Proposed Rules. Supplemental notice of proposed rulemaking (SNPRM); reopening of comment period

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BILLING CODE 3410-DM-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. 2003-NE-21-AD] RIN 2120-AA64 Airworthiness Directives; International Aero Engines AG

(IAE)V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, and V2533-A5 Turbofan Engines AGENCY: Federal Aviation Administration, DOT. ACTION: Supplemental notice of proposed rulemaking (SNPRM); reopening of comment period. SUMMARY: This notice revises an earlier proposed airworthiness directive

(AD)that applies to certain IAE V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, and V2533-A5 turbofan engines. That proposal would have required initial and repetitive inspections of the master magnetic chip detector

(MCD)or the No. 1, 2, 3 bearing chamber MCD. That proposal would also have required replacing certain No. 3 bearings and replacing or recoating certain high pressure compressor

(HPC)stubshaft assemblies as mandatory terminating actions to the repetitive MCD inspections. That proposal resulted from IAE developing a terminating action to the repetitive inspections of the chip detectors. This action revises the proposed rule by expanding its applicability to include additional serial-numbered engines with certain No. 3 bearings installed. We are proposing this AD to prevent failure of the No. 3 bearing, which could result in an in-flight shutdown

(IFSD)and smoke in the cockpit and cabin. DATES: We must receive comments by March 20, 2006. ADDRESSES: Use one of the following addresses to comment on this proposed AD: • By mail: Federal Aviation Administration (FAA), New England Region, Office of the Regional Counsel, Attention: Rules Docket No. 2003-NE-21-AD, 12 New England Executive Park, Burlington, MA 01803-5299. • By fax:

(781)238-7055. • By e-mail: *9-ane-adcomment@faa.gov.* You can get the service information identified in this proposed AD from International Aero Engines AG, 400 Main Street, East Hartford, CT 06108; telephone:

(860)565-5515; fax:

(860)565-5510. You may examine the AD docket, by appointment, at the FAA, New England Region, Office of the Regional Counsel, 12 New England Executive Park, Burlington, MA. FOR FURTHER INFORMATION CONTACT: James Rosa, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; telephone

(781)238-7152; fax

(781)238-7199. SUPPLEMENTARY INFORMATION: Comments Invited We invite you to send any written relevant data, views, or arguments regarding this proposal. Send your comments to an address listed under ADDRESSES. Include “AD Docket No. 2003-NE-21-AD” in the subject line of your comments. If you want us to acknowledge receipt of your mailed comments, send us a self-addressed, stamped postcard with the docket number written on it; we will date-stamp your postcard and mail it back to you. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the proposed AD. If a person contacts us verbally, and that contact relates to a substantive part of this proposed AD, we will summarize the contact and place the summary in the docket. We will consider all comments received by the closing date and may amend the proposed AD in light of those comments. Examining the AD Docket You may examine the AD Docket (including any comments and service information), by appointment, between 8 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. See ADDRESSES for the location. Discussion On September 11, 2003, we issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to add an airworthiness directive

(AD)to apply to International Aero Engines AG IAE V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, and V2533-A5 turbofan engines. The Office of the **Federal Register** published that proposal as a notice of proposed rulemaking

(NPRM)supersedure in the **Federal Register** on September 17, 2003 (68 FR 54400). That NPRM would have required initial and repetitive inspections of the master magnetic chip detector

(MCD)or the No. 1, 2, 3 bearing chamber MCD. Additionally, it would have required replacing certain No. 3 bearings and replacing or recoating certain HPC stubshaft assemblies as mandatory terminating actions to the repetitive MCD inspections. That NPRM resulted from IAE developing a terminating action to the repetitive chip detector inspections. That condition, if not corrected, could result in failure of the No. 3 bearing, which could result in an IFSD and smoke in the cockpit and cabin. Since we issued that NPRM, we have received reports that more engines experienced No. 3 bearing failures attributed to ball spalling and race fracture. A total of 55 failures of the No. 3 bearing have occurred. Of the 55 failures, 12 resulted in IFSDs and 43 resulted in unscheduled engine removals (UER). Of the 12 IFSDs, three were associated with smoke in the cabin and cockpit. The smoke is a result of the ball spalling and race fracture of failed No. 3 bearings, P/N 2A1165, and occurs when there is hard particle contamination in the oil system. The release of coating particles on HPC stubshafts with low-energy plasma coating causes the contamination. The problem exists on certain No. 3 bearings, P/N 2A1165, that are less tolerant to damage from this contamination. As a result of these failures, we have added additional serial-numbered engines to this Supplemental NPRM. Since this change expands the scope of the originally proposed rule, we determined that it is necessary to reopen the comment period to provide additional opportunity for public comment. Also, since we issued that NPRM, IAE discovered that some of the original population of engines are not at risk for No. 3 ball bearing failure, so even though we are adding at least 100 engine SNs to this proposed AD, the number of engines listed in the Costs of Compliance is smaller. Manufacturer's Service Information We have reviewed and approved the technical contents of IAE SB V-2500-ENG-72-0452, Revision 3, dated March 4, 2005, that describes procedures for MCD inspections for engines in the range V10600 to V11365 with No. 3 bearing, P/N 2A1165, installed. We have also reviewed and approved the technical contents of IAE SB V-2500-ENG-72-0459, Revision 2, dated March 4, 2005, that describes procedures for in shop action for engines in the range V10600 to V11365 with No. 3 bearing, P/N 2A1165, installed. FAA's Determination of an Unsafe Condition and Proposed Actions We have evaluated all pertinent information and identified an unsafe condition that is likely to exist or develop on other products of this same type design. Therefore, we are proposing this AD, which would require: • Initial inspection of the master MCD or the No. 1, 2, 3 bearing chamber MCD within 125 hours time-in-service

