82 FR 9501 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 24 (February 7, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 24 (February 7, 2017)
| Page Range | 9501-9502 | |
| FR Document | 2017-02485 |
[Federal Register Volume 82, Number 24 (Tuesday, February 7, 2017)] [Rules and Regulations] [Pages 9501-9502] From the Federal Register Online [www.thefederalregister.org] [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: [email protected]. 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
![Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations 9501
(i) Piper Aircraft, Inc. Service Bulletin No. DATES: Effective February 7, 2017, the Corrections
1301, dated January 6, 2017. final rule amending 15 CFR part 902,
(ii) Reserved. In the Federal Register of January 31,
and 50 CFR parts 300 and 679, that 2017, in FR Doc. 2017–02055, ‘‘March
(3) For service information identified in
this AD, contact Piper Aircraft, Inc., published on December 28, 2016, at 81 12, 2017’’ is corrected to read ‘‘March
Customer Service, 2926 Piper Drive, Vero FR 95435, is stayed to March 11, 2017. 11, 2017’’ in the following places:
Beach, Florida 32960; telephone: (877) 879– FOR FURTHER INFORMATION CONTACT: 1. In the DATES section on page 8810
0275; fax: none; email: customer.service@ in the second column, which is also set
piper.com; Internet: www.piper.com. Rachel Baker, 907–586–7228.
out in its entirety above for clarity and
(4) You may view this referenced service SUPPLEMENTARY INFORMATION:
information at the FAA, Small Airplane
consistency;
Directorate, 901 Locust, Kansas City, 2. On page 8810, third column,
Background
Missouri 64106. For information on the second paragraph, last sentence; and
availability of this material at the FAA, call On December 28, 2016, NMFS 3. On page 8811, in the following
(816) 329–4148. published this final rule to implement amendatory instructions: 2, 4, 6, 7, 8, 9,
(5) You may view this service information Amendment 101 to the Fishery 10, 11, 12, 13, and 14.
that is incorporated by reference at the
National Archives and Records
Management Plan for Groundfish of the Authority: 16 U.S.C. 1801 et seq.
Administration (NARA). For information on Gulf of Alaska (GOA FMP) for the Dated: February 2, 2017.
the availability of this material at NARA, call sablefish individual fishing quota (IFQ) Alan D. Risenhoover,
202–741–6030, or go to: http:// fisheries in the Gulf of Alaska (GOA).
Acting Deputy Assistant Administrator for
www.archives.gov/federal-register/cfr/ibr- This final rule authorizes the use of Regulatory Programs, National Marine
locations.html. longline pot gear in the GOA sablefish Fisheries Service.
Issued in Kansas City, Missouri, on January IFQ fishery. In addition, this final rule [FR Doc. 2017–02463 Filed 2–6–17; 8:45 am]
18, 2017. establishes management measures to
BILLING CODE 3510–22–P
Melvin Johnson, minimize potential conflicts between
Acting Manager, Small Airplane Directorate, hook-and-line and longline pot gear
Aircraft Certification Service. used in the sablefish IFQ fisheries in the
DEPARTMENT OF HEALTH AND
[FR Doc. 2017–01689 Filed 2–6–17; 8:45 am] GOA. This final rule also includes
HUMAN SERVICES
BILLING CODE 4910–13–P regulations developed under the
Northern Pacific Halibut Act of 1982 Food and Drug Administration
(Halibut Act) to authorize harvest of
DEPARTMENT OF COMMERCE halibut IFQ caught incidentally in 21 CFR Parts 201, 801, and 1100
longline pot gear used in the GOA
National Oceanic and Atmospheric sablefish IFQ fishery. This final rule is [Docket No. FDA–2015–N–2002]
Administration necessary to improve efficiency and RIN 0910–AH19
provide economic benefits for the
15 CFR Part 902 sablefish IFQ fleet and minimize Clarification of When Products Made
potential fishery interactions with or Derived From Tobacco Are
50 CFR Parts 300 and 679 whales and seabirds. This action is Regulated as Drugs, Devices, or
[Docket No. 151001910–6999–02] intended to promote the goals and Combination Products; Amendments
objectives of the Magnuson-Stevens to Regulations Regarding ‘‘Intended
RIN 0648–BF42 Fishery Conservation and Management Uses’’; Delayed Effective Date
Act, the Halibut Act, the GOA FMP, and
Fisheries of the Exclusive Economic AGENCY: Food and Drug Administration,
other applicable laws.
Zone Off Alaska; Allow the Use of HHS.
Longline Pot Gear in the Gulf of Alaska On January 20, 2017, the White House ACTION: Final rule; delay of effective
Sablefish Individual Fishing Quota issued a memo instructing Federal date.
