Extension of Public Comment Period for Amendment 123 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP); Bering Sea and Aleutian Islands Halibut Abundance-Based Management of Amendment 80 Prohibited Species Catch Limit, 75569-75570 [2022-26828]
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Federal Register / Vol. 87, No. 236 / Friday, December 9, 2022 / Proposed Rules
information described in
§ 312.23(a)(3)(iv).
(q) Log of outstanding business. The
DSUR may, at the option of the sponsor,
include a log of any outstanding
business concerning the IND for which
the sponsor has requested a reply,
comment, or meeting.
(r) Late-breaking information. The
DSUR must describe any potentially
important safety information about the
investigational drug or the clinical
investigations conducted under the IND
that was identified by the sponsor
during preparation of the DSUR and
after the data lock point.
(s) Overall safety assessment. (1) The
DSUR must provide an overall safety
assessment that is a concise, integrated
evaluation of all new clinical,
nonclinical, and epidemiological safety
information obtained about the drug by
the sponsor during the reporting period
relative to the sponsor’s prior
knowledge of the drug, including
knowledge obtained by the sponsor
during any prior reporting periods. The
assessment must include an evaluation
of the risks associated with use of the
drug that includes an interpretation of
new safety information relative to the
safety information that was previously
obtained by the sponsor. The overall
safety assessment must include the
following items:
(i) Findings that suggest a significant
risk in humans exposed to the drug,
with any associated laboratory values,
and relationship to dose, duration, or
time course of exposure, if known.
(ii) Significant changes in information
concerning adverse events that were
identified in a previous DSUR.
(iii) Deaths that were previously
included in an IND safety report
required in § 312.32.
(iv) Subjects who withdrew from a
clinical investigation because of an
adverse event.
(v) Findings that suggest a significant
risk to specific populations.
(vi) Drug overdose, misuse, and abuse
cases or findings regarding the potential
for abuse to occur.
(vii) Risks associated with long-term
exposure.
(viii) Risks associated with the
method of administration of the drug,
diagnostic procedures related to use of
the drug, or other procedures described
in a protocol.
(ix) Evidence of clinically significant
medication errors.
(x) Drug interactions.
(xi) Any other risks that significantly
affect the safety assessment of the drug.
(2) The overall safety assessment must
describe the balance between benefits,
including theoretical or anticipated
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benefits, and cumulative identified risks
related to use of the drug. The overall
safety assessment must also describe
changes to the benefit-risk profile
compared to the previous DSUR, based
on information obtained during the
reporting period.
(t) Summary of important risks. The
DSUR must provide a cumulative
listing, along with a brief description, of
all the important known risks and
potential risks associated with use of the
drug identified by the sponsor during
the course of clinical and nonclinical
investigations of the drug conducted on
behalf of the sponsor. The listing must
include a description of each risk. Risks
identified by the sponsor in a prior
reporting period must be re-evaluated
annually, and their descriptions must be
updated with any new risk information
obtained during the reporting period.
(u) Conclusion. The DSUR must
briefly summarize the following
information:
(1) All changes to the sponsor’s
previous knowledge of the
investigational drug’s efficacy and safety
resulting from information obtained
during this reporting period.
(2) An outline of actions that have
been taken by the sponsor during the
current reporting period to address
emerging safety findings.
(3) All additional actions that will be
taken in the future by the sponsor to
address emerging safety findings, to the
extent known.
Dated: November 29, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022–26731 Filed 12–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
RIN 0648–BL42
Extension of Public Comment Period
for Amendment 123 to the Fishery
Management Plan for Groundfish of
the Bering Sea and Aleutian Islands
Management Area (BSAI FMP); Bering
Sea and Aleutian Islands Halibut
Abundance-Based Management of
Amendment 80 Prohibited Species
Catch Limit
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Department of Commerce (DOC).
AGENCY:
PO 00000
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Sfmt 4702
75569
Notice; extension of public
comment period.
ACTION:
On November 9, 2022, the
National Marine Fisheries Service
published a Notice of Availability and
request for comments on Amendment
123 to the Fishery Management Plan for
Groundfish of the Bering Sea and
Aleutian Islands Management Area
(BSAI FMP), but inadvertently did not
include the supporting Amendment
text. With this notice, NMFS is
extending the public comment period
by 60 days to February 7, 2023, to afford
the public with additional time to
provide comments on Amendment 123.
