80 FR 74737 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 229 (November 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 229 (November 30, 2015)
| Page Range | 74737-74738 | |
| FR Document | 2015-30271 |
[Federal Register Volume 80, Number 229 (Monday, November 30, 2015)] [Proposed Rules] [Pages 74737-74738] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-30271] ======================================================================= ----------------------------------------------------------------------- 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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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, [email protected]. 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
![Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Proposed Rules 74737
feet above the surface within a 6.0-mile § 71.1 [Amended] DATES: The comment period for the
radius of Clinton Municipal Airport, ■ 2. The incorporation by reference in proposed rule published on September
Clinton, AR, to accommodate new 14 CFR 71.1 of FAA Order 7400.9Z, 25, 2015 (80 FR 57756) is extended.
standard instrument approach Airspace Designations and Reporting Submit either electronic or written
procedures. Controlled airspace is Points, dated August 6, 2015, and comments by December 30, 2015.
needed for the safety and management effective September 15, 2015, is ADDRESSES: You may submit comments
of IFR operations at the airport. amended as follows: as follows:
Class E airspace areas are published Paragraph 6005 Class E Airspace Areas Electronic Submissions
in Paragraph 6005 of FAA Order Extending Upward from 700 feet or More
7400.9Z, dated August 6, 2015, and Above the Surface of the Earth.
Submit electronic comments in the
effective September 15, 2015, which is following way:
* * * * * • Federal eRulemaking Portal: http://
incorporated by reference in 14 CFR
71.1. The Class E airspace designation ASW LA E5 Clinton, LA [New] www.regulations.gov. Follow the
listed in this document will be Clinton Municipal Airport, LA instructions for submitting comments.
published subsequently in the Order. (Lat. 35°35′52″ N., long. 092°27′06″ W.) Comments submitted electronically,
That airspace extending upward from 700 including attachments, to http://
Regulatory Notices and Analyses feet above the surface within a 6.0-mile www.regulations.gov will be posted to
The FAA has determined that this radius of Clinton Municipal Airport. the docket unchanged. Because your
proposed regulation only involves an Issued in Fort Worth, TX, on November 18,
comment will be made public, you are
established body of technical 2015. solely responsible for ensuring that your
regulations for which frequent and Robert W. Beck,
comment does not include any
routine amendments are necessary to confidential information that you or a
Manager, Operations Support Group, ATO
keep them operationally current. It, Central Service Center.
third party may not wish to be posted,
therefore: (1) Is not a ‘‘significant such as medical information, your or
[FR Doc. 2015–30188 Filed 11–27–15; 8:45 am]
regulatory action’’ under Executive anyone else’s Social Security number, or
BILLING CODE 4910–13–P
Order 12866; (2) is not a ‘‘significant confidential business information, such
rule’’ under DOT Regulatory Policies as a manufacturing process. Please note
and Procedures (44 FR 11034; February that if you include your name, contact
DEPARTMENT OF HEALTH AND information, or other information that
26, 1979); and (3) does not warrant
HUMAN SERVICES identifies you in the body of your
preparation of a regulatory evaluation as
the anticipated impact is so minimal. comments, that information will be
Food and Drug Administration posted on http://www.regulations.gov.
Since this is a routine matter that will
• If you want to submit a comment
only affect air traffic procedures and air 21 CFR Parts 201, 801, and 1100 with confidential information that you
navigation, it is certified that this rule,
do not wish to be made available to the
when promulgated, would not have a [Docket No. FDA–2015–N–2002]
public, submit the comment as a
significant economic impact on a
RIN 0910–AH19 written/paper submission and in the
substantial number of small entities
manner detailed (see ‘‘Written/Paper
under the criteria of the Regulatory
Clarification of When Products Made Submissions’’ and ‘‘Instructions’’).
Flexibility Act.
or Derived From Tobacco Are
Written/Paper Submissions
Environmental Review Regulated as Drugs, Devices, or
Combination Products; Amendments Submit written/paper submissions as
This proposal will be subject to an to Regulations Regarding ‘‘Intended follows:
environmental analysis in accordance Uses’’; Reopening of the Comment • Mail/Hand delivery/Courier (for
with FAA Order 1050.1F, Period written/paper submissions): Division of
‘‘Environmental Impacts: Policies and Dockets Management (HFA–305), Food
Procedures’’ prior to any FAA final AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers
regulatory action. HHS. Lane, Rm. 1061, Rockville, MD 20852.
