SOLICITATION NOTICE
A -- Clinical Data and Drug Utilization Information Associated with Campylobacter Infections and Acute Gastrointestinal Infection
- Notice Date
- 6/5/2002
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Division of Construction and Agency Support Contracting, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-V2598
- Response Due
- 6/20/2002
- Archive Date
- 7/5/2002
- Point of Contact
- Patricia Wright, Contract Specialist, Phone (301) 827-7163, Fax (301) 827-7103,
- E-Mail Address
-
pwright@oc.fda.gov
- Description
- The Food and Drug Administration intends to award a Purchase Order on a sole source basis to Clinical Pharmacy Associates, Inc, 11710 Beltsville Drive, Suite 510, Beltsville, Maryland 20705. Clinical Pharmacy Associates, Inc, shall provide the FDA with clinical data and drug utilization information associated with Campylobacter infections and acute gastrointestinal infection. The contractor shall provide data and information concerning factors related to the usage patterns of fluoroquinolones in relationship to other antimicrobials in outpatient healthcare settings. The contract shall collaborate with FDA on obtaining and analyzing Blue Cross and Blue Shield Association database contents as well as data formatting and delivery of the data and information to accommodate FDA's specific requirements. The contractor shall provide professional expertise as needed to help FDA understand healthcare provider prescribing. Data requested shall also form collaborations to collect data on antimicrobial utilization in ambulatory settings. The contractor shall provide reports and testimony regarding all relevant findings resulting from this work.The contractor shall provide FDA with a written interim progress midway through the performance period. The contractor is expected to be in routine contact with FDA during the contract period. Deliverables data supplied will include but not be limited to: 1) reviews of the published literature, 2) antimicrobial usage in the treatment of acute gastrointestinal and/or C. jejuni infections, 3) data collected from ambulatory care and/or inpatient experience studies conducted by CPA on fluoroquinolone usage for acute gastrointestinal and/or C. jejuni infections, 4) extraction of fluoroquinolone usage patterns in C. jejuni and acute gastrointestinal from a subset of the Blue Cross and Blue Shield Association patient experience based on linking medical claims (for acute gastroenteritis) with prescription claims (for fluoroquinolones) in outpatients from around the US or any other method that is applicable, and 5) other data and information from appropriate sources to which the contractor has access. The final products shall be submitted to FDA in a mutually agreed upon format which may include electronic data submission, hardcopy data submission, oral or written reports including testimony, or a combination of formats. The FDA anticipates a four (4) month period of performance. An award will be made fifteen (15) days from date of this notice. This is not a request for quotes, however, sources may submit descriptive literature which full demonstrate their product meets the specification which shall be considered by the agency. This sole source procurement will be awarded as a simplified acquisition in accordance which FAR Subpart 13.5
- Record
- SN00088211-W 20020607/020605213950 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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