DHHS/PHS/FDA/Office of Facilities, Acquisitions, And Central Services, Division Of Contracts and Program Management, HFA-511(ITCB), 5600 Fishers Lane, Rockville, MD 20857

B -- PROFESSIONAL SERVICES OF A REGULATORY EXPERT SOL 008198 DUE 071700 POC Trudy Dartouzos, ph: 301/827-7165; fax: 301/827-7103 See note #1. The Food and Drug Administration [FDA], the Center for Veterinary Medicine [CVM], intends to award a purchase order using the simplified acquisition process for the following Scope of Work: An HHS regulatory agency [CVM/FDA] seeks a contractor to provide services of a scientific and regulatory expert to draft and update guidance documents. The expert will participate in weekly meetings with a representative of the Office of New Animal Drug Evaluation in north Rockville, Maryland. The contractor drafts new and revised guidances that document processes that the regulated industry can follow when submitting applications and agency reviewers can readily apply to evaluation of New Animal Drug Applications Abbreviated New Animal Drugs, and Investigational New Animal Drug Applications. Examples of the guidances are shown for the CVM Program Policy and Procedures Manual, on the CVM Homepage [http://www.fda.gov/cvm/]. Contractor qualifications: Must have understanding of the regulatory process specific to Food & Drug Administration Center for Veterinary Medicine [FDA/CVM], editorial capability of drafting documents according to "Plain Language" principals [www.planlanguage.gov (Examples are shown at Reference Library)], and knowledge of the regulations under which FDA and the CVM operate specifically including the following, CVM Program policies and Procedures Manual, 21 CFR parts 1-99, and 500-599, FDA Staff manual Guides, The Federal Food Drug and Cosmetic Act, Section 512; FDA's Good Guidance practices, [62 FR 8961-8972; February 27, 1997]. The contractor possesses sufficient independent knowledge of Center policies and procedures to produce guidance documents that will withstand peer review with minimal input from Center officials. Because of the scientific and technical nature of the guidances, the expert should have a doctorate level degree in veterinary medicine, or sciences closely related to animal agriculture. Performance Terms: The contractor will deliver at least two guidances per month, totaled quarterly, for the one-year term of contract, in accordance with performance goals mutually agreed upon. The following provision also applies to this aquisition: 52.232.33 Mandatory Information of Electronic Funds Transfer Payment. Please provide federal tax identification and Dunn & Bradstreet numbers. This procurement will be awarded as a simplified acquisition in accordance with FAR Subpart 13.5. Written quotes may be faxed to Trudy Dartouzos, fax number: 301/827-7103. Written quotes are due by 2 p.m., 7/17/00. Posted 06/28/00 (W-SN469350). (0180)

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