List of Subjects in 14 CFR Part 71 ACTION:Notice of proposed rulemaking; • For written/paper comments
reopening of the comment period. submitted to the Division of Dockets
Airspace, Incorporation by reference, Management, FDA will post your
Navigation (Air). SUMMARY: The Food and Drug comment, as well as any attachments,
Administration (FDA) is reopening the except for information submitted,
The Proposed Amendment comment period for the notice of marked and identified, as confidential,
In consideration of the foregoing, the proposed rulemaking (NPRM) that if submitted as detailed in
Federal Aviation Administration appeared in the Federal Register of ‘‘Instructions.’’
proposes to amend 14 CFR Part 71 as September 25, 2015. In the NPRM, FDA Instructions: All submissions received
follows: requested comments on the proposed must include the Docket No. FDA–
regulation that describes the 2015–N–2002 for this rulemaking.
PART 71—DESIGNATION OF CLASS A, circumstances in which a product made Received comments will be placed in
B, C, D, AND E AIRSPACE AREAS; AIR or derived from tobacco that is intended the docket and, except for those
jstallworth on DSK7TPTVN1PROD with PROPOSALS
TRAFFIC SERVICE ROUTES; AND for human consumption will be subject submitted as ‘‘Confidential
REPORTING POINTS to regulation as a drug, device, or a Submissions,’’ publicly viewable at
combination product under the Federal http://www.regulations.gov or at the
■ 1. The authority citation for Part 71 Food, Drug, and Cosmetic Act (the Division of Dockets Management
continues to read as follows: FD&C Act). The Agency is taking this between 9 a.m. and 4 p.m., Monday
Authority: 49 U.S.C. 106(f), 106(g); 40103, action in response to a request for an through Friday.
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, extension to allow interested persons • Confidential Submissions—To
1959–1963 Comp., p. 389. additional time to submit comments. submit a comment with confidential
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![74738 Federal Register / Vol. 80, No. 229 / Monday, November 30, 2015 / Proposed Rules
information that you do not wish to be period for the NPRM. The request FOR FURTHER INFORMATION CONTACT:
made publicly available, submit your conveyed concern that the current 60- Barry L. Steffen, Policy Development
comments only as a written/paper day comment period does not allow Division, Office of Policy Development
submission. You should submit two sufficient time to develop a meaningful and Research, Department of Housing
copies total. One copy will include the or thoughtful response to the NPRM. and Urban Development, 451 7th Street
information you claim to be confidential FDA has considered the request and SW., Room 8114, Washington, DC
with a heading or cover note that states is reopening the comment period for the 20410–8000, telephone 202–402–5926.
‘‘THIS DOCUMENT CONTAINS NPRM for 30 days, until December 30, (This is not a toll-free number.) Persons
CONFIDENTIAL INFORMATION.’’ The 2015. The Agency believes that with hearing- or speech-impairments
Agency will review this copy, including reopening the comment period for an may access this number through TTY
the claimed confidential information, in additional 30 days allows adequate time number by calling the Federal Relay
its consideration of comments. The for interested persons to submit Service number at 800–877–8339 (this is
second copy, which will have the comments without significantly
claimed confidential information a toll-free number).
delaying rulemaking on these important
redacted/blacked out, will be available issues. SUPPLEMENTARY INFORMATION:
for public viewing and posted on http:// Dated: November 23, 2015.
www.regulations.gov. Submit both I. Background
Leslie Kux,
copies to the Division of Dockets On October 1, 2015, at 80 FR 59092,
Associate Commissioner for Policy.
