Attachment B - 60 day FRN

9224

Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices

Dated: February 24, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–4177 Filed 2–26–10; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–10–10BT]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

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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 404–639–5960 or send
comments to Maryam I. Daneshvar, CDC
Acting Reports Clearance Officer, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an e-mail to
[email protected].
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.
Proposed Project
National Quitline Data Warehouse —
New—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description:
Despite the high level of public
knowledge about the adverse effects of
smoking, tobacco use remains the
leading preventable cause of disease and

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death in the United States. Tobacco use
results in approximately 440,000 deaths
annually, including approximately
38,000 deaths from secondhand smoke
exposure. Adults who smoke contribute
to $92 billion annually in lost worker
productivity, and die an average of 14
years earlier than nonsmokers. Although
the prevalence of current smoking
among adults decreased significantly
since its peak in the 1960s, overall
smoking prevalence among U.S. adults
has remained virtually unchanged
during the past five years. Large
disparities in smoking prevalence
continue to exist among members of
racial/ethnic minority groups and
individuals of low socioeconomic
status.
The National Tobacco Control
Program (NTCP) was established by
CDC to help reduce tobacco-related
disease, disability, and death. The
NTCP’s four goal areas are: (1) The
prevention of initiation of tobacco use
among young people, (2) the elimination
of nonsmokers’ exposure to secondhand
smoke, (3) the promotion of quitting
among adults and young people, and (4)
the elimination of tobacco-related
disparities. The NTCP has provided
funding for State quitlines, which
provide telephone-based tobacco
cessation services—including
individualized counseling and self-help
material—to help tobacco users quit.
Quitlines overcome many of the barriers
to tobacco cessation classes and
traditional clinics because they are free
and available at the caller’s
convenience. Quitline services in all
States can be accessed through a tollfree national portal number at 1–800–
QUIT–NOW. According to CDC’s Best
Practices for Comprehensive Tobacco
Control, approximately six to eight
percent of tobacco users potentially can
be reached successfully by quitlines;
however, currently, only one to two
percent of tobacco users contact
quitlines.
All States collect intake information
about quitline callers and the services
provided to them, but have varied with
respect to the schedule for follow-up
with callers, the number of follow-up
attempts per caller, and the collection of
information related to follow-up. With
leadership from the North American
Quitline Consortium (NAQC) and other
tobacco control organizations, the field
has collaborated to develop a Minimum
Data Set (MDS) consisting of a set of
suggested intake questions that should
be asked of all callers, and follow-up
questions that should be asked of a

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representative sample of callers who
have both completed intake and
received a quitline service.
CDC requests OMB approval to collect
information for a National Quitline Data
Warehouse (NDQW) based on a uniform
follow-up protocol and standardized
instruments adapted from the MDS.
Respondents will be the 50 States, the
District of Columbia, and Guam.
Additional funding for the expansion of
tobacco quitline services,
standardization of the information
collection, and transmission to the
shared NQDW is provided under the
American Recovery and Reinvestment
Act of 2009 (ARRA).
Intake information will be collected
from approximately 60,833 callers per
month over a 24-month period. Minimal
information will be collected from
callers who contact the Quitline on
behalf of another person. The
information collection will also include
seven-month follow-up data from a
random sample of approximately 3,400
callers per month across all States,
beginning in month eight (i.e., seven full
months after the first intakes) and
continuing through month 24. Finally,
the Tobacco Control Manager for each
ARRA awardee (State, district or
territory) will be required to submit a
quarterly report describing services
provided. The quarterly report will be
used to quantify improvements in the
capacity of the quitlines to assist
tobacco users over time and to evaluate
the expenditure of Recovery Act dollars.
The NQDW will have significant
implications for the development of
policies and programs aimed at tobacco
use cessation and reduction of tobacco
use. The information to be collected in
the NQDW will be used to determine
the role quitlines are playing in
promoting tobacco use cessation,
measure the number of tobacco users
being served by State Quitlines,
determine reach of quitlines to high-risk
populations (e.g., racial and ethnic
minorities and the medically
underserved), measure the number
using each State quitline who quit,
determine whether some combinations
of services contribute to higher quit
rates than others, and improve the
timeliness, access to, and quality of data
collected by quitlines.
CDC requests OMB approval to collect
information for a two-year period. All
information will be collected
electronically. There are no costs to
respondents other than their time.

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9225

Federal Register / Vol. 75, No. 39 / Monday, March 1, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses
per
respondent

Average
burden per
response
(in hours)

Total
burden
(in hours)

Form name

Caller who contacts the Quitline on behalf
of someone else.
Caller who contacts the Quitline for personal use.
Quitline caller who received a Quitline
service.
Tobacco Control Manager ........................

Intake Questionnaire ................................

230,000

1

1/60

3,833

...................................................................

500,000

1

10/60

83,333

Follow-up Questionnaire ..........................

28,900

1

7/60

3,372

Quitline Services Questionnaire ...............

52

4

7/60

24

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

...................................................................

....................

....................

....................

90,562

Dated: February 23, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–4164 Filed 2–26–10; 8:45 am]
BILLING CODE 4163–18–P

Food and Drug Administration
[Docket No. FDA–2010–N–0084]

Agency Information Collection
Activities; Proposed Collection;
Comment Request; Pretesting of
Tobacco Communications
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
pretesting of tobacco communications.
DATES: Submit written or electronic
comments on the collection of
information by April 30, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to http://www.regulations.
gov. Submit written comments on the
collection of information to the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852. All comments should be
identified with the docket number
found in brackets in the heading of this
document.

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FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794, e-mail: Jonnalynn.capezzuto@fda.
hhs.gov.

Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’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
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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Number of
respondents

Type of respondent

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Pretesting of Tobacco Communications
In order to conduct educational and
public information programs relating to
tobacco use, as authorized by section
903(d)(2)(D) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C.
393(d)(2)(D)) and to develop stronger
health warnings on tobacco packaging
as authorized by the Family Smoking
Prevention and Tobacco Control Act
(Tobacco Control Act), it is beneficial
for FDA to conduct research and studies
relating to the control and prevention of
disease as authorized by section 301 of
the Public Health Service Act (42 U.S.C
241(a)). In conducting such research,
FDA will employ formative pretests to
assess the likely effectiveness of tobacco
communications with specific target
audiences. The information collected
will serve two major purposes. First, as
formative research it will provide the
critical knowledge needed about target
audiences. FDA must first understand
critical influences on people’s
decisionmaking process when choosing
to use, not use, or quit using tobacco
products. In addition to understanding
the decisionmaking processes of adults,
it is also critical to understand the
decisionmaking processes among
adolescents (ages 13 to 17), where
communications will aim to discourage
tobacco use before it starts. Knowledge
of these decisionmaking processes will
be applied by FDA to help design
effective communication strategies,
messages, and warning labels. Second,
as initial testing, it will allow FDA to
assess the potential effectiveness of
messages and materials in reaching and
successfully communicating with their
intended audiences. Pretesting messages
with a sample of the target audience
will allow FDA to refine messages while
they are still in the developmental stage.
By utilizing appropriate qualitative and
quantitative methodologies, FDA will be
able to: (1) Better understand
characteristics of the target audience-its
attitudes, beliefs, and behaviors-and use

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