NICHD Biological Testing Facility (BTF)

THIS IS A NOTICE OF INTENT TO AWARD WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION. THIS IS NOT A SOLICITATION OR A REQUEST FOR COMPETITIVE PROPOSALS. The purpose of this announcement is for the Contraceptive Development Program (CDP), within the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, to issue a modification on a sole source basis, under the authority of 41 U.S.C. 253 (c)(1) as implemented by FAR6.302-1,Only one responsible source and no other supplies or services will satisfy agency requirements and FAR 6.301-1(a)(2)(ii) to extend the ordering period of the existing IDIQ contract with SRI International (SRI), entitled - NICHD Biological Testing Facility (BTF). The objective is to extend the ordering period to ensure continuation of mission critical research while the NICHD procurement team continues to pursue the re-competition of these services under a new full and open cost reimbursement contract. The proposed twenty-seven (27) month extension of the ordering period is necessary to prevent a lapse in continuity of critical services essential to the NICHD BTF and Contraceptive Clinical Trials Network (CCTN). This will ensure uninterrupted support for the conduct, coordination, and regulatory compliance of ongoing preclinical Good Laboratory Practices (GLP) studies and Good Manufacturing Practices (GMP) of investigational products (IP), and clinical contraceptive studies, avoiding costly and mission-compromising delays that would arise from a transition to a new contractor at this stage. Specifically, this action is necessary to ensure SRI continues providing the preclinical and clinical services supporting ongoing CCTN Phase I-III contraceptive clinical trial activities under Good Clinical Practices guidelines. SRI will also continue providing ancillary services such as meeting coordination, GMP investigational product (IP) manufacture, release, product formulation, packaging, distribution, stability testing, and regulatory support services as needed. In addition, SRI would continue developing preclinical Good Laboratory Practices (GLP) and GMP protocols that allow for the review of data quality, data analyses, and the composition of study reports with the intent of submitting them to the Food and Drug Administration and other relevant regulatory authorities. SRI is also tasked with compound storage and database management for past, current, and future preclinical studies. Due to delays and changes in resource allocations, the projected workload, IP manufacturing, and clinical trial delays, the required work will take longer to finalize. An extension of the ordering period is required to complete these critical activities, ensuring continuity without disruption or loss of investment. As the incumbent contractor, SRI is uniquely positioned to continue this work due to its deep institutional knowledge, integrated in-house GLP and GMP-certified facilities, and regulatory and data continuity. SRI has developed proprietary and customized protocols for investigational product (IP) formulation, manufacturing, and data management systems specific to the CCTN's current investigational products. No other known contractor can assume this work without causing significant delays, duplicative costs, and risks to data integrity and regulatory timelines. The breadth of SRI's internal capabilities'spanning compound storage, database infrastructure, absorption, distribution, metabolism, excretion/pharmacokinetic (ADME/PK) profiling, and FDA-compliant reporting'constitutes a comprehensive platform not readily available elsewhere. SRI's responsibilities include the following activities along with ancillary functions related to the coordinating databases, data management, preclinical studies and manufacturing of investigational products: Efficacy evaluation in various animal models. GLP studies for safety and toxicology evaluation of active pharmaceutical ingredients (API). In-house GLP facility for animal care and maintenance. Absorption, distribution, metabolism, excretion/pharmacokinetic (ADME/PK) profiling of API. Development of stable formulation for different routes of administration in clinical studies. In-house GMP facilities for IP manufacture, stability and product release of steroids and other compounds to be used in clinical studies Project planning, initiation, implementation and project management. Maintenance and update databases. In-house bioinformatics and web development and application. Compound library, data, document, product, and specimen/reagent inventory management. Receive, format, store, ship, and record compounds/products and biological agents. Regulatory documentation and support for clinical study reports for submission to the Food and Drug Administration (FDA). Statistical analysis of preclinical data and assistance in manuscript preparation for publication of study results System security plan (SSP). Adherent and in compliance of federal information security management act (FISMA) and Section 508 Compliance. Transitioning to a new contractor at this juncture would introduce unacceptable risks of service disruption, regulatory noncompliance, and data loss. The complexity of ongoing multi-phase clinical and preclinical studies requires uninterrupted coordination of investigational product manufacture, bioanalytical data integration, and FDA-submission-ready documentation. A competitive award at this time would necessitate a lengthy onboarding period, duplication of past work, and incur steep transition costs. These disruptions would result in unrecoverable delays in FDA submissions and loss of time-sensitive preclinical data'undermining years of prior Government investment and delaying access to novel fertility optimization products for the American public. Specifically, interruption in these activities would result in unacceptable and costly delays as well as unrecoverable losses in vital areas such as incomplete GLP studies and clinical GMP manufacturing and the submission of finalized data to the FDA for clinical development of novel contraceptive products. In view of that, it is critical that these services not be interrupted, as this operation is essential to the success of BTF, CCTN, and CDP. The loss of acquired experience and knowledge from ongoing activities would cause considerable detriment to government investment if the expertise of SRI is not utilized to complete the ongoing projects. The proposed extension directly supports NICHD's strategic mission to accelerate development of safe and effective fertility optimization methods. This includes responding to urgent public health needs for more accessible and acceptable family planning options. Disruptions to current workstreams would delay progress on investigational methods uniquely suited to meet unmet needs'such as male hormonal contraceptives and long-acting female injectables'and compromise the return on investment from prior clinical and regulatory activities funded by the Government. There will not be a solicitation or Request for Proposals (RFP) issued as a result of this announcement. Any responses or inquiries to this notice must demonstrate clear and convincing evidence that competition will be advantageous to the Government. All information received from this notice shall be used for planning and market research purposes only. The statutory authority for this sole source action is implemented by FAR 6.302-1,Only one responsible source and no other supplies or services will satisfy the agency's requirements. The award is subject to approval of the Justification and Approval for Sole Source (J&A). Once the J&A is approved, this action will serve to change the IDIQ contract's ordering period via a modification to the contract. Notwithstanding the stated intent, if other organizations believe they can fully meet the Government's requirement, they may submit a written capabilities statement (NOT TO EXCEED 10 PAGES). The capabilities statement must contain sufficient documentation to establish a bona fide capability to fulfill the requirement and must be received by the response date listed in this posting. A determination not to compete with this requirement, based upon responses to this notice, is solely within the discretion of the Government. NICHD will not be responsible for any costs incurred by interested parties in responding to this notice. Acknowledgement of receipt of responses will not be made, nor will respondents be notified of the evaluation of the information received. Interested parties may respond and provide a capability statement no later than 2:00 p.m. Eastern Standard Time (EST), August 28, 2025, via email to Theresa Ranjit, Contracting Officer, at Theresa.Ranjit@nih.gov and Alice Pagan, Contracting Officer, at Alice.Pagan@nih.gov . Emails must reference the announcement number in the subject line. This is not an RFP, and this announcement does not commit the Government to award a contract. The reference number to be used is 75N94020D00003.