SOURCES SOUGHT
A -- Non-Clinical ADME Studies
- Notice Date
- 8/8/2013
- 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
- HHSN-NIH-NIDA-SBSS-14-007
- Archive Date
- 9/6/2013
- Point of Contact
- Patrick Kenney, Phone: 301.443.6677, Kenneth E Goodling, Phone: (301)443-6677
- E-Mail Address
-
Patrick.Kenney@nih.gov, kg25d@nih.gov
(Patrick.Kenney@nih.gov, kg25d@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a 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 businesses to perform the requirements defined below; (2) whether the capable organizations are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; woman owned small businesses; or small disadvantaged small 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(s), including whether a set-aside in a specific category is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The National Institute on Drug Abuse (NIDA) is seeking capability statements from qualified small businesses to perform nonclinical ADME (Absorption, Distribution, Metabolism, and Execretion) studies to support its medications development program. These nonclinical ADME studies typically include bioavailability and pharmacokinetic studies, mass balance studies, tissue distribution studies, and toxicokinetic analysis of new potential medications. In addition, this project 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 potential medication 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 Food and Drug Administration (FDA) guidance and regulations. NIDA and NIDA sponsored investigators use the data obtained for submissions to the FDA. The reports shall be acceptable in format and substance for submission to the FDA in support of Investigational New Drug (IND) and New Drug Application (NDA) procedures. To handle substances under the Controlled Substances Act of 1970, it is mandatory that the organization possess a Drug Enforcement Agency (DEA) Research Registration for Schedules II to V. Also, organizations must demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. All organizations must comply with the FDA’s Good Laboratory Practices Program. 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 in the area(s) specified above and work in the field of drug abuse; 2) Personnel: Name, professional qualifications and specific experience in the work requested for scientists and/or technical personnel, particularly for those who may be assigned to key positions; and 3) Facilities: Availability and description of facilities and equipment required to conduct the type of work required. 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. Interested organizations must demonstrate and document, in any capability statements submitted, extensive experience with and the ability to perform under these task areas. 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. 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 to provide feedback to respondents with respect to any information submitted. Interested organizations presenting a capability statement must provide the following: 1) company name, address and DUNS number; 2) point of contact, 3) phone/fax/email; 4) NAICS Codes, 5) business size and status; 6) the capability information in response to the requirement and qualification identified in this notice; and 7) small business classification. Please submit written capability statements by August 22, 2013 to the NIDA Contracting Officer.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHSN-NIH-NIDA-SBSS-14-007/listing.html)
- Record
- SN03142315-W 20130810/130808235550-0879e9596b7893a79455387912391a47 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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