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Resources for Regulatory Partners

Below are links to documents, other FDA sites, and regulatory partners’ websites. If there is a resource that is not listed, and you think it should be displayed on this page, please contact OP.Feedback@fda.hhs.gov.

  • Instructional Video Resource for Submission of FDA Grant Applications Using eRA Commons System - The first part of the session includes a PowerPoint presentation given by the National Institutes of Health (NIH) eRA Partner Engagement Team who provided an overview of the cooperative agreement and grants competing FDA application and registration processes, FDA's transition to ASSIST, and helpful resources to aid the applicant during the application process. The second part of the session is a Question and Answer period, held with the attendees to further clarify the information presented.
  • Code of Federal Regulations - Title 21 – Food and Drugs  - The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration
  • Federalism Outreach 
  • Directory of State and Local Officials (DSLO) disclaimer icon - Search regularly updated contact information for state and local regulatory officials involved with food, animal feed, animal health, and food defense
  • AFDO Resource Page disclaimer icon- Association of Food and Drug Officials. AFDO is an international, non-profit organization that is in the forefront of streamlining and simplifying regulations by either drafting regulatory rules or by commenting on government proposals

FPTF Resources

Retail Food

Grade “A” Milk Safety

Shellfish Sanitation Program

MFRPS Resources

AFRPS Resources

General Resources

Important information regarding the process to apply for a grant or cooperative agreement:

A critical step to successfully applying for a grant or cooperative agreement is meeting the registration requirements. Registration can take 6 weeks or more, so begin the registration process now. Also, take the time to verify all of your registrations are up-to­-date. Please note that SAM now replaces CCR; if you previously registered under CCR, you will need to re-register under SAM for any applications you wish to submit. Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award.

  • Dun and Bradstreet Universal Numbering System (DUNS) disclaimer icon - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) disclaimer icon (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons disclaimer icon - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov disclaimer icon – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Information Sharing

FDA plays a critical role in protecting the United States from chemical, biological, radiological, nuclear, and emerging infectious disease threats. FDA ensures that medical countermeasures (MCMs)—including drugs, vaccines and diagnostic tests—to counter these threats are safe, effective, and secure. For more information, please use the links below, and you can also check out the FDA Office of Counterterrorism and Emerging Threats website.