Advisory Committee; Allergenic Products Advisory Committee; Termination; Removal From List of Standing Committees, 56662-56663 [2024-15136]

Download as PDF 56662 Federal Register / Vol. 89, No. 132 / Wednesday, July 10, 2024 / Rules and Regulations (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, AIR–520, Continued Operational Safety Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD. (1) For more information about this AD, contact Nicole Tsang, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206–231–3959; email: Nicole.S.Tsang@faa.gov. (2) Boeing material identified in this AD that is not incorporated by reference is available at the address specified in paragraph (l)(3) of this AD. (l) Material Incorporated by Reference ddrumheller on DSK120RN23PROD with RULES1 (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this material as applicable to do the actions required by this AD, unless the AD specifies otherwise. (i) Boeing Special Attention Requirements Bulletin 737–35–1210 RB, dated June 17, 2024. (ii) Boeing Special Attention Requirements Bulletin 737–35–1211 RB, dated June 17, 2024. (3) For Boeing material, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110–SK57, Seal Beach, CA 90740–5600; telephone 562–797– 1717; website myboeingfleet.com. (4) You may view this material at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206–231–3195. (5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ ibr-locations or email fr.inspection@nara.gov. Issued on June 20, 2024. Suzanne Masterson, Deputy Director, Integrated Certificate Management Division, Aircraft Certification Service. [FR Doc. 2024–15229 Filed 7–8–24; 11:15 am] BILLING CODE 4910–13–P 15:36 Jul 09, 2024 Food and Drug Administration 21 CFR Part 14 [Docket No. FDA–2024–N–3008] Advisory Committee; Allergenic Products Advisory Committee; Termination; Removal From List of Standing Committees Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Final rule. AGENCY: (k) Related Information VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 262001 The Food and Drug Administration (FDA or Agency) is announcing the termination of the Allergenic Products Advisory Committee, Center for Biologics Evaluation and Research. This document announces the reasons for termination and removes the Allergenic Products Advisory Committee from the Agency’s list of standing advisory committees. DATES: This rule is effective July 10, 2024. FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of Scientific Advisors and Consultants, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993–0002, 240–506–4946, Prabhakara.Atreya@fda.hhs.gov. SUPPLEMENTARY INFORMATION: The Allergenic Products Advisory Committee (the Committee) was established on July 9, 1984 (49 FR 30688). The Committee advises the Commissioner of Food and Drugs (Commissioner) or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease, and makes appropriate recommendations to the Commissioner of its findings regarding the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the products, on clinical and laboratory studies of such products, on amendments or revisions to SUMMARY: PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 regulations governing the manufacture, testing, and licensing of allergenic biological products, and on the quality and relevance of FDA’s research programs that provide the scientific support for regulating these agents. Over the past several years, the Committee has met infrequently. As such, the effort and expense of maintaining the Committee can no longer be justified. The Committee will be terminated on July 9, 2024. The responsibilities of this Committee will be integrated into the Vaccines and Related Biological Products Advisory Committee (VRBPAC) charter ensuring that FDA has a mechanism to seek independent expert input on allergenic biological products. Specifically, the VRBPAC charter will be revised such that VRBPAC will be available to provide advice and recommendations to the Commissioner on allergenic biological products or materials for humans for the diagnosis, prevention, or treatment of allergies and allergic disease, as appropriate. Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), the Agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule. Notice and public comment and a delayed effective date are unnecessary because the Committee is not being adequately used, and termination of the committee is effective on July 9, 2024, in accordance with 21 CFR 14.55. This final rule merely removes the name of the Allergenic Products Advisory Committee from the list of standing advisory committees in § 14.100 (21 CFR 14.100). Therefore, the Agency is amending § 14.100(b) as set forth in the regulatory text of the document. List of Subjects in 21 CFR Part 14 Administrative practice and procedure, Advisory committees, Color additives, Drugs, Radiation protection. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows: PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE 1. The authority citation for part 14 continues to read as follows: ■ Authority: 5 U.S.C. 1001 et seq.; 15 U.S.C. 1451–1461; 21 U.S.C. 41–50, 141–149, 321– 394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264, 284m, 284m–1; Pub. L. 107–109, 115 Stat. 1419. E:\FR\FM\10JYR1.SGM 10JYR1 Federal Register / Vol. 89, No. 132 / Wednesday, July 10, 2024 / Rules and Regulations § 14.100 [Amended] II. Background Information and Regulatory History 2. Amend § 14.100 by removing paragraph (b)(1) and redesignating paragraphs (b)(2) through (4) as paragraphs (b)(1) through (3). ■ Dated: July 5, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–15136 Filed 7–9–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2024–0601] RIN 1625–AA00 Safety Zone; Petit Fleur Events Wedding Fireworks, Lake St. Clair; Grosse Pointe Farms, MI Coast Guard, DHS. Temporary final rule. AGENCY: ACTION: The Coast Guard is establishing a temporary safety zone for navigable waters on Lake St. Clair, Grosse Pointe Farms, MI. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards associated with fireworks displays created by Petit Fleur Events. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Detroit, or his designated representative. SUMMARY: This rule is effective from 10 p.m. through 11 p.m. July 27, 2024. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2024– 0601 in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rule. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Tracy Girard, Waterways Department, Sector Detroit, Coast Guard; telephone (313) 568–9564, email Tracy.M.Girard@uscg.mil. SUPPLEMENTARY INFORMATION: ddrumheller on DSK120RN23PROD with RULES1 DATES: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code VerDate Sep<11>2014 15:36 Jul 09, 2024 Jkt 262001 The Coast Guard is issuing this temporary rule under authority in 5 U.S.C. 553(b)(B). This statutory 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 ‘‘impracticable, unnecessary, or contrary to the public interest.’’ The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event sponsor notified the Coast Guard with insufficient time to publish an NPRM and immediate action is necessary to protect personnel, vessels, and the marine environment on Lake St. Clair. It is impracticable and contrary to the public interest to publish a NPRM because we must establish this safety zone by July 27, 2024. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. For the same reasons discussed in the preceding paragraph, delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with a fireworks display. III. Legal Authority and Need for Rule The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Detroit (COTP) has determined that potential hazards associated with fireworks displays will be a safety concern for anyone within a 200-yard radius of the launch site. The likely combination of recreational vessels, darkness punctuated by bright flashes of light, and fireworks debris falling into the water presents risks of collisions which could result in serious injuries or fatalities. This rule is necessary to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during the fireworks display. IV. Discussion of the Rule This rule establishes a safety zone from 10 p.m. through 11 p.m. on July 27, 2024. The safety zone will encompass all U.S. navigable waters of Lake St. Clair within a 200-yard radius of the fireworks launch site located 42°23.1′ N, 082°53.71′ W in Grosse Pointe Farms, MI. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 56663 fireworks display. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Detroit or his designated representative. The Captain of the Port Detroit or his designated representative may be contacted via VHF Channel 16. V. Regulatory Analyses We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors. A. Regulatory Planning and Review Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a ‘‘significant regulatory action,’’ under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB). This regulatory action determination is based on the size, location, and duration of the safety zone. Vessel traffic will be able to safely transit around this safety zone which would impact a small, designated area of Lake St. Clair for approximately one hour during the evening when vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF–FM Marine Channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone. B. Impact on Small Entities The Regulatory Flexibility Act of 1980, 5 U.S.C. 601–612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term ‘‘small entities’’ comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator. E:\FR\FM\10JYR1.SGM 10JYR1

