SOURCES SOUGHT
A -- Women’s Health Initiative Clinical Coordinating Center (CCC)
- Notice Date
- 10/17/2014
- 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
- NHLBI-CSB-WH-2016-02-CM
- Point of Contact
- Cornelius Moore, Phone: (301) 435-0343, Iris Merscher, Phone: 301-435-0365
- E-Mail Address
-
mooreco@nhlbi.nih.gov, iris.merscher@nih.gov
(mooreco@nhlbi.nih.gov, iris.merscher@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. I. BACKGROUND: The National Heart, Lung, and Blood Institute (NHLBI) provides global leadership for a research, training, and education program to promote the prevention and treatment of heart, lung, and blood diseases and enhance the health of all individuals. The Institute collaborates with patients, families, health care professionals, scientists, professional societies, patient advocacy groups, community organizations, and the media to promote the application of research results and leverage resources to address public health needs. The NHLBI, Extramural Research Program, Division of Cardiovascular Sciences (DCVS), Women's Health Initiative Branch (WHI) supports clinical trials and observational studies to improve understanding of the causes and prevention of major diseases affecting the health of women. Current studies focus on cardiovascular disease, cancer, and fractures, in collaboration with NCI, NIAMS, NIA, NINDS, and ORWH. The large multi-center observational epidemiology studies seek to identify risk markers for disease or better quantify known markers using questionnaire, clinical examination, and laboratory data. The large and long-term multi-center clinical trials test promising but unproven interventions such as hormone therapy, diet, and supplements to prevent major diseases and evaluate overall effects on health. The Branch has established an infrastructure to support the utilization of data and blood samples from the studies by the scientific community. II. Purpose and Objectives The proposed acquisition is a renewal of a requirement that supports the Women's Health Initiative (WHI) core operations and the follow up of clinical events. The objectives are to: • expand knowledge about the determinants of cardiovascular disease in older women (and conversely determinants of successful aging with absence of cardiovascular disease) • expand the study as a scientific resource for the research community • mentor young investigators • facilitate a new generation of large simple prevention trials The current structure consistent of a Coordinating Center, four Regional Centers, and committee/scientific interest groups shall be maintained. Coordinating Center Core Functions: These functions relate to maintaining and updating the data and biologic specimens as well, as the continuing follow-up of outcomes in ~85,000 participants. Core functions include: • coordinate this large and complex study; maintain investigator, public, and study participant websites and documentation/data resources; • make data and biologic specimens available to the research community; • provide data and analytic support for paper proposals approved by the Publications and Presentations Committee; • provide data and basic support for proposed ancillary studies and consortium studies; deposit curated data into BioLINCC and dbGAP at the required intervals; • update study files with clinical outcome, laboratory, and ancillary study data; provide support for administrative functions such as committee meetings and conference calls; • provide annual study updates to Steering Committee, NHLBI, and OSMB. Regional Center Functions: (not object of this requirement but described here for informational purposes): Participant follow-up and events adjudication. The functions of the Regional Centers are: • Continue outcomes documentation and adjudication in the Medical Records Cohort. Though the number of women followed decreases over time, numbers of outcomes remain high because of increased rates. These outcomes in aging women are critical to realizing the primary objective of the current renewal, i.e. the study of CVD related to aging. These and other adjudicated outcomes will continue to support any clinical trials funded during the current period, as well as any future trials, and in addition they anchor CMS and self-reported outcomes. • Continue collecting self-reported outcomes in the Self-Report Cohort. Self-reported outcomes are necessary to inform planning and conduct (including further documentation/adjudication of outcomes as needed) of ancillary studies and clinical trials. • Continue collecting data on activities of daily living and quality of life which are intrinsic to study goals. • Maintain optimal retention through mail contact and phone calls as needed to follow up on outcomes. • Continue mentoring young investigators though the Regional Centers. • Continue recruiting non-WHI investigators to collaborate or to analyze the data themselves. In the majority of cases WHI data are now being analyzed by the investigators themselves. If the Government chooses to exercise each Option period, the Contractor shall perform study activities in accordance with the protocol and manual of operating procedures. III. Project/Contractor Requirements: A. STUDY COORDINATION ACTIVITIES 1. Maintain a high level of cooperation and coordination with WHI Investigators and the NHLBI Project and Contracts Offices 2. Provide a Manual of Operating Procedures to accomplish the goals of the WHI contract period; distribute to WHI Regional Centers and Project Office 3. Provide central adjudication and limited outcomes liaison staff to assist the WHI Regional Centers in outcomes ascertainment; monitor Regional Center performance in outcomes ascertainment 4. Coordinate and support investigator effort for active participation in study management, scientific investigations, and writing groups. 