A--Biological Testing Facility

Amendment / Modification

This amendment (0003) addresses questions received in response to the solicitation. The questions and the Government's responses are provided in an attachment titled "RFP 75N94026R00005 BTF Amendment 3 Attachment 1."

• The primary content of this amendment is the attached Q&A document.

• All other contents of the original RFP remain unchanged.

• The Period of Performance is noted as 09/30/2026 to 09/29/2033.

Amendment / Modification

This amendment provides answers to questions received regarding the RFP for the Biological Testing Facility (BTF) Repro Task Order. The answers are for guidance only and do not supersede the RFP terms.

Key clarifications include:

• Scope of Repro Task Order: The task order is intended to support a diverse portfolio of preclinical development activities for drugs, devices, and combination products. Offerors should consider proposing for three distinct potential products per year, each at a different stage of development and product class (e.g., small molecule drug, antibody, drug-device combination). Activities may include in vitro, ex vivo, and in vivo studies, ADME/PK/PD profiling, formulation development, safety, and toxicology. Offerors should propose a flexible approach.
• Period of Performance: The anticipated period of performance for the Repro Task Order is two (2) years, from September 30, 2026, through September 29, 2028.
• Supporting Documents: Supporting documents will be reviewed. The page limitations for Technical Volume 1 have been amended to provide more space for proposals:
  • IDIQ Technical Response: 30 Pages
  • Administrative Task Order: 30 Pages
  • Repro Task Order: 30 Pages
  • Sample Tasks: 30 Pages per Sample Task (totaling 180 pages).
• Font Size: The font size for figures and tables must be consistent with Attachment 1 (Packaging and Delivery of Proposals).
• Price Quotes: Offerors with an approved purchasing system are exempt from the requirement to include three recent price quotes for items over $1000. However, they must provide evidence of their approved system.

This amendment clarifies the scope, period of performance, page limitations for proposal volumes, font size requirements, and price quote requirements.

Offerors should consider the clarified scope and the revised page limitations when preparing their proposals. The exemption for price quotes for those with approved purchasing systems is also noted.

Amendment / Modification

• This amendment clarifies the due date and time for proposal submissions.

• The new deadline for proposal submission is 4:00 PM Eastern on May 28, 2026.

• The solicitation's proposal submission deadline has been modified.

• The deadline for submitting proposals has been extended to May 28, 2026, at 4:00 PM Eastern.

Amendment / Modification

• This amendment clarifies which Request for Proposal (RFP) document is the correct one to use for this solicitation.

• Two RFP documents were initially attached to the SAM.gov solicitation notice posted on April 13, 2026.

• Offerors are instructed to use the official solicitation document titled "7594026R00005_BTF_Solicitation_4_13_26.pdf" for all purposes, including proposal preparation and submission.

• The RFP version titled "Sol_7594026R00005.pdf" is not applicable and should be disregarded.

• The clarification pertains to the RFP document attachments.

• Offerors must ensure they are using the correct RFP document for their proposals. The deadline for proposal submission has not been changed by this amendment, but it is crucial to use the specified document.

Amendment / Modification

This amendment clarifies which Request for Proposal (RFP) document is the correct one for the solicitation 75N94026R00005. Two RFP documents were initially attached to the SAM.gov notice.

• The official solicitation document to be used is titled "75N94026R00005_BTF_Solicitation_4_13_26.pdf".
• The RFP version titled "Sol_75N94026R00005.pdf" is not applicable and should be disregarded.

Offerors must use the specified official solicitation document for all purposes, including proposal preparation and submission. The anticipated Period of Performance remains unchanged (09/30/2026 - 09/29/2033).

Solicitation / RFP / RFQ

This solicitation is for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to support its mission of developing safe and effective contraceptive agents and/or therapies. The Biological Testing Facility (BTF) plays a crucial role in bridging the discovery of contraceptive targets to the development and approval of contraceptive products.

• The primary objective is to support the NICHD's mission in developing contraceptive agents and therapies.

• The contract will involve work described in SECTION C (Description/Specifications/Work Statement).

• Reporting requirements include electronic submission of all reports via the NICHD Contracts Portal, compliant with Section 508 of the Rehabilitation Act of 1973.

• Technical Progress Reports will be required quarterly and annually, with a final report upon contract completion.

• Reporting of Financial Conflict of Interest (FCOI) is required.

• Invention disclosure reports, confirmatory licenses, and government support certifications are required.

• Packaging, marking, and shipping of deliverables must be in accordance with Government specifications.

• Inspection and acceptance of materials and services will be performed by the Contracting Officer's Representative (COR).

• This is an Indefinite Quantity (IDIQ) contract.

• Minimum contract value: $100,000

• Maximum contract value: $49,000,000

• Period of Performance: TBD through TBD (as stated in Section F, but also noted as TBD through TBD in Section B).

