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COMMERCE BUSINESS DAILY ISSUE OF MARCH 25,1999 PSA#2310National Cancer Institute, Research Contracts Branch, PCPSS, 6120
Executive Blvd, Room 635, Bethesda, MD 20892-7226 A -- PHASE I CLINICAL STUDIES OF CHEMOPREVENTIVE AGENTS SOL
N01-CN-85080-70 POC Erin C. Lange, Contracting Officer, 301-435-3828
WEB: Research Contracts and Acquisition Branch Current Requests,
http://deaxtra.nci.nih.gov/awards/rfps_published.asp. E-MAIL: Erin C.
Lange, el45g@NIH.gov. The Chemoprevention Branch of the Division of
Cancer Prevention (DCP), National Cancer Institute (NCI), National
Institutes of Health (NIH), is expanding the existing Master Agreement
pool with the objective of conducting phase I clinical trials to
evaluate the pharmacokinetics, pharmacology, and toxicology of
chemopreventive agents, as well as to evaluate the modulation of
biological markers of carcinogenesis. The application of biological
markers to clinical prevention trials carries great promise in relation
to ultimate cancer prevention. When cancer incidence reduction itself
is used as an endpoint in studies of this type, a very large number of
subjects tested for long durations is often required. The design of
phase 1a clinical trials will be small, single-dose, efficient studies
that determine the dose-response of a given chemopreventive agent on
pharmacokinetics, pharmacology, and toxicology. The second segment,
phase 1b study, will involve a sequential, short-term (3-6 month),
dose-escalation trial (in some cases randomized, placebo-controlled,
and blinded) in a small group of subjects in which the endpoints will
be pharmacokinetics, pharmacology, toxicology, and exploration of the
modulation of quantifiable biological effects that are correlated with
cancer incidence reduction. The maximum tolerated dose and the minimum
effective dose will be determined. Master Agreements will be awarded to
all respondents whose technical proposal is considered acceptable. The
Master Agreement award is non-monetary and is exclusively for the
purpose of compiling a pool of contractors who are pre-qualified to
perform services to perform specific Phase I studies. Each Master
Agreement holder will be eligible to compete for future contract awards
to carry out specific Phase I studies. Master Agreement holders
receiving a contract award will be selected through this pool, based on
technical merit and on budgetary considerations for specific tasks
involved. Any MA awarded as a result of this solicitation will be in
effect from the effective date to February 15, 2003. This solicitation
will be open for the duration of the existing MA pool with due dates
for receipt of proposals semi-annually, June 1 and December 1 (or the
next business day) of each year. All responsible sources meeting these
criteria are encouraged to submit a proposal and a sample requirement
to be considered by the NCI. ALL MASTER AGREEMENT HOLDERS ALREADY IN
THE EXISTING MASTER AGREEMENT POOL NEED NOT RESPOND TO THIS
ANNOUNCEMENT. The RFP may be accessed through the Research Contracts
Branch Home Page by using the following Internet address:
http://deaxtra.nci.nih.gov/awards/rfps_published.asp. 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 SOLICITATION
AND AMENDMENTS. Point of contact: Erin C. Lange, Contracting Officer,
NCI, RCB, PCPSS; 6120 Executive Boulevard, Executive Plaza South, Room
635, Rockville, MD 20852; Phone: 301-435-3828;. Fax: (301) 402-8579.
Electronic mail address: el45g@nih.gov. All requests should reference
the RFP No. N01-CN-85080-70. No collect calls will be accepted. See
Numbered Note 26. Posted 03/23/99 (W-SN311394). (0082) Loren Data Corp. http://www.ld.com (SYN# 0010 19990325\A-0010.SOL)
A - Research and Development Index Page
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