Agency Forms Undergoing Paperwork Reduction Act Review, 5103-5104 [2018-02206]
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5103
Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
National Strategy for Combating
Antibiotic Resistant Bacteria by
improving and strengthening
surveillance of antimicrobial resistance
through GISP. Additionally, data from
GISP will also allow CDC to monitor
and evaluate the effectiveness of public
health interventions conducted to
support the National Strategy for
Combating Antibiotic Resistant Bacteria.
There are no costs to respondents other
than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
Sentinel site conducting core surveillance.
Sentinel site conducting enhanced
surveillance.
Regional laboratory ...........................
Demographic/Clinical Data ...............
20
240
11/60
880
Demographic/Clinical Data ...............
10
840
12/60
1,680
4
3,300
40/60
8,800
Regional laboratory ...........................
Antimicrobial Susceptibility Testing
Results.
Control Strain Susceptibility Testing
4
48
5/60
16
Total ...........................................
...........................................................
........................
........................
........................
11,376
Leroy A. 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. 2018–02222 Filed 2–2–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–18–0773]
sradovich on DSK3GMQ082PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled National
Surveillance for Severe Adverse Events
Among Persons on Treatment of Latent
Tuberculosis Infection to the Office of
Management and Budget (OMB) for
review and approval. CDC previously
published a ‘‘Proposed Data Collection
Submitted for Public Comment and
Recommendations’’ notice on August
22, 2017 to obtain comments from the
public and affected agencies. CDC
received one substantive comments
related to the previous notice. This
notice serves to allow an additional 30
days for public and affected agency
comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(a) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
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18:08 Feb 02, 2018
Jkt 244001
functions of the agency, including
whether the information will have
practical utility;
(b) Evaluate the accuracy of the
agencies estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected;
(d) Minimize the burden of the
collection of information on those who
are to respond, including, through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and
(e) Assess information collection
costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
Proposed Project
National Surveillance for Severe
Adverse Events Associated with
Treatment of Latent Tuberculosis
Infection—(0920–0773, expiration
01/31/2018)—Extension—Division of
Tuberculosis Elimination (DTBE),
National Center for HIV, Viral Hepatitis,
STD, and TB Prevention NCHHSTP),
Centers for Disease Control and
Prevention (CDC).
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Background and Brief Description
This project seeks a three-year
extension to continue the passive
reporting system for severe adverse
events (SAEs) associated with therapy
for Latent Tuberculosis Infection (LTBI).
The system will rely on medical chart
review and/or onsite investigations by
TB control staff. 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. Reports of SAEs related to
rifampicin plus pyrazinamide (RZ) and
isoniazid (INH) 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.
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. 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. Reporting of SAEs will be
conducted through telephone, email, or
during CDC site visits.
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05FEN1
5104
Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
CDC will analyze and periodically
publish reports summarizing national
LTBI treatment adverse events statistics
and will conduct special analyses for
publication in peer-reviewed scientific
journals to further describe and
interpret these data.
In this extension request, CDC is
requesting approval for approximately
Type of respondent
Form name
Physician .........................................................................................................
Nurse ...............................................................................................................
Medical Clerk ...................................................................................................
Estimated Annualized Burden Hours
Number of
respondents
NSSAE ...........
NSSAE ...........
NSSAE ...........
Leroy A. 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. 2018–02206 Filed 2–2–18; 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
Title: National and Tribal Evaluation
of the 2nd Generation of the Health
Profession Opportunity Grants.
OMB NO.: 0970–0462.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS) is proposing data
collection activities as part of the Health
Profession Opportunity Grants (HPOG)
to serve TANF and Other Low Income
Individuals. ACF has developed a multipronged research and evaluation
approach for the HPOG Program to
better understand and assess the
activities conducted and their results.
Two rounds of HPOG grants have been
awarded—the first in 2010 (HPOG 1.0)
and the second in 2015 (HPOG 2.0).
There are federal evaluations associated
with each round of grants. HPOG grants
provide funding to government
agencies, community-based
organizations, post-secondary
educational institutions, and tribalaffiliated organizations to provide
education and training services to
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60 burden hours annually. There is no
cost to respondents.
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Temporary Assistance for Needy
Families (TANF) recipients and other
low-income individuals, including
tribal members. Under HPOG 2.0, ACF
provided grants to five tribal-affiliated
organizations and 27 non-tribal entities.
