[Federal Register Volume 83, Number 14 (Monday, January 22, 2018)]
[Proposed Rules]
[Pages 2952-2953]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2017-N-5319]


Devices Proposed for a New Use With an Approved, Marketed Drug; 
Public Hearing; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of public hearing; reopening of the comment 
period.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
reopening the comment period for the document published in the Federal 
Register on September 26, 2017, announcing a public hearing on a 
potential approach for device sponsors who seek to obtain marketing 
authorization for their products that are intended for a new use with 
an approved, marketed drug when the sponsor for the approved, marketed 
drug does not wish to pursue or collaborate on the new use. In the 
document, in addition to seeking comments on the potential approach, 
FDA also welcomed comments on public health, scientific, regulatory, or 
legal considerations relating to other medical products intended for 
new uses with approved, marketed medical products of a different type 
where the sponsor for the approved, marketed product does not wish to 
pursue or collaborate on the new use. We are reopening the comment 
period in response to a request for an extension to allow interested 
persons additional time to submit comments.

DATES: FDA is reopening the comment period on the document published on 
September 26, 2017 (82 FR 44803). Submit either electronic or written 
comments by February 21, 2018.

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 February 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of February 21, 2018. 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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2017-N-5319 for ``Devices Proposed for a New Use With an Approved, 
Marketed Drug; Public Hearing; Request for Comments.'' Received 
comments, those filed in a timely manner (see ADDRESSES), will be 
placed in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff 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 Dockets Management Staff. 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John Barlow Weiner, Office of 
Combination Products, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 32, Rm. 5129, Silver Spring,

[[Page 2953]]

MD 20993, 301-796-8930, [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register on September 26, 
2017 (82 FR 44803), FDA published a document announcing a public 
hearing on November 16, 2017, regarding a potential approach for device 
sponsors who seek to obtain marketing authorization for their products 
that are intended for a new use with an approved, marketed drug when 
the sponsor for the approved, marketed drug does not wish to pursue or 
collaborate on the new use. The purpose of the public hearing was to 
obtain comments from stakeholders on the potential approach presented 
in the Federal Register document as well as comments on public health, 
scientific, regulatory, or legal considerations relating to other 
medical products intended for new uses with approved, marketed medical 
products of a different type where the sponsor for the approved, 
marketed product does not wish to pursue or collaborate on the new use. 
We sought this type of public engagement because of the potential 
importance of the issue for public health and the need for input across 
the medical product industry and among public health stakeholders 
regarding how FDA should proceed. The comments that FDA receives in 
relation to this public hearing may help inform the further development 
of this approach.
    The document stated that comments would be accepted until January 
15, 2018, and that untimely comments would not be considered. Near the 
end of the comment period, we received a request, submitted on behalf 
of several potential commenters, for more time to develop comments. We 
have considered this request and are reopening the comment period for 
an additional 30 days. We believe that this reopening allows adequate 
time for interested persons to submit comments without delaying further 
Agency efforts on this topic.

    Dated: January 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00991 Filed 1-19-18; 8:45 am]
 BILLING CODE 4164-01-P