Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Maternal and Child Health Bureau Performance Measures for Discretionary Grant Information System, OMB No. 0915-0298-Revision, 28566-28569 [2023-09466]
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Federal Register / Vol. 88, No. 86 / Thursday, May 4, 2023 / Notices
auspices of ICH. ICH seeks to achieve
greater regulatory harmonization
worldwide to ensure that safe, effective,
high-quality medicines are developed,
registered, and maintained in the most
resource-efficient manner.
By harmonizing the regulatory
requirements in regions around the
world, ICH guidelines enhance global
drug development, improve
manufacturing standards, and increase
the availability of medications. For
example, ICH guidelines have
substantially reduced duplicative
clinical studies, prevented unnecessary
animal studies, standardized the
reporting of important safety
information, and standardized
marketing application submissions.
The six Founding Members of the ICH
are the FDA; the Pharmaceutical
Research and Manufacturers of America;
the European Commission; the
European Federation of Pharmaceutical
Industries Associations; the Japanese
Ministry of Health, Labour, and Welfare;
and the Japanese Pharmaceutical
Manufacturers Association. The
Standing Members of the ICH
Association include Health Canada and
Swissmedic. ICH membership continues
to expand to include other regulatory
authorities and industry associations
from around the world (refer to https://
www.ich.org/).
ICH works by engaging global
regulatory and industry experts in a
detailed, science-based, and consensusdriven process that results in the
development of ICH guidelines. The
regulators around the world are
committed to consistently adopting
these consensus-based guidelines,
realizing the benefits for patients and for
industry.
As a Founding Regulatory Member of
ICH, FDA plays a major role in the
development of each of the ICH
guidelines, which FDA then adopts and
issues as guidance for industry. FDA’s
guidance documents do not establish
legally enforceable responsibilities.
Instead, they describe the Agency’s
current thinking on a topic and should
be viewed only as recommendations,
unless specific regulatory or statutory
requirements are cited.
In the Federal Register of June 15,
2022 (87 FR 36135), FDA published a
notice announcing the availability of a
draft guidance entitled ‘‘Q9(R1) Quality
Risk Management.’’ The notice gave
interested persons an opportunity to
submit comments by July 15, 2022.
After consideration of the comments
received and revisions to the guideline,
a final draft of the guideline was
submitted to the ICH Assembly and
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endorsed by the regulatory agencies on
January 18, 2023.
This guidance finalizes the draft
guidance of the same title issued on
June 15, 2022. The final guidance
includes: (1) updated references, (2) a
dedicated section to the subjectivity of
QRM, (3) clarification on the application
of risk management in the use of
digitalization and emerging
technologies, (4) an emphasis on root
cause analysis, (5) a clearer definition of
‘‘risk-based decision-making,’’ and (6)
an improved distinction between
hazards, harms, and associated risks.
The final guidance further addresses
detection controls’ link to reducing the
probability of the occurrence of harm,
situations which call for higher levels of
QRM formality, and the importance of
QRM regarding distribution practices.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Q9(R1) Quality
Risk Management.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR parts 210 and
211 relating to current good
manufacturing practice requirements
have been approved under OMB control
number 0910–0139.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.regulations.gov, https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents.
Dated: May 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–09517 Filed 5–3–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Maternal and Child Health
Bureau Performance Measures for
Discretionary Grant Information
System, OMB No. 0915–0298—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA is submitting a request
for public comment on redesigned
Maternal and Child Health Bureau
(MCHB) Performance Measures for
Discretionary Grant Information System
(DGIS) forms. The purpose of the
redesigned DGIS forms is to facilitate
higher quality data collection and
develop streamlined, clear DGIS metrics
to support communications about the
range of HRSA’s maternal and child
health (MCH) programs. Proposed
revisions include eliminating 52 forms,
adding 25 new forms, and revising 23
existing forms. In addition, three forms
have not undergone substantive
revisions since the previously approved
Office of Management and Budget
(OMB) package and are included in the
time burden estimate. HRSA seeks
comments from the public regarding the
burden estimate, below, or any other
aspect of the Information Collection
Request (ICR).
DATES: Comments on this ICR must be
received no later than July 3, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email Samantha Miller, the
HRSA Information Collection Clearance
Officer, at paperwork@hrsa.gov or call
301–594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUMMARY:
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Information Collection Request Title:
MCHB Performance Measures for DGIS,
OMB No. 0915–0298 Revision.
