requirements in order to ensure that users of the toll facilities are properly identified and tolls are charged to the appropriate account of the user.
(d)A toll agency that operates any toll facility pursuant to authority under a 1604 toll program must upgrade its toll collection system to meet any applicable standards and interoperability tests that have been officially adopted through rulemaking by the FHWA.
(e)With respect to facilities that are tolled pursuant to the Value Pricing Pilot Program, this part only applies if tolls are imposed on a facility after the effective date of this rule. However, such facility is subject to this part if the facility's toll collection system is changed or upgraded after the effective date of the regulations in this part. § 950.9 Enforcement.
(a)The tolling authority of any facility operating pursuant to authority under a 1604 toll program shall be suspended in the event the relevant toll agency is not in compliance with this part within six
(6)months of receiving a written notice of non-compliance from FHWA. If the toll agency demonstrates that it is taking the necessary steps to come into compliance within a reasonable period of time, FHWA shall extend such tolling authority.
(b)The FHWA may take other action as may be appropriate, including action pursuant to § 1.36 of this title. [FR Doc. E7-18529 Filed 9-19-07; 8:45 am] BILLING CODE 4910-22-P DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-103842-07] RIN 1545-BG33 Qualified Films Under Section 199; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Cancellation of notice of public hearing on proposed rulemaking. SUMMARY: This document cancels a public hearing on proposed regulations under section 199 of the Internal Revenue Code. These regulations involve the deduction for income attributable to domestic production activities under section 199 and affect taxpayers who produce qualified films under section 199(c)(4)(A)(i)(II) and (c)(6) and taxpayers who are members of an expanded affiliated group under section 199(d)(4). DATES: The public hearing, originally scheduled for October 2, 2007, at 10 a.m., is cancelled. FOR FURTHER INFORMATION CONTACT: Richard A. Hurst of the Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration), at *Richard.A.Hurst@irscounsel.treas.gov.* SUPPLEMENTARY INFORMATION: A notice of public hearing that appeared in the **Federal Register** on Thursday, June 7, 2007 (72 FR 31478), announced that a public hearing was scheduled for October 2, 2007, at 10 a.m., in the IRS Auditorium, Internal Revenue Building, 1111 Constitution Avenue, NW., Washington, DC. The subject of the public hearing is under section 199 of the Internal Revenue Code. The public comment period for these regulations expired on September 5, 2007. The notice of proposed rulemaking and notice of public hearing instructed those interested in testifying at the public hearing to submit a request to speak and an outline of the topics to be addressed. As of Tuesday, September 11, 2007, no one has requested to speak. Therefore, the public hearing scheduled for October 2, 2007, is cancelled. LaNita Van Dyke, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel (Procedure and Administration). [FR Doc. E7-18507 Filed 9-19-07; 8:45 am] BILLING CODE 4830-01-P DEPARTMENT OF THE TREASURY Alcohol and Tobacco Tax and Trade Bureau 27 CFR Parts 4, 5, 7, and 24 [Notice No. 75; Re: Notice No. 73] RIN 1513-AB07 Labeling and Advertising of Wines, Distilled Spirits and Malt Beverages; Comment Period Extension AGENCY: Alcohol and Tobacco Tax and Trade Bureau, Treasury. ACTION: Notice of proposed rulemaking; extension of comment period. SUMMARY: In response to an industry member request, the Alcohol and Tobacco Tax and Trade Bureau extends the comment period for Notice No. 73, Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages, a notice of proposed rulemaking published in the **Federal Register** on July 31, 2007, for an additional 90 days. DATES: Written comments must be received on or before January 27, 2008. ADDRESSES: You may send comments on this notice to one of the following addresses: • *http://www.regulations.gov* (Federal e-rulemaking portal; follow the instructions for submitting comments); or • Director, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412. You may view copies of this notice, Notice No. 73, and any comments we receive about the proposals described in Notice No. 73 under the appropriate docket number on the Regulations.gov Web site at *http://www.regulations.gov.* A link to the Regulations.gov Web site is also available on the TTB Web site at *http://www.ttb.gov/regulations_laws/all_rulemaking.shtml.* In addition, you may view copies of the same materials described above by appointment at the TTB Information Resource Center, 1310 G Street, NW., Washington, DC 20220. To make an appointment, telephone
(202)927-2400. FOR FURTHER INFORMATION CONTACT: Lisa M. Gesser, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 128, Morganza, MD 20660; telephone
(301)290-1460; or Joanne C. Brady, Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 45797, Philadelphia, PA 19149; telephone
(215)333-7050. SUPPLEMENTARY INFORMATION: On July 31, 2007, The Alcohol and Tobacco Tax and Trade Bureau
(TTB)published Notice No. 73, Labeling and Advertising of Wines, Distilled Spirits, and Malt Beverages, in the **Federal Register** (72 FR 41860). In that notice of proposed rulemaking, TTB requests public comment on possible changes to the labeling and advertising requirements of alcohol beverage products regulated by TTB. When published, the comment period for TTB Notice No. 73 was scheduled to close on October 29, 2007. After the publication of Notice No. 73, TTB received a request from Wine America, a national association of American wineries to extend the comment period for an additional 90 days beyond the October 29, 2007 closing date. In support of their extension request, Wine America indicates that the wine industry is now entering the grape harvest season, which is its busiest time of the year. They further note that because of this, wine industry members would not have adequate time to address the rulemaking comment request in a comprehensive manner. In response to this request, TTB extends the comment period for Notice No. 73 for an additional 90 days. Therefore, comments on Notice No. 73 are now due on or before January 27, 2008. Drafting Information Lisa M. Gesser of the Regulations and Procedures Division drafted this notice. Signed: September 10, 2007. John J. Manfreda, Administrator. [FR Doc. E7-18510 Filed 9-19-07; 8:45 am] BILLING CODE 4810-31-P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Parts 52 and 81 [EPA-R09-OAR-2006-0583; FRL-8470-9] Extension of Public Comment Period for Proposed Rule on Approval and Promulgation of Implementation Plans; Designation of Areas for Air Quality Planning Purposes; State of California; PM-10; Affirmation of Determination of Attainment for the San Joaquin Valley Nonattainment Area AGENCY: Environmental Protection Agency (EPA). ACTION: Extension of public comment period. SUMMARY: The EPA is announcing an extension of the public comment period for the proposed rule entitled “Approval and Promulgation of Implementation Plans; Designation of Areas for Air Quality Planning Purposes; State of California; PM-10; Affirmation of Determination of Attainment for the San Joaquin Valley Nonattainment Area.” The proposed rule was initially published in the **Federal Register** on August 27, 2007. Written comments on the proposed rule were to be submitted to EPA on or before September 26, 2007 (a 30-day comment period). The EPA is extending the public comment period until October 26, 2007. DATES: The public comment period for this proposed rule is extended until October 26, 2007. ADDRESSES: Submit your comments, identified by docket number EPA-R09-OAR-2006-0583, by one of the following methods:
