Health Document Submission Requirements for Tobacco Products; Revised Draft Guidance for Industry; Availability, 62505-62506 [2016-21686]
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Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
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‘‘Health Document Submission
Requirements for Tobacco Products.’’
The revised draft guidance is intended
to assist persons making certain
document submissions to FDA as
required by the Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act).
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 revised
draft guidance before it begins work on
the final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 11,
2016.
ADDRESSES:
You may submit comments
as follows:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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’’).
Food and Drug Administration
Written/Paper Submissions
Dated: September 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21687 Filed 9–8–16; 8:45 am]
BILLING CODE 4164–01–P
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[Docket No. FDA–2009–D–0600]
Health Document Submission
Requirements for Tobacco Products;
Revised Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a revised
draft guidance for industry entitled
SUMMARY:
VerDate Sep<11>2014
17:11 Sep 08, 2016
Jkt 238001
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.’’
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
62505
Instructions: All submissions received
must include the Docket No. FDA–
2009–D–0600 for ‘‘Health Document
Submission Requirements for Tobacco
Products.’’ 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.
Submit written requests for single
copies of the revised draft guidance to
the Center for Tobacco Products, Food
and Drug Administration, Document
Control Center, Bldg. 71, Rm. G335,
10903 New Hampshire Ave., Silver
Spring, MD 20993–2000. Send two selfaddressed adhesive labels to assist that
office in processing your requests. See
E:\FR\FM\09SEN1.SGM
09SEN1
62506
Federal Register / Vol. 81, No. 175 / Friday, September 9, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
FOR FURTHER INFORMATION CONTACT:
Katherine Collins, Center for Tobacco
Products, Food and Drug
Administration, Document Control
Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD
20993–2000, 1–877–287–1373, email:
AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a revised draft guidance for industry
entitled ‘‘Health Document Submission
Requirements for Tobacco Products.’’
We are issuing this draft guidance
consistent with our good guidance
practices (GGP) regulation (21 CFR
10.115). The draft guidance, when
finalized, is intended to assist persons
making certain document submissions
to FDA as required by the Tobacco
Control Act.
The Tobacco Control Act, enacted on
June 22, 2009, amends the FD&C Act
and provides FDA with the authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public’s health (Pub. L. 111–
31). Among other things, the Tobacco
Control Act adds section 904(a)(4) to the
FD&C Act (21 U.S.C. 387d(a)(4)),
requiring each tobacco product
manufacturer or importer, or agents
thereof to submit all documents
developed after June 22, 2009, that
relate to any ‘‘health, toxicological,
behavioral, or physiological effects of
current or future tobacco products, their
constituents (including smoke
constituents), ingredients, components,
and additives.’’
The revised draft guidance includes
guidance for manufacturers or importers
of products that are newly deemed as
tobacco products that are subject to
Chapter IX of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act).
Cigarettes, cigarette tobacco, roll-yourown tobacco, and smokeless tobacco
were immediately subject to the tobacco
provisions of the FD&C Act, including
section 904(a)(4), and to FDA’s
regulatory authority. As for other types
of tobacco products, section 901(b) of
the FD&C Act (21 U.S.C. 387a) grants
FDA authority to deem those products
subject to the law as well. Pursuant to
that authority, FDA issued a rule
deeming all other products that meet the
statutory definition of ‘‘tobacco
product’’, set forth in section 201(rr) of
the FD&C Act, except for accessories of
those products, as subject to the FD&C
Act (81 FR 28974). FDA published the
VerDate Sep<11>2014
17:11 Sep 08, 2016
Jkt 238001
final rule on May 10, 2016 (81 FR
28974), and it became effective on
August 8, 2016. Manufacturers and
importers of tobacco products that have
been deemed subject to the FD&C Act
are now required to comply with
Chapter IX of the FD&C Act, including
section 904(a)(4).
II. Significance of Guidance
FDA is issuing this revised draft
guidance consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, represents the current
thinking of FDA on health document
submission requirements. It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This revised draft guidance also refers
to previously approved collections of
information found in FDA statute. The
revised draft guidance includes
information and recommendations for
how to provide health document
submissions. The collections of
information in section 904(a)(4) of the
FD&C Act have been approved under
OMB control number 0910–0654.
IV. Electronic Access
Persons with access to the Internet
may obtain an electronic version of the
draft guidance at either https://
www.regulations.gov or https://
www.fda.gov/TobaccoProducts/
Labeling/RulesRegulationsGuidance/
default.htm.
Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21686 Filed 9–8–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2567]
E17 General Principles for Planning
and Design of Multi-Regional Clinical
Trials; International Council for
Harmonisation; 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
SUMMARY:
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
guidance entitled ‘‘E17 General
Principles for Planning and Design of
Multi-Regional Clinical Trials.’’ The
draft guidance was prepared under the
auspices of the International Council for
Harmonisation (ICH), formerly the
International Conference on
Harmonisation. The draft guidance
describes general principles for
planning and designing multi-regional
clinical trials (MRCT). MRCTs
conducted according to the guidance
will investigate treatment effects in
overall populations with multiple
ethnic factors (intrinsic and extrinsic
factors as described in the ICH guidance
entitled ‘‘E5 Ethnic Factors in the
Acceptability of Foreign Clinical Data’’
(E5 guidance)) and evaluate the
consistency of treatment effects across
populations. The draft guidance is
intended to increase the acceptability of
data from MRCTs as the primary source
of evidence supporting marketing
approval in global regulatory
submissions and to thereby facilitate
more efficient drug development and
earlier access to medicines.
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 on 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 November 8,
2016.
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
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 81, Number 175 (Friday, September 9, 2016)]
[Notices]
[Pages 62505-62506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21686]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0600]
Health Document Submission Requirements for Tobacco Products;
Revised Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a revised draft guidance for industry entitled ``Health
Document Submission Requirements for Tobacco Products.'' The revised
draft guidance is intended to assist persons making certain document
submissions to FDA as required by the Family Smoking Prevention and
Tobacco Control Act (Tobacco Control Act).
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
revised draft guidance before it begins work on the final version of
the guidance, submit either electronic or written comments on the draft
guidance by October 11, 2016.
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-2009-D-0600 for ``Health Document Submission Requirements for
Tobacco Products.'' 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.
Submit written requests for single copies of the revised draft
guidance to the Center for Tobacco Products, Food and Drug
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New
Hampshire Ave., Silver Spring, MD 20993-2000. Send two self-addressed
adhesive labels to assist that office in processing your requests. See
[[Page 62506]]
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT: Katherine Collins, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, Bldg.
71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000,
1-877-287-1373, email: AskCTP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a revised draft guidance for
industry entitled ``Health Document Submission Requirements for Tobacco
Products.'' We are issuing this draft guidance consistent with our good
guidance practices (GGP) regulation (21 CFR 10.115). The draft
guidance, when finalized, is intended to assist persons making certain
document submissions to FDA as required by the Tobacco Control Act.
The Tobacco Control Act, enacted on June 22, 2009, amends the FD&C
Act and provides FDA with the authority to regulate the manufacture,
marketing, and distribution of tobacco products to protect the public's
health (Pub. L. 111-31). Among other things, the Tobacco Control Act
adds section 904(a)(4) to the FD&C Act (21 U.S.C. 387d(a)(4)),
requiring each tobacco product manufacturer or importer, or agents
thereof to submit all documents developed after June 22, 2009, that
relate to any ``health, toxicological, behavioral, or physiological
effects of current or future tobacco products, their constituents
(including smoke constituents), ingredients, components, and
additives.''
The revised draft guidance includes guidance for manufacturers or
importers of products that are newly deemed as tobacco products that
are subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act). Cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco were immediately subject to the tobacco
provisions of the FD&C Act, including section 904(a)(4), and to FDA's
regulatory authority. As for other types of tobacco products, section
901(b) of the FD&C Act (21 U.S.C. 387a) grants FDA authority to deem
those products subject to the law as well. Pursuant to that authority,
FDA issued a rule deeming all other products that meet the statutory
definition of ``tobacco product'', set forth in section 201(rr) of the
FD&C Act, except for accessories of those products, as subject to the
FD&C Act (81 FR 28974). FDA published the final rule on May 10, 2016
(81 FR 28974), and it became effective on August 8, 2016. Manufacturers
and importers of tobacco products that have been deemed subject to the
FD&C Act are now required to comply with Chapter IX of the FD&C Act,
including section 904(a)(4).
II. Significance of Guidance
FDA is issuing this revised draft guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, represents the current thinking of FDA on health
document submission requirements. It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
This revised draft guidance also refers to previously approved
collections of information found in FDA statute. The revised draft
guidance includes information and recommendations for how to provide
health document submissions. The collections of information in section
904(a)(4) of the FD&C Act have been approved under OMB control number
0910-0654.
IV. Electronic Access
Persons with access to the Internet may obtain an electronic
version of the draft guidance at either https://www.regulations.gov or
https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.
Dated: August 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21686 Filed 9-8-16; 8:45 am]
BILLING CODE 4164-01-P