SOLICITATION NOTICE
A -- Pediatric Pharmacology Research Unit (PPRU)Coordinating Center
- Notice Date
- 5/25/2004
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- 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
- RFP-NICHD-2004-09
- Response Due
- 9/14/2004
- Archive Date
- 9/29/2004
- Point of Contact
- Mya Hlaing, Contracting Officer, Phone 301-435-6958, Fax 301-402-3676, - James Quinn, Chief, Contracts Management Branch, Phone 301-435-6964, Fax 301-402-3676,
- E-Mail Address
-
mh89m@nih.gov, quinnja@mail.nih.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The National Institute of Child Health and Human Development/NIH is planning to award a contract for coordinating a clinical trial of (13) pediatric pharmacology research units (PPRU) and some obstetric pharmacology research units (OPRU). Thirteen sites at children?s hospital were selected to carry out the overall objectives of facilitating and promoting the pediatric labeling of new drugs or drug already on the market. Labeling of drugs requires close interaction among trial sites, the pharmaceutical company sponsor and the Food and Drug Administration. In addition to studies for pediatric labeling the Network performs research studies in pharmacogenomics, ontogeny of drug metabolizing enzymes and receptors and biomarker identification and validation. To accomplish its mission the Network must closely work with the pharmaceutical industry. The PPRU Network conducts two types of studies: 1) Studies originating from pharmaceutical companies and 2) Investigator-initiated studies without a pharmaceutical company sponsorship. The data coordinating center must be capable of: 1) developing and maintaining start-up, progress, completion, reports, summaries and labeling status of all drugs involved in Network protocols; 2) developing quarterly, annual, and customized reports; 3) preparing and maintaining of operating documents, policies and procedures; 4) archiving of data, developing and maintaining of clinical management system, developing of standardized Case Report Forms (CRFs); 5) preparation of IND applications and submission of required FDA reports; 6) developing and maintaining of computerized system for electronic submission of data. The CC will be involved in the management of multi-site investigator-initiated protocols. Small Businesses that believe they can perform these functions may request a copy of the Request for Proposal. The North American Industry Classification System (NAICS) is 541710. The Request for Proposal NICHD-2004-09 will be available on or about June 14, 2004 at http://FedBizOpps.gov. The proposal submission due date for the RFP is September 14, 2004. The request for RFP should be sent to: Ms. Mya N. Hlaing, Contracting Officer, Contracts Management Branch, NICHD, 6100 EXECUTIVE BLVD, Suite 7A-07, MSC 7510, Bethesda, MD 20892-7510. (If sending by overnight carrier, use 6100 Executive Blvd., Suite 7A-07, Rockville, Maryland 20852). Fully electronic copies will not be accepted. The referenced number for this announcement is RFP-NICHD-2004-09. All correspondence must cite the referenced number as provided.
- Record
- SN00591922-W 20040527/040525211845 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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