DATES: Comments on Amendment 123
and supporting documents must be
received by February 7, 2023 as
specified under ADDRESSES.
ADDRESSES: You may submit comments,
identified by NOAA–NMFS–2022–0088,
by any of the following methods:
• Electronic Submission: Submit all
electronic public comments via the
Federal eRulemaking Portal. Go to
https://www.regulations.gov and enter
NOAA–NMFS–2022–0088 in the Search
box. Click the ‘‘Comment Now!’’ icon,
complete the required fields, and enter
or attach your comments.
• Mail: Submit written comments to
Josh Keaton, Acting Assistant Regional
Administrator, Sustainable Fisheries
Division, Alaska Region NMFS, Attn:
Records Office. Mail comments to P.O.
Box 21668, Juneau, AK 99802–1668.
Instructions: Comments sent by any
other method, to any other address or
individual, or received after the end of
the comment period, may not be
considered by NMFS. All comments
received are a part of the public record
and will generally be posted for public
viewing on www.regulations.gov
without change. All personal identifying
information (e.g., name, address),
confidential business information, or
otherwise sensitive information
submitted voluntarily by the sender will
be publicly accessible. NMFS will
accept anonymous comments (enter ‘‘N/
A’’ in the required fields if you wish to
remain anonymous).
Electronic copies of Amendment 123
and the final Environmental Impact
Statement/Regulatory Impact Review
(collectively referred to as the
‘‘Analysis’’) prepared for this proposed
rule may be obtained from https://
www.regulations.gov. The Analysis may
also be found on the Alaska Regional
Office website at: https://
www.fisheries.noaa.gov/resource/
document/final-environmental-impactstatement-bering-sea-and-aleutianislands-bsai-halibut.
SUMMARY:
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75570
Federal Register / Vol. 87, No. 236 / Friday, December 9, 2022 / Proposed Rules
FOR FURTHER INFORMATION CONTACT:
DEPARTMENT OF COMMERCE
Bridget Mansfield, 907–586–7228.
On
November 9, 2022, the National Marine
Fisheries Service published a Notice of
Availability (NOA) and request for
comments on Amendment 123 to the
Fishery Management Plan for
Groundfish of the Bering Sea and
Aleutian Islands Management Area
(BSAI FMP) (87 FR 67665, November 9,
2022). After inquiries from the public,
NMFS realized that a supporting
document containing the revised BSAI
FMP text was not made available for
public review with the November 9,
2022 publication of the NOA. The BSAI
FMP revised text was posted to
regulations.gov on December 2, 2022.
With this notification, NMFS is
extending the comment period on the
FMP Amendment to provide 60 days
from the date of publication of this
notification in the Federal Register.
NMFS is soliciting public comments
on proposed Amendment 123 through
the end of the comment period (see
DATES). NMFS is separately seeking
public comment on a proposed rule that
would implement Amendment 123.
Respondents do not need to submit
the same comments on Amendment 123
and the proposed rule. All relevant
written comments received by the end
of the applicable comment period,
whether specifically directed to the
BSAI FMP amendment or the proposed
rule will be considered by NMFS in the
approval/disapproval decision for
Amendments 123 and addressed in the
response to comments in the final rule.
Comments received after the end of the
applicable comment period will not be
considered in the approval/disapproval
decision on Amendment 123. To be
considered, comments must be received,
not just postmarked or otherwise
transmitted, by the last day of the
comment period (see DATES).
SUPPLEMENTARY INFORMATION:
Authority: 16 U.S.C. 1801 et seq.
Dated: December 6, 2022.
Jennifer M. Wallace,
Acting Director, Office of Sustainable
Fisheries, National Marine Fisheries Service.
[FR Doc. 2022–26828 Filed 12–8–22; 8:45 am]
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National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 221128–0250]
RIN 0648–BL42
Fisheries of the Exclusive Economic
Zone Off Alaska; Bering Sea and
Aleutian Islands Halibut AbundanceBased Management of Amendment 80
Prohibited Species Catch Limit
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Proposed rule; request for
comments.
