Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 37873 

1Prior to this, the formula was based on poverty 

data from the decennial Census long-form, which 

was replaced with the American Community 

Survey. 

2https://www.census.gov/library/working-papers/ 

2021/acs/2021_CensusBureau_01.html. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average time 

per response 

(in hours) 

Total hours 

Preparation of DHCP letters; § 200.5 .................................. 6 1.3 8 100 800 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We have identified 24 DHCP letters 

that 18 distinct sponsors submitted to 

FDA during the 3-year period (2019 to 

2021). Based on our Document 

Archiving, Reporting, and Regulatory 

Tracking System, we estimate eight 

DHCP letters will be submitted annually 

from six application holders. Based on 

our experience, we assume that each 

letter will require 100 hours to prepare 

and disseminate as recommended in the 

guidance. Our estimate reflects a 

downward adjustment by five responses 

and 500 hours annually. We attribute 

this decrease to the effectiveness of the 

guidance and the decreased number of 

DHCP letters submitted for FDA review. 

Dated: June 16, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13536 Filed 6–23–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Proposed Temporary Changes in State 

Title V Maternal and Child Health Block 

Grant Allocations 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice seeks comments 

on proposed 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) Block 

Grant. Since Fiscal Year (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. HRSA proposes 

that the ACS 2020 experimental 

estimates be excluded from calculating 

MCH block grant allocations and that 

the FY 2023 funding allocation 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 would 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: Interested persons are invited to 

comment on this proposed change. 

Submit written comments no later than 

July 25, 2022. All comments received on 

or before this date will be considered. 

ADDRESSES: All written comments 

concerning this notice should be 

submitted to Christopher Dykton, 

Acting Director of the Division of State 

and Community Health, at the contact 

information below. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Dykton, Acting Director of 

the Division of State and Community 

Health, Maternal and Child Health 

Bureau (MCHB), HRSA, Room 18N35, 

5600 Fishers Lane, Rockville, Maryland 

20857; telephone: (301) 433–2204; 

email: MCHBlockGrant@hrsa.gov. 

SUPPLEMENTARY INFORMATION: The 

purpose of the Title V MCH Block 

Grant, administered by HRSA’s MCHB, 

is to improve the health of the nation’s 

mothers, infants, children, including 

children with special health care needs, 

and their families by creating federal/ 

state partnerships that provide each 

state/jurisdiction with needed flexibility 

to respond to its individual MCH 

population needs. Pursuant to section 

502(c) of Title V of the Social Security 

Act (42 U.S.C. 702(c)), for any available 

funding in excess of 1983 levels 

($406,649,394), Title V MCH Block 

Grant funds are allocated to States and 

the District of Columbia based on the 

number of children living in poverty in 

an individual state as a proportion of 

the total number of children living in 

poverty in the U.S., using data for the 

number of children in poverty in each 

State from the U.S. Census Bureau’s 

ACS. Incorporating the proportion of 

total number of children living in 

poverty into the state funding formula 

for the Title V MCH Block Grant ensures 

that a portion of the funding is 

distributed according to greatest need. 

Beginning in FY 2013, data for the 

number of children in poverty in each 

state has been based on the U.S. Census 

Bureau’s ACS.1 In FY 2013, the 

allocation was based on 3-year rolling 

ACS estimates instead of 1-year or 5- 

year ACS estimates also produced at 

that time to strike a balance between 

reliability and currency of data. See 77 

FR 65693 (October 30, 2012). However, 

since 2014 (for FY 2017), when the 

Census Bureau discontinued the release 

of 3-year ACS estimates, HRSA has been 

using three pooled ACS 1-year estimates 

for this purpose. 

In 2020, due to the COVID–19 

pandemic, there were disruptions in the 

ACS data collection that prevented the 

Census Bureau from releasing standard 

1-year ACS estimates for 2020. 

According to the Census Bureau report, 

‘‘An Assessment of the COVID–19 

Pandemic’s Impact on the 2020 ACS 1- 

Year Data,’’ 2 both survey administration 

methods (mailed questionnaires and 

interviewing in-person) were impacted 

beginning in March 2020. For example, 

no mailings were completed from April 

through June 2020, and when they 

resumed, they did not include the 

mailing of most of the reminder letters 

and postcards. Similarly, there was an 

abrupt switch from in-person to 

telephone-only interviews from March 

2020 through June 2020, and the 

universe of addresses for which 

telephone numbers can be obtained is 

likely different than the universe of 

addresses obtained through in-person 

methods, over-representing certain 

types of addresses. In May, the option 

to complete the interview online 

became available. In-person 


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37874 Federal Register / Vol. 87, No. 121 / Friday, June 24, 2022 / Notices 

3The 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. 

