Regulatory Affairs Support

This Procurement will be a 100% Service-Disabled Veteran-Owned Small Business Set-Aside. The National Institute on Drug Abuse (NIDA) intends to solicit proposals from qualified Service-Disabled Veteran-Owned Small Businesses (NAICS Code 541990: Size standard is up to $14,000,000, effective March 12, 2012). NIDA intends to solicit proposals to provide regulatory support for the development and filing of regulatory submissions for NIDA. This includes, but is not limited to, 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 cost-reimbursement indefinite delivery, indefinite quantity type contract with options for additional work. NIDA anticipates that at least one task order will be awarded with the contract. RFP No. N01DA-12-8902 will be available electronically on or about March 20, 2012. You can access the RFP through the FedBizOpps (URL: http://www.fedbizopps.gov or through the NIDA website at the following address: (URL: http://www.drugabuse.gov/funding/funding-opportunities/nida-requests-contract-proposals-rfps). All information required for the submission of an offer will be contained in or accessible through the RFP package. Responses to the RFP will be due on or about 45 days after we release the RFP. NIDA will consider proposals submitted by any responsible offeror. 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 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. This advertisement does not commit the Government to award a contract.