Fishery; Amendment 101; Correction agencies to temporarily postpone the
effective date for 60 days after January SUMMARY: In accordance with the
AGENCY: National Marine Fisheries 20, 2017, of any regulations or guidance memorandum of January 20, 2017, from
Service (NMFS), National Oceanic and documents that have published in the the Assistant to the President and Chief
Atmospheric Administration (NOAA), Federal Register but not yet taken effect, of Staff, entitled ‘‘Regulatory Freeze
Commerce. for the purpose of ‘‘reviewing questions Pending Review,’’ this action delays the
ACTION: Stay of final rule; correction. of fact, law, and policy they raise.’’ effective date of the final rule
SUMMARY: NMFS published a ‘‘Stay of Because its effective date has already (‘‘Clarification of When Products Made
final rule’’ on January 31, 2017—in passed, we enacted a stay of the rule or Derived From Tobacco Are Regulated
accordance with the memorandum of published on December 28, 2016, at 81 as Drugs, Devices, or Combination
January 20, 2017, from the Assistant to FR 95435 (see DATES above) until March Products; Amendments to Regulations
the President and Chief of Staff, entitled 12, 2017, in a ‘‘Stay of final rule’’ Regarding ‘Intended Uses’ ’’), which
‘‘Regulatory Freeze Pending Review,’’ document published on January 31, published on January 9, 2017, from
published in the Federal Register on 2017 (82 FR 8810). February 8, 2017, until March 21, 2017.
January 24, 2017 (the Memorandum)— DATES: The effective date of the rule
Need for Correction
to delay the effective date of the final amending 21 CFR Chapter I published at
mstockstill on DSK3G9T082PROD with RULES
rule NMFS published on December 28, After the ‘‘Stay of final rule’’ 82 FR 2193 on January 9, 2017 is
2016. This notification corrects the published on January 31, 2017, NMFS is delayed until March 21, 2017.
effectiveness date from ‘‘March 12, correcting the effective date of ‘‘March FOR FURTHER INFORMATION CONTACT:
2017’’ to ‘‘March 11, 2017.’’ For 12, 2017’’ to ‘‘March 11, 2017’’ to better Center for Tobacco Products, Food and
consistency and clarity, the complete align with current fisheries management Drug Administration, 10903 New
new DATES section has been set out goals. NMFS publishes this notification Hampshire Ave., Document Control
below in its entirety. to correct the stay of effective date. Center, Bldg. 71, Rm. G335, Silver
VerDate Sep<11>2014 18:06 Feb 06, 2017 Jkt 241001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\FR\FM\07FER1.SGM 07FER1](https://thefederalregister.org/doc/82_FR_9525/page/1.svg)
![9502 Federal Register / Vol. 82, No. 24 / Tuesday, February 7, 2017 / Rules and Regulations
Spring, MD 20993–0002, email: DEPARTMENT OF HOMELAND 19, 2017 and from 8 a.m. to noon, and
AskCTP@fda.hhs.gov. SECURITY from 2:30 p.m. to 6:30 p.m. on January
20, 2017. Additionally, the bridge will
SUPPLEMENTARY INFORMATION: On Coast Guard be allowed to remain closed to
January 9, 2017, the Food and Drug navigation from 7 a.m. January 30, 2017
Administration (FDA or Agency) issued 33 CFR Part 117 through 6 p.m. on February 10, 2017.
a final rule describing the circumstances The Coast Guard coordinated this
in which products made or derived from [Docket No. USCG–2016–1021]
closure period with the bridge owner
tobacco are regulated as drugs, devices, Drawbridge Operation Regulation; St. and the waterway users. The bridge will
or combination products. The rule also Johns River, Jacksonville, FL be unable to open for emergencies; the
amended the ‘‘intended use’’ regulations small boat span can be used as an
found at 21 CFR 201.128 and 801.4. The AGENCY: Coast Guard, DHS. alternate route for vessels unable to pass
rule was published with an effective ACTION:Notice of deviation from through the bridge while in the closed-
date of February 8, 2017. drawbridge regulation. to-navigation position. The Coast Guard
FDA bases this action on the will also inform the users of the
SUMMARY: The Coast Guard has issued a waterways through Local and Broadcast
memorandum of January 20, 2017 (82 temporary deviation from the operating
FR 8346), from the Assistant to the Notices to Mariners of the change in
schedule that governs the Florida East operating schedule for the bridge to
President and Chief of Staff, entitled Coast Railway Bridge, St. Johns River, ensure vessel operators can arrange their
‘‘Regulatory Freeze Pending Review.’’ mile 24.9, at Jacksonville, FL. The transits to minimize any impact caused
That memorandum directed the heads deviation is necessary to perform major by the temporary deviation.
