Agency Forms Undergoing Paperwork Reduction Act Review, 55812-55814 [2022-19564]
Download as PDF
<![CDATA[
55812
Federal Register / Vol. 87, No. 175 / Monday, September 12, 2022 / Notices
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2022–19559 Filed 9–9–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Clinical Laboratory Improvement
Advisory Committee
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
In accordance with the
Federal Advisory Committee Act, the
CDC announces the following meeting
for the Clinical Laboratory Improvement
Advisory Committee (CLIAC). This
meeting is open to the public, limited
only by the number of webcast lines
available. Time will be available for
public comment.
DATES: The meeting will be held on
November 9, 2022, from 11:00 a.m. to
6:00 p.m., EST, and November 10, 2022,
from 11:00 a.m. to 6:00 p.m., EST.
ADDRESSES: This is a virtual meeting.
Meeting times are tentative and subject
to change. The confirmed meeting
times, agenda items, and meeting
materials, including instructions for
accessing the live meeting broadcast,
will be available on the CLIAC website
at https://www.cdc.gov/cliac. Check the
website on the day of the meeting for
the web conference link.
FOR FURTHER INFORMATION CONTACT:
Heather Stang, MS, Deputy Chief,
Quality and Safety Systems Branch,
Division of Laboratory Systems, Center
for Surveillance, Epidemiology, and
Laboratory Services, Deputy Director for
Public Health Science and Surveillance,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE,
Mailstop V24–3, Atlanta, Georgia
30329–4027; Telephone: (404) 498–
2769; Email: HStang@cdc.gov.
SUPPLEMENTARY INFORMATION:
Purpose: This Committee is charged
with providing scientific and technical
advice and guidance to the Secretary,
HHS; the Assistant Secretary for Health;
the Director, CDC; the Commissioner,
Food and Drug Administration (FDA);
and the Administrator, Centers for
Medicare & Medicaid Services (CMS).
The advice and guidance pertain to
general issues related to improvement in
clinical laboratory quality and
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:06 Sep 09, 2022
Jkt 256001
laboratory medicine and specific
questions related to possible revision of
the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) standards.
Examples include providing guidance
on studies designed to improve quality,
safety, effectiveness, efficiency,
timeliness, equity, and patientcenteredness of laboratory services;
revisions to the standards under which
clinical laboratories are regulated; the
impact of proposed revisions to the
standards on medical and laboratory
practice; and the modification of the
standards and provision of nonregulatory guidelines to accommodate
technological advances, such as new
test methods, the electronic
transmission of laboratory information,
and mechanisms to improve the
integration of public health and clinical
laboratory practices.
Matters To Be Considered: The agenda
will include agency updates from CDC,
CMS, and FDA. Presentations and
CLIAC discussions will focus on the
clinical and public health response to
the monkeypox outbreak, efforts to
address public health and clinical
laboratory workforce challenges, and
reports from two CLIAC workgroups:
the CLIA Regulations Assessment
Workgroup and the CLIA Certificate of
Waiver and Provider-performed
Microscopy Procedures Workgroup.
Agenda items are subject to change as
priorities dictate.
Public Participation
It is the policy of CLIAC to accept
written public comments and provide a
brief period for oral public comments
pertinent to agenda items.
Oral Public Comment: Public
comment periods for each agenda item
are scheduled immediately prior to the
Committee discussion period for that
item. In general, each individual or
group requesting to present an oral
comment will be limited to a total time
of five minutes (unless otherwise
indicated). Speakers should email
CLIAC@cdc.gov or notify the contact
person above (see FOR FURTHER
INFORMATION CONTACT) at least five
business days prior to the meeting date.
Written Public Comment: CLIAC
accepts written comments until the date
of the meeting (unless otherwise stated).
However, it is requested that comments
be submitted at least five business days
prior to the meeting date so that the
comments may be made available to the
Committee for their consideration and
public distribution. Written comments
should be submitted by email to
CLIAC@cdc.gov or to the contact person
above. All written comments will be
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
included in the meeting minutes posted
on the CLIAC website.
