AD-SCCC_Sources Sought Notice.pdf

SOURCES SOUGHT NOTICE

Agency/Office Department of Health and Human Services, National Institutes of Health

Contracting Office Location Office of Acquisition & Logistics Management (OALM) 6701 Rockledge Drive, Bethesda, Maryland

Type Research & Development Sources Sought

Solicitation Number

HHS–NIH–NIAID–RDSS–26–75N93026R00009

Title

AUTOIMMUNE DISEASES STATISTICAL & CLINICAL COORDINATING CENTER (AD-SCCC)

Classification Code A – Research and Development

NAICS Code 541715 – Research and Development in the Physical, Engineering and Life Sciences (except Nanotechnology and Biotechnology)

Response Date March 6, 2026, 3PM Local Time

Primary Point of Contact Patrick Finn, Contracting Officer patrick.finn@nih.gov 240-669-5401

Secondary Point of Contact Robert Corno, Contracting Officer robert.corno@nih.gov 240-669-5151

Introduction/Synopsis This is a Research and Development (R&D) 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 including small and small disadvantaged businesses to perform a potential R&D requirement.

Background The Division of Allergy, Immunology, and Transplantation (DAIT), National Institutes of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), project is for work related to the contract below:

“Autoimmune Diseases Statistical & Clinical Coordinating Center (AD-SCCC)”, RHO Federal Systems Division, Inc. (Contract 75N93022C00003)

This contract was awarded on a competitive basis for a five-year period from February 1, 2022 through January 31, 2027. A term type/level of effort contract was awarded for the delivery of mailto:patrick.finn@nih.gov mailto:robert.corno@nih.gov

56,170 direct labor hours per year for Years 1-5. The total value of the contract is $49,268,667 and includes options for extension of the term for a total performance period of 5 years and options for increases in the level of effort, with the purpose of establishing an Autoimmune Diseases Statistical & Clinical Coordinating Center (AD- SCCC) that will provide a broad range of support critical for the design, development, execution, and analysis of clinical research sponsored by NIAID in autoimmune diseases and diseases related to mucosal immunology and primary immune deficiencies. The scope of clinical research to be supported by the AD- SCCC includes: (i) clinical trials at all phases to evaluate the safety and efficacy of investigational products and innovative approaches for disease treatment and prevention; (ii) studies of underlying mechanisms as integral components of clinical trials; (iii) clinical studies (e.g., genetic studies, microbiome studies, surveys of current therapies, etc.); and (iv) surrogate/biomarker studies. The scope of statistical and clinical support functions to be performed by the AD-SCCC includes statistical design and analysis;

protocol development; study initiation and management; clinical safety and pharmacovigilance support; safety oversight; management of clinical study collaboration portals; manuscript preparation and management of sample repositories.

The NIAID, NIH, conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The causes, pathogenesis, diagnosis, treatment, and prevention of autoimmune diseases are major areas of emphasis for NIAID’s Division of Allergy, Immunology, and Transplantation (DAIT). DAIT pursues research on autoimmune diseases by supporting investigator-initiated research projects, cooperative clinical studies, national networks of research centers, and demonstration and education research projects.

A critical component of the Division’s mission focuses on clinical research to develop new and/or improved strategies to treat or prevent autoimmune diseases through rigorous evaluations of the safety and efficacy of investigational products and therapeutic interventions, studies to elucidate underlying mechanisms of disease, studies to develop and evaluate surrogate/biomarkers of disease stage, severity and progression, and clinical studies of disease natural history.

This Sources Sough 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 NIAID.

Purpose and Objectives The purpose of this Research and Development (R&D) Sources Sought Notice is to discern whether or not there are other contractors, including small or small disadvantaged businesses, capable of and interested in performing the work described herein. The NIAID does not intend to award a contract on the basis of responses received nor otherwise pay for the preparation of any information submitted.

As a result of this R&D Sources Sought Notice, the NIAID may issue a Request for Proposals (RFP) if it deemed necessary and appropriate. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME.

However, should such a requirement materialize, no basis for claims against NIAID shall arise as a result of a response to this Sources Sought Notice or the NIAID’s use of such information as either part of our evaluation process or in developing specifications of any subsequent requirement.

The objective of this acquisition is to continue to support to a broad range of services critical for the design, development, execution, and analysis of clinical research in autoimmune diseases. The major clinical research programs to be supported include, Autoimmunity Centers of Excellence (ACE) and Immune Tolerance Network (ITN), as well as investigator initiated clinical trials (IICT), and other clinical trials or study activities supported by NIAID herein collectively referred to as NIAID supported research.

