Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Extension of Comment Period, 64178-64179 [2022-23033]

Download as PDF 64178 Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Proposed Rules flight standards district office/certificate holding district office. considered timely if they are received on or before that date. (i) Additional Information (1) Refer to European Union Aviation Safety Agency (EASA) AD 2022–0008, dated January 19, 2022, for related information. This EASA AD may be found in the AD docket at regulations.gov under Docket No. FAA–2022–1302. (2) For more information about this AD, contact Barbara Caufield, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: (781) 238–7146; email: barbara.caufield@faa.gov. 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’’). (j) Material Incorporated by Reference None. Issued on October 7, 2022. Christina Underwood, Acting Director, Compliance & Airworthiness Division, Aircraft Certification Service. [FR Doc. 2022–22399 Filed 10–21–22; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 201 and 314 [Docket No. FDA–2021–N–0862] RIN 0910–AH62 Nonprescription Drug Product With an Additional Condition for Nonprescription Use; 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 that appeared in the Federal Register of June 28, 2022. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is extending the comment period on the proposed rule published on June 28, 2022 (87 FR 38313). Either electronic or written comments must be submitted by November 25, 2022. 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 November 25, 2022. Comments received by mail/hand delivery/courier (for written/paper submissions) will be lotter on DSK11XQN23PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 16:46 Oct 21, 2022 Jkt 259001 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– 2021–N–0862 for ‘‘Nonprescription Drug Product With an Additional Condition for Nonprescription Use.’’ 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 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 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: Chris Wheeler, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993–0002, 301– 796–0151, Chris.Wheeler@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of June 28, 2022, FDA published a proposed rule entitled ‘‘Nonprescription Drug Product With an Additional Condition for Nonprescription Use.’’ The 120-day comment period for the proposed rule is scheduled to close on October 26, 2022. The proposed rule, if finalized, would establish requirements for a nonprescription drug product that has an additional condition for nonprescription use that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers without the supervision of a healthcare practitioner. The Agency has received separate requests for a 30-day and 90-day E:\FR\FM\24OCP1.SGM 24OCP1 Federal Register / Vol. 87, No. 204 / Monday, October 24, 2022 / Proposed Rules extension of the comment period for the proposed rule. Each request conveyed concern that the current 120-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the proposed rule. FDA has considered the requests and is extending the comment period for the proposed rule until November 25, 2022. The Agency believes that this extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. Dated: October 18, 2022. Lauren K. Roth, Associate Commissioner for Policy. BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 147 [Docket Number USCG–2022–0313] RIN 1625–AA00 Safety Zone; Vito Floating Production System, Outer Continental Shelf Facility, Mississippi Canyon Block 939, Gulf of Mexico Coast Guard, DHS. Notice of proposed rulemaking. AGENCY: The Coast Guard is proposing to establish a safety zone around the Vito Floating Production System (FPS), located in Mississippi Canyon Block 939 on the Outer Continental Shelf (OCS) in the Gulf of Mexico. Establishing a safety zone around the facility would significantly reduce the threat of allisions, collisions, security breaches, oil spills, releases of natural gas, and thereby protect the safety of life, property, and the environment. Only vessels measuring less than 100 feet in length overall and not engaged in towing, attending vessels, or those vessels specifically authorized by the Eighth Coast Guard District Commander or a designated representative are permitted to enter or remain in the safety zone. We invite your comments on this proposed rulemaking. DATES: Comments and related material must be received by the Coast Guard on or before November 23, 2022. ADDRESSES: You may submit comments identified by docket number USCG– 2022–0313 using the Federal eRulemaking Portal at https:// lotter on DSK11XQN23PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 16:46 Oct 21, 2022 Jkt 259001 I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FPS Floating Production System FR Federal Register NPRM Notice of proposed rulemaking OCS Outer Continental Shelf § Section U.S.C. United States Code [FR Doc. 2022–23033 Filed 10–20–22; 8:45 am] ACTION: www.regulations.gov. See the ‘‘Public Participation and Request for Comments’’ portion of the SUPPLEMENTARY INFORMATION section for further instructions on submitting comments. FOR FURTHER INFORMATION CONTACT: If you have questions about this proposed rulemaking, call or email LCDR David Newcomb, District Eight OCS, U.S. Coast Guard; telephone 504–671–2106, David.T.Newcomb@uscg.mil. SUPPLEMENTARY INFORMATION: II. Background, Purpose, and Legal Basis Under the authority provided in 14 U.S.C. 544, 43 U.S.C. 1333, and Department of Homeland Security Delegation No. 0170.1, 33 CFR part 147 permits the establishment of safety zones for facilities located on the OCS for the purpose of protecting life and property on the facilities. The protections included in a safety zone established under 33 CFR part 147 are promoting safety of life and property on the facilities as well as their appurtenances and attending vessels and also for the adjacent waters located in and around each facility. Therefore, a safety zone under 33 CFR part 147 may also include provisions to restrict, prevent, or control certain activities, including access by vessels or persons to maintain safety of life, property and the environment. Shell Exploration and Production Company requested that the Coast Guard establish a safety zone around its facility located in the deepwater area of the Gulf of Mexico on the OCS. The Coast Guard determined that establishing a safety zone around this facility would significantly reduce the threat of allisions, oil spills, and releases of natural gas, and thereby protect the safety of life, property, and the environment. III. Discussion of Proposed Rule The safety zone proposed by this rulemaking is on the OCS in the deepwater area of the Gulf of Mexico in Mississippi Canyon Block 939 at the center point of N 28°01′32.325″, W 89°12′33.254″. The safety zone would be permanent. For the purpose of safety zones established under 33 CFR part 147, the deepwater area is considered to PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 64179 be waters of 304.8 meters (1,000 feet) or greater depth extending to the limits of the Exclusive Economic Zone (EEZ) contiguous to the territorial sea of the United States and extending to a distance up to 200 nautical miles from the baseline from which the breadth of the sea is measured. Navigation in the vicinity of the safety zone consists of large commercial shipping vessels, fishing vessels, cruise ships, tugs with tows and the occasional recreational vessel. The deepwater area also includes an extensive system of fairways. Only vessels measuring less than 100 feet in length overall and not engaged in towing, attending vessels as defined in 33 CFR 147.20, or those vessels specifically authorized by the Eighth Coast Guard District Commander or a designated representative are permitted to enter or remain in the safety zone. The transit of other vessels into and through the safety zone area would be prohibited. Requests for entry will be considered and reviewed on a case-bycase basis. These proposed regulations are consistent with the existing safety zones on other OCS platforms in the Gulf of Mexico. Persons or vessels that require authorization to enter the safety zone must request it from the Commander, Eighth Coast Guard District or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the Commander or a designated representative. 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 Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB). Aligning with 33 CFR 147.15, the safety zone established will extend to a maximum distance of 500 meters around the OCS facility measured from each point on its outer edge, but may not interfere with the use of recognized sea lanes essential to navigation. Vessel traffic would be able to safely transit E:\FR\FM\24OCP1.SGM 24OCP1