5. Coordinate, participate in, and provide any information necessary for study committee conference calls and meetings, including minutes and other correspondence as needed B. TRAINING ACTIVITIES 1. Train WHI Regional Center staff as necessary in data collection, entry, and management, and outcomes ascertainment procedures. C. DATA COLLECTION ACTIVITIES 1. Retain study participants over the life of the contract. Revise current data collection forms as necessary; print and distribute forms. 2. Develop data collection and management procedures. 3. Conduct follow-up mailings of data collection forms for outcomes ascertainment and selected exposures to participants enrolled in the WHI Extension. 4. Search the National Death Index annually to locate matches for WHI participants. Obtain death certificates as appropriate. Obtain CMS data on WHI participants at regular intervals; merge with WHI database. D. DATA MANAGEMENT ACTIVITIES 1. Maintain WHI database including quality assurance and quality control procedures. Maintain confidentiality and security of data. Provide expertise necessary to integrate data from outside the WHI (e.g. CMS) into the WHI database. 2. Maintain and update as needed the WHI web-based data entry and management system, including quality control procedures. All web applications must comply with section 508, see http://www.section508.gov/. 3. Develop/update an information systems security plan in accordance with Table 3 of the Federal Information Security Safeguard Requirements Summary at http://irm.cit.nih.gov/security/table3.htm. 4. Coordinate the purchase and support the installation of any hardware and software needed to acquire and transmit data according to manual of operating procedures. 5. Collect, edit, store, analyze and report on data from the WHI Regional Centers in accordance with the protocol and manual of operating procedures. 6. Prepare NHLBI Data Repository datasets in accordance with the NHLBI Limited Access Data Clause and the NHLBI Policy for Distribution of Data. E. BIOMEDICAL ACTIVITIES 1. Maintain the WHI biologic specimen resource in accordance with the protocol and manual of operating procedures. 2. Track inventory of available specimens. 3. Provide specimens to investigators in accordance with study policies/procedures for access to specimens. 4. Oversee analyses of biologic specimens to test specific hypotheses as required by the protocol and manual of operating procedures. 5. Conduct feasibility and quality assurance studies as needed, maintain pooled reference samples. F. REPORTING ACTIVITIES 1. Analyze the relative frequencies of outcomes of interest across treatment groups and report the data annually for the Observational Studies Monitoring Board (OSMB), or as requested by the Project Officer. 2. Prepare and distribute interim Regional Center performance reports. 3. Prepare and distribute annual study progress reports. G. SCIENTIFIC ACTIVITIES 1. Provide scientific & operational expertise to support WHI investigators and non-WHI scientists in preparing to use the WHI resources, including the WHI database and biologic specimens, including maintenance of WHIScience.org. All web applications must comply with section 508, see http://www.section508.gov/. 2. In collaboration with WHI and other ancillary study investigators, generate hypotheses and design approaches to testing hypotheses that complement WHI study results. Generate paper proposals; participate in manuscript development. 3. Participate in evaluation of proposals for manuscripts and ancillary studies. 4. As required, provide effort and resources for contractually-funded ancillary studies. 5. Conduct pilot laboratory studies, as needed. The Contractor shall initiate this work only after approval from the appropriate study committees and when so directed by a written Work Assignment from an NHLBI contracting officer. 6. Submit plan for coordination of and participate in scientific activities across various disciplines, including but not limited to cardiovascular, cancer, aging, health services research, and genetics. Propose methods of engaging scientific expertise not available among WHI investigators. Note: most scientific activities are expected to be WHI-wide collaborations. 7. Propose estimated numbers of WHI-approved publications and ancillary studies each year. IV. Anticipated Period of Performance If the government decides to exercise each option period, the ultimate contract period of performance will be April 1, 2016 through March 30, 2021. The anticipated period of performance of any resultant contract from this potential requirement shall begin on or around April 1, 2016 through March 30, 2017, and include an option to exercise up to four (4) additional one year optional periods of performance. V. Capability Statement/Information Sought Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: 1. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts. 2. Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information. 3. The respondents' DUNS number, organization name, address, point of contact, and size and type of business must be listed on their capability statement. 4. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition. 5. The capability statement shall not exceed 10 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins. 6. All proprietary information should be marked as such. Statements should also include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner. VI. Closing Statement: The capability statement should be submitted electronically (via email) to Iris Merscher, Contract Specialist, at iris.merscher@nih.gov, on November 3, 2014, 8:00 A.M., EASTERN TIME and must reference synopsis number NHLBI-CSB-WH-2016-02-CM. All responses must be received by the specified due date and time in order to be considered. This Sources Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this notice, the NHLBI may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. "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)."
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