Abstract: Approval from OMB is
sought to implement revisions to the
MCHB Performance Measures for DGIS.
The goals of the redesigned performance
measures are to: (1) improve clarity and
validity of DGIS forms; (2) increase
alignment with MCHB’s Strategic Plan
and other performance measurement
efforts; (3) produce timely, actionable
data for program management; (4)
support communications about the
range of HRSA’s MCH programs; (5)
reduce the number and complexity of
data collection forms; and (6) improve
data quality.
The revised forms are grouped into
two general categories: central measures
and program specific measures. Central
measures include basic, topical, activity,
and outcome forms. There are also four
sets of program-specific forms. Grant
programs are assigned forms based on
their activities and individual grantees
respond to only a limited number of
forms that are relevant to their specific
program. Many of these forms are
specific to certain types of programs and
are not required of all grantees.
Forms are proposed to be added,
removed, or revised beyond what was
specified in the Federal Register notice
(87 FR 35220) published on June 9,
2022. Many of the changes are a result
of the redesigned categorization of
measures. For example, the proposed set
of activity forms capture common types
of activities conducted across MCHB
investments and replace the set of
Population Domain forms (Adolescent
Health, Capacity Building, Child Health,
Children with Special Health Care
Needs (CSHCN), Life Course/Cross
Cutting, Maternal/Women Health, and
Perinatal/Infant Health). The proposed
set of basic forms consolidate and
simplify the set of financial forms (Form
1, 3, 5, 7, and 8). Other changes reflect
efforts to reduce burden or the need to
relocate measures from the Population
Domain forms to program-specific forms
(i.e., Healthy Start). Specifically, HRSA
is making the following changes to the
current information collection for DGIS:
Removing the following 52 existing
forms: Capacity Building (CB) 1 (State
Capacity for Advancing the Health of
MCH Populations), CB 3 (Impact
Measurement), CB 4 (Sustainability), CB
5 (Scientific Publications), CB 6
(Products), CB 8 (Quality Improvement),
Women’s/Maternal Health (WMH) 1
(Prenatal Care), WMH 2 (Perinatal/
Postpartum Care), WMH 3 (Well Woman
Visit/Preventive Health Care), WMH 4
(Depression Screening), Perinatal Infant
Health (PIH) 1 (Safe Sleep), PIH 2
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(Breast Feeding), PIH 3 (Newborn
Screening), Child Health (CH) 1 (Well
Child Visit), CH 2 (Quality of Well Child
Visit), CH 3 (Developmental Screening),
CH 4 (Injury Prevention), CSHCN 1
(Family Engagement), CSHCN 2 (Access
to and Use of Medical Home), CSHCN
3 (Transition to Adult Health Care),
Adolescent Health (AH) 1 (Adolescent
Well Visit), AH 2 (Injury Prevention),
AH 3 (Screening for Major Depressive
Disorder), Life Course/Cross Cutting
(LC) 1 (Adequate Health Insurance
Coverage), LC 2 (Tobacco and eCigarette
Cessation), LC 3 (Oral Health), Division
of Workforce Development (Training) 01
(MCH Training Program and Healthy
Tomorrows Family Member/Youth/
Community Member Participation),
Training 05 (Policy), Training 06
(Diversity of Long-Term Trainees),
Training 10 (Leadership), Training 11
(Work with MCH Populations), Training
12 (Interdisciplinary Practice),
Emergency Medical Services for
Children (EMSC) 01 (Using NEMSIS
Data to Identify Pediatric Patient Care
Needs), EMSC 02 (Pediatric Emergency
Care Coordination), EMSC 03 (Use of
Pediatric-Specific Equipment), EMSC 05
(Pediatric Traumatic Emergencies),
EMSC 06 (Written Inter-facility Transfer
Guidelines that Contain All the
Components as per the Implementation
Manual), EMSC 07 (Written Interfacility Transfer Agreements That
Covers Pediatric Patients), Healthy Start
(HS) 01 (Reproductive Life Plan), HS 02
(Usual Source of Care), HS 03
(Interconception Planning), HS 05
(Father/Partner Involvement during
Pregnancy), HS 06 (Father and/or
Partner Involvement with Child 0–24
Months), HS 07 (Daily Reading), HS 08
(CAN Implementation), HS 09 (CAN
Participation), Form 3 (Budget Details
by Types of Individuals Served), Form
5 (Number of Individuals Served
(Unduplicated)), Form 7 (Discretionary
Grant Project Summary Data and
Demographics), Form 9 (ProgramSpecific Project Performance/Outcome
Measures), Technical Assistance/
Collaboration Form, and Continuing
Education Form.
