Notice of Intent To Make Temporary Changes in the State Title V Maternal and Child Health Block Grant Allocations, 55447-55448 [2022-19477]
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Federal Register / Vol. 87, No. 174 / Friday, September 9, 2022 / Notices
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‘‘Submitting Documents Using RealWorld Data and Real-World Evidence to
FDA for Drug and Biological Products.’’
As one mechanism to inform FDA’s
RWE program under the 21st Century
Cures Act (Pub. L. 114–255), and
specifically to help FDA understand the
scope and use of RWD/RWE submitted
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regarding safety and/or effectiveness,
the Center for Drug Evaluation and
Research (CDER), the Center for
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Excellence (OCE) track certain types of
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described in this guidance and to
promote consistency in this effort,
CDER, CBER, and OCE encourage
sponsors and applicants to identify
whether their submissions include
certain uses of RWD/RWE. To assist
FDA in tracking of RWD/RWE
submissions, FDA recommends that the
sponsor or applicant include the
following information in their cover
letter: (1) purposes of using RWD/RWE,
(2) study designs using RWD to generate
RWE, and (3) RWD sources used to
generate RWE.
This guidance finalizes the draft
guidance entitled ‘‘Submitting
Documents Using Real-World Data and
Real-World Evidence to FDA for Drugs
and Biologics’’ issued on May 9, 2019
(84 FR 20368). FDA considered
comments received on the draft
guidance as the guidance was finalized,
and changes were made to improve
clarity.
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 ‘‘Submitting
Documents Using Real-World Data and
Real-World Evidence to FDA for Drug
and Biological Products.’’ 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.
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information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
VerDate Sep<11>2014
18:57 Sep 08, 2022
Jkt 256001
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; and the collections
of information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
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search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: September 6, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19494 Filed 9–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Intent To Make Temporary
Changes in the State Title V Maternal
and Child Health Block Grant
Allocations
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Response to solicitation of
comments.
AGENCY:
HRSA plans to move forward
in implementing temporary changes to
the method of calculating poverty-based
allocations under Title V of the Social
Security Act for HRSA’s State Title V
Maternal and Child Health (MCH)
Services Block Grant, beginning in
Fiscal Year (FY) 2023. Since FY 2017,
the poverty-based allocation has been
based on the U.S. Census Bureau’s 3year American Community Survey
(ACS) estimates using three pooled 1year estimates. However, due to the
COVID–19 pandemic, there were
disruptions in the ACS data collection
in 2020 resulting in data quality issues
that prevented the Census Bureau from
releasing standard 1-year ACS estimates;
instead, the Census Bureau released
experimental estimates. The ACS 2020
experimental estimates will be excluded
from calculating Title V MCH Services
Block Grant allocations, and the FY
2023 funding allocation will be based
on the same poverty data used in the FY
2022 allocation (i.e., pooled 1-year
SUMMARY:
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
55447
estimates for 2017, 2018, and 2019
ACS). Funding allocations for FY 2024
and FY 2025 will continue to
incorporate the latest 1-year ACS data
while skipping 2020 (i.e., for FY 2024,
the 2018, 2019, and 2021 ACS data will
be used; for FY 2025, the 2019, 2021,
and 2022 ACS data will be used). In FY
2026, the temporary change to the
method for calculating allocations will
no longer be necessary, and HRSA will
resume pooling of three consecutive 1year estimates (2021–2023).
DATES: Effective Date: October 1, 2022.
FOR FURTHER INFORMATION CONTACT:
Christopher Dykton, Acting Director of
the Division of State and Community
Health, Maternal and Child Health
Bureau, HRSA, Room 18N35, 5600
Fishers Lane, Rockville, Maryland
20857; telephone: (301) 433–2204;
email: MCHBlockGrant@hrsa.gov.
