November 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus''. This draft guidance provides recommendations for assessing blood donor suitability and blood product safety and maintaining blood and blood product availability in response to pandemic (H1N1) 2009 virus. It is intended for establishments that manufacture Whole Blood and blood components intended for use in transfusion and blood components intended for further manufacture, including recovered plasma, Source Plasma and Source Leukocytes.

Pursuant to subsection (e)(4) of the Privacy Act of 1974, as amended (5 U.S.C. 552a), the FCC proposes to add a new system of records, FCC/MB-1, ``Ownership Report for Commercial Broadcast Stations.'' The FCC's Media Bureau (MB) will use the information contained in FCC/MB-1 to administer the FCC's regulatory responsibilities that relate to ownership of commercial broadcast stations, including AM and FM radio and television, as well as to interests in daily newspapers that are subject to the Commission's media ownership rules. The Commission uses these records in this system:

The Agricultural Marketing Service (AMS) proposes to amend the regulations governing the United States (U.S.) Standards for Condition of Food Containers. AMS regularly reviews standards to determine if they meet current industry practices. Based on our most recent review, we believe that the U.S. Standards for Condition of Food Containers needs to be revised. The revisions are necessary in order to provide standards that reflect current industry practices. Revisions to the U.S. Standards for Condition of Food Containers include simplifying Tables I, I-A, II, II-A, III, III-A, and III-B for sampling plans for normal, tightened, and reduced condition of container inspection to reflect the type of sampling plan used (single or double). It also includes updating the Acceptable Quality Levels (AQLs), Tables IV Metal Containers, VGlass Containers, VIRigid and Semirigid Containers, VIIFlexible Containers (Plastic, Cello, Paper, Textile, etc.), and XDefects of Label, Marking, or Code (currently Table VIII) to incorporate new defects and updating current defects to include defects that would correspond to new packaging technologies such as aseptic packaging, metal cans with easy open lids, and plastic rings that hold several containers together. This revision also proposes adding new defect tables entitled Table VIIIUnitizing (Plastic or other type of casing/unitizing) and Table IXInterior Can Defects. Finally, removing the Operating Characteristic (OC) curves for on-line sampling and inspection. Other minor non-substantive changes are also proposed.

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on an experimental study of Nutrition Facts label formats.

The Food and Drug Administration (FDA) is announcing a meeting with sponsors of certain opioid drug products regarding the development of Risk Evaluation and Mitigation Strategies (REMS) for these products. Other members of the public are invited to attend and observe. The REMS is intended to ensure that the benefits of these drugs continue to outweigh certain risks. FDA has encouraged affected sponsors to work collectively to develop a proposed REMS. The purpose of this meeting is to hear from sponsors about the status of the development of a proposed REMS and their views regarding the specific features of the REMS for these products. To promote transparency of the REMS development process, other members of the public are invited to attend the meeting as observers. Additional opportunities for public input will be provided before FDA finalizes the elements of the REMS.

The Food and Drug Administration (FDA) is extending to January 25, 2010, the comment period for the notice entitled ``Acrylamide in Food; Request for Comments and for Scientific Data and Information,'' that appeared in the Federal Register of August 26, 2009 (74 FR 43134). In the notice, FDA requested comments and scientific data and information on acrylamide in food. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health 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 Wednesday, July 29, 2009, Volume 74, Number 144 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.