OMB previously approved data
collection under OMB Control Number
0970–0462 for: the HPOG 2.0 National
and Tribal Evaluation (Approved
August 2015); and the National
Evaluation impact study; the National
Evaluation descriptive study; and the
Tribal Evaluation (All approved June
2017). The proposed data collection
activities described in this Federal
Register Notice will provide data for the
impact and cost benefit studies of the 27
non-tribal grantees participating in the
National Evaluation of HPOG 2.0.
National Evaluation: The National
Evaluation pertains only to the 27 nontribal grantees that received HPOG 2.0
funding. The design for the National
Evaluation features an implementation
study, a systems change analysis, and
cost benefit analysis. In addition, the
National Evaluation is using an
experimental design to measure and
analyze key participant outcomes
including completion of education and
training, receipt of certificates and/or
degrees, earnings, and employment in a
healthcare career. The impact
evaluation will assess the outcomes for
study participants that were offered
HPOG 2.0 training, financial assistance,
and support services, compared to what
their outcomes would have been if they
had not been offered HPOG 2.0 services.
This Notice provides the opportunity to
comment on a proposed new
information collection activity for the
HPOG 2.0 National Evaluation’s impact
study—the HPOG 2.0 Impact Evaluation
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10
10
10
Number of
responses per
respondent
1
1
1
Average
burden per
response
(in hours)
1
4
1
first follow-up survey, referred to as the
Short-Term Follow-up Survey. The first
follow-up survey of both treatment and
control group members will be
administered approximately 15 months
after baseline data collection and
random assignment. The survey will
collect data about key outcomes of
interest, including participants’ tenure
and experience in HPOG programming;
certifications and educational
achievements; job placement; and
receipt of benefits. These are the key
outcomes of interest for which data are
not otherwise available through existing
data sources. Previously approved
collection activities under 0970–0462
will continue under this new request for
the National Evaluation of the non-tribal
grantees.
In subsequent requests for clearance,
we will submit (1) additional data
collection instruments to support the
descriptive study of the 27 non-tribal
grantees participating in the HPOG 2.0
National Evaluation, including grantee
interview guides and participant
interview guides; and (2) the second
follow-up survey—the Intermediate
Follow-up Survey—for the HPOG 2.0
National Evaluation impact study. The
second follow-up survey is for
collecting data from both treatment and
control group members at the 27 nontribal grantees, approximately 36
months after baseline data collection
and random assignment. This
submission will also include data
collection necessary for the National
Evaluation’s cost benefit analysis.
Respondents: For the National
Evaluation impact study: HPOG 2.0
study participants at the 27 non-tribal
grantees.
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Agencies
[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5103-5104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02206]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-18-0773]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled National Surveillance for Severe Adverse
Events Among Persons on Treatment of Latent Tuberculosis Infection to
the Office of Management and Budget (OMB) for review and approval. CDC
previously published a ``Proposed Data Collection Submitted for Public
Comment and Recommendations'' notice on August 22, 2017 to obtain
comments from the public and affected agencies. CDC received one
substantive comments related to the previous notice. This notice serves
to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(a) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected;
(d) Minimize the burden of the collection of information on those
who are to respond, including, through the use of appropriate
automated, electronic, mechanical, or other technological collection
techniques or other forms of information technology, e.g., permitting
electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
Proposed Project
National Surveillance for Severe Adverse Events Associated with
Treatment of Latent Tuberculosis Infection--(0920-0773, expiration 01/
31/2018)--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
This project seeks a three-year extension to continue the passive
reporting system for severe adverse events (SAEs) associated with
therapy for Latent Tuberculosis Infection (LTBI). The system will rely
on medical chart review and/or onsite investigations by TB control
staff. 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.
Reports of SAEs related to rifampicin plus pyrazinamide (RZ) and
isoniazid (INH) 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.
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. 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. Reporting of SAEs will be conducted through telephone,
email, or during CDC site visits.
[[Page 5104]]
CDC will analyze and periodically publish reports summarizing
national LTBI treatment adverse events statistics and will conduct
special analyses for publication in peer-reviewed scientific journals
to further describe and interpret these data.
In this extension request, CDC is requesting approval for
approximately 60 burden hours annually. There is no cost to
respondents.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Physician........................... NSSAE..................... 10 1 1
Nurse............................... NSSAE..................... 10 1 4
Medical Clerk....................... NSSAE..................... 10 1 1
----------------------------------------------------------------------------------------------------------------
Leroy A. 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. 2018-02206 Filed 2-2-18; 8:45 am]
BILLING CODE 4163-18-P