Proposed Data Collection Submitted for Public Comment and Recommendations, 19308-19310 [2023-06738]
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19308
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
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.
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
Awardee Lead Profile Assessment
(ALPA) (OMB Control No. 0920–1215,
Exp. 03/31/2024)—Revision—National
Center for Environmental Health
(NCEH), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The Centers for Disease Control and
Prevention (CDC) is requesting
Paperwork Reduction Act (PRA)
clearance for a three-year revised
Information Collection Request (ICR)
titled ‘‘Awardee Lead Profile
Assessment (ALPA)’’ (OMB Control No.
0920–1215; Exp. 03/31/2024). The goal
of this ICR is to build on the CDC’s
existing childhood lead poisoning
prevention program. CDC requires that
ongoing and new CDC Childhood Lead
Poisoning Prevention Programs
(CLPPPs), including the FY21
‘‘Childhood Lead Poisoning Prevention
and Surveillance of Blood Lead Levels
in Children’’ (CDC–RFA–EH21–2102),
complete the ALPA annually. This
annual information collection will be
used to identify jurisdictional legal
frameworks governing CDC-funded
CLPPPs in the United States and
strategies for implementing childhood
lead poisoning prevention activities.
CDC can use this information to inform
guidance, resource development, and
technical assistance activities in support
of the ultimate goal, which is
eliminating lead exposure in children.
The dissemination of these ALPA
results will ensure that both funded and
non-funded jurisdictions are able to: (1)
identify policies and other factors that
support or hinder childhood lead
poisoning prevention efforts; (2)
understand what strategies are being
used by funded public health agencies
to implement childhood lead poisoning
prevention activities; and (3) use this
knowledge to develop and apply similar
strategies to support the national agenda
to eliminate childhood lead poisoning.
This program management information
collection has been revised in several
ways, including the addition of new
answer options and questions to
understand usage of the updated blood
lead reference value (BLRV).
CDC will use one data collection
mode, a web survey. A change in the
mode of collection will not affect the
total time burden requested as the time
per response is the same for either
mode, and the time to take the survey
has remained consistent from 2021
estimates (47 minutes per response)
despite revisions to the survey. This
time estimate per response is based on
pilot tests of the revised survey among
eight respondents, and includes the
time needed to review the ALPA
Training Manual.
In total, the annual number of
respondents remains unchanged at 75,
and the annual time burden requested
remains at 59 hours. There are no costs
to respondents other than their time.
The respondents are participating in
this survey as a program requirement.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
State or Local Governments (or their bona fide fiscal agents)
ALPA Web Survey .................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2023–06736 Filed 3–30–23; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
BILLING CODE 4163–18–P
ddrumheller on DSK120RN23PROD with NOTICES1
[60Day–23–23DT; Docket No. CDC–2023–
0022]
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:
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
75
1
Average
burden per
response
(in hours)
47/60
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 Reporting of the
Essentials for Childhood (EfC):
Preventing Adverse Childhood
Experiences through Data to Action
Program. This data collection will help
to ensure that associated programs are
SUMMARY:
E:\FR\FM\31MRN1.SGM
31MRN1
ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
progressing toward achievement of their
stated goals and objectives, as well as
consistently demonstrating efficient and
appropriate use of federal funds.
DATES: CDC must receive written
comments on or before May 30, 2023.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2023–
0022 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: 404–639–7570; 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,
VerDate Sep<11>2014
17:54 Mar 30, 2023
Jkt 259001
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
Reporting of the Essentials for
Childhood (EfC): Preventing Adverse
Childhood Experiences through Data to
Action Program—New—National Center
for Injury Prevention and Control
(NCIPC), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
The purpose of this information
collection effort is to collect Essentials
for Childhood (EfC) program recipient
data related to surveillance,
implementation, program evaluation,
and performance monitoring. This data
collection is necessary to ensure that
programs are progressing toward
achievement of their stated goals and
objectives, as well as consistently
demonstrating efficient and appropriate
use of federal funds. CDC will use the
information collected to further
understand the facilitators, barriers, and
critical factors to implementing specific
violence prevention strategies and
conducting related program evaluation
activities. Data collected will also be
used to inform CDC’s training and
technical assistance, program
improvement, and the development of
future funding opportunities.
Data collection is designed to address
the following key program evaluation
questions:
• To what extent have recipients
accomplished the short-term and
intermediate-term outcomes outlined in
the Logic Model?
• To what extent do recipients
effectively implement ACEs prevention
strategies during the period of
performance?
• To what extent have recipients
leveraged multi-sector partnerships and
resources among state agencies
(additional funding at the local level)
and other sectors to prevent ACEs,
including forming sustainable systems
and partnerships, and realigning/
focusing/mobilizing resources to
prevent ACEs?
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Fmt 4703
Sfmt 4703
19309
• In what ways has the recipient built
or enhanced their state-level
surveillance system to monitor ACEs,
PCEs, and social determinants of health?
• How has the recipient integrated
and addressed racial and health
inequities and social determinants of
health in preventing ACEs?
• To what extent have recipients
enhanced their statewide action plan to
implement complementary ACEs
prevention strategies (additional
funding for implementation at the local
level)?
• To what extent have funded
recipients enhanced their ability to use
ACEs and PCEs surveillance and
evaluation data to inform prevention
strategy allocation?
• To what extent have recipients
enhanced their ability to disseminate
and use data to inform partner, policy,
or other action?
• To what extent have recipients seen
a sustainable increase in capacity and
activities related to routine monitoring
of ACEs and PCEs data among youth?
• To what extent have recipients seen
a sustainable increase in capacity and
activities related to routine monitoring
of near real-time surveillance to monitor
indicators of ACEs?
• To what extent have recipients
demonstrated ability to link ACEs and
PCEs data to those on the social
determinants of health, and utilize these
data to inform prevention strategies? (if
applicable)
• What is the reach/exposure to the
ACEs prevention program efforts?
• Are ACEs prevention strategies
reaching populations at highest risk for
ACEs?
• To what extent have recipients
demonstrated use of surveillance and
evaluation data to inform prevention
strategy allocation and implementation
to improve health equity?
• What has been the reach/exposure
of ACEs and PCEs data dissemination
efforts?
Information will be collected annually
from recipients through the DVP
Partners Portal, a web-based data
collection system. The DVP Partners
Portal allows recipients to fulfill their
annual reporting obligations efficiently
by employing user-friendly, easily
accessible web-based instruments to
collect necessary information for both
progress reports and continuation
applications. Because information from
previous reports will be carried over
and pre-populated for the next annual
reporting, recipients will only need to
enter changes, provide progress updates,
and add any new information after the
first year of reporting, which will help
to reduce recipient burden.
E:\FR\FM\31MRN1.SGM
31MRN1
19310
Federal Register / Vol. 88, No. 62 / Friday, March 31, 2023 / Notices
CDC requests OMB approval for an
estimated 552 annual burden hours.
There are no costs to respondents other
than their time to participate.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents
Essentials for Childhood
(EfC) Grantees.
Total .............................
4
10
480
Key Informant Interview—Principal Investigator
Key Informant Interview—Principal Investigator/
Implementor.
Surveillance Capacity Assessment—Surveillance Lead.
Implementation Capacity Assessment ..............
Evaluation and Surveillance Survey—Surveillance Lead or Evaluator.
12
12
2
2
1
1
24
24
12
1
0.5
6
12
12
1
1
0.5
1
6
12
........................
........................
........................
552
............................................................................
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0142]
Research Involving Children as
Subjects and Not Otherwise
Approvable by an Institutional Review
Board: Process for Referrals to Food
and Drug Administration and Office for
Human Research Protections,
Guidance for Institutional Review
Boards, Investigators, and Sponsors;
Draft Guidance for Industry;
Availability; Agency Information
Collection Activities; Proposed
Collection; Comment Request
Food and Drug Administration,
HHS.
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Research Involving
Children as Subjects and Not Otherwise
Approvable by an IRB: Process for
Referrals to FDA and OHRP.’’ This
guidance is intended to assist
institutional review boards (IRBs),
institutions, investigators, and sponsors
in understanding the processes used for
review of research involving children as
subjects that is not otherwise
approvable by an IRB and has been
referred to FDA, the Office for Human
Research Protections (OHRP), or both,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:54 Mar 30, 2023
Total
burden
(in hours)
2
[FR Doc. 2023–06738 Filed 3–30–23; 8:45 am]
ACTION:
Average
burden per
response
(in hours)
Annual Reporting—Project Leads .....................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
AGENCY:
Number of
responses per
respondent
Number of
respondents
Form name
Jkt 259001
for review. When final, this guidance
will replace the final guidance issued by
FDA in December 2006 entitled,
‘‘Guidance for Clinical Investigators,
Institutional Review Boards and
Sponsors: Process for Handing Referrals
to FDA Under 21 CFR 50.54: Additional
Safeguards for Children in Clinical
Investigations’’ and the guidance issued
by the OHRP entitled ‘‘Children as
Research Subjects and the HHS ‘407’
Process,’’ issued on May 26, 2005. This
draft guidance is not final nor is it in
effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by May 30, 2023 to ensure that the
Agency and OHRP consider your
comment on this draft guidance before
they begin work on the final version of
the guidance. Submit electronic or
written comments on the proposed
collection of information in the draft
guidance by May 30, 2023.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
PO 00000
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Fmt 4703
Sfmt 4703
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–D–0142 for ‘‘Research Involving
Children as Subjects and Not Otherwise
Approvable by an IRB: Process for
Referrals to FDA and OHRP, Guidance
for Institutional Review Boards,
Investigators, and Sponsors.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
E:\FR\FM\31MRN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 62 (Friday, March 31, 2023)]
[Notices]
[Pages 19308-19310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06738]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-23-23DT; Docket No. CDC-2023-0022]
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 proposed information
collection, as required by the Paperwork Reduction Act of 1995. This
notice invites comment on a proposed information collection project
titled Reporting of the Essentials for Childhood (EfC): Preventing
Adverse Childhood Experiences through Data to Action Program. This data
collection will help to ensure that associated programs are
[[Page 19309]]
progressing toward achievement of their stated goals and objectives, as
well as consistently demonstrating efficient and appropriate use of
federal funds.
