small-bus-sources-sought.pdf

Small Business Sources Sought Synopsis Clinical Coordinating Center (CCC) – Women’s Health Initiative (WHI)

Notice Number: 75N98026R00167

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 the applicable NAICS code should NOT submit a response to this notice. The applicable NAICS code for this acquisition is 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) with a size standard of 1,000 employees.

BACKGROUND:

In 1991, Dr. Bernadine Healy obtained funding for the Women’s Health Initiative (WHI) to study the etiology and prevention of major chronic diseases in postmenopausal women. WHI enrolled 68,132 women ages 50–79 in randomized controlled clinical trials and 93,676 women in an observational study (total N=161,808). The randomized trials evaluated postmenopausal hormone therapy, a low-fat dietary pattern, and calcium and vitamin D supplementation, generating findings that substantially changed clinical practice and informed prevention strategies. In particular, findings from the hormone therapy trial contributed to major changes in hormone therapy use and declines in breast and ovarian cancer rates. The estimated societal value of the estrogen-plus-progestin trial over the decade following publication was approximately $200 for every $1 invested by NIH/NHLBI. The observational study has supported a broad range of epidemiologic research and has been particularly valuable in explaining discrepancies between randomized trial and observational findings.

Beginning with the first renewal in 2005, WHI continued long-term follow-up while progressively increasing efficiency and strengthening the cohort as a platform for prevention research and investigator-initiated ancillary studies. Across subsequent renewals, the original 40 clinical centers were streamlined to four regional centers, while outcomes processing was largely centralized at the CCC. Regional centers focus on contacting non-responders, collecting medical records, and contributing to study management, scientific leadership, and mentoring. Since 2010, outcomes adjudication has focused on the sub-cohort of participants in the Medical Records Cohort, while the remaining Self-Report Cohort has been followed through self-report and linkages to the Centers for Medicare and Medicaid Services (CMS) and National Death Index (NDI) data. The Long Life Study (LLS), a subset of the Medical Records Cohort, enrolled 7,875 women ages 63–97 in 2012-13 for in-home assessments of anthropometry, blood pressure, physical function, and biospecimen collection. During the fourth renewal (2021–2028), LLS2 conducted a second in-home examination of 5,905 consenting participants, including women from LLS1, LILAC, and the Medical Records Cohort.

LLS1 and LLS2 data and biospecimens have supported multiple independently funded ancillary studies and provide a valuable foundation for future research.

WHI has continued to demonstrate the value of maintaining a large, deeply phenotyped cohort and established infrastructure for efficient prevention research. A large, simple, low-risk prevention trial embedded within WHI and its follow-up trial recently concluded, while an ongoing observational study is measuring physical activity and physical function. WHI’s established infrastructure enables targeted, rapid enrollment of well-characterized participants and leverages existing procedures, substantially reducing the cost and time required compared with developing a new cohort. The LLS and LLS2 examinations, stored biospecimens, extensive longitudinal data, and ancillary study infrastructure further enhance the cohort’s scientific value. Together, these resources position WHI as a unique national platform for addressing emerging questions in chronic disease prevention, healthy aging, and women’s health during the proposed renewal period.

OBJECTIVES

The overall goal of this proposed WHI renewal is for the study to continue to serve as a resource for innovative epidemiological research. Research will expand knowledge about the determinants of cardiovascular disease among older women, successful aging in the absence of cardiovascular disease, and maintaining quality of life in the presence of cardiovascular disease (resilience).

Critical objectives of this renewal are to enable the WHI Clinical Coordinating Center (CCC) to:

• Ensure the transfer of all WHI participant contact information and any follow-up data collected during the previous contract period from all four regional centers to the CCC in order to close-out clinical event adjudication within the first six months of the contract period.

• Continue core study functions including maintaining, advising, and providing continued access to the extensive repository of core and ancillary study WHI data and biospecimens by qualified researchers, including early career scientists.

• Together with the NHLBI Project Office, collaborate with the All of Us research program to establish synergistic data collection protocols and ancillary studies.

• Maintain the comprehensive biospecimen repositories collected from WHI, its sub-cohorts, and ancillary studies in over the last three decades to serve as a platform for independently funded ancillary studies across a broad range of research disciplines, from basic to translational.

• Ensure all contract- and grant-supported WHI data that is not yet available in BioLINCC, BioData Catalyst (BDC), and dbGaP are transferred together with annual updates.

• Direct established WHI Scientific Interest Groups (SIGs) to drive scientific productivity to advance women’s health and foster career development opportunities for early career researchers.

• Perform regular passive surveillance of living WHI participants via linkages with CMS, NDI, and the Virtual Pooled Registry (VPR)–Cancer Linkage System. These data sources will provide ongoing updates on health care utilization, cancer diagnoses, and deaths.

• Conduct periodic mailings to provide updated information on the self-reported health status of study participants. This should not include any verification and adjudication.

• Maintain participant newsletters and webinars for continued participant engagement and contact.

