A -- MAINTENANCE AND OPERATION OF A SYNTHETIC CHEMICAL FACILITY

Notice Date

October 24, 2000

Contracting Office

National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

ZIP Code

20892-7510

Solicitation Number

NICHD-SS-01-01

Response Due

December 9, 2000

Point of Contact

Ms. Annette Carter Contract Specialist (301) 496-4611

Description

MAINTENANCE AND OPERATION OF A SYNTHETIC CHEMICAL FACILITY SMALL BUSINESS SOURCES SOUGHT 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 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 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) 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 (2nd generation) and derivatives (3rd generation); 2) steroid haptens linked to bovine serum albumin as well as to histamine conjugates for the development of radioimmuno-assay (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 requirement, 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 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 and heterocycles 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: Ms. Annette Carter Contract Specialist Contracts Management Branch, OAM, NICHD 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

Record

Loren Data Corp. 20001026/ASOL006.HTM (W-298 SN505072)