4https://www.census.gov/programs-surveys/acs/ 

data/experimental-data.html. 

interviewing resumed in July, but not 

for all areas. 

All of these changes affected response 

rates, in terms of who was most likely 

to complete the mailed surveys or 

participate in interviews, etc. 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. Therefore, the Census Bureau 

decided not to release standard 2020 

ACS 1-year estimates. The Census 

Bureau is providing only ‘‘experimental 

estimates’’ for 2020 ACS 1-year data.3

The Census Bureau indicated that the 

experimental 2020 estimates were 

released in an attempt to account for the 

differential response from more 

educated, higher income, single-family 

households, but also acknowledged the 

approach has not been thoroughly 

investigated.4

Upon their release, HRSA examined 

the 2020 ACS experimental estimates 

and compared the change in poverty 

share using a 3-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. Using the 2020 

experimental estimates, HRSA noted an 

increase in the variability, with 12 states 

having their largest observed relative 

percentage change, 9 states having large 

(>5 percent) relative percentage 

changes, and 6 states having large (>5 

percent) relative decreases in poverty 

share from the prior year. Moreover, in 

years prior, large relative percentage 

changes were most often increases, but 

the opposite occurred in 2020 using the 

experimental estimates, i.e., six states 

would have a large decrease vs. three 

states would have a large increase. 

Thus, due to the greater observed data 

variability and number of states that 

would experience large decreases in 

their poverty share, HRSA has concerns 

about the accuracy of the 2020 

experimental estimates as applied to the 

MCH allocation. For smaller states, in 

particular, large relative decreases in 

poverty share can result in meaningful 

absolute decreases in the poverty-based 

allocation. As state budgets are 

impacted by the COVID–19 pandemic, 

HRSA proposes a conservative approach 

that limits such decreases based on 

uncertain experimental estimates to the 

extent possible. 

In order to ameliorate these concerns 

and because of the nature of the data, 

HRSA proposes that the ACS 2020 

experimental estimates not be used in 

calculating MCH block grant allocations. 

Instead, HRSA proposes that the FY 

2023 funding allocation 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 

would 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 3 consecutive 1-year 

estimates (2021–2023). HRSA’s proposal 

to temporarily change the method of 

calculating allocations continues to 

support the objective of distributing 

funding according to greatest need. In so 

doing, HRSA will avoid the use of lower 

quality and potentially inaccurate 

poverty data for 2020 that would result 

in larger funding fluctuations than 

observed in previous years, and will 

continue to use the latest available data 

in future years. With this approach, no 

state will see a decrease in its povertybased allocation of funding in FY 2023. 

If the poverty data used for the FY 

2022 allocation is used again for the FY 

2023 allocation, all states will receive 

the same proportion of poverty-based 

funding as they received in FY 2022, 

which will prevent potentially 

inaccurate changes in allocations. HRSA 

recognizes the possibility that the 

changes seen with 2020 ACS 

experimental estimates may actually 

reflect real changes in the distribution of 

children in poverty which may be seen 

when the 2021 ACS 1-year estimates (to 

be released in Fall 2022) are 

incorporated. If that is the case, then the 

difference in FY 2024 allocations as 

compared to the FY 2023 allocations 

will accurately reflect those changes by 

incorporating the 2021 data. 

Diana Espinosa, 

Deputy Administrator. 

[FR Doc. 2022–13475 Filed 6–23–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

[OMB No. 0906–xxxx–New] 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request Information 

Collection Request Title: Optimizing 

Virtual Care Grant Program 

Performance Measures 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than August 23, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or by mail to 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 paperwork@hrsa.gov 

or call Samantha Miller, the acting 

HRSA Information Collection Clearance 

Officer at (301) 443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information collection request title for 

reference. 

Information Collection Request Title: 

Optimizing Virtual Care Grant Program 

Performance Measures, OMB No. 0906– 

xxxx—New. 

Abstract: The Health Center Program 

and supplemental awards for health 

centers are authorized by Section 330(d) 

of the Public Health Service Act (42 

U.S.C. 254b(d)). Notably, HRSA is 


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