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U.S. Department of Health and Human Services

Animal & Veterinary

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by Carol Haley, Ph.D.
FDA Veterinarian Newsletter January/February 1998 Volume XIII, No I

Written guidance, in the form of "guidelines", compliance policy guides, "question and answer documents", letters, etc., help FDA staff, regulated industry, and the field offices keep abreast of changing policies. Guidance can be used for a variety of purposes, such as explaining new regulations, conveying a change in policy about regulatory discretion for a class of products, or explaining how reviewers evaluate studies submitted in support of new animal drug applications. Obviously, guidance is meant to be helpful. Unfortunately, confusion about how guidance can be used led the Indiana Medical Devices Manufacturers Council to file a citizen petition with FDA and to bring the matter up with Congress in 1995. The industry felt that FDA misused guidance and that guidance document development needed improvement. FDA's eventual response to these concerns was the publication of its policy regarding "Good Guidance Practices" (GGPs) in the Federal Register on February 27,1997.

The GGP policy was developed to ensure that FDA addressed the main concerns expressed by regulated groups and others who commented on FDA's use of guidance. The policy requires that guidance 1) not be applied as legally binding requirements, 2) be developed with adequate public participation, and 3) be readily available to the public. FDA staff are expected to abide by GGPs, and the policy states that staff involved in the development of guidance must receive training in GGPs.

The Good Guidance policy stresses that guidance documents are not legally binding on the public or the Agency. A guidance document represents the Agency's current thinking on the subject discussed in the document. Because guidance documents are not legally binding, FDA staff or industry may deviate from a guidance document with appropriate justification. FDA staff must get supervisory concurrence before they deviate from a guidance document.

FDA staff who are developing guidance are strongly encouraged to find ways to get as much public input as possible. Public participation in the development of guidance can take a number of forms, including workshops and meetings. In addition, a two-tiered system ensures that certain types of guidance documents (e.g., those that deal with highly controversial issues or are first interpretations of regulations), called Level 1 guidance, be made available for public comment before they are implemented. A notice of availability of the draft document will be placed in the Federal Register, and comments will be sent to the Dockets Management Branch of FDA. Level 1 guidances may be implemented without prior public comment in certain special circumstances, for example, if there is a public health reason for immediate implementation.

Other guidances are called Level 2 guidance and may be implemented without prior public input. However, the public may comment on both Level 1 and Level 2 guidances at any time after implementation.

The Good Guidance Practice policy requires Centers to make all their guidance documents available to the public. Also, FDA will maintain a list of all guidance documents on its homepage and regularly publish in the Federal Register a list of new guidance documents and a list of guidance documents that have been withdrawn.

The public is welcome to request new guidances or revisions of old guidances at any time. Periodically, FDA will publish in the Federal Register a list of possible topics for guidance document development or revision during the next year. The agency will request comment from the public on this list.

GGPs should help the Agency develop guidance that is more useful to all its customers and ensure that the public has ready access to guidance documents.