CureSCI_CC___NHDR_Sought_Notice_1.pdf

Sources Sought Notice

CureSCi Long-Term Follow-Up (LTFU) Consortium: Coordinating Center Activities, Natural History Data Resource (NHDR), and Related Support

Introduction

This Sources Sought Notice is for interested small businesses. This notice is NOT a request for proposals and does not commit the Government to award a contract now or in the future. No solicitation is available at this time. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether small businesses are classified as HUBZone; service-disabled, veteran-owned; 8(a); veteran- owned; woman-owned; or small disadvantaged; 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. The NAICS Code for this acquisition is 541715 – Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Small business organizations must have their size status certified by the Small Business Administration. An organization that is not considered a small business under NAICS code 541715 should not submit a response to this notice.

Background

The National Heart, Lung, and Blood Institute (NHLBI) requires continued support for activities associated with the Cure Sickle Cell Initiative (CureSCi), including operation of the Sickle Cell Disease Natural History Data Resource (NHDR) and selected CureSCi coordinating functions.

The NHDR was established to improve understanding of the natural history of sickle cell disease (SCD) through systematic collection of high-quality longitudinal data. The NHDR provides a well-characterized cohort of participants who may serve as contemporaneous comparators for individuals enrolled in Gene Therapy (GT), Hematopoietic Cell Transplant (HCT), and other interventional clinical trials or comparative-effectiveness studies. The NHDR includes clinical data, laboratory data, patient-reported outcomes, and other protocol-required information collected longitudinally from participating clinical centers.

The Food and Drug Administration (FDA) requires 15 years of follow-up for GT recipients, but no infrastructure existed to systematically follow outcomes over that period of time, or to compare them systematically to non-curative standard-of-care management. To address this gap, NHLBI established two patient cohorts within its CureSCi. The GT and HCT patients to be followed through the WARRIOR- SCD study (Whole-person Assessment of Response and Risk after transformative therapies: Investigating Outcomes and Resilience in Sickle Cell Disease), a 15-year effort to collect long-term clinical outcomes, patient-reported outcomes (PROs), along with biospecimen collection and genetic testing for eligible participants; and the NHDR, as a comparator cohort of SCD patients who have not received GT or HCT. NHDR and WARRIOR-SCD are both part of NHLBI's CureSCi LTFU Consortium.

THIS NOTICE ADDRESSES THE CC (Coordinating Center) and NHDR (Natural History Data Resource)

ONLY.

It is anticipated that one (1) award may be made on or about April 2028 for a period of ten (10) years.

Objectives

The objective of this contract is to provide CureSCi Coordinating Center functions and continuity of ongoing operations of the NHDR (https://curesicklecell-nhdr.rti.org/ ), including longitudinal data collection, biospecimen collection support, data management, reporting, MetaData Catalog (MDC) support, and other related activities necessary to coordinate and harmonize data and biospecimen collection with the WARRIOR-SCD study (https://cibmtr.org/CIBMTR/Collaborations/WARRIOR-SCD , supported by a separate contract), and other broader CureSCi program goals. Both NHDR and WARRIOR- SCD are components of the CureSCi LTFU Consortium. Additionally, the contractor will engage the participants and sickle cell disease community to support retention and health education; and support independently funded, investigator initiated ancillary studies using the NHDR data and/or specimens.

The Contractor shall have multi-center clinical study management experience and all necessary data management, informatics, statistical, and administrative expertise necessary for maintaining or amending the study plan and for biospecimen collection, as approved by NHLBI.

The Contractor shall provide all personnel, supervision, materials, systems, facilities, and other resources necessary to perform the requirements of this contract. The Contractor has latitude to determine specific processes, tools, and staffing approaches to meet performance standards, subject to Government-approved plans and applicable federal, NIH, and NHLBI requirements.

The Contractor shall perform all work in a timely, professional, and scientifically sound manner. The Contractor shall be capable of:

A. General Requirements

1. Maintain accurate, complete, and current project documentation.

2. Coordinate effectively with NHLBI staff, participating sites, repositories, committees, and authorized subcontractors.

