Document ID: FDA-2015-N-2002-0008
Agency: fda
Document Type: Proposed Rule
Title: 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
Posted Date: 2015-11-30T05:00Z

[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.

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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, 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