Management. If you do not wish your HUD published a proposed rule in the
name and contact information to be [FR Doc. 2015–30271 Filed 11–27–15; 8:45 am]
Federal Register on Federal Policy for
made publicly available, you can BILLING CODE 4164–01–P
the Protection of Human Subjects.
provide this information on the cover
HUD’s proposed rule adopted the policy
sheet and not in the body of your
comments and you must identify this on the protection of human subjects set
DEPARTMENT OF HOUSING AND
information as ‘‘confidential.’’ Any forth in a proposed rule issued by the
URBAN DEVELOPMENT
information marked as ‘‘confidential’’ Department of Health and Human
will not be disclosed except in 24 CFR Part 60 Services and 15 other Federal
accordance with 21 CFR 10.20 and other Departments and Agencies and
[Docket No FR–5888–P–02] published on September 8, 2015, at 80
applicable disclosure law. For more
information about FDA’s posting of FR 53933. Through the September 8,
Federal Policy for the Protection of
comments to public dockets, see 80 FR 2015, and October 1, 2015, rules, the
Human Subjects, Extension of Public
56469, September 18, 2015, or access Comment Period Federal Departments and Agencies
the information at: http://www.fda.gov/ proposed revisions to modernize,
regulatoryinformation/dockets/ AGENCY: Office of the General Counsel, strengthen, and make more effective the
default.htm. HUD. Federal Policy for the Protection of
Docket: For access to the docket to ACTION: Extension of public comment Human Subjects that was promulgated
read background documents or the period. as a Common Rule in 199, and sought
electronic and written/paper comments comment on the proposed revisions
received, go to http:// SUMMARY: Through this notice, HUD is through December 7, 2015.
www.regulations.gov and insert the extending the public comment period
docket number, found in brackets in the on its proposed rule pertaining to Since the proposed rules were
heading of this document, into the Federal Policy for the Protection of published in September and October,
‘‘Search’’ box and follow the prompts Human Subjects, published in the respectively, requests have been made
and/or go to the Division of Dockets Federal Register on October 1, 2015. to extend the public comment period to
Management, 5630 Fishers Lane, Rm. DATES: Comment Due Date: The
allow time to more thoroughly review
1061, Rockville, MD 20852. comment due date of December 7, 2015, the proposed revisions offered for
FOR FURTHER INFORMATION CONTACT: for the proposed rule published on comment by the Federal Departments
Bryant Godfrey or Darin Achilles, Office October 1, 2015, at 80 FR 59092, is and Agencies. The Department of Health
of Regulations, Center for Tobacco extended to January 6, 2016. and Human Services and the 15 other
Products, Food and Drug ADDRESSES: You may submit comments,
Federal Department Agencies have
Administration, 10903 New Hampshire identified by docket ID number HHS– extended the time to submit public
Ave, Silver Spring, MD 20993–0002, OPHS–2015–0008, by one of the comments on the September 8, 2015,
877–287–1373, CTPRegulations@ following methods: proposed rule to January 6, 2016, and
fda.hhs.gov. • Federal eRulemaking Portal: http:// HUD extends its public comment period
SUPPLEMENTARY INFORMATION: In the www.regulations.gov. Enter the above for its October 1, 2015, proposed rule to
Federal Register of September 25, 2015 docket ID number in the ‘‘Enter this same date—January 6, 2016.
(80 FR 57756), FDA proposed a Keyword or ID’’ field and click on Dated: November 24, 2015.
regulation that describes the ‘‘Search.’’ On the next Web page, click Camille E. Acevedo,
circumstances in which a product made on ‘‘Submit a Comment’’ action and
Associate General Counsel for Legislation and
or derived from tobacco that is intended follow the instructions.
jstallworth on DSK7TPTVN1PROD with PROPOSALS
Regulations.
for human consumption will be subject • Mail/Hand delivery/Courier [For
[FR Doc. 2015–30317 Filed 11–27–15; 8:45 am]
to regulation as a drug, device, or a paper, disk, or CD–ROM submissions]
combination product under the FD&C to: Jerry Menikoff, M.D., J.D., OHRP, BILLING CODE 4210–67–P
Act. Interested persons were originally 1101 Wootton Parkway, Suite 200,
given until November 24, 2015, to Rockville, MD 20852.
comment on the NPRM. Comments received, including any
The Agency has received a request for personal information, will be posted
a 45-day extension of the comment without change to www.regulations.gov.
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Document Created: 2018-03-01 11:12:58
Document Modified: 2018-03-01 11:12:58
| 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 | Proposed Rules | |
| Action | Notice of proposed rulemaking; reopening of the comment period. | |
| 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. | |
| 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, [email protected] | |
| FR Citation | 80 FR 74737 | |
| RIN Number | 0910-AH19 | |
| CFR Citation | 21
CFR
1100 21 CFR 201 21 CFR 801 |
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