FDA_OSIST_Sources_Sought_Notice_12_19_2025.pdf

U.S. Department of Health and Human Services Food and Drug Administration (FDA)

Office of the Chief Scientist / Office of Occupational Safety and Health (OOSH) OSIST Support Services (OC-2026-131562)

PURPOSE

This Sources Sought Notice is issued solely for market research purposes in accordance with FAR Part 10. This is not a Request for Proposal (RFP), Invitation for Bid (IFB), or Request for Quote (RFQ). No contract will be awarded from this notice. No reimbursement will be provided for responding.

The FDA seeks to identify qualified and capable small businesses able to provide support services described in the attached draft Statement of Work (SOW) for the Occupational Safety, Industrial Hygiene, Information Systems, and Training (OSIST) Support Services requirement.

BACKGROUND

FDA requires a contract to obtain multidisciplinary support across the following areas:

• Occupational Safety, Policy & Laboratory Quality Support

• Primary Barrier Equipment Maintenance & Support

• Industrial Hygiene Support Services

• Information & Data Management

• Training Development & Management.

These services support FDA's mission to ensure safe, compliant, and high-performing laboratory and workplace environments. The work is to be performed at one of FDA laboratories located throughout the United States.

This work is currently being performed as a small business set-aside under FDA contract #75F40123D00043.

SCOPE OVERVIEW

Contractors may be required to provide support in one or more of the following task areas:

1. Program & Project Management

2. Transition Services

3. Occupational Safety, Policy, & Laboratory Quality Support

4. Primary Barrier Equipment Maintenance, Testing, Decontamination & Certification

5. Industrial Hygiene Support Services

6. Information & Data Management Support

7. Training Development & Management

A draft SOW is included for industry review.

ANTICIPATED NAICS CODE

FDA is considering the following NAICS code: 541990: All Other Professional, Scientific, and Technical Services.

Respondents may recommend a more appropriate NAICS code as part of their response with a brief rationale.

REQUESTED INFORMATION

To comply with the updated FAR market research guidance, FDA seeks to assess industry capabilities, refine requirements, re-evaluate acquisition strategy and approach, and identify potential contract vehicles, including but not limited to GSA Schedule contracts.

Response Format: Complete the attached Excel template (FDAOSIST VendorResponseMatrix.xlsx) with the requested information organized in the following categories:

A. Basic Vendor Information

• Business Name & Address

• Point of Contact (name, email, phone)

• Unique Entity Identifier (UEI) and CAGE Code

• Recommended NAICS Code and rationale

• Small business size classification under the recommended NAICS (e.g., small business, 8(a), WOSB, SDVOSB, HUBZone) B. Contract Vehicles

• GSA or other governmentwide vehicles your company holds that are suitable for this type of work

C. Subcontracting Intent

• Do you anticipate subcontracting? (Yes/No)

• If yes, estimated percentage and areas where subcontracting may occur

D. Capability Assessment For each Task Area (1-7), indicate:

• Capable as Prime: Yes/No

• Years of Experience: Number of years performing specific tasks

• Brief Capability Description: Specific experience summary E. Specialized Task Area Details Task Area 4 - Primary Barrier Equipment:

• Experience with biomedical/research laboratory settings

• Types of facilities serviced (BSL-2, BSL-3, BSL-4, Vivaria, ABSL, cleanrooms)

• Specific barrier systems routinely serviced (BSCs, HEPA-filtered devices, isolators, etc.)

Task Area 5 - Industrial Hygiene:

• Federal agencies/biomedical facilities served

• Scope of IH work (exposure monitoring, sampling, ventilation testing, risk assessments, etc.)

Task Area 7 - Training Development:

• Experience with eLearning authoring tools (Articulate Storyline, Rise, Lectora, Adobe Captivate, etc.)

• Years of experience with each platform

• Examples of training developed for federal agencies

F. Relevant Past Work Provide up to three examples of relevant work:

• Agency/Client Name

• Approximate Contract Value

• Period of Performance

• Description of work performed as it relates to the SOW

G. Optional Industry Feedback

• Potential barriers to small business participation

• SOW clarity or scope recommendations

RESPONSE FORMAT

• Complete the provided Excel template: FDAOSISTVendorResponseMatrix.xlsx

• File naming convention: FDAOSISTResponse_[Company Name].xlsx

• Page limit: Information should fit within the template structure

• Font: 11-point or larger within Excel cells

PROPRIETARY INFORMATION

Do not submit proprietary, classified, or sensitive information.

DISCLAIMER

This notice does not obligate the Government to award a contract. No reimbursement will be made for costs associated with responding.

SUBMISSION INSTRUCTIONS

Submit completed Excel response template via email to: Sr. Contract Specialist, Sheneil Green Email: Sheneil.green@fda.hhs.gov , Subject Line: FDA OSIST Sources Sought Response – [Company Name]