Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Reopening of the Comment Period, 74737-74738 [2015-30271]

Download as PDF Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Proposed Rules feet above the surface within a 6.0-mile radius of Clinton Municipal Airport, Clinton, AR, to accommodate new standard instrument approach procedures. Controlled airspace is needed for the safety and management of IFR operations at the airport. Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order. Regulatory Notices and Analyses The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. Environmental Review This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, ‘‘Environmental Impacts: Policies and Procedures’’ prior to any FAA final regulatory action. § 71.1 [Amended] Paragraph 6005 Class E Airspace Areas Extending Upward from 700 feet or More Above the Surface of the Earth. * * * ASW LA E5 Clinton, LA [New] Clinton Municipal Airport, LA (Lat. 35°35′52″ N., long. 092°27′06″ W.) That airspace extending upward from 700 feet above the surface within a 6.0-mile radius of Clinton Municipal Airport. Issued in Fort Worth, TX, on November 18, 2015. Robert W. Beck, Manager, Operations Support Group, ATO Central Service Center. [FR Doc. 2015–30188 Filed 11–27–15; 8:45 am] BILLING CODE 4910–13–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’’; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice of proposed rulemaking; reopening of the comment period. List of Subjects in 14 CFR Part 71 ACTION: Airspace, Incorporation by reference, Navigation (Air). SUMMARY: The Proposed Amendment In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR Part 71 as follows: jstallworth on DSK7TPTVN1PROD with PROPOSALS * PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for Part 71 continues to read as follows: ■ Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389. VerDate Sep<11>2014 15:18 Nov 27, 2015 Jkt 238001 The Food and Drug Administration (FDA) is reopening the comment period for the notice of proposed rulemaking (NPRM) that appeared in the Federal Register of September 25, 2015. In the NPRM, FDA requested comments on the proposed regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. PO 00000 Frm 00023 Fmt 4702 The comment period for the proposed rule published on September 25, 2015 (80 FR 57756) is extended. Submit either electronic or written comments by December 30, 2015. ADDRESSES: You may submit comments as follows: DATES: 2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015, is amended as follows: ■ * 74737 Sfmt 4702 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 this rulemaking. Received comments 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 E:\FR\FM\30NOP1.SGM 30NOP1 jstallworth on DSK7TPTVN1PROD with PROPOSALS 74738 Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Proposed Rules 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.fda.gov/ regulatoryinformation/dockets/ default.htm. 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: Bryant Godfrey or Darin Achilles, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993–0002, 877–287–1373, CTPRegulations@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In the Federal Register of September 25, 2015 (80 FR 57756), FDA proposed a regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the FD&C Act. Interested persons were originally given until November 24, 2015, to comment on the NPRM. The Agency has received a request for a 45-day extension of the comment VerDate Sep<11>2014 15:18 Nov 27, 2015 Jkt 238001 period for the NPRM. The request conveyed concern that the current 60day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the NPRM. FDA has considered the request and is reopening the comment period for the NPRM for 30 days, until December 30, 2015. The Agency believes that reopening the comment period for an additional 30 days allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues. FOR FURTHER INFORMATION CONTACT: Dated: November 23, 2015. Leslie Kux, Associate Commissioner for Policy. I. Background [FR Doc. 2015–30271 Filed 11–27–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 60 [Docket No FR–5888–P–02] Federal Policy for the Protection of Human Subjects, Extension of Public Comment Period AGENCY: Office of the General Counsel, HUD. ACTION: Extension of public comment period. Through this notice, HUD is extending the public comment period on its proposed rule pertaining to Federal Policy for the Protection of Human Subjects, published in the Federal Register on October 1, 2015. DATES: Comment Due Date: The comment due date of December 7, 2015, for the proposed rule published on October 1, 2015, at 80 FR 59092, is extended to January 6, 2016. ADDRESSES: You may submit comments, identified by docket ID number HHS– OPHS–2015–0008, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Enter the above docket ID number in the ‘‘Enter Keyword or ID’’ field and click on ‘‘Search.’’ On the next Web page, click on ‘‘Submit a Comment’’ action and follow the instructions. • Mail/Hand delivery/Courier [For paper, disk, or CD–ROM submissions] to: Jerry Menikoff, M.D., J.D., OHRP, 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. Comments received, including any personal information, will be posted without change to www.regulations.gov. SUMMARY: PO 00000 Frm 00024 Fmt 4702 Sfmt 9990 Barry L. Steffen, Policy Development Division, Office of Policy Development and Research, Department of Housing and Urban Development, 451 7th Street SW., Room 8114, Washington, DC 20410–8000, telephone 202–402–5926. (This is not a toll-free number.) Persons with hearing- or speech-impairments may access this number through TTY number by calling the Federal Relay Service number at 800–877–8339 (this is a toll-free number). SUPPLEMENTARY INFORMATION: On October 1, 2015, at 80 FR 59092, HUD published a proposed rule in the Federal Register on Federal Policy for the Protection of Human Subjects. HUD’s proposed rule adopted the policy on the protection of human subjects set forth in a proposed rule issued by the Department of Health and Human Services and 15 other Federal Departments and Agencies and published on September 8, 2015, at 80 FR 53933. Through the September 8, 2015, and October 1, 2015, rules, the Federal Departments and Agencies proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 199, and sought comment on the proposed revisions through December 7, 2015. Since the proposed rules were published in September and October, respectively, requests have been made to extend the public comment period to allow time to more thoroughly review the proposed revisions offered for comment by the Federal Departments and Agencies. The Department of Health and Human Services and the 15 other Federal Department Agencies have extended the time to submit public comments on the September 8, 2015, proposed rule to January 6, 2016, and HUD extends its public comment period for its October 1, 2015, proposed rule to this same date—January 6, 2016. Dated: November 24, 2015. Camille E. Acevedo, Associate General Counsel for Legislation and Regulations. [FR Doc. 2015–30317 Filed 11–27–15; 8:45 am] BILLING CODE 4210–67–P E:\FR\FM\30NOP1.SGM 30NOP1

