Agency Forms Undergoing Paperwork Reduction Act Review, 27313-27314 [2015-11510]
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27313
Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
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. 2015–11511 Filed 5–12–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Proposed Project
Centers for Disease Control and
Prevention
[30Day–15–15JX]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (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
asabaliauskas on DSK5VPTVN1PROD with NOTICES
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
HIV Outpatient Study (HOPS)—
New—National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention requests a three-year
approval for the HIV Outpatient Study
data collection activity. The HIV
Outpatient Study (HOPS) is a
prospective longitudinal cohort of HIVinfected outpatients at nine wellestablished private HIV care practices
and university-based U.S. clinics.
Clinical data are abstracted on ongoing
basis from the medical records of adult
HIV-infected HOPS study participants,
who also complete an optional seven
minute telephone/web-based behavioral
assessment as part of their annual clinic
visit.
Before enrolling in this study, all
potential study participants will
undergo an informed consent process
(including signing of a written informed
consent) which is estimated to take 15
minutes.
The core areas of HOPS research
extending through the present HIV
treatment era include (i) monitoring
death rates and causes of death (ii)
characterizing the optimal patient
management strategies to reduce HIVrelated morbidity and mortality (e.g.,
effectiveness of antiretroviral therapies
and other clinical interventions (iii)
monitoring of sexual and drug use
behaviors to inform Prevention with
Positives, and (iv) investigating
disparities in the HIV care continuum
by various demographic factors. In
recent years, the HOPS has been
instrumental in bringing attention to
emerging issues in chronic HIV
infection with actionable opportunities
for prevention, including:
cardiovascular disease, fragility
fractures, renal and hepatic disease, and
cancers. The HOPS remains an
important source for multi-year trend
data concerning conditions and
behaviors for which data are not readily
available elsewhere, including: rates of
opportunistic illnesses, rates of
comorbid conditions (e.g., hypertension,
obesity, diabetes) and antiretroviral drug
resistance.
Data will be collected through
medical record abstraction by trained
abstractors and by telephone or internetbased, computer-assisted interviews at
nine funded study sites in six U.S.
cities.
Collection of data abstracted from
patient medical records provides data in
five general categories: Demographics
and risk behaviors for HIV infection;
symptoms; diagnosed conditions
(definitive and presumptive);
medications prescribed (including dose,
duration, and reasons for stopping); all
laboratory values, including CD4+ Tlymphocyte (CD4+) cell counts, plasma
HIV–RNA determinations, and
genotype, phenotype, and trophile
results. Data on visit frequency, AIDS,
and death are acquired from the clinic
chart.
Data collected using a brief Telephone
Audio-Computer Assisted SelfInterview (T–ACASI) survey or an
identical web-based Audio-Computer
Assisted Self-Interview (ACASI)
include: Age, sex at birth, use of alcohol
and drugs, cigarette smoking, adherence
to antiretroviral medications, types of
sexual intercourse, condom use, and
disclosure of HIV status to partners.
We estimate consenting 450 new
participants per year across all HOPS
study sites (50 participants at each of
the 9 sites). The consent process takes
approximately 15 minutes to complete.
Medical record abstractions will be
completed on all eligible participants.
All eligible participants will be offered
the opportunity to participate in an
optional short survey that will take
approximately seven minutes.
Participation of respondents is
voluntary. There is no cost to the
respondents other than their time. The
estimated annual burden hours are 405.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
HOPS study Patients ......................................
HOPS Study Patients ......................................
Behavioral survey ..........................................
Consent form .................................................
VerDate Sep<11>2014
17:27 May 12, 2015
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E:\FR\FM\13MYN1.SGM
Number of
responses per
respondent
2,500
450
13MYN1
1
1
Avg. burden
per response
(in hrs.)
7/60
15/60
27314
Federal Register / Vol. 80, No. 92 / Wednesday, May 13, 2015 / Notices
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. 2015–11510 Filed 5–12–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–15AHO; Docket No. CDC–2015–
0031]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, 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. This notice invites
comment on a proposed information
collection for a retrospective evaluation
of the prevalence of acute flaccid
myelitis with MRI grey matter findings
among children aged ≤18 years.
DATES: Written comments must be
received on or before July 13, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0031 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.
VerDate Sep<11>2014
17:27 May 12, 2015
Jkt 235001
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road, NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION:
Under the Paperwork Reduction Act
of 1995 (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. In
addition, the PRA also requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each new proposed
collection, each proposed extension of
existing collection of information, and
each reinstatement of previously
approved information collection before
submitting the collection to OMB for
approval. To comply with this
requirement, we are publishing this
notice of a proposed data collection as
described below.
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.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
Proposed Project
Retrospective evaluation of the
prevalence of acute flaccid myelitis with
MRI grey matter findings among
children aged ≤18 years—NEW—
National Center for Immunization and
Respiratory Diseases, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Acute onset limb weakness,
commonly referred to as acute flaccid
paralysis (AFP), is a relatively
uncommon syndrome among children.
