SOURCES SOUGHT
A -- Toxicological Evaluations of Potential Medications to Treat Drug Abuse
- Notice Date
- 11/3/2022 7:34:26 AM
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- N01DA-23-8939
- Response Due
- 11/18/2022 8:00:00 AM
- Archive Date
- 12/15/2022
- Point of Contact
- Polina Klimenkova, Phone: 3018276848
- E-Mail Address
-
polina.klimenkova@nih.gov
(polina.klimenkova@nih.gov)
- Description
- This is a SMALL BUSINESS SOURCES SOUGHT NOTICE to determine the availability of ALL small businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, women-owned small businesses, and other small businesses) to fulfill the needs of NIH and NIDA for this future requirement. The NIDA Medications Discovery and Toxicology Branch has the mission to facilitate, through preclinical medications discovery and safety assessment efforts, the translation of basic research findings into pharmacotherapies for the treatment of substance use disorders.� When preclinical development candidates are identified, this contract provides a resource for the development of safety data that support filing Investigational New Drug (IND) applications and New Drug Application(s) (NDA) to the U.S. Food and Drug Administration (FDA).� In this context, the primary objective of this research and development contract is to support preclinical safety pharmacology studies and preclinical acute and repeat dose toxicology studies in rodents, rabbits, dogs and/or nonhuman primates (monkeys) on test articles that are potential pharmacotherapies (medications) to treat substance use disorders. It is anticipated that NIDA will use the results of these preclinical studies in IND and NDA filings with the FDA in accordance with FDA Guidances, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines and Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) regulations. Please see the attachment for more details.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/a36b1c6c95d74419b584bf7a6fae1ab7/view)
- Record
- SN06509739-F 20221105/221103230102 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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