NOT-HD-01-002: 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:  October 23, 2000

NOTICE:  HD-01-002

SOURCES SOUGHT:  NICHD-SS-01-01 (Small Business)

National Institute of Child Health and Human Development

The Contraception and Reproductive Health Branch (CRHB) of the National 
Institute of Child Health and Human Development (NICHD) is planning to 
recompete its contract for a Synthetic Chemical Facility (SCF) capable of 
synthesizing potential anti-fertility 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 small 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,  (4) 13-dehydro-16-
fluoro-prostaglandin-F2alpha, and (5) heterocyclic compounds including 
seconucleosides and hexahydro-indenopyridine diastereomers.

The required service is defined as code 325412 under the North American 
Industry Classification System (NAICS).  For the purposes of this synopsis, a 
small business is defined as one that employs no more than 750 persons. 

Small businesses that believe they have the ability to satisfy the stated 
requirements, and meet the above size standards, are encouraged to submit a 
capability statement within 45 days of the publication of this synopsis.  Your 
capability statement should be limited to 25 pages or less and include:  (1) a 
description of relevant experience in the synthesis, purification, and 
characterization of specific compounds such as steroids, unnatural amino 
acids, and heterocycles on a laboratory scale, (2) a description of available 
equipment and facilities accredited as meeting cGMP standards, and including 
possession of a nuclear license and a controlled substance license.

THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSALS.   If responses indicate the 
likelihood of satisfactory competition among qualified small businesses, the 
anticipated solicitation will be restricted to small businesses only.  
Interested organizations should submit a letter of interest and a capability 
statement, via E-mail, FAX, or mail, within 45 days of the publication date of 
this Notice, 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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