Magnuson-Stevens Fishery Conservation and Management Act Provisions; Fisheries of the Northeastern United States; Atlantic Sea Scallop Fishery; Closure of the Limited Access General Category Scallop Fishery to Individual Fishing Quota Scallop Vessels, 58497-58498 [E8-23708]
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Federal Register / Vol. 73, No. 195 / Tuesday, October 7, 2008 / Rules and Regulations
bioequivalent drugs is unavailable.
However, such reporting would clearly
be in their interest. In addition, section
1102(b) of the Act requires us to prepare
a regulatory impact analysis if a rule
may have a significant impact on the
operations of a substantial number of
small rural hospitals. This analysis must
conform to the provisions of section 604
of the RFA. For purposes of section
1102(b) of the Act, we define a small
rural hospital as a hospital that is
located outside of a metropolitan
statistical area and has fewer than 100
beds. We are not preparing an analysis
for section 1102(b) of the Act, because
the Secretary has determined that this
final rule will not have a significant
impact on the operations of a substantial
number of small rural hospitals. Small
rural hospitals would be affected only to
the extent that no FDA-approved,
therapeutically and bioequivalent drug
is available in that State for a particular
outpatient drug provided through their
outpatient pharmacies. As discussed
above for pharmacies, States may
choose to change reimbursement for
drugs that are not multiple source drugs
within the State, but this change is
expected to increase reimbursement.
Section 202 of the Unfunded
Mandates Reform Act of 1995 (UMRA)
also requires that agencies assess
anticipated costs and benefits before
issuing any rule whose mandates
require spending on State, local, or
tribal governments in the aggregate, or
by the private sector, in any 1 year of
$100 million in 1995, updated annually
for inflation. In 2008, that threshold is
approximately $130 million. This final
rule does not contain any mandates that
will impose spending costs on State,
local, or tribal governments in the
aggregate, or by the private sector, of
$130 million.
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
This regulation will impose only a very
small burden, if any, on States. When a
pharmacy has notified a State that a
drug on the CMS FUL list may not be
available as a multiple source drug in
that State, the State should determine
whether the pharmacy’s assertion of
lack of general availability in the State
is valid. The State, however, has no
obligation to make an independent
assessment of drug availability in the
absence of such notification by a
pharmacy. This final rule will only
revise payment rates in those rare cases
VerDate Aug<31>2005
18:31 Oct 06, 2008
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in which a particular FDA-approved
therapeutically, pharmaceutically, and
bioequivalent drug is not generally
available to the public through retail
pharmacies in a particular State and, as
a result, only one therapeutically, and
bioequivalent drug product is generally
available to the public through those
pharmacies. In this circumstance, a
State would need to confirm the
information received from its
pharmacies regarding drug availability.
This would impose only a small burden
on States. State systems are designed to
allow for payment changes as a routine
matter and to change the composition of
the FUL groups or delete FUL groups.
Since this regulation does not impose
any significant costs on State or local
governments, the requirements of E.O.
13132 are not applicable.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
List of Sections in 42 CFR Part 447
Accounting, Administrative practice
and procedure, Drugs, Grant programs—
health, Health facilities, Health
professions, Medicaid, Reporting and
recordkeeping requirements, rural areas.
■ For the reasons set forth in the
preamble, the Centers for Medicare &
Medicaid Services, is confirming the
interim rule published on March 14,
2008 (73 FR 13785) as final with the
following changes:
PART 447—PAYMENTS FOR
SERVICES
1. The authority citation for part 447
continues to read as follows:
■
Authority: Sec. 1102 of the Social Security
Act (42 U.S.C. 1302).
2. Section 447.502 the definition of
‘‘Multiple source drug’’ is amended by
revising paragraph (3)(i) to read as
follows:
■
§ 447.502
Definitions.
*
*
*
*
*
Multiple source drug * * *
*
*
*
*
*
(3) * * *
(i) A drug product is considered sold
or marketed in a State if it appears in
a published national listing of average
wholesale prices, selected by the
Secretary, provided that the listed
product is generally available to the
public through retail pharmacies in that
State.
*
*
*
*
*
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program)
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58497
Dated: August 20, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
Approved: August 21, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8–23653 Filed 10–6–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 070817467–8554–02]
RIN 0648–XK82
Magnuson-Stevens Fishery
Conservation and Management Act
Provisions; Fisheries of the
Northeastern United States; Atlantic
Sea Scallop Fishery; Closure of the
Limited Access General Category
Scallop Fishery to Individual Fishing
Quota Scallop Vessels
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; closure.