AGENCY:
NMFS proposes regulations to
implement Amendment 123 to the
Fishery Management Plan (FMP) for
Groundfish of the Bering Sea and
Aleutian Islands Management Area
(BSAI). If approved, the proposed rule
would amend regulations governing
limits on Pacific halibut (Hippoglossus
stenolepis) (halibut) prohibited species
catch (PSC), or bycatch, in the BSAI.
Namely, the proposed amendment
would link the halibut PSC limit to
halibut abundance for the Amendment
80 commercial groundfish trawl fleet in
the BSAI groundfish fisheries. This
action responds to the obligation in
section 303(a)(11) of the MagnusonStevens Fishery Conservation and
Management Act (Magnuson-Stevens
Act) to minimize bycatch to the extent
practicable, and is consistent with the
Magnuson-Stevens Act national
standards. This action: minimizes
halibut PSC to the extent practicable
under National Standard 9; ensures that
the FMP will continue to achieve
optimum yield in the BSAI groundfish
fisheries on a continuing basis under
National Standard 1; is based upon the
best scientific information available
under National Standard 2; to the extent
it involves an allocation of fishing
privileges, is fair and equitable,
reasonably promotes conservation by
reducing incidental halibut mortality
caused by the Amendment 80 trawl
fleet, and does not result in any
excessive shares of fishing privileges
under National Standard 4; and takes
into account the importance of fishery
resources to fishing communities under
National Standard 8. The action is
expected to provide incentives for the
Amendment 80 fleet to minimize
halibut mortality at all times and
conserve and improve bycatch
SUMMARY:
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Sfmt 4702
management of the halibut resource,
and it may result in additional harvest
opportunities in the commercial halibut
fishery. This action is intended to
promote the goals and objectives of the
Magnuson-Stevens Act, other applicable
laws, and Amendment 123 to the BSAI
FMP.
DATES: Submit comments on or before
January 23, 2023.
ADDRESSES: You may submit comments,
identified by NOAA–NMFS–2022–0088,
by any of the following methods:
• Electronic Submission: Submit all
electronic public comments via the
Federal eRulemaking Portal. Go to
https://www.regulations.gov and enter
NOAA–NMFS–2022–0088 in the Search
box. Click the ‘‘Comment Now!’’ icon,
complete the required fields, and enter
or attach your comments.
• Mail: Submit written comments to
Josh Keaton, Acting Assistant Regional
Administrator, Sustainable Fisheries
Division, Alaska Region NMFS, Attn:
Records Office. Mail comments to P.O.
Box 21668, Juneau, AK 99802–1668.
Instructions: Comments sent by any
other method, to any other address or
individual, or received after the end of
the comment period, may not be
considered by NMFS. All comments
received are a part of the public record
and will generally be posted for public
viewing on www.regulations.gov
without change. All personal identifying
information (e.g., name, address),
confidential business information, or
otherwise sensitive information
submitted voluntarily by the sender will
be publicly accessible. NMFS will
accept anonymous comments (enter ‘‘N/
A’’ in the required fields if you wish to
remain anonymous).
Electronic copies of Amendment 123
may be obtained from https://
www.regulations.gov. The final
Environmental Impact Statement/
Regulatory/Impact Review (collectively
referred to as the ‘‘Analysis’’) prepared
for this proposed rule may be found on
the Alaska Regional Office website at:
https://www.fisheries.noaa.gov/
resource/document/finalenvironmental-impact-statement-beringsea-and-aleutian-islands-bsai-halibut.
Written comments regarding the
burden-hour estimates or other aspects
of the collection-of-information
requirements contained in this proposed
rule may be submitted by mail to NMFS
at the above address; emailed to OIRA_
Submission@omb.eop.gov; or faxed to
202–395–5806.
FOR FURTHER INFORMATION CONTACT:
Bridget Mansfield, 907–586–7228.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\09DEP1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 236 (Friday, December 9, 2022)]
[Proposed Rules]
[Pages 75569-75570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26828]
=======================================================================
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 679
RIN 0648-BL42
Extension of Public Comment Period for Amendment 123 to the
Fishery Management Plan for Groundfish of the Bering Sea and Aleutian
Islands Management Area (BSAI FMP); Bering Sea and Aleutian Islands
Halibut Abundance-Based Management of Amendment 80 Prohibited Species
Catch Limit
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Department of Commerce (DOC).
