Department of Health and Human Services July 2009 – Federal Register Recent Federal Regulation Documents

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will be holding a public meeting. The meeting is open to the public.

The Food and Drug Administration (FDA) is announcing a public meeting entitled ``International Cooperation on Cosmetics Regulations (ICCR)Preparation for ICCR3 Meetings in Tokyo, Japan'' to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming meetings in Tokyo, Japan. The topics to be discussed are the topics for discussion at the forthcoming ICCR steering committee meeting. The purpose of the meeting is to solicit public input prior to the next steering committee and expert working group meetings in Tokyo, Japan, scheduled for the week of September 7, 2009.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at Area IV of the Santa Susana Field Laboratory, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 2009, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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 The draft guidance describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers. The draft guidance is intended to foster consistency of applications across regions and facilitate joint discussions with and among regulatory authorities.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Drug-Induced Liver Injury: Premarketing Clinical Evaluation.'' This guidance is intended to assist the pharmaceutical industry and others engaged in new drug development in the assessment of the potential of a drug to cause severe drug-induced liver injury (DILI) during the conduct of premarketing trials. This guidance defines severe DILI as injury that is fatal or requires liver transplantation.

HRSA will be awarding noncompetitively Part C Ryan White HIV/ AIDS program funds to support comprehensive primary care services for persons living with HIV/AIDS including primary medical care, laboratory testing, oral health care, outpatient mental health and substance abuse treatment, specialty and subspecialty care, referrals for health and support services, and adherence monitoring/education services to the Wyoming Department of Health in order to ensure continuity of critical HIV medical care and treatment services, and to avoid a disruption of HIV clinical care to clients in the State of Wyoming.

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 Heart, Lung, and Blood Institute (NHLBI), 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) has determined the regulatory review period for DUREZOL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Human Parvovirus B19 Transmission by Plasma-Derived Products,'' dated July 2009. The guidance document provides to manufacturers of plasma-derived products recommendations for performing parvovirus B19 NAT as an in-process test for Source Plasma and recovered plasma to identify and help to prevent the use of plasma units containing high levels of parvovirus B19. The guidance also recommends how to report to FDA implementation of parvovirus B19 NAT. The guidance announced in this notice finalizes the draft guidance of the same title, dated July 2008.

HHS gives notice concerning the final effect of the HHS decision to designate a class of employees at the Standard Oil Development Company in Linden, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 18, 2009, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Office of Community Services (OCS) announces the awarding of a $96,952 single source program expansion supplement to the Community Action Legal Services, Inc. (CAPLAW), located in Boston, MA, to support training and technical assistance on legal issues faced by Community Action Agencies (CAAs) related to the American Recovery and Reinvestment Act of 2009 (ARRA). The project activities are designed to support and strengthen the ability of the CAA network to comply with, and carry out, Community Services Block Grant (CSBG) activities funded by ARRA. The training projects and resources developed under the award will include analysis and explanation of the practical impact of ARRA for States and CSBG-eligible entities so that they can work more effectively to reach the ARRA goals and document how they have in fact reached those goals and used the ARRA funds. The project's overall approach is based on the following five key elements: (1) Technical assistance and issue-specific consultation; (2) Publications, including online postings on the CAPLAW Web site, e-Bulletins, and a print newsletter, which is also available on CAPLAW's Web site; (3) Online toolkit; (4) Presentations at CAA conferences, including CAPLAW's 2009 national training conference, and CAPLAW audio conferences.