Adding the following 25 new forms:
Direct and Enabling Services, Training
and Workforce Development,
Partnerships and Collaboration,
Engagement of Persons with Lived
Experience, Technical Assistance,
Outreach and Education, Research,
Guidelines and Policy, Data and
Information Systems, Quality
Improvement and Evaluation,
Knowledge Change, Behavior Change,
EMSC 10 (Prehospital Emergency
Medical Services Pediatric Readiness
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Recognition Program), HS 10 (Prenatal
Care), HS 11 (Perinatal/Postpartum
Care), HS 12 (Well Woman Visit/
Preventive Health Care), HS 13
(Depression Screening), HS 14 (Safe
Sleep), HS 15 (Breastfeeding), HS 16
(Well Child Visit), HS 17 (Adequate
Health Insurance Coverage), HS 18
(Prenatal Tobacco and eCigarette Use),
HS 19 (Low Birthweight), HS 20
(Preterm Birth), and HS 21 (Infant
Mortality).
Revising the following 23 existing
forms: Health Equity, Healthy Start Site
Form, Family to Family Form 1,
Financial Form (MCHB Project Budget
Details), Project Abstract (MCH
Discretionary Grant Project Abstract),
Project Abstract-Research Projects Only,
Form 10 (Program-Specific and Project
Developed Measures), Products,
Publications, and Submissions Data
Collection Form, Faculty and Staff
Information, Short-Term Trainees,
Medium-Term Trainees, Long-Term
Trainees, Former Long-Term Trainees,
LEAP Trainee Information, Training 02
(MCH Training Program and Healthy
Tomorrows Cultural Competence),
Training 03 (Healthy Tomorrows Title V
Collaboration), Training 04 (Title V
Collaboration), Training 07 (MCH
Pipeline Program-Work with MCH
Populations), Training 08 (MCH
Pipeline Program-Work with
underserved or vulnerable populations),
Training 09 (MCH Pipeline-Graduate
Program Enrollment), Training 15
(Consultation and Training for Mental
and Behavioral Health), HS 04 (Intimate
Partner Violence Screening), and EMSC
04 (Pediatric Medical Emergencies).
The following 3 forms are included
with no substantive changes from the
prior approved OMB package: Training
14 (Medium-Term Trainees Skill and
Knowledge), EMSC 08 (Established
Permanence of EMSC), and EMSC 09
(Established Permanence of EMSC by
Integrating EMSC Priorities into
Statutes/Regulations).
Additional non-substantive revisions
include updates to terminology, goals,
benchmark data sources, and
significance sections included in the
measures’ detail sheets. A performance
measure detail sheet defines and
describes each performance measure.
Forms and detail sheets showing the
proposed revisions are available upon
request.
Need and Proposed Use of the
Information: The performance data
collected through the DGIS serves
several purposes, including grantee
monitoring, program planning, and
performance reporting, and the ability to
demonstrate alignment between MCHB
discretionary programs and the Title V
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Federal Register / Vol. 88, No. 86 / Thursday, May 4, 2023 / Notices
MCH Services Block Grant program.
This revision will facilitate higher
quality data collection; streamlined,
clear DGIS metrics; and support
communications about the range of
HRSA’s MCH programs.
Likely Respondents: Grantees for
MCHB Discretionary Grant Programs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
ddrumheller on DSK120RN23PROD with NOTICES1
Form name
Responses
per
respondent
Total
responses
Burden hours
per response
Total burden
hours
Project abstract ....................................................................
Project Abstract (Research Projects Only) ..........................
Financial Form .....................................................................
Health Equity ........................................................................
Direct and Enabling Services ..............................................
Training and Workforce Development .................................
Partnerships and Collaboration ...........................................
Engagement of Persons with Lived Experience ..................
Technical Assistance ...........................................................
Outreach and Education ......................................................
Research ..............................................................................
Guidelines and Policy ..........................................................
Data and Information Systems ............................................
Quality Improvement and Evaluation ...................................
Knowledge Change ..............................................................
Behavior Change .................................................................
Products and Publications ...................................................
Training Form 2 ...................................................................
