Department of Health and Human Services May 7, 2012 – Federal Register Recent Federal Regulation Documents

The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Karen L. Blyth for a period of 20 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Ms. Blyth was convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 U.S.C. 335a(l)(1)(B)), of 10 felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Ms. Blyth was given notice of the proposed debarment and an opportunity to request a hearing within the time frame prescribed by regulation. As of March 23, 2012 (30 days after receipt of the notice), Ms. Blyth had not responded. Ms. Blyth's failure to respond constitutes a waiver of her right to a hearing concerning this action.

The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring David H.M. Phelps for a period of 20 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. Phelps was convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 U.S.C. 335a(l)(1)(B)), of 10 felony counts under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Phelps was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of March 31, 2012 (30 days after receipt of the notice), Mr. Phelps had not responded. Mr. Phelps's failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor name from Bioniche Teoranta to Mylan Institutional, LLC; a change of sponsor for fomepizole injectable solution from Synerx Pharma, LLC, to Mylan Institutional, LLC; and a change of sponsor address for Modern Veterinary Therapeutics, LLC.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in Patent Applications USSN 09/808,149, filed Mar 15, 2001, issued Mar 30, 2004; PCT/US02/07836, filed Mar 14, 2002, designated EP, 02723446,7 and US 10/471,468, issued Feb 9, 2010; USSN 11/739,540, filed Apr 29, 2007; and USSN 12/647,980, filed Dec 28, 2009; entitled ``Ocular Therapeutic Agent Delivery Devices and Methods For Making and Using Such Devices'', by Michael R. Robinson et al (NEI, CC, and NIBIB) (E-241-1999/0), to ODIN Biotech having a place of business in 4000 Hanover Street, Dallas, TX. The patent rights in this invention have been assigned to the United States of America. The exclusive patent license is one which qualifies under the Start-up Exclusive Patent License Agreement program, which is in place from October 1, 2011 through September 30, 2012.

This final rule implements section 2401 of the Affordable Care Act, which establishes a new State option to provide home and community-based attendant services and supports. These services and supports are known as Community First Choice (CFC). While this final rule sets forth the requirements for implementation of CFC, we are not finalizing the section concerning the CFC setting.