The Director, Strategic Business
Initiatives Unit, Office of the Chief
Operating Officer, Centers for Disease
Control and Prevention, has been
delegated the authority to sign Federal
Register notices pertaining to
announcements of meetings and other
committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Kalwant Smagh,
Director, Strategic Business Initiatives Unit,
Office of the Chief Operating Officer, Centers
for Disease Control and Prevention.
[FR Doc. 2022–19569 Filed 9–9–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day–22–0573]
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 HIV
Surveillance System (NHSS)’’ 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 April 1, 2022, to obtain
comments from the public and affected
agencies. CDC received two comments
related to the previous notice. No
changes were made to the information
collection plan. 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;
E:\FR\FM\12SEN1.SGM
12SEN1
Federal Register / Vol. 87, No. 175 / Monday, September 12, 2022 / Notices
(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.
Comments and recommendations for the
proposed information collection should
be sent within 30 days of publication of
this notice to www.reginfo.gov/public/
do/PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function. 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.
lotter on DSK11XQN23PROD with NOTICES1
Proposed Project
National HIV Surveillance System
(NHSS) (OMB Control No. 0920–0573,
Exp. 11/30/2022)—Revision—National
Center for HIV, Viral Hepatitis, STD,
and TB Prevention (NCHHSTP), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
Collected with authorization under
Sections 304 and 306 of the Public
Health Service Act (42 U.S.C. 242b and
242k), the National HIV Surveillance
System (NHSS) data are the primary
data used to monitor the extent and
characteristics of the HIV burden in the
United States. HIV surveillance data are
used to describe trends in HIV
incidence, prevalence and
characteristics of infected persons and
used widely at the federal, state, and
local levels for planning and evaluating
prevention programs and healthcare
services, to allocate funding for
prevention and care, and to monitor
progress toward achieving national
prevention goals of the Ending the HIV
Epidemic in the U.S initiative.
The Division of HIV Prevention
(DHP), National Center for HIV, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), CDC, in collaboration with
health departments in the states, the
District of Columbia, and U.S.
dependent areas, conducts national
VerDate Sep<11>2014
17:06 Sep 09, 2022
Jkt 256001
surveillance for cases of HIV infection
that includes critical data reported
across the spectrum of HIV disease
stages from HIV diagnosis to death.
NHSS data collection activities are
currently supported through cooperative
agreements with health departments
under CDC Funding Opportunity
Announcements PS18–1802: Integrated
HIV Surveillance and Prevention
Programs for Health Departments;
PS20–2010: Integrated HIV Programs for
Health Departments to Support Ending
the HIV Epidemic in the United States;
PS18–1801: Accelerating the Prevention
and Control of HIV/AIDS, Viral
Hepatitis, STDs, and TB in the U.S.—
Affiliated Pacific Islands; and PS23–
2302: Accelerating the Prevention and
Control of HIV, Viral Hepatitis, STDs,
and TB in the U.S. Affiliated Pacific
Islands.
The systematic data collection in
NHSS provides the essential data used
to calculate population-based HIV
incidence estimates, describe the
geographic distribution of disease,
monitor HIV transmission and drug
resistance patterns and genetic diversity
of HIV among infected persons, detect
and respond to HIV clusters of recent
and rapid transmission, and monitor
perinatal exposures. NHSS data are also
used locally to identify persons with
HIV who are not in medical care and
linking them to care and needed
services. Describing geographic
distribution allows CDC to assess social
determinants of health in the context of
HIV which allows identification health
inequities, and guides steps to address
and monitor the health equity over time
moving forward. NHSS data continue to
be collected, maintained, and reported
using standard case definitions, report
forms and software. The system is
periodically updated to keep pace with
changes in testing technology and
advances in HIV care and treatment, as
well as changing prevention program
monitoring and evaluation needs.
The changes requested in this
Revision include program-initiated
modifications to currently collected data
elements and forms including changes
to the Adult Case Report Form (ACRF),
the Pediatric Case Report Form (PCRF),
the Perinatal HIV Exposure Reporting
(PHER)form, and the Standards
Evaluation Report (SER). We request
approval to continue data collection
using our currently approved data
collection instruments through
December 2022 and implement the
proposed form changes starting in
January 2023.