Training Form 3 ...................................................................
Training Form 4 ...................................................................
Training Form 7 ...................................................................
Training Form 8 ...................................................................
Training Form 9 ...................................................................
Training Form 14 .................................................................
Training Form 15 .................................................................
Faculty and Staff Information ...............................................
Short-Term Trainees ............................................................
Medium-Term Trainees ........................................................
Long-Term Trainees ............................................................
Former Long-Term Trainees ................................................
LEAP Trainee Information ...................................................
HS 4 .....................................................................................
HS 10 ...................................................................................
HS 11 ...................................................................................
HS 12 ...................................................................................
HS 13 ...................................................................................
HS 14 ...................................................................................
HS 15 ...................................................................................
HS 16 ...................................................................................
HS 17 ...................................................................................
HS 18 ...................................................................................
HS 19 ...................................................................................
HS 20 ...................................................................................
HS 21 ...................................................................................
Healthy Start Site Form .......................................................
EMSC 4 ................................................................................
EMSC 8 ................................................................................
EMSC 9 ................................................................................
EMSC 10 ..............................................................................
Family to Family Form 1 ......................................................
Form 10 ................................................................................
817
58
817
817
476
250
380
416
300
500
65
78
50
346
200
200
672
168
41
130
6
6
6
6
52
124
8
121
112
106
6
101
101
101
101
101
101
101
101
101
101
101
101
101
101
58
58
58
58
59
200
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
817
58
817
817
476
250
380
416
300
500
65
78
50
346
200
200
672
168
41
130
6
6
6
6
52
124
8
121
112
106
6
101
101
101
101
101
101
101
101
101
101
101
101
101
101
58
58
58
58
59
400
1.33
0.66
0.87
0.47
1.89
2.42
1.04
1.58
2.24
0.61
3.11
0.70
0.67
0.29
1.64
1.56
4.23
0.69
0.99
1.52
0.83
0.75
0.92
3.64
3.17
1.92
0.67
2.49
6.37
1.60
0.65
0.57
0.31
0.61
0.33
0.50
0.43
0.45
0.39
0.40
0.33
0.38
0.37
0.36
0.32
0.92
0.09
0.42
0.46
2.76
12.87
1,087
38
711
384
900
605
395
657
672
305
202
55
34
100
328
312
2,843
116
41
198
5
5
6
22
165
238
5
301
713
170
4
58
31
62
33
51
43
45
39
40
33
38
37
36
32
53
5
24
27
163
5,148
Total ..............................................................................
* 817
........................
817
........................
17,615
* The number of grantees is an estimate as it fluctuates each year.
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Federal Register / Vol. 88, No. 86 / Thursday, May 4, 2023 / Notices
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
ddrumheller on DSK120RN23PROD with NOTICES1
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID Resource Related
Research Projects (R24 Clinical Trial Not
Allowed).
Date: May 26, 2023.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G42,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Sandip Bhattacharyya,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3G42,
Rockville, MD 20852, (240) 292–0189,
sandip.bhattacharyya@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
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Dated: April 28, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2023–09441 Filed 5–3–23; 8:45 am]
National Institute of Environmental
Health Sciences; Notice of Closed
Meetings
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Minority Health
and Health Disparities; Notice of
Closed Meeting
[FR Doc. 2023–09466 Filed 5–3–23; 8:45 am]
28569
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Institute on
Minority Health and Health Disparities
Special Emphasis Panel.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Minority Health and Health Disparities
Special Emphasis Panel; NIH Support for
Conferences and Scientific Meetings (R13).
Date: June 15, 2023.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
NIMHD, DEM II, Suite 800, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Xinli Nan, M.D., Ph.D.,
Scientific Review Officer, Office of
Extramural Research Activities, National
Institute on Minority Health and Health
Disparities, National Institutes of Health,
6707 Democracy Boulevard, Suite 800,
Bethesda, MD 20892, (301) 594–7784,
Xinli.Nan@nih.gov.
Dated: April 28. 2023.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–09449 Filed 5–3–23; 8:45 am]
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National Institutes of Health
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel: Centers for Oceans and
Human Health 4: Impacts of Climate Change
on Oceans and Great Lakes.
Date: May 23–25, 2023.
Time: 10:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, Keystone Building, 530
Davis Drive, Research Triangle Park, NC
27713 (Virtual Meeting).
