As noting in a newly published request for information on prescription drug software (83FR58574), FDA has a regulation which lays out its own rules for issuing these guidance documents. See 21 CFR 10.115.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.115
FDA has two types of Guidance Documents, Level 1 or Level 2. Level 1 sets out FDA interpretation of statute, regulation, or has complex scientific content. Any other guidance document is "Level 2."
The regulation was established by 64 FR 56477, 13pp, 9/19/2000, with a trivial amendment regarding a web link in 2018, 83 FR 13416, 3/29/2018.
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Subpart B--General Administrative Procedures
| Sec. 10.115 Good guidance practices. |
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.
(b) What is a guidance document? (1) Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue.
(2) Guidance documents include, but are not limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies.
(3) Guidance documents do not include: Documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding, or other communications directed to individual persons or firms.
(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.
(d) Are you or FDA required to follow a guidance document? (1) No. Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.
(2) You may choose to use an approach other than the one set forth in a guidance document. However, your alternative approach must comply with the relevant statutes and regulations. FDA is willing to discuss an alternative approach with you to ensure that it complies with the relevant statutes and regulations.
(3) Although guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore, FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.
(e) Can FDA use means other than a guidance document to communicate new agency policy or a new regulatory approach to a broad public audience? The agency may not use documents or other means of communication that are excluded from the definition of guidance document to informally communicate new or different regulatory expectations to a broad public audience for the first time. These GGP's must be followed whenever regulatory expectations that are not readily apparent from the statute or regulations are first communicated to a broad public audience.
(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 Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. If you wish to submit the draft of a proposed guidance document electronically, submit it through https://www.regulations.gov at Docket No. FDA-2013-S-0610. It is only necessary to submit one copy.
(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.
(g) What are FDA's procedures for developing and issuing guidance documents? (1) FDA's procedures for the development and issuance of Level 1 guidance documents are as follows:
(i) Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. For example, FDA can do this by participating in or holding public meetings and workshops.
(ii) After FDA prepares a draft of a Level 1 guidance document, FDA will:
(A) Publish a notice in the Federal Register announcing that the draft guidance document is available;
(B) Post the draft guidance document on the Internet and make it available in hard copy; and
(C) Invite your comment on the draft guidance document. Paragraph (h) of this section tells you how to submit your comments.
(iii) After FDA prepares a draft of a Level 1 guidance document, FDA also can:
(A) Hold public meetings or workshops; or
(B) Present the draft guidance document to an advisory committee for review.
(iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will:
(A) Review any comments received and prepare the final version of the guidance document that incorporates suggested changes, when appropriate;
(B) Publish a notice in the Federal Register announcing that the guidance document is available;
(C) Post the guidance document on the Internet and make it available in hard copy; and
(D) Implement the guidance document.
(v) After providing an opportunity for comment, FDA may decide that it should issue another draft of the guidance document. In this case, FDA will follow the steps in paragraphs (g)(1)(ii), (g)(1)(iii), and (g)(1)(iv) of this section.
(2) FDA will not seek your comment before it implements a Level 1 guidance document if the agency determines that prior public participation is not feasible or appropriate.
(3) FDA will use the following procedures for developing and issuing Level 1 guidance documents under the circumstances described in paragraph (g)(2) of this section:
(i) After FDA prepares a guidance document, FDA will:
(A) Publish a notice in the Federal Register announcing that the guidance document is available;
(B) Post the guidance document on the Internet and make it available in hard copy;
(C) Immediately implement the guidance document; and
(D) Invite your comment when it issues or publishes the guidance document. Paragraph (h) of this section tells you how to submit your comments.
(ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the guidance document when appropriate.
(4) FDA will use the following procedures for developing and issuing Level 2 guidance documents:
(i) After it prepares a guidance document, FDA will:
(A) Post the guidance document on the Internet and make it available in hard copy;
(B) Immediately implement the guidance document, unless FDA indicates otherwise when the document is made available; and
(C) Invite your comment on the Level 2 guidance document. Paragraph (h) of this section tells you how to submit your comments.
(ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the document when appropriate. If a version is revised, the new version will be placed on the Internet.
(5) You can comment on any guidance document at any time. Paragraph (h) of this section tells you how to submit your comments. FDA will revise guidance documents in response to your comments when appropriate.
(h) How should you submit comments on a guidance document? (1) If you choose to submit comments on any guidance document under paragraph (g) of this section, you must send them to the Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(2) Comments should identify the docket number on the guidance document, if such a docket number exists. For documents without a docket number, the title of the guidance document should be included.
(3) Comments will be available to the public in accordance with FDA's regulations on submission of documents to the Division of Dockets Management specified in 10.20(j).
(i) What standard elements must FDA include in a guidance document? (1) A guidance document must:
(i) Include the term "guidance,"
(ii) Identify the center(s) or office(s) issuing the document,
(iii) Identify the activity to which and the people to whom the document applies,
(iv) Prominently display a statement of the document's nonbinding effect,
(v) Include the date of issuance,
(vi) Note if it is a revision to a previously issued guidance and identify the document that it replaces, and
(vii) Contain the word "draft" if the document is a draft guidance.
(2) Guidance documents must not include mandatory language such as "shall," "must," "required," or "requirement," unless FDA is using these words to describe a statutory or regulatory requirement.
(3) When issuing draft guidance documents that are the product of international negotiations (e.g., guidances resulting from the International Conference on Harmonisation), FDA need not apply paragraphs (i)(1) and (i)(2) of this section. However, any final guidance document issued according to this provision must contain the elements in paragraphs (i)(1) and (i)(2) of this section.
(j) Who, within FDA, can approve issuance of guidance documents? Each center and office must have written procedures for the approval of guidance documents. Those procedures must ensure that issuance of all documents is approved by appropriate senior FDA officials.
(k) How will FDA review and revise existing guidance documents? (1) The agency will periodically review existing guidance documents to determine whether they need to be changed or withdrawn.
(2) When significant changes are made to the statute or regulations, the agency will review and, if appropriate, revise guidance documents relating to that changed statute or regulation.
(3) As discussed in paragraph (f)(3) of this section, you may at any time suggest that FDA revise a guidance document.
(l) How will FDA ensure that FDA staff are following GGP's? (1) All current and new FDA employees involved in the development, issuance, or application of guidance documents will be trained regarding the agency's GGP's.
(2) FDA centers and offices will monitor the development and issuance of guidance documents to ensure that GGP's are being followed.
(m) How can you get copies of FDA's guidance documents? FDA will make copies available in hard copy and, as feasible, through the Internet.
(n) How will FDA keep you informed of the guidance documents that are available? (1) FDA will maintain on the Internet a current list of all guidance documents. New documents will be added to this list within 30 days of issuance.
(2) Once a year, FDA will publish in the Federal Register its comprehensive list of guidance documents. The comprehensive list will identify documents that have been added to the list or withdrawn from the list since the previous comprehensive list.
(3) FDA's guidance document lists will include the name of the guidance document, issuance and revision dates, and information on how to obtain copies of the document.
(o) What can you do if you believe that someone at FDA is not following these GGP's? If you believe that someone at FDA did not follow the procedures in this section or that someone at FDA treated a guidance document as a binding requirement, you should contact that person's supervisor in the center or office that issued the guidance document. If the issue cannot be resolved, you should contact the next highest supervisor. You can also contact the center or office ombudsman for assistance in resolving the issue. If you are unable to resolve the issue at the center or office level or if you feel that you are not making progress by going through the chain of command, you may ask the Office of the Chief Mediator and Ombudsman to become involved.
[65 FR 56477, Sept. 19, 2000, as amended at 83 FR 13416, Mar. 29, 2018]
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Tidbit
See FDA's announcement of a new program to have pre pivotal trial meetinss with FDA about innovative (eg Bayesian) designs. August 2018. https://www.gpo.gov/fdsys/pkg/FR-2018-08-30/pdf/2018-18801.pdf
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