SUPPLEMENTARY INFORMATION: Beginning
in FY 2023, HRSA will temporarily
change the method of calculating the
poverty-based allocation to States and
the District of Columbia under section
502(c) of Title V of the Social Security
Act (42 U.S.C. 702(c)). Because of data
collection disruptions due to the
COVID–19 pandemic, the Census
Bureau did not release standard 1-year
ACS estimates for 2020. Survey
administration methods (mailed
questionnaires and interviewing inperson) were impacted beginning in
March 2020, which affected response
rates, in terms of who was most likely
to complete mailed surveys or
participate in interviews, etc.1 The
Census Bureau concluded that the 2020
ACS 1-year data were not ‘‘reasonable’’
as respondents disproportionately ‘‘had
higher levels of education, had more
married couples and few never married
citizens, had less Medicaid coverage,
had higher median household incomes,
and fewer non-citizens, and were more
likely to live in single-family housing
units’’ than respondents in previous
years. Instead, the Census Bureau
decided to provide only experimental
estimates for 2020 ACS 1-year data.2
HRSA examined the 2020 ACS
experimental estimates and compared
the change in poverty share using a 31 https://www.census.gov/library/working-papers/
2021/acs/2021_CensusBureau_01.html.
2 The Census Bureau defines experimental data
products as ‘‘innovative statistical products created
using new data sources or methodologies that
benefit data users in the absence of other data
products . . . Census Bureau experimental data
may not meet all of HRSA’s data quality standards.
Because of this, HRSA clearly identifies
experimental data products and includes
methodology and supporting research with their
release.’’ https://www.census.gov/data/
experimental-data-products.html.
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09SEN1
55448
Federal Register / Vol. 87, No. 174 / Friday, September 9, 2022 / Notices
year estimate incorporating the 2020
experimental estimate with prior yearto-year changes since 2014—the first
year of annual updates to poverty share
data using 3-year ACS estimates. HRSA
noted greater observed data variability
and a greater number of States that
would experience large decreases in
their poverty share. HRSA was
concerned about the accuracy of the
2020 experimental estimates as applied
to the Title V MCH Services Block Grant
allocation.
In order to ameliorate these concerns
and because of the nature of the data,
the ACS 2020 experimental estimates
will not be used in calculating Title V
MCH Services Block Grant allocations.
Instead, HRSA will base the FY 2023
funding allocation on the same poverty
data used in the FY 2022 allocation (i.e.,
pooled 1-year estimates for 2017, 2018,
and 2019 ACS). Funding allocations for
FY 2024 and FY 2025 will continue to
incorporate the latest 1-year ACS data
while skipping the 2020 experimental
data (i.e., for FY 2024, the 2018, 2019,
and 2021 ACS data will be used; for FY
2025, the 2019, 2021, and 2022 ACS
data will be used). In FY 2026, the
temporary change to the method for
calculating allocations will no longer be
necessary, and HRSA will resume
pooling of three consecutive 1-year
estimates (2021–2023).
The proposed temporary change in
State Title V MCH Services Block Grant
allocations was announced in the
Federal Register at 87 FR 37873 on June
24, 2022. A comment period of 30 days
was established to allow interested
parties to submit comments. HRSA
received two responses. One comment
expressed support for the proposed
temporary change. HRSA appreciates
this comment. The other comment is
beyond the scope of this notice, as it did
not specifically address the proposed
changes in the State Title V MCH
Services Block Grant allocation, but
instead expressed concern about child
vaccinations.
Diana Espinosa,
Deputy Administrator.
[FR Doc. 2022–19477 Filed 9–8–22; 8:45 am]
BILLING CODE 4165–15–P
jspears on DSK121TN23PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
Request for Public Comment: 30-Day
Information Collection: Urban Indian
Organization On-Site Review
AGENCY:
Indian Health Service, HHS.
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18:57 Sep 08, 2022
Jkt 256001
Notice and request for
comments; request for approval.
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
Indian Health Service (IHS) invites the
general public to comment on a new
information collection titled, ‘‘Urban
Indian Organization On-Site Review.’’
IHS is requesting the Office of
Management and Budget (OMB) to
approve this new collection. The
purpose of this notice is to announce
the IHS’ intent to submit this collection
to OMB and to allow 30 days for public
comment to be submitted directly to
OMB.
SUMMARY:
Consideration will be given to all
comments received by October 11, 2022.
ADDRESSES: A copy of the supporting
statement is available at
www.regulations.gov (see Docket ID:
IHS_FRDOC_0001).
Direct Your Comments to OMB: Send
your comments and suggestions
regarding the proposed information
collection contained in this notice,
especially regarding the estimated
public burden and associated response
time to: Office of Management and
Budget, Office of Regulatory Affairs,
New Executive Office Building, Room
10235, Washington, DC 20503,
Attention: Desk Officer for IHS.
FOR FURTHER INFORMATION CONTACT: To
request additional information, please
contact Evonne Bennett, Information
Collection Clearance Officer at:
Evonne.Bennett@ihs.gov or 301–443–
4750.
