2a - 60 day FRN

Attachment 2a 60-day FRN 10 31 2013.pdf

Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Manufactured, Imported, or Packaged in the U.S.

2a - 60 day FRN

OMB: 0920-0338

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Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2013–25862 Filed 10–30–13; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention

appropriate) discussing the health
effects of these ingredients.
HHS has delegated responsibility for
implementing the required information
collection to CDC’s Office on Smoking
and Health. Respondents are not
required to submit specific forms;
however, they are required to meet
reporting guidelines and to submit the
ingredient report by chemical name and
Chemical Abstract Service (CAS)
Registration Number, consistent with
accepted reporting practices for other
companies that are required to report
ingredients added to other consumer
products. Typically, respondents submit
a summary report to CDC with the
ingredient information for multiple
products, or a statement that there are
no changes to their previously
submitted ingredient report.
Respondents may submit the required
information to CDC through a
designated representative. The
information collection is subject to strict
confidentiality provisions.
Ingredient reports for new SLT
products are due at the time of first
importation. Thereafter, ingredient
reports are due annually on March 31.
Information is submitted to OSH by
mailing a written report on the
respondent’s letterhead, which may be
accompanied by a Compact Disc (CD),
three-inch floppy disk, or thumb drive.
Electronic mail submissions are not
accepted. Annual submission reports
are mailed to: Office on Smoking and
Health, Attention: FCLAA Program
Manager, National Center for Chronic
Disease Prevention and Health
Promotion, Centers for Disease Control
and Prevention, 4770 Buford Highway
NE., MS F–79, Atlanta, GA 30341–3717.
Upon receipt and verification of the
annual nicotine and ingredient report,
OSH issues a Certificate of Compliance
to the respondent.
There are no costs to respondents
other than their time. Office of
Management and Budget (OMB)
approval is requested for three years.

Proposed Project
Annual Submission of the Ingredients
Added to, and the Quantity of Nicotine
Contained in, Smokeless Tobacco
Manufactured, Imported, or Packaged in
the U.S. (OMB No. 0920–0338, exp.
02/28/2014)—Extension—Office on
Smoking and Health, National Center
for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description

[60Day–14–0338)

Agency Forms Undergoing Paperwork
Reduction Act Review
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to CDC, LeRoy Richardson,
1600 Clifton Road, MS D–74, Atlanta,
GA 30333 or send an email to omb@
cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.

65323

The oral use of smokeless tobacco
(SLT) products represents a significant
health risk. Smokeless tobacco products
contain carcinogens which can cause
cancer and a number of non-cancerous
oral conditions, as well as leading to
nicotine addiction and dependence.
Furthermore, SLT use is not a safe
substitute for cigarette smoking.
Adolescents who use smokeless tobacco
are more likely to become cigarette
smokers.
The Centers for Disease Control and
Prevention (CDC), Office on Smoking
and Health (OSH), has primary
responsibility for the Department of
Health and Human Services (HHS)
smoking and health program. HHS’s
overall goal is to reduce death and
disability resulting from the use of
smokeless tobacco products and other
forms of tobacco through programs of
information, education and research.
The Comprehensive Smokeless
Tobacco Health Education Act of 1986
(CSTHEA, 15 U.S.C. 4401 et seq., Pub.
L. 99–252) requires each person who
manufactures, packages, or imports
smokeless tobacco products to provide
the Secretary of HHS with a list of
ingredients added to tobacco in the
manufacture of smokeless tobacco
products. CSTHEA further requires
submission of the quantity of nicotine
contained in each smokeless tobacco
product. Finally, the legislation
authorizes HHS to undertake research,
and to report to Congress (as deemed

mstockstill on DSK4VPTVN1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Form name

Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Smokeless Tobacco Manufacturers,
Packagers, and Importers.

SLT Nicotine and Ingredient Report

13

1

1,713

22,269

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65324

Federal Register / Vol. 78, No. 211 / Thursday, October 31, 2013 / Notices

Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.

or other forms of information
technology. Written comments should
be received within 60 days of this
notice.

[FR Doc. 2013–25860 Filed 10–30–13; 8:45 am]

Centers for Disease Control and
Prevention

List of Ingredients Added to Tobacco
in the Manufacture of Cigarette Products
(OMB No. 0920–0210, exp. 2/28/2014)—
Extension—Office on Smoking and
Health, National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).

[60Day–14–0210]

Background and Brief Description

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Proposed Data Collections Submitted
for Public Comment and
Recommendations
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
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 or send
comments to CDC, LeRoy Richardson,
1600 Clifton Road, MS D–74, Atlanta,
GA 30333 or send an email to omb@
cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques

cigarette products since 1986.
Respondents are commercial cigarette
manufacturers, packagers, or importers,
or their designated representatives.
Respondents are not required to submit
specific forms; however, they are
required to submit a list of all
ingredients used in their products. CDC
requires the ingredient report to be
submitted by chemical name and
Chemical Abstract Service (CAS)
Registration Number, consistent with
accepted reporting practices for other
companies currently required to report
ingredients added to other consumer
products. Typically, respondents submit
a summary report to CDC with the
ingredient information for multiple
products, or a statement that there are
no changes to their previously
submitted ingredient report. The
estimated burden per response is 6.5
hours. The total estimated annualized
burden hours are 501.
Ingredient reports for new products
are due at the time of first importation.
Thereafter, ingredient reports are due
annually on March 31. Information is
submitted to OSH by mailing a written
report on the respondent’s letterhead,
which may be accompanied by a
compact disk (CD), three-inch floppy
disk, or thumb drive. Annual ingredient
reports should be mailed to: Office on
Smoking and Health, Attention: FCLAA
Program Manager, National Center for
Chronic Disease Prevention and Health
Promotion, Centers for Disease Control
and Prevention, 4770 Buford Highway,
NE., MS F–79 Atlanta, GA 30341–3717.
Electronic mail submissions are not
accepted. Upon receipt and verification
of the annual ingredient report, OSH
issues a Certificate of Compliance to the
respondent.
There are no costs to respondents
other than their time. Office of
Management and Budget (OMB)
approval is requested for three years.

Proposed Project

Cigarette smoking is the leading
preventable cause of premature death
and disability in the United States. Each
year, more than 443,000 premature
deaths occur as the result of diseases
related to cigarette smoking. The
Centers for Disease Control and
Prevention (CDC), Office on Smoking
and Health (OSH) has the primary
responsibility for the Department of
Health and Human Services (HHS)
smoking and health program. HHS’s
overall goal is to reduce death and
disability resulting from cigarette
smoking and other forms of tobacco use
through programs of information,
education and research.
The Comprehensive Smoking
Education Act of 1984 (CSEA, 15 U.S.C.
1336 or Pub. L. 98–474) requires each
person who manufactures, packages, or
imports cigarettes to provide the
Secretary of HHS with a list of
ingredients added to tobacco in the
manufacture of cigarettes. The
legislation also authorizes HHS to
undertake research, and to report to the
Congress (as deemed appropriate)
discussing the health effects of these
ingredients.
HHS has delegated responsibility for
implementing the CSEA’s ingredient
reporting requirements to CDC’s OSH.
OSH has collected ingredient reports on

mstockstill on DSK4VPTVN1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Cigarette Manufacturers, Packagers, and Importers .......................................

77

1

6.5

501

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File Typeapplication/pdf
File Title2013-25860.pdf
Authorarp5
File Modified2013-10-31
File Created2013-10-31

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