Changes include minor modifications
to dates and time periods in the SER to
align with information needs and assess
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
55813
program performance the next report
cycle in 2023. Changes made to both the
ACRF and PCRF include addition of two
variables to collect sexual orientation
information and updated gender
identity response options. Modification
of the gender identity response options
and collection of a new variable on
sexual orientation proposed in this
revision will allow CDC to better
address prevention needs of sexual
minority populations (e.g., including
lesbian, gay, bisexual and transgender
(LGBT) populations). In addition, to
better reflect the most recent changes in
testing technology in the data collection,
two new HIV test types have been added
and two new response options related to
self-testing have been added. Finally,
three new HIV testing history variables
to summarize self-testing activities have
been added to the ACRF (only) and
formatting changes have been made to
improve usability of both forms.
Critical perinatal exposure
information has been consolidated
across the PHER and PCRF to one
revised PCRF form to reduce
redundancy and include some new and
revised data elements needed to assess
progress with perinatal elimination
efforts and support HIV prevention
activities. In all, 10 variables in the
PHER form will no longer be collected;
7 variables from the PHER form were
combined with existing variables on the
PCRF; 13 variables were moved from the
PHER form to the new PCRF; 5 new
variables were added to the PCRF
including 4 related to breastfeeding/
chestfeeding and premastication risk
behaviors and one variable related to
documentation of laboratory results in a
person’s labor and delivery record;
response options for the existing
delivery method variable were revised
on the PCRF to align with current
medical practices.
Health departments will use the
revised PCRF form to report both
perinatal exposures and pediatric case
reports. The number of jurisdictions that
will submit pediatric case reports is 59
and a subset will also report perinatal
exposure information using the revised
PCRF form. The estimated burden per
response for the PCRF has been revised
from an average of 20 minutes to 35
minutes per response to account for
these changes and increased reporting of
perinatal exposure data elements.
Burden estimates have been revised to
reflect program changes when needed.
HIV Incidence data collection is being
discontinued as a separate activity and
removed from the ICR. HIV incidence
continues to be estimated by CDC via
statistical methods. Burden estimates
have been updated to reflect the
E:\FR\FM\12SEN1.SGM
12SEN1
55814
Federal Register / Vol. 87, No. 175 / Monday, September 12, 2022 / Notices
discontinuation of incidence data
collection, discontinued use of the
PHER form for perinatal exposure
reporting, and the revised PCRF.
Additionally, the revised burden
estimate includes small increases in
burden for case and laboratory updates,
deduplication activities and increased
case investigations due to the increase
in the number of persons living with
HIV, requiring additional laboratory and
case information reporting and linkage
to care activities. Small decreases were
made to the burden estimates for case
reports to account for decreases in adult
and pediatric HIV diagnoses reported.
Health department staff compile
information from laboratories,
physicians, hospitals, clinics, and other
health care providers to complete the
HIV adult and pediatric case and
perinatal exposure reports. These data
are recorded using standard report
forms either on paper or electronically
and entered in the electronic reporting
system. CDC estimates that
approximately 789 adult HIV case
reports and 57 perinatal exposure and
pediatric case reports are processed by
each health department annually.
Updates to case reports are also
entered into the reporting system by
health departments if additional
information is received from
laboratories, vital statistics, or
additional providers. Health
departments also conduct evaluations
on a subset of case reports (e.g., reabstraction, validation). CDC estimates
that on average approximately 85
evaluations of case reports, 2,519
updates to case reports and 10,130
updates of electronic laboratory test data
will be processed by each of the 59
health departments annually. All 59
health departments will also conduct
routine deduplication activities for new
diagnoses and cumulative case reports.
CDC estimates that health departments
on average will follow-up on 3,032
reports as part of deduplication
activities annually. Case report
information is compiled over time by
health departments, de-identified and
forwarded to CDC on monthly basis for
inclusion in the national HIV
surveillance database.
