Department of Health and Human Services August 24, 2005 – 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 the information collection requirements relating to the blood establishment registration and product listing requirements and Form FDA 2830.

The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on certain device panels of the Medical Devices Advisory Committee, the National Mammography Quality Assurance Advisory Committee, the Device Good Manufacturing Practice Advisory Committee, and the Technical Electronic Products Radiation Safety Standards Committee in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies and those that will or may occur through August 31, 2006. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on advisory committees and, therefore, encourages nominations of qualified candidates from these groups.

Provide a clear and concise summary of the proposed goals, major objectives and activities required for achievement of program goals and amount of funding requested for budget year one of this cooperative agreement. Laboratory Services 1. Perform routine QA/QC on rapid-testing specimens from all sites supported by the Emergency Plan for AIDS Relief until the national reference lab is operational. 2. Perform confirmational CD4 testing and analysis to determine clinical eligibility of patients for ART at expansion sites that lack the capacity to conduct such testing. 3. Perform confirmational STI testing for diagnosis. Training 1. Provide training in local languages to local health care professionals including physicians, nurses, lab technicians and pharmacy technicians, community health workers volunteers and appropriate program staff. a. Train how to design, implement and evaluate confidential VCT program sites to enable them to provide counseling and rapid testing for HIV/AIDS. b. Train social workers in providing psycho-social support to PLWHA and their families, including bereavement counseling, crisis management, and support for orphan and vulnerable children. c. Train health care professionals, in clinical care and treatment of HIV/AIDS/TB, OI and HAART including basic and palliative care. d. Train nurses and community health workers in care for PLWHAs, including counseling PLWHAs engaged in treatment and drug administration. e. Train pharmacists in drug-supply commodity management, forecasting, and packaging. f. Train lab technicians in use of automated laboratory equipment for hematology, biochemistry, biology. g. Train how to maintain laboratory equipment. h. Train in laboratory safety and proper disposal of bio-hazardous materials protocol. i. Train in the use of universal precautions and the management of needle-stick or splash injuries. j. Provide post-training follow-up to identify gaps in resources or effectiveness of particular protocols. k. Provide regular routine in-service trainings in local languages for health service and lab personnel to review new and best practice techniques and solicit ``insider insight''an account of implementation success and challenges. 2. Implement monitoring and evaluation strategies at each program site, assessing: a. Number of trainings held b. Number and type of participants c. Pre- and post-training skill levels d. Number of equipment maintenance calls. You may include additional information in the application appendices. The appendices will not count toward the narrative page limit. This additional information includes the following: Curricula Vitae or Resumes of current staff who will work on the activity Organizational Charts Letters of Support Project Budget and Justification for year one only The budget justification will not count in the narrative page limit. Although the narrative addresses activities for the entire project, the applicant should provide a detailed budget only for the first year of activities, while addressing budgetary plans for subsequent years. You must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy, and there is no charge. To obtain a DUNS number, access www.dunandbradstreet.com or call 1-866-705-5711. For more information, see the HHS/CDC Web site at: https:// www.cdc.gov/od/pgo/funding/pubcommt.htm. If your application form does not have a DUNS number field, please write your DUNS number at the top of the first page of your application, and/or include your DUNS number in your application cover letter. Additional requirements that could require you to submit additional documentation with your application are listed in section ``VI.2. Administrative and National Policy Requirements.''

The National Vaccine Program Office (NVPO), a program office within the Office of Public Health and Science, DHHS, is soliciting nominations of qualified candidates to be considered for appointment as members and representatives to the National Vaccine Advisory Committee (NVAC). The activities of this Committee are governed by the Federal Advisory Committee Act (FACA). Consistent with the National Vaccine Plan, the Committee advises and makes recommendations to the Assistant Secretary for Health in his/ her capacity as the Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.