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.
| (g) | What are the FDA's procedures for developing and issuing guidance documents? |
| | (1) | The FDA's procedures for the development and issuance of Level 1 guidance documents are as follows: |
| | (i) | Before the FDA prepares a draft of a Level 1 guidance document, the FDA can seek or accept early input from individuals or groups outside the agency. For example, the FDA can do this by participating in or holding public meetings and workshops. |
| | (ii) | After the FDA prepares a draft of a Level 1 guidance document, the 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| | (A) | Publish a notice in the Federal Register announcing that the draft guidance document is available; |
| | (B) | Post the draft guidance document on the Internet and make it available in hard copy; and |
| | (C) | Invite your comment on the draft guidance document.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 the FDA prepares a draft of a Level 1 guidance document, the 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| | (B) | Present the draft guidance document to an advisory committee for review.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, the 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, the FDA may decide that it should issue another draft of the guidance document. In this case, the FDA will follow the steps in paragraphs (g)(1)(ii), (g)(1)(iii), and (g)(1)(iv) of this section. |
| | (2) | The 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) | The 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 the FDA prepares a guidance document, the 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 the FDA receives comments on the guidance document, the FDA will review those comments and revise the guidance document when appropriate. |
| | (4) | The FDA will use the following procedures for developing and issuing Level 2 guidance documents: |
| | (i) | After it prepares a guidance document, the FDA will: |
| | (A) | Post the guidance document on the Internet and make it available in hard copy; |
| | (B) | Immediately implement the guidance document, unless the 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 the FDA receives comments on the guidance document, the 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. The 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 the FDA's regulations on submission of documents to the Division of Dockets Management specified in § 10.20 (j). |