(1)*Federal eRulemaking portal: http://www.regulations.gov.*
(2)*E-mail: lo.doris@epa.gov.*
(3)*Mail or deliver:* Doris Lo (AIR-2), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105-3901. *Instructions:* All comments will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through the *www.regulations.gov* or e-mail. *www.regulations.gov* is an anonymous access system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. *Docket:* The index to the docket for this action is available electronically at *www.regulations.gov* and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed directly below. FOR FURTHER INFORMATION CONTACT: Doris Lo, EPA Region IX,
(415)972-3959, *lo.doris@epa.gov.* SUPPLEMENTARY INFORMATION: The proposed rule was signed by the Regional Administrator on August 15, 2007 and published in the **Federal Register** on August 27, 2007 (72 FR 49046). EPA has received a request for an additional 30 days to comment on the proposed rule and is granting that request. Therefore EPA is extending the comment period until October 26, 2007. Dated: September 13, 2007. Laura Yoshii, Acting Regional Administrator, Region 9. [FR Doc. E7-18586 Filed 9-19-07; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 171, 173, and 175 [Docket No. PHMSA-2006-25446 (HM-243)] RIN 2137-AE19 Hazardous Materials: Fuel Cell Cartridges and Systems Transported on Board Passenger Aircraft in Carry-on Baggage AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT). ACTION: Notice of proposed rulemaking (NPRM). SUMMARY: PHMSA is proposing to amend the Hazardous Materials Regulations
(HMR)to permit certain fuel cell cartridges and fuel cell systems designed for portable electronic devices to be transported by passengers and crew in carry-on baggage on board passenger-carrying aircraft. The proposed rule would cover fuel cells containing certain hazardous materials (flammable liquids, including methanol; formic acid; certain borohydride materials; or butane) and meeting certain performance and consumer use standards, which we are proposing to incorporate by reference into the HMR. We have evaluated the possible transportation safety risks presented by these fuel cell cartridges and systems and have determined they may safely be transported in the cabin of a passenger-carrying aircraft. DATES: Written comments should be submitted on or before November 19, 2007. ADDRESSES: You may submit comments identified by the docket number (PHMSA-2006-25446 (HM-243) by any of the following methods: • *Web site:* Until September 27, 2007, electronic submissions to the DOT Docket Management System (DMS), located at *http://dms.dot.gov.* Starting on September 28, 2007, all electronic submissions must be made to the Federal Docket Management System's
(FDMS)eRulemaking Portal located at *http://www.regulations.gov,* and the information in the DOT DMS will be migrated to the FDMS. This work is being done as part of a larger project to consolidate the federal rulemaking docket systems. Please note the FDMS is significantly different from the DOT DMS and may assign a new docket number to each existing docket. Follow the instructions specific to each docket Web site for submitting comments. On December 31, 2007, the DOT DMS will be permanently decommissioned. • *Fax:* 1-202-493-2251. • *Mail:* Docket Operations, U.S. Department of Transportation, West Building, Ground Floor, Room W12-140, Routing Symbol M-30, 1200 New Jersey Avenue, SE., Washington, DC 20590. • *Hand Delivery:* To Docket Operations, Room W12-140 on the ground floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. • *Federal eRulemaking Portal:* Go to *http://www.regulations.gov.* Follow the online instructions for submitting comments. *Instructions:* All submissions must include the agency name and docket number or Regulatory Identification Number
(RIN)for this notice. For detailed instructions on submitting comments and additional information on the rulemaking process, see the Public Participation heading of the Supplementary Information section of this document. Note that all comments received will be posted without change to the docket management system, including any personal information provided. Please see the Privacy Act heading under SUPPLEMENTARY INFORMATION . *Docket:* For access to the dockets to read background documents or comments received, go to *http://dms.dot.gov,* and after September 28, 2007, to *http://www.regulations.gov* at any time or to Docket Operations, U.S. Department of Transportation (see ADDRESSES ). FOR FURTHER INFORMATION CONTACT: Eileen Edmonson, Office of Hazardous Materials Standards,
(202)366-8553, Pipeline and Hazardous Materials Safety Administration (PHMSA) 1200 New Jersey Avenue, SE., Washington, DC 20590, facsimile telephone number
(202)366-7435, or by e-mail to *Eileen.Edmonson@dot.gov.* SUPPLEMENTARY INFORMATION: I. Background Fuel cell cartridges and fuel cell systems are an emerging energy technology developed to provide a more efficient, longer-lasting, and renewable power source for electrically operated equipment. Fuel cells are designed to replace, augment, or recharge existing battery sources. Various types of fuels may be used in fuel cell systems, including but not limited to gases meeting the criteria for classification as Division 2.1 (flammable gases), solids meeting the criteria for classification as Division 4.3 (dangerous when wet), and liquids meeting the criteria for classification as Class 3 (flammable) or Class 8 (corrosive) material. Specific materials used in fuel cells include methanol and other types of flammable liquids, butane, hydrogen in metal hydride, borohydrides, and formic acid. II. Current HMR Requirements Applicable to the Transportation of Fuel Cells Under the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180), fuel cells generally must be transported in accordance with requirements applicable to the material they contain. Thus, a fuel cell containing a corrosive material must conform to the packaging and hazard communication requirements applicable to that corrosive material when offered for transportation. After careful evaluation of possible transportation safety risks, PHMSA adopted packaging, testing, and hazard communication requirements for transporting fuel cell systems and fuel cell cartridges containing flammable liquids, including methanol or methanol and water solutions, as cargo by all modes (final rule published December 29, 2006; 71 FR 7896). The HMR requirements are consistent with international transportation standards applicable to the transportation of fuel cell cartridges and systems containing flammable liquids in the 14th Revised Edition of the UN Recommendations on the Transport of Dangerous Goods (UN Recommendations). III. International Standards Applicable to the Transportation of Fuel Cells The International Civil Aviation Organization
