NOT-HD-01-007: MAINTENANCE AND OPERATION OF A SYNTHETIC CHEMICAL FACILITY

Department of Health
and Human Services (HHS)
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MAINTENANCE AND OPERATION OF A SYNTHETIC CHEMICAL FACILITY

Release Date:  July 26, 2001

NOTICE:  NOT-HD-01-007

RFP AVAILABLE:  NIH-NICHD-01-09

National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov)

The Contraception and Reproductive Health Branch (CRHB) of the National 
Institute of Child Health and Human Development (NICHD) is recompeting its 
contract for a Synthetic Chemical Facility (SCF) capable of synthesizing 
potential antifertility agents on a laboratory scale (1-5 grams), as well as 
on a relatively larger scale (greater than 1 kg).  These agents are obtained 
for comprehensive contraceptive evaluation under current Good Manufacturing 
Practices (cGMP), including toxicology studies, primate testing, and 
preclinical safety studies conducted under separate contracts.  The NICHD 
seeks businesses capable of synthesizing drugs, chemicals, chemical 
intermediates, steroids, and optically pure and/or resolved unnatural amino 
acids (greater than 99 percent enantiomeric excess), for further contraceptive 
development by the Government.  The areas of chemical synthesis include:  (1) 
steroids, including orally active estrogens without 17-ethynyl alcohol, long-
acting androgens, e.g., testosterone bucyclate and 7alpha, 11beta-dimethyl-19-
nortestosterone bucyclate, orally active 7alpha-methyl-19-nortestosterone 
(MENT) analogs, and antiprogestins, e.g., CDB-2914, 21-substituted analogs 
(second generation) and derivatives (third generation), (2) steroid haptens 
linked to bovine serum albumin as well as to histamine conjugates for the 
development of radioimmunoassay (RIA), (3) radiolabeled compounds for RIA as 
tracers and for metabolism studies, and (4) heterocyclic compounds, including 
seconucleosides and hexahydro-indenopyridine diastereomers. 

The required service is defined as code 325412 under the North American 
Industry Classification System (NAICS). 

The Request for Proposals (RFP) will be issued on or about July 20, 2001 and 
will be available on the NICHD web page (http://www.nichd.nih.gov/oam_cmb).  
Proposals are due by 4:00 P.M. EDT on September 19, 2001.  All responsible 
sources may submit proposals for consideration.  In order to be considered for 
evaluation, the potential offerors must meet the following mandatory 
requirements at the time of proposal submission:  (1) The contractor must have 
capabilities for relatively large-scale synthesis (1000 grams).  (2) The 
contractor"s facilities must meet requirements for cGMP set up by the Food and 
Drug Administration (see 21 CFR Parts 201, 207, 210, 211 and 229), must have a 
nuclear license to handle radioisotopes, and must have a controlled substance 
license.  This notice does not commit the government to award a contract.  

Proposals should be submitted to:

Ms. Annette Carter
Contract Specialist
Contracts Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 7A07, MSC 7510
Bethesda, MD 20892-7510
Telephone:  301-496-4611
FAX:  301-402-3676
E-mail:  nichdcmb@mail.nih.gov
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