Proposed Data Collections Submitted for Public Comment and Recommendations, 36066-36067 [2014-14787]
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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
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total
burden
hours
Type of respondent
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]
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 omb@cdc.gov.
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
VerDate Mar<15>2010
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
PO 00000
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
E:\FR\FM\25JNN1.SGM
25JNN1
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 ..........................................................................
.....................
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]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
mstockstill on DSK4VPTVN1PROD with NOTICES
Average
burden per response
(in hours)
10
10
10
1
1
1
1
4
1
10
40
10
........................
........................
........................
60
NSSAE ........
NSSAE ........
NSSAE ........
Total ................................................................................
Number of
responses per
respondent
Number
of
respondents
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 omb@cdc.gov.
VerDate Mar<15>2010
18:01 Jun 24, 2014
Jkt 232001
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.
E:\FR\FM\25JNN1.SGM
25JNN1
]]>Agencies
[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36066-36067]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14787]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-14-0773]
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 omb@cdc.gov.
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 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 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 3-year extension of the previously
approved National Surveillance for Severe Adverse Events Associated
with
[[Page 36067]]
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
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Physician.................... NSSAE............ 10 1 1 10
Nurse........................ NSSAE............ 10 1 4 40
Medical Clerk................ NSSAE............ 10 1 1 10
----------------------------------------------------------------------------------
Total.................... ................. .............. .............. .............. 60
----------------------------------------------------------------------------------------------------------------
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
