SOURCES SOUGHT
A -- Maintenance and Operation of a Synthetic Chemical Facility
- Notice Date
- 8/8/2006
- Notice Type
- Sources Sought
- 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
- Reference-Number-SS-NIH-NICHD-2007-02
- Response Due
- 8/28/2006
- Archive Date
- 9/12/2006
- Description
- Small Business Sources Sought: The Contraception and Reproductive Health Branch, Center for Population Research, and National Institute of Child Health and Human Development is planning to recompete its current contract for a Chemical Synthesis Facility (CSF) capable of synthesizing potential antifertility agents on a laboratory scale (smaller than 1-5g) in small animals, and relatively larger quantities (up to 1kg) of some drugs for comprehensive antifertility testing for preclinical and clinical studies. The latter 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% enantiomeric excess), for further contraceptive development by the Government. The areas of chemical synthesis include: 1) orally active steroids, including orally active estrogens without 17-ethynyl alcohol, long-acting androgens, e.g., testosterone bucyclate and 7alpha, llbeta-dimethyl-19-nortestostero bucyclate, orally active 7alpha-mdthyl-19-nortestosterone (MENT) analogs, and selective progesterone modulators including CDB-2914, 21 substituted analogs, CDB-4124 (second generation) and derivatics (third generation); 2) steroid haptens linked to bovine serum albumin, as well as to histamine conjugates for the development of radioimmuno-assay (RIA); 3) radio labeled compounds for RIA as tracers and for metabolism studies; 4) heterocyclic compounds including lonidamine analogs and hexahydro-indenopyridine diastereomers as well as their enantiomers; 5) gossypol acetic acid derivatives; and 6) alkylated imuno sugars such as N-alkyldeoxynojirimycin and N-alkylated galoctoce analogs. The required service as defined as code 541710 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 500 persons. Small businesses that believe they have the size standards, are encouraged to submit a capability statement with 45-days of the publication of this synopsis. Your capability statement should be limited to twenty-five 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, heterocycles, and alkylated immosugars on a laboratory scale; 2) a description of available equipment and facilities accredited as meeting cGMP standards and possessing 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 capability statement, via e-mail, fax, or mail, within 45 days of the date of this publication, to: Robert Stallings, Contract Specialist, Contracts Management Branch, OAM, NICHD, 6100 Executive Boulevard, Suite 7A07, MSC 7510, Bethesda, Maryland, 20892-7510; e-mail-nichdcmb@mail.nih.gov.
- Record
- SN01108793-W 20060810/060808220431 (fbodaily.com)
- Source
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