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

Project 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 reemerging
infectious diseases (e.g., SARS-CoV-2, Ebola, influenza, etc.), 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 (https://www.niaid.nih.gov/research/emerging-infectiousdiseases-
pathogens). 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 or emergency use authorization by
the Food and Drug Administration (FDA) or other regulatory authorities, 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 also sponsors
Investigational Device Exemption applications (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 around June
2022. It is anticipated that the contract will include six Term Option Periods, with a
term of 12 months for each Term Option exercised, 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 will be available electronically on/about April 22, 2021, and may be accessed
through beta.SAM.gov. This notice does not commit the Government to award a contract.
No collect calls will be accepted. No facsimile transmissions will be accepted.