SOURCES SOUGHT
A -- Inner City Asthma Consortium: Statistical and Clinical Coordinating Center (ICAC-SACCC)
- Notice Date
- 11/4/2009
- 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 Institute of Allergy and Infectious Diseases, Office of Acquisitions, 6700 B Rockledge Room 3214 MSC7612, Bethesda, Maryland, 20892-7612
- ZIP Code
- 20892-7612
- Solicitation Number
- HHS-NIH-NIAID(AI)-SBSS-09-081
- Point of Contact
- Brandon de White, Phone: 301-451-3687, Donald E Collie, Phone: 301-496-0992
- E-Mail Address
-
whitebra@niaid.nih.gov, dcollie@niaid.nih.gov
(whitebra@niaid.nih.gov, dcollie@niaid.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 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. Background The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The causes, pathogenesis, diagnosis, treatment, and prevention of asthma and allergic diseases are major areas of emphasis for NIAID's Division of Allergy, Immunology, and Transplantation (DAIT). DAIT vigorously pursues research on asthma and allergic diseases by supporting investigator-initiated research projects, cooperative clinical studies, a national network of research centers, and demonstration and education research projects. Purpose and Objectives The Statistical and Clinical Coordinating Center for the Inner City Asthma Consortium (SACCC-ICAC) provides critical services for the design, implementation, oversight (including regulatory support and compliance, safety and clinical site monitoring and reporting, training, and distribution and quality control of study products), and analysis of DAIT-supported asthma clinical studies and associated mechanistic studies being conducted by the Inner City Asthma Consortium. The initial SACCC-ICAC contract was awarded to Rho Federal Systems, Inc. in 2002 (Contract Number N01-AI-25482) and has served to provide a broad range of clinical research support services to the Inner City Asthma Consortium. Under this contract, those services will be continued. Project Requirements Potential sources must demonstrate and document the following in their capability statements: The Contractor shall establish and manage the SACCC-ICAC to provide statistical, clinical, technical, regulatory and administrative support for asthma clinical studies and associated mechanistic studies, including support for the following: (1) statistical design and analysis, including interim and final analyses of study data; (2) data collection, management, quality assurance and reporting; (3) regulatory activities, including compliance with Federal and country-specific regulatory requirements and current Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) guidelines for research involving human subjects; (4) safety oversight and reporting, including support for the activities of independent Data and Safety Monitoring Boards (DSMBs) and other safety oversight structures; (5) clinical site monitoring and training for clinical site personnel; (6) preparation of study products; (7) distribution and quality control of study products; and (8) establishment and management of a repository for biological specimens. In addition, technical and administrative support shall be provided for the ICAC Steering Committee, ICAC Implementation Monitoring Committee, and ICAC External Scientific Advisory Group. Anticipated Period of Performance It is anticipated that up to one cost reimbursement completion type contract will be awarded for a period of five years, beginning approximately September 2010. The anticipated annual total effort is approximately 19.0 FTEs per annum. Capability Statement/information sought Capability statements submitted as a result of this announcement should demonstrate the offerors' qualifications and experience, specifically providing evidence as to their capability to perform this requirement, with particular attention to the following: Personnel/Management: adequacy, appropriateness and relevance of expertise, experience, qualifications, and availability of the key professional and technical staff with a project of similar size, scope, and complexity. Past Performance: Past performance is considered essential. In addition to demonstrating that they have met the above qualifications, interested parties must identify at least three other projects of similar size and complexity. Each response should include the following Business Information: • DUNS • Company Name • Company Address. • Company Point of Contact, Phone and Email address • Do you have a Government approved accounting system? If so, please identify the agency that approved the system • Size and Type of Business (e.g., small business, 8(a), woman owned, veteran owned, etc.) pursuant to the applicable NAICS code • All offerors must be register on the Central Contractor Registration (CCR) located at http://www.ccr.gov/index.asp Responses must be submitted not later than November 18, 2009; 3:00 PM, local time. Capability statements will not be returned and will not be accepted after the due date. These statements may be submitted by e-mail or paper copy to Mr. Brandon White, Contract Specialist. He can be e-mailed at the address provided below. Electronic submissions should be submitted in PDF format, however, Microsoft Word will be accepted. In the subject line Reference: HHS-NIH-NIAID(AI)-SBSS-09-081. A paper copy can be sent to the following address: National Institutes of Health National Institute of Allergy and Infectious Diseases Office of Acquisitions ATTN: Brandon White 6700B Rockledge Drive, Room 3214, MSC 7612 Bethesda, Maryland 20892-7612 Email Address: whitebra@niaid.nih.gov Disclaimer and Important Notes 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.
- Web Link
-
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- SN01997953-W 20091106/091104235228-153319b5f6849cb85665c01e14d35ae0 (fbodaily.com)
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