AGENCY:
SUMMARY: NMFS announces that the
Limited Access General Category
(LAGC) Scallop Fishery will close to
individual fishing quota (IFQ) scallop
vessels until it re-opens on December 1,
2008, under current regulations. This
action is based on the determination
that the third quarter scallop total
allowable catch (TAC) for LAGC IFQ
scallop vessels (including vessels issued
an IFQ letter of authorization (LOA) to
fish under appeal), is projected to be
landed. This action is being taken to
prevent IFQ scallop vessels from
exceeding the 2008 third quarter TAC,
in accordance with the regulations
implementing Amendment 11 to the
Atlantic Sea Scallop Fishery
Management Plan (FMP), enacted by
Framework 19 to the FMP, and the
Magnuson-Stevens Fishery
Conservation and Management Act.
DATES: The closure of the LAGC fishery
to all IFQ scallop vessels is effective
0001 hr local time, October 5, 2008,
through November 30, 2008.
FOR FURTHER INFORMATION CONTACT:
Christopher Biegel, Fishery
Management Specialist, (978) 281–9112,
fax (978) 281–9135.
SUPPLEMENTARY INFORMATION:
Regulations governing fishing activity in
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07OCR1
58498
Federal Register / Vol. 73, No. 195 / Tuesday, October 7, 2008 / Rules and Regulations
jlentini on PROD1PC65 with RULES
the LAGC fishery are found at §§ 648.59
and 648.60. Regulations specifically
governing IFQ scallop vessel operations
in the LAGC fishery are specified at
§ 648.53(a)(8)(iii). These regulations
authorize vessels issued a valid IFQ
scallop permit to fish in the LAGC
fishery under specific conditions,
including a TAC. The TACs were
established by the final rule that
implemented Framework 19 to the FMP
(73 FR 30790 May 29, 2008) and
included a TAC of 623,747 lb (282,927
kg) that may be landed by IFQ vessels
during the third quarter of the 2008
fishing year. The regulations at
§ 648.53(a)(8)(iii) require the LAGC
fishery to be closed to IFQ vessels once
the Northeast Regional Administrator
has determined that the TAC is
projected to be landed.
Based on dealer reporting and vessel
pre-landing reports through Vessel
Monitoring Systems (VMS), a projection
concluded that, given current activity
levels by IFQ scallop vessels in the area,
623,747 lb (282,927 kg) will have been
landed on October 4, 2008. Therefore, in
accordance with the regulations at
§ 648.53(a)(8)(iii), the LAGC scallop
fishery is closed to all general IFQ
vessels as of 0001 hr local time, October
5, 2008. IFQ scallop vessels are not
allowed to fish for, possess, or retain
scallops, or declare, or initiate, a scallop
trip following this closure for the
remainder of the 2008 third quarter,
ending on November 30, 2008. This
closure is in effect for the remainder of
the third quarter of the 2008 scallop
fishing year under current regulations.
The LAGC scallop fishery is scheduled
to re-open to IFQ scallop vessels on
December 1, 2008.
Classification
This action is required by 50 CFR part
648 and is exempt from review under
Executive Order 12866.
This action closes the LAGC scallop
fishery to all IFQ scallop vessels until
December 1, 2008, under current
regulations. The regulations at
§ 648.53(a)(8)(iii) require such action to
ensure that IFQ scallop vessels do not
exceed the 2008 third quarter TAC. The
LAGC scallop fishery opened for the
third quarter of the 2008 fishing year at
0001 hours on September 1, 2008. Data
indicating the IFQ scallop fleet has
landed all of the 2008 third quarter TAC
have only recently become available.
The Assistant Administrator for
Fisheries, NOAA (AA), finds good cause
pursuant to 5 U.S.C. 553(b)(B) to waive
prior notice and the opportunity for
public comment because it would be
contrary to the public interest. If
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18:31 Oct 06, 2008
Jkt 217001
implementation of this closure is
delayed to solicit prior public comment,
the quota for this quarter will be
exceeded, thereby undermining the
conservation objectives of the FMP.
Also, if the magnitude of any overage is
significant, it would warrant a decrease
in the fourth quarter quota. This would
have a negative economic impact on
vessels that fish seasonally in that
period. The AA further finds, pursuant
to 5 U.S.C 553(d)(3), good cause to
waive the thirty (30) day delayed
effectiveness period for the reasons
stated above.
