Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correction, 83781-83782 [2024-24100]

Download as PDF Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Rules and Regulations dates. This amendment also identifies the airport and its location, the procedure, and the amendment number. khammond on DSKJM1Z7X2PROD with RULES Availability and Summary of Material Incorporated by Reference The material incorporated by reference is publicly available as listed in the ADDRESSES section. The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule. The Rule This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Air Missions (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts. The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided. Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days. The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same VerDate Sep<11>2014 15:57 Oct 17, 2024 Jkt 265001 reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. Lists of Subjects in 14 CFR Part 97 Air Traffic Control, Airports, Incorporation by reference, Navigation (Air). Issued in Washington, DC on September 27, 2024. Thomas J. Nichols, Standards Section Manager, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Office of Safety Standards, Flight Standards Service, Aviation Safety, Federal Aviation Administration. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: ■ Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722. 2. Part 97 is amended to read as follows: ■ Effective 31 October 2024 Kake, AK, AFE/PAFE, NDB/DME RWY 11, Amdt 1A, CANCELED Ketchikan, AK, KTN/PAKT, ILS Y OR LOC Y RWY 11, Amdt 8A Ketchikan, AK, KTN/PAKT, ILS Z OR LOC Z RWY 11, Amdt 2 Ketchikan, AK, KTN/PAKT, LOC X RWY 11, Amdt 1A Imperial, CA, IPL, VOR–A, Amdt 5 Sacramento, CA, MHR, RNAV (GPS) RWY 4R, Amdt 3 Fort Myers, FL, RSW, ILS OR LOC RWY 6, Amdt 8 Fort Myers, FL, RSW, RNAV (GPS) Y RWY 6, Amdt 2 Fort Myers, FL, RSW, RNAV (GPS) Y RWY 24, Amdt 2 Fort Myers, FL, RSW, RNAV (RNP) Z RWY 6, Orig Fort Myers, FL, RSW, RNAV (RNP) Z RWY 24, Orig Fort Myers, FL, RSW, VOR OR TACAN RWY 24, Amdt 2D St Petersburg, FL, KSPG, RNAV (GPS) RWY 18, Amdt 2 St Petersburg, FL, KSPG, VOR RWY 18, Amdt 10, CANCELED Iowa City, IA, IOW, RNAV (GPS) RWY 25, Amdt 3 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 83781 Iowa City, IA, IOW, RNAV (GPS) RWY 30, Amdt 2 Iowa City, IA, KIOW, Takeoff Minimums and Obstacle DP, Amdt 5A Iowa City, IA, IOW, VOR–A, Amdt 1 Augusta, KS, 3AU, RNAV (GPS) RWY 18, Orig Augusta, KS, 3AU, RNAV (GPS) RWY 36, Amdt 2 Augusta, KS, 3AU, Takeoff Minimums and Obstacle DP, Amdt 2 Augusta, KS, 3AU, VOR–A, Amdt 3 Perryville, MO, PCD, RNAV (GPS) RWY 2, Amdt 1 Perryville, MO, PCD, RNAV (GPS) RWY 20, Amdt 1 Perryville, MO, KPCD, Takeoff Minimums and Obstacle DP, Amdt 1 White Sulphur Springs, MT, 7S6, RNAV (GPS) RWY 1, Orig White Sulphur Springs, MT, 7S6, RNAV (GPS) RWY 19, Orig White Sulphur Springs, MT, 7S6, Takeoff Minimums and Obstacle DP, Orig Youngstown/Warren, OH, YNG, RNAV (GPS) RWY 32, Amdt 1 Klamath Falls, OR, LMT, ILS Y OR LOC Y RWY 32, Amdt 21 Klamath Falls, OR, LMT, RNAV (GPS) RWY 14, Amdt 2 Klamath Falls, OR, LMT, RNAV (GPS) RWY 32, Amdt 1 Brownwood, TX, BWD, LOC RWY 17, Amdt 5 Brownwood, TX, BWD, RNAV (GPS) RWY 17, Amdt 1D Brownwood, TX, BWD, VOR RWY 17, Orig Brownwood, TX, BWD, VOR RWY 35, Amdt 2 Lubbock, TX, F82, RNAV (GPS) RWY 17, Orig Lubbock, TX, F82, RNAV (GPS) RWY 35, Orig Lubbock, TX, F82, Takeoff Minimums and Obstacle DP, Orig [FR Doc. 2024–23953 Filed 10–17–24; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 16 [Docket No. FDA–2024–N–3654] RIN 0910–AI97 Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule; correction. 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 SUMMARY: E:\FR\FM\18OCR1.SGM 18OCR1 83782 Federal Register / Vol. 89, No. 202 / Friday, October 18, 2024 / Rules and Regulations 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] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Financial Crimes Enforcement Network 31 CFR Part 1010 the language exempting certain public utilities from the definition of ‘‘reporting company’’ in the beneficial ownership information reporting rule to more clearly implement the language of the exemption found in the Corporate Transparency Act. DATES: This rule is October 18, 2024. FOR FURTHER INFORMATION CONTACT: The FinCEN Regulatory Support Section at 1–800–767–2825 or electronically at frc@fincen.gov. SUPPLEMENTARY INFORMATION: I. Background On September 30, 2022, FinCEN issued the beneficial ownership information (BOI) reporting rule (‘‘Reporting Rule’’).1 That rule implemented the reporting requirements of section 6403 of the Corporate Transparency Act (CTA), enacted into law as part of the National Defense Authorization Act of Fiscal Year 2021 (NDAA).2 The CTA requires certain types of domestic and foreign entities, called ‘‘reporting companies,’’ to submit information about ‘‘beneficial owners’’ to FinCEN.3 The CTA generally defines a reporting company as a corporation, limited liability company, or other similar entity that is created or registered to do business in the United States by the filing of a document with a secretary of state or similar office under the law of a State or Indian Tribe.4 The CTA exempts twenty-three categories of entities from that definition.5 One such exemption is for ‘‘a public utility that provides telecommunications services, electrical power, natural gas, or water and sewer services within the United States.’’ 