Department of Health and Human Services May 2010 – Federal Register Recent Federal Regulation Documents

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

This document sets forth a correction to the OIG Federal

This document corrects several technical and typographical errors in the final rule with comment period that appeared in the November 25, 2009 Federal Register entitled ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010; Final Rule'' (74 FR 61738), as well as errors in the December 10, 2009 correction notice to the ``Medicare Program; Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2010; Corrections'' (74 FR 65449).

U.S. Federal agency responses to Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) test method recommendations on the murine local lymph node assay (LLNA), an alternative safety testing method used to assess the potential of chemicals and products to cause allergic contact dermatitis (ACD), are now available. ICCVAM recommended an updated LLNA test method protocol, a reduced LLNA procedure (rLLNA), and LLNA test method performance standards. In accordance with the ICCVAM Authorization Act, ICCVAM previously forwarded recommendations to Federal agencies and made these recommendations available to the public (74 FR 50212). Agencies have now notified ICCVAM in writing of their findings and ICCVAM is making these responses available to the public. Federal agency responses are available on the NICEATM-ICCVAM Web site at https:// iccvam.niehs.nih.gov/methods/immunotox/rLLNA.htm and https:// iccvam.niehs.nih.gov/methods/immunotox/llnaPerfStds.htm. The ICCVAM recommendations are provided in ICCVAM Test Method Evaluation Reports, which are available on the NICEATM-ICCVAM Web site at https:// iccvam.niehs.nih.gov/methods/immunotox/LLNA-LD/TMER.htm and https:// iccvam.niehs.nih.gov/methods/immunotox/PerfStds/llna-ps.htm.

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 February 8, 2010 (Vol. 75, No. 25, p. 6207) 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. 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 the guidance entitled ``Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco.'' This guidance document discusses FDA's intended enforcement policies with respect to two provisions of the final regulations restricting the sale and distribution of cigarettes and smokeless tobacco to protect children and adolescents. One provision restricts the use of a trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product. The second provision requires that labeling or print advertisements appear in a black-and-white text only format, except in certain ``adult only'' locations or in publications that do not have significant readership by children and adolescents under the age of 18. This guidance document will be implemented immediately, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

Under the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.