SOLICITATION NOTICE
A -- Phase I Resource Center (PIRC)
- Notice Date
- 11/30/2004
- 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 Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- N01-AT-55007-20
- Response Due
- 2/17/2005
- Point of Contact
- Charles Lerner, Contracting Officer, Phone (301) 435-3831, Fax (301) 402-8579, - Susan Hoffman, Contracting Officer, Phone (301) 435-3799, Fax (301) 402-8579,
- E-Mail Address
-
cl74r@nih.gov, sh191h@nih.gov
- Description
- The National Center for Complementary and Alternative Medicine (NCCAM) is seeking proposals from qualified organizations that have the ability to accrue a specified number of study subjects for Phase I clinical trials and clinical pharmacology studies. The main objective of the contract to be awarded as a result of this solicitation is to set up a Phase I Resource Center (PIRC) to conduct multiple early phase clinical studies with NCCAM-selected botanical dietary supplements. The studies will include some or all of, but are not limited to, the following: dose escalation and tolerability, clinical pharmacokinetics, bioequivalence, and dietary supplement-drug interactions. Phase II efficacy studies will be supported only upon pre-approval by NCCAM. The botanical dietary supplement materials to be studied shall include those developed by dietary supplements manufacturers and individual investigators for NCCAM as well as commercially available in-use botanical dietary supplement materials. NCCAM requires a flexible team of clinicians, statisticians, data managers, and research nurses who have, or have access to, expertise and capabilities to carry out these studies and have access to clinical and research laboratory analyses facilities for botanical dietary supplements. The Contractor must be organized appropriately to attract about 30 study subjects per trial for 1-3 trials per year with a pool of at least 500 potential participants. The study subjects will be mostly healthy volunteers but may also include selected types of patients. NCCAM intends to make one 3-year contract award under this solicitation. Investigators are encouraged to work together and to seek collaborations within and outside their institutions in order to enhance their proposal. Since studies on dietary supplements research may involve multidisciplinary research in multiple organ systems, experience in and capacity to perform such studies will be considered a valuable asset. The North American Industry Classification System (NIACS) code is 541710. The Request for Proposal (RFP) will be issued ELECTRONICALLY approximately December 17, 2004. The RFP will be available on the NCCAM and the Research Contracts Branch (RCB) websites at: http://nccam.nih.gov/research/announcements/active.htm and http://rcb.cancer.gov/rcb-internet/appl/rfp/published_rfps.jsp. It is the offerors’ responsibility to monitor the above Internet site for the release of this solicitation and amendments, if any. POTENTIAL OFFERORS WILL BE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY OF THE SOLICITAION AND AMENDMENTS. Point of contact: Charles Lerner, Contracting Officer (CO), Research Contracts Branch, National Cancer Institute, Executive Plaza South, Room 6024, MSC 7195, 6120 Executive Blvd, Bethesda, MD 20892-7195. Phone: (301) 435-3831; Fax: (301) 402-8579. ALL QUESTIONS/INQUIRIES SHALL BE SUBMITTED ELECTRONICALLY TO CHARLES LERNER, CONTRACTING OFFICER,at lernerc@mail.nih.gov. All requests for information should reference RFP No. N01-AT-55007-20. No collect calls will be accepted. NOTE: THIS NOTICE MAY HAVE POSTED ON WWW.FEDBIZOPPS.GOV ON THE DATE INDICATED IN THE NOTICE ITSELF (30-NOV-2004). IT ACTUALLY APPEARED OR REAPPEARED ON THE FEDBIZOPPS SYSTEM ON 06-OCT-2005, BUT REAPPEARED IN THE FTP FEED FOR THIS POSTING DATE. PLEASE CONTACT fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link to FedBizOpps document.
(http://www.fbo.gov/spg/HHS/NIH/RCB/N01-AT-55007-20/listing.html)
- Record
- SN00911854-F 20051008/051006214635 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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