Document ID: FDA-2015-N-2002-1990
Agency: fda
Document Type: 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’’; Further Delayed Effective Date; Request for Comments; Extension of Comment Period
Posted Date: 2017-05-18T04:00Z

[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.

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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