Additional information will be
reported by health departments for
monitoring and evaluation of health
department investigations, including
activities to identify persons who are
not in HIV medical care, linking them
to HIV medical care (e.g., Data-to-Care
activities) and other services and for
identifying and responding to clusters.
CDC estimates health departments will
on average process 929 responses
related to investigation reporting and
monitoring annually.
Health departments actively review
HIV surveillance and other data to
detect clusters that include groups of
persons with HIV related by recent and
rapid transmission. Data on clusters will
be collected to monitor situations
necessitating public health intervention,
assess health department response, and
evaluate outcomes of intervention
activities. Health departments with
detected clusters will complete an
initial cluster report form when a cluster
is first identified, a cluster follow-up
form for each quarter in which the
cluster response remains active and a
cluster close-out form when cluster
response activities are closed or at
annual intervals while a cluster
response remains active. CDC estimates
on average health departments will
provide information for 2.5 initial
cluster reports, five Cluster Follow-up
Form reports, and 2.5 Cluster Close-out
Form reports annually.
The annual Standards Evaluation
Report (SER) is used by CDC and health
departments to improve data quality,
interpretation, usefulness, and
surveillance system efficiency, as well
as to monitor progress toward meeting
surveillance program objectives. The
information collected for the SER
includes a brief set of questions about
evaluation outcomes and the collection
of laboratory data.
OMB approval is requested for three
years. The total estimated annualized
burden in hours is 60,731. There are no
costs to the respondents other than time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Health Departments ........................................
Health Departments ........................................
Adult HIV Case Report (ACRF) .....................
Perinatal Exposure and Pediatric HIV Case
Report (PCRF).
Case Report Evaluations ...............................
Case Report Updates .....................................
Laboratory Updates ........................................
Deduplication Activities ..................................
Investigation Reporting and Evaluation .........
Initial Cluster Report Form .............................
Cluster Follow-up Form ..................................
Cluster Close-out Form ..................................
Annual Reporting: Standards Evaluation Report (SER).
Health
Health
Health
Health
Health
Health
Health
Health
Health
lotter on DSK11XQN23PROD with NOTICES1
Number of
respondents
Type of respondents
Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments
Departments
........................................
........................................
........................................
........................................
........................................
........................................
........................................
........................................
........................................
789
57
20/60
35/60
59
59
59
59
59
59
59
59
59
85
2,519
10,130
3,032
929
2.5
5
2.5
1
20/60
2/60
0.5/60
10/60
1/60
1
0.5
1
8
[FR Doc. 2022–19564 Filed 9–9–22; 8:45 am]
BILLING CODE 4163–18–P
17:06 Sep 09, 2022
Jkt 256001
PO 00000
Frm 00036
Fmt 4703
Sfmt 9990
E:\FR\FM\12SEN1.SGM
Average
burden per
response
(in hours)
59
59
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
VerDate Sep<11>2014
Number of
responses per
respondent
12SEN1
]]>Agencies
[Federal Register Volume 87, Number 175 (Monday, September 12, 2022)]
[Notices]
[Pages 55812-55814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19564]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-22-0573]
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 HIV Surveillance System (NHSS)''
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 April 1, 2022, to obtain
comments from the public and affected agencies. CDC received two
comments related to the previous notice. No changes were made to the
information collection plan. 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;
[[Page 55813]]
(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. Comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function. 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 HIV Surveillance System (NHSS) (OMB Control No. 0920-0573,
Exp. 11/30/2022)--Revision--National Center for HIV, Viral Hepatitis,
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
Collected with authorization under Sections 304 and 306 of the
Public Health Service Act (42 U.S.C. 242b and 242k), the National HIV
Surveillance System (NHSS) data are the primary data used to monitor
the extent and characteristics of the HIV burden in the United States.
HIV surveillance data are used to describe trends in HIV incidence,
prevalence and characteristics of infected persons and used widely at
the federal, state, and local levels for planning and evaluating
prevention programs and healthcare services, to allocate funding for
prevention and care, and to monitor progress toward achieving national
prevention goals of the Ending the HIV Epidemic in the U.S initiative.
