April 17, 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Submission of Summary Bioequivalence Data for ANDAs.'' The draft guidance is intended to assist abbreviated new drug application (ANDA) applicants in complying with the new requirements in the final rule on the submission of bioequivalence data published in the Federal Register in January 2009. The final rule requires ANDA applicants to submit data from all bioequivalence studies (BE studies) the applicant conducts on a drug product formulation submitted for approval, including both studies that demonstrate and studies that fail to demonstrate that a generic product meets the current bioequivalence criteria. The draft guidance provides recommendations to applicants planning to include BE studies for submission in ANDAs, and is applicable to BE studies conducted during both preapproval and postapproval periods.

The Nuclear Regulatory Commission (NRC) is making available preliminary draft proposed rule language to amend its regulations to add a new part 37 to Title 10 of the Code of Federal Regulations. This new part 37 will contain the security (physical protection) requirements that are designed to provide reasonable assurance of preventing the theft or diversion of category 1 and category 2 quantities of radioactive material as designated by the International

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting, to be held by teleconference. This meeting will be equivalent to an in-person meeting and will be open to the public. Pre- registration is required for both public attendance by phone as well as public comment. Any individual who wishes to attend the meeting and/or participate in the public comment session should e-mail nvpo@hhs.gov.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Intervet, Inc. The supplemental NADA provides for a revised human food safety warning for use of fenbendazole suspension in horses.

We, the U.S. Fish and Wildlife Service, have received an application from Hossain Ahmadi (applicant) for a 3-year incidental take permit for five species under the Endangered Species Act of 1973,

This staff accounting bulletin (``SAB'') amends Topic 5.M. in the Staff Accounting Bulletin Series entitled Other Than Temporary Impairment of Certain Investments in Debt and Equity Securities (``Topic 5.M.''). On April 9, 2009, the FASB issued FASB Staff Position No. FAS 115-2 and FAS 124-2, Recognition and Presentation of Other- Than-Temporary Impairments (``FSP 115-2'') to provide guidance for assessing whether an impairment of a debt security is other than temporary. This SAB maintains the staff's previous views related to equity securities. It also amends Topic 5.M. to exclude debt securities from its scope.

The Committee is submitting to the Office of Management and Budget for their review the following collection as required by the Paperwork Reduction Act (44 U.S.C. Chapter 35).

Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR), Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement concerning corporate aircraft costs. This OMB clearance expires on June 30, 2009.

This notice revises an earlier proposed airworthiness directive (AD), and supersedes an existing AD applicable to General Electric Company (GE) CF34-1A, -3A, -3A1, -3A2, -3B, and -3B1 turbofan engines. This proposed AD reopens the comment period, since we added additional requirements based on responses we received. This proposed AD would now require:

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

EPA is proposing to approve the State Implementation Plan (SIP) revision submitted by the Georgia Department of Natural Resources through the Georgia Environmental Protection Division on February 13, 2009. The revisions include minor changes to Georgia's Air Quality Rules found at Chapter 391-3-20-.17, pertaining to rules for Enhanced Inspection and Maintenance. Specifically, the changes update the amount of repair costs that may qualify for a waiver. This action is being taken pursuant to section 110 of the Clean Air Act.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donor Testing, Donor Notification, and `Lookback''' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Commission requests comments on a channel substitution proposed by New York Television, Inc. (``New York TV''), the licensee of WYNO-DT, DTV channel 34, Buffalo, New York. New York TV requests the substitution of DTV channel 49 for post-transition DTV channel 34 at Buffalo.