SOURCES SOUGHT
A -- Cardiovascular Health Study
- Notice Date
- 1/11/2011
- 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-RDSS-HV-11-33
- Archive Date
- 1/27/2011
- Point of Contact
- Michelle J. Brown, Phone: (301) 594-4588
- E-Mail Address
-
brownj@nhlbi.nih.gov
(brownj@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Background The National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), plans to renew the Cardiovascular Health Study – Core Support contract to maintain the Cardiovascular Health Study (CHS) organization and resources for ongoing and future epidemiologic research in cardiovascular disease and other relevant topics in older adults. The CHS is a multi-center longitudinal study of risk factors for development and progression of cardiovascular disease and stroke in men and women ages 65 and older (see www.chs-nhlbi.org). Previous NHLBI contracts supported collection of data, blood and urine samples, and DNA from 5,888 CHS participants at four field centers during 10 annual examinations during the period 1989-1999 and semi-annual phone calls through May 2005. A transition phase contract awarded in 2005 and renewed in 2008 has provided support for core study functions, while investigator-initiated grants and other sources that fund CHS research projects provide the balance of support. Of CHS’ more than 175 total such ancillary studies, led by a broad range of investigators and institutions, approximately 35 are currently active. These research projects expand the CHS enterprise by submitting periodic updates of cohort members’ vital status, validated clinical events of interest, and other newly collected data for incorporation into the main CHS data set maintained by the core support contract. Results from these ancillary studies are disseminated in accordance with CHS policies via presentations at scientific conferences and publications in peer-reviewed scientific journals. To date, more than 700 CHS papers have been published. A small business sources sought announcement was previously issued for this requirement to assess the capability of small businesses to meet the project requirements for this acquisition. If the findings from that announcement indicate that two or more small businesses are found capable of performing this requirement, it will be set-aside for small business. Purpose and Objectives The goal of the proposed project is to maximize scientific yield from NHLBI’s past investment in this highly productive study. The specific objectives are to facilitate continued access to study resources and expertise by investigators new to CHS; promote ongoing and future scientific productivity, collaboration, and mentorship of junior investigators; provide direction and analytic support to existing CHS working groups; and facilitate establishment of a new health services research working group. Project Requirements 1. Serve as the repository for CHS data. a. Develop and maintain appropriate analytic data files. b. Develop and implement procedures for updating analytic data files. c. Ensure proper storage of approximately 3,300 previously collected brain MRI scans to ensure their integrity and availability for transfer of copies to qualified researchers. d. Integrate into the database additional data provided from ancillary studies collected through new cohort participant contacts and/or analyses of previously collected images, recordings, and biospecimens including blood, urine, and DNA. e. Develop and implement procedures to ensure that ancillary study investigators provide newly collected data to the study in accordance with the CHS Ancillary Study Policy (http://www.chs-nhlbi.org/AncillaryS.htm) and the NHLBI Policy for Dataset Preparation (https://biolincc.nhlbi.nih.gov/new_data_set_policy/). f. Maintain confidentiality and security of all electronic study data, including personal identifiers, protected health information (PHI), and Medicare-CHS linked data. Maintain secure storage of hard copies of medical records. g. Distribute analytic data sets to researchers with approved CHS paper proposals as described in the CHS Publications Protocol (see http://www.chs-nhlbi.org/Publications.htm). Provide data user support such as CHS study procedures and designated staff to respond to inquiries about data or ancillary studies, enhanced data documentation. h. Obtain annual updates of Medicare data for CHS cohort members; process and merge the data with the CHS data set to create linked analytic files for research purposes. Distribute linked data files to qualified researchers in accordance with the CHS Publications Protocol and CMS data sharing policies. i. Provide individual level data to the NHLBI as requested, including de-identified data sets prepared according to the NHLBI Policy for Dataset Preparation. 2. Maintain the CHS biospecimens repository. a. Ensure proper storage of previously collected CHS biospecimens, including approximately 330,000 vials of blood and DNA and 11,000 tubes of urine, to ensure their integrity and availability for assays or transfer to approved investigators. b. Provide periodic updates of the repository inventory. 3. Maintain and update as needed a public website with downloadable files including but not limited to study manuals, protocols, publications lists, manuscript proposals, and CHS personnel directory, to permit CHS investigators and investigators outside CHS, following appropriate procedures, to participate in data analysis and publication and to propose ancillary studies. 4. Maintain a password-protected internal website accessible by CHS investigators with information to facilitate study operations, including but not limited to a study calendar, meeting reports and minutes, manuscript proposals, and IRB approval documents. 5. Provide administrative leadership and coordination of the CHS organization. a. In collaboration with the NHLBI, maintain and support the existing Steering Committee structure and function including representation from the NHLBI Program Office, the CHS Contractor, the former CHS Field Centers, and other relevant entities. b. In collaboration with the NHLBI and under the leadership of the CHS Steering Committee, maintain and support a CHS governance structure optimal for scientific progress, including mechanisms for internal expert reviews of ancillary study and manuscript proposals and draft manuscripts. c. Coordinate, arrange, participate in, and provide any information necessary for regular study meetings and conference calls for the Steering Committee, subcommittees, and working groups, as well as other necessary study meetings and calls. Prepare and distribute minutes of Steering Committee meetings and calls. d. Prepare and distribute to the Steering Committee an annual report on the study status and accomplishments including: update summaries of data collected from ancillary studies and provided to the core support contract, publications, ancillary studies, biospecimen repository status, activities of the CHS working groups, and other information of relevance to study conduct and performance. 