(ICAO)adopted provisions for transporting fuel cell systems and fuel cell cartridges containing flammable liquid as cargo on board aircraft in the 2007-2008 edition of the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions). These provisions are consistent with those for fuel cell systems and cartridges in the UN Recommendations. At that time, ICAO also adopted under Section 8; 1.1.2(r) provisions for transporting fuel cell systems and cartridges containing flammable liquids (including methanol), formic acid, and butane, in carry-on baggage on board passenger-carrying aircraft under certain conditions. This passenger carry-on authorization applies to fuel cell cartridges with a maximum quantity of 200 ml (6.76 ounces) for liquids, 200 ml (6.76 ounces) for metal fuel cell cartridges containing butane, and 120 ml (4.1 ounces) for non-metallic fuel cell cartridges containing butane. No more than two spare fuel cell cartridges are allowed per passenger. One of the conditions for the passenger authorization in the ICAO Technical Instructions is that the fuel cell systems and cartridges must conform to the industry technical specification governing the design and consumer use of fuel cell cartridges, power units, and power systems developed by the IEC. The IEC Specification No. IEC/PAS 62282-6-1 First Edition, with Technical Corrigendum 1, 2006, addresses fuel cell systems with outputs that do not exceed 60 volts and 240 watts. The IEC specification provides detailed manufacturing, safety, and testing requirements to address use, misuse, and consumer transportation. To ensure the capability of the fuel cell and cartridge to withstand normal conditions of consumer handling and transportation, the specification requires various design type tests such as pressure differential, vibration, temperature cycling, high temperature exposure, drop, compressive loading, connection cycling, external short circuit, and long-term storage. Members of the fuel cell industry and the IEC prepared and submitted proposals (included in this docket) to the ICAO Dangerous Goods Panel that the Panel considered in making its decision to permit certain fuel cell systems and cartridges to be transported by passengers on board aircraft beginning on January 1, 2007. The proposals provide an assessment of the benefits and risks associated with transporting fuel cell systems and cartridges containing butane, formic acid, methanol, hydrogen stored in metal hydrides, and sodium borohydride-based and potassium borohydride-based fuels. PHMSA conducted its own independent technical assessment of the safety risks associated with each of the proposed fuel cell system and cartridge technologies; based on this evaluation, PHMSA supported the passenger provisions adopted in the ICAO Technical Instructions. IV. Flammable Gas (Butane) and Leakage Criteria In our technical evaluation for this NPRM, PHMSA, in coordination with the Federal Aviation Administration's (FAA's) William J. Hughes Technical Center (FAA Tech Center), conducted an additional examination specific to the design type testing criteria for fuel cell cartridges containing liquefied flammable gas (butane). This evaluation concluded that the industry technical specification developed to govern the design and use of fuel cell cartridges and systems, IEC/PAS 62282-6-1, required amendment to ensure fuel cells containing a flammable gas are designed and tested to a standard that is equivalent to the safety standard established for certain non-bulk gas packagings in the HMR. Based on the PHMSA and FAA evaluations, the ICAO Dangerous Goods Panel at its Working Group 2006 meeting (October 25-November 3, 2006) recommended that the IEC amend its fuel cell specification to mandate a zero-leak standard as a basis for successfully passing the design-type tests. This zero-leak standard would be demonstrated by subjecting the cartridge test sample to a water bath test (consistent with Section 6.2.4.1 of the UN Recommendations) after each design type test. The IEC revised its test protocols and acceptance criteria and issued an addendum (included in this docket) to the IEC PAS 62282-6-1 on April 18, 2007, published as “IEC/PAS 62282-6-1 First Edition, with Technical Corrigendum 1, 2006.” The IEC plans to continue to review this standard for possible improvements. PHMSA will monitor further developments to the standard and, subject to technical review, may propose to adopt a later version in a subsequent rulemaking. V. Petitions for Rulemaking On March 2, 2006, the U.S. Fuel Cell Council petitioned PHMSA to permit airline passengers and crew to transport fuel cell systems and cartridges in carry-on baggage (Petition No. P-1475). In its petition, the U.S. Fuel Cell Council requests that PHMSA revise § 175.10 to permit portable electronic devices, such as cameras, laptop computers, and hand-held audio devices, powered by fuel cell systems and cartridges containing flammable liquid, formic acid, or butane to be transported by passengers and crew on passenger-carrying aircraft under the conditions adopted by ICAO. On August 23, 2006, Medis Technologies, Ltd., and Millennium Cell, Inc., petitioned PHMSA to permit fuel cell systems and cartridges containing Class 8 borohydride materials to be transported by passengers and crew in carry-on baggage on board passenger-carrying aircraft (Petition No. P-1483). Medis Technologies and Millennium Cell assert that Class 8 borohydride materials present the same risks in transportation as formic acid, also a Class 8 material. Both petitions may be viewed until September 27, 2007, in the DMS docket for this rulemaking at *http://dms.dot.gov* , and beginning on September 28, 2007, in the FDMS docket for this rulemaking at *http://www.regulations.gov.