PURPOSE, CONTRACT STRUCTURE, AND PERIOD OF PERFORMANCE

The required services shall be performed at the contractor’s site. The contract is anticipated to be single award Indefinite Delivery, Indefinite Quantity type contract. The anticipated period of performance is February 1, 2028 – January 31, 2038.

PROJECT REQUIREMENTS

There are two main task areas for this acquisition.

Task Area A – Core operations: Task area A shall encompass core study operations, including the close-out of event verification and adjudication, maintain access to core and ancillary study data and biospecimens, collaboration with other on-going NIH research programs, maintenance of the WHI biorepository, preservation of the SIGs, passive surveillance and periodic health status updates of study participants, mailing of participant newsletters, webinars, data analysis, and manuscript writing. The major tasks to be performed include the following:

1. Perform activities related to contract transition from the previous contractor, if needed, and as directed by NHLBI. Execute a seamless transition of CCC responsibilities from the previous contractor. Receive in transfer all existing protocols, documents, minutes and reports from the previous contractor.

Identify points of contact, schedules, and milestones, and any actions required of the Government.

2. Perform administrative, operational, and technical duties to support study implementation and productive collaboration among the study personnel with outside researchers collaborating with WHI, including NIH, NHLBI, and NIH research programs. Activities include, but are not limited to:

a. Maintain effective communication among the CCC, NHLBI, NIH research programs, and collaborating investigators. Maintain and regularly update the WHI website.

b. Organize and support WHI committees, including steering, publications and presentations, and ancillary studies, as well as SIGs.

c. Prepare agendas, materials, minutes, action items, and follow-up documentation for study meetings.

d. Develop and maintain study policies, procedures, manuals, and operational guidance.

e. Provide scientific and operational recommendations to NHLBI.

f. Identify emerging scientific opportunities and methodological approaches that can enhance the value of WHI.

g. Monitor study activities, milestones, risks, and dependencies.

h. Support transitions in CCC leadership, staffing, and organizational responsibilities as directed by NHLBI.

3. Ensure the transfer of all WHI participant contact information and any follow-up data collected during the previous contract period from all four regional centers to the CCC in order to close-out clinical event adjudication within the first six months of the contract period.

a. Close-out the event adjudication process based on medical or vital status records collected through the end the last contract period.

b. Provide a final events file for the medical record cohort.

4. Conduct core study functions, including maintaining, advising, and providing continued access to the extensive repository of core and ancillary study WHI data and biospecimens by qualified researchers, including early career scientists.

a. Maintain the infrastructure necessary to collect, process, integrate, document, protect, and disseminate WHI data.

b. Maintain security and confidentiality of all study data, including personal identifiers and personal health information (PHI).

5. Together with the NHLBI Project Office, collaborate with the All of Us research program to establish synergistic data collection protocols and ancillary studies.

a. Work cooperatively with the NHLBI Project Office, All of Us, and any subcontractors and consultants in all relevant aspects of the study.

6. Maintain the comprehensive biospecimen repository collected from the WHI, its subcohorts, and ancillary studies over the last three decades to serve as a platform for independently funded ancillary studies across a broad range of research disciplines, from basic to translational.

a. Track inventory of available specimens.

b. Provide specimens to investigators in accordance with study policies/procedures for access to specimens.

c. Oversee analyses of biologic specimens to test specific hypotheses as required by the protocol and manual of operating procedures.

d. Conduct feasibility and quality assurance studies as needed.

7. Direct established WHI SIGs to drive scientific productivity to advance women’s health and foster career development opportunities for early career researchers.

a. Enable the SIGs to stimulate and identify new research opportunities and scientific directions via ancillary studies to WHI.

b. Collaborate with the SIGs to prepare abstracts and manuscripts using

WHI data for presentations and publications.

c. Conduct statistical analyses, develop statistical methodologies as needed, and advise on appropriate study designs.

8. Perform regular passive surveillance of living WHI participants via linkages with CMS, NDI, and the VPR–Cancer Linkage System. These data sources will provide ongoing updates on health care utilization, cancer diagnoses, and deaths.

a. Prepare and submit participant linkage files in accordance with applicable requirements.

b. Establish standardized procedures for importing and processing linkage data.

c. Update participant outcome status and relevant study databases on an established schedule.

9. Conduct periodic mailings to provide updated data on the self-reported health status of study participants. This should not include any verification and adjudication.

a. Maintain standardized questionnaires for collection of self-reported health status and other approved participant-reported information.

b. Prepare cover letters, instructions, return materials, and other supporting materials required for the mailing.

c. Receive and process completed questionnaires. Make final processed data available for analysis.

10. Distribute participant newsletters and conduct webinars for continued participant engagement and contact.

a. Develop newsletter content addressing topics relevant to WHI participants and the objectives of the study.

b. Provide updates regarding WHI activities, accomplishments, and ongoing research.

c. Communicate general findings from WHI research in clear, accessible, and scientifically accurate language.

d. Highlight the contributions of WHI participants to women's health research.

e. Provide information about upcoming WHI activities, participant opportunities, webinars, and other engagement activities.

