Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Delayed Effective Date, 9501-9502 [2017-02485]
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Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations
(i) Piper Aircraft, Inc. Service Bulletin No.
1301, dated January 6, 2017.
(ii) Reserved.
(3) For service information identified in
this AD, contact Piper Aircraft, Inc.,
Customer Service, 2926 Piper Drive, Vero
Beach, Florida 32960; telephone: (877) 879–
0275; fax: none; email: customer.service@
piper.com; Internet: www.piper.com.
(4) You may view this referenced service
information at the FAA, Small Airplane
Directorate, 901 Locust, Kansas City,
Missouri 64106. For information on the
availability of this material at the FAA, call
(816) 329–4148.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Kansas City, Missouri, on January
18, 2017.
Melvin Johnson,
Acting Manager, Small Airplane Directorate,
Aircraft Certification Service.
[FR Doc. 2017–01689 Filed 2–6–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
15 CFR Part 902
50 CFR Parts 300 and 679
[Docket No. 151001910–6999–02]
RIN 0648–BF42
Fisheries of the Exclusive Economic
Zone Off Alaska; Allow the Use of
Longline Pot Gear in the Gulf of Alaska
Sablefish Individual Fishing Quota
Fishery; Amendment 101; Correction
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Stay of final rule; correction.
AGENCY:
NMFS published a ‘‘Stay of
final rule’’ on January 31, 2017—in
accordance with the memorandum of
January 20, 2017, from the Assistant to
the President and Chief of Staff, entitled
‘‘Regulatory Freeze Pending Review,’’
published in the Federal Register on
January 24, 2017 (the Memorandum)—
to delay the effective date of the final
rule NMFS published on December 28,
2016. This notification corrects the
effectiveness date from ‘‘March 12,
2017’’ to ‘‘March 11, 2017.’’ For
consistency and clarity, the complete
new DATES section has been set out
below in its entirety.
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SUMMARY:
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Effective February 7, 2017, the
final rule amending 15 CFR part 902,
and 50 CFR parts 300 and 679, that
published on December 28, 2016, at 81
FR 95435, is stayed to March 11, 2017.
DATES:
FOR FURTHER INFORMATION CONTACT:
Rachel Baker, 907–586–7228.
SUPPLEMENTARY INFORMATION:
Background
On December 28, 2016, NMFS
published this final rule to implement
Amendment 101 to the Fishery
Management Plan for Groundfish of the
Gulf of Alaska (GOA FMP) for the
sablefish individual fishing quota (IFQ)
fisheries in the Gulf of Alaska (GOA).
This final rule authorizes the use of
longline pot gear in the GOA sablefish
IFQ fishery. In addition, this final rule
establishes management measures to
minimize potential conflicts between
hook-and-line and longline pot gear
used in the sablefish IFQ fisheries in the
GOA. This final rule also includes
regulations developed under the
Northern Pacific Halibut Act of 1982
(Halibut Act) to authorize harvest of
halibut IFQ caught incidentally in
longline pot gear used in the GOA
sablefish IFQ fishery. This final rule is
necessary to improve efficiency and
provide economic benefits for the
sablefish IFQ fleet and minimize
potential fishery interactions with
whales and seabirds. This action is
intended to promote the goals and
objectives of the Magnuson-Stevens
Fishery Conservation and Management
Act, the Halibut Act, the GOA FMP, and
other applicable laws.
On January 20, 2017, the White House
issued a memo instructing Federal
agencies to temporarily postpone the
effective date for 60 days after January
20, 2017, of any regulations or guidance
documents that have published in the
Federal Register but not yet taken effect,
for the purpose of ‘‘reviewing questions
of fact, law, and policy they raise.’’
Because its effective date has already
passed, we enacted a stay of the rule
published on December 28, 2016, at 81
FR 95435 (see DATES above) until March
12, 2017, in a ‘‘Stay of final rule’’
document published on January 31,
2017 (82 FR 8810).
Need for Correction
After the ‘‘Stay of final rule’’
published on January 31, 2017, NMFS is
correcting the effective date of ‘‘March
12, 2017’’ to ‘‘March 11, 2017’’ to better
align with current fisheries management
goals. NMFS publishes this notification
to correct the stay of effective date.
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9501
Corrections
In the Federal Register of January 31,
2017, in FR Doc. 2017–02055, ‘‘March
12, 2017’’ is corrected to read ‘‘March
11, 2017’’ in the following places:
1. In the DATES section on page 8810
in the second column, which is also set
out in its entirety above for clarity and
consistency;
2. On page 8810, third column,
second paragraph, last sentence; and
3. On page 8811, in the following
amendatory instructions: 2, 4, 6, 7, 8, 9,
10, 11, 12, 13, and 14.
Authority: 16 U.S.C. 1801 et seq.
Dated: February 2, 2017.
Alan D. Risenhoover,
Acting Deputy Assistant Administrator for
Regulatory Programs, National Marine
Fisheries Service.
