Suggestions, Recommendations, and Comments for Topics That May Be Considered by the Food and Drug Administration Combination Product Policy Council; Establishment of a Docket, 4349-4351 [2017-00646]
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Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
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
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submission. You should submit two
copies total. One copy will include the
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‘‘THIS DOCUMENT CONTAINS
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will review this copy, including the
claimed confidential information, in our
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.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:
Paula R. Trumbo, Center for Food Safety
and Applied Nutrition (HFS–830), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
2579.
SUPPLEMENTARY INFORMATION: In the
Federal Register of November 23, 2016
(81 FR 84595), we published a
document requesting scientific data,
information, and comments that would
help us evaluate the beneficial
physiological effects to human health of
isolated or synthetic non-digestible
carbohydrate that are added to food. We
requested such scientific data,
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information, and comments to help us
determine whether a particular isolated
or synthetic non-digestible carbohydrate
should be added to our definition of
‘‘dietary fiber’’ that is found in the
Nutrition and Supplement Facts label
final rule, which appeared in the
Federal Register of May 27, 2016 (81 FR
33741). Only those isolated or synthetic
non-digestible carbohydrates that meet
the definition can be declared as a
dietary fiber on a Nutrition and
Supplement Facts label. The notice also
announced the availability of a
document entitled ‘‘Science Review of
Isolated and Synthetic Non-Digestible
Carbohydrates,’’ which summarizes a
scientific literature review that we
conducted of clinical studies associated
with the 26 specific isolated or synthetic
non-digestible carbohydrates. We
provided a 45-day comment period that
ended on January 9, 2017.
We have received requests to extend
the period during which interested
parties may submit scientific data,
information, and comments regarding
isolated or synthetic non-digestible
carbohydrates generally and regarding
our scientific literature review summary
document specifically. The requests
conveyed concern that the original 45day comment period would not allow
sufficient time to develop meaningful or
thoughtful scientific data, information,
or comments.
We have considered the requests but
were unable to issue a notice extending
the comment period before January 9,
2017. Consequently, we are reopening
the comment period for an additional 30
days. Interested parties have until
February 13, 2017, to submit scientific
data, information, or comments to the
docket. We believe that this action
allows adequate time for interested
persons to submit additional scientific
data, information and comments.
Dated: January 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–00725 Filed 1–12–17; 8:45 am]
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4349
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.
Notice; establishment of docket;
request for comments.
ACTION:
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:
SUMMARY:
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
E:\FR\FM\13JAN1.SGM
13JAN1
4350
Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
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 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.fda.gov/
VerDate Sep<11>2014
19:06 Jan 12, 2017
Jkt 241001
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,
CombinationProductCouncil@
fda.hhs.gov.
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 seniorlevel 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.
Frm 00072
Fmt 4703
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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
SUPPLEMENTARY INFORMATION:
PO 00000
II. Range of Policy Issues To Be
Considered
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
E:\FR\FM\13JAN1.SGM
13JAN1
Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0040]
How To Prepare a Pre-Request for
Designation; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘How to
Prepare a Pre-Request for Designation
(Pre-RFD).’’ The purpose of this
guidance is to explain the Pre-RFD
process at the FDA Office of
Combination Products (OCP), describe
and help a sponsor understand the type
of information that the sponsor should
include in a Pre-RFD, and assist
sponsors in obtaining a preliminary
assessment from FDA through the PreRFD process. The Pre-RFD process is
available to provide informal, nonbinding feedback regarding the
regulatory identity or classification of a
human medical product as a drug,
device, biological product, or
combination product. In addition, this
informal process provides information
about a non-combination or
combination product’s assignment to
the appropriate Agency Center (Center
for Drug Evaluation and Research
(CDER), Center for Devices and
Radiological Health (CDRH), or Center
for Biologics Evaluation and Research
(CBER)) for premarket review and
regulation. This draft guidance is not
final nor is it in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by April 13, 2017.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
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19:06 Jan 12, 2017
Jkt 241001
Submit either written or electronic
comments on this collection of
information by March 14, 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
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–D–0040 for ‘‘How to Prepare a PreRequest for Designation (Pre-RFD); Draft
Guidance for Industry.’’ 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
PO 00000
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Fmt 4703
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4351
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.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.
Submit comments on information
collection issues to the Office of
Management and Budget in the
following ways:
• Fax to the Office of Information and
Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX: 202–395–7285, or
email to oira_submission@omb.eop.gov.
All comments should be identified with
the title, ‘‘How to Prepare a Pre-Request
for Designation (Pre-RFD); Draft
Guidance for Industry.’’
Submit written requests for single
copies of the draft guidance document
entitled ‘‘How to Prepare a Pre-Request
for Designation (Pre-RFD)’’ to the Office
of Combination Products, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5129,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8619. See the SUPPLEMENTARY
E:\FR\FM\13JAN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 4350]]
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 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.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, CombinationProductCouncil@fda.hhs.gov.
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
[[Page 4351]]
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
