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Sources SoughtSolicitation 75F40127R00007

FDA Scientific and Regulatory Support Services Indefinite Delivery Indefinite Quantity Contract

Submission deadlineNov 19, 2026See documents for time and submission instructions
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About this opportunity

AI summary

The Food and Drug Administration issues this Sources Sought Notice to conduct market research on qualified vendors, including potential 8(a) vendors, capable of providing multidisciplinary scientific and regulatory professional services. The contemplated Indefinite Delivery/Indefinite Quantity contract covers fourteen task areas supporting FDA Centers and Offices, such as program management, IT architecture, statistical computing, data standards, business analysis, outreach, AI-augmented analysis, scientific research, laboratory support, and transition services. Qualified sources under NAICS codes 541690 and 541990 may respond, and the agency is not accepting formal proposals at this time. The anticipated period of performance encompasses five one-year ordering periods plus an optional six-month extension.

Scope of work

  • Program and project management
  • IT architecture and integration advisory services
  • Statistical computing support
  • Data standards development and harmonization
  • Knowledge and records management
  • Data management and data quality
  • Business analysis support
  • AI-augmented scientific and regulatory analysis

Minimum qualifications

  • Program Manager IV designated as key personnel with required credentials
  • Support personnel adequately trained and possessing credentials specified in labor categories
  • Compliance with Homeland Security Presidential Directive-12 (HSPD-12) to obtain PIV cards
  • Completion of applicable FDA Information Security Awareness training
  • FedRAMP compliance for all cloud service providers used under the contract

Documents to include with your response

  • Draft Transition-In Plan
  • Program Management Plan (PMP)
  • Task Order Management Plan (TOMP)
  • Quality Assurance Plan (QAP)
  • FDA 3398 Form (Non-Disclosure Agreement)
  • HHS-745 form
  • E-QIP
  • FDA 3530 form
  • NAR forms

Contract details

Term
Five (5) one-year ordering periods and an additional six (6)-month option period
Place of performance
FDA Centers and Offices, predominantly in the Washington, DC Metropolitan area, including Rockville, White Oak, Calverton, and Silver Spring

Federal notice details

Solicitation number
75F40127R00007
Agency
Department of Health and Human Services
Buying office
Food and Drug Administration › FDA Office of ACQ Grant SVCS
Notice type
Sources Sought
Responses due
Nov 19, 2026, 2:00 PM ET
Posted on SAM.gov
Nov 4, 2026
NAICS
541990 · All Other Professional, Scientific, and Technical Services
Product/service code
R799
Set-aside
Small Business Set Aside - Total
Place of performance
Silver Spring, MD, 20993
Contracting contact
Amanda Edger
amanda.edger@fda.hhs.gov
Additional contact
Ian Weiss
Ian.Weiss@fda.hhs.gov
3017965728
View official notice on SAM.gov

Source: SAM.gov. Read the official notice for the complete description and current instructions.

Incumbent and award research

Likely prior awards for this requirement

Likely match

Awarded by the same buying office (75F401) with descriptions matching "scientific" or "regulatory", performed in MD. The notice does not name its current contract, so confirm before relying on it.

Vendor and awardValueEnds
DNA HIVE LLC75F40125C00095 · BAA# FY25C3AP3 - (H20) A NEXT GENERATION MEDICAL COUNTERMEASURES SCIENTIFIC PLATFORM FOR R$7.5MSep 29, 2028
REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION, INC.75F40126C00214 · IS TO ENGAGE RUF TO PROVIDE INDEPENDENT STAKEHOLDER CONVENING, SCIENTIFIC ENGAGEMENT, OPER$2.5MSep 29, 2027
KAIVA STRATEGIES, LLC75F40126F19025 · 2-YEAR AND 11-MONTH, FIRM FIXED PRICE (FFP) TASK ORDER FOR THE FDA OFFICE OF FOOD CHEMICAL$454.9KJun 14, 2027
TUNNELL CONSULTING INC75F40126F19009 · SCIENTIFIC TECHNICAL CAPACITY TO SUSTAIN REGULATORY REVIEW$27.9MApr 19, 2027
VETS SYNERGETIC GROUP LLC75F40125F19063 · REGULATORY SCIENTIFIC SUPPORT - TO PROVIDE SCIENTIFIC-RELATED PROFESSIONAL SERVICES WILL B$239.6KDec 31, 2026

Market context

Awards in the same category (All Other Professional, Scientific, and Technical Services). This is not this requirement's award history.

Recent similar awards: Department of Health and Human Services, NAICS 541990, performed in MD

Vendor and awardValueEnds
SCITECH SERVICES INC75F40126P00269 · CARR POWERFUGE PILOT SEPARATION SYSTEM$278.8KApr 14, 2029
AKIMA SECURE TECHNOLOGIES, LLC75F40126P00226 · FIRM FIXED PRICE CENTER FOR TOBACCO PRODUCTS (CTP) FREEDOM OF INFORMATION ACT (FOIA) PROG$1.8MSep 29, 2028
UNIVERSITY OF MARYLAND, BALTIMORE75N90025C00014 · STATE OF MARYLAND:1108634 [25-002246] THE CONTINUUM OF CARE IN HOSPITALIZED PATIENTS WITH$4.7MAug 14, 2028
VETS SYNERGETIC GROUP LLC75F40126F19100 · TASK ORDER TO SUPPORT PATIENT SAFETY IN POST ACUTE CARE TRANSITIONS FOR HOME AS A HEALTHCA$1.5MJul 28, 2028
FAST-TRACK DRUGS & BIOLOGICS, L.L.C.75N94024F00002 · APREMILAST FOR THE TREATMENT OF ALCOHOL USE DISORDER -- CONTRACT RESEARCH ORGANIZATION STU$5.8MDec 31, 2027

Top vendors in this category: Department of Health and Human Services, NAICS 541990, since Oct 1, 2024

3,194 contract awards in this NAICS over the period.

  1. 1. RESEARCH TRIANGLE INSTITUTE$213.0M
  2. 2. QLARANT INTEGRITY SOLUTIONS LLC$199.4M
  3. 3. SAFEGUARD SERVICES LLC$170.8M
  4. 4. BOOZ ALLEN HAMILTON INC$145.3M
  5. 5. VETS SYNERGETIC GROUP LLC$87.4M

Source: USAspending.gov federal award data (U.S. federal public data). A contract is called the incumbent only when the notice or its documents cite it by number.

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