3. Provide qualified staff sufficient to perform all contract requirements without interruption. It is expected that the Contractor will designate a Program Manager as the primary Government point of contact, to be approved by NHLBI.

4. Maintain continuity of operations throughout the period of performance.

5. Notify the Contracting Officer’s Representative (COR) promptly of actual or anticipated issues affecting cost, schedule, technical performance, data integrity, or operational continuity.

6. Comply with all applicable Federal, NIH, NHLBI, human subjects, privacy, security, biospecimen, records management, and data-sharing requirements.

7. Maintain a risk, decision, and action-item logs, updated within 7 business days of new items being identified.

B. Support CureSCi Coordinating Center Activities that include:

1. Data Strategy Coordination

2. Meeting Coordination

3. Website Maintenance

4. Centralized Program Document Library (CPDL) Maintenance

5. CureSC Metadata Catalog Management (https://curesicklecell.rti.org/MetaCatalog )

6. Publications Support

C. Natural History and Data Resource. The Contractor shall maintain and support the NHDR by providing comprehensive, end-to-end operational support to ensure the continuity, stability, and effective operation of the NHDR. Support shall include, but is not limited to, the following https://curesicklecell-nhdr.rti.org/ https://cibmtr.org/CIBMTR/Collaborations/WARRIOR-SCD https://curesicklecell.rti.org/MetaCatalog activities:

1. Core NHDR Operations Support

2. Participant Retention

3. Cohort Expansion

4. Clinical Data Collection

5. Patient-Reported Outcome (PRO) Operations

6. Biospecimen Collection

7. Data Management and Quality Control

8. Analysis and Reporting Support

9. Site and Subcontract Management

D. Participant Engagement and Educational Materials Development. If requested by NHLBI, the

Contractor shall support participant and community engagement activities, and development of educational and communications materials related to CureSCi and NHDR activities.

E. Ancillary Studies to NHDR. The Contractor shall support independently funded ancillary studies by providing Contractor-collected data, in accordance with established procedures and timelines, for NHLBI-approved investigators.

F. Privacy and Data Handling

The Contractor shall ensure that all data handling complies with applicable Federal requirements, approved protocols, and NHLBI direction.

G. Transition and Continuity

The Contractor shall support orderly transition of activities from funding support mechanisms and, if applicable, to a successor contract or contractor, if required by NHLBI. The Contractor shall minimize disruption to ongoing CureSCi operations, NHDR follow-up, data systems, and coordinating activities.

Anticipated Period of Performance

The Government intends to negotiate one (1) contract award, for the potential period of ten (10) years, with an approximate award date on or around April 2028.

Capability Statements – How to submit a response

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. The capability statements 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 use a 12-point font size minimum.

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 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 Sources Sought Notice number 75N98026R00150.

Point of Contact

Elizabeth Bulger, Contracting Officer, Research and Development (R&D) NHLBI Branch, R&D and Professional Services – Division B, Office of Acquisition and Logistics Management (OALM), Office of the Director, NIH; Phone: (301) 435-3498; E-mail: elizabeth.bulger@nih.gov

Department of Health and Human Services, National Institutes of Health, Office of Acquisition and Logistics Management (OALM), Research and Development and Professional Services – Division B, 6701 Rockledge Drive, RKL2, Bethesda, MD 20817 UNITED STATES.

Information Submission Instructions

Interested parties shall submit capability statements via electronic mail and must reference the Sources Sought Notice number 75N98026R00150 in the subject line of the e-mail submission.

The due date for receipt of capability statements is 3:00 p.m. Eastern Standard Time (EST) on October 2, 2026. All responses must be received by the specified due date and time in order to be considered.

Capability statements shall be submitted electronically to the designated Contracting Officer and Contract Specialist as follows:

Elizabeth Bulger, Contracting Officer: elizabeth.bulger@nih.gov Jessica Williams, Contract Specialist: jessica.williams3@nih.gov

This notice does not obligate the Government to award a contract(s) 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 SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation/Request for Proposal (RFP).

mailto:elizabeth.bulger@nih.gov mailto:elizabeth.bulger@nih.gov mailto:jessica.williams3@nih.gov