Drug Formulation and Manufacturing Contract II (DFMC)

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.

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.

Responses:

• 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.

• 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 NIH Enterprise of Institutes and Centers.