Department of Health and Human Services November 30, 2010 – Federal Register Recent Federal Regulation Documents

This final rule amends Medicaid regulations to conform with the decision by the United States District Court for the District of Columbia on May 23, 2008 in Alameda County Medical Center, et al. v. Michael O. Leavitt, Secretary, U.S. Department of Health and Human Services, et al., 559 F. Supp. 2d (2008) that vacated a final rule with comment period published in the Federal Register in May 29, 2007. This regulatory action takes ministerial steps to remove the vacated provisions from the Code of Federal Regulations and reinstate the prior regulatory language impacted by the May 29, 2007 final rule with comment period.

The Food and Drug Administration (FDA) is proposing to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in regulations governing the use of radioactive drugs for basic informational research (21 CFR 361.1).

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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for FDA regulations related to the exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile (SNS).

Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans (ANA) is required to provide members of the public an opportunity to comment on proposed changes in interpretive rules, general statements of policy, and rules of agency procedure or practice, and to give notice of the final adoption of such changes at least 30 days before the changes become effective. In accordance with notice requirements of NAPA, ANA herein describes its proposed interpretive rules, general statements of policy, and rules of agency procedure or practice as they relate to the Fiscal Year (FY) 2011 Funding Opportunity Announcements (FOA) for the following programs: Social and Economic Development Strategies (SEDS), Social and Economic Development StrategiesTribal Governance (SEDSTG), Social and Economic Development Strategies Assets for Independence (SEDSAFI), Native Language Preservation and Maintenance (Language P&M), Native Language Preservation and MaintenanceEsther Martinez Initiative (LanguageEMI), and Environmental Regulatory Enhancement (ERE). This notice also provides additional information about ANA's plan for administering the programs.