[FR Doc. 2017–02463 Filed 2–6–17; 8:45 am]
BILLING CODE 3510–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 801, and 1100
[Docket No. FDA–2015–N–2002]
RIN 0910–AH19
Clarification of When Products Made
or Derived From Tobacco Are
Regulated as Drugs, Devices, or
Combination Products; Amendments
to Regulations Regarding ‘‘Intended
Uses’’; Delayed Effective Date
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule; delay of effective
date.
In accordance with the
memorandum of January 20, 2017, from
the Assistant to the President and Chief
of Staff, entitled ‘‘Regulatory Freeze
Pending Review,’’ this action delays the
effective date of the final rule
(‘‘Clarification of When Products Made
or Derived From Tobacco Are Regulated
as Drugs, Devices, or Combination
Products; Amendments to Regulations
Regarding ‘Intended Uses’ ’’), which
published on January 9, 2017, from
February 8, 2017, until March 21, 2017.
DATES: The effective date of the rule
amending 21 CFR Chapter I published at
82 FR 2193 on January 9, 2017 is
delayed until March 21, 2017.
FOR FURTHER INFORMATION CONTACT:
Center for Tobacco Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Document Control
Center, Bldg. 71, Rm. G335, Silver
SUMMARY:
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9502
Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations
Spring, MD 20993–0002, email:
AskCTP@fda.hhs.gov.
DEPARTMENT OF HOMELAND
SECURITY
On
January 9, 2017, the Food and Drug
Administration (FDA or Agency) issued
a final rule describing the circumstances
in which products made or derived from
tobacco are regulated as drugs, devices,
or combination products. The rule also
amended the ‘‘intended use’’ regulations
found at 21 CFR 201.128 and 801.4. The
rule was published with an effective
date of February 8, 2017.
FDA bases this action on the
memorandum of January 20, 2017 (82
FR 8346), from the Assistant to the
President and Chief of Staff, entitled
‘‘Regulatory Freeze Pending Review.’’
That memorandum directed the heads
of Executive Departments and Agencies
to temporarily postpone for 60 days
from the date of the memorandum the
effective dates of all regulations that had
been published in the Federal Register
but had not yet taken effect, for the
purpose of ‘‘reviewing questions of fact,
law, and policy they raise.’’ FDA,
therefore, is delaying the effective date
of the rule that published on January 9,
2017 (82 FR 2193), to March 21, 2017.
To the extent that 5 U.S.C. 553 applies
to this action, it is exempt from notice
and comment because it constitutes a
rule of procedure under 5 U.S.C.
553(b)(A). Alternatively, the Agency’s
implementation of this action without
opportunity for public comment,
effective immediately upon publication
today in the Federal Register, is based
on the good cause exceptions in 5 U.S.C.
553(b)(B) and (d)(3). Seeking public
comment is impracticable, unnecessary,
and contrary to the public interest. The
delay in the effective date until March
21, 2017, is necessary to give Agency
officials the opportunity for further
review and consideration of the new
regulation, consistent with the
memorandum described previously.
Given the imminence of the effective
date and the brief length of the
extension of the effective date, seeking
prior public comment on this delay
would have been impracticable, as well
as contrary to the public interest in the
orderly issue and implementation of
regulations.
Coast Guard
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SUPPLEMENTARY INFORMATION:
Dated: February 2, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–02485 Filed 2–6–17; 8:45 am]
BILLING CODE 4164–01–P
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33 CFR Part 117
[Docket No. USCG–2016–1021]
Drawbridge Operation Regulation; St.
Johns River, Jacksonville, FL
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the Florida East
Coast Railway Bridge, St. Johns River,
mile 24.9, at Jacksonville, FL. The
deviation is necessary to perform major
bridge repairs. This deviation allows the
bridge to remain in the closed-tonavigation position.
DATES: This deviation is effective from
7 a.m. on January 11, 2017 to 6 p.m. on
February 10, 2017.
ADDRESSES: The docket for this
deviation, [USCG–2016–1021] is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH’’.
Click on Open Docket Folder on the line
associated with this deviation.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Mr. Rod Elkins,
Seventh Coast Guard District, Bridge
Branch; telephone 305–415–6989, email
Rodney.j.elkins@uscg.mil.
SUPPLEMENTARY INFORMATION: Florida
East Coast Railway requested a
temporary deviation from the operating
schedule that governs the Florida East
Coast Railway Bridge, St. Johns River,
mile 24.9, Jacksonville, FL. The bridge
is a single leaf bascule railway bridge
with a five foot vertical clearance in the
closed position. The deviation is
necessary to perform major bridge
repairs. The normal operating schedule
for the bridge is found in 33 CFR
117.325 which indicates that the draw
is normally in the fully open position,
displaying flashing green lights to
indicate that vessels may pass.
