Guidance for Industry on Compliance With Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents; Availability, 52203-52204 [2013-20506]
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Federal Register / Vol. 78, No. 163 / Thursday, August 22, 2013 / Notices
available to all interested persons in a
timely fashion.
SUPPLEMENTARY INFORMATION:
II. Comments
I. Background
tkelley on DSK3SPTVN1PROD with NOTICES
301–796–9441, FDASIASECTION907@
fda.hhs.gov.
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
On July 9, 2012, the President signed
FDASIA (Pub. L. 112–144) into law.
Section 907 of FDASIA requires that
FDA report on and address certain
information regarding clinical trial
participation by demographic subgroups
and subset analysis of the resulting data.
Specifically, section 907(a) of FDASIA
requires the Secretary of Health and
Human Services (the Secretary), acting
through the FDA Commissioner, to
publish on FDA’s Internet Web site a
report ‘‘addressing the extent to which
clinical trial participation and the
inclusion of safety and effectiveness
data by demographic subgroups
including sex, age, race, and ethnicity,
is included in applications submitted to
the FDA,’’ and provide such publication
to Congress. The report entitled
‘‘Reporting of Inclusion of Demographic
Subgroups in Clinical Trials and Data
Analysis in Applications for Drugs,
Biologics, and Devices’’ is available at
https://www.fda.gov/Regulatory
Information/Legislation/FederalFood
DrugandCosmeticActFDCAct/
SignificantAmendmentstotheFDCAct/
FDASIA/ucm356316.htm.
Section 907(b) of FDASIA further
requires the Secretary, again acting
through the Commissioner, to publish
an action plan on the Internet Web site
of FDA and provide such publication to
Congress. The action plan is to contain
recommendations, as appropriate, to
improve the completeness and quality
of analyses of data on demographic
subgroups in summaries of product
safety and effectiveness and in labeling;
on the inclusion of such data, or the
lack of availability of such data in
labeling; and on ways to improve public
availability of such data to patients,
health care providers, and researchers.
These recommendations are to include,
as appropriate, a determination that
distinguishes between product types
and applicability. The action plan is due
not later than 1 year after the
publication of the report described
previously.
FDA is opening a docket for 90 days
to provide an opportunity for interested
individuals to submit comments on the
report for use in the development of the
action plan. When submitting comments
please reference the section of the report
to which your comments pertain. This
docket is intended to ensure that
stakeholders have an opportunity to
provide comments and that such
information submitted to FDA is
VerDate Mar<15>2010
17:07 Aug 21, 2013
Jkt 229001
Dated: August 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20352 Filed 8–20–13; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0277]
Guidance for Industry on Compliance
With Regulations Restricting the Sale
and Distribution of Cigarettes and
Smokeless Tobacco To Protect
Children and Adolescents; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Compliance With Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to
Protect Children and Adolescents.’’ This
guidance is intended to help small
entities and other stakeholders comply
with FDA’s regulations restricting the
sale and distribution of cigarettes and
smokeless tobacco to protect children
and adolescents.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850–3229. Send
one self-addressed adhesive label to
assist that office in processing your
request or include a fax number to
which the guidance document may be
sent. See the SUPPLEMENTARY
SUMMARY:
PO 00000
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Fmt 4703
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52203
INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Office of Compliance and Enforcement,
Center for Tobacco Products, Food and
Drug Administration, 9200 Corporate
Blvd., Rockville, MD 20850–3229, 877–
287–1373, ctpcompliance@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Family Smoking Prevention and
Tobacco Control Act (Tobacco Control
Act) (Pub. L. 111–31; 123 Stat. 1776)
was enacted on June 22, 2009, amending
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) and providing FDA with
authority to regulate tobacco products.
Section 102 of the Tobacco Control Act
requires FDA to publish final
regulations regarding cigarettes and
smokeless tobacco which are identical
in their provisions to the regulations
issued by FDA on August 28, 1996 (61
FR 44396), with certain specified
exceptions. In the Federal Register of
March 19, 2010 (75 FR 13225), FDA
published its final regulations entitled
‘‘Regulations Restricting the Sale and
Distribution of Cigarettes and Smokeless
Tobacco to Protect Children and
Adolescents,’’ codified at 21 CFR part
1140. The final regulations apply to
manufacturers, distributors, and
retailers who manufacture, distribute, or
sell cigarettes or smokeless tobacco
products.
These regulations took effect on June
22, 2010, and impose restrictions on
sales and distribution, including youth
access, and advertising and labeling of
cigarettes, including roll-your-own
tobacco, cigarette tobacco, and
smokeless tobacco. For instance,
retailers are: Prohibited from selling
cigarettes, including roll-your-own
tobacco, cigarette tobacco, or smokeless
tobacco to persons under the age of 18;
required to verify the age of all
customers under the age of 27 by
checking a photographic identification
that includes the bearer’s date of birth;
and prohibited from distributing free
samples of cigarettes.
FDA announced the publication of a
draft guidance document on this subject
on June 9, 2010 (75 FR 32791), and
issued a revised draft guidance on
March 23, 2011 (76 FR 16424), to
E:\FR\FM\22AUN1.SGM
22AUN1
52204
Federal Register / Vol. 78, No. 163 / Thursday, August 22, 2013 / Notices
remove potential ambiguities and
address several issues not included in
the original draft guidance. In response
to comments submitted to the public
docket, at stakeholder meetings, and in
calls from the public, FDA has provided
additional clarifying examples to assist
in complying with part 1140.