* VI. Proposals in This NPRM In this NPRM, we are proposing to permit the transportation in carry-on baggage on passenger-carrying aircraft of fuel cell cartridges and systems containing Class 3 flammable liquids, including methanol; formic acid and borohydride materials meeting the definition for a Class 8 material; and butane, a Division 2.1 gas. As proposed in this NPRM, the fuel cells must conform to certain performance criteria. The proposals in this NPRM are consistent with the passenger authorizations adopted for the 2007-2008 edition of the ICAO Technical Instructions. Based on our assessment to date, we agree with the U.S. Fuel Cell Council that fuel cell cartridges and systems containing flammable liquids, formic acid, and butane do not pose an unreasonable safety risk when carried on board aircraft by passengers and crew members, provided they meet the specified performance standards. We also agree with Medis Technologies and Millennium Cell that fuel cell cartridges and systems containing borohydride materials pose similar safety risks and will operate in a similar manner as those containing formic acid. It is important to note, however, that we are continuing to work with the FAA Tech Center to evaluate the safety risks posed by the air transportation of fuel cell cartridges and systems containing various types and classes of hazardous materials. We expect to conclude this evaluation prior to issuing a final rule under this docket; it will be placed in the docket for this rulemaking. As indicated above, we are proposing to require fuel cell cartridges and systems to meet rigorous performance criteria that are consistent with the conditions applicable to the passenger authorization in the ICAO Technical Instructions. First, we are proposing to incorporate into the HMR the industry technical specification and addendum developed by the IEC governing the design and consumer use of fuel cell cartridges, power units, and power systems (IEC/PAS 62282-6-1 First Edition, with Technical Corrigendum 1, 2006). The IEC technical specification is a comprehensive standard that addresses design, manufacturing, testing, and transportation specific to micro-fuel cells. It prescribes requirements for valves, filling, packaging performance, failure mode analysis, consumer refilling, materials of construction, exterior and exhaust temperature limits, warnings, certification, markings, and manufacturers' instructions. As revised by the recent addendum, the IEC specification mandates a zero-leak standard as a basis for successfully passing the design-type tests and, thus, is equivalent to the safety standard established for certain non-bulk gas packagings in the HMR. We also propose to limit fuel cell cartridges and systems carried by airline passengers and crew to those marked “APPROVED FOR CARRIAGE IN AIRCRAFT CABIN ONLY” by the manufacturer. This marking is the manufacturer's certification that the fuel cell cartridges and systems conform to the performance standard established in the revised IEC technical specification. In addition, in this NPRM, we are proposing to limit the amount of hazardous material that may be contained in each individual fuel cell authorized for transportation in carry-on baggage on board passenger-carrying aircraft. Consistent with the standard adopted for the ICAO Technical Instructions, we propose to limit fuel cells containing liquid fuels to 200 mL (6.76 ounces) of fuel per cartridge, fuel cells containing liquefied gases to 200 mL (6.76 ounces) of fuel per metal cartridge and 120 mL (4 fluid ounces) of fuel per non-metallic fuel cell cartridge, and fuel cells containing solid materials to 200 g (7 ounces) of fuel per cartridge. Also consistent with the ICAO Technical Instructions, each passenger or crew member would be permitted to carry up to two spare cartridges. To reduce possible releases, we propose to prohibit passengers and crew members from refilling fuel cell cartridges and systems, except to install a spare cartridge. In addition, we propose to limit fuel cell cartridges and systems carried by passengers and crew members to a type and design that will not continue to charge batteries when the device being powered is not in use. Again, these prohibitions are consistent with the passenger authorizations for fuel cells adopted under the ICAO Technical Instructions. VII. Transportation Security Administration The Department of Homeland Security's Transportation Security Administration
(TSA)is authorized to prescribe security standards for all modes of transportation, including aviation (49 U.S.C. 114(d)). Under this authority, TSA prohibits airline passengers from carrying weapons, explosives, or incendiary devices and has published several interpretative rules to provide guidance on the types of property TSA considers subject to the prohibition (68 FR 7444; 68 FR 9902; 70 FR 9877). As PHMSA developed this NPRM, we consulted with TSA concerning current security limitations applicable to the carriage of fuel cells by aircraft passengers and crew members and shared with TSA our technical analysis supporting this rulemaking. We understand that TSA is considering whether any additional security measures for fuel cells or fuel cell systems may be appropriate. In any case, this rulemaking would not limit TSA's authority to address security concerns related to the transportation of fuel cells or fuel cell systems. On September 26, 2006, TSA imposed a strict limit on liquids, gels, and aerosols an aircraft passenger is permitted to take through a security checkpoint in carry-on baggage. TSA limits these materials to 3-ounce (100 mL) or smaller containers placed in a clear quart-size, zip-top plastic bag. Fuel cell cartridges and systems would be subject to this limitation, notwithstanding any rule adopted in this proceeding. VIII. Rulemaking Analyses and Notices A. Statutory/Legal Authority for This Rulemaking This notice of proposed rulemaking is published under the following statutory authorities: 1. 49 U.S.C. 5103(b) authorizes the Secretary of Transportation to prescribe regulations for the safe transportation, including security, of hazardous material in intrastate, interstate, and foreign commerce. This NPRM proposes regulations to promote the safe transportation of fuel cells carried by airline passengers and crew members. To this end, as detailed above, PHMSA proposes to limit the types and quantities of fuel cell cartridges and fuel cell systems permitted on passenger aircraft, prescribe specific performance-based design and packaging criteria for these articles, and limit the manner in which they may be used during air transportation. 2. Section 5120 of Federal hazardous materials transportation law (49 U.S.C. 5120), authorizes the Secretary of Transportation to participate in the development of international standards for the transportation of hazardous materials and grants the Secretary broad discretion to harmonize the HMR with international standards. Section 5120(c) permits the Secretary to establish more stringent standards for transportation in the United States as necessary in the public interest. The proposals in this NPRM would harmonize the HMR with international requirements for fuel cell systems and cartridges to the extent these are consistent with PHMSA's safety objectives. B. Executive Order 12866 and DOT Regulatory Policies and Procedures This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and was not reviewed by the Office of Management and Budget. This NPRM is a non-significant rule under the Regulatory Policies and Procedures of the Department of Transportation [44 FR 11034]. Fuel cells are an emerging technology designed to meet the growing demand for alternative energy sources. Fuel cell technology has not yet achieved wide-spread commercialization, but is being developed for use in mobile