Proposed Data Collections Submitted for Public Comment and Recommendations, 58092-58094 [2022-20602]
Download as PDF
58092
Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
these are federal customers and policy
makers, state and local officials who
rely on NCHS data, the broader
educational, research, and public health
community, and other data users.
Respondents may include data users
who register for and/or attend NCHS
sponsored conferences; persons who
access the NCHS website and the
detailed data available through it;
consultants; and others. Respondent
data items may include (in broad
categories) information regarding
respondent’s gender, age, occupation,
affiliation, location, etc., to be used to
characterize responses only. Other
questions will attempt to obtain
information that will characterize the
respondents’ familiarity with and use of
NCHS data, their assessment of data
content and usefulness, general
satisfaction with available services and
products, and suggestions for
improvement of surveys, services and
products.
In order to capture anticipated
feedback opportunities, this extension
request allows for both respondents and
time per response for a total estimated
annual burden total of 2,250 hours.
There is no cost to respondents other
than their time to participate in the
survey. The resulting information will
be for NCHS internal use.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Questionnaire for conference registrants/attendees.
Focus groups ....................................
Web-based Surveys ..........................
Other Customer Surveys ..................
Total ...........................................
Public/private researchers,
ants, and others.
Public/private researchers,
ants, and others.
Public/private researchers,
ants, and others.
Public/private researchers,
ants, and others.
1
15/60
250
Consult-
500
1
1
500
Consult-
4,000
1
15/60
1,000
Consult-
2,000
1
15/60
500
...........................................................
........................
........................
........................
2,250
BILLING CODE 4163–18–P
products for HIV prevention among
potential users and providers.
DATES: CDC must receive written
comments on or before November 22,
2022.
You may submit comments,
identified by Docket No. CDC–2022–
0113 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.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–22–22IX; Docket No. CDC–2022–
0113]
Proposed Data Collections 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, invites the general public and
other federal agencies to take this
opportunity to comment on proposed
information collections, as required by
the Paperwork Reduction Act of 1995.
This notice invites comment on a
proposed information collection project
titled Study of PrEPline reported PrEPadherent patients with HIV acquisition.
The purpose of this project is to
understand preferences for long-acting
pre-exposure prophylaxis (LA-PrEP)
SUMMARY:
lotter on DSK11XQN23PROD with NOTICES1
Total burden
(in hrs.)
1,000
[FR Doc. 2022–20603 Filed 9–22–22; 8:45 am]
17:04 Sep 22, 2022
Avg. burden
per response
(in hrs.)
Consult-
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
Number of
respondents
Form name
Jkt 256001
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
(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.
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
E:\FR\FM\23SEN1.SGM
23SEN1
58093
Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses; and
5. Assess information collection costs.
Proposed Project
Study of PrEPline Reported PrEPAdherent Patients with HIV
Acquisition—New—National Center for
HIV, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
As the use of antiretroviral
preexposure prophylaxis (PrEP)
continues to grow in the United States,
despite the high effectiveness of PrEP
(>95%) when taken as prescribed,
sporadic case reports are appearing that
document HIV acquisition among
patients apparently adherent to the
prescribed PrEP dosing schedule.
Because PrEP medications can alter the
immune responses on which HIV testing
relies, ambiguous test results also occur
and present diagnostic challenges to
clinicians. Careful selection of tests, and
the timing and sequence in which they
are done to confirm whether HIV
infection has occurred, and resistance
characteristics of the virus, if present,
are increasingly necessary. In addition,
objective measures of the amount of
PrEP drug in patients around the time
of potential HIV acquisition is important
to assess medication adherence and
further characterize PrEP effectiveness
in ‘‘real world’’ settings. A system of
active case detection and confirmation
of HIV acquisition in PrEP-adherent
patients was successfully piloted and
can now be continuously implemented
by leveraging clinician contacts to the
National Clinician Consultation Center’s
(NCCC) PrEPline, PEPline, and HIV
Warmline; and by obtaining consent for
specimens to be shipped to the
University of California San Francisco
(UCSF) or the Centers for Disease
Control and Prevention (CDC) for
research assays. Monitoring and
improving our understanding of the
occurrence of ambiguous test results,
the proportion of eligible patients who
consent to enroll in the SeroPrEP study
and provide specimens to reference/
research labs to confirm HIV status and
measure PrEP drug levels.
