[Federal Register Volume 82, Number 9 (Friday, January 13, 2017)]
[Notices]
[Pages 4349-4351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00646]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0086]


Suggestions, Recommendations, and Comments for Topics That May Be 
Considered by the Food and Drug Administration Combination Product 
Policy Council; Establishment of a Docket

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of docket; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is establishing a 
docket to receive suggestions, recommendations, and comments for topics 
from interested parties, including academic institutions, regulated 
industry, patient representatives, and other interested organizations, 
on policy issues that may be considered by the FDA Combination Product 
Policy Council (Council). These comments will help the Agency identify 
and address combination product policy issues that need clarification 
through guidance, notice and comment procedures, or other means.

DATES: Submit either electronic or written comments by April 13, 2017.

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

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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-2017-N-0086 for ``Suggestions, Recommendations, and Comments for 
Topics That May Be Considered by the Food and Drug Administration 
Combination Product Policy Council.'' 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 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 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: Nina L. Hunter, Office of Medical 
Products and Tobacco (OMPT), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 1, Rm. 2312, Silver Spring, MD 20993-0002, 301-
796-6171, FAX: 301-847-8514, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In April 2016, FDA established the Council to ensure better 
coordination of combination product policy development and 
implementation across the Agency and consistent, predictable 
communication of combination product policy decisions to the public 
through guidance, notice and comment procedures, or other means.
    Chaired by the Deputy Commissioner of OMPT, the Council provides a 
senior-level forum through which combination product policy issues can 
be raised, considered, developed, and implemented. Council members 
include the following senior leaders: The Center Directors and one 
representative from the Center for Biologics Evaluation and Research, 
Center for Drug Evaluation and Research, and Center for Devices and 
Radiological Health; the Office Director from the Office of Combination 
Products (OCP); and the Associate Commissioner for Special Medical 
Programs. Additional staff from the Centers and other FDA offices 
provide expertise as needed for specific combination product policy 
topics under consideration. While there are various other mechanisms 
available to raise issues for Agency consideration, by establishing 
this docket, FDA seeks to provide a forum for the public to recommend 
specific topics that should have direct, collective engagement and 
consideration by the Council. The Agency believes that this process 
will also further enhance transparency in FDA's approach to policy 
development and implementation.

II. Range of Policy Issues To Be Considered

    FDA envisions a variety of combination product policy topics that 
may be appropriate for consideration by the Council, which typically 
would meet one or more of the following criteria:
     A novel combination product policy issue requiring senior 
management input;
     An identical issue on which FDA seems to have taken 
inconsistent combination product policy positions;
     An existing combination product policy position that 
should be reconsidered in light of scientific or regulatory advances; 
or
     A combination product policy that may be triggered by a 
specific combination product, but that will be applicable to other 
combination products.

III. Establishment of a Docket and Request for Comments

    The docket is being made available for public suggestions, 
recommendations, and comments relating to the combination product 
policy criteria identified in this document that may warrant 
consideration by the Council. Submissions should describe the 
following: (1) The combination product policy issue recommended for 
discussion (e.g., clarifying previous advice or precedents on a 
specified combination product policy topic, reconciling apparently 
differing perspectives within FDA or between FDA and regulated industry 
on a specified combination product policy topic); (2) the rationale for 
doing so, including why it requires direct engagement by the Council; 
(3) recommendations on how the combination product policy issue could 
be addressed; and (4) existing policy documents (e.g., final guidance) 
relevant to the combination product policy issue.
    Note that combination product policy issues concerning any draft 
guidance or proposed rule should be submitted to the docket for that 
draft guidance or rulemaking; product-specific disputes should first be 
addressed through the appropriate appeals mechanism of the Center or 
other Agency component involved; and general recommendations for topics 
to address through guidance or rulemaking should be made to the Center, 
OCP, or other relevant Agency component through the mechanisms provided 
by that component.
    The Agency will carefully consider all comments submitted. FDA 
generally will not respond directly to the person or organization 
submitting the

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comment. In general, combination product policy decisions reached by 
the Council are communicated and implemented in accordance with FDA's 
good guidance practices regulation (21 CFR 10.115) or notice and 
comment procedures.

    Dated: January 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00646 Filed 1-12-17; 8:45 am]
 BILLING CODE 4164-01-P