Department of Health and Human Services July 2010 – 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 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 an information request regarding the use of menthol in cigarettes.

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.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).

The U.S. Department of Health and Human Services announces establishment of the Advisory Board on Elder Abuse, Neglect, and Exploitation, as directed by section 2022, Subtitle HElder Justice Act, of the Affordable Care Act, Public Law 111-148.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of the publication entitled ``Preventing Deaths and Injuries of Fire Fighters Using Risk Management Principles at Structure Fires.''

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 13: Bulk Density and Tapped Density of Powders General Chapter.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance provides the results of the ICH Q4B evaluation of the Bulk Density and Tapped Density of Powders General Chapter harmonized text from each of the three pharmacopoeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The draft guidance conveys recognition of the three pharmacopoeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The draft guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. This draft guidance is the thirteenth annex to the core Q4B guidance, which was made available in the Federal Register of February 21, 2008 (73 FR 9575).

The Department of Health and Human Services (HHS or ``the Department'') is issuing this notice of proposed rulemaking to modify the Standards for Privacy of Individually Identifiable Health Information (Privacy Rule), the Security Standards for the Protection of Electronic Protected Health Information (Security Rule), and the rules pertaining to Compliance and Investigations, Imposition of Civil Money Penalties, and Procedures for Hearings (Enforcement Rule) issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The purpose of these modifications is to implement recent statutory amendments under the Health Information Technology for Economic and Clinical Health Act (``the HITECH Act'' or ``the Act''), to strengthen the privacy and security protection of health information, and to improve the workability and effectiveness of these HIPAA Rules.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on communication studies involving medical devices and radiation-emitting products regulated by FDA. This information will be used to explore concepts of interest and assist in the development and modification of communication messages and campaigns to fulfill the agency's mission to protect the public health.