Coastal Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region; 2020-2021 Closure of Commercial Run-Around Gillnet for King Mackerel, 7815-7816 [2021-02134]
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Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
42 CFR Part 1001
RIN 0936–AA08
Fraud and Abuse; Removal of Safe
Harbor Protection for Rebates
Involving Prescription
Pharmaceuticals and Creation of New
Safe Harbor Protection for Certain
Point-of-Sale Reductions in Price on
Prescription Pharmaceuticals and
Certain Pharmacy Benefit Manager
Service Fees
Office of Inspector General
(OIG), Health and Human Services
(HHS).
ACTION: Final rule; delay of effective
date; correction.
jbell on DSKJLSW7X2PROD with RULES
AGENCY:
SUMMARY: In accordance with the
memorandum of January 20, 2021, from
the Assistant to the President and Chief
of Staff, entitled ‘‘Regulatory Freeze
Pending Review,’’ and given the
pendency of litigation, Pharmaceutical
Care Management Association v. U.S.
Department of Health and Human
Services, et al., Civil Action No. 21–95
(JDB) (D.D.C.), challenging the final rule,
this action temporarily delays for 60
days from the date of the memorandum
the effective date of certain amendments
as promulgated by the final rule titled
‘‘Fraud and Abuse; Removal of Safe
Harbor Protection for Rebates Involving
Prescription Pharmaceuticals and
Creation of New Safe Harbor Protection
for Certain Point-of-Sale Reductions in
Price on Prescription Pharmaceuticals
and Certain Pharmacy Benefit Manager
Service Fees,’’ published in the
November 30, 2020, Federal Register.
This document announces that the
effective date for the certain provisions
of the final rule is delayed until March
22, 2021, the first business day after 60
days from the date of the memorandum.
This document also corrects a technical
error in the amendatory instructions.
DATES: As of January 29, 2021, the
effective date of the amendments to 42
CFR 1001.952 (h)(6) through (9), (cc),
and (dd) published at 85 FR 76666,
November 30, 2020, is delayed until
March 22, 2021.
This correction is effective as of
March 22, 2021. The amendatory
instructions in FR 2020–25841 (85 FR
76666), published on November 30,
2020 is corrected.
FOR FURTHER INFORMATION CONTACT:
Aaron Zajic, (202) 619–0335.
SUPPLEMENTARY INFORMATION: The
January 20, 2021 memorandum from the
VerDate Sep<11>2014
15:58 Feb 01, 2021
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Assistant to the President and Chief of
Staff, entitled ‘‘Regulatory Freeze
Pending Review,’’ instructed Federal
agencies to consider delaying the
effective date of rules published in the
Federal Register, but which have not
yet taken effect, for a period of 60 days
from the date of the memorandum to
permit review of the rule. This action is
consistent with that memorandum
insofar as the Department has decided
to review the rule at issue, and needs
time to determine what additional
action, if any, is appropriate.
The Department also has good cause
to delay this rule’s effective date
without advance notice and comment
under 5 U.S.C. 553(b)(B) because of the
pendency of litigation challenging the
final rule, and the Department’s interest
in evaluating its position in that
litigation. The litigation includes both
procedural and substantive challenges
to the rule and its effective date. Though
the provisions of the rule being delayed
by this notice do not fully overlap with
the provisions at issue in the pending
litigation, the intersections between the
rule’s various provisions and the overall
regulatory framework are complex. HHS
intends to evaluate those interactions as
part of its regulatory review process, but
needs additional time to do so beyond
the current effective date of January 29,
2021.
Accordingly, this final rule delays the
effective date of certain portions of the
safe harbor regulation concerning
discounts for prescription
pharmaceutical products at 42 CFR
1001.952. The effective date of new
paragraphs (h)(6) through (9), (cc), and
(dd) of that rule, which would have
been January 29, 2021, is now March 22,
2021. The temporary delay in the
effective date of this final rule is
necessary to give Department officials
the opportunity for further review and
consideration of the revisions to
paragraphs (h)(5)(vi) and (viii), as well
as the addition of new paragraphs
(h)(5)(iii), (6) through (9), (cc), and (dd)
of 42 CFR 1001.952, consistent with the
memorandum of January 20, 2021.
Separately, November 2020 final rule
contained a technical error in the
amendatory instructions that would
have prevented the Office of the Federal
Register from properly incorporating the
amendments to § 1001.952 into the CFR.
This document also corrects that error.
■ In FR 2020–25841 (85 FR 76666),
published on November 30, 2020, the
following corrections are made:
■
§ 1001.952
AGENCY:
[Corrected]
1. On page 76730, third column,
instruction 2 (including a. and b.) is
corrected to read as follows:
■
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7815
2. Section 1001.952 is amended by
adding paragraphs (h)(6) through (9),
(cc), and (dd) to read as follows:
§ 1001.952
[Corrected]
2. On page 76731, first column,
§ 1001.952 is corrected by removing ‘‘(5)
* * * ’’, and the text of paragraphs (vi)
through (viii).
■
§ 1001.952
[Corrected]
3. On page 76731, third column, add
amendatory instruction 3 to read as
follows:
3. Effective January 1, 2022,
§ 1001.952 is amended by revising
paragraphs (h)(5)(vi) and (vii) and
adding paragraph (h)(5)(viii) to read as
follows:
■
§ 1001.952
Exceptions.
*
*
*
*
*
(h) * * *
(5) * * *
(vi) Services provided in accordance
with a personal or management services
contract;
(vii) Other remuneration, in cash or in
kind, not explicitly described in this
paragraph (h)(5); or
(viii) A reduction in price or other
remuneration in connection with the
sale or purchase of a prescription
pharmaceutical product from a
manufacturer to a plan sponsor under
Medicare Part D either directly to the
plan sponsor under Medicare Part D, or
indirectly through a pharmacy benefit
manager acting under contract with a
plan sponsor under Medicare Part D,
unless it is a price reduction or rebate
that is required by law.
*
*
*
*
*
Norris Cochran,
Acting Secretary.
[FR Doc. 2021–02132 Filed 1–29–21; 8:45 am]
BILLING CODE 4152–01–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket No. 160426363–7275–02; RTID
0648–XA837]
Coastal Migratory Pelagic Resources
of the Gulf of Mexico and Atlantic
Region; 2020–2021 Closure of
Commercial Run-Around Gillnet for
King Mackerel
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
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ACTION:
Federal Register / Vol. 86, No. 20 / Tuesday, February 2, 2021 / Rules and Regulations
Temporary rule; closure.
SUMMARY: NMFS implements an
accountability measure (AM) through
this temporary rule for commercial
harvest of king mackerel in the southern
zone of the Gulf of Mexico (Gulf)
exclusive economic zone (EEZ) using
run-around gillnet gear. NMFS has
determined that the commercial annual
catch limit (ACL) for king mackerel
using run-around gillnet gear in the
southern zone of the Gulf EEZ has been
reached. Therefore, NMFS closes the
southern zone to commercial king
mackerel fishing using run-around
gillnet gear in the Gulf EEZ on January
28, 2021. This closure is necessary to
protect the Gulf king mackerel resource.
DATES: The closure is effective from 12
p.m. local time on January 28, 2021,
until 6 a.m. local time on January 18,
2022.
FOR FURTHER INFORMATION CONTACT:
Kelli O’Donnell, NMFS Southeast
Regional Office, telephone: 727–824–
5305, email: kelli.odonnell@noaa.gov.
SUPPLEMENTARY INFORMATION: The
fishery for coastal migratory pelagic fish
in the Gulf includes king mackerel,
Spanish mackerel, and cobia, and is
managed under the Fishery
Management Plan for the Coastal
Migratory Pelagic Resources of the Gulf
of Mexico and Atlantic Region (FMP).
The FMP was prepared by the Gulf of
Mexico and South Atlantic Fishery
Management Councils and is
implemented by NMFS under the
authority of the Magnuson-Stevens
Fishery Conservation and Management
Act (Magnuson-Stevens Act) by
regulations at 50 CFR part 622. All
weights for Gulf migratory group king
mackerel (Gulf king mackerel) apply as
either round or gutted weight.
The commercial fishery for Gulf king
mackerel is divided into western,
northern, and southern zones. The
southern zone for Gulf king mackerel
encompasses an area of the Gulf EEZ off
Collier and Monroe Counties in south
Florida, which is the EEZ south of a line
extending due west from the boundary
of Lee and Collier Counties on the
Florida west coast, and south of a line
extending due east from the boundary of
Monroe and Miami-Dade Counties on
the Florida east coast (50 CFR
622.369(a)(1)(iii)).
The commercial ACL for Gulf king
mackerel is divided into separate ACLs
for hook-and-line and run-around
gillnet gear. The use of run-around
gillnets for king mackerel is restricted to
the Gulf southern zone. The commercial
gillnet quota (equivalent to the
commercial gillnet ACL) for Gulf king
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15:58 Feb 01, 2021
Jkt 253001
mackerel is 575,400 lb (260,997 kg)
during the fishing year from July 1,
2020, through June 30, 2021 (50 CFR
622.384(b)(1)(iii)(B)).
Regulations at 50 CFR 622.388(a)(1)
require NMFS to close any component
of the king mackerel commercial sector
when its applicable quota has been
reached, or is projected to be reached,
by filing a notification to that effect with
the Office of the Federal Register. NMFS
has determined that for the 2020–2021
fishing year, the commercial quota for
Gulf king mackerel on vessels using runaround gillnet gear in the southern zone
has been reached. Accordingly,
commercial fishing using such gear in
the southern zone is closed at 12 p.m.
local time on January 28, 2021, until 6
a.m. local time on January 18, 2022, the
beginning of the next fishing season,
i.e., the day after the 2022 Martin Luther
King, Jr. Federal holiday. Vessel
operators that have been issued a
Federal commercial permit to harvest
Gulf king mackerel using run-around
gillnet gear in the southern zone must
have landed ashore and bartered,
traded, or sold such king mackerel prior
to 12 p.m. local time on January 28,
2021.
Persons aboard a vessel using hookand-line gear in the southern zone for
which a Federal commercial permit for
Gulf king mackerel has been issued,
except persons aboard such a vessel also
issued a Federal commercial permit to
harvest Gulf king mackerel using runaround gillnet gear, may fish for or
retain Gulf king mackerel unless the
southern zone commercial quota for
hook-and-line gear has been met and the
hook-and-line component of the
commercial sector has been closed. In
addition, as long as the recreational
sector for Gulf king mackerel is open (50
CFR 622.384(e)(1)), a person aboard a
vessel that has a valid Federal
commercial gillnet permit for king
mackerel may continue to retain king
mackerel under the recreational bag and
possession limits set forth in 50 CFR
622.382(a)(1)(ii) and (a)(2).
During the commercial closure, Gulf
king mackerel harvested using runaround gillnet gear in the southern zone
may not be purchased or sold. This
prohibition does not apply to Gulf king
mackerel harvested using run-around
gillnet gear in the southern zone that
were harvested, landed ashore, and sold
prior to the closure and were held in
cold storage by a dealer or processor (50
CFR 622.384(e)(2)).
Classification
NMFS issues this action pursuant to
section 305(d) of the Magnuson-Stevens
Act. This action is required by 50 CFR
PO 00000
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Fmt 4700
Sfmt 4700
622.388(a)(1), which was issued
pursuant to section 304(b) of the
Magnuson-Stevens Act, and is exempt
from review under Executive Order
12866.
