Department of Health and Human Services July 19, 2010 – Federal Register Recent Federal Regulation Documents

This is a notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in US Patent Application 61/241,620 entitled ``Development of an Immunotoxin in Which All B-Cell Epitopes Have Been Removed and Which Has High Cytotoxic Activity'' [HHS Ref. E-269-2009/0-US-01], US Patent Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas Exotoxin A That Reduce Non-Specific Toxicity'' [HHS Ref. E-292-2007/0- US-01], US Patent Application 60/703,798 entitled ``Mutated Pseudomonas Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/0-US-01], and all continuing applications and foreign counterparts, to MedImmune, LLC. This license may also include non-exclusive rights to US Patent Application 60/525,371 entitled ``Mutated Anti-CD22 Antibodies and Immunoconjugates'' [HHS Ref. E-046-2004/0-US-01], US Patent Application 60/325,360 entitled ``Mutated Anti-CD22 Antibodies with Increased Affinity to CD22 Expressing Leukemia Cells'' [HHS Ref. E-129-2001/0-US- 01], US Patent Application 60/041,437 entitled ``Recombinant Immunotoxins Targeted to CD22 Bearing Cells and Tumors'' [HHS Ref. E- 059-1997/0-US-01], US Patent 5,747,654 entitled ``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity'' [HHS Ref. E-163-1993/0-US-01], PCT application PCT/US96/16327 entitled ``Immunotoxin Containing A Disulfide-Stabilized Antibody Fragment'' [HHS Ref. E-163-1993/2-PCT-01], and all continuing applications and foreign counterparts. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.

The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of ammonium formate as an acidifying agent in swine feed. This action is in response to a food additive petition filed by Kemira Oyj of Finland.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, the Department of Health and Human Services is hereby giving notice that the Advisory Commission on Childhood Vaccines (ACCV) will hold a special meeting, to be held by teleconference. This meeting will be equivalent to an in-person meeting and will be open to the public.

The Office of the Assistant Secretary for Planning Evaluation (ASPE) is developing a national inventory of comparative effectiveness research (CER) and CER-related information. This initiative is driven by the American Recovery and Reinvestment Act of 2009 (ARRA) which provided $1.1 billion for research and development in the area of CER. ARRA allocated $400 million to the Office of the Secretary (OS) in the U.S. Department of Health and Human Services (HHS), $400 million to the National Institutes of Health (NIH), and $300 million to the Agency for Healthcare Research and Quality. ARRA also established the Federal Coordinating Council for CER, which, after significant public input, developed a strategic framework and recommended high-level priorities for OS funds. While the FCC's Report to Congress drew on an initial CER inventory focused on federal investments, the process of cataloguing CER activities and infrastructure will be critical to tracking ongoing and future investments in CER. An important component of this effort is creating an inventory of CER to ensure that patients, clinicians, and other decision makers can identify and locate relevant CER in a timely manner.