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) - Search regularly updated contact information for state and local regulatory officials involved with food, animal feed, animal health, and food defense
- AFDO Resource Page - 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
- FDA Retail Food Protection Program - Program webpage with informative links to program standards, contacts, and more on the FDA's initiative and cooperative efforts with our stakeholders.
- Voluntary National Retail Food Regulatory Program Standards - The Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) define what constitutes a highly effective and responsive program for the regulation of foodservice and retail food establishments.
Grade “A” Milk Safety
- Milk Safety Programs & Shippers List - Access a directory of FDA Milk Safety Program specialists and the Interstate Milk Shippers List
- Raw Milk & Pasteurized Milk – Links for videos, news, consumer information, guidance documents, and other milk industry information
- Milk Guidance Documents & Regulatory Information – Indexes and links to coded memoranda, drug residue data base annual reports, NCIMS model documents and other guidance
- Dairy Grade “A” Voluntary Hazard Analysis Critical Control Point – Obtain the latest information about the National Conference on Interstate Milk Shipments’ HACCP program
Shellfish Sanitation Program
- Interstate Certified Shellfish Shippers List - Provides contact information for the FDA Shellfish Specialists and state regulatory authorities
- Interstate Shellfish Sanitation Conference (ISSC) – Obtain conference information, publications and reports, state vibrio plans, and other ISSC data
- National Shellfish Sanitation Program (NSSP) – Guides for the Control of Molluscan Shellfish and NSSP information page
- FDA Office of Regulatory Affairs University (ORAU)- Training information for regulatory partners
- Association of Food and Drug Officials (AFDO) - AFDO Manufactured Food Regulatory Program Alliance (MFRPA) - Learn what the MFRPA’s goals are and how to secure membership
- Directory of State and Local Officials – A portal where you can find State and Local food, animal feed, animal health, and food defense regulatory official contact information
- FoodSHIELD – A web system that allows public health and food regulatory officials at the local, state, and federal levels across the nation to work together. It also helps communicate food safety information among other government agencies.
- AFRPS General Overview Slides (Presented March 11, 2014) (PDF - 306KB) – Presentation overview of the Animal Feed Regulatory Program Standards
- FDA Center for Veterinary Medicine – Link to FDA’s Center for Veterinary Medicine
- FAQ's for Applicants
- Step-By-Step: Applying for Grants
- SF424 application and electronic submission information
- USAspending.gov - see past contract, grant, and cooperative agreement awardees
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) - 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) (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 - 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 – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
- 20.88 Agreement Templates
- Long Term Food 20.88 Agreement Template (PDF - 146KB) – Sample of a Five Year, Single Signature Long Term ISA
- Case Specific 20.88 Agreement Template (PDF - 10KB) – Sample Letter for requesting non-public information
- 20.88 Certification Statement Template (PDF - 42KB) – Sample Confidentiality Commitment statement to not disclose non-public information shared by the FDA
- Information Sharing Guidance Documents
- Information Sharing Matrix (PDF - 63KB) – Visual guide of the information sharing process
- Information Sharing Ownership and Disclosure Chart (PDF - 136KB) – Visual of the different information sharing levels
- Trade Secret Flowchart (PDF - 156KB) – Shows who is allowed to access trade secret information
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.
- State, Tribal, Local, and Territorial Public Health Preparedness
- MCMi News and Events, Including Updates for Public Health Stakeholders, and Funding Opportunities
- Counterterrorism and Emerging Threats
- FMD-76 – Evaluation of Inspectional Performance - This addresses the oversight of contract inspections in the following program areas: food, feed establishment, egg, tissue residue, medical device and other inspection programs.
- Official Establishment Inventory (OEI) Data Collection Form
- Official Establishment Inventory (OEI) Data Collection Work Instruction
- SOP 130 OEI Development and Maintenance Procedure