phones, laptop computers, and, to a lesser extent, camcorders, digital cameras, and personal digital assistants (“PDAs”). The U.S. Fuel Cell Council found, as a result of its 2006 survey of 181 industry respondents, that sales from 2005 to 2006 of all fuel cell and fuel cell-based systems, of which those designed for portable electronic devices are currently a small part, increased by 7 percent to $353 million, and research and development expenditures and industry employment over the same period increased by 11 and 12 percent to $796 million and 7,074 employees, respectively. The industry projects fuel cells for portable electronic devices will achieve significant market penetration by 2009. By proposing to authorize their carriage by airline passengers and crew, the regulatory changes addressed in this rulemaking will lift barriers to the commercialization and distribution of fuel cell cartridges for use in personal electronic equipment. The costs associated with this rulemaking proposal primarily relate to the costs for testing fuel cell designs in accordance with the IEC consensus standard. We expect most fuel cell manufacturers will voluntarily comply with the IEC standard as a positive marketing tool because it addresses broad consumer safety issues and provides independent assurance that fuel cells will meet a rigorous safety standard. Thus, the incremental costs imposed by this NPRM are expected to be minimal. C. Executive Order 13132 This proposed rule has been analyzed in accordance with the principles and criteria set forth in Executive Order 13132 (“Federalism”). Any rule resulting from this rulemaking will preempt State, local, and Indian tribe requirements but will not have 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. Federal hazardous materials transportation law (49 U.S.C. 5125(b)) expressly preempts State, local, and Indian tribe requirements on certain covered subjects, as follows:
(1)The designation, description, and classification of hazardous materials;
(2)The packing, repacking, handling, labeling, marking, and placarding of hazardous materials;
(3)The preparation, execution, and use of shipping documents related to hazardous materials, and requirements related to the number, contents, and placement of those documents;
(4)The written notification, recording, and reporting of the unintentional release in transportation of hazardous materials; and
(5)The design, manufacture, fabrication, inspection, marking, maintenance, reconditioning, repair, or testing of a packaging or container represented, marked, certified, or sold as qualified for use in transporting hazardous material. This proposed rule addresses covered subject items (1), (2), (3), and
(5)above and would preempt State, local, and Indian tribe requirements not meeting the “substantively the same” standard. Pursuant to 49 U.S.C. 5125(b)(2), we would deem federal preemption effective upon the effective date of the final rule. We are proposing to make the final rule effective approximately 90 days after it is published in the **Federal Register** . D. Executive Order 13175 This proposed rule was analyzed in accordance with the principles and criteria set forth in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this proposed rule does not have tribal implications and does not impose substantial direct compliance costs, the funding and consultation requirements of Executive Order 13175 do not apply. E. Regulatory Flexibility Act The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) requires an agency to review regulations to assess their impact on small entities, unless the agency determines the rule is not expected to have a significant impact on a substantial number of small entities. The proposed rule will relax regulatory barriers to the transportation of fuel cells used in personal electronic devices and, accordingly, is expected to have a positive impact on small businesses that manufacture, distribute, transport, or use such items. As indicated above, we expect the incremental costs imposed by this NPRM to be minimal. Therefore, I certify that, if adopted, the proposals in this NPRM will not have a significant impact on a substantial number of small entities. This proposed rule has been developed in accordance with Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”) and DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act to ensure that potential impacts of draft rules on small entities are properly considered. F. Paperwork Reduction Act Section 1320.8(d), Title 5, Code of Federal Regulations, requires PHMSA to provide interested members of the public and affected agencies an opportunity to comment on information collection and recordkeeping requests. This NPRM does not include new information collection or recordkeeping requirements. G. 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 contained in the heading of this document can be used to cross-reference this action with the Unified Agenda. H. Unfunded Mandates Reform Act This proposed rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $120.7 million or more to either State, local or tribal governments, in the aggregate, or to the private sector, and is the least burdensome alternative that achieves the objective of the rule. I. Environmental Assessment The National Environmental Policy Act (NEPA), §§ 4321-4375, requires that federal agencies analyze proposed actions to determine whether the action will have a significant impact on the human environment. The Council on Environmental Quality
(CEQ)regulations order federal agencies to conduct an environmental review considering
(1)the need for the proposed action,
(2)alternatives to the proposed action,
(3)probable environmental impacts of the proposed action and alternatives, and
(4)the agencies and persons consulted during the consideration process. 40 CFR 1508.9(b). Purpose and Need Fuel cells are an emerging energy technology designed to replace, augment, or recharge existing battery sources. The fuel cell designs currently under development are powered by one of a variety of hazardous materials fuels, including methanol and other types of flammable liquids, butane flammable gas, dangerous when wet hydrogen in metal hydride, and corrosive liquids containing formic acid or borohydride materials. The HMR and the ICAO Technical Instructions already include provisions for transporting fuel cell systems and fuel cell cartridges containing flammable liquid as cargo on board aircraft. See 49 CFR 173.230, and Special Provision 146 of the HMR, and Packing Instruction 313 of the 2007-2008 edition of the ICAO Technical Instructions. In addition, the ICAO also adopted (in Section 8:1.1.2(r)) provisions that will permit these devices to be fueled by formic acid or butane, and transported in carry-on baggage on board passenger-carrying aircraft under certain conditions. This rulemaking proposes to harmonize the HMR with these additional ICAO requirements. To limit both the safety and environmental consequences should an incident occur, this rulemaking also proposes restrictions on the fuel cell system