2026_BTF_Presol_Notice_MAR_27_2026_1.pdf

RFP 75N94026R00005 National Institutes of Health (NIH)

PRE-SOLICITATION NOTICE

Title: Biological Testing Facility

THIS PRE-SOLICITATION SYNOPSIS IS NOT AN AUTHORIZATION TO START

WORK

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL (RFP). NO QUOTES

OR BIDS ARE BEING SOLICITED BY THE GOVERNMENT THROUGH THIS NOTICE,

NOR WILL ANY BE ACCEPTED FOR REVIEW IN RESPONSE TO THIS SYNOPSIS.

The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child

Health and Human Development (NICHD) intends to issue a solicitation for the recompete of the

Biological Testing Facility (BTF) through full and open competition procedures. This requirement is classified under North American Industry Classification System (NAICS) number

541715. The Government anticipates awarding a single Indefinite-Delivery, Indefinite-Quantity

(IDIQ) cost-reimbursement type contract featuring a seven (7) year ordering period commencing on or around September 30, 2026.

The Contraceptive Development Program (CDP) maintains a continuing need for the discovery, chemistry, and subsequent development of the anti-fertility agents. The BTF fulfills a unique role in bridging the discovery and optimization of contraceptive agents to the development and approval of the contraceptive drug. To this end, the studies at the BTF will encompass discovery and optimization of compounds as anti-fertility agents. In addition, the BTF has an important role in enriching and providing the pre-clinical support services necessary to make progress toward the development of high quality, safe and effective male and female contraceptive products.

The primary objective of this contract is for the Biological Testing Facility (BTF) to serve with the capability to carry out the in vitro enzymatic and cell based assays, in vivo studies, anti-fertility assessments, endocrine activity, toxicity, formulation, stability, Absorption Distribution

Metabolism Excretion (ADME) profiling and Drug Metabolism Pharmacokinetics (DMPK) profiling of new chemical compounds, delivery systems, and devices and all activities related to preclinical development of products that can be tested in clinical trials for fertility management, reproductive health, and therapeutics. Additionally, this contract will require a state-of-the-art facility and the capability and capacity to carry out biological safety and efficacy evaluations of new entities with the goal of satisfying the regulatory requirements necessary to be able to introduce the new entities into clinical trials.

The Contractor shall assist in identifying the appropriate tests and assays that will most efficiently establish safety and efficacy of products pursuant to clinical testing. To this end, the

Contractor shall be knowledgeable about drug evaluation in a wide variety of species including but not limited to rodents, rabbits and non-human primates. This initiative will provide overall project management and the capabilities to support all phases of preclinical development of contraceptives, including process and product development, clinical lot production, formulation, preclinical enabling studies and associated tasks leading to the filing of investigational new drug

RFP 75N94026R00005 National Institutes of Health (NIH)

(IND) applications. The Contractor shall assist in identifying products that are ready for development and production by assembling information on experimental anti-fertility agents and/or therapies. This will be accomplished by collecting, maintaining, analyzing and disseminating information arising from all preclinical development efforts, including data generated by or with the support of NICHD. The Contractor shall identify potential subcontractors with the capability and interest in producing clinical product lots and to issue and administer subcontracts for the production of products as assigned by the Project Officer. The

Contractor shall also perform all preclinical testing of the products necessary for IND application, either in-house or via subcontracts, and compile and submit these data in the form of a formal IND submission to the Food and Drug Administration (FDA). The Contractor shall provide information management and IND preparation and filing support as part of their in-house activities as required by the FDA.

Additional Information:

The RFP (75N94026R00005) will be made available on or about April 13, 2026, with a due date for receipt of proposals on or about May 28, 2026.

The RFP is only available electronically and must be accessed through “Contract Opportunities” at the https://sam.gov/ website. All information required for submission of a proposal must be contained in the electronic RFP package. It is the Offeror's responsibility to monitor the above website for the release of this RFP and amendments, if any. All responsible sources may submit a proposal, which shall be considered by the agency. This notice does not commit the Government to award a contract.

POTENTIAL OFFERORS ARE RESPONSIBLE FOR DOWNLOADING THEIR OWN COPY

OF THE SOLICITATION AND ANY POSSIBLE AMENDMENTS. ALL INQUIRIES SHALL

BE SUBMITTED ELECTRONICALLY TO THE POINTS OF CONTACTS LISTED HEREIN.

You must be registered in System for Award Management (SAM) Database to receive a

Government contract award. You may register for SAM at:

https://www.sam.gov/portal/public/SAM/.

Primary Point of Contact

Sean Dunn

Contract Specialist sean.dunn@nih.gov

Secondary Point of Contact

Gannon White

Contracting Officer gannon.white@nih.gov

Contracting Office Address

Research and Development and Professional Services – Division B

6701 Rockledge Dr, RK2 RM 411-N

Bethesda, Maryland 20817-7786 https://www.sam.gov/portal/public/SAM/ mailto:sean.dunn@nih.gov mailto:gannon.white@nih.gov