SOURCES SOUGHT
B -- Provide Assistance to the Development of Current Good Manufacturing Practices in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements Final Rule
- Notice Date
- 3/18/2004
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- Reference-Number-F61003
- Response Due
- 3/28/2004
- Archive Date
- 4/12/2004
- Point of Contact
- Hamilton Brown, Contract Specialist, Phone (301) 827-7043, Fax (301) 827-7101,
- E-Mail Address
-
hbrown@oc.fda.gov
- Description
- The Food and Drug Administration intends to award a purchase order on a sole source basis to Ms. Karen F. Strauss under the authority of FAR 6.302-1 and Note 22. BACKGROUND: The Dietary Supplement Health and Education Act (DSHEA) (Public Law 103-417) was signed into law on October 25, 1994. DSHEA, among other things, amended the Federal Food, Drug, and Cosmetic Act by adding section 402(g) (21 U.S.C. 342(g)) that gives the Department of Health and Human Services and the Food and Drug Administration (FDA) by delegation the authority to prescribe current good manufacturing practice (CGMP) regulations for dietary supplements. FDA proposed CGMP regulations for dietary ingredients and dietary supplements on March 13, 2003, with a 90-day public comment period. The public comment period was extended 60-days and closed on August 11, 2003. The agency received over 400 comment letters totaling over 1600 pages. Publishing a dietary ingredient and dietary supplement CGMP final rule during December 2004 is a high-priority activity for the FDA and the Department of Health and Human Services. A Final Rule will establish the minimum CGMPs necessary to ensure that activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements are conducted in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. SCOPE OF WORK: The Contractor shall attend meetings as needed to discuss the Final Rule, assist the Project Lead to determine who responds to which comments and review the work of other preamble and codified drafters. The Contractor's role shall include the following activities: 1) Works closely with the Lead Rule Writer (LRW) throughout this project 2) Reviews comments to preamble and codified as assigned 3) Assists the LRW in determining who drafts response to which comments and reviews and comments on draft responses 4) Assists in identifying issues that must be responded to in the Preamble of the Final Rule 5) Identifies dietary supplement CGMP outside experts for Special Government Employee (SGE) status 6) Helps develop questions with input from scientific consultants for SGE response 7) Attends meetings (as necessary) with appropriate staff including LRW, Decision Maker, Economists, Scientific Consultants, and Senior Advisors 8) Meets with Center Director, Decision Maker, Senior Advisors, and LRW as needed to bring closure to unresolved policy issues regarding Final Rule and to ensure that decisions are incorporated in the Final Rule 9) Helps develop revised codified 10) Attends meetings as needed to discuss Final Rule 11) Assists LRW in reviewing clearance comments and determining who responds to which comments. FDA/CFSAN/ONPLDS will provide the following: 1) office space in the Wiley Building, 5100 Paint Branch Parkway, College Park, MD 20740 2) a desk PC and printer, access to the FDA intranet, 3) remote access Dell Latitude laptop computer, and remote access to the FDA intranet The Contractor shall provide ISP connectivity. LEVEL OF EFFORT AND PERIOD OF PERFORMANCE Eleven (11) month period of performance. The Contractor effort shall not exceed 10 hours per week, 43 hours per month, and 520 hours during the period of performance. The Contractor shall be present at the CFSAN Wiley Building or FDA Parklawn Building up to 5 hours per week. DELIVERABLES The contractor shall assist in revising the codified by a time established by CFSAN/FDA, contingent on and with the collaborative effort of the LRW and others in FDA/CFSAN identified by the Project Officer. The contractor shall assist in revising the preamble by a time established by CFSAN/FDA, contingent on and with the collaborative effort of the Project Officer and others in FDA/CFSAN identified by the Project Officer. JUSTIFICATION Publishing a dietary ingredient and dietary supplement CGMP final rule during fiscal year 2005 is a high-priority activity for the FDA and the Department of Health and Human Services. A Final Rule will establish the minimum CGMPs necessary to ensure that activities related to manufacturing, packaging, or holding dietary ingredients or dietary supplements are conducted in a manner that will not adulterate and misbrand such dietary ingredients or dietary supplements. The Final Rule developed under this requirement will permit the requesting organization to meet the dietary supplement regulatory goals of the FDA for publishing a Final Rule in December 2004. Ms. Karen Strauss was with the Department of Health and Humans Services for 19 years with six years at the Center for Food Safety and Applied Nutrition (CFSAN) FDA from 12/1997 to 1/2004. Ms. Strauss holds a M.S. Degree in Food Science and Nutrition. While at the FDA she was responsible for drafting the Current Good Manufacturing Practices in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements Proposed Rule. Ms. Strauss' unique understanding and thorough knowledge of the operations of CFSAN in the area of dietary supplement CGMP regulation will enable her to provide a critical leadership role. Ms. Strauss' experience in developing the proposed rule is crucial to FDA in developing the Final Rule. To our knowledge, Karen Strauss is the only person with the experience and knowledge of the Current Good Manufacturing Practices in Manufacturing, Packing, or Holding Dietary Ingredients and Dietary Supplements Proposed Rule. This notice is being made under the authority of FAR 5.201 and the FDA will consider any other expressions of interest and/or bids/proposals received.
- Place of Performance
- Address: College Park, MD and contractor site
- Record
- SN00549528-W 20040320/040318213453 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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