• Task Orders will be issued based on the work described in SECTION C.

• Proposals will be evaluated based on technical factors (including experience and past performance) and cost/price factors. Technical factors are significantly more important than cost/price.

• The Government reserves the right to make a single award, multiple awards, or no award.

• Evaluation of options will be performed by adding the total price for all options to the total price for the basic requirement.

• Offerors must submit a Data Management and Sharing Plan.

• Offerors must address research involving live vertebrate animals in a "Vertebrate Animal Section" (VAS) of their technical proposal.

• Mandatory qualification criteria must be met at the time of receipt of Final Proposal Revisions/Technical Proposals.

• This acquisition is UNRESTRICTED.

• NAICS Code: 541715

• Small Business Size Standard: 1,000 employees

• The solicitation is for an Indefinite Delivery, Indefinite Quantity (IDIQ) contract.

• The contract will be awarded on or about September 27, 2026.

• Management, Administration, and Database task orders, along with Sample Task Orders 2, 3, and 4, will be awarded concurrently and are included in this RFP for evaluation purposes.

Solicitation / RFP / RFQ

This solicitation is for the Biological Testing Facility (BTF) to support research for the optimization of pharmaceutical agents, devices, and combination products for fertility management and reproductive health. The BTF will conduct biological studies for preclinical compounds and device development, utilizing in vitro and in vivo assays, formulation, and delivery studies to evaluate lead candidates targeting validated fertility management and reproductive health pathways. The objective is to provide a state-of-the-art facility for preclinical development, supporting all phases from discovery to filing for Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications.

• Preclinical research and development services including bioinformatics, efficacy evaluation, safety and toxicology evaluation, ADME/DMPK profiling, formulation, and animal care.

• Management of databases, data, documents, products, specimens, and inventory.

• Compliance with Animal Welfare Act and Public Health Service Policy on Humane Care and Use of Laboratory Animals.

• Preparation of clinical study reports and documentation for IND applications.

• Contract Type: Indefinite Delivery Indefinite Quantity (IDIQ)

• Period of Performance: Anticipated 09/30/2026 through 09/29/2033.

• Estimated Value: Minimum $100,000; Maximum $49,000,000.

• Proposal Submission Deadline: May 28, 2026, by 4:00 PM EST.

• Questions Deadline: May 1, 2026, via email.

• Proposals must be submitted electronically via the eCPS website.

• Evaluation will be based on technical factors (experience, compliance, project management) and cost/price factors. Technical factors are of paramount importance.

• Not set-aside for small business.

• Offerors must be registered in the System for Award Management (SAM).

• The solicitation includes multiple attachments detailing proposal preparation, packaging, delivery, and specific task order requirements.

• Key personnel are required, and their commitment must be documented.

• Specific clauses regarding security, data management, and reporting are incorporated by reference.

Solicitation / RFP / RFQ

This is a pre-solicitation notice for a Biological Testing Facility (BTF) requirement by the National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The government intends to issue a solicitation for the recompete of the BTF through full and open competition. The contract will support the discovery, chemistry, and development of anti-fertility agents, fulfilling a role in bridging discovery to development and approval of contraceptive drugs. The BTF will encompass discovery and optimization of compounds as anti-fertility agents and provide pre-clinical support services for male and female contraceptive products.

• Conduct in vitro enzymatic and cell-based assays.

• Perform in vivo studies, anti-fertility assessments, endocrine activity, toxicity, formulation, and stability testing.

• Conduct Absorption Distribution Metabolism Excretion (ADME) profiling and Drug Metabolism Pharmacokinetics (DMPK) profiling of new chemical compounds, delivery systems, and devices.

• Provide biological safety and efficacy evaluations of new entities for regulatory requirements.

• Assist in identifying appropriate tests and assays for safety and efficacy.

• Support all phases of preclinical development of contraceptives, including process and product development, clinical lot production, formulation, and preclinical enabling studies.

• Assist in identifying products ready for development and production.

• Provide information management and IND preparation and filing support.

• Contract Type: Indefinite-Delivery, Indefinite-Quantity (IDIQ) cost-reimbursement.

• Period of Performance: Seven (7) year ordering period.

• Anticipated Commencement: On or around September 30, 2026.

• NAICS Code: 541715

• The RFP will be made available on or about April 13, 2026.

• The due date for receipt of proposals is on or about May 28, 2026.

• The RFP will be available electronically via SAM.gov "Contract Opportunities."

• Offerors are responsible for monitoring the website for the RFP and any amendments.

• All inquiries must be submitted electronically.

• Full and open competition.

• Offerors must be registered in the System for Award Management (SAM) database.

• This notice is a pre-solicitation synopsis and not an authorization to start work.

• No quotes or bids are being solicited at this time.

• This notice does not commit the Government to award a contract.