The Division of HIV Prevention (DHP), National Center for HIV,
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), CDC, in
collaboration with health departments in the states, the District of
Columbia, and U.S. dependent areas, conducts national surveillance for
cases of HIV infection that includes critical data reported across the
spectrum of HIV disease stages from HIV diagnosis to death. NHSS data
collection activities are currently supported through cooperative
agreements with health departments under CDC Funding Opportunity
Announcements PS18-1802: Integrated HIV Surveillance and Prevention
Programs for Health Departments; PS20-2010: Integrated HIV Programs for
Health Departments to Support Ending the HIV Epidemic in the United
States; PS18-1801: Accelerating the Prevention and Control of HIV/AIDS,
Viral Hepatitis, STDs, and TB in the U.S.--Affiliated Pacific Islands;
and PS23-2302: Accelerating the Prevention and Control of HIV, Viral
Hepatitis, STDs, and TB in the U.S. Affiliated Pacific Islands.
The systematic data collection in NHSS provides the essential data
used to calculate population-based HIV incidence estimates, describe
the geographic distribution of disease, monitor HIV transmission and
drug resistance patterns and genetic diversity of HIV among infected
persons, detect and respond to HIV clusters of recent and rapid
transmission, and monitor perinatal exposures. NHSS data are also used
locally to identify persons with HIV who are not in medical care and
linking them to care and needed services. Describing geographic
distribution allows CDC to assess social determinants of health in the
context of HIV which allows identification health inequities, and
guides steps to address and monitor the health equity over time moving
forward. NHSS data continue to be collected, maintained, and reported
using standard case definitions, report forms and software. The system
is periodically updated to keep pace with changes in testing technology
and advances in HIV care and treatment, as well as changing prevention
program monitoring and evaluation needs.
The changes requested in this Revision include program-initiated
modifications to currently collected data elements and forms including
changes to the Adult Case Report Form (ACRF), the Pediatric Case Report
Form (PCRF), the Perinatal HIV Exposure Reporting (PHER)form, and the
Standards Evaluation Report (SER). We request approval to continue data
collection using our currently approved data collection instruments
through December 2022 and implement the proposed form changes starting
in January 2023.
Changes include minor modifications to dates and time periods in
the SER to align with information needs and assess program performance
the next report cycle in 2023. Changes made to both the ACRF and PCRF
include addition of two variables to collect sexual orientation
information and updated gender identity response options. Modification
of the gender identity response options and collection of a new
variable on sexual orientation proposed in this revision will allow CDC
to better address prevention needs of sexual minority populations
(e.g., including lesbian, gay, bisexual and transgender (LGBT)
populations). In addition, to better reflect the most recent changes in
testing technology in the data collection, two new HIV test types have
been added and two new response options related to self-testing have
been added. Finally, three new HIV testing history variables to
summarize self-testing activities have been added to the ACRF (only)
and formatting changes have been made to improve usability of both
forms.
Critical perinatal exposure information has been consolidated
across the PHER and PCRF to one revised PCRF form to reduce redundancy
and include some new and revised data elements needed to assess
progress with perinatal elimination efforts and support HIV prevention
activities. In all, 10 variables in the PHER form will no longer be
collected; 7 variables from the PHER form were combined with existing
variables on the PCRF; 13 variables were moved from the PHER form to
the new PCRF; 5 new variables were added to the PCRF including 4
related to breastfeeding/chestfeeding and premastication risk behaviors
and one variable related to documentation of laboratory results in a
person's labor and delivery record; response options for the existing
delivery method variable were revised on the PCRF to align with current
medical practices.
Health departments will use the revised PCRF form to report both
perinatal exposures and pediatric case reports. The number of
jurisdictions that will submit pediatric case reports is 59 and a
subset will also report perinatal exposure information using the
revised PCRF form. The estimated burden per response for the PCRF has
been revised from an average of 20 minutes to 35 minutes per response
to account for these changes and increased reporting of perinatal
exposure data elements.