(TIS)after the effective date of the proposed AD; and • Repetitive inspections of the master MCD or the No. 1, 2, 3 bearing chamber MCD within 125 hours time-since-last inspection; and • Replacement of the No. 3 bearing, P/N 2A1165, at the next shop visit for any reason; and • Replacement of HPC stubshafts that have a low-energy plasma coating with HPC stubshafts that have a high-energy plasma coating. Costs of Compliance We estimate that this proposed AD would affect 123 engines installed on airplanes of U.S. registry. We also estimate it would take 150 work hours per engine to perform the proposed actions, and that the average labor rate is $65 per work hour. Required parts would cost about $33,788 per engine. Based on these figures, we estimate the total cost of the proposed AD to U.S. operators to be $5,355,174. Authority for This Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority. We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action. Regulatory Analysis We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. For the reasons discussed above, I certify that the proposed regulation: 1. Is not a “significant regulatory action” under Executive Order 12866; 2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and 3. Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. We prepared a summary of the costs to comply with this proposal and placed it in the AD Docket. You may get a copy of this summary at the address listed under ADDRESSES. List of Subjects in 14 CFR Part 39 Air transportation, Aircraft, Aviation safety, Safety. The Proposed Amendment Under the authority delegated to me by the Administrator, the Federal Aviation Administration proposes to amend 14 CFR part 39 as follows: PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority: 49 U.S.C. 106(g), 40113, 44701. § 39.13 [Amended] 2. Section 39.13 is amended by removing Amendment 39-13183 (68 FR 33621, June 5, 2003) and by adding the following new airworthiness directive: **International Aero Engines AG (IAE):** Docket No. 2003-NE-21-AD. Comments Due Date

(a)The Federal Aviation Administration

(FAA)must receive comments on this airworthiness directive

(AD)action by March 20, 2006. Affected ADs

(b)This AD supersedes AD 2003-11-23, Amendment 39-13183. Applicability

(c)This AD applies to International Aero Engines AG

(IAE)V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, and V2533-A5 turbofan engines with engine serial numbers V10600 through V11365 and bearings P/N 2A1165 installed. These engines are installed on, but not limited to, Airbus Industrie A319, A320, and A321 series airplanes. Unsafe Condition

(d)This AD results from reports of No. 3 bearing failures that caused in-flight shutdown

(IFSD)and smoke in the cockpit and cabin. We are issuing this AD to prevent failure of the No. 3 bearing, which could result in an IFSD and smoke in the cockpit and cabin. Compliance

(e)You are responsible for having the actions required by this AD performed within the compliance times specified unless the actions have already been done. Inspection of the Master Magnetic Chip Detector

(MCD)or the No. 1, 2, 3 Bearing Chamber MCD

(f)For engines listed in Appendix 1, Tables 1 and 2 of IAE service bulletin

(SB)V-2500-ENG-72-0452, Revision 3, dated March 4, 2005, and that have a No. 3 bearing, part number (P/N) 2A1165, installed at new production build, do the following:

(1)Within 125 hours time-in-service

(TIS)after the effective date of this AD, inspect the master MCD or the No. 1, 2, 3 bearing chamber MCD.

(2)Thereafter, within 125 hours time-since-last inspection, inspect the master MCD or the No. 1, 2, 3 bearing chamber MCD.