II. Significance of Guidance
FDA is issuing this guidance
document consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The guidance represents the
Agency’s current thinking on
‘‘Compliance with Regulations
Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents.’’ It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
An electronic version of the guidance
document is available on the Internet at
https://www.regulations.gov and https://
www.fda.gov/TobaccoProducts/
GuidanceCompliance
RegulatoryInformation/default.htm.
Dated: August 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–20506 Filed 8–21–13; 8:45 am]
tkelley on DSK3SPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:07 Aug 21, 2013
Jkt 229001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment
Request: NIH NCI Central Institutional
Review Board (CIRB) Initiative (NCI)
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI),
National Institutes of Health (NIH), will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited on one or more of the
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: CAPT Michael
Montello, Pharm. D., MBA, Cancer
Therapy Evaluation Program,
Operations and Informatics Branch,
9609 Medical Center Drive, Rockville,
MD 20850 or call non-toll-free number
(240) 276–6080 or Email your request,
including your address to:
mike.montello@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
SUMMARY:
PO 00000
Frm 00078
Fmt 4703
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received within 60 days of the date of
this publication.
Proposed Collection: NIH NCI Central
Institutional Review Board (CIRB)
Initiative (NCI), 0925–0625, Revision,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: The National Cancer
Institute (NCI) Central Institutional
Review Board (CIRB) provides a
centralized approach to human subject
protection and provides a cost efficient
approach avoiding duplication of effort
at each institution. The CIRB provides
the services of a fully constituted IRB
and provides a comprehensive and
efficient mechanism to meet regulatory
requirements pertaining to human
subject protections including: Initial
reviews, continuing reviews, review of
amendments, and adverse events. The
Initiative consists of three central IRBs:
Adult CIRB—late phase emphasis,
Adult CIRB—early phase emphasis, and
Pediatric CIRB. CIRB membership
includes oncology physicians, surgeons,
nurses, patient advocates, ethicists,
statisticians, pharmacists, attorneys and
other health professionals. The benefits
of the CIRB Initiative reaches research
participants, investigators and research
staff, Institutional Review Boards (IRB),
and Institutions. Benefits include: Study
participants having dedicated review of
NCI-sponsored trials for participant
protections, access to more trials more
quickly and access to trials for rare
diseases, accrual to trials begin more
rapidly, ease of opening trials,
elimination of need to submit study
materials to local IRBs, and elimination
of the need for a full board review. The
benefits to the National Clinical Trials
Network and Experimental TherapyClinical Trials Network include a cost
efficient approach that avoids
duplication of efforts at each institution.
A variety of information collection tools
are needed to support NCI’s CIRB
activities which include: Worksheets,
forms and a survey that is provided to
all customers contacting the CIRB
helpdesk.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
2,199.
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Pages 52203-52204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20506]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0277]
Guidance for Industry on Compliance With Regulations Restricting
the Sale and Distribution of Cigarettes and Smokeless Tobacco To
Protect Children and Adolescents; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Compliance With
Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco to Protect Children and Adolescents.'' This guidance
is intended to help small entities and other stakeholders comply with
FDA's regulations restricting the sale and distribution of cigarettes
and smokeless tobacco to protect children and adolescents.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850-3229. Send one self-addressed
adhesive label to assist that office in processing your request or
include a fax number to which the guidance document may be sent. See
the SUPPLEMENTARY INFORMATION section for information on electronic
access to the guidance.
Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Office of Compliance and Enforcement,
Center for Tobacco Products, Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373,
ctpcompliance@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31; 123 Stat. 1776) was enacted on June 22,
2009, amending the Federal Food, Drug, and Cosmetic Act (FD&C Act) and
providing FDA with authority to regulate tobacco products. Section 102
of the Tobacco Control Act requires FDA to publish final regulations
regarding cigarettes and smokeless tobacco which are identical in their
provisions to the regulations issued by FDA on August 28, 1996 (61 FR
44396), with certain specified exceptions. In the Federal Register of
March 19, 2010 (75 FR 13225), FDA published its final regulations
entitled ``Regulations Restricting the Sale and Distribution of
Cigarettes and Smokeless Tobacco to Protect Children and Adolescents,''
codified at 21 CFR part 1140. The final regulations apply to
manufacturers, distributors, and retailers who manufacture, distribute,
or sell cigarettes or smokeless tobacco products.
These regulations took effect on June 22, 2010, and impose
restrictions on sales and distribution, including youth access, and
advertising and labeling of cigarettes, including roll-your-own
tobacco, cigarette tobacco, and smokeless tobacco. For instance,
retailers are: Prohibited from selling cigarettes, including roll-your-
own tobacco, cigarette tobacco, or smokeless tobacco to persons under
the age of 18; required to verify the age of all customers under the
age of 27 by checking a photographic identification that includes the
bearer's date of birth; and prohibited from distributing free samples
of cigarettes.
FDA announced the publication of a draft guidance document on this
subject on June 9, 2010 (75 FR 32791), and issued a revised draft
guidance on March 23, 2011 (76 FR 16424), to
[[Page 52204]]
remove potential ambiguities and address several issues not included in
the original draft guidance. In response to comments submitted to the
public docket, at stakeholder meetings, and in calls from the public,
FDA has provided additional clarifying examples to assist in complying
with part 1140.
II. Significance of Guidance
FDA is issuing this guidance document consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the Agency's current thinking on ``Compliance with Regulations
Restricting the Sale and Distribution of Cigarettes and Smokeless
Tobacco To Protect Children and Adolescents.'' It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statute and regulations.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
An electronic version of the guidance document is available on the
Internet at https://www.regulations.gov and https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.
Dated: August 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20506 Filed 8-21-13; 8:45 am]
BILLING CODE 4160-01-P