Burden estimates have been revised to reflect program changes when
needed. HIV Incidence data collection is being discontinued as a
separate activity and removed from the ICR. HIV incidence continues to
be estimated by CDC via statistical methods. Burden estimates have been
updated to reflect the
[[Page 55814]]
discontinuation of incidence data collection, discontinued use of the
PHER form for perinatal exposure reporting, and the revised PCRF.
Additionally, the revised burden estimate includes small increases in
burden for case and laboratory updates, deduplication activities and
increased case investigations due to the increase in the number of
persons living with HIV, requiring additional laboratory and case
information reporting and linkage to care activities. Small decreases
were made to the burden estimates for case reports to account for
decreases in adult and pediatric HIV diagnoses reported.
Health department staff compile information from laboratories,
physicians, hospitals, clinics, and other health care providers to
complete the HIV adult and pediatric case and perinatal exposure
reports. These data are recorded using standard report forms either on
paper or electronically and entered in the electronic reporting system.
CDC estimates that approximately 789 adult HIV case reports and 57
perinatal exposure and pediatric case reports are processed by each
health department annually.
Updates to case reports are also entered into the reporting system
by health departments if additional information is received from
laboratories, vital statistics, or additional providers. Health
departments also conduct evaluations on a subset of case reports (e.g.,
re-abstraction, validation). CDC estimates that on average
approximately 85 evaluations of case reports, 2,519 updates to case
reports and 10,130 updates of electronic laboratory test data will be
processed by each of the 59 health departments annually. All 59 health
departments will also conduct routine deduplication activities for new
diagnoses and cumulative case reports. CDC estimates that health
departments on average will follow-up on 3,032 reports as part of
deduplication activities annually. Case report information is compiled
over time by health departments, de-identified and forwarded to CDC on
monthly basis for inclusion in the national HIV surveillance database.
Additional information will be reported by health departments for
monitoring and evaluation of health department investigations,
including activities to identify persons who are not in HIV medical
care, linking them to HIV medical care (e.g., Data-to-Care activities)
and other services and for identifying and responding to clusters. CDC
estimates health departments will on average process 929 responses
related to investigation reporting and monitoring annually.
Health departments actively review HIV surveillance and other data
to detect clusters that include groups of persons with HIV related by
recent and rapid transmission. Data on clusters will be collected to
monitor situations necessitating public health intervention, assess
health department response, and evaluate outcomes of intervention
activities. Health departments with detected clusters will complete an
initial cluster report form when a cluster is first identified, a
cluster follow-up form for each quarter in which the cluster response
remains active and a cluster close-out form when cluster response
activities are closed or at annual intervals while a cluster response
remains active. CDC estimates on average health departments will
provide information for 2.5 initial cluster reports, five Cluster
Follow-up Form reports, and 2.5 Cluster Close-out Form reports
annually.
The annual Standards Evaluation Report (SER) is used by CDC and
health departments to improve data quality, interpretation, usefulness,
and surveillance system efficiency, as well as to monitor progress
toward meeting surveillance program objectives. The information
collected for the SER includes a brief set of questions about
evaluation outcomes and the collection of laboratory data.
OMB approval is requested for three years. The total estimated
annualized burden in hours is 60,731. There are no costs to the
respondents other than time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Health Departments.................... Adult HIV Case Report 59 789 20/60
(ACRF).
Health Departments.................... Perinatal Exposure and 59 57 35/60
Pediatric HIV Case
Report (PCRF).
Health Departments.................... Case Report Evaluations. 59 85 20/60
Health Departments.................... Case Report Updates..... 59 2,519 2/60
Health Departments.................... Laboratory Updates...... 59 10,130 0.5/60
Health Departments.................... Deduplication Activities 59 3,032 10/60
Health Departments.................... Investigation Reporting 59 929 1/60
and Evaluation.
Health Departments.................... Initial Cluster Report 59 2.5 1
Form.
Health Departments.................... Cluster Follow-up Form.. 59 5 0.5
Health Departments.................... Cluster Close-out Form.. 59 2.5 1
Health Departments.................... Annual Reporting: 59 1 8
Standards Evaluation
Report (SER).
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-19564 Filed 9-9-22; 8:45 am]
BILLING CODE 4163-18-P
