A -- MAINTENANCE AND OPERATION OF A SYNTHETIC CHEMICAL FACILITY.

Notice Date

July 24, 2001

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

RFP-NICHD-2001-09

Response Due

September 19, 2001

Point of Contact

Annette Carter, Contract Specialist (301) 496-4611

E-Mail Address

Click here to contact the Contracting Officer via (nichdcmb@mail.nih.gov)

Description

MAINTENANCE AND OPERATION OF A SYNTHETIC CHEMICAL FACILITY 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% 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; 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 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. EST September 19, 2001. All responsible sources may submit a proposal for consideration. In order to be considered for evaluation, the potential offerors must meet the following mandatory requirements at the time of proposal submissions: 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 advertisement does not commit the government to award a contract. Proposals should be submitted to the following: 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

Web Link

Click here to download a copy of the RFP. (http://www.nichd.nih.gov/funding/funding-opps_rfp.htm)

Record

Loren Data Corp. 20010726/ASOL006.HTM (W-205 SN50S7N2)