June 8, 2009 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA) is issuing non-competitive supplemental funding under the Maternal Child Health Bureau, Healthy Start Eliminating Disparities in Perinatal Health program to ensure that the Northern Manhattan Perinatal Partnership (NMPP), the primary provider of prenatal services in Central Harlem, can continue to provide much needed services to help stem the rise in and ultimately reduce the Infant Mortality Rate (IMR) in the affected service area.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Library of Medicine (NLM), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on March 30, 2009 (Vol. 74, No. 59, Pg. 14137) and allowed 60-days for public comment. One public comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Medication Guides Adding a Toll-Free Number for Reporting Adverse Events.'' Beginning July 1, 2009, manufacturers of prescription drug products approved under the Federal Food, Drug, and Cosmetic Act (the act) that are required to have a Medication Guide must add a verbatim statement to their Medication Guides containing FDA's toll-free number for reporting side effects. These manufacturers are also required to report to FDA that they have complied with this requirement. This guidance explains what statement to add to Medication Guides, where to add it, and how to notify the agency that such a statement has been added.

The Defense Logistics Agency is proposing to amend a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

The Defense Logistics Agency is proposing to amend a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

The Department of the Navy is amending a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

The National Security Agency/Central Security Service is proposing to alter an exempt system of records to its existing inventory of record systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

The U. S. Small Business Administration (SBA) is considering granting a waiver of the Nonmanufacturer Rule for 13 Watt Compact Fluorescent Lamps (CFLs), 26 Watt CFLs, and Occupancy Sensors Dual Technology. According to a request, no small business manufacturers supply these classes of product to the Federal government. If granted, the waiver would allow otherwise qualified small businesses to supply the products of any manufacturer on a Federal contract set aside for small businesses, service-disabled veteran-owned small businesses, or Participants in the SBA's 8(a) Business Development (BD) Program.

The Food and Drug Administration (FDA) is announcing the availability of final product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' explaining the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of additional draft and revised draft product-specific BE recommendations.

The Chairman of the Federal Deposit Insurance Corporation has decided to establish the FDIC Advisory Committee on Community Banking (``the Committee''). The Committee will provide advice and recommendations on a broad range of policy issues that have a particular impact on small community banks throughout the United States and the local communities that are served by those community banks, including a focus on rural areas. The Committee will review various issues concerning community banks that may include, but are not limited to, the latest examination policies and procedures, credit and lending practices, deposit insurance assessments, insurance coverage issues, and regulatory compliance matters, as well as any obstacles to the continued growth and ability of community banks to extend financial services in their local markets in the current market environment. The Chairman certifies that the establishment of this advisory committee is in the public interest in connection with the performance of duties imposed on the FDIC by law.

To comply with the Paperwork Reduction Act of 1995 (PRA), MMS is inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. This information collection request concerns the paperwork requirements in the regulations under 30 CFR 250, Subpart A, ``General.'' The MMS is renewing OMB approved Emergency Request 1010-0177 because information needs to be collected for a longer period than allowed in the Emergency Request. After a major weather event, like a hurricane, lessees and operators need to keep reporting new information to MMS until all MODUs are determined to be safe.

This document contains a correction to a notice and request for comments that was published in the Federal Register on Friday, May 29, 2009 at 74 FR 25811 inviting the general public and other Federal Agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).

This document contains a correction to final and temporary regulations (TD 9448, that were published in the Federal Register on Thursday, May 7, 2009 (74 FR 21438). This regulation relates to the use of actuarial tables in valuing annuities, interests for life or terms of years, and remainder or reversionary interests.

In compliance with the requirements of section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507, the Federal Energy Regulatory Commission (Commission or FERC) has submitted the information collection described below to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should