SOURCES SOUGHT
A -- Pharmcokinetic/Pharmacodynamic Studies of Medications for Substance Abuse Treatment
- Notice Date
- 11/3/2011
- 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 4211 - MSC 9559, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SBSS-12-002
- Archive Date
- 12/3/2011
- Point of Contact
- Joseph A. TamLung, Phone: 3014436677, Kenneth E Goodling, Phone: (301)443-6677
- E-Mail Address
-
tamlungja@mail.nih.gov, kg25d@nih.gov
(tamlungja@mail.nih.gov, kg25d@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested 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. PROJECT REQUIREMENTS: The National Institute on Drug Abuse (NIDA) is seeking capability statements from small businesses having the ability to carry out clinical studies to determine the pharmacokinetics (PK) and pharmacodynamics (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's guidelines/guidance shall be followed. MANDATORY REQUIREMENTS: In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that the successful contractor possess a 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 OHRP-approved assurance of compliance with HHS regulations (45 CFR 46.103) for the protection of human subjects and must have a board certified physician on the project. CAPABILITY STATEMENT/INFORMATION SOUGHT: The established NAICS code is 541712. Information submitted should be relevant and specific in the technical area under consideration, 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 and 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. Also, we will consider appropriateness of professional and technical personnel classifications; any other specific and relevant information about this particular area of procurement that would improve our consideration and evaluation of the information presented. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but is not limited to, government and commercial contracts the organization performed, references (i.e., names, titles, telephone numbers) and any other information serving to document the organization's capability (e.g., awards, commendations, etc.) All capability statements must provide the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type of small business your organization classifies itself as (i.e.: women-owned, HUBZONE, etc.). Written capability statements must be RECEIVED NO LATER THAN November 18, 2011 and mailed to the Contracting Office Address below, Attn: JOSEPH TAM LUNG. Electronic capability statements will be accepted by the primary point of contact. THIS NOTICE IS NOT A REQUEST FOR PROPOSALS. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Contracting Office Address: NIDA R&D Contracts Management Branch 6001 Executive Blvd Suite 4211, MSC 9559 Bethesda, MD 20892-9559* *Use Rockville, MD 20852 for Fed-Ex/USPS/Courier/Hand-Delivery
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-SBSS-12-002/listing.html)
- Record
- SN02617935-W 20111105/111103234640-908d4f74cb5edebf9f142dbdf633f9d5 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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