A--To award Indefinite Delivery Indefinite Quantity (IDIQ) Contract for a Biologic
ID: 75N94024R00034Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NICHDBETHESDA, MD, 20817, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

PSC

HEALTH R&D SERVICES; HEALTH CARE - OTHER; BASIC RESEARCH (AN41)

Original Source

https://sam.gov/opp/d4f28165af9245cfaad0ff354ce5bdad/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to fulfill an Indefinite Delivery Indefinite Quantity (IDIQ) contract for the Biological Testing Facility (BTF), which focuses on the preclinical development of contraceptive products. The objective of this procurement is to support the discovery and optimization of anti-fertility agents, ensuring safety and efficacy evaluations that meet regulatory standards for clinical trials, ultimately aiding in the development of high-quality reproductive health products. Interested small businesses must demonstrate their qualifications, including compliance with Good Laboratory Practice and Good Manufacturing Practice, and provide capability statements by November 21, 2024, with the anticipated contract performance period running from September 3, 2025, to September 2, 2032. For further inquiries, interested parties may contact Adelola O. St John at lk202p@nih.gov or call 301-435-6955.

    Point(s) of Contact
    ST JOHN, ADELOLA O
    (301) 435-6955
    lk202p@nih.gov
    Files
    Title
    Posted
    SOURCES_SOUGHT_SYNOPSIS_BTF_2024_110524_2.pdf
    This notice is a Small Business Sources Sought announcement aimed at gathering information about qualified small business sources capable of fulfilling a future contract for a Biological Testing Facility (BTF). The contract will likely be an Indefinite Delivery Indefinite Quantity (IDIQ) type, focusing on preclinical development of contraceptive products, including safety and efficacy evaluations to meet regulatory standards for clinical trials. The National Institute of Child Health and Human Development (NICHD) will oversee the project, which aims for comprehensive management of all developmental phases, from project planning to filing investigational new drug applications with the FDA. Interested small businesses must demonstrate their experience and qualifications, including facilities for Good Laboratory Practice and Good Manufacturing Practice, and provide in-house or subcontracted production capacity for investigational products. The submission deadline for capability statements is November 21, 2024. This initiative intends to enhance the support for developing high-quality reproductive health products while exploring the diverse capabilities of small businesses in this domain. The anticipated contract performance period is set from September 3, 2025, to September 2, 2032.
    SOURCES_SOUGHT_SYNOPSIS_Final_BTF25_1.pdf
    The government seeks to procure specialized services for preclinical development and testing of contraceptives. Emphasis is on managing the entire project lifecycle, from identifying potential anti-fertility agents to IND application. Selected vendors will operate within a state-of-the-art biological testing facility, offering Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) services. Preclinical services required include efficacy, safety, and toxicology evaluations, with formulation and product development support. The facility should also provide project management and data management capabilities. Responses to this notice will help determine the suitability of small businesses for a potential set-aside acquisition. Capability statements are due by August 26, 2024, with the formal RFP expected in January 2025. The anticipated contract type is a cost reimbursement IDIQ, spanning nearly eight years.
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