1. Guidance Development Merton V. Smith, Ph.D., J.D. Director International Programs and Product Standards Center for Veterinary Medicine, FDA

2. FDA - Laws and Regulations Laws (Statutes) over 200 laws since 1906 that authorize and direct the regulatory activities of the FDA Rules (Regulations) –issued pursuant to statutory authority –implement statutes –have the force and effect of law –published in the FR and in the CFR

3. What are guidance documents? Guidance - a statement of policy on a regulatory issue or an interpretation of a statute or regulation Represents the agency’s current thinking on a regulatory issue VICH guidelines are classified as guidance in the U.S. Notices of availability are published in FR and guidances are available on CVM’s website

4. Guidance Documents Do not have the force and effect of law Not compulsory; an alternative approach can be used if the approach satisfies the requirements of applicable statutes and regulations Defendant can bring evidence into court that alternative approach meets statutory or regulatory requirements

5. Guidance Documents Guidance documents may relate to the: –design, production, labeling, promotion, manufacturing, and testing of regulated products –the processing, content, and evaluation or approval of submissions –inspection and enforcement policies

6. Guidance Development FDA is required to publish a guidance agenda listing upcoming guidance and a comprehensive list of Agency guidance periodically. CVM maintains a guidance agenda on its Internet site listing the guidances it intends to issue in the current year. This enables the public to see what the Center is working on.

7. Procedure for Developing Guidance Procedure is prescribed by regulation (“good guidance practices”) –Draft guidance is made available for public comment (typically 60-day comment period) –Draft guidance may be revised based on public comment –Final guidance is made available to public

8. Guidance Development Public can comment on guidance at any time – –Draft guidances have stated periods for public comment prior to finalizing the guidance, but the Docket remains open for future updates and revisions Guidance can be revised at any time –Advances in science or technology, new information, new policy –If VICH guidance is considered for revision, it would be brought to the VICH Steering Committee for consideration at Step 9 in the VICH review process

9. FDA and VICH Guidelines FDA delegates ensure that VICH guidelines do not contradict United States statutory or regulatory requirements VICH guidelines are revised to conform to FDA's good guidance practices regulation and published as Guidances