DEVELOP A QUALITY ASSURANCE/QUALITY CONTROL (QA/QC) PLAN FOR ACTIVITIES CONDUCTED UNDER TASK AREA D.

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Comprehensive Resources for HIV Microbicides and Biomedical Prevention: The development of highly effective HIV prevention strategies, including a preventive vaccine and other non-vaccine biomedical prevention (nBP) products, remains one of the highest priorities for the Division of AIDS (DAIDS) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). With current global HIV infection estimates exceeding 33 million people, the development of safe, effective, and acceptable nBP products to prevent the sexual transmission of HIV could play a major role in the worldwide reduction of the estimated 5000 new HIV infections per day. As promising nBP products emerge (e.g., microbicides, pre-exposure prophylaxis (PrEP) agents, and Multipurpose Prevention Technologies (MPT’s), there is a critical need to rapidly and efficiently move these candidates into clinical testing. The scope of work encompasses preclinical activities that range from initial product discovery to those required to support clinical trials and/or product licensure. Activities under this area will provide support for HIV nBP product manufacturing and product characterization to preclinical and clinical studies as well as other activities required by the U.S. Food and Drug Administration (FDA) to advance these HIV nBP products into clinical testing. Quality control and quality assurance plans will be developed to support product manufacturing.