DATES:
SUPPLEMENTARY INFORMATION:
Summary of Comments: There was
one comment that was submitted to the
Agency regarding the 60-Day Federal
Register Notice published on February
11, 2022 (87 FR 8020).
Comment Summary: The National
Council of Urban Indian Health
(NCUIH) was the only comment to the
FRN, and a summary of the comments,
requests, and recommendations in
response to the February 11, 2022,
notice, is summarized below. These
comments can be found in full on
www.regulations.gov (see Docket ID:
IHS_FRDOC_0001) and based on
NCUIH’s consultations with Urban
Indian Organizations (UIOs) and
NCUIH’s subject matter expertise. In
summary, the NCUIH recommends the
following:
• Update the Manual regularly and as
needed to remain consistent with other
relevant accreditation processes.
• Provide greater flexibility in the
Manual to accommodate diverse UIO
program/facility goals and services.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
• The IHS to provide a consolidated
list of requirement documents to UIOs
prior to the on-site review.
• Ensure that UIOs can use existing
administrative or site visit data in
meeting the requirements of the Manual.
Additional Recommendations for
UIOs includes that the Office of Urban
Indian Health Programs (OUIHP) host
an Urban Confer with UIOs to learn
directly from UIO leaders about their
experiences with the Manual and
overall review process. The NCUIH also
wanted consideration on (1) Provide a
timeline for processing information
collected in the annual review process;
and (2) Improve overall review by
ensuring reviewers are licensed medical
providers.
IHS Response: The IHS Urban Indian
Organization On-Site Review is
conducted annually by the IHS Area
Offices to evaluate IHS-funded UIOs’
compliance with the Federal
Acquisition Regulations (FAR), the
Indian Health Care Improvement Act
(IHCIA), and other contract and grant
requirements. The on-site review
requirements are based on best-practice
standards for delivering safe and high
quality health care. The OUIHP at IHS
Headquarters provides national
oversight of the annual on-site reviews.
In Fiscal Year (FY) 2018, the OUIHP
executed an Indefinite-Delivery,
Indefinite Quantity contract to revise
the outdated 2013 Annual On-site
Review Manual using current
Accreditation Association for
Ambulatory Health Care (AAAHC), The
Joint Commission, and Commission on
Accreditation of Rehabilitation
Facilities accreditation standards, and
the IHS Manual to improve consistency
and usefulness of on-site reviews. IHS
solicited feedback and
recommendations from UIOs by
conducting seven site visits: 1 outreach
and referral program, 2 limited
ambulatory programs, 2 comprehensive
ambulatory programs, and 2 residential
and outpatient treatment centers. In FY
2020, the OUIHP finalized the Annual
On-site Review Manual incorporating
UIOs’ feedback and recommendations.
In FY 2021, the OUIHP began
development of an electronic Annual
On-site Review application to replace
the hardcopy and a national dashboard
to enhance the efficiency of on-site
reviews. The application enables IHS
Area Office staff and UIOs to document
on-site reviews electronically by (1)
completing corrective action plans; (2)
documenting on-site reviews
simultaneously at UIOs by IHS and UIO
staff; (3) uploading on-site review
documents; (4) calculating compliance
scores to provide real-time feedback; (5)
E:\FR\FM\09SEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55447-55448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19477]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Notice of Intent To Make Temporary Changes in the State Title V
Maternal and Child Health Block Grant Allocations
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Response to solicitation of comments.
-----------------------------------------------------------------------
SUMMARY: HRSA plans to move forward in implementing temporary changes
to the method of calculating poverty-based allocations under Title V of
the Social Security Act for HRSA's State Title V Maternal and Child
Health (MCH) Services Block Grant, beginning in Fiscal Year (FY) 2023.
Since FY 2017, the poverty-based allocation has been based on the U.S.
Census Bureau's 3-year American Community Survey (ACS) estimates using
three pooled 1-year estimates. However, due to the COVID-19 pandemic,
there were disruptions in the ACS data collection in 2020 resulting in
data quality issues that prevented the Census Bureau from releasing
standard 1-year ACS estimates; instead, the Census Bureau released
experimental estimates. The ACS 2020 experimental estimates will be
excluded from calculating Title V MCH Services Block Grant allocations,
and the FY 2023 funding allocation will be based on the same poverty
data used in the FY 2022 allocation (i.e., pooled 1-year estimates for
2017, 2018, and 2019 ACS). Funding allocations for FY 2024 and FY 2025
will continue to incorporate the latest 1-year ACS data while skipping
2020 (i.e., for FY 2024, the 2018, 2019, and 2021 ACS data will be
used; for FY 2025, the 2019, 2021, and 2022 ACS data will be used). In
FY 2026, the temporary change to the method for calculating allocations
will no longer be necessary, and HRSA will resume pooling of three
consecutive 1-year estimates (2021-2023).
