Att 2_60d FRN

Att 2_60d FRN.pdf

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

Att 2_60d FRN

OMB: 0920-0338

Document [pdf]
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70007

Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices
may include adverse acute and chronic
health conditions, primarily respiratory
and dermal, that may be associated with
their exposures. CDC plans to conduct
a scientifically valid environmental
epidemiologic study to assess the
potential adverse health effects among
children.
Plans involve a two-year Feasibility
Study to investigate the association
between exposure to temporary housing
units and health conditions and to
assess the practicality of conducting a
larger longitudinal study. If certain
feasibility objectives are met, such as
identifying a sufficient number of
eligible participants, a 6-year Full Study
will be conducted following the same
study design as the Feasibility Study.
The Feasibility Study will be
conducted in the states of Louisiana and
Mississippi. The study will assess the
potential health impacts from exposures
to various indoor pollutants (e.g.,
formaldehyde and other volatile organic
compounds and plasticizers, including
phthalates) commonly found in higher

assessment for each participant. The
baseline assessment will include a
health questionnaire, clinical
assessment including biological sample
collection, and environmental exposure
measurement. The environmental
exposure assessment will be collecting
biomarkers of exposure and measuring
exposures to environmental pollutants
using personal and indoor sampling
devices over a 7-day period. In the 6month follow-up assessment, a shorter
version of the health questionnaire and
the same clinical and environmental
exposure assessments will be
conducted.
Accounting for a 10% loss to followup, the sample size for the 6-month
follow-up assessment is projected to be
504 children. If a determination is made
to conduct the Full Study, these 504
children will be part of the Full Study
and continue to participate in the rest of
five follow-up assessments occurring at
9-month intervals.
There is no cost to the participants
except their time.

concentrations in the temporary housing
units compared with other types of
housing.
In the study, a 1:1 ratio of exposed
and unexposed children age 5–17 years
will be recruited. Children who resided
in temporary housing units will be
categorized into the ‘‘exposed’’ group
and children who did not reside in
temporary housing units will be
categorized into the ‘‘unexposed’’ group.
A screening questionnaire will be used
to assess eligibility and exposure to
temporary housing units. The screening
questionnaire will be conducted with
one adult resident of each selected
household. Based on responses to the
screening questions, one eligible child
will be selected for the study from each
participating household. To obtain the
desired sample size, we plan to screen
2,500 households in order to identify
700 eligible children. Of these, it is
expected that 80%, or 560 children, will
agree to participate in the study.
The Feasibility Study will involve a
baseline and a 6-month follow-up

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Type of
instrument

Household member 18 years or older ..........
Children ages 5–17 ......................................
Parents of children ages 5–17 .....................
Children ages 5-–17 .....................................

Eligibility Screener ................
Baseline Assessment ...........
Baseline Assessment ...........
6-Month Follow-up Assessment.
6–Month Follow-up Assessment.

Parents of children ages 5–17 .....................

Number of
respondents

Number of
responses per
respondent

Average
burden per
response (in
hours)

Total burden
(in hours)

2,500
560
560
504

1
1
1
1

10/60
1.25
1.5
50/60

417
700
840
420

504

1

1.25

630

Total .......................................................

Dated: November 9, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–28787 Filed 11–15–10; 8:45 am]
BILLING CODE 4163–18–P

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

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[60-Day–11–0338]

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

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19:33 Nov 15, 2010

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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 404–639–5960 or send
comments to Carol E. Walker, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS D–74, Atlanta, GA
30333 or send an e-mail 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

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use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
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. 4/
30/2011)—Extension—National Center
for Chronic Disease Prevention and
Health Promotion (NCCDPHP), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
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

E:\FR\FM\16NON1.SGM

16NON1

70008

Federal Register / Vol. 75, No. 220 / Tuesday, November 16, 2010 / Notices

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

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.
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, by CD, threeinch floppy disk, or thumb drive.
Electronic mail submissions are not
accepted. 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.

the Secretary of Health and Human
Services (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 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

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Form name

Smokeless Tobacco Manufacturers, Packagers, and Importers.

Dated: November 9, 2010.
Carol E. Walker,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–28786 Filed 11–15–10; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request

mstockstill on DSKH9S0YB1PROD with NOTICES

Title: Office of Community Services
(OCS) Community Economic
Development (CED) and Job
Opportunities for Low-Income
Individuals (JOLI) Standard Reporting
Format.
OMB No.: New Collection.

Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

11

1

1,713

18,843

SLT Nicotine and Ingredient
and Report.

Description: The Office of Community
Services (OCS) is collecting key
information about projects funded
through the Community Economic
Development (CED) and Job
Opportunities for Low-Income
Individuals (JOLI) programs. The
legislative requirement for these two
programs is in Title IV of the
Community Opportunities,
Accountability and Training and
Educational Services Act (COATS
Human Services Reauthorization Act) of
October 27, 1998, Public Law 105–285,
section 680(b) as amended. The
Performance Progress Report (PPR) is a
new proposed reporting format that will
collect information concerning the
outcomes and management of CED and
JOLI projects. OCS will use the data to
critically review the overall design and
effectiveness of each program.
The PPR will be administered to all
active grantees of the CED and JOLI

programs. Grantees will be required to
use this reporting tool for their
semiannual reports. The majority of the
questions in this tool were adapted from
a previously approved questionnaire,
Office of Management and Budget
(OMB) Control Number: 0970–0317.
Questions were also adapted to the
OMB-approved reporting format of the
PPR, specifically forms SF–PPR, SF–
PPR–A, SF–PPR–B, and SF–PPR–E.
Additional changes were made to
improve the clarity and quality of the
data and to eliminate unnecessary
questions. The PPR will replace both the
annual questionnaire and the current
semi-annual reporting format, which
will result in an overall reduction in
burden for the grantees while
significantly improving the quality of
the data collected by OCS.
Respondents: Current CED and JOLI
grantees.

ANNUAL BURDEN ESTIMATES
Number of
respondents

Instrument

Questionnaire for current OCS–JOLI grantees ...............................................
Questionnaire for current OCS–CED grantees ...............................................

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Number of
responses per
respondent

40
170

E:\FR\FM\16NON1.SGM

2
2

16NON1

Average
burden
hours per
response
1.50
1.50

Total
burden
hours
120
510


File Typeapplication/pdf
File TitleDocument
SubjectExtracted Pages
AuthorU.S. Government Printing Office
File Modified2010-11-15
File Created2010-11-15

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