Authority: 16 U.S.C. 1801 et seq.
Dated: October 2, 2008.
Emily H. Menashes,
Acting Director, Office of Sustainable
Fisheries, National Marine Fisheries Service.
[FR Doc. E8–23708 Filed 10–2–08; 4:15 pm]
BILLING CODE 3510–22–S
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No. 010319075–1217–02]
RIN 0648–XK42
Magnuson-Stevens Fishery
Conservation and Management Act
Provisions; Fisheries of the
Northeastern United States; Tilefish
Fishery
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule, tilefish
commercial quota adjustment.
AGENCY:
SUMMARY: NMFS announces that the
Administrator, Northeast Region, NMFS
(Regional Administrator), has
determined that the quota for the tilefish
Full-time Tier 2 permit category has
been exceeded for fishing year (FY)
2008, requiring an adjustment of the
Full-time Tier 2 permit category quota
for FY 2009. This action complies with
the Fishery Management Plan for the
Tilefish Fishery (FMP) and is intended
to continue the rebuilding program in
the FMP by taking into account previous
overages of the tilefish quota.
DATES: Effective November 1, 2008,
through October 31, 2009.
FOR FURTHER INFORMATION CONTACT:
Timothy A. Cardiasmenos, Fishery
Policy Analyst, (978) 281–9204.
SUPPLEMENTARY INFORMATION:
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Background
The regulations at 50 CFR 648.290(c)
state that any overages of the quota for
any tilefish limited access category that
occur in a given fishing year will be
subtracted from the quota for that
category in the following fishing year.
This same section also states that, if the
tilefish harvest attributed to the open
access Incidental permit category
exceeds 5 percent of the total allowable
landings (TAL) for a given fishing year,
the trip limit for the Incidental category
may be reduced the following year. In
both of these instances, § 648.290(c)
specifies that, if an adjustment is
required, a notification of adjustment of
the quota will be published in the
Federal Register.
The tilefish TAL for FY 2009 remains
unchanged from previous years at 1.995
million lb (905 mt). The FMP dictates
that the TAL be divided between the
three limited access tilefish permit
categories after the TAL is reduced by
5 percent to account for incidental
tilefish landings (open-access Incidental
permit category) as follows: Sixty-six
percent (1,250,865 lb (567,383 kg)) to
Full-time Tier 1; 15 percent (284,288 lb
(128,951 kg)) to Full-time Tier 2; and 19
percent (360,098 lb (163,338 kg)) to Parttime vessels.
Based upon vessel reports and other
information available, FY 2008 tilefish
landings for limited access Full-time
Tier 2 permit category were 291,620 lb
(132,277 kg), resulting in an overage of
7,332 lb (3,326 kg). This overage amount
is being deducted from the FY 2009
Full-time Tier 2 permit category quota
through this action, which results in an
adjusted quota of 276,956 lb (125,625
kg) for this category in FY 2009.
Adjustments to the remaining permit
categories are not needed at this time,
and the FY 2009 quotas for these
categories therefore, remain status quo,
including the Incidental trip limit for
tilefish for FY 2009, which will remain
at its default value of 300 lb (136 kg).
If final landings data for 2008 indicate
that an adjustment of the quota for any
of the other permit categories is
necessary, a notification of the
adjustment will be published in the
Federal Register.
The FY 2009 tilefish Full-time Tier 2
permit category quota, the FY 2008
tilefish Full-time Tier 2 permit category
landings, and the resulting overage of
the FY 2008 tilefish Full-time Tier 2
permit category quota are presented in
Table 1. The resulting adjusted FY 2009
tilefish Full-time Tier 2 permit category
commercial quota is presented in Table
2.
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07OCR1
Agencies
[Federal Register Volume 73, Number 195 (Tuesday, October 7, 2008)]
[Rules and Regulations]
[Pages 58497-58498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23708]
=======================================================================
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DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 648
[Docket No. 070817467-8554-02]
RIN 0648-XK82
Magnuson-Stevens Fishery Conservation and Management Act
Provisions; Fisheries of the Northeastern United States; Atlantic Sea
Scallop Fishery; Closure of the Limited Access General Category Scallop
Fishery to Individual Fishing Quota Scallop Vessels
AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Temporary rule; closure.
