SOURCES SOUGHT
A -- Clinical Monitoring - Statement of Work
- Notice Date
- 7/20/2016
- 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 & Infectious Diseases/AMOB, 5601 Fishers Lane, 3rd Floor MSC 9822, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- NIHAO2016051
- Archive Date
- 8/18/2016
- Point of Contact
- Sharee Richardson, Phone: 240-669-5116
- E-Mail Address
-
sharee.richardson@nih.gov
(sharee.richardson@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Clinical Monitoring Sources Sought Notice Information General Clinical Research Support Services NIHAO2016050 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 541712 should not submit a response to this notice. For your information we have attached the Statement of Work (SOW). Background and Introduction: The Vaccine Research Center (VRC) at the National Institutes of Health (NIH) was established to facilitate research in vaccine development. The VRC is dedicated to improving global human health through the rigorous pursuit of effective vaccines for human diseases including HIV, agents with bioterrorism potential, emerging infectious diseases (such as Zika Virus) and re-emerging infectious diseases (such as pandemic influenza and Ebola). The VRC is dedicated to translating the latest concepts in disease pathogenesis and immunology into new vaccine strategies, providing safe and effective means to prevent and control human diseases. Purpose and Objectives: To support the VRC services under this initiative will allow the Clinical Trials Program (CTP) to support basic and translational research in the VRC via clinical research activities. The VRC CTP will implement human clinical research trials with current collaborators; accessing sites with experienced principle investigators and study coordinators. New collaborations developed with scientists and sites with expertise in specific areas would be valuable to accelerate vaccine development and testing. Collaborations will allow the VRC CTP to expedite activities related to site activation, site management and regulatory requirements. The VRC operates the NIAID Vaccine Immune T-Cell and Antibody Laboratory (NVITAL) which provides state-of-the-art immunogenicity testing, critically important for evaluation of clinical research specimens. This initiative would provide NVITAL with the opportunity to increase capacity to perform immunologic assays for immunologic testing of candidate vaccines for emerging and re-emerging infectious diseases and threats. Furthermore, it would facilitate a uniform way to coordinate the transport and receipt of viable research samples from sites/collaborators. This solicitation will allow the CTP/VRP, as well as other components of the NIH, to support translational and clinical research at the VRC via clinical research activities. These clinical research activities are directed by the CTP/VRP in conjunction with continuing and new biomedical scientific collaborators. These collaborators with expertise in specific areas are valuable in accelerating vaccine development and testing. The contractor will facilitate these collaborations through clinical trial site activation, clinical trial site management, and federal and international regulatory requirements. Project requirements: Services for this requirement are to provide support for the Vaccine Research Center's Clinical Trials Program's clinical research efforts. This requirement will coordinate clinical activities and complete all necessary clinical trial activities to support the VRC's clinical research efforts and enable the VRC to rapidly establish collaborations with academic institutions and health research organizations in response to the urgent research demands of global importance. This IDIQ will be administered and used primarily to support VRC initiatives. However, other NIH programs may initiate Task Orders under this IDIQ as necessary to help accomplish their mission. Anticipated period of performance: It is anticipated that one (1) Cost Reimbursement Contract will be awarded. The period of performance will be for five (7) years. Capability statement / information sought: Capability statements must specify the offeror's business size and type, and demonstrate similar work that has been performed in the past and the dollar value of that work. Capability statements should also clearly demonstrate the offeror's ability to fully meet the technical and personnel requirements specified above and in the attached SOW. Note that this is not a request for proposals. This notice is for small business respondents only. As such, capability statements should also include documentation indicating that offerors business size meets current standards as determined by the Small Business Administration's Table of Size Standards located at: (https://www.sba.gov/content/small-business-size-standards) for NAICS 541712. Prospective offerors may also note whether they meet any other socio-economic business categories such as 8(a), Hub-Zone, or Service Disabled Veteran when submitting their capability statement. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 5 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Request for Information notice must be submitted electronically (via e-mail) to Sharee Richardson, Contract Specialist, at sharee.richardson@nih.gov in MS Word or Adobe Portable Document Format (PDF). Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00PM (Eastern Prevailing Time) on August 3, 2016. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. 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(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/AMOB/NIHAO2016051/listing.html)
- Place of Performance
- Address: Bethesda, MD, United States
- Record
- SN04188980-W 20160722/160720234319-366f8a1897e58b64334a8735b576bbc7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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