SOLICITATION NOTICE
A -- Cardiovascular Health Study--Core Support
- Notice Date
- 3/10/2011
- Notice Type
- Presolicitation
- 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
- NHLBI-HC-12-11
- Archive Date
- 4/9/2011
- Point of Contact
- Michelle J. Brown, Phone: 3015944588
- E-Mail Address
-
brownj@nhlbi.nih.gov
(brownj@nhlbi.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- The National Heart, Lung, and Blood Institute (NHLBI), NIH intends to negotiate on a non-competitive basis with University of Washington to maintain core coordinating center support for the Cardiovascular Health Study (CHS) (management of data, blood, and MRI repositories; coordination of study operations; tracking of paper and ancillary study proposals and data and materials distribution); provide to NHLBI regularly updated limited access data sets and summary data and descriptive statistics upon request; and provide dedicated analyst and investigator effort to research topic-focused working groups. In addition to coordinating study operations and ensuring confidentiality, the contractor, through the CHS Steering Committee, will provide access to CHS resources and expertise, scientific collaborations with other non-profit and for-profit organizations, and mentorship of early-career investigators. Contract support for the 3.5-year period is expected to be combined with additional funding from investigator-initiated ancillary studies to fully cover coordinating center costs and to conduct scientific investigations. The cited authorities are 41 U.S.C. 253(c)(1), as set forth in FAR 6.302-1 and HHSAR 306-302-1. The proposed period of performance is a one year base with three option periods. The incumbent contractor is uniquely qualified to provide these required services to the NHLBI for this study. Since 1988, the CHS Coordinating Center serves as the repository for the vast CHS data set and provides statistical expertise to support CHS and collaborating investigators in its use. For more than twenty-two years, the coordinating center has acquired a level of familiarity with CHS’s operational methods, study variables, and analytical procedures that are needed for making further scientific development. With strategic management and timely coordination of new data collection efforts in multiple concurrent ancillary studies, and optimal sharing of limited study resources is dependent on continued participation of current contractor staff. The purpose of the Cardiovascular Health Study-Core Support 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 and outcomes 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. 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. 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. 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 to 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. 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. 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. 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. 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. 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. 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. 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. 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 ). Organizations having demonstrated experience in performing the above requirements are invited to submit capability statements. Capability statements must document the following: 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 NIH 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 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. Interested respondents must submit written capability statements demonstrating their ability to perform these services, including senior scientific and analytic staff and facilities. Note: related postings in FBO were referenced as NIH-NHLBI-HV-11-33. Capability statements submitted in response to this notice that do not provide sufficient information for review will not be considered. This is NOT a Request for Proposals (RFP), and responses should NOT include budgetary information. Respondents to this notice shall provide capability statements (original and three copies) no later than 4:00 pm EST on March 25, 2011 to the following address: National Institutes of Health, National Heart, Lung, and Blood Institute, Office of Acquisitions, Rockledge II - Room 6102, 6701 Rockledge Drive - MSC 7902, Bethesda, MD 20892-7902 (use 20817 for express mail), Attention: Michelle Brown, Contract Specialist. Capability statements may also be emailed (as a Word document or PDF): to Michelle Brown at: brownmj@nhlbi.nih.gov. 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. 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NHLBI/NHLBI-HC-12-11/listing.html)
- Place of Performance
- Address: National Heart, Lung, and Blood Institute, Extramural Branch, DERA, OA, Office of Acquisitions, 6701 Rockledge Drive, RKL20/6100 MSC 7902, Bethesda, Maryland, 20892-7902, United States
- Zip Code: 20892-7902
- Zip Code: 20892-7902
- Record
- SN02397680-W 20110312/110310234313-573429c7665c4e6e687dc31972aba7d7 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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