Agencies

[Federal Register Volume 89, Number 132 (Wednesday, July 10, 2024)]
[Rules and Regulations]
[Pages 56662-56663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15136]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2024-N-3008]


Advisory Committee; Allergenic Products Advisory Committee; 
Termination; Removal From List of Standing Committees

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the termination of the Allergenic Products Advisory Committee, Center 
for Biologics Evaluation and Research. This document announces the 
reasons for termination and removes the Allergenic Products Advisory 
Committee from the Agency's list of standing advisory committees.

DATES: This rule is effective July 10, 2024.

FOR FURTHER INFORMATION CONTACT: Prabhakara Atreya, Division of 
Scientific Advisors and Consultants, Center for Biologics Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 71, Silver Spring, MD 20993-0002, 240-506-4946, 
[email protected].

SUPPLEMENTARY INFORMATION: The Allergenic Products Advisory Committee 
(the Committee) was established on July 9, 1984 (49 FR 30688). The 
Committee advises the Commissioner of Food and Drugs (Commissioner) or 
designee in discharging responsibilities as they relate to helping to 
ensure safe and effective drugs for human use and as required, any 
other product for which FDA has regulatory responsibility.
    The Committee reviews and evaluates data concerning the safety, 
effectiveness, and adequacy of labeling of marketed and investigational 
allergenic biological products or materials that are administered to 
humans for the diagnosis, prevention, or treatment of allergies and 
allergic disease, and makes appropriate recommendations to the 
Commissioner of its findings regarding the affirmation or revocation of 
biological product licenses, on the safety, effectiveness, and labeling 
of the products, on clinical and laboratory studies of such products, 
on amendments or revisions to regulations governing the manufacture, 
testing, and licensing of allergenic biological products, and on the 
quality and relevance of FDA's research programs that provide the 
scientific support for regulating these agents.
    Over the past several years, the Committee has met infrequently. As 
such, the effort and expense of maintaining the Committee can no longer 
be justified. The Committee will be terminated on July 9, 2024. The 
responsibilities of this Committee will be integrated into the Vaccines 
and Related Biological Products Advisory Committee (VRBPAC) charter 
ensuring that FDA has a mechanism to seek independent expert input on 
allergenic biological products. Specifically, the VRBPAC charter will 
be revised such that VRBPAC will be available to provide advice and 
recommendations to the Commissioner on allergenic biological products 
or materials for humans for the diagnosis, prevention, or treatment of 
allergies and allergic disease, as appropriate.
    Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40(d) and (e), 
the Agency finds good cause to dispense with notice and public comment 
procedures and to proceed to an immediate effective date on this rule.
    Notice and public comment and a delayed effective date are 
unnecessary because the Committee is not being adequately used, and 
termination of the committee is effective on July 9, 2024, in 
accordance with 21 CFR 14.55. This final rule merely removes the name 
of the Allergenic Products Advisory Committee from the list of standing 
advisory committees in Sec.  14.100 (21 CFR 14.100).
    Therefore, the Agency is amending Sec.  14.100(b) as set forth in 
the regulatory text of the document.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for part 14 continues to read as follows:

    Authority:  5 U.S.C. 1001 et seq.; 15 U.S.C. 1451-1461; 21 
U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 
2112; 42 U.S.C. 201, 262, 263b, 264, 284m, 284m-1; Pub. L. 107-109, 
115 Stat. 1419.

[[Page 56663]]

Sec.  14.100  [Amended]

0
2. Amend Sec.  14.100 by removing paragraph (b)(1) and redesignating 
paragraphs (b)(2) through (4) as paragraphs (b)(1) through (3).

    Dated: July 5, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15136 Filed 7-9-24; 8:45 am]
BILLING CODE 4164-01-P


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