Department of Health and Human Services December 29, 2009 – Federal Register Recent Federal Regulation Documents

Pursuant to Section 814 of the Native American Programs Act of 1974 (NAPA), as amended, the Administration for Native Americans 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) 2010 Funding Opportunity Announcements (FOA) for the following programs: Social and Economic Development Strategies (hereinafter referred to as SEDS), Social and Economic Development StrategiesSpecial Initiative (hereinafter referred to as SEDS-SI), Native Language Preservation and Maintenance (hereinafter referred to as Language Preservation), Native Language Preservation and MaintenanceEsther Martinez Initiative (hereinafter referred to as Language-EMI), and Environmental Regulatory Enhancement (hereinafter referred to as ERE). This notice also provides additional information about ANA's plan for administering the programs.

The Food and Drug Administration (FDA or agency) is issuing a proposed rule that, if finalized, would amend the informed consent regulations to require that the informed consent documents and processes for applicable drug, biologic, and device clinical investigations include a statement that clinical trial information for such clinical investigations has been or will be submitted to the National Institutes of Health/National Library of Medicine (NIH/NLM) for inclusion in the clinical trial registry databank. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that FDA update its informed consent regulations to require that the informed consent documents and processes for certain clinical investigations include a statement that clinical trial information for such investigations has been or will be submitted for inclusion in the clinical trial registry databank.

In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice solicits proposals and recommendations for developing new and modifying existing safe harbor provisions under the Federal anti-kickback statute (section 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts.