Fisheries of the Exclusive Economic Zone Off Alaska; Atka Mackerel in the Bering Sea and Aleutian Islands Management Area, 64433-64434 [2019-25385]
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Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Rules and Regulations
khammond on DSKJM1Z7X2PROD with RULES
Rule and initiated before January 20,
2020.
OHRP has considered this request.
One of the objectives of the revised
Common Rule’s single IRB requirement
is to reduce administrative costs of
cooperative research. For cooperative
research that already has been initially
approved by multiple IRBs, the cost
savings associated with reduced IRB
reviews would not be achieved by
making the single IRB requirement
applicable to such cooperative research.
Members of the regulated community
report that transitioning cooperative
research from multiple IRBs to a single
IRB would, conversely, be costly for
most institutions. Further, excepting
such research from the single IRB
mandate would not adversely affect the
rights and welfare of the research
subjects. For these reasons, OHRP has
decided to except cooperative research
approved before January 20, 2020, from
the single IRB mandate. This general
exception does not apply to NIH
research; an NIH-specific exception is
discussed infra.
OHRP has determined that a relatively
small number of HHS protocols (other
than NIH research) will be eligible for
exception. OHRP surveyed the HHS
agency, other than NIH, that OHRP
expects conducts or supports the
majority of such human subjects
research. Based on the information
provided by that agency, OHRP
understands that this agency is
supporting five ongoing cooperative
research studies that are subject to the
revised Common Rule. Approximately
three to five additional cooperative
research studies supported by this
agency that would be subject to the
revised Common Rule are expected to
be initiated before January 20, 2020.
Cooperative Research Conducted or
Supported by NIH
The NIH policy on the use of a single
IRB for multi-site research has been in
effect since January 25, 2018. It requires
all U.S. sites participating in NIHfunded multi-site (i.e., two or more
sites) studies involving non-exempt
human subjects research where the sites
are following the same protocol to use
a single IRB for the review. Exceptions
to this policy are made where review by
the proposed IRB is prohibited by a
federal, tribal, or state law, regulation,
or policy, or if there is a compelling
justification for the exception. NIH
determines whether to grant an
exception after an assessment of the
need. NIH’s single IRB policy is largely
coextensive with the Common Rule
single IRB requirement, although NIH
designed its policy to exclude certain
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Jkt 250001
categories of cooperative research (e.g.,
training protocols for activities that do
not involve human subjects research at
initiation). NIH also has issued casespecific exceptions to its single IRB
policy for particular research studies.
However, on January 20, 2020, the
revised Common Rule single IRB
requirement will take effect for certain
studies, regardless of whether they are
subject to NIH’s policy, which would
require this NIH-conducted or
supported research to use a single IRB
review structure.
As stated above, if more than one IRB
initially reviewed and approved
cooperative research, imposition of the
single IRB mandate in mid-stream could
result in increased costs and burdens to
regulated entities, rather than cost
savings. Excepting such NIH-conducted
or supported research from mandated
single IRB review will not adversely
affect the rights and welfare of the
research subjects. Further, NIH has
given thoughtful consideration to these
research contexts, and already
determined that single IRB review
should not be required. NIH deliberately
structured its single IRB policy such
that certain research would fall outside
the scope of coverage. Likewise, in
issuing case-by-case exceptions to its
single IRB policy, NIH concluded that
single IRB review is not appropriate for
those particular research contexts. Thus,
OHRP has decided to except NIH
cooperative research from the Common
Rule single IRB mandate if either (a) the
NIH single IRB policy does not apply,
and the research was initially approved
by an IRB before January 20, 2020, or (b)
NIH excepted the research from its
single IRB policy before January 20,
2020. For more information on the NIH
single IRB policy, see: https://
grants.nih.gov/grants/guide/notice-files/
NOT-OD-16-094.html.
This exception is an exercise of
OHRP’s enforcement discretion, as
specifically permitted by 45 CFR
46.114(b)(2), that affects relatively few
research protocols for a limited time. As
required by 45 CFR 46.114(b)(2), OHRP
determines and documents that using a
single IRB is not appropriate for the
described categories of research, and, for
the reasons stated above, OHRP excepts
this research from the single IRB
mandate. The full text of the exception
is listed below, and may also be found
in the ‘‘Single IRB Requirement’’ tab in
the ‘‘Regulations, Policy, & Posting’’
section of the OHRP website (see
https://www.hhs.gov/ohrp/regulationsand-policy/).
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64433
II. Determination of Exception:
Required Use of Single Institutional
Review Board for Cooperative Research
The Office for Human Research
Protections (OHRP) has determined that
for HHS cooperative research subject to
the 2018 Requirements, and for
purposes of 45 CFR 46.114(b)(2)(ii), an
institution may continue to use multiple
IRBs, in lieu of a single IRB, for the
following research:
(1) Cooperative research conducted or
supported by HHS agencies other than
the National Institutes of Health (NIH),
if an IRB initially approved the research
before January 20, 2020.
(2) Cooperative research conducted or
supported by NIH if either:
a. The NIH single IRB policy does not
apply, and the research was initially
approved by an IRB before January 20,
2020, or
b. NIH excepted the research from its
single IRB policy before January 20,
2020.
Note that this determination is only
made for purposes of section
46.114(b)(2)(ii)—namely, for
determining whether certain
cooperative research may be excepted
from the single IRB mandate. This
determination does not prevent, nor
should it be viewed as discouraging, the
voluntary use of a single IRB in
cooperative research subject to the 2018
Requirements that would fall within the
above two categories. Further, note that
category (2)(b), above, applies for the
duration of NIH’s exception from its
policy for the particular research study;
categories (1) and (2)(a) apply for the
duration of the research.
Dated: November 12, 2019.
Jerry Menikoff,
Director, Office for Human Research
Protections.
[FR Doc. 2019–25358 Filed 11–21–19; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 180713633–9174–02]
RTID 0648–XY016
Fisheries of the Exclusive Economic
Zone Off Alaska; Atka Mackerel in the
Bering Sea and Aleutian Islands
Management Area
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
AGENCY:
E:\FR\FM\22NOR1.SGM
22NOR1
64434
ACTION:
Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Rules and Regulations
Temporary rule; closure.
NMFS is prohibiting directed
fishing for Atka mackerel in the Bering
Sea subarea and Eastern Aleutian
District (BS/EAI) of the Bering Sea and
Aleutian Islands management area
(BSAI) by vessels participating in the
BSAI trawl limited access sector. This
action is necessary to prevent exceeding
the 2019 total allowable catch (TAC) of
Atka mackerel in the BS/EAI allocated
to vessels participating in the BSAI
trawl limited access sector.
DATES: Effective 1200 hrs, Alaska local
time (A.l.t.), November 19, 2019,
through 2400 hrs, A.l.t., December 31,
2019.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Steve Whitney, 907–586–7228.
NMFS
manages the groundfish fishery in the
BSAI exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Bering Sea
and Aleutian Islands Management Area
(FMP) prepared by the North Pacific
Fishery Management Council under
authority of the Magnuson-Stevens
Fishery Conservation and Management
Act. Regulations governing fishing by
U.S. vessels in accordance with the FMP
appear at subpart H of 50 CFR part 600
and 50 CFR part 679.
The 2019 TAC of Atka mackerel, in
the BS/EAI, allocated to vessels
participating in the BSAI trawl limited
access sector fishery was established as
a directed fishing allowance of 2,050
metric tons by the final 2019 and 2020
harvest specifications for groundfish in
the BSAI (84 FR 9000, March 13, 2019).
In accordance with § 679.20(d)(1)(iii),
the Regional Administrator finds that
this directed fishing allowance has been
reached. Consequently, NMFS is
prohibiting directed fishing for Atka
mackerel in the BS/EAI by vessels
participating in the BSAI trawl limited
access sector fishing. While this closure
is effective, the maximum retainable
amounts at § 679.20(e) and (f) apply at
any time during a trip.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with RULES
Classification
This action responds to the best
available information recently obtained
from the fishing. The Assistant
Administrator for Fisheries, NOAA,
(AA) finds good cause to waive the
requirement to provide prior notice and
opportunity for public comment
pursuant to the authority set forth at 5
U.S.C. 553(b)(B) as such a requirement
is impracticable and contrary to the
public interest. This requirement is
impracticable and contrary to the public
interest as it would prevent NMFS from
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15:48 Nov 21, 2019
Jkt 250001
responding to the most recent fisheries
data in a timely fashion and would
delay the closure of the Atka mackerel
directed fishing in the BS/EAI for
vessels participating in the BSAI trawl
limited access sector fishing. NMFS was
unable to publish a notice providing
time for public comment because the
most recent, relevant data only became
available as of November 18, 2019.
The AA also finds good cause to
waive the 30-day delay in the effective
date of this action under 5 U.S.C.
553(d)(3). This finding is based upon
the reasons provided above for waiver of
prior notice and opportunity for public
comment.
This action is required by § 679.20
and is exempt from review under
Executive Order 12866.
Authority: 16 U.S.C. 1801 et seq.
Dated: November 19, 2019.
Jennifer M. Wallace,
Acting Director, Office of Sustainable
Fisheries, National Marine Fisheries Service.
[FR Doc. 2019–25385 Filed 11–19–19; 4:15 pm]
BILLING CODE 3510–22–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 679
[Docket No. 180713633–9174–02]
RIN 0648–XY017
Fisheries of the Exclusive Economic
Zone Off Alaska; Pacific Ocean Perch
in the Bering Sea and Aleutian Islands
Management Area
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
NMFS is prohibiting directed
fishing for Pacific ocean perch in the
Eastern Aleutian district (EAI) of the
Bering Sea and Aleutian Islands
management area (BSAI) by vessels
participating in the BSAI trawl limited
access sector fishery. This action is
necessary to prevent exceeding the 2019
total allowable catch (TAC) of Pacific
ocean perch in the EAI allocated to
vessels participating in the BSAI trawl
limited access sector fishery.
DATES: Effective 1200 hrs, Alaska local
time (A.l.t.), November 19, 2019,
through 2400 hrs, A.l.t., December 31,
2019.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Steve Whitney, 907–586–7228.
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
NMFS
manages the groundfish fishery in the
BSAI exclusive economic zone
according to the Fishery Management
Plan for Groundfish of the Bering Sea
and Aleutian Islands Management Area
(FMP) prepared by the North Pacific
Fishery Management Council under
authority of the Magnuson-Stevens
Fishery Conservation and Management
Act. Regulations governing fishing by
U.S. vessels in accordance with the FMP
appear at subpart H of 50 CFR part 600
and 50 CFR part 679.
The 2019 TAC of Pacific ocean perch,
in the EAI, allocated to vessels
participating in the BSAI trawl limited
access sector fishery was established as
a directed fishing allowance of 973
metric tons by the final 2019 and 2020
harvest specifications for groundfish in
the BSAI (84 FR 9000, March 13, 2019).
In accordance with § 679.20(d)(1)(iii),
the Regional Administrator finds that
this directed fishing allowance has been
reached. Consequently, NMFS is
prohibiting directed fishing for Pacific
ocean perch in the EAI by vessels
participating in the BSAI trawl limited
access sector fishery. While this closure
is effective, the maximum retainable
amounts at § 679.20(e) and (f) apply at
any time during a trip.
SUPPLEMENTARY INFORMATION:
Classification
This action responds to the best
available information recently obtained
from the fishery. The Assistant
Administrator for Fisheries, NOAA,
(AA) finds good cause to waive the
requirement to provide prior notice and
opportunity for public comment
pursuant to the authority set forth at 5
U.S.C. 553(b)(B) as such a requirement
is impracticable and contrary to the
public interest. This requirement is
impracticable and contrary to the public
interest as it would prevent NMFS from
responding to the most recent fisheries
data in a timely fashion and would
delay the closure of the Pacific ocean
perch directed fishery in the EAI for
vessels participating in the BSAI trawl
limited access sector fishery. NMFS was
unable to publish a notice providing
time for public comment because the
most recent, relevant data only became
available as of November 18, 2019.
The AA also finds good cause to
waive the 30-day delay in the effective
date of this action under 5 U.S.C.
553(d)(3). This finding is based upon
the reasons provided above for waiver of
prior notice and opportunity for public
comment.
This action is required by § 679.20
and is exempt from review under
Executive Order 12866.
Authority: 16 U.S.C. 1801 et seq.
E:\FR\FM\22NOR1.SGM
22NOR1
Agencies
[Federal Register Volume 84, Number 226 (Friday, November 22, 2019)]
[Rules and Regulations]
[Pages 64433-64434]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25385]
=======================================================================
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 679
[Docket No. 180713633-9174-02]
RTID 0648-XY016
Fisheries of the Exclusive Economic Zone Off Alaska; Atka
Mackerel in the Bering Sea and Aleutian Islands Management Area
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
[[Page 64434]]
ACTION: Temporary rule; closure.
-----------------------------------------------------------------------
SUMMARY: NMFS is prohibiting directed fishing for Atka mackerel in the
Bering Sea subarea and Eastern Aleutian District (BS/EAI) of the Bering
Sea and Aleutian Islands management area (BSAI) by vessels
participating in the BSAI trawl limited access sector. This action is
necessary to prevent exceeding the 2019 total allowable catch (TAC) of
Atka mackerel in the BS/EAI allocated to vessels participating in the
BSAI trawl limited access sector.
DATES: Effective 1200 hrs, Alaska local time (A.l.t.), November 19,
2019, through 2400 hrs, A.l.t., December 31, 2019.
FOR FURTHER INFORMATION CONTACT: Steve Whitney, 907-586-7228.
SUPPLEMENTARY INFORMATION: NMFS manages the groundfish fishery in the
BSAI exclusive economic zone according to the Fishery Management Plan
for Groundfish of the Bering Sea and Aleutian Islands Management Area
(FMP) prepared by the North Pacific Fishery Management Council under
authority of the Magnuson-Stevens Fishery Conservation and Management
Act. Regulations governing fishing by U.S. vessels in accordance with
the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2019 TAC of Atka mackerel, in the BS/EAI, allocated to vessels
participating in the BSAI trawl limited access sector fishery was
established as a directed fishing allowance of 2,050 metric tons by the
final 2019 and 2020 harvest specifications for groundfish in the BSAI
(84 FR 9000, March 13, 2019).
In accordance with Sec. 679.20(d)(1)(iii), the Regional
Administrator finds that this directed fishing allowance has been
reached. Consequently, NMFS is prohibiting directed fishing for Atka
mackerel in the BS/EAI by vessels participating in the BSAI trawl
limited access sector fishing. While this closure is effective, the
maximum retainable amounts at Sec. 679.20(e) and (f) apply at any time
during a trip.
Classification
This action responds to the best available information recently
obtained from the fishing. The Assistant Administrator for Fisheries,
NOAA, (AA) finds good cause to waive the requirement to provide prior
notice and opportunity for public comment pursuant to the authority set
forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and
contrary to the public interest. This requirement is impracticable and
contrary to the public interest as it would prevent NMFS from
responding to the most recent fisheries data in a timely fashion and
would delay the closure of the Atka mackerel directed fishing in the
BS/EAI for vessels participating in the BSAI trawl limited access
sector fishing. NMFS was unable to publish a notice providing time for
public comment because the most recent, relevant data only became
available as of November 18, 2019.
The AA also finds good cause to waive the 30-day delay in the
effective date of this action under 5 U.S.C. 553(d)(3). This finding is
based upon the reasons provided above for waiver of prior notice and
opportunity for public comment.
This action is required by Sec. 679.20 and is exempt from review
under Executive Order 12866.
Authority: 16 U.S.C. 1801 et seq.
Dated: November 19, 2019.
Jennifer M. Wallace,
Acting Director, Office of Sustainable Fisheries, National Marine
Fisheries Service.
[FR Doc. 2019-25385 Filed 11-19-19; 4:15 pm]
BILLING CODE 3510-22-P