SOLICITATION NOTICE
A -- DMID Regulatory Affairs Support
- Notice Date
- 4/6/2021 11:58:36 AM
- Notice Type
- Presolicitation
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- NIHAI75N93021R00010
- Response Due
- 7/21/2021 12:30:00 PM
- Archive Date
- 08/05/2021
- Point of Contact
- Ignacio Reyes, Contract Specialist, Phone: 301-435-7574, Charles H. Jackson Jr., Team Lead, Phone: 240-669-5175
- E-Mail Address
-
ignacio.reyes@nih.gov, charles.jackson@nih.gov
(ignacio.reyes@nih.gov, charles.jackson@nih.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- 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.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/80ec5c4aca734031b1fe2165348743b2/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN05963403-F 20210408/210406230112 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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