SOLICITATION NOTICE
99 -- Consulting Services for Writing Guidance
- Notice Date
- 5/9/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857
- ZIP Code
- 20857
- Solicitation Number
- Reference-Number-D78005
- Response Due
- 5/25/2003
- Archive Date
- 6/9/2003
- Point of Contact
- Stephanie Hawk, Buyer, Phone 301-827-7886, Fax 301-594-2127, - Ida Cofield, Contract Specialist, Phone (301) 827-7156, Fax (301) 827-7151,
- E-Mail Address
-
hawks@cder.fda.gov, icofield@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. This announcement constitutes the only solicitation and a written solicitation will not be issued. This solicitation is issued as a Sole Source No. D78005. These solicitation clauses and provisions are those in effect through Federal Acquisition Circular 97-27. The Standard Industrial Classification (SIC) Code for this acquisition is R799 and the North American Classification System (NAICS) Code is 519190. The FDA intends to issue a purchase order for continued assistance in finalizing ?Part 11? guidance based on objectives set in August of 2002. The Draft guidance was published on February 25, 2003. The contractor will assist in reviewing comments from the industry and in making revisions to the guidance as necessary and helping to amend the language of the rule. The contractor will assist in finalizing the draft cGMP guidance for Part 11. And will assist in reviewing comments from the pharmaceutical community on the guidance. Work should be provided via facsimile or electronic mail, as well as hard copy. Period of Performance: One year from date of award. The following FAR Clauses shall apply to this solicitation: 52.212-1 Instructions to Offerors-Commercial; 52.212-4 Contract Terms and Conditions-Commercial Items; and 52.232-33 Electronic Funds Transfers. All responsible sources that can provide and meet the above requirements shall submit written quotations by the due date referenced above. The award will be issued on a sole source basis to Mr. Sion Wyn due to the fact that he assisted in drafting the February 28, 2003 guidance and it will be unnecessary to devote time and effort to educate him to the work delineated in the contract due to the immediate need of the Agency. Please present all questions and inquiries by e-mail to: hawks@cder.fda.gov. FAR provisions can be found at the following website: http://www/arnet.gov.
- Place of Performance
- Address: 11919 Rockville Pike, HFD-320, Rockville, Maryland
- Zip Code: 20853
- Country: USA
- Zip Code: 20853
- Record
- SN00321116-W 20030511/030509213332 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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