6. In collaboration with the CHS Steering Committee, foster research activities to support continued utilization of CHS resources by both CHS investigators and interested researchers new to CHS, and to promote engagement and mentorship of junior investigators. a. Coordinate and participate in scientific activities across various disciplines, including but not limited to cardiovascular disease epidemiology, genetic epidemiology, clinical cardiology, aging, and other relevant fields. Generate paper proposals and ancillary study proposals, and participate in manuscript development. b. Retain established researchers with expertise in relevant fields to serve as scientific working group leaders and mentors of junior investigators in established scientific working groups, described at http://www.chs-nhlbi.org/WorkingGroups.htm. c. Create and support a new cardiovascular health outcomes and comparative effectiveness research working group, led by an established researcher with relevant expertise that will utilize the CHS-Medicare linked data. d. Provide statistical oversight, support, and programming for the working groups; conduct official analyses and data verification for collaborative studies and studies involving for-profit entities. e. Develop and implement plans to publicize the availability of the CHS resources and the ancillary study mechanism to encourage investigators from outside CHS to collaborate with CHS on scientific investigations using CHS resources. f. Provide scientific guidance to researchers on use of CHS data, including information about the design, collected and derived variables, appropriate analytic approaches, and research gaps; collaborate on ancillary studies and manuscripts. 7. Develop and implement a business plan that augments contract funding with non-contract support for the CHS enterprise through active and future ancillary studies and other potential funding sources (see http://www.chs-nhlbi.org/FundingAS.htm). Anticipated Period of Performance A fixed price contract is anticipated with a period of performance of four years Capability Statement NHLBI is interested in soliciting capability statements from all qualified Offerors demonstrating their ability to perform this research effort. At a minimum prospective Offerors must document capabilities in the following areas. 1. Demonstrate experience and current capability of the organization and proposed personnel in coordination of large, longitudinal collaborative epidemiologic research projects. Describe professional qualifications of scientific staff and available expertise in cardiovascular disease epidemiology, genetic epidemiology, clinical cardiology, aging, and other fields relevant to the CHS Working Groups and the project in general. Describe professional qualifications of biostatistical experts as well as technical and administrative personnel as they relate to the above project requirements. 2. Demonstrate capacity for scientific and financial coordination of multiple concurrent independently funded ancillary studies and collaborative research projects. Demonstrate familiarity with the grants process and the capacity for cost sharing with other funding sources to sustain the CHS enterprise, such as grants from NIH, non-federal sources (for example, professional organizations and unrestricted grants from companies) and fee for service charges to researchers related to use of CHS data and samples. 3. Demonstrate experience and current capability in managing large, complex epidemiologic research databases. Demonstrate knowledge of epidemiologic research methods and statistical analysis of epidemiologic data, including genetic data. Demonstrate capacity to process, maintain, and analyze Medicare claims data linked to study participant data. Demonstrate availability of sufficient computer systems and personnel, including computer programmers and data managers, to support the current and expanding database. 4. Demonstrate capacity for rapid familiarization with regulatory issues related to data collection and data sharing, including human subjects research, informed consent, HIPAA requirements, NIH data sharing policies, and CMS policies on acquisition and use of Medicare claims data. 5. Demonstrate capacity for rapid familiarization with CHS data elements, collection, policies, and major ancillary and collaborative studies. 6. Document availability of facilities for storing and retrieving medical data accurately and efficiently; blood and/or tissue specimen handling, storage, and transfer; and MRI image storage and availability for transfer. Describe capacity for ensuring security of study data, including PHI. 7. Demonstrate capacity to become quickly operational on project requirements to maintain ongoing CHS activities without interruption. 8. Demonstrate capacity to develop and maintain a public website with downloadable files including information about the study, research resources (data and biological specimens) available to approved investigators, and study policies and procedures. Demonstrate capacity to develop and maintain a password-protected internal website to facilitate study operations, accessible by study investigators, including but not limited to a study calendar, meeting reports and minutes, manuscript proposals, and IRB documents. Organizations having demonstrated experience in performing the above requirements are invited to submit capability statements 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 CHS 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. Please identify your size classification relative to North American Industry Classification System (NAICS) code of 541712 for this requirement. If you are a Small Business, include a statement whether or not you are a small business; HUBZone small business; service-disabled, veteran-owned small businesses; 8(a) small business; women-owned small business; or small disadvantaged business in order to assist the government in determining the appropriate acquisition method, including whether a set-aside is possible. 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. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). 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 Michelle Brown, Contract Specialist, at brownmj@nhlbi.nih.gov in either MS Word or Adobe Portable Document Format (PDF), 508 compliant, and 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. 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/NHLBI/HHS-NIH-NHLBI-RDSS-HV-11-33/listing.html)
- Place of Performance
- Address: National Heart, Lung, and Blood Institute, NIH, DHHS, Office of Acquisitions, DERA, 6701 Rockledge Drive, RKL2/6100 MSC 7902, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN02358217-W 20110113/110111234333-fab8a98b49a417776200c443d1be0d6e (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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