Pre-Sol Synopsis.pdf

Document Type: Presolicitation Synopsis Solicitation No.: 75N95023R00009 Project Title: Regulatory Affairs Support Classification Code: R -- Professional, administrative, and management support services NAICS Code: 541690 - Other Scientific and Technical Consulting Services

A. Objectives:

The National Institute on Drug Addiction (NIDA), Division of Therapeutics and Medical Consequences (DTMC), intends to solicit proposals using competitive procedures as a SMALL BUSINESS SET-ASIDE from qualified and capable Small Businesses certified under NAICS Code 541690; to support the regulatory needs generated by NIDA supported studies.

The purpose of this contract is to provide resources to support the regulatory needs generated by NIDA supported studies. NIDA reserves the right to have the contracted services provided to benefit NIDA or any other component of the NIH. This contract will provide such support by preparing regulatory submissions for filing with the Food and Drug Administration (FDA).

These submissions will consist of Initial Investigational New Drug (IND) applications, New Drug Application (NDA) and supplemental NDA (sNDA) submissions, annual reports, protocol amendments, information amendments, and Ad Hoc documents. The vendor will ensure that the regulatory submissions are in accordance with FDA regulations, International Conference on Harmonization (ICH) guidelines and Good Clinical Practice (GCP) guidelines.

B. General Requirements:

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the following tasks on preparing regulatory submissions for filing with the Food and Drug Administration (FDA).

1. IND Application Preparation and Submission

2. IND Annual Report Preparation

3. IND Annual Report Preparation (simplified version)

4. IND Protocol Amendment Preparation

5. IND Information Amendment Preparation

6. Investigator’s Brochure Updates

7. NDA Preparation and Submission

8. sNDA Preparation and Submission

9. Ad Hoc Regulatory Support Functions

D. Additional Information:

NIDA anticipates that one single-award IDIQ contract will be awarded with an ordering period of five (5) years. NIDA anticipates the award of cost-plus fixed fee task orders under this contract. These individual task orders may include options to extend the period of performance and/or options for increased quantities. If options and option quantities are utilized for an individual task order, then they will be clearly defined in the Task Order RFP and be determined and evaluated at the time of task order solicitation and award. NIDA anticipates that at least one task order will be awarded with the contract. Future funding will be made through issuances of task orders and will be dependent on NIDA programmatic needs and availability of funds.

Various task orders will be issued to support distinct tasks and deliverables in accordance with the Statement of Work.

RFP No. 75N95023R00009 will be available electronically on or about February 15, 2023. You can access the RFP through SAM.gov. 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 approximately 30 days from the release date. NIDA will consider proposals submitted by any responsible 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 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.

Points of Contact

Primary Point of Contact:

Alexander Beraud Contract Specialist

Secondary Point of Contact:

Joshua Lazarus Contracting Officer