The study’s target population
includes clinicians calling to NCCC
within 90 days of a reactive/detectable
HIV test (in cases of oral PrEP use) or
180 days of a reactive/detectable HIV
test (in cases of long-acting injectable
cabotegravir use) about case-patients
who reported:
Æ Regularly taking prescribed oral
PrEP medication (emtricitabine or
lamivudine co-formulated with either
tenofovir disoproxil fumarate or
tenofovir alafenamide, or oral
cabotegravir) either:
D Throughout the interval from the
last negative HIV test to the date of first
reactive or detectable HIV test results; or
D During the interval from the last
negative HIV test to stopping injections,
within 18 months before the date of first
reactive or detectable HIV test results.
and for whom either:
Æ Laboratory tests confirm acquisition
of HIV infection while reportedly
medication-adherent; or
Æ Laboratory tests are ambiguous (do
not clearly confirm HIV status).
The study data will be collected via
phone interviews with clinicians calling
the NCCC PrEPline (or other warmlines)
for clinical advice about diagnostic
testing and clinical management of
patients with ambiguous HIV test results
or diagnosed HIV infection while taking
PrEP medications. Data collection will
last approximately five years.
Participation is voluntary. An
estimated one-time reporting burden for
this collection will be approximately 62
hours. This includes the time burden
associated with the Provider Verbal
Consent and completing the Patient
Data Collection Form. CDC will enroll
approximately 125 providers, at 10
minutes per Provider Verbal Consent
and 20 minutes per Patient Data
Collection Form, to provide patient
information over five years. There are
no costs to respondents other than time.
HIV acquisition among PrEP patients,
and their relationship to medication
adherence is necessary to inform
clinician management of these patients
and to ensure clear messaging about
PrEP ‘‘failures’’ (most of which are a
result of non-adherence) and HIV testing
in PrEP patients.
The PrEPline (and other ‘‘warmlines’’
operated by NCCC) and health
department HIV case reporting are
complementary sources of case
identification. Clinicians call the
PrEPline with testing and management
questions soon after receiving test
results for patients continuing or reinitiating PrEP, or transitioning from
PEP to PrEP, and have direct access to
clinical records and patients. In
addition, clinicians call the HIV
Warmline with questions about HIV
screening/testing results and best
practices in evaluation and management
of patients who acquire HIV while on
PrEP. Health departments typically
identify such patients later (especially if
by periodic review of National HIV
Surveillance System data) and then
must reach out to clinicians for clinical
records, and sometimes for patient
consents for research specimens, to
confirm HIV status.
The goals are to conduct a study that
obtains consent and case report
information from clinicians calling the
NCCC’s PrEPline and HIV Warmline to
help identify, assess, and discuss
clinical management of: (1) PrEP
patients with ambiguous HIV test
results; and (2) patients who acquire
HIV infection while being prescribed
PrEP. This information will allow CDC
to: (a) assess the proportion of clinicians
with eligible patients who provide case
information from medical records; (b)
measure the completeness and utility of
data collection forms to be sent to CDC;
(c) assess the proportion of clinicians
with eligible patients who refer patients
to participate in a UCSF National
Institutes of Health-funded study called
SeroPrEP that involves specimen testing
to be performed at designated specialty
reference/research labs; and (d) assess
lotter on DSK11XQN23PROD with NOTICES1
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondents
Form name
Clinician .............................................
Clinician report of patient information
Provider Consent Form ....................
Patient Data Collection Form ...........
125
125
1
1
10/60
20/60
21
42
Total ...........................................
...........................................................
........................
........................
........................
63
VerDate Sep<11>2014
17:04 Sep 22, 2022
Jkt 256001
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
E:\FR\FM\23SEN1.SGM
23SEN1
58094
Federal Register / Vol. 87, No. 184 / Friday, September 23, 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. 2022–20602 Filed 9–22–22; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–22–1185; Docket No. CDC–2022–
0115]
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 Youth Outreach
Generic Clearance for the National
Center for Health Statistics (NCHS). The
goal of this Generic Clearance is to
facilitate outreach efforts in the fields of
math and science to young people
(grades K through college) and those
who support them.
