Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments; Extension of Comment Period, 22741-22742 [2017-10036]

Download as PDF Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Rules and Regulations Manti, UT, Manti-Ephraim, Takeoff Minimums and Obstacle DP, Orig Manti, UT, Manti-Ephraim, WUXOT ONE, Graphic DP Manti, UT, Manti-Ephraim, YMONT ONE, Graphic DP Marion/Wytheville, VA, Mountain Empire, LOC RWY 26, Amdt 3 Marion/Wytheville, VA, Mountain Empire, RNAV (GPS) RWY 26, Amdt 1 Wenatchee, WA, Pangborn Memorial, WENATCHEE TWO, Graphic DP Black River Falls, WI, Black River Falls Area, RNAV (GPS) RWY 26, Orig-B Necedah, WI, Necedah, RNAV (GPS) RWY 36, Orig-D Racine, WI, Batten Intl, Takeoff Minimums and Obstacle DP, Amdt 5A Stevens Point, WI, Stevens Point Muni, ILS OR LOC RWY 21, Amdt 1 Stevens Point, WI, Stevens Point Muni, RNAV (GPS) RWY 21, Amdt 1 Wausau, WI, Wausau Downtown, RNAV (GPS) RWY 31, Amdt 1 Cheyenne, WY, Cheyenne Rgnl/Jerry Olson Field, ILS OR LOC RWY 27, Amdt 35A Rescinded: On April 10, 2017 (82 FR 17117), the FAA published an Amendment in Docket No. 31125, Amdt No. 3739 to Part 97 of the Federal Aviation Regulations under section 97.33, the following entries for Majuro Atoll, RM, effective April 27, 2017, and are hereby rescinded in their entirety: Majuro Atoll, RM, Marshall Islands Intl, RNAV (GPS) RWY 7, Orig-D Majuro Atoll, RM, Marshall Islands Intl, RNAV (GPS) RWY 25, Orig-D [FR Doc. 2017–09908 Filed 5–17–17; 8:45 am] BILLING CODE 4910–13–P SOCIAL SECURITY ADMINISTRATION 20 CFR Part 421 [Docket No. SSA–2016–0011] RIN 0960–AH95 Implementation of the NICS Improvement Amendments Act of 2007 Social Security Administration. Final rule; CRA Revocation. AGENCY: ACTION: We are removing from the Code of Federal Regulations the final rules, Implementation of the NICS Improvement Amendments Act of 2007 (NIAA), published on December 19, 2016. We are doing so because Congress passed, and the President signed, a joint resolution of disapproval of the final rules under the Congressional Review Act. jstallworth on DSK7TPTVN1PROD with RULES SUMMARY: This rule removal is effective on May 18, 2017. DATES: VerDate Sep<11>2014 11:09 May 17, 2017 Jkt 241001 FOR FURTHER INFORMATION CONTACT: Social Security Administration, 410– 965–3735 or Regulations@ssa.gov. For information on eligibility or filing for benefits, call our national toll-free number, 1–800–772–1213 or TTY 1– 800–325–0778, or visit our Internet site, Social Security Online, at https:// www.socialsecurity.gov. SUPPLEMENTARY INFORMATION: On May 5, 2016, we published a notice of proposed rulemaking (NPRM) in the Federal Register (81 FR 27059) in which we proposed adding part 421 to our regulations to fulfill responsibilities that we have under the NIAA. On December 19, 2016, we published a final rule (81 FR 91702) for the Implementation of the NICS Improvement Amendments Act of 2007 (NIAA), which had an effective date of January 18, 2017.1 On February 2, 2017, the United States House of Representatives passed H.J. Res. 40, ‘‘Providing for congressional disapproval under chapter 8 of title 5, United States Code, of the rule submitted by the Social Security Administration relating to Implementation of the NICS Improvement Amendments Act of 2007 (NIAA).’’.2 On February 15, 2017, the United States Senate passed H.J. Res. 40 without amendment,3 and the President signed H.J. Res. 40 into law on February 28, 2017.4 Under the terms of Public Law 115–8, the final rules ‘‘shall have no force or effect.’’ As a result, we are removing them from the Code of Federal Regulations. Authority for removal: This document was prepared under the direction of Nancy A. Berryhill, Acting Commissioner of Social Security. We issued it under the authority of section 702 of the Social Security Act (42 U.S.C. 902(a)(5)), and Public Law 115–8, 131 Stat. 15. List of Subjects in 20 CFR Part 421 Administrative practice and procedure, Freedom of information, Privacy, Reporting and recordkeeping requirements. Nancy A. Berryhill, Acting Commissioner of Social Security. Under the authority of section 702 of the Social Security Act (42 U.S.C. 902(a)(5)), the Congressional Review Act (5 U.S.C. 801 et seq.), and Public Law 1 Although the final rule had an effective date of January 18, 2017, we delayed the compliance date of the rule until December 19, 2017 (81 FR at 91720). Therefore, we did not report any records to the National Instant Criminal Background Check System (NICS) pursuant to the final rule. 2 163 Cong. Rec. H916 (daily ed. Feb. 2, 2017). 