Drug Manufacturing and Formulation Contract II
ID: NIHOD20250424WILLIAMETTIType: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH OLAOBETHESDA, MD, 20892, USA

NAICS

Chemical Manufacturing (325)

PSC

MISCELLANEOUS CHEMICAL SPECIALTIES (6850)

Set Aside

Partial Small Business Set-Aside (FAR 19.5) (SBP)

Original Source

https://sam.gov/opp/b05f429ff6054f9c802fdb5802088c4c/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified vendors for the Drug Formulation and Manufacturing Contract II (DFMC II), aimed at facilitating the manufacturing and documentation processes for investigational drug products. The contract will involve multiple award Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts, focusing on the development of dosage forms for small molecule drug candidates intended for clinical trials and preclinical studies, while ensuring compliance with Good Manufacturing Practices (cGMP) and FDA documentation standards. This initiative is critical for maintaining high standards in drug development and research support, with the goal of centralizing contracts across NIH to enhance efficiency. Interested parties must submit their qualifications, including a capability statement and past performance examples, by May 19, 2025, to Dr. William H. M. Etti at William.Etti@nih.gov.

    Point(s) of Contact
    Dr. William H. M. Etti
    (301) 402-4422
    William.Etti@nih.gov
    Files
    Title
    Posted
    New DFMC SOW_DRAFT 01Feb25 clean.docx
    The National Institutes of Health (NIH) is initiating the Drug Formulation and Manufacturing Contracts II (DFMC II) to facilitate the manufacturing and documentation processes for investigational drug products under the Office of Research Support and Compliance (ORSC). The aim is to develop dosage forms of small molecule drug candidates for clinical trials and preclinical studies. DFMC II comprises multiple award Indefinite Delivery/Indefinite Quantity (ID/IQ) contracts, succeeding the previous DFMC set to end in late 2024. Responsibilities encompass compliance with Good Manufacturing Practices (cGMP) and the preparation of necessary documentation acceptable to the FDA. Key activities include technical support for drug product development, formulation manufacturing studies, stability assessments, and comprehensive supply chain management—covering packaging, labeling, storage, and distribution. The contractor must maintain vendor qualifications and adhere to stringent regulatory standards to guarantee product safety, quality, and compliance throughout the contract duration. Furthermore, the contractor is expected to provide periodic reports detailing project progress, regulatory compliance, and other key operational metrics, while maintaining strict confidentiality of sensitive data. This RFP underscores the NIH's commitment to upholding high standards in drug development and research support while streamlining procurement processes for investigational products.
    Lifecycle
    Title
    Type
    Drug Manufacturing and Formulation Contract II
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