DATES: CDC must receive written
comments on or before November 22,
2022.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2022–
0115 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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:04 Sep 22, 2022
Jkt 256001
(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
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
Youth Outreach Generic Clearance for
the National Center for Health Statistics
(NCHS) (OMB Control No. 0920–1185,
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
Exp. 7/31/2023)—Extension—National
Center for Health Statistics (NCHS),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
NCHS is authorized to collect data
under Section 306 of the Public Health
Service Act (42 U.S.C. 242k). NCHS has
a history of reaching out to young
people to encourage their interest in
Science, Technology, Engineering and
Math (STEM). Examples of past
involvement include adopting local
schools, speaking at local colleges,
conducting a Statistics Day for high
school students, and, most recently,
conducting the NCHS Data Detectives
Camp for middle school students.
The success of these programs has
inspired NCHS leadership and staff to
want to look for new and continuing
opportunities to positively impact the
lives of young people and expand their
interest, understanding of, and
involvement in the sciences. NCHS
requests approval for a New Generic
Clearance mechanism to collect
information for these youth outreach
activities and to inform future NCHS
planning activities. The activities
include hosting the Data Detectives
Camp annually; hosting Statistics Day
annually; creating youth poster sessions
for professional conferences (such as the
NCHS National Conference on Health
Statistics or the American Statistical
Association Conference etc.); hosting a
statistical or health sciences fair or other
STEM related competitions; organizing
a STEM Career Day or similar activity;
developing web-based sites or materials
with youth focus as well as other
programs developed to meet future
youth outreach needs, particularly
activities that encourage STEM.
Information will be collected using a
combination of methodologies
appropriate to each program. These may
include: Registration forms, letters of
recommendation, evaluation forms; mail
surveys; focus groups; automated and
electronic technology (e.g., email, Webbased surveys); and telephone surveys.
OMB approval is requested for three
years to conduct the Youth Outreach
Generic Clearance for the National
Center for Health Statistics (NCHS). The
total estimated annualized burden hours
are 1,750. Participation is voluntary,
and there is no cost to respondents other
than their time to participate.
E:\FR\FM\23SEN1.SGM
23SEN1
Agencies
[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58092-58094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20602]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-22-22IX; Docket No. CDC-2022-0113]
Proposed Data Collections 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, invites the general
public and other federal agencies to take this opportunity to comment
on proposed information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on a proposed
information collection project titled Study of PrEPline reported PrEP-
adherent patients with HIV acquisition. The purpose of this project is
to understand preferences for long-acting pre-exposure prophylaxis (LA-
PrEP) products for HIV prevention among potential users and providers.
DATES: CDC must receive written comments on or before November 22,
2022.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2022-
0113 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 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
[[Page 58093]]
technological collection techniques or other forms of information
technology, e.g., permitting electronic submissions of responses; and
5. Assess information collection costs.
Proposed Project
Study of PrEPline Reported PrEP-Adherent Patients with HIV
Acquisition--New--National Center for HIV, Viral Hepatitis, STD, and TB
Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
As the use of antiretroviral preexposure prophylaxis (PrEP)
continues to grow in the United States, despite the high effectiveness
of PrEP (>95%) when taken as prescribed, sporadic case reports are
appearing that document HIV acquisition among patients apparently
adherent to the prescribed PrEP dosing schedule. Because PrEP
medications can alter the immune responses on which HIV testing relies,
ambiguous test results also occur and present diagnostic challenges to
clinicians. Careful selection of tests, and the timing and sequence in
which they are done to confirm whether HIV infection has occurred, and
resistance characteristics of the virus, if present, are increasingly
necessary. In addition, objective measures of the amount of PrEP drug
in patients around the time of potential HIV acquisition is important
to assess medication adherence and further characterize PrEP
effectiveness in ``real world'' settings. A system of active case
detection and confirmation of HIV acquisition in PrEP-adherent patients
was successfully piloted and can now be continuously implemented by
leveraging clinician contacts to the National Clinician Consultation
Center's (NCCC) PrEPline, PEPline, and HIV Warmline; and by obtaining
consent for specimens to be shipped to the University of California San
Francisco (UCSF) or the Centers for Disease Control and Prevention
(CDC) for research assays. Monitoring and improving our understanding
of the occurrence of ambiguous test results, HIV acquisition among PrEP
patients, and their relationship to medication adherence is necessary
to inform clinician management of these patients and to ensure clear
messaging about PrEP ``failures'' (most of which are a result of non-
adherence) and HIV testing in PrEP patients.