3 163 Cong. Rec. S1169 (daily ed. Feb. 15, 2017). 4 Public Law 115–8, 131 Stat. 15. PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 22741 115–8, 131 Stat. 15, and for the reasons set out in the preamble, we amend title 20, chapter III, of the Code of Federal Regulations as follows: PART 421—[REMOVED] 1. Remove part 421, consisting of §§ 421.100 through 421.170. ■ [FR Doc. 2017–10084 Filed 5–17–17; 8:45 am] BILLING CODE 4191–02–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’’; Further Delayed Effective Date; Request for Comments; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. Final rule; extension of comment period. ACTION: In the Federal Register of January 9, 2017, the Food and Drug Administration (FDA or the Agency) issued a final rule entitled ‘‘Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’ ’’ (Final Rule). On March 20, 2017, FDA published a document in the Federal Register (Final Rule Extension) to delay the effective date of the Final Rule until March 19, 2018, and requested comments on particular issues raised in a petition for reconsideration and stay of action of the Final Rule. The petition for reconsideration raised questions about the amendments to the regulations regarding ‘‘intended uses’’ that are set forth in the Final Rule. In the Final Rule Extension FDA also requested comments regarding any aspect of the Final Rule, or with respect to issues relating to ‘‘intended uses’’ generally, and on whether the delay in the effective date should be modified or revoked. FDA is now issuing this document to extend the comment period. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. SUMMARY: E:\FR\FM\18MYR1.SGM 18MYR1 22742 Federal Register / Vol. 82, No. 95 / Thursday, May 18, 2017 / Rules and Regulations FDA is extending the comment period on the document delaying the effective date and seeking comment on the final rule published March 20, 2017 (82 FR 14319). Submit either electronic or written comments by July 18, 2017. For additional information on the comment date, see ADDRESSES and SUPPLEMENTARY INFORMATION. ADDRESSES: You may submit comments as follows: Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 18, 2017. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. DATES: jstallworth on DSK7TPTVN1PROD with RULES Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, VerDate Sep<11>2014 11:09 May 17, 2017 Jkt 241001 except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–N–2002 for ‘‘Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’; Further Delayed Effective Date; Request for Comments; Extension of Comment Period.’’ Received comments, those filed in a timely manner (see DATES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Robert Berlin, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4238, Silver Spring, MD 20993, 301–796– 8828. SUPPLEMENTARY INFORMATION: In the Federal Register of March 20, 2017, FDA published a document delaying the effective date of the January 9, 2017 (82 FR 2193), final rule entitled ‘‘Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding ‘Intended Uses’ ’’ until March 19, 2018, with a 60-day comment period. FDA requested comments on particular issues raised in a petition for reconsideration and stay of action of the Final Rule, as well as regarding any aspect of the Final Rule, or with respect to issues relating to ‘‘intended uses’’ generally. FDA also requested comments on whether the delay in the effective date of the Final Rule should be modified or revoked. Comments on these issues will inform FDA’s thinking and next steps on these issues. The Agency has received a request for a 30-day extension and another request for a 90-day extension of the comment period for the Final Rule Extension. The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to issues FDA raised in the Final Rule Extension. FDA has considered the requests and is extending the comment period for 60 days, until July 18, 2017. The Agency believes that a 60-day extension allows additional time for interested persons to submit comments on these important issues. Dated: May 12, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–10036 Filed 5–17–17; 8:45 am] BILLING CODE 4164–01–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Parts 1 and 20 [GN Docket No. 13–111; FCC 17–25] Promoting Technological Solutions To Combat Contraband Wireless Device Use in Correctional Facilities Federal Communications Commission. AGENCY: E:\FR\FM\18MYR1.SGM 18MYR1