-----------------------------------------------------------------------
SUMMARY: NMFS announces that the Limited Access General Category (LAGC)
Scallop Fishery will close to individual fishing quota (IFQ) scallop
vessels until it re-opens on December 1, 2008, under current
regulations. This action is based on the determination that the third
quarter scallop total allowable catch (TAC) for LAGC IFQ scallop
vessels (including vessels issued an IFQ letter of authorization (LOA)
to fish under appeal), is projected to be landed. This action is being
taken to prevent IFQ scallop vessels from exceeding the 2008 third
quarter TAC, in accordance with the regulations implementing Amendment
11 to the Atlantic Sea Scallop Fishery Management Plan (FMP), enacted
by Framework 19 to the FMP, and the Magnuson-Stevens Fishery
Conservation and Management Act.
DATES: The closure of the LAGC fishery to all IFQ scallop vessels is
effective 0001 hr local time, October 5, 2008, through November 30,
2008.
FOR FURTHER INFORMATION CONTACT: Christopher Biegel, Fishery Management
Specialist, (978) 281-9112, fax (978) 281-9135.
SUPPLEMENTARY INFORMATION: Regulations governing fishing activity in
[[Page 58498]]
the LAGC fishery are found at Sec. Sec. 648.59 and 648.60. Regulations
specifically governing IFQ scallop vessel operations in the LAGC
fishery are specified at Sec. 648.53(a)(8)(iii). These regulations
authorize vessels issued a valid IFQ scallop permit to fish in the LAGC
fishery under specific conditions, including a TAC. The TACs were
established by the final rule that implemented Framework 19 to the FMP
(73 FR 30790 May 29, 2008) and included a TAC of 623,747 lb (282,927
kg) that may be landed by IFQ vessels during the third quarter of the
2008 fishing year. The regulations at Sec. 648.53(a)(8)(iii) require
the LAGC fishery to be closed to IFQ vessels once the Northeast
Regional Administrator has determined that the TAC is projected to be
landed.
Based on dealer reporting and vessel pre-landing reports through
Vessel Monitoring Systems (VMS), a projection concluded that, given
current activity levels by IFQ scallop vessels in the area, 623,747 lb
(282,927 kg) will have been landed on October 4, 2008. Therefore, in
accordance with the regulations at Sec. 648.53(a)(8)(iii), the LAGC
scallop fishery is closed to all general IFQ vessels as of 0001 hr
local time, October 5, 2008. IFQ scallop vessels are not allowed to
fish for, possess, or retain scallops, or declare, or initiate, a
scallop trip following this closure for the remainder of the 2008 third
quarter, ending on November 30, 2008. This closure is in effect for the
remainder of the third quarter of the 2008 scallop fishing year under
current regulations. The LAGC scallop fishery is scheduled to re-open
to IFQ scallop vessels on December 1, 2008.
Classification
This action is required by 50 CFR part 648 and is exempt from
review under Executive Order 12866.
This action closes the LAGC scallop fishery to all IFQ scallop
vessels until December 1, 2008, under current regulations. The
regulations at Sec. 648.53(a)(8)(iii) require such action to ensure
that IFQ scallop vessels do not exceed the 2008 third quarter TAC. The
LAGC scallop fishery opened for the third quarter of the 2008 fishing
year at 0001 hours on September 1, 2008. Data indicating the IFQ
scallop fleet has landed all of the 2008 third quarter TAC have only
recently become available. The Assistant Administrator for Fisheries,
NOAA (AA), finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive
prior notice and the opportunity for public comment because it would be
contrary to the public interest. If implementation of this closure is
delayed to solicit prior public comment, the quota for this quarter
will be exceeded, thereby undermining the conservation objectives of
the FMP. Also, if the magnitude of any overage is significant, it would
warrant a decrease in the fourth quarter quota. This would have a
negative economic impact on vessels that fish seasonally in that
period. The AA further finds, pursuant to 5 U.S.C 553(d)(3), good cause
to waive the thirty (30) day delayed effectiveness period for the
reasons stated above.
Authority: 16 U.S.C. 1801 et seq.
Dated: October 2, 2008.
Emily H. Menashes,
Acting Director, Office of Sustainable Fisheries, National Marine
Fisheries Service.
[FR Doc. E8-23708 Filed 10-2-08; 4:15 pm]
BILLING CODE 3510-22-S