Antihypertensive and Lipid-Lowering to Prevent Heart Attack Trial (ALLHAT)

The Antihypertensive and Lipid-Lowering to Prevent Heart Attack Trial (ALLHAT) Sources Sought Notice 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. The North American Industry Classification System (NAICS) code is 541712 with a business size standard of 500 employees. An organization that is not considered a small business under NAICS code 541712 should not submit a response to this notice. Background The National Heart, Lung, and Blood Institute (NHLBI), National Institute of Health (NIH), is seeking a small business with the ability to develop and implement procedures for the ALLHAT program to 1) enable and foster scientific contributions based on extensive ALLHAT data and other resources and 2) expand collaborations with relevant clinical and scientific communities outside of ALLHAT. To accomplish these objectives, the coordinating center will 1) utilize administrative and data and analytical resources to enable manuscript preparation and development of ancillary studies and 2) confirm and facilitate the governance structure that will provide overall scientific leadership. Project Requirements and Performance Period: May 15, 2011 to May 14, 2016 1. Expand the ALLHAT database (www.allhat.org) as additional data become available from extended passive follow-up (via relevant administrative data bases) and from analyses of frozen sera and genetic material. a. Accumulate and establish appropriate analytic data files. b. Develop and implement procedures for updating analytic data files. c. Submit an Information Systems Security Plan. 2. Work with the ALLHAT Steering Committee, other selected experts, and NHLBI staff in the development of scientific directions to assure optimal contributions. a. Build on to-date publications and explore new areas using data from the randomized phase of the trial and from the passive follow-up. b. Foster activities leading to utilization of the frozen sera specimens and genetic material through collaboration with the ALLHAT central laboratory and the Genetics of Hypertension Associated Treatment (GenHAT) group. c. Involve appropriate consultants as leaders of relevant scientific areas. d. Foster an environment conducive to productive interdisciplinary collaboration, including mentoring early-stage investigators (with special emphasis on physicians and statisticians). e. Develop methods of analysis and presentation of data collected during ALLHAT, including analysis resulting from the collection of frozen sera and genetic material and passive data collected during the follow-on. 3. Working with the Steering Committee and NHLBI, promote awareness to research and clinical communities ALLHAT scientific and administrative resources. 4. Work with Steering Committee and NHLBI to disseminate emerging ALLHAT and GenHAT results to clinical and lay communities, including publications in peer reviewed journals and presentations at major scientific meetings and other relevant venues, as appropriate, and with strong emphasis on clinical implications; develop a data sharing plan. 5. Provide administrative leadership and coordination to the ALLHAT organization, including GenHAT and other ancillary studies as appropriate. a. In collaboration with the NHLBI and under the leadership of the Steering Committee establish organizational structure optimal for and conducive to scientific progress, interdisciplinary collaboration and outreach to relevant communities, including relevant professional organizations. b. In collaboration with the NHLBI and under the leadership of the Steering Committee implement policies and procedures, including those for collaboration on manuscripts, request for interim limited access data sets and provision of data not available through the NHLBI Limited Access Database process. c. In collaboration with Steering Committee and NHLBI identify, organize, coordinate, and engage appropriate consultants and leaders of cutting edge science to serve as members of working groups. 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 Contract Specialist. Documentation of technical expertise and capability must be presented in sufficient detail for the Government to determine that your organization possesses the necessary functional area expertise and experience to compete for this acquisition. Additionally, the capability 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 that are similar to the ALLHAT project requirements 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 15 single sided or 7.5 double sided pages in length and using a 12-point font size minimum. Interested small business organizations are required to identify their size (i.e., 8(a), HUBZONE, WOSB, Veteran Owned, Small Disadvantaged Business, Service Disabled Veteran Owned, etc.), 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, address, e-mail, telephone number, and 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 be considered non-responsive. 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 Alice Sobsey, Contract Specialist, at sobseyam@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. Responses to this notice will not be considered adequate responses to a solicitation. The solicitation release date is pending.