ACTION: Notice; extension of public comment period.
-----------------------------------------------------------------------
SUMMARY: On November 9, 2022, the National Marine Fisheries Service
published a Notice of Availability and request for comments on
Amendment 123 to the Fishery Management Plan for Groundfish of the
Bering Sea and Aleutian Islands Management Area (BSAI FMP), but
inadvertently did not include the supporting Amendment text. With this
notice, NMFS is extending the public comment period by 60 days to
February 7, 2023, to afford the public with additional time to provide
comments on Amendment 123.
DATES: Comments on Amendment 123 and supporting documents must be
received by February 7, 2023 as specified under ADDRESSES.
ADDRESSES: You may submit comments, identified by NOAA-NMFS-2022-0088,
by any of the following methods:
Electronic Submission: Submit all electronic public
comments via the Federal eRulemaking Portal. Go to https://www.regulations.gov and enter NOAA-NMFS-2022-0088 in the Search box.
Click the ``Comment Now!'' icon, complete the required fields, and
enter or attach your comments.
Mail: Submit written comments to Josh Keaton, Acting
Assistant Regional Administrator, Sustainable Fisheries Division,
Alaska Region NMFS, Attn: Records Office. Mail comments to P.O. Box
21668, Juneau, AK 99802-1668.
Instructions: Comments sent by any other method, to any other
address or individual, or received after the end of the comment period,
may not be considered by NMFS. All comments received are a part of the
public record and will generally be posted for public viewing on
www.regulations.gov without change. All personal identifying
information (e.g., name, address), confidential business information,
or otherwise sensitive information submitted voluntarily by the sender
will be publicly accessible. NMFS will accept anonymous comments (enter
``N/A'' in the required fields if you wish to remain anonymous).
Electronic copies of Amendment 123 and the final Environmental
Impact Statement/Regulatory Impact Review (collectively referred to as
the ``Analysis'') prepared for this proposed rule may be obtained from
https://www.regulations.gov. The Analysis may also be found on the
Alaska Regional Office website at: https://www.fisheries.noaa.gov/resource/document/final-environmental-impact-statement-bering-sea-and-aleutian-islands-bsai-halibut.
[[Page 75570]]
FOR FURTHER INFORMATION CONTACT: Bridget Mansfield, 907-586-7228.
SUPPLEMENTARY INFORMATION: On November 9, 2022, the National Marine
Fisheries Service published a Notice of Availability (NOA) and request
for comments on Amendment 123 to the Fishery Management Plan for
Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI
FMP) (87 FR 67665, November 9, 2022). After inquiries from the public,
NMFS realized that a supporting document containing the revised BSAI
FMP text was not made available for public review with the November 9,
2022 publication of the NOA. The BSAI FMP revised text was posted to
regulations.gov on December 2, 2022. With this notification, NMFS is
extending the comment period on the FMP Amendment to provide 60 days
from the date of publication of this notification in the Federal
Register.
NMFS is soliciting public comments on proposed Amendment 123
through the end of the comment period (see DATES). NMFS is separately
seeking public comment on a proposed rule that would implement
Amendment 123.
Respondents do not need to submit the same comments on Amendment
123 and the proposed rule. All relevant written comments received by
the end of the applicable comment period, whether specifically directed
to the BSAI FMP amendment or the proposed rule will be considered by
NMFS in the approval/disapproval decision for Amendments 123 and
addressed in the response to comments in the final rule. Comments
received after the end of the applicable comment period will not be
considered in the approval/disapproval decision on Amendment 123. To be
considered, comments must be received, not just postmarked or otherwise
transmitted, by the last day of the comment period (see DATES).
Authority: 16 U.S.C. 1801 et seq.
Dated: December 6, 2022.
Jennifer M. Wallace,
Acting Director, Office of Sustainable Fisheries, National Marine
Fisheries Service.
[FR Doc. 2022-26828 Filed 12-8-22; 8:45 am]
BILLING CODE 3510-22-P
