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]

Download as PDF 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: http:// 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. mstockstill on DSK3G9T082PROD with RULES SUMMARY: VerDate Sep<11>2014 18:06 Feb 06, 2017 Jkt 241001 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. PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 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: E:\FR\FM\07FER1.SGM 07FER1 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 mstockstill on DSK3G9T082PROD with RULES 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 VerDate Sep<11>2014 18:06 Feb 06, 2017 Jkt 241001 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 http://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 SUMMARY: PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 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: E:\FR\FM\07FER1.SGM 07FER1

Agencies

[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]


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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