SOURCES SOUGHT
A -- Analytical Services Center for Medications Development
- Notice Date
- 10/23/2012
- 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-13-008
- Archive Date
- 11/22/2012
- Point of Contact
- Andrew Hotaling, Phone: 301.443.6677, Kenneth E Goodling, Phone: (301)443-6677
- E-Mail Address
-
hotalingar@mail.nih.gov, kg25d@nih.gov
(hotalingar@mail.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 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) was established in 1974, and in 1992 it became part of the National Institutes of Health, Department of Health and Human Services. NIDA's mission is to "...lead the Nation in bringing the power of science to bear on drug abuse and addiction." NIDA supports over 85 percent of the world's research on the health aspects of drug abuse and addiction. NIDA-supported science addresses the most fundamental and essential questions about drug abuse, ranging from the molecule to managed care, and from DNA to community outreach research. NIDA is currently seeking capability statements from qualified Small Businesses having the capability to act as a centralized laboratory to carry out validated quantitative and/or qualitative assays for a variety of compounds in biological specimens collected from preclinical and clinical studies. The data obtained will be used by NIDA to support the development of new medications for the treatment of drug addiction. The lab must be able to perform the tasks listed below: 1. Quantitative assay for samples collected from metabolic, pharmacokinetic/toxicokinetic studies: The lab must be able to perform quantitative assays for samples collected from preclinical metabolic and pharmacokinetic/toxicokinetic studies, as well as samples collected from all phases of clinical studies. The analytes include, but are not limited to, potential therapeutic compounds and/their metabolites, abused drugs and/their metabolites, concomitant medications/compounds, and endogenous substances (e.g. proteins, enzymes etc). Sample matrices include biological fluids (plasma, urine, saliva, etc) and tissues (liver, brain, hair etc). The analytical lab must be able to develop and validate new assay methods for drugs/metabolites for which established assays do not exist. The analytes may appear in biological matrices at concentrations of low ng/mL or subnanogram/mL and therefore require the use of state of the art analytical methods including gas chromatography-mass spectrometry (GC-MS), high performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS), liquid chromatography-mass Spectrometry-mass spectrometry (LC-MS-MS) and immunoassays. 2. Assay for surrogate outcome measures and/molecular biomarkers (protein, enzymes, etc): The lab must be able to perform assays for surrogate outcome measures and/molecular biomarkers for the assessment of efficacy and safety of study medications in clinical trials. Monitoring of abused drugs in biological fluids serves as a surrogate outcome measure for assessing drug use in clinical trials. The abused drugs include, but are not limited to, cocaine/benzoylecgonine (a cocaine metabolite), methamphetamine, amphetamine, morphine (or morphine-glucuronide), cannabinoids, and benzodiazepines. Automated qualitative/semi-quantitative immunoassays are general used for screening of abused drugs in biological fluids, primarily in urine. Validated quantitative methods using GC-MS or LC-MS are generally required for confirmatory/quantitative assay for samples which showed positive for screening. Immunoassays are generally required for quantitative assay of molecular biomarkers. 3. Sample collection and shipping containers, as well as on-site test devices: The lab is required to supply clinical sites with sample collection and shipping containers, as well as on-site test devices for screening of abused drugs. The methods for quantitative assays must be validated for reproducibility, accuracy, sensitivity, and specificity at the concentration ranges required for the preclinical and clinical studies. Appropriate FDA guidance regarding assay validation must be followed. The assay must be carried out in compliance with pertinent current Good Laboratory Practices regulations. The analytical laboratory must have automated equipment for handling sample preparation and injection as well as computer software for data acquisition and report generation. The lab must have sufficient resources to ensure high throughput of samples. The lab must provide secured facilities appropriate for storing biological samples and analytical data as well as computerized systems for tracking samples. In order to handle substances under the Controlled Substances Act of 1970, it is mandatory that offerors possess a DEA Registration for Chemical Analysis or a DEA Research Registration for Schedules II to V and demonstrate the capability to obtain a DEA registration for Schedule I controlled substances. CAPABILITY STATEMENT/INFORMATION SOUGHT: 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 and work in the field of drug abuse; (2) Personnel: Name, professional qualifications and specific experience of scientists and/or technical personnel who may be assigned as project director and other key positions; (3) Facilities: Availability and description of facilities and equipment required to conduct this type of work. 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 the above tasks. 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. 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 7, 2012 and mailed to the NIDA Contracting Officer at the address below. 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. Any proprietary information should be so marked. Respondents are advised that the Goverment is under no obligation to acknowledge receipt of the information received or to provide feedback to the 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. Contracting Office Address: NIDA R&D Contracts Management Branch 6001 Executive Blvd., Suite 4211 - MSC 9559 Bethesda, MD 20892-9559* *Note: Use Rockville, MD 20852 for Fed-Ex/UPS/Courier Hand-Delivery
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-01/HHS-NIH-NIDA-SBSS-13-008/listing.html)
- Place of Performance
- Address: n/a, United States
- Record
- SN02917758-W 20121025/121023233810-677c7600b89c0888b2275e2978e368a6 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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