SOLICITATION NOTICE
A -- Best Pharmaceutical For Children Act (BPCA) Coordinating Center (CC) for the Pediatric Off-Patent Drugs Study (PODS) Centers
- Notice Date
- 1/31/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NICHD-2003-02
- Archive Date
- 5/27/2003
- Point of Contact
- Mya Hlaing, Contracting Officer, Phone 301-435-6958, Fax 301-402-3676, - Lynn Salo, Contract Specialist, Phone 301-435-6962, Fax 301-402-3676,
- E-Mail Address
-
mh89m@nih.gov, ls59u@nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH) is planning to study up to 180 pediatric off-patent drugs under the Best Pharmaceutical for Children Act (BPCA) law in the nest five years. Each drug study will have different PODS centers comprised of several clinical sites, depending upon the requirements of each drug stduy. NICHD is planning to award a contract for a Coordinating Center for the Pediatric Off-Patent Drugs Study (PODS) centers. The purpose of this RFP is to solicit proposals for the award of a single BPCA-CC that will provide logistical and statistical support for the PODS Centers. The BPCA-CC Contractor will provide logistical, administrative, pharmaceutical and technical support to maintain, coordinate, and administer multi-site networks of clinical centers. The BPCA-CC will also prepare and submit to the FDA all data from the studies conducted by the PODS Centers and the necessary documentation in the form of a Final Study Report to support labeling of the drugs studied. Subject data collection will take place at the PODS Centers and, if necessary, at their subcontracted clinical sites. It is anticipated that the PODS Centers, established by competitively awarded contracts for the study of off-patent durgs, will change from drug study to drug study, while the BPCA-CC will remain unchanged for the duration of the BPCA-CC contract. The BPCA-CC will oversee the activities of a number of clinical drug trials in various stages of completion, i.e., initiation, implementation, completion and reporting. A major responsibility of the BPCA-CC will be to integrate the drug trials across dissimilar clinical sites, insure integrity of the data and compliance with FDA and NIH policies on the conduct of clinical trials. The activities conducted by the BPCA-CC will support both data collection and evaluation prior to submission of final reports to the FDA and the NICHD. This effort is essential to assuring that the data appearing in the final study report are of high quality and relevant for consideration of drug label modification for pediatric indications. The North American Industry Classification System (NAICS) is 541990. The Request for Proposals (RFP) will be available on or about February 10, 2003 at http://FedBizOpps.gov. All responses must be submitted on or before May 12, 2003 to: Mrs. Mya Hlaing, Contracting Officer, NICHD, CMB, 6100 Building, Suite 7A07, 6100 EXECUTIVE Blvd., MSC 7510, Bethesda, Maryland 20892-7510 (if sending by overnight carrier, use 6100 Executive Blvd., Suite 7A07, Rockville, Maryland 20852). Fully electronic copies will not be accepted. The reference number to be used for this announcement is: RFP NICHD-2003-02. All coorespondence must cite the referenced number as provided.
- Record
- SN00250335-W 20030202/030131213321 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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