Chemical Synthesis Facility

The Contraception Research Branch (CRB) of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health, intends to negotiate on a sole source basis, under the authority of 41 U.S.C.253 (c) (1) and FAR 6.302-1(a) (ii) and HHSAR 306.302-1, a modification to Contract No. HHSN275201200011C entitled, "Chemical Synthesis Facility" to manufacture additional cGMP NCE (new chemical entity) compounds. The current contractor, Ash Stevens, Inc. (ASI), furnishes all the necessary services, qualified personnel, materials, equipment, and facilities needed to implement, maintain, coordinate, necessary expertise and the knowhow of process chemistry in the multistep manufacture of steroidal compounds, including dimethandrolone (DMA), DMAU and DMADC in multi-kilogram scale under Good Manufacturing Practices (GMP). This additional effort can only be provided by ASI because they have the existing infrastructure and validated process under the current contract. Extensive resources have been used to gain expertise in manufacture and controlled substance license. In addition, ASI has the expertise, knowledge and capacity to manufacture multi-kilogram quantities under a cGMP protocol for the current contract. Awarding a new contract to another contractor would create a duplication of effort and would result in substantial delay that would impact other programs that are dependent on timely production of the substances. The CRB program has an urgent need for the compounds in order to conduct clinical trials, thus, the deadline for production of drug product is short. Notably, it would require additional time and expense to apply for federal, state and local licenses for controlled substances, to train staff and to gain experience necessary for process chemistry in manufacture of these substances since they are not commercial products. This would be highly inefficient, and moreover, this would result in unacceptable delays and substantially increased costs to the government. In view of its experience with the activities under the current contract and its existing infrastructure, ASI is uniquely qualified to perform the proposed work. This is not a request for proposals. However, if any responsible source believes it can perform the above requirement, may submit a capability statement electronically for consideration by the NICHD to Timni Mahase, Contracting Officer at mahaset@mail.nih.gov and to Alice Pag'n, Contracting Officer, at alice.pagan@ nih.gov. Information regarding respondents': (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information should be provided if you submit a capability statement. Your capability statement should be no more than 15 pages in length, excluding resumes. All responses must be received electronically no later than September 23, 2016 at 4:00 pm ET and must contain material in sufficient detail to allow the NICHD to determine if the organization can perform this requirement. The capability statement will be considered solely for the purposes of determining whether to conduct a competitive procurement. A determination by the government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the government.