Contact Person: Linda K. Bass, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute Environmental Health
Sciences, P.O. Box 12233, MD EC–30,
Research Triangle Park, NC 27709, 984–287–
3236, bass@niehs.nih.gov.
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel: Research Mechanism for
Emerging Contaminant/Exposure Studies in
the Environmental Health Sciences.
Date: June 5, 2023.
Time: 10:30 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Environmental
Health Sciences, Keystone Building, 530
Davis Drive, Research Triangle Park, NC
27713 (Virtual Meeting).
Contact Person: Leroy Worth, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P.O. Box 12233, MD EC–30/
Room 3171, Research Triangle Park, NC
27709, 984–287–3340, worth@niehs.nih.gov.
Name of Committee: National Institute of
Environmental Health Sciences, Special
Emphasis Panel: VICTER Award R01 Grant
Applications.
Date: June 13–14, 2023.
Time: 10:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 88, Number 86 (Thursday, May 4, 2023)]
[Notices]
[Pages 28566-28569]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09466]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Maternal and Child Health
Bureau Performance Measures for Discretionary Grant Information System,
OMB No. 0915-0298--Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
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SUMMARY: In compliance with the requirement for opportunity for public
comment on proposed data collection projects of the Paperwork Reduction
Act of 1995, HRSA is submitting a request for public comment on
redesigned Maternal and Child Health Bureau (MCHB) Performance Measures
for Discretionary Grant Information System (DGIS) forms. The purpose of
the redesigned DGIS forms is to facilitate higher quality data
collection and develop streamlined, clear DGIS metrics to support
communications about the range of HRSA's maternal and child health
(MCH) programs. Proposed revisions include eliminating 52 forms, adding
25 new forms, and revising 23 existing forms. In addition, three forms
have not undergone substantive revisions since the previously approved
Office of Management and Budget (OMB) package and are included in the
time burden estimate. HRSA seeks comments from the public regarding the
burden estimate, below, or any other aspect of the Information
Collection Request (ICR).
DATES: Comments on this ICR must be received no later than July 3,
2023.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
draft instruments, email Samantha Miller, the HRSA Information
Collection Clearance Officer, at [email protected] or call 301-594-
4394.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the information request collection title
for reference.
[[Page 28567]]
Information Collection Request Title: MCHB Performance Measures for
DGIS, OMB No. 0915-0298 Revision.
Abstract: Approval from OMB is sought to implement revisions to the
MCHB Performance Measures for DGIS. The goals of the redesigned
performance measures are to: (1) improve clarity and validity of DGIS
forms; (2) increase alignment with MCHB's Strategic Plan and other
performance measurement efforts; (3) produce timely, actionable data
for program management; (4) support communications about the range of
HRSA's MCH programs; (5) reduce the number and complexity of data
collection forms; and (6) improve data quality.
The revised forms are grouped into two general categories: central
measures and program specific measures. Central measures include basic,
topical, activity, and outcome forms. There are also four sets of
program-specific forms. Grant programs are assigned forms based on
their activities and individual grantees respond to only a limited
number of forms that are relevant to their specific program. Many of
these forms are specific to certain types of programs and are not
required of all grantees.
