SOURCES SOUGHT
A -- Science Moving TowArds Research Translation and Therapy (SMARTT) - Non-Biologics and Small Molecules Production Facility
- Notice Date
- 5/15/2009
- 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 Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD, Office of Acquisitions, 6701 Rockledge Dr RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902
- ZIP Code
- 20892-7902
- Solicitation Number
- HHS-NIH-NHLBI-SBSS-HV-10-13
- Archive Date
- 6/14/2009
- Point of Contact
- Scott A. Bredow, Phone: 301-435-0333
- E-Mail Address
-
bredowsa@nhlbi.nih.gov
(bredowsa@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Introduction 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 response to this 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 NAICS code 541712 should not submit a response to this notice. Background The NHLBI is seeking a small business with the ability to serve as a non-biologics and small molecules Production Facility (PF) for a new six-year program, Science Moving TowArds Research Translation and Therapy (SMARTT). The purpose of the program is to assist translation to the clinic of novel synthetic, natural, or biologic therapeutic interventions arising in the scientific community for the treatment of heart, lung, and blood diseases. SMARTT will provide resources in the areas of preclinical and clinical-grade production and testing for biologics, non-biologics and small molecules in accordance with Good Manufacturing Practices (GMP), and in the conduct of pharmacology/toxicology studies. In addition, SMARTT will provide regulatory assistance to investigators wishing to conduct early stage clinical trials. SMARTT will consist of: two Production Facilities (PFs) for biologics, and non-biologics and small molecules; a Pharmacology/Toxicology Center (PTC); and a Coordinating Center (CC) that will provide consulting, manufacturing, preclinical study and early phase clinical trial design, administrative and regulatory expertise. The CC will be the monitor and coordinator for organizational and regulatory aspects of the SMARTT program. Project Requirements The non-biologics and small molecules PF will 1) participate in the Steering Committee (SC), and subcommittees as necessary, and attend SC meetings and participate in teleconferences, 2) provide, maintain and update a Manual of Procedures (MOP), 3) develop, in collaboration with the SC and CC, a customer satisfaction survey for investigators to evaluate the quality, acceptability, and timeliness of the product and service provided, 4) develop, in collaboration with the SC and CC, a secure and password protected web site page and maintain and provide updates to the CC as needed, 5) produce scalable clinical and/or research grade non-biologic and small molecule therapeutic products, in accordance with Good Manufacturing Practices (GMP), as defined by the Food and Drug Administration (FDA), and applicable Federal and State regulations, for use by investigators studying a heart, lung or blood topic, 6) prepare and ship products, in accordance with the MOP and Federal and State guidelines, upon completion of GMP production and testing, 7) maintain product-related inventories in a secure and confidential manner, 8) monitor facilities to ensure quality control of product production and accuracy and completeness of production data, and maintain and make available for review, as necessary, records of monitoring activities, and 9) prepare materials for and participate in site visits to the contractor’s facilities and ensure that up-to-date versions of all required certifications, inspections, and assurances are available for review during site visits. Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this study should submit complete documentation of their capabilities to the Contracting Officer. The capabilities statement should include 1) the total number of employees, 2) the professional qualifications of scientists, medical experts, and technical personnel as it relates to the above outlined requirements, 3) a description of general and specific facilities and equipment available, including computer equipment and software, 4) an outline of previous research projects in which the organization and proposed personnel have participated, and 5) any other information considered relevant to this program. The capability statement must not exceed 10 single sided or 5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size standards in accordance with the Small Business Administration. The government requests that no proprietary or confidential business data be submitted in a response to this notice. However, responses that indicate the information therein is proprietary will be properly safeguarded for Government use only. Capability statements must include the name and telephone numbers of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will not be considered. When submitting this information, please reference the solicitation notice number. All capability statements sent in response to this Sources Sought Notice must be submitted electronically (via email) to Scott Bredow, Contracting Officer, at bredowsa@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), within 15 calendar days of the date of this announcement. All responses must be received by the specified due date and time in order to be considered. 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 review of the responses received, pre-solicitation and solicitation notices may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending. The Government intends to negotiate one (1) cost-reimbursement contract for a period of six years with an approximate award date of August 23, 2010. 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-SBSS-HV-10-13/listing.html)
- Place of Performance
- Address: Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions 6701 Rockledge Dr RKL2/6016 MSC 7902, Bethesda, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN01819726-W 20090517/090516161410-6feacceed9e18fb29444859b29c8570d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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