The PrEPline (and other ``warmlines'' operated by NCCC) and health
department HIV case reporting are complementary sources of case
identification. Clinicians call the PrEPline with testing and
management questions soon after receiving test results for patients
continuing or re-initiating PrEP, or transitioning from PEP to PrEP,
and have direct access to clinical records and patients. In addition,
clinicians call the HIV Warmline with questions about HIV screening/
testing results and best practices in evaluation and management of
patients who acquire HIV while on PrEP. Health departments typically
identify such patients later (especially if by periodic review of
National HIV Surveillance System data) and then must reach out to
clinicians for clinical records, and sometimes for patient consents for
research specimens, to confirm HIV status.
The goals are to conduct a study that obtains consent and case
report information from clinicians calling the NCCC's PrEPline and HIV
Warmline to help identify, assess, and discuss clinical management of:
(1) PrEP patients with ambiguous HIV test results; and (2) patients who
acquire HIV infection while being prescribed PrEP. This information
will allow CDC to: (a) assess the proportion of clinicians with
eligible patients who provide case information from medical records;
(b) measure the completeness and utility of data collection forms to be
sent to CDC; (c) assess the proportion of clinicians with eligible
patients who refer patients to participate in a UCSF National
Institutes of Health-funded study called SeroPrEP that involves
specimen testing to be performed at designated specialty reference/
research labs; and (d) assess the proportion of eligible patients who
consent to enroll in the SeroPrEP study and provide specimens to
reference/research labs to confirm HIV status and measure PrEP drug
levels.
The study's target population includes clinicians calling to NCCC
within 90 days of a reactive/detectable HIV test (in cases of oral PrEP
use) or 180 days of a reactive/detectable HIV test (in cases of long-
acting injectable cabotegravir use) about case-patients who reported:
[cir] Regularly taking prescribed oral PrEP medication
(emtricitabine or lamivudine co-formulated with either tenofovir
disoproxil fumarate or tenofovir alafenamide, or oral cabotegravir)
either:
[ssquf] Throughout the interval from the last negative HIV test to
the date of first reactive or detectable HIV test results; or
[ssquf] During the interval from the last negative HIV test to
stopping injections, within 18 months before the date of first reactive
or detectable HIV test results.
and for whom either:
[cir] Laboratory tests confirm acquisition of HIV infection while
reportedly medication-adherent; or
[cir] Laboratory tests are ambiguous (do not clearly confirm HIV
status).
The study data will be collected via phone interviews with
clinicians calling the NCCC PrEPline (or other warmlines) for clinical
advice about diagnostic testing and clinical management of patients
with ambiguous HIV test results or diagnosed HIV infection while taking
PrEP medications. Data collection will last approximately five years.
Participation is voluntary. An estimated one-time reporting burden
for this collection will be approximately 62 hours. This includes the
time burden associated with the Provider Verbal Consent and completing
the Patient Data Collection Form. CDC will enroll approximately 125
providers, at 10 minutes per Provider Verbal Consent and 20 minutes per
Patient Data Collection Form, to provide patient information over five
years. There are no costs to respondents other than time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Clinician..................... Provider Consent 125 1 10/60 21
Form.
Clinician report of patient Patient Data 125 1 20/60 42
information. Collection Form.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 63
----------------------------------------------------------------------------------------------------------------
[[Page 58094]]
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2022-20602 Filed 9-22-22; 8:45 am]
BILLING CODE 4163-18-P