configurations and limits on the amount of hazardous material contained in each fuel cell cartridge. There are no significant environmental impacts associated with this NPRM. Alternatives The alternatives PHMSA is considering are as follows: *No action* —If no action is taken, passengers would not be permitted to transport personal electronic devices powered by fuel cell technology in carry-on baggage on domestic flights. The industry views such authorization as key to continued development and use of this technology. Without explicit action to permit airline passengers to carry fuel cell powered devices, technological development could well be delayed. This action is not recommended. *Actions Proposed in this NPRM—* The actions proposed in this NPRM would harmonize the HMR requirements for fuel cells with those prescribed in the international regulations. These proposed amendments are intended to update, clarify, and provide relief from certain existing regulatory requirements to promote safer transportation practices, finalize outstanding petitions for rulemaking, facilitate international commerce, and make the regulations easier to understand. This action is recommended. *To Regulate All Fuel Cells in the Manner Prescribed in the IEC Standard—* In addition to the materials covered by the proposed rule, the IEC standard covers fuel cells containing solid Division 4.3 (dangerous when wet) materials. As explained above, this design was not included in the ICAO standard to which we are proposing to harmonize in this rulemaking. PHMSA believes those fuel cell designs that have not been included in the ICAO standards warrant further safety review and that adopting a standard inconsistent with the international standard cannot be justified at this time. Analysis of Environmental Impacts We regulate hazardous materials transported by aircraft, vessel, rail, and highway. The potential for environmental damage or contamination exists when packages of hazardous materials are involved in accidents or en route incidents resulting from cargo shifts, valve failures, package failures, or loading, unloading, or handling problems. The ecosystems that could be affected by a release include air, water, soil, and ecological resources (for example, wildlife habitats). The adverse environmental impacts associated with releases of most hazardous materials are short-term impacts that can be greatly reduced or eliminated through prompt clean up of the accident scene. Most hazardous materials are not transported in quantities sufficient to cause significant, long-term environmental damage if they are released. The hazardous material regulatory system is a risk-management system that is prevention oriented and focused on identifying a hazard and reducing the probability and quantity of a hazardous material release. Hazardous materials are categorized by hazard analysis and experience into hazard classes and packing groups. The regulations require each shipper to classify a material in accordance with these hazard classes and packing groups; the process of classifying a hazardous material is itself a form of hazard analysis. Further, the regulations require the shipper to communicate the material's hazards through use of the hazard class, packing group, and proper shipping name on the shipping paper, labels and markings on packages, and placards on transport vehicles. Thus the shipping paper, labels, markings, and placards communicate the most significant findings of the shipper's hazard analysis. Excluding compressed gases, radioactive materials, and explosives, which all have their own packaging strength criteria, a hazardous material is assigned to one of three packing groups based upon its degree of hazard—from a high hazard, Packing Group I, to a low hazard, Packing Group III material—except gases and certain other materials with high integrity packagings. The HMR are designed to ensure the quality, damage resistance, and performance standards of the packaging for each hazardous material are appropriate for the hazards of the material transported. We have reviewed the risks associated with transporting fuel cell systems and cartridges. The amount of hazardous material contained within the fuel cells or cartridges to which this NPRM applies is minimal, limited to 200 mL or 200 g by this proposal. Even if a large number of these devices were compromised and their hazardous materials contents released, the environmental impact of the release would not be significant. We have determined there will be no significant environmental impacts associated with this proposed rule. Consultation and Public Comment As discussed above, PHMSA consulted with the IEC and many companies representing the fuel cell industry here and abroad to prepare for U.N. Dangerous Goods Council meetings on these devices. PHMSA also participated in the technical review of papers prepared by these companies explaining the potential risks and measures taken in the IEC standard to reduce risks for each fuel the IEC standard states may be present in a fuel cell. In addition, also as discussed earlier, PHMSA has consulted extensively with the U.S. Fuel Council, Medis Technologies, Ltd., and Millenium Cell, Inc., in response to their petitions for rulemaking, numbered P-1475 and P-1483, to permit passengers and crew to transport in carry-on baggage on board passenger aircraft fuel cells containing flammable liquid, formic acid, butane, and Class 8 borohydride materials for use in portable electronic devices. PHMSA has also received a letter signed by approximately 18 companies supporting the proposed regulation of fuel cells in the HMR. We invite interested persons to submit comments on the potential environmental, safety, and other impacts of the proposals subject to federal regulation in this NPRM. J. Privacy Act Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, 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), which may also be found at *http://dms.dot.gov,* and on and after September 28, 2007, may be found at *http://www.regulations.gov.* List of Subjects 49 CFR Part 171 Exports, Hazardous materials transportation, Hazardous waste, Imports, Incorporation by reference, Reporting and recordkeeping requirements. 49 CFR Part 173 Hazardous materials transportation, Packaging and containers, Radioactive materials, Reporting and recordkeeping requirements, Uranium. 49 CFR Part 175 Air carriers, Hazardous materials transportation, Incorporation by reference, Radioactive materials, Reporting and recordkeeping requirements. In consideration of the foregoing, we propose to amend 49 CFR Chapter I as follows: PART 171—GENERAL INFORMATION, REGULATIONS, AND DEFINITIONS 1. The authority citation for part 171 continues to read as follows: Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45 and 1.53; Pub. L. 101-410 section 4 (28 U.S.C. 2461 Note); Pub. L. 104-134 section 31001. 2. In § 171.7, in paragraph (a)(3), in the Table, an entry for the International Electrotechnical Commission is added in appropriate alphabetical order to read as follows: § 171.7 Reference material.
