Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period, 44944-44945 [2024-11229]

Download as PDF 44944 Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Proposed Rules 4. Amend § 129.9 by revising paragraphs (a)(3) and (b)(3) to read as follows: ■ § 129.9 Contents of operations specifications. (a) * * * (3) The certificate number and validity of the foreign air carrier’s air operator certificate issued by the State of the Operator or a Regional Safety Oversight Organization on behalf of the State of the Operator; * * * * * (b) * * * (3) In the case of a foreign air carrier, the certificate number and validity of the foreign air carrier’s Air Operator Certificate issued by the State of the Operator or a Regional Safety Oversight Organization on behalf of the State of the Operator; * * * * * Issued under authority provided by 49 U.S.C. 106(f) and 44701(a) in Washington, DC. Robert M. Ruiz, Deputy Executive Director, Flight Standards Service. [FR Doc. 2024–11253 Filed 5–21–24; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201, 500, 501, 510, 514, and 516 [Docket No. FDA–2023–N–5160] RIN 0910–AI43 Labeling Requirements for Approved or Conditionally Approved New Animal Drugs; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Proposed rule; extension of comment period. ACTION: The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule entitled ‘‘Labeling Requirements for Approved or Conditionally Approved New Animal Drugs’’ published in the Federal Register of March 12, 2024, by 60 days. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the proposed rule published March 12, 2024 (89 FR 18262), by 60 khammond on DSKJM1Z7X2PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 15:53 May 21, 2024 Jkt 262001 days. Either electronic or written comments must be submitted by August 9, 2024. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 9, 2024. Comments received by mail/hand delivery/courier (for written/ paper submissions) will be considered timely if they are received on or before that date. Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2023–N–5160 for ‘‘Labeling Requirements for Approved or Conditionally Approved New Animal Drugs.’’ Received comments, those filed PO 00000 Frm 00017 Fmt 4702 Sfmt 4702 in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: Suzanne Sechen, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–402–0814, Suzanne.Sechen@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of March 12, 2024 (89 FR 18262), FDA published a proposed rule entitled ‘‘Labeling Requirements for Approved or Conditionally Approved New Animal Drugs’’ with a 90-day E:\FR\FM\22MYP1.SGM 22MYP1 Federal Register / Vol. 89, No. 100 / Wednesday, May 22, 2024 / Proposed Rules period for submission of public comments. The Agency has received a request for an extension of the comment period for the proposed rule. The request conveyed concern that the current comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule. FDA has considered the request and is extending the comment period for the proposed rule for 60 days, until August 9, 2024. The Agency believes that a 60day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. Dated: May 17, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–11229 Filed 5–21–24; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG–2024–0023] RIN 1625–AA11 Safety Zone; Sea Otter Point, Port of Valdez, AK Coast Guard, DHS. Notice of proposed rulemaking. AGENCY: ACTION: The Coast Guard is proposing to amend its regulations titled, Safety Zone; City of Valdez July 4th Fireworks, Port Valdez; Valdez, AK. The City of Valdez has changed the annual firework displays from July 4th to December 31st each year. It is therefore necessary to amend the CFR to reflect the correct date of the fireworks display. We invite your comments on this proposed rulemaking. SUMMARY: Comments and related material must be received by the Coast Guard on or before June 21, 2024. ADDRESSES: You may submit comments identified by docket number USCG– 2024–0023 using the Federal DecisionMaking Portal at https:// www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. This notice of proposed rulemaking with its plain-language, 100word-or-less proposed rule summary will be available in this same docket. khammond on DSKJM1Z7X2PROD with PROPOSALS DATES: VerDate Sep<11>2014 15:53 May 21, 2024 Jkt 262001 If you have questions on this rulemaking, call or email LTJG Abigail Ferrara, Waterways Management Division, U.S. Coast Guard; 907–835–7209, email Abigail.C.Ferrara@uscg.mil. SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Prince William Sound DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis The Coast Guard began issuing temporary final rules establishing safety zones during the Valdez July 4th fireworks display beginning in 2014. The Coast Guard received no comments or concerns from the public when the temporary safety zones were in place. Due to the repeating nature of the event, on February 28, 2017, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; City of Valdez July 4th Fireworks, Port Valdez; Valdez, AK (82 FR 12076). There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this fireworks display. Since then, the City of Valdez has changed the firework display from July 4th to December 31st. The Coast Gurd again began issuing temporary final rules annually for the new date. Again, due to the repeating nature of the event, we are issuing this NPRM to change the date and time to reflect the correct event details. The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within a 200-yard radius of the firework display before, during, and after the scheduled event. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034. III. Discussion of Proposed Rule The COTP is proposing to amend 33 CFR part 165.1713, titled Safety Zone; City of Valdez July 4th Fireworks, Port Valdez; Valdez, AK to reflect the actual date of the fireworks display of December 31st. The time of the safety zone would change to 7:30 p.m. to 9:00 p.m. The safety zone would still encompass all navigable waters of Port Valdez within a 200-yard radius from a position of 61°07′22″ N and 146°21′13″ W. No vessel or person would be permitted to enter the safety zone without obtaining permission from the PO 00000 Frm 00018 Fmt 4702 Sfmt 4702 44945 COTP or a designated representative. The regulatory text we are proposing appears at the end of this document. IV. Regulatory Analyses We developed this proposed 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 NPRM has not been designated a ‘‘significant regulatory action,’’ under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB). This regulatory action determination is based on extremely limited vessel traffic in the winter months, as well as the size, location, time of day, and duration of the safety zone. Furthermore, vessels may request authorization to transit through the safety zone with the permission of the COTP, Prince William Sound, Alaska. The Coast Guard will still issue a Broadcast Notice to Mariners via VHF– FM marine channel 16 about 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 proposed rule would 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 IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator. If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, E:\FR\FM\22MYP1.SGM 22MYP1

Agencies

[Federal Register Volume 89, Number 100 (Wednesday, May 22, 2024)]
[Proposed Rules]
[Pages 44944-44945]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-11229]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 500, 501, 510, 514, and 516

[Docket No. FDA-2023-N-5160]
RIN 0910-AI43


Labeling Requirements for Approved or Conditionally Approved New 
Animal Drugs; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the proposed rule entitled ``Labeling 
Requirements for Approved or Conditionally Approved New Animal Drugs'' 
published in the Federal Register of March 12, 2024, by 60 days. The 
Agency is taking this action in response to a request for an extension 
to allow interested persons additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published March 12, 2024 (89 FR 18262), by 60 days. Either electronic 
or written comments must be submitted by August 9, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 9, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-N-5160 for ``Labeling Requirements for Approved or 
Conditionally Approved New Animal Drugs.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: With regard to the proposed rule: 
Suzanne Sechen, Center for Veterinary Medicine, Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0814, 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of March 12, 2024 
(89 FR 18262), FDA published a proposed rule entitled ``Labeling 
Requirements for Approved or Conditionally Approved New Animal Drugs'' 
with a 90-day

[[Page 44945]]

period for submission of public comments.
    The Agency has received a request for an extension of the comment 
period for the proposed rule. The request conveyed concern that the 
current comment period does not allow sufficient time to develop a 
meaningful or thoughtful response to the proposed rule.
    FDA has considered the request and is extending the comment period 
for the proposed rule for 60 days, until August 9, 2024. The Agency 
believes that a 60-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.

    Dated: May 17, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-11229 Filed 5-21-24; 8:45 am]
BILLING CODE 4164-01-P
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