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Medical Device Inspections
Program Summary
Title: Medical Device Inspections
GovCB Opps ID : ADP12109585580001250
Document Type: Combined Synopsis/Solicitation (Modified)
FSC Code: H - Quality Control, Testing, and Inspection Services
Set Aside: N/A
Solicitation No.: FDA-08-Devices
Source: https://www.fbo.gov/?s=opportunity&mode=form&id=f238f29f99877b24f75c8240dfcf54b4&tab=cor...
Posted Date:
May 16, 2008
Last Update: May 16, 2008
Due Date: May 31, 2008

Description
Medical Device Inspections
Solicitation Number: FDA-08-Devices
Agency: Department of Health and Human Services
Office: Food and Drug Administration
Location: Office of Acquisitions and Grants Services
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Opportunity History
Solicitation Number:
FDA-08-Devices
Notice Type:
Combined Synopsis/Solicitation
Synopsis:
Added: May 08, 2008 3:29 pm
The Food and Drug Administration intends to award sole source contracts to State Agencies for Medical Device Inspections. The State Agencies must have the authority and capability necessary to gain access to private commercial establishments in order to conduct regulatory inspections in accordance with the Federal Food, Drug and Cosmetic Act. It is anticipated that awards will be made for a 12 month base contract period, with the possibility of a one year option. The solicitation will be available on or about June 15, 2008, on the FedBizOpps website at http://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. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with state organizations under the authority of FAR 6.302-5, Authorized or Required by Statute. This notice is issued for informational purposes and not a request for competitive proposals. Any interested party should submit a statement of capabilities in sufficient detail to determine if the requirements of this synopsis can be met, no later than 15 days from the date of this announcement. A determination by the Government not to compete with the proposed contract based on responses from this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Responses to this notice must be sent via email to Vivian.Lucas@fda.hhs.gov. No phone calls will be accepted
Contracting Office Address:
5630 Fishers Lane, Room 2129
Rockville, Maryland 20857-0001
Primary Point of Contact.:
Vivian E Lucas
Phone: (301) 827-7117
Secondary Point of Contact:
Lisa O'Neill,
Contracting Officer
Phone: 301-827-7184
Fax: 301-827-7039
General Information
Notice Type:
Combined Synopsis/Solicitation
Original Posted Date:
May 8, 2008
Posted Date:
May 16, 2008
Response Date:
May 31, 2008 5:00 am
Original Response Date:
May 14, 2008 5:00 am Eastern
Archiving Policy:
Automatic, on specified date
Original Archive Date:
September 30, 2008
Archive Date:
September 30, 2008
Original Set Aside:
N/A
Set Aside:
N/A
Classification Code:
H -- Quality control, testing & inspection services
NAICS Code:
923 -- Administration of Human Resource Programs/923120 -- Administration of Public Health Programs




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