Proposed Data Collection Submitted for Public Comment and Recommendations, 10336-10337 [2023-03322]
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<![CDATA[
10336
Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
Centers for Disease Control and
Prevention
[60Day–23–1080; Docket No. CDC–2023–
0010]
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 effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other federal
agencies the opportunity to comment on
a continuing information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled HIV Outpatient
Study (HOPS). HOPS is a CDC data
collection for standardized HIV clinical
and behavioral data at private HIV care
practices and university-based U.S.
clinics participating in the HOPS
program.
SUMMARY:
CDC must receive written
comments on or before April 18, 2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2023–
0010 by either of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road, NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to
the address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 404–639–7118; Email: omb@
cdc.gov.
lotter on DSK11XQN23PROD with NOTICES1
DATES:
VerDate Sep<11>2014
17:13 Feb 16, 2023
Jkt 259001
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 the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. 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 submissions
of responses; and
5. Assess information collection costs.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Proposed Project
HIV Outpatient Study (HOPS) (OMB
Control No. 0920–1080, Exp. 02/29/
2024)—Extension—National Center for
HIV, 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 (CDC) requests a three-year
approval for the HIV Outpatient Study
(HOPS) data collection. HOPS is a
prospective longitudinal cohort of
patients in HIV care at eight well
established private HIV care practices
and university-based U.S. clinics, in:
Tampa, Florida; Washington, DC; Stony
Brook, New York; Chicago, Illinois;
Denver, Colorado; and Philadelphia,
Pennsylvania. Clinical data are
abstracted on an ongoing basis from the
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
medical records of adult HOPS study
participants, who also complete an
optional telephone/web-based
behavioral assessment as part of their
annual clinic visit, which on average
takes about seven minutes. 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 for
persons living with HIV; and (iv)
investigating disparities in the HIV care
continuum by various demographic
factors. In recent years, 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. HOPS
remains an important source for
multiyear 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
eight 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); and
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
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.
E:\FR\FM\17FEN1.SGM
17FEN1
10337
Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
CDC anticipates that 450 new HOPS
study participants will be recruited
annually into HOPS from a pool of
patients with HIV currently in HIV-care
at the eight aforementioned clinics (50–
60 patients per site). Patients are
approached during one of their routine
clinic visits to participate in HOPS.
Patients interested in participating in
each year. Medical record abstractions
will be completed on all HOPS
participants and impose no direct
burden on HOPS study participants.
Participation of respondents is
voluntary. CDC request OMB approval
for an estimated 428 annual burden
hours. There is no cost to the
respondents other than their time.
HOPS are given detailed information
about the nature of the study and
provided with written informed consent
that must be completed prior to
enrollment. The 450 newly enrolled
participants each year will be added to
the database of existing participants
such that approximately 2,700
participants will be seen in the HOPS
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hr)
Total burden
(in hr)
Form name
HOPS Study Patients .......................
HOPS Study Patients .......................
Behavioral survey .............................
Consent form ....................................
2,700
450
1
1
7/60
15/60
315
113
Total ...........................................
...........................................................
........................
........................
........................
428
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2023–03322 Filed 2–16–23; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–23–23CO; Docket No. CDC–2023–
0011]
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 effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other federal
agencies the opportunity to comment on
a proposed information collection, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed information
collection project titled the National
Center for Health Statistics (NCHS)
Rapid Surveys System (RSS). The RSS
is a new survey system being designed
to complement the current household
survey systems at NCHS. The RSS will
use survey data from probability-based
online panels to produce time-sensitive
estimates of new and emerging public
health topics, attitudes, and behaviors.
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Type of respondent
VerDate Sep<11>2014
17:13 Feb 16, 2023
Jkt 259001
CDC must receive written
comments on or before April 18, 2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2023–
0011 by any of the following methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: Jeffrey M. Zirger, Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE, MS H21–8, Atlanta,
Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. CDC will post, without
change, all relevant comments to
www.regulations.gov.