The Contractor shall provide the following:

A. Statistical Design

1. Provide expertise, advice and assistance pin the development of statistical design plans for the development of concept and full study proposals for NIAID supported clinical research;

2. Provide assistance in the preparation of concept and full proposals and study-specific protocols;

3. Provide assistance in the preparation of concept and full proposals and protocols for mechanistic studies;

4. Provide support for preclinical safety study evaluation by providing statistical expertise for, and participate in, evaluating the accuracy and validity of data from preclinical safety studies in support of clinical trials if applicable;

5. Provide assistance for clinical trials and mechanistic studies post-study initiation.

B. Statistical Analysis

1. Development and preparation of the Statistical Analysis Plan (SAP) for each clinical trial in conjunction with the Study Management Teams (SMTs);

2. Preparation of interim and final analyses;

3. Preparation of summary data reports;

4. Development and preparation of results for posting as required by ClinicalTrials.gov;

5. Review of the accuracy and completeness of statistical data and data analyses for all abstracts, manuscripts, and presentations reporting on the clinical studies conducted by the relevant NIAID-sponsored networks and investigators prior to presentation or submission for publication.

6. Collaboration with NIAID-supported research, including the NIAID Clinical Data and Safety Management Center (CDSMC);

C. Protocol Development and Study Initiation

1. Provide expert advice and assistance to SMTs in the development of protocols for clinical trials and mechanistic studies;

2. Provide expert advice, assistance and coordination in the preparation, writing, review and approval of protocol-related documents and materials in collaboration with NIAID, SMTs, and the CDSMC and other NIAID supported research.

D. Data Management and Reporting E. Clinical Safety and Pharmacovigilance Center Support F. Safety Oversight Structure Support G. Clinical Study Internet-Based Collaboration Portals H. Training I. Repository of Biological Specimens J. Other Technical and Administrative Support K. Scientific and Technical Personnel L. Facilities, Equipment and Other Resources M. Quality Assurance/Quality Control N. Overall Project Management O. Initial and Final Transitions

Project Requirements The Contractor shall establish an Autoimmune Diseases Statistical & Clinical Coordinating Center (AD- SCCC) that will provide a broad range of support critical for the design, development, execution, and analysis of clinical research sponsored by NIAID in autoimmune diseases and diseases related to mucosal immunology and primary immune deficiencies. The scope of clinical research to be supported by the AD- SCCC includes: (i) clinical trials at all phases to evaluate the safety and efficacy of investigational products and innovative approaches for disease treatment and prevention; (ii) studies of underlying mechanisms as integral components of clinical trials; (iii) clinical studies (e.g., genetic studies, microbiome studies, surveys of current therapies, etc.); and

(iv) surrogate/biomarker studies. The scope of statistical and clinical support functions to be performed by the AD-SCCC includes statistical design and analysis; protocol development; study initiation and management; clinical safety and pharmacovigilance support; safety oversight;

management of clinical study collaboration portals; manuscript preparation and management of sample repositories.

Performance Requirement and Anticipated Period of Performance A term/level of effort type contract is anticipated. The performance requirement will be for the delivery of 23,927 direct labor hours during the period February 1, 2027 through July 31, 2027 (6-months), and two additional 6-month period options to extend services, Option 1 (from August 1, 2027 through January 31, 2028), and Option 2 (from February 1, 2028 through July 31, 2028) are also anticipated for a total period of performance of 18 months.

Capability Statement/Information Sought Capability Statements that are submitted in response to this announcement should clearly convey information regarding the respondent’s capabilities, including: (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.

Interested contractors must submit a capability statement (five page limitation, excluding resumes) describing their company’s experience and ability to perform this effort that includes the following:

(1) a summary list of similar work previously performed; (2) the professional qualifications and specific experience of staff who may be assigned to the requirement; (3) resumes for proposed key personnel, including the Principal Investigator, that reflect education, and previous work relevant to the proposed requirement; (4) a general description of the facilities and other resources needed to perform the work; and (5) demonstrated ability to carry out the work.

Each response should include the following Business Information:

a. Unique Entity ID number

b. Company Name

c. Company Address

d. Company Points of Contact (both technical and administrative), including names, titles, addresses, telephone and fax numbers and Email addresses

e. Current GSA Schedule appropriate to this Sources Sought

f. Do you have a Government-approved accounting system? If so, please identify the agency that approved the system.

g. Type of Company (i.e., large business, non-profit, educational institution, small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM). All offerors must be registered in the SAM, located at http://www.sam.gov/

Responses must be submitted no later than 3:00 PM (Local Time), March 6, 2026. Capability statements will not be returned and will not be accepted after the due date. These statements should be submitted electronically (via e-mail) to Patrick Finn, Contracting Officer, at patrick.finn@nih.gov. These statements should be submitted in Adobe Portable Document Format (PDF); however, capability statements in Microsoft Word will also be accepted. The e-mail subject line must specify HHS–NIH–NIAID–RDSS–26–75N93026R00009. Facsimile responses will not be accepted.

Common Cut-off Date:

Electronically submitted, tailored capability statements are due not later than 3:00 PM (E.S.T.), on March 6, 2026. CAPABILITY STATEMENTS WILL NOT BE RETURNED AND WILL NOT BE

ACCEPTED AFTER THE DUE DATE.

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 Presolicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

The Government will not entertain questions regarding this Market Research; however, general questions may be emailed to the following addresses:

Contracting Officer: Patrick Finn Email Address: patrick.finn@nih.gov

Contracting Officer: Robert Corno Email Address: robert.corno@nih.gov

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.

mailto:robert.corno@nih.gov