SOURCES SOUGHT
A -- Non-Clinical ADME Studies
- Notice Date
- 5/28/2008
- 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, 6101 Executive Boulevard, Room 260 - MSC 8402, Bethesda, Maryland, 20892
- ZIP Code
- 20892
- Solicitation Number
- N01DA-9-8883
- Archive Date
- 3/31/2009
- Point of Contact
- Tonya D Anderson,, Phone: (301) 443-6677, Kenneth E Goodling,, Phone: (301)443-6677
- E-Mail Address
-
tanders@mail.nih.gov, kg25d@nih.gov
- Small Business Set-Aside
- N/A
- Description
- The National Institute on Drug (NIDA) is seeking capability statements from small businesses to perform nonclinical ADME studies to support its medications development program. The nonclinical ADME studies for this requirement typically include in vitro evaluation of permeability, bioavailability and pharmacokinetic studies, mass balance studies, tissue distribution studies, in vitro and in vivo metabolism studies, and toxicokinetics of new medications. In addition, this requirement also involves analytical services which include structure identification of major metabolites by mass spectrometry or nuclear magnetic resonance (NMR), and the development of sensitive and specific assays for a drug and its metabolites in biological matrices using methods such as high performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), liquid chromatography with tandem mass spectrometry (LC/MS/MS), gas chromatograph -mass spectrometry (GC-MS). These studies should be performed in accordance with pertinent FDA guidance and regulations. The data obtained will be used by NIDA and NIDA sponsored investigators for submissions to the FDA in support of INDs and NDAs. In order to handle substances under the Controlled Substances Act of 1970, the organization must possess a DEA Registration for Chemical Analysis or Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. This is a SOURCES SOUGHT NOTICE to determine the availability of small businesses (e.g., 8(a), veteran-owned small businesses, services-disabled veteran owned small businesses, HUB Zone small businesses, small disadvantaged businesses, and women-owned small businesses) having capability to perform the requirement. The established NAICS code is 541712. Information sent 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 drug abuse research. Also, we will consider appropriateness of professional and technical personnel classifications; 3) Facilities: Availability and description of dedicated laboratory space, facilities, and equipment required to conduct this type of work; and 4) Current status of Drug Enforcement Agency (DEA) Research Registration. 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. Organizations should demonstrate capability to administer and coordinate interrelated tasks in an effective and timely manner. Documentation may include, but not be 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. 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. Small business concerns that believe they possess the capability necessary to successfully undertake the work described above should submit an original and two copies of their capability statement which minimally includes 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 SUBMITTED NO LATER THAN JUNE 12, 2008 to NIDA, 6101 Executive Boulevard, Room 260, MSC 8402, Bethesda, MD 20892-8402, Attn: Tonya D. Anderson.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=c5fa71195e120178d5dc1b997233cbfc&tab=core&_cview=1)
- Place of Performance
- Address: Bethesda, Maryland, United States
- Record
- SN01581820-W 20080530/080528220028-c5fa71195e120178d5dc1b997233cbfc (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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