Table of Contents

Guidance Documents
Withdrawn/Replaced
Under Development
Purpose
Legal Effect
How to Comment
Obtaining Copies
Additional Information
CFR Citations

Purpose of Guidance Documents

Guidance documents are intended to:

provide information to the public and assistance to the regulated industry by clarifying requirements that have been imposed by Congress or issued by FDA in regulations, by explaining how to comply with statutory and regulatory requirements, and provide specific review and enforcement approaches to help ensure that FDA employees implement the agency's mandate in an effective, fair, and consistent manner.

Certain guidance documents provide information on important characteristics of pre-clinical and clinical test procedures, manufacturing practices, and scientific protocols. Others provide information on how to comply with the relevant statutes and regulations, avoid enforcement actions, or evaluate a submission.

Legal Effect of Guidance Documents

Guidance documents are not legally binding on the public or the agency. They represent the agency's current thinking on the subject. While we will take steps to ensure that CVM staff do not deviate from the guidance without appropriate justification and appropriate supervisory concurrence, it is acceptable for the regulated industry to use alternative methods that comply with the relevant statute or regulations. If a regulated company or person wishes to use an approach that is different from that described in a guidance document, FDA is willing to discuss the alternative methods of complying with the applicable statutes or regulations. FDA encourages the industry to discuss alternative methods before implementing them to avoid unnecessary or wasteful expenditures of resources.

CVM develops and issues its guidance documents (guidances) in accordance with FDA's good guidance practices (GGP) regulations (21 CFR 10.115) published in the Federal Register on September 19, 2000 (65 FR 5646). The procedures differ for developing and issuing Level 1 and Level 2 guidances. Usually, the agency must request public comment before implementing Level 1 guidances, while it may implement Level 2 guidances without prior comment. Thus, CVM usually publishes Level 1 guidances in draft form with a request for comments and, after it reviews comments, publishes the guidance in final form. The criteria for determining whether a guidance is Level 1 or 2 are found at 21 CFR 10.115(c). (See Code of Federal Register Citations at the end of this document.)

The GGP regulations encourage public participation in the development and issuance of guidances. For example, the public may comment at any time on a draft or final guidance that the agency has issued. Anyone may suggest that the agency revise or withdraw an existing guidance, and anyone may submit a draft of a proposed guidance. The GGP regulations at 21 CFR 10.115 (f) describe how the public may participate. (See Code of Federal Register Citations at the end of this document.)

To Comment on CVM Published Guidance

The agency welcomes comments on current guidance documents at any time. Comments should be sent to the location provided on the cover sheet of the guidance or to the Dockets Management Branch (HFA-305), 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For directions on how to comment on guidance documents under development, see CVM Guidance Documents Under Development.

Federal Register Notices

Docket No. 1998N-0046, OC 200445.  Annual Comprehensive List of Guidance Documents at the Food and Drug Administration.  Pages  824-913 [FR Doc. 05-00155]   January 5, 2005 | htm | | pdf | Comments due January 5, 2006

Docket No. 2004D-0160, CVM 200454. Withdrawal of Guidance Document on Use of Unapproved Hormone Implants in Veal Calves. Pages 42443 -42444 [FR Doc. 04-16036] July 15, 2004 | htm | | pdf |

Docket No. 2004N-0234, OC 2004131. Annual Guidance Agenda. Pages 41510-41540 [FR Doc. 04-15660] July 9, 2004 | htm |  | pdf | Comments by July 9, 2006

Docket No. 2004N-0234, OC 200689. Annual Guidance Agenda. Pages 52125-52136 [FR Doc. E6-14549]  | [htm] | | [pdf]  |
Comments may be submitted anytime.

To Obtain Copies of Published Guidance

To make the development and issuance of guidance documents transparent, the agency uses the Internet and other means to make documents accessible to the public. Electronic versions of CVM's guidance documents are found on CVM's website and on FDA's website . Notification of publication of CVM's recently issued guidance documents can be found on CVM's website . The public may search for notices of availability of guidance documents at on the Federal Register's website. Paper copies of CVM guidance documents can be obtained by writing to: Food and Drug Administration, Center for Veterinary Medicine HFV-12, Communications Staff, 7519 Standish Place, Rockville, Maryland 20855, or by calling (240) 276-9300. A question on a published guidance should be sent to the person listed in the guidance document as the person to contact.

Additional Information

Additional information can be found in the FDA Compliance Policy Guides and the CVM Program Policy and Procedures Manual. For information on special symbols and other issues, see the Conventions used in FDA CVM hypertext documents CVM Guidance for Industry.

Code of Federal Regulations Citations

21 CFR 10.115(c)
Sec. 10.115(c) Good guidance practices.
* * * * *
(c) What other terms have a special meaning?

(1) ``Level 1 guidance documents'' include guidance documents that:

(i) Set forth initial interpretations of statutory or regulatory requirements;
(ii) Set forth changes in interpretation or policy that are of more than a minor nature;
(iii) Include complex scientific issues; or
(iv) Cover highly controversial issues.

(2) ``Level 2 guidance documents'' are guidance documents that set forth existing practices or minor changes in interpretation or policy. Level 2 guidance documents include all guidance documents that are not classified as Level 1.

(3) ``You'' refers to all affected parties outside of FDA.

21 CFR 10.115(f)
Sec. 10.115(f) Good guidance practices.
* * * * *

(f) How can you participate in the development and issuance of guidance documents?

(1) You can provide input on guidance documents that FDA is developing under the procedures described in paragraph (g) of this section.

(2) You can suggest areas for guidance document development. Your suggestions should address why a guidance document is necessary.

(3) You can submit drafts of proposed guidance documents for FDA to consider. When you do so, you should mark the document ``Guidance Document Submission'' and submit it to Dockets Management Branch (HFA- 305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

(4) You can, at any time, suggest that FDA revise or withdraw an already existing guidance document. Your suggestion should address why the guidance document should be revised or withdrawn and, if applicable, how it should be revised.

(5) Once a year, FDA will publish, both in the Federal Register and on the Internet, a list of possible topics for future guidance document development or revision during the next year. You can comment on this list (e.g., by suggesting alternatives or making recommendations on the topics that FDA is considering).

(6) To participate in the development and issuance of guidance documents through one of the mechanisms described in paragraphs (f)(1), (f)(2), or (f)(4) of this section, you should contact the center or office that is responsible for the regulatory activity covered by the guidance document.

(7) If FDA agrees to draft or revise a guidance document, under a suggestion made under paragraphs (f)(1), (f)(2), (f)(3) or (f)(4) of this section, you can participate in the development of that guidance document under the procedures described in paragraph (g) of this section.

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