Pursuant to 5 U.S.C. 553(b)(B), there
is good cause to waive prior notice and
an opportunity for public comment on
this action, as notice and comment is
unnecessary and contrary to the public
interest. Such procedures are
unnecessary because the regulations
associated with the commercial quota
and associated AM for Gulf king
mackerel have already been subject to
notice and public comment, and all that
remains is to notify the public of the
closure. Prior notice and opportunity for
public comment on this action is
contrary to the public interest because
of the need to immediately implement
the closure to protect the Gulf king
mackerel resource. The capacity of the
fishing fleet allows for rapid harvest of
the commercial quota, and any delay in
the closure could result in the
commercial quota being exceeded. Prior
notice and opportunity for public
comment would require time and would
potentially result in a harvest that
exceeds the commercial quota.
For the aforementioned reasons, there
is good cause under 5 U.S.C. 553(d)(3)
to waive the 30-day delay in
effectiveness of this action.
Authority: 16 U.S.C. 1801 et seq.
Dated: January 27, 2021.
Jennifer M. Wallace,
Acting Director, Office of Sustainable
Fisheries, National Marine Fisheries Service.
[FR Doc. 2021–02134 Filed 1–28–21; 4:15 pm]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 200221–0062; RTID 0648–
XA780]
Fisheries of the Exclusive Economic
Zone Off Alaska; Pacific Cod by
Vessels Using Pot Gear in the Central
Regulatory Area of the Gulf of Alaska
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
SUMMARY: NMFS is prohibiting directed
fishing for Pacific cod by vessels using
pot gear in the Central Regulatory Area
of the Gulf of Alaska (GOA). This action
E:\FR\FM\02FER1.SGM
02FER1
]]>Agencies
[Federal Register Volume 86, Number 20 (Tuesday, February 2, 2021)]
[Rules and Regulations]
[Pages 7815-7816]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02134]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 622
[Docket No. 160426363-7275-02; RTID 0648-XA837]
Coastal Migratory Pelagic Resources of the Gulf of Mexico and
Atlantic Region; 2020-2021 Closure of Commercial Run-Around Gillnet for
King Mackerel
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
[[Page 7816]]
ACTION: Temporary rule; closure.
-----------------------------------------------------------------------
SUMMARY: NMFS implements an accountability measure (AM) through this
temporary rule for commercial harvest of king mackerel in the southern
zone of the Gulf of Mexico (Gulf) exclusive economic zone (EEZ) using
run-around gillnet gear. NMFS has determined that the commercial annual
catch limit (ACL) for king mackerel using run-around gillnet gear in
the southern zone of the Gulf EEZ has been reached. Therefore, NMFS
closes the southern zone to commercial king mackerel fishing using run-
around gillnet gear in the Gulf EEZ on January 28, 2021. This closure
is necessary to protect the Gulf king mackerel resource.
DATES: The closure is effective from 12 p.m. local time on January 28,
2021, until 6 a.m. local time on January 18, 2022.
FOR FURTHER INFORMATION CONTACT: Kelli O'Donnell, NMFS Southeast
Regional Office, telephone: 727-824-5305, email:
[email protected].
SUPPLEMENTARY INFORMATION: The fishery for coastal migratory pelagic
fish in the Gulf includes king mackerel, Spanish mackerel, and cobia,
and is managed under the Fishery Management Plan for the Coastal
Migratory Pelagic Resources of the Gulf of Mexico and Atlantic Region
(FMP). The FMP was prepared by the Gulf of Mexico and South Atlantic
Fishery Management Councils and is implemented by NMFS under the
authority of the Magnuson-Stevens Fishery Conservation and Management
Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622. All
weights for Gulf migratory group king mackerel (Gulf king mackerel)
apply as either round or gutted weight.
The commercial fishery for Gulf king mackerel is divided into
western, northern, and southern zones. The southern zone for Gulf king
mackerel encompasses an area of the Gulf EEZ off Collier and Monroe
Counties in south Florida, which is the EEZ south of a line extending
due west from the boundary of Lee and Collier Counties on the Florida
west coast, and south of a line extending due east from the boundary of
Monroe and Miami-Dade Counties on the Florida east coast (50 CFR
622.369(a)(1)(iii)).
