Sources_Sought_Notice-Chemical_Synthesis_Facility-FINAL_1.pdf

SOURCES SOUGHT NOTICE

Solicitation Number: 75N94022R00001

Notice Type: Sources Sought Classification Code: A – Research and Development

NAICS Code:

541 – Professional, Scientific, and Technical Services/541712 – Research and Development in the Physical Engineering, and Life Sciences (except Biotechnology)

Location: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Key Dates:

Response Date: 15 days after issuance

Purpose of the Announcement: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; servicedisabled, veteranowned small businesses; 8(a) small businesses; veteranowned small businesses; womanowned small businesses;

or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a setaside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The requirement is assigned a code of 541712 in the North American Industry Classification System (NAICS), and the small business size standard for such requirements is 1000 employees or less.

Background: The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks capability statements from interested and qualified potential sources for a Chemical Synthesis Facility (CSF) capable of synthesizing potential antifertility agents on a laboratory milligram scale to a relatively larger kilogram scale. The kilogram scale chemical agents are manufactured under current Good Manufacturing Practices (cGMP) for comprehensive contraceptive evaluation, including toxicology studies and preclinical safety studies before entering human clinical studies. The CSF shall synthesize and purify chemical intermediates and antifertility agents. 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 requirements of this facility include the following:

The Chemical Synthesis Facility (CSF) will be capable of:

• Rapidly synthesizing laboratory scale milligram quantities of specific chemical compounds required for in vitro and initial in vivo contraceptive investigation,

• Synthesize and purify relatively larger quantities of up to 10 kilograms of drug candidates for comprehensive antifertility testing by the Government, including toxicology studies, and preclinical and clinical studies under current Good Manufacturing Practices (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 and

• 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 may be subcontracted out at cost with Project Officer’s prior approval. The successful contractor maybe required to collaborate with other investigators in the CRHB research program in order to make progress toward the development of safe and effective male and female contraceptive drugs.

Responses: Capability statements in response to this announcement should be no longer than 15 pages inclusive of all material. Responses will be evaluated on the basis of experience, expertise, and capabilities in the following technical areas:

The anticipated contract type will be a cost reimbursement a base year of one year with six option years.

The RFP is anticipated to be posted on or about April 8, 2022 on beta.SAM.gov website:

www.beta.sam.gov

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any nonproprietary technical information in any resultant solicitation(s).

Interested Small businesses that believe they possess the capabilities necessary to undertake this project should submit an electronic copy of their capability statement, addressing the areas above. Capability statements must identify organization name, address, point of contact, the business status, size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code and DUNS number.

Written capability statements should be received by the Contracting Officer by no later than March 21, http://www.beta.sam.gov/

2022. Responses should be no more than 15 pages. These pages exclude resumes. Capability statements should be emailed to : Dana Harris (harrisd@mail.nih.gov) and Gannon White (gannon.white@nih.gov).

Contracting Office Address:

Contracts Management Branch 6710B Rockledge Dr., Suite 1124, MSC7000 Bethesda, Maryland 208927510 United States Primary Point of Contact.:

Dana Harris Contracting Officer harrisd@mail.nih.gov Phone: 301.443.7798 Secondary Point of Contact:

Gannon White Contract Specialist gannon.white@nih.gov Phone: 301.402.9178 mailto:harrisd@mail.nih.gov mailto:mahaset@mail.nih.gov mailto:alice.pagan@nih.gov