Regulatory Affairs Support

This Procurement will be a 100% Small Business Set-Aside. The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified Small Businesses (NAICS Code 541990: Size Standard is up to $15.0 million).

NIDA intends to solicit proposals to provide regulatory support for the development and filing of regulatory submissions for NIDA. This includes the preparing, compiling, indexing and filing of Initial Investigational New Drug (IND) Applications, New Drug Application (NDA) submissions, Annual Reports, Protocol Amendments and Information Amendments as needed for ongoing INDs held by NIDA, and Ad Hoc regulatory documents for submission and registration with regulatory agencies. All submissions are to be developed in accordance with the Food and Drug Administration (FDA) regulations, International Conference on Harmonization (ICH) guidances and Good Clinical Practice (GCP) guidelines.

NIDA anticipates the award of a single, five-year, indefinite delivery, indefinite quantity contract (IDIQ) – type contract. NIDA anticipates awarding fixed price and/or cost reimbursement task orders as needed throughout the period of performance to maintain flexibility in issuing work. This award is a competitive renewal of Contract No. HHSN271201200027C, titled “Regulatory Filing Support for the Development of Medications.”

RFP No. N01DA-17-8933 will be available electronically on or about 15 days from the date of this posting. You can access the RFP through the FedBizOpps (URL: http://fedbizopps.gov) or through the NIDA website (URL:  http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of a proposal will be contained in or accessible through the RFP package. Responses to the RFP will be due 30 days from the release date. NIDA anticipates an August 2017 award date. NIDA will consider proposals submitted by any responsible Small Business offeror. This advertisement does not commit the Government to award a contract.

Based upon market research, the Government is not using the policies contained in Part 12, Acquisition of Commercial Items, in its solicitation for the described supplies or services. However, interested persons or organizations may identify to the Contracting Officer their interest and capability to satisfy the Government's requirement with a commercial item within 15 days of this notice.