AP_-_Attachment_5-Presolicitation_Notice-Posting_3.pdf

Solicitation Number: 75N94022R00001

Solicitation Title: Chemical Synthesis Facility

Announcement Type: Pre-Solicitation Notice

Classification Code: A – Research and Development

NAICS Code:

541 – Professional, Scientific, and Technical Services/541715 – Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY.

AN RFP WILL BE ISSUED VIA SAM.GOV ON OR ABOUT APRIL 18, 2022.

Background:

The Contraceptive Development Program (CDP) 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. The RFP will be a full and open competitive procurement under the North American Industry Classification Systems Code 541715.

The CDP 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 devices.

The CSF’s main goal is the cGMP manufacture of drug substances for clinical trials conducted by the Contraceptive Clinical Trials Network (CCTN). The CDP’s mission of providing new and/or improved safe and effective contraceptive methods necessitates making scientific progress. Many of the compounds evaluated by the CDP are new chemical entities (NCEs) and are not available “commercially off the shelf” (COTS). Such NCEs must be custom synthesized. The use of a CSF with the ability to make products under cGMP is required and critical for carrying out the CDP’s mission.

The CSF must be capable of:

1. Rapidly synthesizing laboratory-scale gram quantities of specific chemical compounds required for in vitro and in vivo investigations.

2. The synthesis and purification of larger quantities (up to 10 kilograms) of drug candidates under current cGMP for comprehensive testing, including toxicology studies and preclinical and clinical studies.

3. The synthesis of non-cGMP chemicals and/or chemical intermediates of up to 10 kg for use in other ongoing contracts.

4. The synthesis of stable isotope and radiolabeled compounds for pharmacokinetic and metabolic studies

5. Peptide synthesis on milligram scale to kilogram scale under non-cGMP or cGMP conditions.

The radiolabeled and/or peptide synthesis may be subcontracted out. In addition, collaboration with other investigators in the CDP research program is required to promote the development of safe and effective male and female contraceptive methods.

The RFP will be available electronically on or about April 18, 2022 on the Contract Opportunities website: https://sam.gov. The due date for submission of proposals in response to the RFP is anticipated to be on or about June 3, 2022. The reference number to be used for this announcement is:

75N94022R00001. 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:

Contracts Management Branch

6710B Rockledge Dr., Suite 1124, MSC7000

Bethesda, Maryland 20892-7510

United States

Primary Point of Contact:

Mr. Dana Harris

Contracting Officer harrisd@nih.gov

Phone: 301.443.7798

Secondary Point of Contact:

Mr. Gannon White

Contract Specialist gannon.white@nih.gov

Phone: 301.402.9178 https://sam.gov/