Department of Health and Human Services February 26, 2013 – Federal Register Recent Federal Regulation Documents

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 reinstatement 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 FDA's regulations on foreign clinical studies not conducted under an investigational new drug application (IND).

The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Richard Stowell for a period of 3 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Stowell was convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 U.S.C. 335a(l)(1)(B)), of three felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Stowell was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of December 14, 2012, Mr. Stowell had not responded. Mr. Stowell's failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators.'' This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators. This guidance provides FDA's responses to the most frequently asked questions regarding financial disclosure by clinical investigators. The guidance announced in this notice finalizes the draft guidance of the same title dated May 2011 and replaces the guidance entitled, ``Guidance for Industry: Financial Disclosure by Clinical Investigators,'' dated March 2001.

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) 2013 Funding Opportunity Announcements (FOA) for the following programs: (1) Social and Economic Development Strategies (hereinafter referred to as SEDS); (2) Native Asset Building Initiative (hereinafter referred to as NABI); (3) Sustainable Employment and Economic Development Strategies (hereinafter referred to as SEEDS); (4) Native Language Preservation and Maintenance (hereinafter referred to as Language Preservation); (5) Native Language Preservation and MaintenanceEsther Martinez Initiative (hereinafter referred to as LanguageEMI); and 6) Environmental Regulatory Enhancement (hereinafter referred to as ERE). This notice of public comment also provides additional information about ANA's plan for administering the programs.