Rare Disease Regulatory Operations Support Consultant

Project Information

Bid Title
Rare Disease Regulatory Operations Support Consultant
Issuing Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Location
Maryland
Published Date
Aug 12, 2026
Closing Date
Aug 19, 2026
Government Level
Federal
Status
Closed
Ref. #
75N98026R00147
Original Source
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Set Aside
Total Small Business Set-Aside (FAR 19.5)
Project Description
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Rare Disease Regulatory Operations Support Consultant
Active
Contract Opportunity
Notice ID
75N98026R00147
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
NATIONAL INSTITUTES OF HEALTH
Office
NATIONAL INSTITUTES OF HEALTH NICHD
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General Information
  • Contract Opportunity Type: Sources Sought (Original)
  • Original Published Date: Aug 12, 2026 08:10 pm EDT
  • Original Response Date: Aug 19, 2026 10:30 am EDT
  • Inactive Policy: Manual
  • Original Inactive Date: Aug 20, 2026
  • Initiative:
    • None
Classification
  • Original Set Aside: Total Small Business Set-Aside (FAR 19.5)
  • Product Service Code: R499 - SUPPORT- PROFESSIONAL: OTHER
  • NAICS Code:
    • 541690 - Other Scientific and Technical Consulting Services
  • Place of Performance:
    Bethesda , MD 20892
    USA
Description

The National Institutes of Health (NIH), Office of the Director (OD) is conducting a market survey to determine the availability and technical capability of qualified small businesses, including 8(a) small businesses, small, disadvantaged businesses, woman-owned small businesses, service-disabled veteran-owned small businesses or HUBZone small businesses capable of providing the services of International Orphan Drug Designation (ODD) Sponsor/Representation, European Medicines Agency (EMA) and international regulatory consultants.



Interested firms with the capability of providing all the required services shall submit a capability statement to assist the Government in determining in accordance with the Federal Acquisition Regulation 19.104-1.



The intended procurement will be classified under North American Industrial Classification (NAICS) code 541690 with a size standard of $19m. All respondents are required to identify their firm’s size and type of business. Interested firms responding to this market survey must provide (a) capability statement demonstrating their experience, skills and capability to fulfill the Government’s requirements for the above. The capability statement shall be in sufficient enough details so that the Government can determine the experience and capability of your firm to provide the items and services in this posting/notice. Offers must also be accompanied by applicable descriptive literature, delivery timeframe, warranties and other information that demonstrates that the offer meets all the foregoing requirements. Capability statements must include the name and telephone number, and email address of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to the market survey that do not provide sufficient information for evaluation will be considered non-responsive. A copy of the capability statement must be received via email to robinsti@mail.nih.gov Attn: Tina Robinson prior to 10:30 am eastern daylight time on August 19, 2026. Capability statement must reference solicitation# 75N98026R00147. Submission by email must also reference solicitation # 75N98026R00147 on the subject line of the email. Any questions must be sent via email to robinsti@mail.nih.gov and must include solicitation# 75N98026R00147 on the subject line of email. Capability statements, etc will not be returned to firm/sender. This synopsis is for information and planning purposes and is not to be construed as a commitment by the Government, nor will the Government pay for information solicited.




Attachments/Links
Contact Information
Contracting Office Address
  • 6701 ROCKLEDGE DRIVE ROOM 1120
  • BETHESDA , MD 20817
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • Aug 12, 2026 08:10 pm EDTSources Sought (Original)
Commodity Codes
  • FSC RProfessional, Administrative and Management Support Services
  • NAICS 541690Other Scientific and Technical Consulting Services
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