Chemical Synthesis Facility (CSF)

Added: Mar 23, 2017 12:05 pm

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. AN RFP WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT APRIL 7, 2017.

Background

The Contraception Research Branch (CRB) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is planning to issue an RFP for the recompetition of the Chemical Synthesis Facility (CSF) contract. This RFP will be a full and open competitive procurement, North American Industry Classification Systems (NAICS) Code 541712.

The CRB supports research and research training programs in contraceptive discovery and development. Major research areas include (1) studies of mechanisms of action and effects of approved contraceptive methods and reproductive hormones, (2) evaluation of novel methods under development (drugs, devices, and procedures), and (3) development and evaluation of optimal formulations and dosages of contraceptive agents and spermicidal microbicides.

The CSF's main goal is the manufacture of drug substances for contraceptive clinical trials under current Good Manufacturing Practices (cGMP). The CFS must be capable of synthesizing potential anti-fertility agents and chemical intermediates. The Contractor shall prepare and submit and/or keep the Drug Master File (DMF) current and acceptable to FDA. In addition, the Contractor shall provide all the relevant regulatory documentations on the manufactured drug substance including but not limited to Certificate of Analysis (CoA), Chemistry Manufacture and Control (CMC), other analytical data, stability data and amendments as necessary in support of Investigational New Drug (IND) acceptable to FDA.

The CSF shall be capable of:

• Rapidly synthesizing laboratory scale gram quantities of specific chemical compounds required for in vitro and initial in vivo contraceptive investigations.
• Synthesize and purify relatively larger quantities of up to 10 kilograms of drug candidates for comprehensive anti-fertility testing by the Government, including toxicology studies and preclinical and clinical studies under cGMP.
• Synthesizing chemicals and/or chemical intermediates of up to 10 kg for use in other ongoing chemical, peptide and related contracts and other contract programs.
• Stable isotope and radiolabeled synthesis of compounds for pharmacokinetic and metabolism studies.
• Peptide synthesis on a laboratory milligram scale to a larger scale of up to 1 kg that may require manufacture under cGMP. The radiolabeled and/or peptide synthesis with specific radioactivity may be requested. May be required to collaborate with other investigators in the CRB research program in order to make progress toward the development of safe and effective male and female contraceptive drugs.

This RFP will be available electronically on or about April 7, 2017 on FedBizOpps (FBO) website: http://www.fedbizopps.gov. The due date for submission of proposals in response to the RFP is anticipated to be on or about May 22, 2017. The reference number to be used for this announcement is: NIH-NICHD-CRB-2017-04. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. This is not an RFP and this announcement does not commit the Government to award a contract.


Contracting Office Address:

Department of Health and Human Services
National Institutes of Health, Office of Acquisitions
Eunice Kennedy Shriver National Institute of Child Health
      and Human Development
6710B Rockledge Drive, MSC 7000
Bethesda, MD. 20817, United States.