(a)* * *
(3)* * * Source and name of material 49 CFR reference * * * * * * * International Electrotechnical Commission
(IEC)3, rue de Varembé, P.O. Box 131, CH—1211, GENEVA 20, Switzerland: Fuel cell technologies—Part 6-1: Micro fuel cell power systems—Safety, IEC/PAS 62282-6-1 First Edition, with Technical Corrigendum 1, 2006 § 175.10 * * * * * * * 2. In § 171.8, two new definitions for “fuel cell” and “fuel cell cartridge” are added in alphabetical order to read as follows: § 171.8 Definitions and abbreviations. *Fuel cell* means an electrochemical device that converts the energy of the chemical reaction between a fuel, such as hydrogen or hydrogen rich gases, alcohols, hydrocarbons, and an oxidant, such as air or oxygen, to direct current (d.c.) power, heat, and other reaction products. *Fuel cell cartridge* or *Fuel cartridge* means a removable article that contains and supplies fuel to the micro fuel cell power unit or internal reservoir, not to be refilled by the user. PART 173—SHIPPERS—GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS 3. The authority citation for part 173 continues to read as follows: Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45, 1.53. 4. In § 173.230, paragraph
(a)is revised and new paragraph
(d)is added, to read as follows: § 173.230 Fuel cell cartridges containing flammable liquids.
(a)A fuel cell cartridge must be designed and constructed to prevent the fuel it contains from leaking during normal conditions of transportation and be free of electric charge generating components.
(d)Fuel cells intended for transportation in carry-on baggage on board passenger aircraft must also comply with the applicable provisions prescribed in § 175.10 of this subchapter. PART 175—CARRIAGE BY AIRCRAFT 5. The authority citation for part 175 continues to read as follows: Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.45, 1.53. 6. In § 175.10, paragraph (a)(18) is added to read as follows: § 175.10 Exceptions for passengers, crew members, and air operators.
(a)* * *
(18)Portable electronic devices (for example, cameras, cellular phones, laptop computers, and camcorders) powered by fuel cell systems, and not more than two spare fuel cartridges per passenger or crew member, when transported in carry-on baggage by aircraft under the following conditions:
(i)Fuel cell cartridges may contain only Class 3 flammable liquids (including methanol), Class 8 formic acid, Class 8 borohydride materials, or Division 2.1 butane;
(ii)The maximum quantity of fuel in any fuel cell cartridge may not exceed:
(A)200 mL (6.76 ounces) for liquids,
(B)120 mL (4 fluid ounces) for liquefied gases in non-metallic fuel cell cartridges, or 200 mL for metal fuel cell cartridges;
(C)200 g (7 ounces) for solids;
(iii)No more than two spare fuel cell cartridges may be carried by a passenger;
(iv)Fuel cell systems containing fuel and fuel cell cartridges including spare cartridges are permitted in carry-on baggage only;
(v)Fuel cell cartridges may not be refillable by the user. Refueling of fuel cell systems is not permitted except that the installation of a spare cartridge is allowed. Fuel cell cartridges that are used to refill fuel cell systems but that are not designed or intended to remain installed (fuel cell refills) in a portable electronic device are not permitted;
(vi)Fuel cell systems and fuel cell cartridges must conform to IEC/PAS 62282-6-1 (IBR; see § 171.7 of this subchapter);
(vii)Interaction between fuel cells and integrated batteries in a device must conform to IEC/PAS 62282-6-1. Fuel cell systems for which the sole function is to charge a battery in the device are not permitted;
(viii)Fuel cell systems must be of a type that will not charge batteries when the portable electronic device is not in use; and
(ix)Each fuel cell cartridge and system that conforms to the requirements in this paragraph (a)(18) must be durably marked by the manufacturer with the wording: “APPROVED FOR CARRIAGE IN AIRCRAFT CABIN ONLY” to certify that the fuel cell cartridge or system meets the specifications in IEC/PAS 62282-6-1 and with the maximum quantity and type of fuel contained in the cartridge or system. Issued in Washington, DC, on September 14, 2007, under the authority delegated in 49 CFR part 106. Theodore L. Willke, Associate Administrator for Hazardous Materials Safety. [FR Doc. E7-18532 Filed 9-19-07; 8:45 am] BILLING CODE 4910-60-P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 RIN 1018-AV19 Endangered and Threatened Wildlife and Plants; 12-Month Petition Finding and Proposed Rule To List the Polar Bear (Ursus Maritimus) as Threatened Throughout Its Range AGENCY: Fish and Wildlife Service, Interior. ACTION: Reopening of comment period; notice of availability of new information. SUMMARY: We, the U.S. Fish and Wildlife Service (Service), announce the availability of nine new United States Geological Survey
(USGS)reports produced for the Service to provide current data and modeling outputs relevant to the final determination of whether the polar bear ( *Ursus maritimus* ) qualifies for listing under the Endangered Species Act of 1973, as amended (Act). We intend to take these reports into consideration as we make our final listing determination on the polar bear. We also are reopening the public comment period on the January 9, 2007, proposed rule to list the polar bear as threatened throughout its range under the Act (72 FR 1064). We are reopening the comment period for an additional 15 days to allow interested parties to comment on the nine USGS reports listed below. The comment period is being limited to 15 days because of the statutory deadline, which requires a final listing determination within one year of publication of the proposed rule, unless an extension of up to six months is granted due to substantial disagreement regarding the sufficiency or accuracy of the available data relevant to the determination. Please note that comments previously submitted should not be resubmitted. This comment period is open only for comments on the nine USGS reports listed below. Comments submitted during the prior comment period have been incorporated into the public record and will be fully considered during preparation of our final determination. DATES: We will accept public comments until October 5, 2007. ADDRESSES: You may submit comments and materials to us by any one of the following methods:
(1)You may mail or hand-deliver written comments and information to the Supervisor, U.S. Fish and Wildlife Service, Marine Mammals Management Office, 1011 East Tudor Road, Anchorage, AK 99503.
(2)You may send comments by electronic mail (e-mail) to: *Polar_Bear_Finding@fws.gov.* For instructions on how to file comments electronically, see the “Public Comments Solicited” section below. In the event that our Internet connection is not functional, please submit your comments by one of the alternate methods listed in this section.
