SOURCES SOUGHT
A -- The Atherosclerosis Risk in Communities (ARIC) Study – Coordinating Center
- Notice Date
- 6/3/2015
- 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-17-02
- Archive Date
- 7/3/2015
- Point of Contact
- Tara C Knox, Phone: 301-402-0834, Scott A Bredow, Phone: (301) 435-0333
- E-Mail Address
-
knoxt@mail.nih.gov, bredows@mail.nih.gov
(knoxt@mail.nih.gov, bredows@mail.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 NAICS code 541712 should not submit a response to this notice. Background The National Heart, Lung, and Blood Institute (NHLBI) is seeking a small business with the ability to serve as the Coordinating Center (CC) for a five-year renewal of the NHLBI Atherosclerosis Risk in Communities (ARIC) Study. The ARIC Study is a study of the correlates, predictors, and progression of subclinical to clinical cardiovascular disease (CVD) in a biracial population-based sample of men and women who were aged 45-64 years at inception of the study (https://www2.cscc.unc.edu/aric/ ). Fifteen thousand, seven hundred ninety-two (15,792) black and white participants were recruited from four (4) Field Centers during 1987-1989 (Forsyth County, NC; Jackson, MS; suburbs of Minneapolis, MN; and Washington County, MD). The goal of this acquisition is to maximize use of data and samples amassed in ARIC over 29 years to address new questions about the development and progression of clinical cardiovascular disease (CVD) and related conditions. The scientific objectives are to (1) enhance statistical power to perform analyses of predictors of clinical events, particularly in informative subgroups; (2) study the progression of subclinical to clinical CVD; (3) identify new risk factors or interactions among factors that inform disease pathophysiology; and (4) evaluate the feasibility and validity of surveillance for myocardial infarction (MI) and heart failure (HF) using electronic health record (EHR) technology. The operational goals are to (1) support continued cohort follow-up and data collection on clinical events; (2) continue to foster scientific collaborations; (3) support conduct of a limited clinical examination of the ARIC participants as a platform for ancillary study examination components. Project Requirements The important overall technical requirements associated with the Atherosclerosis Risk in Communities (ARIC) Study - Coordinating Center include the following: • Provide appropriate senior personnel with expertise in cardiovascular disease epidemiology, clinical cardiovascular disease, longitudinal studies management, biostatistics, bioinformatics, medical informatics, EHR systems, human genetics, genomics, administrative and biorepository management. • Develop and maintain a web-based data collection system for and provide other services as necessary to enable regular follow-up contacts of participants by field centers. The computer systems and software shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards • Develop and maintain a web-based data collection system for and provide other services as necessary to enable abstraction of data from medical records, death certificates, and other relevant materials; and conduct expert review and classification thereof. The computer systems and software shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards • Develop and maintain a public and private web site for the ARIC program. The public website designed under this contract shall meet the requirements of Section 508 of the Rehabilitation Act. More information is available on the Web at: http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards • Support a re-examination of ARIC participants, including developing and maintain a data collection system for Visit 6. • Design and implement appropriate quality assurance and quality control programs. • Perform administrative, operational, and technical duties to support productive collaboration among the study personnel at all ARIC centers, outside researchers collaborating with ARIC, and the NHLBI Project Office. • Establish and maintain study databases, including updating the databases with data from newly ascertained events and ancillary studies both for internal use and for posting on BioLINCC (https://biolincc.nhlbi.nih.gov) and other NIH databases, such as dbGaP (http://www.ncbi.nlm.nih.gov/gap), as appropriate. • Establish and manage a biological specimen repository. • Conduct a feasibility and calibration study of community surveillance for MI and HF using digitally transmitted data from Electronic Health Record (EHR) systems of the hospitals in the ARIC study catchment areas. The study will assess the feasibility of obtaining the EHR data from community hospitals and determine how to access the numeric and text digital data and will be followed by a calibration study comparing incidence estimates from data from the traditional ARIC data collection process for MI and HF and with estimates from data obtained via digital transmission of EHR for MI and HF. • Coordinate and participate collaboratively in study committees to provide a transparent committee process, open access to study documents, clear policies for access to data and materials, and an approval process for proposed manuscripts and ancillary studies that is fair and balanced. • Arrange for and manage annual meetings of an NHLBI-appointed Observational Studies Monitoring Board (OSMB) as directed by the NHLBI Project Office. • Conduct statistical analyses and prepare scientific publications and presentations. • Perform activities related to study closeout as directed by the NHLBI Project Office. • Work cooperatively with all study investigators and staff, the NHLBI Project Office, and any subcontractors and consultants in all relevant aspects of the study. • Prepare final limited access data sets. The data sets shall include data with full documentation, prepared in accordance with NHLBI policies available at: http://www.nhlbi.nih.gov/research/funding/human-subjects/set-preparation-guidelines.htm. • Plan for a smooth and seamless transition of Coordinating Center's responsibilities from the existing Coordinating Center Contractor, if necessary, including o obtaining IRB approval with appropriate consideration for conditions that have been established and existing in the previous contract (including informed consent conditions agreed to by the participants, and existing IRB approved conditions at the original Field Centers); o transition of all data and biospecimens from the existing Contractor, including plans for confidentiality and security of all data as necessary; o transition of all existing protocols, documents, minutes, and reports from the current Contractor as necessary; and o transition of the internal and public use web sites. Anticipated Period of Performance November 15, 2016 - November 14, 2021 Capability Statement Small business concerns that believe they possess the capabilities necessary to undertake this work should submit complete documentation of their capabilities to the Contracting Officer. Firms must be able to meet the Mandatory Qualification Criterion to provide evidence that they can serve as a Research Coordinating Center (RCC) for a multi-center epidemiology study, with expertise in conducting scientific research, including but not limited to, developing research questions and hypotheses and conducting statistical analyses of longitudinal data from epidemiologic cohort studies. The capabilities statement must specifically address each project requirement separately. 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 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. Capability statements must provide evidence of ability to perform and experience in performing the tasks described above and will be reviewed based on the following: (1) the professional qualifications of scientific and technical personnel in accordance with the above requirements; (2) demonstrated capacity of individuals, administrative structure, and the institutional support to perform the functions of a multi-functional center for a collaborative epidemiology study, including protocol development, operational and scientific coordination, information processing, maintenance of a well curated repository of data and biospecimens; implementation of a system to ensure appropriate data sharing and biospecimen sharing; (3) facilities and equipment available to perform the required tasks; (4) evidence of the ability to assess and monitor quality control for data acquisition; (5) evidence of ability to analyze data from longitudinal epidemiologic studies and publish results in peer reviewed journals, and a proven track record of collaboration with other research programs; (6) demonstrated ability to effectively manage both administrative and financial aspects of a contract to promote and support an integrated data collection effort; (7) the small business status of the firm under NAICS Code 541712. Evaluation of the capability statements shall be based on the technical capabilities listed above. Each technical point (criterion) will be weighted equally. 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 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 Tara Knox, Contracting Officer, (email: Tara.Knox@nih.gov) and Scott Bredow, Contracting Officer (email: Scott.Bredow@nih.gov) in either MS Word or Adobe Portable Document Format (PDF), by 04:00 pm EST on the fifteenth (15th) calendar day from the date of this announcement to the address shown above. All responses must be received by the specified due date and time in order to 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 the response. No proprietary, classified, confidential, or sensitive information should be included in your 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 Indefinite Quantity Indefinite Delivery (IDIQ) contract, for a period of five years with an approximate award date of November 15, 2016. 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).
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