DMID Regulatory Affairs Support   3

Project History:

Re-competition (Contract # HHSN272201500018C)

Current Contractor:

Technical Resources International, Inc.

6500 Rock Spring Drive, Suite 650

Bethesda, MD 20817

Description:

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which is funded through a variety of research grants and contracts.

Developing and testing new vaccines and therapies have historically been a major focus of the research supported by the DMID. Much of this research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases (e.g., avian influenza and West Nile Virus), as well as those supporting the evaluation of the safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm). In order to ensure that the development, testing and manufacture of products evaluated under DMID-supported clinical research are executed with a rigor that will support licensure by the Food and Drug Administration (FDA), DMID supports an infrastructure to provide regulatory assistance in the development and testing of these products.

Currently, DMID sponsors approximately 100 Investigational New Drug Applications (INDs) or Master Files (MFs) which span more than 200 clinical trials. This includes both multicenter trials and single center studies, and encompasses Phase 1, 2, and 3 clinical trials performed at both domestic and foreign sites. DMID files approximately 10-20 new INDs each year, and in this capacity, serves as the official IND sponsor and liaisons with the FDA with respect to all regulatory requirements. Currently, the DMID IND portfolio is comprised of approximately 75% vaccine and other biologic (monoclonal) INDs, 20% drug INDs, and 5% MFs. DMID is also the sponsor of an open Investigational Device Exemption application (IDE) and supports interaction with the FDA for studies that support 501(k) filings.

The purpose of this solicitation is to provide scientific, regulatory, technical, project management, and administrative assistance for a broad spectrum of DMID research activities poised for regulatory approval or licensure.

It is anticipated that a single cost-reimbursement, Level of Effort type contract will be awarded with a one-year base period of performance beginning on or about June 2022. It is anticipated that the contract will include six Term Option Periods, with a term of 12 monthsfor each Term Option exrecised, and the inclusion of quantity options for each contract year to be exercised at the discretion of the government. The total potential period of performance, including options, is seven years.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP is available electronically on/about 04/29/2021, and may be accessed through FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.