(3)You may submit your comments via the Federal eRulemaking Portal at *http://www.regulations.gov.* Follow the instructions for submitting comments. For information on obtaining copies of the nine USGS reports, see the “Obtaining Copies of the Nine USGS reports” section below. FOR FURTHER INFORMATION CONTACT: Rosa Meehan, Marine Mammals Management Office (see ADDRESSES ) (telephone 907-786-3800). Persons who use a telecommunications device for the deaf
(TDD)may call the Federal Information Relay Service
(FIRS)at 800-877-8339. SUPPLEMENTARY INFORMATION: On January 9, 2007 (72 FR 1064), the Service published a 12-month petition finding and proposed rule to list the polar bear ( *Ursus maritimus* ) as threatened throughout its range under the Act. The document announced a 3-month public comment period on the proposed rule, which closed on April 9, 2007. We also held three public hearings during the proposed rule's comment period, as announced in the February 15, 2007, **Federal Register** (72 FR 7381). On September 7, 2007, the Service received nine reports prepared by the USGS that provide new data and modeling outputs relevant to the final determination of whether the polar bear qualifies for listing as threatened or endangered under the Act. These reports are:
(1)Polar Bear Population Status in the Northern Beaufort Sea by Stirling *et al.*
(2)Polar Bear Population Status in Southern Hudson Bay Canada by Obbard *et al.*
(3)Polar Bears in the Southern Beaufort Sea I: Survival and Breeding in Relation to Sea Ice Conditions, 2001-2006 by Regehr *et al.*
(4)Polar Bears in the Southern Beaufort Sea II: Demography and Population Growth in Relation to Sea Ice Conditions by Hunter *et al.*
(5)Polar Bears in the Southern Beaufort Sea III: Stature, Mass, and Cub Recruitment in Relationship to Time and Sea Ice Extent Between 1982 and 2006 by Rode *et al.*
(6)Uncertainty in Climate Model Predictions of Arctic Sea Ice Decline: An Evaluation Relevant to Polar Bears by DeWeaver.
(7)Predicting the Future Distribution of Polar Bear Habitat in the Polar Basin from Resource Selection Functions Applied to 21st Century General Circulation Model Projections of Sea Ice by Durner *et al.*
(8)Predicting Movements of Female Polar Bears between Summer Sea Ice Foraging Habitats and Terrestrial Denning Habitats of Alaska in the 21st Century: Proposed Methodology and Pilot Assessment by Bergen *et al.*
(9)Forecasting the Range-wide Status of Polar Bears at Selected Times in the 21st Century by Amstrup *et al.* We are notifying the public of the availability of these reports and our intent to consider them in making our final listing determination. We also are reopening the comment period for 15 days to provide the public the opportunity to provide comments or information on these reports. We are asking for public comments on these reports and a review of the extent to which they add to the knowledge base for making the final decision. Obtaining Copies of the Nine USGS Reports You may obtain copies of any of the nine USGS reports: • By mail from the U.S. Department of the Interior, United States Geological Survey, Office of Communication, 119 National Center, Reston, VA 20192; • By calling USGS Public Affairs at
(703)648-4460; • By visiting the USGS Web site at *http://www.usgs.gov/newsroom/special/polar_bears/* ; or • Via link to the USGS Web site from the Service's Web site: *http://www.fws.gov/* . Copies of the reports are also available for public inspection, by appointment during normal business hours, at the U.S. Fish and Wildlife Service, Marine Mammals Management Office (see ADDRESSES ). Public Comments Solicited Comments and information submitted during the initial comment period on the January 9, 2007 (72 FR 1064), proposed rule should not be resubmitted, as this comment period is open only for comments on the nine USGS reports listed above. Our final determination of whether the polar bear qualifies as threatened or endangered under the Act will take into consideration all comments and information we receive during both comment periods. You may submit your comments and any materials concerning the above reports by any one of several methods (see ADDRESSES ). If you use e-mail to submit your comments, please include “Attn: Polar Bear Finding” in your e-mail subject header, preferably with your name and return address in the body of your message. Before including your address, phone number, e-mail address, or other personal identifying information in your comments, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold from public view your personal identifying information, we cannot guarantee that we will be able to do so. Author The primary author of this notice is staff of the U.S. Fish and Wildlife Service. Authority: The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 *et seq.* ). Dated: September 13, 2007. H. Dale Hall, Director, U.S. Fish and Wildlife Service. [FR Doc. 07-4652 Filed 9-17-07; 11:03 am]
Connectionstraces to 23
Traces to 23 documents
27 references not yet in our index
  • 21 CFR 1301
  • Pub. L. 109-56
  • 119 Stat. 591
  • Pub. L. 109-469
  • Pub. L. 106-310
  • 114 Stat. 1222
  • 5 USC 601-612
  • 23 CFR 950
  • Pub. L. 109-59
  • 119 Stat. 1144
  • Pub. L. 102-240
  • Pub. L. 96-354
  • Pub. L. 104-4
  • 109 Stat. 48
  • 49 CFR 1.48
  • 26 CFR 1
  • 40 CFR 1508.9(b)
  • 49 CFR 173.230
  • 49 CFR 171
  • 49 CFR 173
  • 49 CFR 175
  • 49 USC 5101-5128
  • 49 CFR 1.45
  • Pub. L. 101-410
  • Pub. L. 104-134
  • 49 CFR 106
  • 50 CFR 17
Citation graph
cites case law
Proposed Rules
Notice of Proposed Rulemaking
U.S.C.§ 823
Stat.Public Law 111–356
C.F.R.§ 1301.28
U.S.C.§ 801
Fed. Reg.Notices
Fed. Reg.Notices
Fed. Reg.Proposed Rules
U.S.C.§ 821
U.S.C.§ 1532
Cite21 CFR 1301
Pub. L.Pub. L. 109-56
Stat.119 Stat. 591
Cites 50 · showing 12Cited by 0 across 0 sources
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