Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

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###### Department of Health and Human Services

###### Food and Drug Administration

          - 21 CFR Part 16
          - [Docket No. FDA-2024-N-3654]
          - RIN 0910-AI97

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Direct final rule; correction.

# SUMMARY:

                        The Food and Drug Administration (FDA, Agency, or we) is correcting a final rule entitled “Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments” that appeared                               ( print page 83782)                            in the                         **Federal Register**                         of September 20, 2024. The final rule inadvertently omitted the effective date for a provision in the regulatory text. This document corrects the error in the                         **DATES**                         portion.                    

# DATES:

Effective February 3, 2025.

# FOR FURTHER INFORMATION CONTACT:

Joyce Strong, Office of Policy, Legislation, and International Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-9148.

# SUPPLEMENTARY INFORMATION:

                    In FR Doc. 2024-21231, published in the                     **Federal Register**                     of Friday, September 20, 2024 (89 FR 77019), on page 77019, in the third column, the                     **DATES**                     section is corrected to read as follows:                

**DATES:***Effective date:*                     This rule is effective February 3, 2025, except for amendatory instruction number 3, amending 21 CFR 16.1(b)(2), which is effective December 18, 2025. Either electronic or written comments on the direct final rule or its companion proposed rule must be submitted by December 4, 2024. If FDA receives no significant adverse comments within the specified comment period, the Agency intends to publish a document confirming the effective date of the final rule in the                     **Federal Register**                     within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the                     **Federal Register**                     withdrawing this direct final rule within 30 days after the comment period on this direct final rule ends.                

Dated: October 10, 2024.

Eric Flamm,

Acting Associate Commissioner for Policy.

[FR Doc. 2024-24100 Filed 10-17-24; 8:45 am]

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