11. Work cooperatively with collaborating investigators to obtain informed consent when needed, while maintaining participation rates.

a. As needed for ancillary studies or other research activities requiring participant consent, the Contractor shall implement consent activities in a manner designed to maximize participant understanding, minimize participant burden, facilitate timely completion of consent requirements, and maintain participant engagement and participation.

12. Maintain study databases, including regularly updating the databases with data from ancillary studies both for internal use and for posting on publicly available NIH data repositories, including the NHLBI BioLINCC (https://biolincc.nhlbi.nih.gov/home/), BDC, and other NIH databases, such as dbGaP (https://www.ncbi.nlm.nih.gov/gap) or other newly implemented databases as directed by the NIH. Ensure all contract- and grant-supported WHI data that is not yet available in BioLINCC, BDC, and dbGaP are transferred together with annual updates.

a. Maintain WHI database including quality assurance and quality control procedures.

b. Maintain confidentiality and security of data. Provide expertise necessary to integrate data from outside the WHI (e.g., CMS) into the WHI database.

c. Monitor WHI data quality.

d. Ensure alignment with NIH/NHLBI data sharing policies, which includes the delivery of all ancillary data to the CCC at the time of first publication or project completion, whichever comes first.

e. Transfer all ancillary study data and newly obtained data supported as part of the contract, as allowed, to NIH/NHLBI repositories on an annual basis.

13. Coordinate and participate collaboratively in study committees to provide a transparent committee process, open access to study documents, clear policies for access to study data and materials, and an approval process for proposed manuscripts and ancillary studies.

a. Maintain committee charters, membership rosters, terms of reference, and operating procedures.

b. Maintain documented committee procedures and decision-making processes.

c. Provide support for implementation of transparent and consistently applied policies governing access to WHI data, biospecimens, and other study resources.

d. Maintain and administer a standardized process for proposed WHI manuscripts and other scientific publications using WHI data or materials.

14. Prepare and submit technical reports and financial invoices.

a. Monthly invoices should be submitted within 30 days.

b. Prepare and submit a final progress report and final financial report on or before the completion date of the contract. Report shall summarize the work performed over the entire contract period and include salient results, recommendations, and conclusions.

Task Area B – Study Closeout or Transfer to a New Entity: If implemented, this task area will encompass transfer of CCC activities to another entity or study closeout.

1. Perform activities related to contract transition or closeout, as directed by

NHLBI.

a. If required by NHLBI, provide training and support for transitioning out study operations to a successor contractor, in accordance with

FAR52.237-3.

b. Provide a seamless transition of responsibilities to the new entity.

c. Assist successor with obtaining IRB approval with consideration for conditions that exist in the current contract, including informed consent.

d. Communicate effectively with successor contractor personnel and provide training during the transition period.

e. Establish a detailed protocol for the transfer and long-term storage of biospecimens to the new entity.

f. Prepare and implement procedures for disposition of study materials, including, but not limited to data, specimens, manuals, protocols, and dictionaries.

CAPABILITY STATEMENT/INFORMATION:

Interested parties are expected to review this notice to familiarize themselves with the requirements of this project. The following information shall be included in the capability statement to demonstrate the ability to provide the required services:

1. Capability statements must provide evidence of ability and experience to perform 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 and the institutional support to perform the functions of a CCC for a large, collaborative epidemiology study, including operational and scientific coordination with independently funded ancillary studies, data processing, maintenance of a well curated repository of data and biospecimens; and implementation of a system to ensure appropriate data and biospecimen sharing; (3) evidence of ability to analyze data from longitudinal epidemiologic studies and publish results in peer reviewed journals; and (4) a proven track record of collaboration with other research programs and experience performing other projects of similar size and complexity.

2. The respondents’ DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.)

pursuant to the North American Industry Classification System (NAICS) code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) with a size standard of 1,000 employees.

3. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition.

4. The capability statement shall not exceed 15 single-sided pages

(including all attachments, 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.

5. 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.

CLOSING STATEMENT

Point of Contact:

Lynn Furtaw, Contracting Officer, lynn.furtaw@nih.gov at 301-827-7713, Department of Health and Human Services, National Institutes of Health, National Heart, Lung and Blood Institute, Office of Acquisitions, 6701 Rockledge Drive, Rockledge 2, Bethesda, MD, 20892-7902, UNITED STATES.

Submission Instructions:

Interested parties shall submit capability statements via email to Lynn Furtaw, Contracting Officer at lynn.furtaw@nih.gov and Noelle Decenzo, Contract Specialist at noelle.decenzo@nih.gov . The due date for receipt of statements is October 2, 2026, 3:00 p.m. Eastern Time.

All responses must be received by the specified due date and time to be considered.

mailto:lynn.furtaw@nih.gov mailto:lynn.furtaw@nih.gov mailto:noelle.decenzo@nih.gov

This Sources Sought Notice 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 SAM. 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).