60 day FRN

36066

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

activities, program implementation, and
program impact.
Progress reporting through the MIS is
required for CDC funded awardees.
There are no costs to respondents other
than their time. There are no changes to
the content of the information

collection, the frequency of information
collection, or the estimated burden per
response. The only change is a decrease
in the number of tobacco control
program respondents from 53 to 51.
Puerto Rico and the Virgin Islands were

originally funded under DP09–901 but
discontinued their participation under
the DP14–1415 cost extension. As a
result, the total estimated annualized
burden hours will decrease from 636 to
612.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hours)

Total
burden
hours

Form name

State Tobacco Control Program .......

Management Information System ....

51

2

6

612

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

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

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

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

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

612

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. 2014–14788 Filed 6–24–14; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–0773]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

mstockstill on DSK4VPTVN1PROD with NOTICES

Number of
responses per
respondent

Number of
respondents

Type of respondent

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].
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

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18:01 Jun 24, 2014

Jkt 232001

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
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 Surveillance for Severe
Adverse Events Associated with
Treatment of Latent Tuberculosis
Infection (OMB No. 0920–0773, expires
11/30/2014)—Extension—Division of
Tuberculosis Elimination (DTBE),
National Center for HIV, Viral Hepatitis,
STD, and TB Prevention NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
As part of the national tuberculosis
(TB) elimination strategy, the American
Thoracic Society and CDC have
published recommendations for targeted
testing for TB and treatment for latent
TB infection (LTBI) (Morbidity and

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Frm 00079

Fmt 4703

Sfmt 4703

Mortality Weekly Report (MMWR)
2000;49[RR06];1–54). However, between
October 2000 and September 2004, the
CDC received reports of 50 patients with
severe adverse events (SAEs) associated
with the use of the two or three-month
regimen of rifampin and pyrazinamide
(RZ) for the treatment of LTBI; 12 (24%)
patients died (MMWR 2003;52[31]:735–
9).
In 2004, CDC began collecting reports
of SAEs associated with any treatment
regimen for LTBI. For surveillance
purposes, an SAE was defined as any
drug-associated reaction resulting in a
patient’s hospitalization or death after at
least one treatment dose for LTBI.
During 2004–2008, CDC received 17
reports of SAEs in 15 adults and two
children; all patients had received
isoniazid (INH) and had experienced
severe liver injury MMWR 2010;
59:224–9).
Reports of SAEs related to RZ and
INH have prompted a need for this
project (a national surveillance system
of such events). The objective of the
project is to determine the annual
number and temporal trends of SAEs
associated with any treatment for LTBI
in the United States. Surveillance of
such events will provide data to support
periodic evaluation or potential revision
of guidelines for treatment of persons
with LTBI.
On December 9, 2011, CDC published
the Recommendations for Use of an
Isoniazid-Rifapentine Regimen with
Direct Observation to Treat Latent
Mycobacterium tuberculosis Infection in
MMWR 2011;60(48);1650–1653.
Isoniazid-Rifapentin (3HP) is a new
biweekly 3-month treatment regimen for
LTBI. Since 2011, there have been 28
reports of SAE; 26 of these were
associated with 3HP.
The CDC requests approval for a 3year extension of the previously
approved National Surveillance for
Severe Adverse Events Associated with

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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]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–14–0621]

mstockstill on DSK4VPTVN1PROD with NOTICES

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].

VerDate Mar<15>2010

18:01 Jun 24, 2014

Jkt 232001

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

PO 00000

Frm 00080

Fmt 4703

Sfmt 4703

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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