Agencies

[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)]
[Proposed Rules]
[Pages 74737-74738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-30271]


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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''; Reopening of the Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice of proposed rulemaking (NPRM) that 
appeared in the Federal Register of September 25, 2015. In the NPRM, 
FDA requested comments on the proposed regulation that describes the 
circumstances in which a product made or derived from tobacco that is 
intended for human consumption will be subject to regulation as a drug, 
device, or a combination product under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act). The Agency is taking this action in 
response to a request for an extension to allow interested persons 
additional time to submit comments.

DATES: The comment period for the proposed rule published on September 
25, 2015 (80 FR 57756) is extended. Submit either electronic or written 
comments by December 30, 2015.

ADDRESSES: You may submit comments as follows:

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 this rulemaking. Received comments 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

[[Page 74738]]

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.fda.gov/regulatoryinformation/dockets/default.htm.
    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: Bryant Godfrey or Darin Achilles, 
Office of Regulations, Center for Tobacco Products, Food and Drug 
Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, 
877-287-1373, CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 25, 
2015 (80 FR 57756), FDA proposed a regulation that describes the 
circumstances in which a product made or derived from tobacco that is 
intended for human consumption will be subject to regulation as a drug, 
device, or a combination product under the FD&C Act. Interested persons 
were originally given until November 24, 2015, to comment on the NPRM.
    The Agency has received a request for a 45-day extension of the 
comment period for the NPRM. The request conveyed concern that the 
current 60-day comment period does not allow sufficient time to develop 
a meaningful or thoughtful response to the NPRM.
    FDA has considered the request and is reopening the comment period 
for the NPRM for 30 days, until December 30, 2015. The Agency believes 
that reopening the comment period for an additional 30 days allows 
adequate time for interested persons to submit comments without 
significantly delaying rulemaking on these important issues.

    Dated: November 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-30271 Filed 11-27-15; 8:45 am]
 BILLING CODE 4164-01-P

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