Forms are proposed to be added, removed, or revised beyond what was
specified in the Federal Register notice (87 FR 35220) published on
June 9, 2022. Many of the changes are a result of the redesigned
categorization of measures. For example, the proposed set of activity
forms capture common types of activities conducted across MCHB
investments and replace the set of Population Domain forms (Adolescent
Health, Capacity Building, Child Health, Children with Special Health
Care Needs (CSHCN), Life Course/Cross Cutting, Maternal/Women Health,
and Perinatal/Infant Health). The proposed set of basic forms
consolidate and simplify the set of financial forms (Form 1, 3, 5, 7,
and 8). Other changes reflect efforts to reduce burden or the need to
relocate measures from the Population Domain forms to program-specific
forms (i.e., Healthy Start). Specifically, HRSA is making the following
changes to the current information collection for DGIS:
Removing the following 52 existing forms: Capacity Building (CB) 1
(State Capacity for Advancing the Health of MCH Populations), CB 3
(Impact Measurement), CB 4 (Sustainability), CB 5 (Scientific
Publications), CB 6 (Products), CB 8 (Quality Improvement), Women's/
Maternal Health (WMH) 1 (Prenatal Care), WMH 2 (Perinatal/Postpartum
Care), WMH 3 (Well Woman Visit/Preventive Health Care), WMH 4
(Depression Screening), Perinatal Infant Health (PIH) 1 (Safe Sleep),
PIH 2 (Breast Feeding), PIH 3 (Newborn Screening), Child Health (CH) 1
(Well Child Visit), CH 2 (Quality of Well Child Visit), CH 3
(Developmental Screening), CH 4 (Injury Prevention), CSHCN 1 (Family
Engagement), CSHCN 2 (Access to and Use of Medical Home), CSHCN 3
(Transition to Adult Health Care), Adolescent Health (AH) 1 (Adolescent
Well Visit), AH 2 (Injury Prevention), AH 3 (Screening for Major
Depressive Disorder), Life Course/Cross Cutting (LC) 1 (Adequate Health
Insurance Coverage), LC 2 (Tobacco and eCigarette Cessation), LC 3
(Oral Health), Division of Workforce Development (Training) 01 (MCH
Training Program and Healthy Tomorrows Family Member/Youth/Community
Member Participation), Training 05 (Policy), Training 06 (Diversity of
Long-Term Trainees), Training 10 (Leadership), Training 11 (Work with
MCH Populations), Training 12 (Interdisciplinary Practice), Emergency
Medical Services for Children (EMSC) 01 (Using NEMSIS Data to Identify
Pediatric Patient Care Needs), EMSC 02 (Pediatric Emergency Care
Coordination), EMSC 03 (Use of Pediatric-Specific Equipment), EMSC 05
(Pediatric Traumatic Emergencies), EMSC 06 (Written Inter-facility
Transfer Guidelines that Contain All the Components as per the
Implementation Manual), EMSC 07 (Written Inter-facility Transfer
Agreements That Covers Pediatric Patients), Healthy Start (HS) 01
(Reproductive Life Plan), HS 02 (Usual Source of Care), HS 03
(Interconception Planning), HS 05 (Father/Partner Involvement during
Pregnancy), HS 06 (Father and/or Partner Involvement with Child 0-24
Months), HS 07 (Daily Reading), HS 08 (CAN Implementation), HS 09 (CAN
Participation), Form 3 (Budget Details by Types of Individuals Served),
Form 5 (Number of Individuals Served (Unduplicated)), Form 7
(Discretionary Grant Project Summary Data and Demographics), Form 9
(Program-Specific Project Performance/Outcome Measures), Technical
Assistance/Collaboration Form, and Continuing Education Form.
Adding the following 25 new forms: Direct and Enabling Services,
Training and Workforce Development, Partnerships and Collaboration,
Engagement of Persons with Lived Experience, Technical Assistance,
Outreach and Education, Research, Guidelines and Policy, Data and
Information Systems, Quality Improvement and Evaluation, Knowledge
Change, Behavior Change, EMSC 10 (Prehospital Emergency Medical
Services Pediatric Readiness Recognition Program), HS 10 (Prenatal
Care), HS 11 (Perinatal/Postpartum Care), HS 12 (Well Woman Visit/
Preventive Health Care), HS 13 (Depression Screening), HS 14 (Safe
Sleep), HS 15 (Breastfeeding), HS 16 (Well Child Visit), HS 17
(Adequate Health Insurance Coverage), HS 18 (Prenatal Tobacco and
eCigarette Use), HS 19 (Low Birthweight), HS 20 (Preterm Birth), and HS
21 (Infant Mortality).
Revising the following 23 existing forms: Health Equity, Healthy
Start Site Form, Family to Family Form 1, Financial Form (MCHB Project
Budget Details), Project Abstract (MCH Discretionary Grant Project
Abstract), Project Abstract-Research Projects Only, Form 10 (Program-
Specific and Project Developed Measures), Products, Publications, and
Submissions Data Collection Form, Faculty and Staff Information, Short-
Term Trainees, Medium-Term Trainees, Long-Term Trainees, Former Long-
Term Trainees, LEAP Trainee Information, Training 02 (MCH Training
Program and Healthy Tomorrows Cultural Competence), Training 03
(Healthy Tomorrows Title V Collaboration), Training 04 (Title V
Collaboration), Training 07 (MCH Pipeline Program-Work with MCH
Populations), Training 08 (MCH Pipeline Program-Work with underserved
or vulnerable populations), Training 09 (MCH Pipeline-Graduate Program
Enrollment), Training 15 (Consultation and Training for Mental and
Behavioral Health), HS 04 (Intimate Partner Violence Screening), and
EMSC 04 (Pediatric Medical Emergencies).
