Medical Devices; Quality System Regulation Amendments; Correction, 82945 [2024-23701]

Download as PDF Federal Register / Vol. 89, No. 199 / Tuesday, October 15, 2024 / Rules and Regulations 7400.11J is publicly available online at www.faa.gov/air_traffic/publications/. You may also contact the Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 600 Independence Avenue SW, Washington, DC 20597; telephone: (202) 267–8783. FAA Order JO 7400.11J lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points. Good Cause for No Notice and Comment Section 553(b)(3)(B) of Title 5, United States Code, (the Administrative Procedure Act) authorizes agencies to dispense with notice and comment procedures for rules when the agency for ‘‘good cause’’ finds that those procedures are ‘‘impracticable, unnecessary, or contrary to the public interest.’’ Under this section, an agency, upon finding good cause, may issue a final rule without seeking comment prior to the rulemaking. The FAA finds that prior notice and public comment to this final rule is unnecessary due to the brief length of the extension of the effective date and the fact that there is no substantive change to the rule. Delay of Effective Date Accordingly, pursuant to the authority delegated to me, the effective date of the final rule for Airspace Docket 23–AGL– 26, as published in the Federal Register on August 19, 2024 (89 FR 66987), FR Doc. 2024–18431, and corrected on September 30, 2024 (89 FR 79429), FR Doc. 2024–22253, is hereby delayed until December 26, 2024. ■ Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., P. 389. Issued in Washington, DC, on October 8, 2024. Brian Eric Konie, Acting Manager, Rules and Regulations Group. [FR Doc. 2024–23612 Filed 10–11–24; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration khammond on DSKJM1Z7X2PROD with RULES 21 CFR Part 820 [Docket No. FDA–2021–N–0507] RIN 0910–AH99 Medical Devices; Quality System Regulation Amendments; Correction AGENCY: Food and Drug Administration, HHS. VerDate Sep<11>2014 ACTION: Final rule; correction. Jkt 265001 DEPARTMENT OF HOMELAND SECURITY The Food and Drug Administration (FDA or Agency) is correcting a final rule that appeared in the Federal Register on February 2, 2024. In that final rule, FDA amended the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the device CGMP. FDA is correcting an editorial error that inadvertently omitted a definition in the codified of the final rule. This action is editorial in nature and is intended to ensure the accuracy and clarity of the Agency’s regulations. SUMMARY: DATES: Effective February 2, 2026. FOR FURTHER INFORMATION CONTACT: Laurie Sternberg, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5517, Silver Spring, MD 20993–0002, 240–402–0425. In the Federal Register of February 2, 2024 (89 FR 7496), FDA published a final rule that amended the device CGMPs requirements in 21 CFR part 820. The preamble indicated that the definition for ‘‘batch’’ or ‘‘lot’’ was set forth at § 820.3 (21 CFR 820.3) but the definition for ‘‘batch’’ or ‘‘lot’’ was inadvertently omitted from the codified portion of § 820.3 in the final rule. FDA is, therefore, correcting the codified for § 820.3 to include the definition of ‘‘batch’’ or ‘‘lot’’ as was intended and to be consistent with the preamble of the final rule. In FR Doc. 2024–01709 appearing on page 7524 in the Federal Register of Friday, February 2, 2024 (89 FR 7496), the following correction is made: SUPPLEMENTARY INFORMATION: § 820.3 [Corrected] 1. On page 7524, in amendment number 4, in the first column, in paragraph (a) of § 820.3, the definition for ‘‘Batch or lot’’ is added in alphabetical order to read as follows: ‘‘Batch or lot means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.’’ ■ Dated: October 7, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2024–23701 Filed 10–11–24; 8:45 am] BILLING CODE 4164–01–P 15:50 Oct 11, 2024 82945 PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 Coast Guard 33 CFR Part 117 [Docket No. USCG–2024–0845] RIN 1625–AA09 Drawbridge Operation Regulation; Wappinger Creek, New Hamburg, New York Coast Guard, DHS. Final rule. AGENCY: ACTION: The Coast Guard is removing the existing drawbridge operation regulation for the Metro-North Commuter Railroad Bridge, mile 0.0 across the Wappinger Creek at New Hamburg, New York. In 1991, the Metro-North Railroad Bridge was allowed to no longer be maintained as a movable structure and in 2004, the bridge was converted to a fixed bridge. The operating regulation is no longer applicable or necessary. DATES: This rule is effective October 15, 2024. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov. Type the docket number (USCG–2024–0845) in the ‘‘SEARCH’’ box and click ‘‘SEARCH’’. In the Document Type column, select ‘‘Supporting & Related Material.’’ FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Ms. Judy Leung-Yee, Project Officer, First Coast Guard District, telephone 212–514–4336, email Judy.K.Leung-Yee@uscg.mil. SUPPLEMENTARY INFORMATION: SUMMARY: I. Table of Abbreviations [Delete/Add Any Abbreviations Not Used/Used in This Document] CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register Pub. L. Public Law § Section U.S.C. United States Code II. Background Information and Regulatory History The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are E:\FR\FM\15OCR1.SGM 15OCR1

Agencies

[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Rules and Regulations]
[Page 82945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 820

[Docket No. FDA-2021-N-0507]
RIN 0910-AH99


Medical Devices; Quality System Regulation Amendments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is correcting 
a final rule that appeared in the Federal Register on February 2, 2024. 
In that final rule, FDA amended the device current good manufacturing 
practice (CGMP) requirements of the Quality System (QS) regulation to 
harmonize and modernize the device CGMP. FDA is correcting an editorial 
error that inadvertently omitted a definition in the codified of the 
final rule. This action is editorial in nature and is intended to 
ensure the accuracy and clarity of the Agency's regulations.

DATES: Effective February 2, 2026.

FOR FURTHER INFORMATION CONTACT: Laurie Sternberg, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5517, Silver Spring, MD 20993-0002, 240-
402-0425.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 2, 2024 
(89 FR 7496), FDA published a final rule that amended the device CGMPs 
requirements in 21 CFR part 820. The preamble indicated that the 
definition for ``batch'' or ``lot'' was set forth at Sec.  820.3 (21 
CFR 820.3) but the definition for ``batch'' or ``lot'' was 
inadvertently omitted from the codified portion of Sec.  820.3 in the 
final rule. FDA is, therefore, correcting the codified for Sec.  820.3 
to include the definition of ``batch'' or ``lot'' as was intended and 
to be consistent with the preamble of the final rule.
    In FR Doc. 2024-01709 appearing on page 7524 in the Federal 
Register of Friday, February 2, 2024 (89 FR 7496), the following 
correction is made:


Sec.  820.3  [Corrected]

0
1. On page 7524, in amendment number 4, in the first column, in 
paragraph (a) of Sec.  820.3, the definition for ``Batch or lot'' is 
added in alphabetical order to read as follows:
    ``Batch or lot means one or more components or finished devices 
that consist of a single type, model, class, size, composition, or 
software version that are manufactured under essentially the same 
conditions and that are intended to have uniform characteristics and 
quality within specified limits.''

    Dated: October 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-23701 Filed 10-11-24; 8:45 am]
BILLING CODE 4164-01-P
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