Director Policy and Regulations Staff Center for Veterinary Medicine Foundations of Regulation The Federal Government is composed of three distinct branches legislative executive and judicial which powers are vested by the US Constitution ID: 730439
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Diane L. Heinz, DVM, MBADirectorPolicy and Regulations StaffCenter for Veterinary Medicine
Foundations of RegulationSlide2
The Federal Government is composed of three distinct branches: legislative, executive, and judicial, which powers are vested by the U.S. ConstitutionThe Legislative Branch of the Federal Government consists of the elected House of Representatives and the Senate, which together form the United States Congress
Laws and RegulationsSlide3
The Constitution grants Congress the sole authority to enact legislation Bills are passed by Congress and signed into law by the President
Laws and RegulationsSlide4
A new law often does not include all the details needed to explain how an individual, business, state or local government, or others might follow the lawThe Executive Branch of the Federal Government is responsible for the day-to-day enforcement and administration of federal laws
Laws and RegulationsSlide5
The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress. It and other federal laws establish the legal statutory framework within which FDA operatesThe FD&C Act can be found in the United States Code, which contains all general and permanent U.S. laws, beginning at 21 U.S.C. 301
Over 200 laws since 1906 that authorize and direct the regulatory activities of the FDA
FDA - Laws and RegulationsSlide6
Rule - issued pursuant to statutory authority, implements a law, and has the force and effect of law“Regulation” is the common name for a rule that imposes regulatory requirementsFDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates
What is a rule?Slide7
Violation of a validly adopted regulation can result in a sanction just as severe as one received for violation of a statute passed by CongressTo have the force of law a regulation must be issued under a delegation of authority from Congress and according to appropriate rulemaking requirements
RegulationSlide8
The Administrative Procedure Act (APA) of 1946 Law that governs the way in which agencies of the Federal Government may propose and establish regulations Notice-and-comment rulemakingRegulationSlide9
Used as a vehicle to involve the interested public in a regulatory action at an early stage, before the agency has arrived at even a tentative decision on a particular regulatory changeSometimes used to test public reaction to a proposal
Not a requirement of the rulemaking process
Advance Notice of Proposed Rulemaking (ANPRM)Slide10
Informs the public that a federal agency is considering a regulatory changeDescribes the new rule or changes being considered to an existing rulePublic is invited to participate by submitting written comments to the agency
Notice of Proposed Rulemaking (NPRM)Slide11
After considering all public comments to a proposed rulePublished with agency’s conclusions on comments and thorough explanation of reasons for decisions
Final RulemakingSlide12
Published first as a final rule with an accompanying statement indicating the rule will take effect in X days unless someone submits a significant adverse or negative comment within a stated number of daysIf significant adverse comment received, proceed with normal notice-and-comment rulemaking
Used when agencies are confident that a rule will be non-controversial
Direct Final RuleSlide13
Once a regulation is completed and has been published as a final rule, it is codified when it is added to the Code of Federal Regulations (CFR)The CFR is the official record of all regulations created by the Federal Government
It is divided into 50 volumes, called titles, each of which focuses on a particular area
Almost all food and drug regulations appear in Title 21
Code of Federal RegulationsSlide14
Established in 1935 by the Federal Register ActPublished by the Office of the Federal RegisterOfficial daily publication of the Federal Government
Provides notification and record of agency rulemaking actions and other notices and announcement of agency actions and meetings.
Federal RegisterSlide15
Each Federal Register notice has a unique identifier, or docket numberA docket is the file that includes all the relevant public information about the agency action identified in the notice and and to which the public can submit comments
DocketSlide16
Guidance - a statement of policy on a regulatory issue or an interpretation of a statute or regulationRepresents the Agency’s current thinking on a regulatory issue
Used to communicate new or different regulatory expectations to a broad audience
What are guidance documents?Slide17
Guidance documents are prepared to establish clarity and consistency in FDA policies, regulatory activities, and inspection and enforcement procedures Guidance documents provide industry with specific recommendations on how to comply with the statutes and regulations and avoid enforcement actions
Guidance DocumentsSlide18
Do not have the force and effect of lawNot compulsoryAn alternative approach can be used if the approach satisfies the requirements of the applicable statutes and regulations
Guidance DocumentsSlide19
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
Guidance DocumentsSlide20
Ideas for development of guidance may come from FDA staff, regulated industry, or the publicThe public is encouraged to suggest topics for guidance documents and to participate actively in the guidance process
Early input through FDA-sponsored public meetings and workshops
Submission of draft or revised
guidances
When are guidances developed?Slide21
Each Office within CVM may receive suggestions or drafts of guidance and may meet with industry, trade groups, or consumer groups to come up with new guidance approachesIf the same subject matter and policy relates to more than two or three persons or firms, it might indicate that guidance should be developed in that area
When are guidances developed?Slide22
FDA is required to annually publish a guidance agenda that lists possible topics for future guidance document development or revision during the next yearThis enables the public to see what the Agency is working on
Guidance DevelopmentSlide23
FDA’s Good Guidance Practices (GGP) regulation ( 21 C.F.R. § 10.115) governs the development and issuance of guidances, and it gives interested persons a number of opportunities to provide input into the guidance development process
