SOURCES SOUGHT
A -- Pharmacokinetic & Pharmacodynamic Studies for Medications Development
- Notice Date
- 11/23/2016
- Notice Type
- Sources Sought
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 3155, MSC 9593, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SBSS-17-004
- Point of Contact
- Christopher A. Weaver, Phone: (301) 443-6677, Andrew Hotaling, Phone: (301) 443-6677
- E-Mail Address
-
christopher.weaver@nih.gov, hotalingar@mail.nih.gov
(christopher.weaver@nih.gov, hotalingar@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Institutes of Health (NIH), through the National Institute on Drug Abuse (NIDA), is seeking capability statements from Small Business organizations to provide the Government a resource to carry out clinical studies to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of new medications for the treatment of substance use disorders. 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) with the capability to carry out clinical studies to determine the PK and PD of new medications for the treatment of substance use disorders. As medications are often taken with other treatment drugs or drugs of abuse (such as cocaine, methamphetamine, etc.), information on the extent and nature of the interaction between the medications and other treatment drugs/drugs of abuse will also be a focus of this contract. Such studies require the intravenous administration of drugs to human subjects. The data obtained will be submitted to the Food and Drug Administration (FDA) in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications). All studies must be carried out under pertinent FDA regulations, such as current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations. The pertinent FDA guidelines/guidance shall be followed. Capability statements received will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. MANDATORY REQUIREMENTS: In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that the successful contractor possess a Drug Enforcement Administration (DEA) Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. The successful contractor must also have an Office of Human Research Protections (OHRP)-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects and must have a board certified physician on the project. Interested organizations must demonstrate and document, in the capability statement submitted, extensive experience in the technical area under consideration. Send information relevant and specific, on each of the following qualifications: 1) Experience: An outline of previous similar projects, specifically the techniques employed in the areas described above. 2) Personnel: Name, professional qualifications of personnel with specific experience in the work requested and knowledge of, and experience in, the field of research. 3) Facilities: Availability and description of the facilities and equipment required to conduct this type of work. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented is desirable. Documentation may include, but not limited to, contracts both Government and commercial the organization performed, references, i.e., names, titles, telephone numbers and any other information serving to document the organizations capability, e.g., awards, commendations, etc. The NAICS code is 541712. THIS IS NOT A REQUEST FOR PROPOSALS. This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for preparing any information sent for the Government's use. Any proprietary information should be so marked. Interested organizations submitting a capability statement must provide the following: 1) company name and address; 2) point of contact; 3) phone/fax/email; 4) NAICS Codes; 5) business size and status; 6) capability information in response to the requirement; and 7) type(s) of business, if any (e.g., small, veteran-owned, service-disabled veteran-Owned, women-owned, 8(a), small disadvantaged business, and HUBZone). Written capability statements must be submitted to Christopher A. Weaver, whose contact information is included, NO LATER THAN 12/07/2016. Paper or electronic capability statements will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-SBSS-17-004/listing.html)
- Record
- SN04335738-W 20161125/161123234042-4ae2685fb32ff127f197991524770878 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |