MODIFICATION
R -- Consulting Services to Write Regulations
- Notice Date
- 3/25/2005
- Notice Type
- Modification
- 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
- 3/29/2005
- Archive Date
- 4/9/2005
- Point of Contact
- Gwen Hubbard, Purchasing Agent, Phone (301) 827-7172, Fax (301) 827-7103, - Leonard Grant, Contracting Officer, Phone (301) 827-7173, Fax (301) 827-7101,
- E-Mail Address
-
ghubbard@oc.fda.gov, lgrant@oc.fda.gov
- Description
- 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 April 1, 2005. The purpose of this procurement is to acquire the following services: (1) Review complex computer related regulatory language necessary for writing, editing and re-commenting on a revised 21 CFR Part 11 Regulation and any needed Agency follow-up Guidance. Some of these will be first of a kind and require extensive background in FDA regulatory and review policy as well as in computer system science. (2) Draft, quality control, and edit guidance and Regulation documents for dealing with the Regulation 21 CFR Part 11. These include highly visible Agency policy issues on automated systems used in FDA regulated industry that poses unique use and information, issues. (3) Recommend policy and procedures for dealing with computer, electronic and automated systems in FDA regulated industry. This area is currently under review by senior management in both FDA and HHS and requires historical perspective, industry knowledge and extremely strong computer science and writing skills. (4) Interact with CDER, CBER, CVM, CDRH and CFSAN, or other government agencies and recommend FDA Regulation, policies and guidance, and to address automated systems as they relate to FDA regulated industry. The period of performance will be from April 1, 2005 through December 30, 2006. Mr. Wyn is the only known source capable of performing this effort and meeting the requirements of FDA based on his work 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 of non-commercial services made in accordance with FAR Part 13 Simplified Acquisition Procedures. This notice of intent is not a request for competitive proposals. A solicitation document is not available. However, all responsive sources may submit a capability statement that will be considered by the government. Sources interested in responding to this notice must be able to provide convincing evidence that they possess the requisite expertise and experience to successfully perform the services as specified above. Responses must be in writing and must be received no later than 2:30 p.m., on March 29, 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 (25-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
- SN00776384-F 20050327/050325213236 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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