The deviation period is from 7 a.m. on
January 11, 2017 to 6 p.m. on February
10, 2017. During this period, the bridge
is allowed to remain closed to
navigation from 7 a.m. to 11 a.m., and
from 1 p.m. to 5 p.m. on January 11,
2017 from 7 a.m. to noon and from 2
p.m. to 5 p.m. on January 12, 2017 from
8 a.m. to noon, and from 2:30 p.m. to
6:30 p.m. on January 13, 2017 from 7
a.m. to 11 a.m., and from 1 p.m. to 5
p.m. on January 18, 2017 and January
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19, 2017 and from 8 a.m. to noon, and
from 2:30 p.m. to 6:30 p.m. on January
20, 2017. Additionally, the bridge will
be allowed to remain closed to
navigation from 7 a.m. January 30, 2017
through 6 p.m. on February 10, 2017.
The Coast Guard coordinated this
closure period with the bridge owner
and the waterway users. The bridge will
be unable to open for emergencies; the
small boat span can be used as an
alternate route for vessels unable to pass
through the bridge while in the closedto-navigation position. The Coast Guard
will also inform the users of the
waterways through Local and Broadcast
Notices to Mariners of the change in
operating schedule for the bridge to
ensure vessel operators can arrange their
transits to minimize any impact caused
by the temporary deviation.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the effective period of this
temporary deviation. This deviation
from the operating regulations is
authorized under 33 CFR 117.35.
Dated: 18 January 2017.
Barry Dragon,
Director, Bridge Branch, Seventh Coast Guard
District.
[FR Doc. 2017–02456 Filed 2–6–17; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2016–1026]
Drawbridge Operation Regulation;
Perquimans River, Hertford, NC
Coast Guard, DHS.
Notice of deviation from
drawbridge regulation.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the US17
(Perquimans) Bridge across the
Perquimans River, mile 12.0, at
Hertford, NC. This deviation is
necessary to perform a bridge deck
replacement project. This deviation
allows the bridge to remain in the
closed-to-navigation position.
DATES: This deviation is effective
without actual notice from February 7,
2017 through 6 p.m. on March 17, 2017.
For the purposes of enforcement, actual
notice will be used from January 25,
2017 at 3:25 p.m., until February 7,
2017.
SUMMARY:
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[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)]
[Rules and Regulations]
[Pages 9501-9502]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02485]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 801, and 1100
[Docket No. FDA-2015-N-2002]
RIN 0910-AH19
Clarification of When Products Made or Derived From Tobacco Are
Regulated as Drugs, Devices, or Combination Products; Amendments to
Regulations Regarding ``Intended Uses''; Delayed Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; delay of effective date.
-----------------------------------------------------------------------
SUMMARY: In accordance with the memorandum of January 20, 2017, from
the Assistant to the President and Chief of Staff, entitled
``Regulatory Freeze Pending Review,'' this action delays the effective
date of the final rule (``Clarification of When Products Made or
Derived From Tobacco Are Regulated as Drugs, Devices, or Combination
Products; Amendments to Regulations Regarding `Intended Uses' ''),
which published on January 9, 2017, from February 8, 2017, until March
21, 2017.
DATES: The effective date of the rule amending 21 CFR Chapter I
published at 82 FR 2193 on January 9, 2017 is delayed until March 21,
2017.
FOR FURTHER INFORMATION CONTACT: Center for Tobacco Products, Food and
Drug Administration, 10903 New Hampshire Ave., Document Control Center,
Bldg. 71, Rm. G335, Silver
[[Page 9502]]
Spring, MD 20993-0002, email: AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On January 9, 2017, the Food and Drug
Administration (FDA or Agency) issued a final rule describing the
circumstances in which products made or derived from tobacco are
regulated as drugs, devices, or combination products. The rule also
amended the ``intended use'' regulations found at 21 CFR 201.128 and
801.4. The rule was published with an effective date of February 8,
2017.
FDA bases this action on the memorandum of January 20, 2017 (82 FR
8346), from the Assistant to the President and Chief of Staff, entitled
``Regulatory Freeze Pending Review.'' That memorandum directed the
heads of Executive Departments and Agencies to temporarily postpone for
60 days from the date of the memorandum the effective dates of all
regulations that had been published in the Federal Register but had not
yet taken effect, for the purpose of ``reviewing questions of fact,
law, and policy they raise.'' FDA, therefore, is delaying the effective
date of the rule that published on January 9, 2017 (82 FR 2193), to
March 21, 2017.
To the extent that 5 U.S.C. 553 applies to this action, it is
exempt from notice and comment because it constitutes a rule of
procedure under 5 U.S.C. 553(b)(A). Alternatively, the Agency's
implementation of this action without opportunity for public comment,
effective immediately upon publication today in the Federal Register,
is based on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3).
Seeking public comment is impracticable, unnecessary, and contrary to
the public interest. The delay in the effective date until March 21,
2017, is necessary to give Agency officials the opportunity for further
review and consideration of the new regulation, consistent with the
memorandum described previously. Given the imminence of the effective
date and the brief length of the extension of the effective date,
seeking prior public comment on this delay would have been
impracticable, as well as contrary to the public interest in the
orderly issue and implementation of regulations.
Dated: February 2, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-02485 Filed 2-6-17; 8:45 am]
BILLING CODE 4164-01-P