Agencies

[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Proposed Rules]
[Pages 64178-64179]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 314

[Docket No. FDA-2021-N-0862]
RIN 0910-AH62


Nonprescription Drug Product With an Additional Condition for 
Nonprescription Use; 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 that appeared in the 
Federal Register of June 28, 2022. The Agency is taking this action in 
response to requests for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the proposed rule 
published on June 28, 2022 (87 FR 38313). Either electronic or written 
comments must be submitted by November 25, 2022.

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 November 25, 2022. 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-2021-N-0862 for ``Nonprescription Drug Product With an Additional 
Condition for Nonprescription Use.'' 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: Chris Wheeler, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 3330, Silver Spring, MD 20993-0002, 301-
796-0151, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of June 28, 2022, 
FDA published a proposed rule entitled ``Nonprescription Drug Product 
With an Additional Condition for Nonprescription Use.'' The 120-day 
comment period for the proposed rule is scheduled to close on October 
26, 2022. The proposed rule, if finalized, would establish requirements 
for a nonprescription drug product that has an additional condition for 
nonprescription use that an applicant must implement to ensure 
appropriate self-selection or appropriate actual use, or both, by 
consumers without the supervision of a healthcare practitioner.
    The Agency has received separate requests for a 30-day and 90-day

[[Page 64179]]

extension of the comment period for the proposed rule. Each request 
conveyed concern that the current 120-day comment period does not allow 
sufficient time to develop a meaningful or thoughtful response to the 
proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule until November 25, 2022. The Agency believes that 
this extension allows adequate time for interested persons to submit 
comments without significantly delaying rulemaking on these important 
issues.

    Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23033 Filed 10-20-22; 8:45 am]
BILLING CODE 4164-01-P

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