Department of Health and Human Services May 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing a revised request for application (RFA) that will replace the announcements published June 25, 2004 (69 FR 35651) and February 4, 2005 (70 FR 6015). FDA, in collaboration with the Centers for Disease Control and Prevention (CDC), is announcing the availability of conference grant funding for meetings of State Food Safety and Food Security Task Forces. The original announcement of availability of funding for State Food Safety Task Force Meetings, published in the Federal Register on January 24, 2000 (65 FR 3720), is superseded by this announcement. This revised announcement provides new policies that apply to the State Food Safety and Food Security Task Force Meetings Conference Grant Program. The FDA views this program as an ongoing program announcement, contingent on the availability of funds.

In accordance with the requirements of the Privacy Act, the Department of Health and Human Services (HHS) is publishing a notice of the revision of an existing system of records, 09-90-0200, Child Care Subsidy Program. The revised system will collect family income data from employees in the National Institutes of Health, as well as the Health Resources and Services Administration, the Food and Drug Administration (FDA), the Program Support Center (PSC), the Office of the Secretary (OS), the Administration on Aging (AoA), the Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry (CDC/ATSDR) and the Substance Abuse and Mental Health Services Administration (SAMHSA) who are already covered by this system, for the purpose of determining their eligibility for child care subsidies, and the amounts of the subsidies. It also will collect information from the employees' child care provider(s) for verification purposes, e.g., that the provider is licensed. Collection of data will be by subsidy application forms submitted by employees. HHS is also revising the name of the General Accounting Office (GAO) in Routine Use number 5 because the name of that office has changed to the Government Accountability Office.

The Department of Health and Human Services (DHHS), Office of Public Health and Science, is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Blood Safety and Availability (ACBSA). The ACBSA provides advice to the Secretary and the Assistant Secretary for Health on blood safety policy issues which encompass broad public health and societal implications that cannot be resolved through analysis of scientific data alone.

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 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 for an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements when development of an analytical method for residue detection is required by FDA for a drug prescribed for extralabel use in animals.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Third Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

42 U.S.C. 299c, section 921 of the Public Health Service (PHS Act), established a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to actions of the Agency to enhance the quality, improve the outcomes, and reduce the costs of health care services, as well as improve access to such services, through scientific research and the promotion of improvements in clinical practice and in the organization, financing, and delivery of health care services. Seven current members' terms will expire in November 2005. To fill these positions in accordance with the legislative mandate establishing the Council, we are seeking individuals who are distinguished in the conduct of research, demonstration projects, and evaluations with respect to health care; individuals distinguished in the fields of health care quality research or health care improvement; individuals distinguished in the practice of medicine; individuals distinguished in the other health professions; individuals either representing the private health care sector (including health plans, providers, and purchasers) or individuals distinguished as administrators of health care delivery systems; individuals distinguished in the fields of health care economics, management science, information systems, law, ethics, business, or public policy; and individuals representing the interests of patients and consumers of health care. Individuals are particularly sought with experience and success in activities specified in the preceding summary paragraph above, describing the statutory mandates and work of the Agency.

In compliance with the Privacy Act of 1974, as amended by Public Law 100-503, the Computer Matching and Privacy Protection Act of 1988, we are publishing a notice of a computer matching program that OCSE will conduct on behalf of itself and State Agencies administering Unemployment Compensation programs under Federal or State law to facilitate the administration of such programs. The match will utilize National Directory of New Hires (NDNH) records and State Unemployment Compensation (UC) records.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials,'' dated April 2005. The draft guidance provides sponsors of vaccine trials with recommendations on assessing the severity of clinical and laboratory abnormalities in healthy adult and adolescent volunteers enrolled in clinical trials. In particular, the draft guidance includes toxicity grading scale tables to use as a guideline for selecting the assessment criteria.