DATES: Effective Date: October 1, 2022.
FOR FURTHER INFORMATION CONTACT: Christopher Dykton, Acting Director of
the Division of State and Community Health, Maternal and Child Health
Bureau, HRSA, Room 18N35, 5600 Fishers Lane, Rockville, Maryland 20857;
telephone: (301) 433-2204; email: [email protected].
SUPPLEMENTARY INFORMATION: Beginning in FY 2023, HRSA will temporarily
change the method of calculating the poverty-based allocation to States
and the District of Columbia under section 502(c) of Title V of the
Social Security Act (42 U.S.C. 702(c)). Because of data collection
disruptions due to the COVID-19 pandemic, the Census Bureau did not
release standard 1-year ACS estimates for 2020. Survey administration
methods (mailed questionnaires and interviewing in-person) were
impacted beginning in March 2020, which affected response rates, in
terms of who was most likely to complete mailed surveys or participate
in interviews, etc.\1\ The Census Bureau concluded that the 2020 ACS 1-
year data were not ``reasonable'' as respondents disproportionately
``had higher levels of education, had more married couples and few
never married citizens, had less Medicaid coverage, had higher median
household incomes, and fewer non-citizens, and were more likely to live
in single-family housing units'' than respondents in previous years.
Instead, the Census Bureau decided to provide only experimental
estimates for 2020 ACS 1-year data.\2\
---------------------------------------------------------------------------
\1\ https://www.census.gov/library/working-papers/2021/acs/2021_CensusBureau_01.html.
\2\ The Census Bureau defines experimental data products as
``innovative statistical products created using new data sources or
methodologies that benefit data users in the absence of other data
products . . . Census Bureau experimental data may not meet all of
HRSA's data quality standards. Because of this, HRSA clearly
identifies experimental data products and includes methodology and
supporting research with their release.'' https://www.census.gov/data/experimental-data-products.html.
---------------------------------------------------------------------------
HRSA examined the 2020 ACS experimental estimates and compared the
change in poverty share using a 3-
[[Page 55448]]
year estimate incorporating the 2020 experimental estimate with prior
year-to-year changes since 2014--the first year of annual updates to
poverty share data using 3-year ACS estimates. HRSA noted greater
observed data variability and a greater number of States that would
experience large decreases in their poverty share. HRSA was concerned
about the accuracy of the 2020 experimental estimates as applied to the
Title V MCH Services Block Grant allocation.
In order to ameliorate these concerns and because of the nature of
the data, the ACS 2020 experimental estimates will not be used in
calculating Title V MCH Services Block Grant allocations. Instead, HRSA
will base the FY 2023 funding allocation on the same poverty data used
in the FY 2022 allocation (i.e., pooled 1-year estimates for 2017,
2018, and 2019 ACS). Funding allocations for FY 2024 and FY 2025 will
continue to incorporate the latest 1-year ACS data while skipping the
2020 experimental data (i.e., for FY 2024, the 2018, 2019, and 2021 ACS
data will be used; for FY 2025, the 2019, 2021, and 2022 ACS data will
be used). In FY 2026, the temporary change to the method for
calculating allocations will no longer be necessary, and HRSA will
resume pooling of three consecutive 1-year estimates (2021-2023).
The proposed temporary change in State Title V MCH Services Block
Grant allocations was announced in the Federal Register at 87 FR 37873
on June 24, 2022. A comment period of 30 days was established to allow
interested parties to submit comments. HRSA received two responses. One
comment expressed support for the proposed temporary change. HRSA
appreciates this comment. The other comment is beyond the scope of this
notice, as it did not specifically address the proposed changes in the
State Title V MCH Services Block Grant allocation, but instead
expressed concern about child vaccinations.
Diana Espinosa,
Deputy Administrator.
[FR Doc. 2022-19477 Filed 9-8-22; 8:45 am]
BILLING CODE 4165-15-P
