SOLICITATION NOTICE
H -- QSIT Medical Device Inspections
- Notice Date
- 8/10/2004
- Notice Type
- Solicitation Notice
- NAICS
- 923120
— Administration of Public Health Programs
- 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
- 223-04-QSIT
- Response Due
- 8/20/2004
- Archive Date
- 9/24/2004
- Point of Contact
- Calvin Armstrong, Contract Specialist, Phone (301) 827-7117, Fax (301) 827-7101, - Phillip Osborne, Contracting Officer , Phone 301-827-5061, Fax 301-827-7101,
- E-Mail Address
-
carmstro@oc.fda.gov, phillip.osborne@fda.gov
- Description
- The Food and Drug Administration intends to award sole source contracts to state agencies for Quality System Inspection Technique (QSIT) medical device inspections. This program meets the criteria set forth in 41 USC 253(c)(1). The services can be obtained only from state organizations possessing the authority necessary to conduct regulatory inspections. The contracts are renewed annually, but adjustments in the length of the contracts may be made for management purposes or at the request of the state. Individual performance periods may range from 12 to 24 months. Contractors must meet the following requirements: (1) The contractor must possess legal authority under state law necessary to gain access to any regulated private commercial establishment for the unique purpose of conducting regulatory inspections and investigations to determine compliance with the medical device provision of the Federal Food, Drug, and Cosmetic Act at any geographical location with the state; (2) have trained personnel experienced with the inspection procedures and evidence development techniques necessary to assess the conformance of an establishment with the federal law and regulations or comparable state requirements; and (3) demonstrate experience with state regulatory or voluntary procedures for corrective violative practices. Only governmental organizations have the unique qualifications to perform this kind of activity. This proposed Contract action is for services for which the government intends to solicit and negotiate with only one source under the authority of FAR 6.302. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received within forty-five days after date of publication of this synopsis will be considered by the government. A determination by the government not to compete this proposed contract based upon the responses to this notice is solely within the discretion of the government. The solicitation will be available on or about August 20, 2004 on the FedBizOpps website at http://www.fedbizopps.gov. Prospective offerors are responsible for downloading the solicitation and amendments. It is the offerors responsibility to monitor the Fedbizopps website for the release of the solicitation and amendments. Hard copies will be provided to individuals eligible under the American with Disabilities Act and Rehabilitation Act upon request.
- Place of Performance
- Address: Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD.
- Zip Code: 20857
- Country: United States of America
- Zip Code: 20857
- Record
- SN00640361-W 20040812/040810211813 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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