DATES: CDC must receive written comments on or before May 30, 2023.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0022 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: 404-639-7570;
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
Reporting of the Essentials for Childhood (EfC): Preventing Adverse
Childhood Experiences through Data to Action Program--New--National
Center for Injury Prevention and Control (NCIPC), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The purpose of this information collection effort is to collect
Essentials for Childhood (EfC) program recipient data related to
surveillance, implementation, program evaluation, and performance
monitoring. This data collection is necessary to ensure that programs
are progressing toward achievement of their stated goals and
objectives, as well as consistently demonstrating efficient and
appropriate use of federal funds. CDC will use the information
collected to further understand the facilitators, barriers, and
critical factors to implementing specific violence prevention
strategies and conducting related program evaluation activities. Data
collected will also be used to inform CDC's training and technical
assistance, program improvement, and the development of future funding
opportunities.
Data collection is designed to address the following key program
evaluation questions:
To what extent have recipients accomplished the short-term
and intermediate-term outcomes outlined in the Logic Model?
To what extent do recipients effectively implement ACEs
prevention strategies during the period of performance?
To what extent have recipients leveraged multi-sector
partnerships and resources among state agencies (additional funding at
the local level) and other sectors to prevent ACEs, including forming
sustainable systems and partnerships, and realigning/focusing/
mobilizing resources to prevent ACEs?
In what ways has the recipient built or enhanced their
state-level surveillance system to monitor ACEs, PCEs, and social
determinants of health?
How has the recipient integrated and addressed racial and
health inequities and social determinants of health in preventing ACEs?
To what extent have recipients enhanced their statewide
action plan to implement complementary ACEs prevention strategies
(additional funding for implementation at the local level)?
To what extent have funded recipients enhanced their
ability to use ACEs and PCEs surveillance and evaluation data to inform
prevention strategy allocation?
To what extent have recipients enhanced their ability to
disseminate and use data to inform partner, policy, or other action?
To what extent have recipients seen a sustainable increase
in capacity and activities related to routine monitoring of ACEs and
PCEs data among youth?
To what extent have recipients seen a sustainable increase
in capacity and activities related to routine monitoring of near real-
time surveillance to monitor indicators of ACEs?
To what extent have recipients demonstrated ability to
link ACEs and PCEs data to those on the social determinants of health,
and utilize these data to inform prevention strategies? (if applicable)
What is the reach/exposure to the ACEs prevention program
efforts?
Are ACEs prevention strategies reaching populations at
highest risk for ACEs?
To what extent have recipients demonstrated use of
surveillance and evaluation data to inform prevention strategy
allocation and implementation to improve health equity?
What has been the reach/exposure of ACEs and PCEs data
dissemination efforts?
Information will be collected annually from recipients through the
DVP Partners Portal, a web-based data collection system. The DVP
Partners Portal allows recipients to fulfill their annual reporting
obligations efficiently by employing user-friendly, easily accessible
web-based instruments to collect necessary information for both
progress reports and continuation applications. Because information
from previous reports will be carried over and pre-populated for the
next annual reporting, recipients will only need to enter changes,
provide progress updates, and add any new information after the first
year of reporting, which will help to reduce recipient burden.
[[Page 19310]]
CDC requests OMB approval for an estimated 552 annual burden hours.
There are no costs to respondents other than their time to participate.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden Total
Type of respondents Form name Number of responses per per response burden (in
respondents respondent (in hours) hours)
----------------------------------------------------------------------------------------------------------------
Essentials for Childhood (EfC) Annual Reporting-- 2 4 10 480
Grantees. Project Leads.
Key Informant 12 2 1 24
Interview--Princi
pal Investigator.
Key Informant 12 2 1 24
Interview--Princi
pal Investigator/
Implementor.
Surveillance 12 1 0.5 6
Capacity
Assessment--Surve
illance Lead.
Implementation 12 1 0.5 6
Capacity
Assessment.
Evaluation and 12 1 1 12
Surveillance
Survey--Surveilla
nce Lead or
Evaluator.
------------------------------------------------------------
Total...................... .................. .............. .............. .............. 552
----------------------------------------------------------------------------------------------------------------
Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2023-06738 Filed 3-30-23; 8:45 am]
BILLING CODE 4163-18-P