(3)If you find bearing material on the master MCD or No. 1, 2, 3 bearing chamber MCD, replace the engine before further flight. Replacement of No. 3 Bearing

(g)For engines listed in Appendix 1, Tables 1 and 2 of IAE SB V-2500-ENG-72-0459, Revision 2, dated March 4, 2005, that have a serial number

(SN)from V10600 through V11365 inclusive, and that have a No. 3 bearing, part number (P/N) 2A1165, installed at new production, replace the No. 3 bearing at the next shop visit for any reason.

(h)After the effective date of this AD, do not install any No. 3 bearing, P/N 2A1165, removed in paragraph

(g)of this AD, into any engine. Replacement or Rework of High Pressure Compressor

(HPC)Stubshaft

(i)For engines listed in Appendix 1, Tables 1 and 2 of IAE SB V-2500-ENG-72-0459, Revision 2, dated March 4, 2005, that have a SN from V10600 through V11365 inclusive, at the next shop visit for any reason, replace the HPC stubshaft that has a low-energy plasma coating with an HPC stubshaft that has a high-energy plasma coating. Terminating Action

(j)Performing the requirements specified in paragraphs

(g)and

(i)of this AD is terminating action to the repetitive MCD inspections specified in paragraph (f)(1) through (f)(3) of this AD. Alternative Methods of Compliance (AMOCs)

(k)The Manager, Engine Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19. Material Incorporated by Reference

(l)For lists identifying engines within the engine SN range of V10600 to V11365 inclusive, known to have had P/N 2A1165 installed, you must use Appendix 1, Tables 1 and 2 of IAE SB V-2500-ENG-72-0452, Revision 3, dated March 4, 2005, and IAE SB V-2500-ENG-72-0459, Revision 2, dated March 4, 2005. Related Information

(m)The following service bulletins contain additional information and procedures:

(1)You can find information on inspecting the master MCD and the No. 1, 2, 3 bearing chamber MCD in section 79-00-00-601 of the Aircraft Maintenance Manual.

(2)Additional information on inspection procedures is included in IAE SB V-2500-ENG-72-0452, Revision 3, dated March 4, 2005.

(3)You can find information on replacing the No. 3 bearing, and replacing or recoating the HPC stubshaft in IAE SB V-2500-ENG-72-0459, Revision 2, dated March 4, 2005. Issued in Burlington, Massachusetts, on January 9, 2006. Peter A. White, Acting Manager, Engine and Propeller Directorate, Aircraft Certification Service. [FR Doc. E6-379 Filed 1-13-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 56 [Docket No. 2001N-0322 (formerly 01N-0322)] Institutional Review Boards: Requiring Sponsors and Investigators to Inform Institutional Review Boards of Any Prior Institutional Review Board Reviews; Withdrawal AGENCY: Food and Drug Administration, HHS. ACTION: Advance notice of proposed rulemaking; withdrawal. SUMMARY: The Food and Drug Administration

(FDA)is announcing the withdrawal of an advance notice of proposed rulemaking (ANPRM) entitled “Institutional Review Boards: Requiring Sponsors and Investigators to Inform IRBs of Any Prior IRB Reviews” that published in the **Federal Register** of March 6, 2002 (67 FR 10115). DATES: The ANPRM is withdrawn February 16, 2006. FOR FURTHER INFORMATION CONTACT: Patricia M. Beers Block, Good Clinical Practice Program (HF-34), Food and Drug Administration, 5600 Fishers Lane, rm. 9C24, Rockville, MD 20857, 301-827-3340. SUPPLEMENTARY INFORMATION: In 1998, the Department of Health and Human Services, Office of the Inspector General

(OIG)issued several reports on institutional review boards (IRBs). The OIG sought to identify the challenges facing IRBs and to make recommendations on improving Federal oversight of IRBs. One recommendation was that sponsors and clinical investigators be required to notify IRBs of any prior review (see OIG, Department of Health and Human Services, “Institutional Review Boards: A Time for Reform,” p. 14, June 1998; *http://oig.hhs.gov/oei/reports/oei-01-97-00193.pdf* ). The OIG report stated that the OIG had: * * * heard of a few situations where sponsors and/or research investigators who were unhappy with one IRB's reviews switched to another without the new IRB being aware of the other's prior involvement. This kind of IRB shopping deprives the new IRB of information that it should have and that can be important in protecting human subjects. The ground rules should be changed so that sponsors and investigators have the clear obligation to inform an IRB of any prior reviews (footnote omitted). The obligation should be applied to all those conducting research funded by HHS or carried out on FDA-regulated products. It will have particular importance for those sponsors and investigators working with independent IRBs. Id. After reviewing the OIG's recommendation, FDA published an ANPRM on March 6, 2002 (67 FR 10115) (see *http://www.fda.gov/OHRMS/DOCKETS/98fr/030602a.pdf* ) announcing it was considering whether to amend its IRB regulations to require sponsors and investigators to inform IRBs about any prior IRB review decisions. We invited public comments on:

(1)The frequency of IRB shopping and under what circumstances IRB shopping has occurred;

(2)what information about prior IRB review should be disclosed, where should it be disclosed, and who should disclose it; and

(3)what methods, other than disclosure of prior IRB reviews, might prove to be valuable for dealing with IRB shopping. In response to this ANPRM, FDA received 55 comments. The majority of the comments reported they had little or no first hand knowledge of instances of IRB shopping, and did not believe IRB shopping presented a significant problem. Many comments expressed concern about the logistics of maintaining a system that would enable the exchange of information among IRBs, especially when studies involved multiple study sites. There was concern that maintaining such a system would substantially increase the IRBs' workload and not provide any additional human subject protection. There was also concern that waiting for information from other IRBs prior to the review of research proposals within a particular institution might contribute to delays in the review of these proposals. The Office for Human Research Protections

(OHRP)also informed FDA that it considered the OIG's recommendation to require sponsors and investigators to notify IRBs of any prior IRB review of a research plan. OHRP concluded that it had no reason to believe that IRB shopping was occurring with any regularity in the review of HHS conducted or supported human subjects research. Based on these reasons, FDA concluded that IRB shopping either does not occur or does not present a problem to an extent that would warrant rulemaking at this time. In a letter dated February 26, 2005, FDA advised the OIG of these findings and conclusions. FDA is now withdrawing this ANPRM. A withdrawal does not prevent the agency from taking action in the future. Should FDA decide to undertake rulemaking sometime in the future, the agency will provide new opportunities for comment. Dated: January 4, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6-357 Filed 1-13-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 210 [Docket No. 2005N-0285] Current Good Manufacturing Practice Regulation and Investigational New Drugs; Companion Document to Direct Final Rule AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and Drug Administration

(FDA)is publishing this companion proposed rule to the direct final rule, published elsewhere in this issue of the **Federal Register** , which is intended to amend our current good manufacturing practice

(CGMP)regulations for human drugs, including biological products, to exempt most investigational “Phase 1” drugs from complying with the regulatory requirements. We will instead exercise oversight of production of these drugs under the agency's general statutory CGMP authority and investigational new drug application

(IND)authority. Elsewhere in this issue of the **Federal Register** , FDA is announcing the availability of a draft guidance for industry entitled “INDs—Approaches to Complying With CGMP During Phase 1” to provide further guidance on the subject. DATES: Submit written or electronic comments by April 3, 2006. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/comments* . FOR FURTHER INFORMATION CONTACT: Monica Caphart, Center for Drug Evaluation and Research (HFD-320), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-9047; or Christopher Joneckis, Center for Biologics Evaluation and Research (HFM-1), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-435-5681. SUPPLEMENTARY INFORMATION: I. Background As described more fully in the related direct final rule, a Phase 1 clinical trial includes the initial introduction of an investigational new drug into humans. Such studies are aimed at establishing basic safety and are designed to determine the metabolism and pharmacologic actions of the drug in humans. The total number of subjects in a Phase 1 study is limited—generally no more than 80 subjects. This is in contrast to Phase 2 and Phase 3 trials, which may involve substantially greater numbers of subjects, exposing more subjects to the drug product, and which aim to test the effectiveness of the drug product. For several reasons, we believe that production of human drug products, including biological drug products, intended for use in Phase 1 clinical trials should be exempted from complying with the specific regulatory requirements set forth in parts 210 and 211 (21 CFR parts 210 and 211). First, even if exempted from the requirements of our CGMP regulations in parts 210 and 211, investigational drugs remain subject to the statutory provisions that deem a drug adulterated for failure to comply with CGMPs (21 U.S.C. 351(a)(2)(B)). Second, we oversee drugs for use in Phase 1 trials through our existing IND authority. Every IND must contain, among other things, a section on chemistry, manufacturing, and control information that describes the composition, manufacture, and control of the investigational drug product (21 CFR 312.23(a)(7)). This information should suffice to enable us to adequately protect subjects in early Phase 1 trials. II. Additional Information This proposed rule is a companion to the direct final rule published in the final rules section of this issue of the **Federal Register** . The proposed rule and the direct final rule are identical. This companion proposed rule provides the procedural framework to proceed with standard notice-and-comment rulemaking if the direct final rule receives significant adverse comment and is withdrawn. The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. Any comments received on this companion proposed rule will also be treated as comments on the direct final rule and vice versa. For additional information, see the corresponding direct final rule published in the final rules section of this issue of the **Federal Register** . All persons who may wish to comment should review the rationale for these amendments set out in the preamble discussion of the direct final rule. A significant adverse comment is one that explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment recommending a rule change in addition to this rule will not be considered a significant adverse comment, unless the comment states why this rule would be ineffective without the additional change. If no significant adverse comment is received in response to the direct final rule, no further action will be taken related to this companion proposed rule. Instead, we will publish a confirmation notice within 30 days after the comment period ends, and we intend the direct final rule to become effective 30 days after publication of the confirmation notice. If we receive significant adverse comments, we will withdraw the direct final rule. We will proceed to respond to all of the comments received regarding the direct final rule, treating those comments as comments to this proposed rule. The agency will address the comments in a subsequent final rule. We will not provide additional opportunity for comment. III. Legal Authority Under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 201 *et seq* .) a drug is deemed adulterated if the methods used in, or the facilities, or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated in conformity with CGMPs to ensure that such drug meets the requirements of the act as to safety, and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. The rulemaking authority conferred on FDA by Congress under the act permits the agency to amend its regulations as contemplated by this direct final rule. Section 701(a) of the act (21 U.S.C. 371) gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the act. We refer readers to the legal authority section of the preamble of the 1978 CGMP regulations for a fuller discussion (43 FR 45014 at 45020-45026, September 29, 1978). IV. Environmental Impact The agency has determined that under 21 CFR 25.30(h) this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. V. Analysis of Impacts FDA examined the impacts of this proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this proposed rule is not a significant regulatory action as defined by the Executive order. Under the Regulatory Flexibility Act, if a rule has a significant impact on a substantial number of small entities, an agency must analyze regulatory options that would minimize any significant impact of the rule on small entities. The agency has considered the effect that this rule would have on small entities. Because exempting production of drugs for use in Phase 1 studies from compliance with specific regulatory requirements does not add any burden, the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $115 million using the most current

