A02 Request for Information.pdf

Request for Information/Sources Sought

THIS IS A REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT (SS) ONLY. This RFI/SS does not constitute a solicitation, nor does it restrict the Government as to the ultimate acquisition approach. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Any contract that might be awarded based on information received or derived from this market research will be the outcome of a competitive process. Responders are advised that the Government will not pay for any information or administrative costs incurred in response to this RFI/SS. All costs associated with responding to this RFI/SS will be solely at the interested party’s expense. Not responding to this RFI/SS does not preclude participation in any future Request for Proposal (RFP), if any is issued. The Government has not made a commitment to procure any of the services described below. No evaluation letters and/or results will be issued to parties responding to this RFI/SS.

This RFI/SS is issued solely for information and planning purposes to gauge interest and capabilities for the upcoming requirement for the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development (DHA R&D) Medical Research and Development Command (MRDC). This requirement is for (1) regulatory consultation, (2) regulatory oversight, and (3) Contract Research Organization (CRO) support to include administrative, financial, clinical, nonclinical, manufacturing, product accountability, quality support and regulatory support for medical products to include but not limited to: drugs, biologics, medical devices, and combination products to support the medical product development mission as is necessary to facilitate full program coordination, management, policy development, execution, and oversight across all of ORA.

The ORA provides regulatory and clinical support for the life cycle development of the Food and Drug Administration (FDA) regulated medical products sponsored by the Department of Defense (DoD) in addition to providing consultative support for medical products that are sponsored by other organizations. ORA has a requirement to provide various levels of support as defined below to enable product development of medical products, enable submissions to the FDA, and ensure all Code of Federal Regulations (CFR) Sponsor responsibilities are met in a manner consistent with FDA guidance and industry best practices.

This requirement requires a mix of consultation, oversight and CRO services (full) support in the following areas listed below.

Regulatory Business Support: Regulatory support (consultation, oversight, or full support) to the ORA Business Office and work closely with the ORA subject matter experts to provide regulatory business and project management support. Personnel supporting these tasks shall be knowledgeable of and able to apply project management skills and FDA product development requirements to facilitate required tasks and interactions with multiple customers, internal and external to ORA, for the development of medical products.

Planning, Programming, Budgeting, and Execution: Financial management support for Planning, Programming, Budgeting, and Execution applying the pertinent laws, regulations, policies, procedures, and work processes to requirements for product development.

Administrative Support-Regulatory Management: Administrative support to the ORA and serve as the subject matter expert on administrative related tasks.

Regulatory Project Management: Project management support to coordinate the planning, executing, monitoring, controlling, and closing of regulatory projects.

Regulatory Affairs, Strategy and Intelligence: Ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy, to include identifying and mitigating risk, and provide support to integrated project teams and working groups for submissions to and communications with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health submissions.

Clinical Trial Management: Regulatory support for clinical trial project management, clinical development strategies, execution of clinical trials, and provision of clinical site training.

Clinical Trial Monitoring: Clinical trial monitoring to ensure clinical trials are conducted and deliverables provided according to 21 CFR 312, 21 CFR 812, International Conference on Harmonization (ICH) practices, other applicable regulations, policies, and ORA SOPs.

Data Management and Biostatistics: Clinical data management support according to the applicable FDA regulations, guidance, and industry standards. Data management support includes performing clinical data management activities or providing clinical data management oversight, support responsibilities. Provide biostatistical support and deliverables that meet the applicable regulations, guidance, and standards, including industry standards (clinical and nonclinical). Biostatistical support includes performing biostatistical support or providing statistical oversight activities.

Pharmacovigilance: Medical regulatory support for activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to investigational products.

Investigational Product and Chemistry, Manufacturing, and Controls: Function as the Product Technical Operations lead at the individual team level by providing regulatory and technical support to the development of manufacturing strategies and execution of investigational product activities throughout all phases of the product development to ensure compliance with the applicable regulations, guidance documents, policies, and standards.

Nonclinical Support: Regulatory support for nonclinical development to ensure compliance with the applicable regulations, guidance documents, policies, and standards. Provide nonclinical subject matter expertise to integrated product teams or working groups and update ORA leadership as needed. Studies include, but are not limited to bench performance testing, biocompatibility, In vivo or in vitro, toxicological, pharmacokinetics, and genotoxicity studies.

Medical Writing: Write, review, edit, and/or advise on the development of regulatory documents and dossiers.

Regulatory Operations (Regulatory Publishing/Document Submission/Document Control):

Prepare, publish, and submit documents in accordance with all pertinent laws, regulations, guidance documents, best practices, and policies for drug, biologic, device, and combination product types; provide document control and archiving support for electronic and paper records;

and provide publishing, submission, and document control subject matter expertise to ORA and its external partners.

Quality: Ensure quality requirements and management activities in support of medical product development for all medical product types as per 21 CFR or International Organization for Standardization (ISO) and ICH. This task includes quality control and quality assurance of deliverables as well as external quality assurance of contract research organizations. For medical devices, provide quality support to ensure compliance with quality requirements for medical device development and clinical studies as per applicable parts of 21 CFR Part 820 (FDA Quality System Regulation) and FDA guidance.

The Government currently estimates approximately 37 Full Time Equivalent (FTE) Support personnel will be needed to fulfill the task requirements outlined above.

How to Respond:

Qualified responders should submit a comprehensive and fully integrated Capability Statement that addresses the scope of work outlined within this RFI/SS. The Capability Statement should discuss:

• The responder’s relevant experience and expertise to provide the support services based upon the size and scope of this requirement as outlined above.

• Information relating to novel ideas and industry best practices to meet the needs of the

Government’s requirement as outlined within this RFI/SS.

• Examples or references of previously completed deliverables related to this requirement.

• The responder’s ability to provide personnel with Information Technology/Automated Data Processing (IT/ADP) level II security clearance.

• Any need to subcontract and the approach to subcontracting.

• Specific capabilities that match the work outlined within this RFI/SS for the Government to make a fair and accurate capability determination.

Each response must not be more than ten (10) pages in length and the responder shall complete the below table and submit the below table as part of their RFI/SS response.

Company Name:

Company Address:

Point of Contact:

Telephone Number:

E-mail Address:

Tax Identification Number (TIN):

Unique Entity ID Number (UEI):

Commercial and Government Entity Code (CAGE):

Company Web Page (If Available):

Company Size Status (Large or Small Business):

Company Other Classifications (Examples: Hub Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned, 8A):

Company Registered in SAM (Yes or No):

Company Government Contracts That Could Be Used To Fulfill This Requirement (Examples:

Federal Supply Schedule, Government-Wide Acquisition Contracts, OASIS+, OMNIBUS IV, or Other Contracting Vehicles)

Responders shall submit a Capability Statement (PDF or Microsoft Word) in response to this RFI/SS via email to the Contract Specialist, Mr. Ronnie Sanford, at the following email address:

ronald.s.sanford2.civ@health.mil no later than 08 October 2025 by 3:00 P.M. Eastern Time.

All responses received will be considered; however, a determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government. The Government will not entertain questions regarding this RFI/SS.

mailto:ronald.s.sanford2.civ@health.mil