The following 3 forms are included with no substantive changes from
the prior approved OMB package: Training 14 (Medium-Term Trainees Skill
and Knowledge), EMSC 08 (Established Permanence of EMSC), and EMSC 09
(Established Permanence of EMSC by Integrating EMSC Priorities into
Statutes/Regulations).
Additional non-substantive revisions include updates to
terminology, goals, benchmark data sources, and significance sections
included in the measures' detail sheets. A performance measure detail
sheet defines and describes each performance measure. Forms and detail
sheets showing the proposed revisions are available upon request.
Need and Proposed Use of the Information: The performance data
collected through the DGIS serves several purposes, including grantee
monitoring, program planning, and performance reporting, and the
ability to demonstrate alignment between MCHB discretionary programs
and the Title V
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MCH Services Block Grant program. This revision will facilitate higher
quality data collection; streamlined, clear DGIS metrics; and support
communications about the range of HRSA's MCH programs.
Likely Respondents: Grantees for MCHB Discretionary Grant Programs.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours
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Number of Responses per Total Burden hours Total burden
Form name respondents respondent responses per response hours
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Project abstract................ 817 1 817 1.33 1,087
Project Abstract (Research 58 1 58 0.66 38
Projects Only).................
Financial Form.................. 817 1 817 0.87 711
Health Equity................... 817 1 817 0.47 384
Direct and Enabling Services.... 476 1 476 1.89 900
Training and Workforce 250 1 250 2.42 605
Development....................
Partnerships and Collaboration.. 380 1 380 1.04 395
Engagement of Persons with Lived 416 1 416 1.58 657
Experience.....................
Technical Assistance............ 300 1 300 2.24 672
Outreach and Education.......... 500 1 500 0.61 305
Research........................ 65 1 65 3.11 202
Guidelines and Policy........... 78 1 78 0.70 55
Data and Information Systems.... 50 1 50 0.67 34
Quality Improvement and 346 1 346 0.29 100
Evaluation.....................
Knowledge Change................ 200 1 200 1.64 328
Behavior Change................. 200 1 200 1.56 312
Products and Publications....... 672 1 672 4.23 2,843
Training Form 2................. 168 1 168 0.69 116
Training Form 3................. 41 1 41 0.99 41
Training Form 4................. 130 1 130 1.52 198
Training Form 7................. 6 1 6 0.83 5
Training Form 8................. 6 1 6 0.75 5
Training Form 9................. 6 1 6 0.92 6
Training Form 14................ 6 1 6 3.64 22
Training Form 15................ 52 1 52 3.17 165
Faculty and Staff Information... 124 1 124 1.92 238
Short-Term Trainees............. 8 1 8 0.67 5
Medium-Term Trainees............ 121 1 121 2.49 301
Long-Term Trainees.............. 112 1 112 6.37 713
Former Long-Term Trainees....... 106 1 106 1.60 170
LEAP Trainee Information........ 6 1 6 0.65 4
HS 4............................ 101 1 101 0.57 58
HS 10........................... 101 1 101 0.31 31
HS 11........................... 101 1 101 0.61 62
HS 12........................... 101 1 101 0.33 33
HS 13........................... 101 1 101 0.50 51
HS 14........................... 101 1 101 0.43 43
HS 15........................... 101 1 101 0.45 45
HS 16........................... 101 1 101 0.39 39
HS 17........................... 101 1 101 0.40 40
HS 18........................... 101 1 101 0.33 33
HS 19........................... 101 1 101 0.38 38
HS 20........................... 101 1 101 0.37 37
HS 21........................... 101 1 101 0.36 36
Healthy Start Site Form......... 101 1 101 0.32 32
EMSC 4.......................... 58 1 58 0.92 53
EMSC 8.......................... 58 1 58 0.09 5
EMSC 9.......................... 58 1 58 0.42 24
EMSC 10......................... 58 1 58 0.46 27
Family to Family Form 1......... 59 1 59 2.76 163
Form 10......................... 200 2 400 12.87 5,148
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Total....................... * 817 .............. 817 .............. 17,615
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* The number of grantees is an estimate as it fluctuates each year.
[[Page 28569]]
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions; (2) the accuracy of the
estimated burden; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-09466 Filed 5-3-23; 8:45 am]
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