Drug Formulation and Manufacturing Contract II (DFMC)

This is a Sources Sought Notice only. This notice is issued solely for market research and planning purposes under FAR Part 10 and does not constitute a solicitation. Responses to this notice will assist the government in determining the appropriate acquisition strategy, including whether a small business set-aside is appropriate.

Overview:

The National Institutes of Health (NIH) is conducting market research to identify qualified vendors capable of performing the contract requirement as stated in the attached statement of work.

A draft Statement of Work (SOW) is attached to provide additional details.

Please take a moment to thoroughly review the attached Statement of Work (SOW), which outlines the full scope and details of the drug formulation and manufacturing contract requirement.

Background:

The goal of the contract is to complete all the manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for investigational drug products. Throughout the period of performance (PoP) of the contract, the contractor must maintain the technical capabilities, minimum resources and organizational compliances with which to successfully conduct any awarded contract activity. The contractor must also maintain a good standing as a Qualified Vendor as determined by ORSC. Additionally, unless otherwise requested, any assigned research must be performed in compliance with all current FDA, World Health Organization (WHO), USP, ISO, and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to current good manufacturing practices (cGMP) as may be applicable.

Clarifications:

• Vendors responding to the National Institutes of Health (NIH) issued Sources Sought Note, should review the provided draft Statement of Work (SOW) to identify requirements and deliverables. The vendor's response should identify and describe how their capabilities and resources will meet the requirements and deliverables they identified in the SOW. While there is no set limit in pages, it is expected that the vendor will be able to briefly respond in an efficient and effective manner.
• Clarification on Drug Formulation and Manufacturing Notices
• Please note that the Sources Sought notice titled Drug Formulation and Manufacturing Contract (DMFC) is an active posting as of April 28, 2025. This notice is distinct from the pre-solicitation notice 75N95024R00077 titled Drug Manufacturing and Formulation Program (DMFP), which has been inactive since or around September 2024.
• As of now, there is no active contract in place for either the DFMC or the DMFP.
• The initial contract, DFMC-I, was written and awarded in response to sudden changes to the capabilities and resources of the NIH Clinical Center Central Pharmacy. The current proposed contract, DFMC-II, is to build upon the success of DFMC-I. It is expected that for DFMC-II there will be an increase in awarded Task Orders (TOs) due to the current goal of centralizing contracts to support across the National Institutes of Health.
• Submission Instructions Interested parties should submit the following information no later than May 19, 2025 by 5:00pm Eastern Standard Time:
• Company name and address
• UEI number and CAGE Code
• NAICS code(s) applicable to the requirement
• Business size and type (e.g., 8(a), HUBZone, SDVOSB, WOSB)
• A capability statement (no more than 15 pages)
• Past performance examples related to the requirement
• Point(s) of contact (name, phone, and email)
• Submissions should be sent electronically to the Contracting Officer, Dr. William H. M. Etti, email address: William.etti@nih.gov with title of the sources sought notice (Drug Formulation and Manufacturing Contract) and notice identification number.

Disclaimer

This is not a request for proposal or quotation. This Sources Sought Notice does not commit the government to contract for any supply or service. The government will not reimburse any costs incurred in responding to this notice. Responses will not be returned. Not responding to this notice does not preclude participation in any future solicitation, if one is issued.