SOLICITATION NOTICE
R -- Consulting Services to Write Regulations
- Notice Date
- 3/10/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical 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
- 7800905gh
- Response Due
- 3/25/2005
- Archive Date
- 4/9/2005
- Point of Contact
- Gwen Hubbard, Purchasing Agent, Phone (301) 827-7172, Fax (301) 827-7103, - Gwen Hubbard, Purchasing Agent, Phone (301) 827-7172, Fax (301) 827-7103,
- E-Mail Address
-
ghubbard@oc.fda.gov, ghubbard@oc.fda.gov
- Description
- This is a combined synopsis/solicitation for commercial items or services prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. The Food and Drug Administration, CDER intends to award a non-competitive simplified acquisition contract to the Sion Wyn, Director, Conformity, LL26 OZF, U.K. for follow up consulting services to write the revised Part 11 Regulation. The anticipated award date is March 25, 2005. The purpose of this procurement is to enhance the regulation of pharmaceutical manufacturing. The duties include the following: (1) Assist in writing and finalizing a revised Regulation, 21 CFR Part 11. (2) Assist in reviewing comments from the pharmaceutical community on the Regulation and Agency guidances. Mr. Wyn was essential in drafting/editing the Final Guidance on Part 11 August, 2003, which was one of the goals from the Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach for the Agency to complete. He possesses a high level of knowledge regarding technical information needed regarding the Part 11 FDA regulations and the computer systems used in the pharmaceutical industry. This will be a non-competitive award made in accordance with FAR Part 12 Acquisition of Commercial Items and FAR Part 13 Simplified Acquisition Procedures. This notice of intent is not a request for competitive proposals. A solicitation document is not available. However, the Government will consider all proposals received before 2:30 p.m., March 25, 2005. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information may be faxed to Gwen Hubbard on (301) 827-7106. NOTE: THIS NOTICE WAS NOT POSTED TO WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (10-MAR-2005); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/HHS/FDA/DCASC/7800905gh/listing.html)
- Place of Performance
- Address: Rockville, MD
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN00766075-F 20050312/050310213324 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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