60 day FRN

36067

Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices
Treatment of Latent Tuberculosis
Infection. This project will continue the
passive reporting system for SAEs
associated with therapy for LTBI. The
system will rely on medical chart
review and/or onsite investigations by
TB control staff.
Potential respondents are any of the
60 reporting areas for the national TB
surveillance system (the 50 states, the
District of Columbia, New York City,
Puerto Rico, and 7 jurisdictions in the
Pacific and Caribbean).
Data will be collected using the data
collection form for SAEs associated with
LTBI treatment. Based on previous
reporting, CDC anticipates receiving an

average of 10 responses per year from
the 60 reporting areas. The data
collection form is completed by
healthcare providers and health
departments for each reported
hospitalization or death related to
treatment of LTBI and contains
demographic, clinical, and laboratory
information.
CDC will analyze and periodically
publish reports summarizing national
LTBI treatment adverse events statistics
and also will conduct special analyses
for publication in peer-reviewed
scientific journals to further describe
and interpret these data.

The Food and Drug Administration
(FDA) collects data on adverse events
related to drugs through the MedWatch:
The FDA Medical Products Reporting
Program (OMB# 0910–0291, exp. 6/30/
2015). CDC is encouraging health
departments and healthcare providers to
report SAEs to FDA. Reporting will be
conducted through telephone, email, or
during CDC site visits.
CDC is requesting approval for
approximately 60 burden hours
annually. The only cost to respondents
is time to gather medical records and
time to complete the reporting form.
There are no costs to respondents other
than their time.

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent

Form name

Physician ................................................................................
Nurse ......................................................................................
Medical Clerk ..........................................................................

NSSAE ........
NSSAE ........
NSSAE ........

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

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

Leroy 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. 2014–14787 Filed 6–24–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–0621]

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Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden, invites the general public and
other Federal agencies to take this
opportunity to comment on proposed
and/or continuing information
collections, as required by the
Paperwork Reduction Act of 1995. To
request more information on the below
proposed project or to obtain a copy of
the information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to [email protected].

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Number of
responses per
respondent

Average
burden per response
(in hours)

10
10
10

1
1
1

1
4
1

10
40
10

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

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

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

60

Number
of
respondents

Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. 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; (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; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search

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Total
burden
hours

data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. Written comments should
be received within 60 days of this
notice.
Proposed Project
National Youth Tobacco Survey
(NYTS) 2015–2017 (OMB No. 0920–
0621, expires 01/31/2015)—Revision—
National Center for Chronic Disease
Prevention and Health Promotion
(NCCDPHP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Tobacco use is a major preventable
cause of morbidity and mortality in the
U.S. A limited number of health risk
behaviors, including tobacco use,
account for the overwhelming majority
of immediate and long-term sources of
morbidity and mortality. Because the
majority of tobacco users begin using
tobacco before the age of 18, there is a
critical need for public health programs
directed towards youth, and for
information to support these programs.
Since 2004, the CDC has periodically
collected information about tobacco use
among adolescents (NYTS 2004, 2006,
2009, 2011, 2012, 2013, 2014 OMB no.
0920–0621, exp. 01/31/2015). This
surveillance activity builds on previous
surveys funded by the American Legacy
Foundation in 1999, 2000, and 2002.

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36068

Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices

At present, the NYTS is the most
comprehensive source of nationally
representative tobacco data among
students in grades 9–12, moreover, the
NYTS is the only source of such data for
students in grades 6–8. The NYTS has
provided national estimates of tobacco
use behaviors, information about
exposure to pro- and anti-tobacco
influences, information about racial and
ethnic disparities in tobacco-related
topics, and most recently, estimates of
use of emerging products such as water
pipes (hookahs) and electronic
cigarettes (e-cigarettes). Information
collected through the NYTS is used to
identify trends over time, to inform the
development of tobacco cessation
programs for youth, and to evaluate the
effectiveness of existing interventions
and programs.
CDC plans to request OMB approval
to conduct additional cycles of the
NYTS in 2015, 2016, and 2017. The
survey will be conducted among
nationally representative samples of
students attending public and private

youth, it may be necessary in the future
to make additional requests to OMB for
changes in the NYTS instruments to
reflect the varying landscape.
Results of the NYTS will continue to
be used for public health program
planning and evaluation. Information
collected through the NYTS is expected
to provide measures and data for
monitoring progress on one of the 20
tobacco-related objectives for Healthy
People 2020 and serve as
complementary data for five other
tobacco-related objectives.
OMB approval will be requested for
three years. Changes described in the
Revision request include changes to
instrument content, a decrease in the
average annualized number of
respondents, and a decrease in the
average annualized burden hours. There
are no changes in the estimated burden
per response for any type of respondent.
Participation is voluntary and there are
no costs to respondents other than their
time.

schools in grades 6–12, and will be
administered to students as an optically
scannable, eight-page booklet of
multiple-choice questions. Information
supporting the NYTS also will be
collected from state-, district-, and
school-level administrators and
teachers. During the 2015–2017
timeframe, a number of changes will be
incorporated that reflect the
collaboration between CDC and the
Food and Drug Administration that has
been ongoing since 2011 to assist the
agency with measuring progress toward
meeting strategic goals established by
the Family Smoking Prevention and
Tobacco Control Act. The 2015 survey
will examine the following topics: Use
of cigarettes, smokeless tobacco, cigars,
pipes, bidis, snus, hookahs, electronic
vapor products, and dissolvable tobacco
products; knowledge and attitudes;
media and advertising; access to tobacco
products; secondhand smoke exposure;
and cessation. Given the dynamic
nature of the tobacco control
environment, particularly related to

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Type of respondent

Form name

State Administrators ..........................

Students ............................................

State-level Recruitment Script for
the NYTS.
District-level Recruitment Script for
the NYTS.
School-level Recruitment Script for
the NYTS.
Data Collection Checklist for the
NYTS.
National Youth Tobacco Survey ......

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

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

District Administrators .......................
School Administrators .......................
Teachers ...........................................

Leroy 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. 2014–14789 Filed 6–24–14; 8:45 am]

30/60

18

150

1

30/60

75

220

1

30/60

110

973

1

15/60

243

20,077

1

45/60

15,058

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

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

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

15,504

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2014–0007]

Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.

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Under the National
Childhood Vaccine Injury Act (NCVIA)
(42 U.S.C. 300aa–26), the Centers for
Disease Control and Prevention (CDC)
within the Department of Health and
Human Services (HHS) develops

SUMMARY:

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hours

1

AGENCY:

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response
(in hours)

35

Proposed Revised Vaccine Information
Materials for Td, Tdap, Haemophilus
influenzae type b, and Rotavirus
Vaccines

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responses per
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vaccine information materials that all
health care providers are required to
give to patients/parents prior to
administration of specific vaccines.
HHS/CDC seeks written comment on
proposed updated vaccine information
materials for tetanus/diphtheria vaccine
(Td), tetanus/diphtheria and acelullar
pertussis vaccine (Tdap), Haemophilus
influenzae type b (Hib) vaccine, and
rotavirus vaccine.
DATES: Written comments must be
received on or before August 25, 2014.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2014–
0007, by any of the following methods:
• Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Written comments should be
addressed to Suzanne Johnson-DeLeon
([email protected]), National Center for

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