New Animal Drugs in Genetically Engineered Animals, 58205 [E9-27305]

Download as PDF Federal Register / Vol. 74, No. 217 / Thursday, November 12, 2009 / Rules and Regulations regulation’s effective date of September 10, 2009 remains unchanged. The Commission finds that, for good cause and the reasons cited above, including the brief length of the extension we are granting, notice and solicitation of comment regarding the extension of the compliance date for Regulation S–AM are impracticable, unnecessary, or contrary to the public interest.5 In this regard, the Commission also notes that Covered Persons need to be informed as soon as possible of the extension and its length in order to plan and adjust their implementation process accordingly. By the Commission. Dated: November 5, 2009. Elizabeth M. Murphy, Secretary. [FR Doc. E9–27126 Filed 11–10–09; 8:45 am] ACTION: Final rule; amendment. SUMMARY: On October 30, 2009 (74 FR 56114), the Department of Defense published a final rule revising 32 CFR part 311 to update Office of the Secretary of Defense (OSD) and Joint Staff (JS) policy, assign responsibilities, and prescribe procedures for the effective administration of the Privacy Act (PA) Program in OSD and JS. In the published rule, the section on procedures for exemptions was inadvertently dropped. This rule amendment is being published to add this section back to 32 CFR part 311. DATES: Effective Date: This rule is effective November 30, 2009. FOR FURTHER INFORMATION CONTACT: Cindy Allard, 703–588–6830. SUPPLEMENTARY INFORMATION: Public Law 96–511, ‘‘Paperwork Reduction Act’’ (44 U.S.C. Chapter 35) It has been certified that 32 CFR part 311 does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995. Executive Order 13132, ‘‘Federalism’’ It has been certified that 32 CFR part 311 does not have federalism implications, as set forth in Executive Order 13132. This rule does not have substantial direct effects on: (1) The States; (2) The relationship between the National Government and the States; or (3) The distribution of power and responsibilities among the various levels of Government. List of Subjects in 32 CFR Part 311 Privacy Act. BILLING CODE 8011–01–P Executive Order 12866, ‘‘Regulatory Planning and Review’’ ■ DEPARTMENT OF HEALTH AND HUMAN SERVICES It has been certified that 32 CFR part 311 does not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribunal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President’s priorities, or the principles set forth in this Executive Order 12866, as amended by Executive Order 13422. PART 311—[AMENDED] Food and Drug Administration 21 CFR Part 528 New Animal Drugs in Genetically Engineered Animals CFR Correction In Title 21 of the Code of Federal Regulations, Parts 500–599, revised as of April 1, 2009, on page 359, the heading for part 528 is corrected to read ‘‘NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS’’. [FR Doc. E9–27305 Filed 11–10–09; 8:45 am] BILLING CODE 1505–01–D DEPARTMENT OF DEFENSE Section 202, Public Law 104–4, ‘‘Unfunded Mandates Reform Act’’ Office of the Secretary [DoD–2006–OS–0033; RIN 0790–AI26] 32 CFR Part 311 Office of the Secretary of Defense and Joint Staff Privacy Program AGENCY: Department of Defense. 5 See WReier-Aviles on DSKGBLS3C1PROD with RULES 58205 Section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) (‘‘APA’’) (an agency may dispense with prior notice and comment when it finds, for good cause, that notice and comment are ‘‘impracticable, unnecessary, or contrary to the public interest). The change to the compliance date is effective upon publication in the Federal Register. This date is less than 30 days after publication in the Federal Register, in accordance with the APA, which allows effectiveness in less than 30 days after publication for ‘‘a substantive rule which grants or recognizes an exemption or relieves a restriction.’’ See 5 U.S.C. 553(d)(1). VerDate Nov<24>2008 13:02 Nov 10, 2009 Jkt 220001 It has been certified that 32 CFR part 311 does not contain a Federal mandate that may result in the expenditure by State, local and tribunal governments, in aggregate, or by the private sector, of $100 million or more in any one year. Public Law 96–354, ‘‘Regulatory Flexibility Act’’ (5 U.S.C. 601) It has been certified that 32 CFR part 311 is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. The rule implements the procedures for the effective administration of the Privacy Act Program in OSD and the JS. PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 Accordingly, 32 CFR part 311 is amended as follows: 1. The authority citation for part 311 continues to read as follows: ■ Authority: 5 U.S.C. 552a. 2. Section 311.8 is added to read as follows: ■ § 311.8 Procedures for exemptions. (a) General information. The Secretary of Defense designates those Office of the Secretary of Defense (OSD) systems of records which will be exempt from certain provisions of the Privacy Act. There are two types of exemptions, general and specific. The general exemption authorizes the exemption of a system of records from all but a few requirements of the Act. The specific exemption authorizes exemption of a system of records or portion thereof, from only a few specific requirements. If an OSD Component originates a new system of records for which it proposes an exemption, or if it proposes an additional or new exemption for an existing system of records, it shall submit the recommended exemption with the records system notice as outlined in § 311.6. No exemption of a system of records shall be considered automatic for all records in the system. The systems manager shall review each requested record and apply the exemptions only when this will serve significant and legitimate Government purpose. (b) General exemptions. The general exemption provided by 5 U.S.C. 552a(j)(2) may be invoked for protection of systems of records maintained by law enforcement activities. Certain functional records of such activities are E:\FR\FM\12NOR1.SGM 12NOR1

Agencies

[Federal Register Volume 74, Number 217 (Thursday, November 12, 2009)]
[Rules and Regulations]
[Page 58205]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27305]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 528


New Animal Drugs in Genetically Engineered Animals

CFR Correction

    In Title 21 of the Code of Federal Regulations, Parts 500-599, 
revised as of April 1, 2009, on page 359, the heading for part 528 is 
corrected to read ``NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED 
ANIMALS''.

[FR Doc. E9-27305 Filed 11-10-09; 8:45 am]
BILLING CODE 1505-01-D

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