Professional Services to Assist with Documentation in the Area of Historical Policy-Making and Regulation Development

This is a solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 and FAR Subpart 13.1, as supplemented with additional information included in this notice. Quotes are being requested and this announcement constitutes the only solicitation. This is a small business set-aside solicitation in accordance with FAR Subpart 19.5 Set-Asides for Small Business. The purpose of this procurement is to augment the continuation of CVM’s mission to protect human and animal health. It is important to document how and why the MUMS Act was passed by Congress. It is also important to document the reasoning behind current MUMS regulations and policy. A historical record, with links to related/source documents, created by a contractor with expert knowledge, will allow retention of essential knowledge and information. The Contractor shall create a repository of historical knowledge that can continue to be updated by CVM. This information must be of quality and level of detail sufficient to enable CVM to make policy decisions in the future and to provide perspective on past decisions. The Contractor shall provide support to FDA/CVM in mission delivery. This support shall include the creation and delivery of a document/repository on the complete history of minor use/minor species topics, including the development of the MUMS Act and establishment of OMUMS. Within CVM, the Office of Minor Use and Minor Species Animal Drug Development (OMUMS) is responsible for promoting legal availability of drugs for use in minor species animals and for minor uses (uncommon diseases) in major species animals. OMUMS has three (3) major program areas: Designation, Indexing, and the Minor Use Animal Drug Program (MUADP). OMUMS also provides education and outreach to drug companies and other stakeholders, including veterinarians and producers. The final product shall be electronic files that include a narrative describing the development of FDA’s minor use/minor species policies in the areas of new animal drug approval (including DESI finalization) and enforcement discretion. Links/references must be identified, and copies acquired of related/source documents (e.g., National Aquaculture Act, Federal Register Notices, Congressional report language, preambles to implementing regulations). The Director of OMUMS will determine the acceptability of the final product. Be advised that the FDA does not accept documents which contain the use of macros. Document submissions required throughout the period of performance of this contract must not have macro-enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.