The commercial ACL for Gulf king mackerel is divided into separate
ACLs for hook-and-line and run-around gillnet gear. The use of run-
around gillnets for king mackerel is restricted to the Gulf southern
zone. The commercial gillnet quota (equivalent to the commercial
gillnet ACL) for Gulf king mackerel is 575,400 lb (260,997 kg) during
the fishing year from July 1, 2020, through June 30, 2021 (50 CFR
622.384(b)(1)(iii)(B)).
Regulations at 50 CFR 622.388(a)(1) require NMFS to close any
component of the king mackerel commercial sector when its applicable
quota has been reached, or is projected to be reached, by filing a
notification to that effect with the Office of the Federal Register.
NMFS has determined that for the 2020-2021 fishing year, the commercial
quota for Gulf king mackerel on vessels using run-around gillnet gear
in the southern zone has been reached. Accordingly, commercial fishing
using such gear in the southern zone is closed at 12 p.m. local time on
January 28, 2021, until 6 a.m. local time on January 18, 2022, the
beginning of the next fishing season, i.e., the day after the 2022
Martin Luther King, Jr. Federal holiday. Vessel operators that have
been issued a Federal commercial permit to harvest Gulf king mackerel
using run-around gillnet gear in the southern zone must have landed
ashore and bartered, traded, or sold such king mackerel prior to 12
p.m. local time on January 28, 2021.
Persons aboard a vessel using hook-and-line gear in the southern
zone for which a Federal commercial permit for Gulf king mackerel has
been issued, except persons aboard such a vessel also issued a Federal
commercial permit to harvest Gulf king mackerel using run-around
gillnet gear, may fish for or retain Gulf king mackerel unless the
southern zone commercial quota for hook-and-line gear has been met and
the hook-and-line component of the commercial sector has been closed.
In addition, as long as the recreational sector for Gulf king mackerel
is open (50 CFR 622.384(e)(1)), a person aboard a vessel that has a
valid Federal commercial gillnet permit for king mackerel may continue
to retain king mackerel under the recreational bag and possession
limits set forth in 50 CFR 622.382(a)(1)(ii) and (a)(2).
During the commercial closure, Gulf king mackerel harvested using
run-around gillnet gear in the southern zone may not be purchased or
sold. This prohibition does not apply to Gulf king mackerel harvested
using run-around gillnet gear in the southern zone that were harvested,
landed ashore, and sold prior to the closure and were held in cold
storage by a dealer or processor (50 CFR 622.384(e)(2)).
Classification
NMFS issues this action pursuant to section 305(d) of the Magnuson-
Stevens Act. This action is required by 50 CFR 622.388(a)(1), which was
issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is
exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior
notice and an opportunity for public comment on this action, as notice
and comment is unnecessary and contrary to the public interest. Such
procedures are unnecessary because the regulations associated with the
commercial quota and associated AM for Gulf king mackerel have already
been subject to notice and public comment, and all that remains is to
notify the public of the closure. Prior notice and opportunity for
public comment on this action is contrary to the public interest
because of the need to immediately implement the closure to protect the
Gulf king mackerel resource. The capacity of the fishing fleet allows
for rapid harvest of the commercial quota, and any delay in the closure
could result in the commercial quota being exceeded. Prior notice and
opportunity for public comment would require time and would potentially
result in a harvest that exceeds the commercial quota.
For the aforementioned reasons, there is good cause under 5 U.S.C.
553(d)(3) to waive the 30-day delay in effectiveness of this action.
Authority: 16 U.S.C. 1801 et seq.
Dated: January 27, 2021.
Jennifer M. Wallace,
Acting Director, Office of Sustainable Fisheries, National Marine
Fisheries Service.
[FR Doc. 2021-02134 Filed 1-28-21; 4:15 pm]
BILLING CODE 3510-22-P
