Biological Testing Facility

THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT May 30, 2014. The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is planning to solicit proposals to re-compete its contract for a Biological Testing Facility (BTF) through full and open competition procedures. This requirement is defined as code 541712 under the North American Industry Classification System (NAICS). It is anticipated that a single Indefinite/Delivery, Indefinite/Quantity (IDIQ) Task Order cost reimbursement contract will be awarded with a Base Year plus options with a period of performance beginning on or about September 21, 2014. The Contraceptive Discovery and Development Branch (CDDB), within NICHD, was established in 1976, the CDDB has had a continuing need for the discovery chemistry and subsequent development of the anti-fertility agents. The Biological Testing Facility (BTF) fulfills a unique role in bridging the discovery and optimization 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 to provide 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 must have the capability to assess the contraceptive activity, endocrine activity, toxicity and pharmacokinetics of new chemical compounds, formulations, delivery systems, and devices for contraception and/or therapies under development by or with the support of NICHD. The Contractor will be required to assist in identifying the appropriated tests and assays that will most efficiently establish safety and efficacy of products pursuant to clinical testing. To this end, the Contractor must 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 (IND) applications. The Contractor will be required to 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 will be required to 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 will also be required to 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. The Contractor will be expected to provide information management and IND preparation and filing support as part of their in-house activities as required by the FDA. This Pre-Solicitation announcement is for the RFP for the Biological Testing Facility only. The RFP (NIH-NICHD-CDDB-2014-17) will be made available on or about May 30, 2014. The RFP may be accessed electronically only via the FedBizOpps website (http://www.fbo.gov). Offerors are responsible for routinely checking the FedBizOpps website for any possible solicitation amendments that may be issued.