Agencies

[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)]
[Rules and Regulations]
[Pages 22741-22742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10036]

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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''; Further Delayed Effective
Date; Request for Comments; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension of comment period.

-----------------------------------------------------------------------

SUMMARY: In the Federal Register of January 9, 2017, the Food and Drug
Administration (FDA or the Agency) issued a final rule entitled
``Clarification of When Products Made or Derived From Tobacco Are
Regulated as Drugs, Devices, or Combination Products; Amendments to
Regulations Regarding `Intended Uses' '' (Final Rule). On March 20,
2017, FDA published a document in the Federal Register (Final Rule
Extension) to delay the effective date of the Final Rule until March
19, 2018, and requested comments on particular issues raised in a
petition for reconsideration and stay of action of the Final Rule. The
petition for reconsideration raised questions about the amendments to
the regulations regarding ``intended uses'' that are set forth in the
Final Rule. In the Final Rule Extension FDA also requested comments
regarding any aspect of the Final Rule, or with respect to issues
relating to ``intended uses'' generally, and on whether the delay in
the effective date should be modified or revoked. FDA is now issuing
this document to extend the comment period. The Agency is taking this
action in response to requests for an extension to allow interested
persons additional time to submit comments.

[[Page 22742]]

DATES: FDA is extending the comment period on the document delaying the
effective date and seeking comment on the final rule published March
20, 2017 (82 FR 14319). Submit either electronic or written comments by
July 18, 2017. For additional information on the comment date, see
ADDRESSES and SUPPLEMENTARY INFORMATION.

ADDRESSES: You may submit comments as follows: Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 18, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 18, 2017. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-2002 for ``Clarification of When Products Made or Derived
From Tobacco Are Regulated as Drugs, Devices, or Combination Products;
Amendments to Regulations Regarding `Intended Uses'; Further Delayed
Effective Date; Request for Comments; Extension of Comment Period.''
Received comments, those filed in a timely manner (see DATES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Robert Berlin, Office of Policy, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4238,
Silver Spring, MD 20993, 301-796-8828.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 20, 2017,
FDA published a document delaying the effective date of the January 9,
2017 (82 FR 2193), final rule entitled ``Clarification of When Products
Made or Derived From Tobacco Are Regulated as Drugs, Devices, or
Combination Products; Amendments to Regulations Regarding `Intended
Uses' '' until March 19, 2018, with a 60-day comment period. FDA
requested comments on particular issues raised in a petition for
reconsideration and stay of action of the Final Rule, as well as
regarding any aspect of the Final Rule, or with respect to issues
relating to ``intended uses'' generally. FDA also requested comments on
whether the delay in the effective date of the Final Rule should be
modified or revoked. Comments on these issues will inform FDA's
thinking and next steps on these issues.
The Agency has received a request for a 30-day extension and
another request for a 90-day extension of the comment period for the
Final Rule Extension. The requests conveyed concern that the current
60-day comment period does not allow sufficient time to develop a
meaningful or thoughtful response to issues FDA raised in the Final
Rule Extension.
FDA has considered the requests and is extending the comment period
for 60 days, until July 18, 2017. The Agency believes that a 60-day
extension allows additional time for interested persons to submit
comments on these important issues.

Dated: May 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10036 Filed 5-17-17; 8:45 am]
BILLING CODE 4164-01-P

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