6 In the Reporting Rule, FinCEN gave precision to the CTA’s public utility exemption by making a reference to the Internal Revenue Code, which defines a regulated public utility for tax purposes. The Reporting Rule states that the exemption applies to ‘‘[a]ny entity that is a regulated public utility as defined in 26 U.S.C. 7701(a)(33)(A) that provides telecommunications services, electrical power, natural gas, or water RIN 1506–AB49 Update to the Public Utility Exemption Under the Beneficial Ownership Information Reporting Rule Financial Crimes Enforcement Network (FinCEN), Treasury. ACTION: Final rule. khammond on DSKJM1Z7X2PROD with RULES AGENCY: FinCEN is publishing this final rule to clarify an exemption under the beneficial ownership information reporting rule that FinCEN published on September 30, 2022. This rule modifies SUMMARY: VerDate Sep<11>2014 15:57 Oct 17, 2024 Jkt 265001 1 87 FR 59498 (Sept. 30, 2022), codified at 31 CFR 1010.380. 2 The CTA is Title LXIV of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021, Public Law 116–283 (Jan. 1, 2021). Division F of the NDAA is the Anti-Money Laundering Act of 2020, which includes the CTA. Section 6403 of the CTA, among other things, amends the Bank Secrecy Act (BSA) by adding a new section 5336, Beneficial Ownership Information Reporting Requirements, to subchapter II of chapter 53 of title 31, United States Code. 3 31 U.S.C. 5336(b)(1). 4 31 U.S.C. 5336(a)(11)(A). 5 31 U.S.C. 5336(a)(11)(B). 6 31 U.S.C. 5336(a)(11)(B)(xvi). PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 and sewer services within the United States.’’ 7 While the CTA’s public utility exemption mentions four types of public utilities (telecommunications services, electrical power, natural gas, and water and sewer services), questions have arisen about the application of the exemption to providers of telecommunications services because the specific provision cross-referenced in the Internal Revenue Code definition—subparagraph (A) of 26 U.S.C. 7701(a)(33)—is only part of the definition of a regulated public utility that provides telecommunications services. Unlike covered providers of electrical power, natural gas, and water and sewer services, which are defined in subparagraph (A), covered providers of telecommunications services are defined by operation of subparagraphs (D) and (A) together. Subparagraph (D) specifies that a regulated public utility includes ‘‘a corporation engaged in the furnishing or sale of telephone or telegraph service, if the rates for such furnishing or sale meet the requirements of subparagraph (A),’’ and subparagraph (A) sets forth those requirements with regard to rates. FinCEN intended to cross-reference both of these provisions in the Reporting Rule’s public utility exemption but inadvertently omitted a reference to subparagraph (D) in the final rule.8 On June 10, 2024, FinCEN issued guidance in the form of a Frequently Asked Question clarifying that the CTA’s exemption for public utilities includes a corporation engaged in the furnishing or sale of telephone or telegraph services if the rates for such furnishing or sale meet the requirements of 26 U.S.C. 7701(a)(33)(A), as specified in 26 U.S.C. 7701(a)(33)(D).9 II. The Final Rule In this final rule, FinCEN is amending its regulations, consistent with its June 10, 2024 guidance, to make clear that certain telecommunications services providers are exempt from reporting requirements under the CTA. To avoid any confusion arising from the crossreference to subparagraph (A), FinCEN is adding a cross-reference to subparagraph (D). As amended, the regulation will provide as follows (new language in bold italics): ‘‘(xvi) Public utility. Any entity that is a regulated public utility as defined in 26 U.S.C. 7701(a)(33)(A) or (D) that provides 7 31 CFR 1010.380(c)(2)(xvi). had cross-referenced both (A) and (D) in the proposed rule, 86 FR 69920 (Dec. 8, 2021). 9 FinCEN Frequently Asked Question L.8. (Jun. 10, 2024) available at https://www.fincen.gov/boifaqs. 8 FinCEN E:\FR\FM\18OCR1.SGM 18OCR1

Agencies

[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Rules and Regulations]
[Pages 83781-83782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24100]


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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


Regulatory Hearing Before the Food and Drug Administration; 
General Provisions; Amendments; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; correction.

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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

[[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]
BILLING CODE 4164-01-P
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