This week, we will continue looking at some of the background information relating to the FDA Guidance Documents.
This content is from the eCFR and is authoritative but unofficial.
| (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 the FDA's regulations on submission of documents to the Division of Dockets Management specified in § 10.20(j). |
| (i) | What standard elements must the 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| | (vii) | Contain the word "draft" if the document is a draft guidance.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 the 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| | (3) | When issuing draft guidance documents that are the product of international negotiations (e.g., guidances resulting from the International Conference on Harmonisation), the FDA need not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 the 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. 21 CFR 10.115 (up to date as of 8/19/2022) Good guidance practices. 21 CFR 10.115(g)(4)(i)(B) 21 CFR 10.115(j) (enhanced display) page 4 of 5 [65 FR 56477, Sept. 19, 2000, as amended at 83 FR 13416, Mar. 29, 2018]. |
| (k) | How will the 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 the FDA revise a guidance document. |
| (l) | How will the FDA ensure that the FDA staff is following the 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 the FDA's guidance documents? |
| | The FDA will make copies available in hard copy and, as feasible, through the Internet. |
| (n) | How will the FDA keep you informed of the guidance documents that are available? |
| | (1) | The 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, the 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) | The 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 the FDA did not follow the procedures in this section or that someone at the 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. |
Continued next week.