Please note: Submit all comments
through the Federal eRulemaking portal
(www.regulations.gov) or by U.S. mail to
the address listed above.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact Jeffrey M. Zirger,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE, MS
H21–8, Atlanta, Georgia 30329;
Telephone: 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
DATES:
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
information, and each reinstatement of
previously approved information
collection before submitting the
collection to the OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
The OMB is particularly interested in
comments that will help:
1. 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;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected;
4. 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 submissions
of responses; and
5. Assess information collection costs.
Proposed Project
National Center for Health Statistics
(NCHS) Rapid Surveys System (RSS)—
New—National Center for Health
Statistics (NCHS), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C.), as
amended, authorizes that the Secretary
of Health and Human Services (HHS),
acting through NCHS, collect data about
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10336-10337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03322]
[[Page 10336]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-1080; Docket No. CDC-2023-0010]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing effort to reduce public burden and maximize the
utility of government information, invites the general public and other
federal agencies the opportunity to comment on a continuing information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled HIV Outpatient Study (HOPS). HOPS is a CDC data collection for
standardized HIV clinical and behavioral data at private HIV care
practices and university-based U.S. clinics participating in the HOPS
program.
DATES: CDC must receive written comments on or before April 18, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0010 by either of the following methods:
Federal eRulemaking Portal: www.regulations.gov. Follow
the instructions for submitting comments.
Mail: Jeffrey M. Zirger, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road,
NE, MS H21-8, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. CDC will post, without change, all relevant comments
to www.regulations.gov.
Please note: Submit all comments through the Federal eRulemaking
portal (www.regulations.gov) or by U.S. mail to the address listed
above.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact Jeffrey M. Zirger, Information Collection
Review Office, Centers for Disease Control and Prevention, 1600 Clifton
Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7118;
Email: [email protected].
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 the OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
The OMB is particularly interested in comments that will help:
1. 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;
2. Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to
be collected;
4. 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
submissions of responses; and
5. Assess information collection costs.
Proposed Project
HIV Outpatient Study (HOPS) (OMB Control No. 0920-1080, Exp. 02/29/
2024)--Extension--National Center for HIV, 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 (CDC) requests a
three-year approval for the HIV Outpatient Study (HOPS) data
collection. HOPS is a prospective longitudinal cohort of patients in
HIV care at eight well established private HIV care practices and
university-based U.S. clinics, in: Tampa, Florida; Washington, DC;
Stony Brook, New York; Chicago, Illinois; Denver, Colorado; and
Philadelphia, Pennsylvania. Clinical data are abstracted on an ongoing
basis from the medical records of adult HOPS study participants, who
also complete an optional telephone/web-based behavioral assessment as
part of their annual clinic visit, which on average takes about seven
minutes. 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 for
persons living with HIV; and (iv) investigating disparities in the HIV
care continuum by various demographic factors. In recent years, 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. HOPS remains an important source for
multiyear 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 eight 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); and 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 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.
[[Page 10337]]
CDC anticipates that 450 new HOPS study participants will be
recruited annually into HOPS from a pool of patients with HIV currently
in HIV-care at the eight aforementioned clinics (50-60 patients per
site). Patients are approached during one of their routine clinic
visits to participate in HOPS. Patients interested in participating in
HOPS are given detailed information about the nature of the study and
provided with written informed consent that must be completed prior to
enrollment. The 450 newly enrolled participants each year will be added
to the database of existing participants such that approximately 2,700
participants will be seen in the HOPS each year. Medical record
abstractions will be completed on all HOPS participants and impose no
direct burden on HOPS study participants.
Participation of respondents is voluntary. CDC request OMB approval
for an estimated 428 annual burden hours. There is no cost to the
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 hr) (in hr)
----------------------------------------------------------------------------------------------------------------
HOPS Study Patients........... Behavioral 2,700 1 7/60 315
survey.
HOPS Study Patients........... Consent form.... 450 1 15/60 113
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 428
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2023-03322 Filed 2-16-23; 8:45 am]
BILLING CODE 4163-18-P
