The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) seeks capability statements from interested and qualified potential sources for the NICHD Biological Testing Facility (BTF). The NIH, NICHD is the lead Federal agency that fulfills a unique role in bridging the discovery of contraceptive targets to the development and approval of the contraceptive products. The BTF fulfills a unique role in bridging the discovery of contraceptive targets to the development and approval of the contraceptive products. The primary objective is to provide a state-of-the-art facility and the capability 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 chemical entities into clinical trials. 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. Purpose and Objectives: 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 (IND) applications. Project requirements: 1. Assist in identifying products that are ready for development and production by assembling information on experimental anti-fertility agents and/or therapies; 2. In-house investigational product production or identify potential subcontractors with the capability and interest in producing clinical product lots and to issue and administer subcontracts for the production of products; 3. Perform all preclinical testing of the products necessary for Investigation New Drug (IND) application, either in-house or via subcontracts, and to compile and submit these data in the form of a formal IND submission to the FDA; and 4. Provide information management and IND preparation and filing support as part of their in-house activities as required by the FDA. Overall Areas of Expertise: 1) Preclinical Services: a. Efficacy Evaluation Services b. Safety and Toxicology Evaluation and ADME/PK Profiling Services c. Formulation Services d. GMP facilities for product preparation, stability and product release of steroids and other compounds to be used in clinical studies e. Animal care and maintenance services 2) General Services: a. Project Planning, Initiation, Implementation and Management b. Database, Data, Document, Product, Specimen/Reagent and Inventory Management. c. Receive, Format, Store, Ship and Record Compounds/Products and Biological Agents d. System Security Plan (SSP) Anticipated period of performance: 09/03/2020 – 9/2/2025 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 areas cited above. The anticipated contract type will be a cost reimbursement IDIQ . The RFP is anticipated to be posted on or about March 30, 2020 on FedBizOpps (FBO) website: http://www.fedbizopps.gov. Businesses that believe they possess the capabilities necessary to undertake this project should submit electronic copies in addition to two (2) hard copies of their capability statement, addressing the areas above. Please limit responses to fifteen (15) pages or less. Any proprietary information should be so marked. Written capability statements should be received by the Contracting Officer by no later than 12:00 PM(noon) Eastern Time on December 11, 2019. Capability statements must identify the business status of the organization (i.e. educational institution, non- profit, large business, small business, 8 (a), or other corporate or non-corporate entity). Information submitted should be pertinent and specific in the technical area under consideration, on each of the following qualifications (1) Experience: an outline of previous projects, specific work previously performed or being performed and any in-house research and development effort; (2) Personnel: Name, professional qualifications and specific experience of scientist, engineers and technical personnel who may be assigned as principal investigator and/or project officer: (3) Facilities: Availability and description of special facilities required to perform in the technical areas under consideration, and a statement regarding industrial security clearance. Any other specific and pertinent information as pertains to this particular area of procurement that would enhance our consideration and evaluation of the information submitted. Information in the anticipated RFP supersedes any information in this pre-solicitation announcement. Inquiries should be directed to: Adelola St John, Contracting Officer, DHHS/NIH, National Institute of Child Health and Human Development, email:
[email protected] or
[email protected].