(2003)Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount. For a further discussion of the impacts of this rulemaking, see the Analysis of Impacts section in the corresponding direct final rule published in the final rules section of this issue of the **Federal Register** . VI. Paperwork Reduction Act of 1995 This proposed rule contains no new information collection requirements that are subject to review by the Office of Management and Budget

(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Under the proposed rule, the production of human drug products, including biological drug products, intended for use in Phase 1 clinical trials would be exempted from complying with the specific regulatory requirements set forth in parts 210 and 211. Parts 210 and 211 contain information collection requirements that have been approved by OMB under control number 0910-0139. As explained in the following paragraph, the information collection requirements in parts 210 and 211 would be reduced under this proposed rule. The OMB-approved hourly burden to comply with the information collection requirements in parts 210 and 211 (control number 0910-0139) is 848,625 hours. FDA estimates that, under the proposed rule, approximately 7,315 drugs would be exempted from complying with the specific regulatory requirements set forth in parts 210 and 211. Based on this number and the total number of drugs that are subject to parts 210 and 211, FDA estimates that the burden hours approved under control number 0910-0139 would be reduced by approximately 50,493 hours. Thus, as a result of the proposed rule, the amended burden hours in control number 0910-0139 would be approximately 798,132 hours. VII. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. We invite comments on the federalism implications of this proposed rule. VIII. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. This comment period runs concurrently with the comment period for the direct final rule; any comments received will be considered as comments regarding the direct final rule. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 210 Drugs, Packaging and containers. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs it is proposed that 21 CFR part 210 be amended as follows: PART 210—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL 1. The authority citation for 21 CFR part 210 continues to read as follows: Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264. 2. Section 210.2 is revised by adding paragraph

(c)to read as follows: § 210.2 Applicability of current good manufacturing practice regulations.

(c)An investigational drug for use in a Phase 1 study, as defined in § 312.21(a) of this chapter, is subject to the statutory requirements set forth at 21 U.S.C. 351(a)(2)(B). The production of such drug is exempt from compliance with the regulations in part 211 of this chapter. However, this exemption does not apply to an investigational drug for use in a Phase 1 study once the investigational drug has been made available for use by or for the sponsor in a Phase 2 or Phase 3 study, as defined in § 312.21(b) and

(c)of this chapter, or the drug has been lawfully marketed. If the investigational drug has been made available in a Phase 2 or 3 study or the drug has been lawfully marketed, the drug for use in the Phase 1 study must comply with part 211 of this chapter. Dated: January 9, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06-350 Filed 1-12-06; 8:45 am]

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