GuidancesSlide24
Set forth first interpretations of statutory or regulatory requirements;Set forth changes in interpretation or policy that are significant;Include complex scientific issues; or
Cover highly controversial issues
Most
guidances
are level 1
Level 1 GuidanceSlide25
Set forth existing practices or minor changes in interpretation or policyInclude all guidance documents that are not classified as Level 1
Level 2 GuidanceSlide26
Draft guidance is made available for public comment (typically 60-day comment period)Draft guidance may be revised based on public commentFinal guidance is made available to public
Procedure for Developing Level 1 GuidanceSlide27
However, FDA may implement a level 1 guidance immediately, without prior public comment, ifthe Agency determines that prior public participation is not feasible or appropriate (e.g., if there is a real public health issue);
OR
if a new statutory requirement, Executive Order, or court order requires immediate implementation
Procedure for Developing Level 1 GuidanceSlide28
Level 2 guidance is made available to the public in finalProcedure for Developing Level 2 GuidanceSlide29
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
Guidance DevelopmentSlide30
VICH – International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal ProductsInternational program of co-operation between regulatory authorities and the animal health industries
EU, Japan, and US (Australia, NZ, and Canada)
Includes both pharmaceutical and biological veterinary medicinal products
VICH GuidelinesSlide31
The VICH recommends ways to achieve greater harmonization in the interpretation and application of technical guidances and requirements for product registration to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines
VICH GuidelinesSlide32
Composed of delegates from regulatory authorities and industryDiscuss scientific and technical aspects of product registration
VICH experts ensure their parties are represented
The main “end-product” – a harmonized guideline that reflects scientific consensus regarding regulatory requirements
VICH GuidelinesSlide33
FDA delegates ensure that VICH guidelines do not contradict United States statutory or regulatory requirementsVICH guidelines are revised to conform to FDA's good guidance practices regulation and published as guidances
FDA and VICH GuidelinesSlide34
Consistent with the Federal Advisory Committee Act, FDA has established advisory committees when it is in the public interest in connection with the performance of the Agency’s regulatory dutiesFDA also has established some advisory committees as a result of specific statutory mandates
Advisory CommitteesSlide35
The procedures and rules that govern FDA’s advisory committee program are set forth in general terms in the Agency’s regulations (21 CFR Part 14)
Advisory CommitteesSlide36
FDA seeks input from advisory committees on a broad scope of complex issues related to the products it regulates Advisory committee meetings also facilitate public discussion of important topics and provide a means for the public to provide comments to the Agency
Every advisory committee meeting includes an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing
Advisory CommitteesSlide37
FDA’s advisory committees provide independent expert advice and recommendations to the Agency on scientific, technical, and policy matters related to FDA-regulated productsThese issues typically relate to a specific food or medical product, a class of foods or medical products, the development and implementation of a specific regulatory program, or the development and implementation of a regulatory policy
Advisory CommitteesSlide38
When not obligated by statute, FDA considers the following three factors in deciding whether to convene an advisory committee meeting: Is the matter at issue of such significant public interest that it would be highly beneficial to obtain the advice of an advisory committee as part of the Agency’s regulatory decision-making process?
Is the matter at issue so controversial that it would be highly beneficial to obtain the advice of an advisory committee as part of the Agency’s regulatory decision-making process?
Is there a special type of expertise that an advisory committee could provide that is needed for the Agency to fully consider a matter?
Advisory CommitteesSlide39
Examples of Scenarios:FDA is evaluating a first-in-class antimicrobial for use in food-producing animalsFDA has significant questions or concerns regarding the development or implementation of a regulatory policy or guidance document
FDA has concerns regarding post-approval adverse events reported for an approved drug
Advisory CommitteesSlide40
Although advisory committees provide recommendations to FDA, FDA makes the final decisions on any matters considered by an advisory committee
Advisory CommitteesSlide41
The First Amendment of the Constitution allows citizens to petition the government “in favor of or against policies that affect them or in which they feel strongly” At the FDA, the citizen petition process (21 CFR Part 10) is used to request the Commissioner to issue, amend, or revoke a regulation or order, or to take or refrain from taking any other form of administrative action
Citizen PetitionsSlide42
Members of Congress communicate through FDA’s Office of LegislationCongressional inquiries include:requests for information on specific CVM programs or policies requests for information on behalf of constituents
requesting witnesses to appear at hearings
requesting technical assistance when drafting legislation
Congressional InquiriesSlide43
Neutral and independent resource for members of FDA-regulated industries when they experience problems with the regulatory process that have not been resolved at the center or district level Works to resolve externally and internally generated problems for which there are no legal or established means of redress by finding approaches that are acceptable to both the affected party and to the Agency
Office of the OmbudsmanSlide44
Freedom of Information Act provides that any person has a right to obtain access to federal agency records, except to the extent that such records (or portions of them) are protected from public disclosureFreedom of Information RequestsSlide45
FDA encourages participation from all public stakeholders in its decision-making processes Congress/LawRegulation
Guidance
Advisory Committee
Citizen Petition
Freedom of Information Request
Foundations of Regulation