From August–October 2014, several
clusters of AFP among children were
reported from several states within the
United States (U.S.) and an
epidemiologic investigation was
initiated to elucidate the possible causes
of these cases.
CDC originally collected data under
OMB Control Numbers 0920–1011 and
0920–0009. Cases were characterized by
distinctive abnormalities on spinal
magnetic resonance imaging (MRI), in
which pathologic changes were largely
restricted to the central grey matter of
the spinal cord. Due to these findings
and to differentiate this illness from
other forms of AFP, CDC used the term
‘acute flaccid myelitis’ (AFM).
The main goal of this study is to
obtain data in order to estimate the
baseline rate of AFM that is
accompanied by MRI changes confined
to spinal grey matter among children
≤18 years of age that were seen at six
pediatric medical centers in the United
States. Data on spinal MRIs from years
2005–2014 will be collected from six
sentinel medical centers. Physicians at
these medical centers will examine the
MRI reports and extract data on specific
variables using a database developed by
CDC.
Data will then be sent to CDC, where
2005–2013 data will be compared with
2014 data in order to assess if 2014 rates
of AFM were higher than in previous
years. Furthermore, this evaluation will
provide important information
regarding characteristics of patients
presenting with AFM and grey matter
changes, assist in determining the
potential for surveillance focusing on
MRI findings because AFM is not
routinely conducted in the United
States and identify possible risk factors.
The data will be used to estimate a
baseline for the rate of AFM that occurs
in the United States each year. This
information has not been previously
collected, since the U.S. does not collect
routine surveillance for AFM/AFP.
The participation of respondents is
voluntary. There is no cost to the
respondents other than their time. The
E:\FR\FM\13MYN1.SGM
13MYN1
]]>Agencies
[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27313-27314]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11510]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-15JX]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (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 omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
HIV Outpatient Study (HOPS)--New--National Center for HIV/AIDS,
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and Prevention requests a three-
year approval for the HIV Outpatient Study data collection activity.
The HIV Outpatient Study (HOPS) is a prospective longitudinal cohort of
HIV-infected outpatients at nine well-established private HIV care
practices and university-based U.S. clinics. Clinical data are
abstracted on ongoing basis from the medical records of adult HIV-
infected HOPS study participants, who also complete an optional seven
minute telephone/web-based behavioral assessment as part of their
annual clinic visit.
Before enrolling in this study, all potential study participants
will undergo an informed consent process (including signing of a
written informed consent) which is estimated to take 15 minutes.
The core areas of HOPS research extending through the present HIV
treatment era include (i) monitoring death rates and causes of death
(ii) characterizing the optimal patient management strategies to reduce
HIV-related morbidity and mortality (e.g., effectiveness of
antiretroviral therapies and other clinical interventions (iii)
monitoring of sexual and drug use behaviors to inform Prevention with
Positives, and (iv) investigating disparities in the HIV care continuum
by various demographic factors. In recent years, the HOPS has been
instrumental in bringing attention to emerging issues in chronic HIV
infection with actionable opportunities for prevention, including:
cardiovascular disease, fragility fractures, renal and hepatic disease,
and cancers. The HOPS remains an important source for multi-year trend
data concerning conditions and behaviors for which data are not readily
available elsewhere, including: rates of opportunistic illnesses, rates
of comorbid conditions (e.g., hypertension, obesity, diabetes) and
antiretroviral drug resistance.
Data will be collected through medical record abstraction by
trained abstractors and by telephone or internet-based, computer-
assisted interviews at nine funded study sites in six U.S. cities.
Collection of data abstracted from patient medical records provides
data in five general categories: Demographics and risk behaviors for
HIV infection; symptoms; diagnosed conditions (definitive and
presumptive); medications prescribed (including dose, duration, and
reasons for stopping); all laboratory values, including CD4+ T-
lymphocyte (CD4+) cell counts, plasma HIV-RNA determinations, and
genotype, phenotype, and trophile results. Data on visit frequency,
AIDS, and death are acquired from the clinic chart.
Data collected using a brief Telephone Audio-Computer Assisted
Self-Interview (T-ACASI) survey or an identical web-based Audio-
Computer Assisted Self-Interview (ACASI) include: Age, sex at birth,
use of alcohol and drugs, cigarette smoking, adherence to
antiretroviral medications, types of sexual intercourse, condom use,
and disclosure of HIV status to partners.
We estimate consenting 450 new participants per year across all
HOPS study sites (50 participants at each of the 9 sites). The consent
process takes approximately 15 minutes to complete.
Medical record abstractions will be completed on all eligible
participants. All eligible participants will be offered the opportunity
to participate in an optional short survey that will take approximately
seven minutes.
Participation of respondents is voluntary. There is no cost to the
respondents other than their time. The estimated annual burden hours
are 405.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Avg. burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
HOPS study Patients.................. Behavioral survey........ 2,500 1 7/60
HOPS Study Patients.................. Consent form............. 450 1 15/60
----------------------------------------------------------------------------------------------------------------
[[Page 27314]]
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. 2015-11510 Filed 5-12-15; 8:45 am]
BILLING CODE 4163-18-P