of Executive Departments and Agencies bridge repairs. This deviation allows the In accordance with 33 CFR 117.35(e),
to temporarily postpone for 60 days bridge to remain in the closed-to- the drawbridge must return to its regular
from the date of the memorandum the navigation position. operating schedule immediately at the
effective dates of all regulations that had DATES: This deviation is effective from end of the effective period of this
been published in the Federal Register 7 a.m. on January 11, 2017 to 6 p.m. on temporary deviation. This deviation
but had not yet taken effect, for the February 10, 2017. from the operating regulations is
purpose of ‘‘reviewing questions of fact, ADDRESSES: The docket for this authorized under 33 CFR 117.35.
law, and policy they raise.’’ FDA, deviation, [USCG–2016–1021] is Dated: 18 January 2017.
therefore, is delaying the effective date available at http://www.regulations.gov.
Barry Dragon,
of the rule that published on January 9, Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH’’. Director, Bridge Branch, Seventh Coast Guard
2017 (82 FR 2193), to March 21, 2017.
District.
To the extent that 5 U.S.C. 553 applies Click on Open Docket Folder on the line
[FR Doc. 2017–02456 Filed 2–6–17; 8:45 am]
to this action, it is exempt from notice associated with this deviation.
BILLING CODE 9110–04–P
and comment because it constitutes a FOR FURTHER INFORMATION CONTACT: If
rule of procedure under 5 U.S.C. you have questions on this temporary
553(b)(A). Alternatively, the Agency’s deviation, call or email Mr. Rod Elkins, DEPARTMENT OF HOMELAND
implementation of this action without Seventh Coast Guard District, Bridge SECURITY
opportunity for public comment, Branch; telephone 305–415–6989, email
Rodney.j.elkins@uscg.mil. Coast Guard
effective immediately upon publication
today in the Federal Register, is based SUPPLEMENTARY INFORMATION: Florida
on the good cause exceptions in 5 U.S.C. East Coast Railway requested a 33 CFR Part 117
553(b)(B) and (d)(3). Seeking public temporary deviation from the operating [Docket No. USCG–2016–1026]
schedule that governs the Florida East
comment is impracticable, unnecessary,
Coast Railway Bridge, St. Johns River, Drawbridge Operation Regulation;
and contrary to the public interest. The
mile 24.9, Jacksonville, FL. The bridge Perquimans River, Hertford, NC
delay in the effective date until March
is a single leaf bascule railway bridge
21, 2017, is necessary to give Agency with a five foot vertical clearance in the AGENCY: Coast Guard, DHS.
officials the opportunity for further closed position. The deviation is ACTION:Notice of deviation from
review and consideration of the new necessary to perform major bridge drawbridge regulation.
regulation, consistent with the repairs. The normal operating schedule
memorandum described previously. for the bridge is found in 33 CFR SUMMARY: The Coast Guard has issued a
Given the imminence of the effective 117.325 which indicates that the draw temporary deviation from the operating
date and the brief length of the is normally in the fully open position, schedule that governs the US17
extension of the effective date, seeking displaying flashing green lights to (Perquimans) Bridge across the
prior public comment on this delay indicate that vessels may pass. Perquimans River, mile 12.0, at
would have been impracticable, as well The deviation period is from 7 a.m. on Hertford, NC. This deviation is
as contrary to the public interest in the January 11, 2017 to 6 p.m. on February necessary to perform a bridge deck
orderly issue and implementation of 10, 2017. During this period, the bridge replacement project. This deviation
regulations. is allowed to remain closed to allows the bridge to remain in the
navigation from 7 a.m. to 11 a.m., and closed-to-navigation position.
Dated: February 2, 2017.
mstockstill on DSK3G9T082PROD with RULES
from 1 p.m. to 5 p.m. on January 11, DATES: This deviation is effective
Leslie Kux, 2017 from 7 a.m. to noon and from 2 without actual notice from February 7,
Associate Commissioner for Policy. p.m. to 5 p.m. on January 12, 2017 from 2017 through 6 p.m. on March 17, 2017.
[FR Doc. 2017–02485 Filed 2–6–17; 8:45 am] 8 a.m. to noon, and from 2:30 p.m. to For the purposes of enforcement, actual
BILLING CODE 4164–01–P 6:30 p.m. on January 13, 2017 from 7 notice will be used from January 25,
a.m. to 11 a.m., and from 1 p.m. to 5 2017 at 3:25 p.m., until February 7,
p.m. on January 18, 2017 and January 2017.
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Document Created: 2017-02-07 00:27:36
Document Modified: 2017-02-07 00:27:36
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule; delay of effective date. | |
| 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. | |
| Contact | Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Document Control Center, Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, email: [email protected] | |
| FR Citation | 82 FR 9501 | |
| RIN Number | 0910-AH19 | |
| CFR Citation | 21
CFR
1100 21 CFR 201 21 CFR 801 |
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