86822 Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

III. Paperwork Reduction Act of 1995 

While these guidances contain no 

collection of information, they do refer 

to previously approved FDA collections 

of information. The previously 

approved collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3521). The collections 

of information in 21 CFR part 312 for 

investigational new drugs have been 

approved under 0910–0014. The 

collections of information in 21 CFR 

part 314 for applications for FDA 

approval to market a new drug and in 

21 CFR part 320 for bioavailability and 

bioequivalence requirements have been 

approved under OMB control number 

0910–0001. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: October 24, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–25391 Filed 10–30–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request; Information 

Collection Request Title: Maternal and 

Child Health Jurisdictional Survey 

Instrument for the Title V Maternal and 

Child Health Block Grant Program 

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 December 30, 

2024. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14NWH04, 5600 Fishers 

Lane, Rockville, Maryland 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 Joella Roland, the HRSA 

Information Collection Clearance 

Officer, at (301) 443–3983. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the ICR title 

for reference. 

Information Collection Request Title: 

Maternal and Child Health (MCH) 

Jurisdictional Survey Instrument for the 

Title V MCH Block Grant Program, OMB 

No. 0906–0042—Revision 

Abstract: The purpose of the Title V 

MCH Services Block Grant 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. Unique to the MCH 

Block Grant is a commitment to 

performance accountability, while 

assuring State flexibility. Utilizing a 

three-tiered national performance 

measure framework, which includes 

National Outcome Measures, National 

Performance Measures, and EvidenceBased and -Informed Strategy Measures, 

State MCH Block Grant programs report 

annually on their performance relative 

to the selected national performance 

and outcome measures. Such reporting 

enables the State and Federal program 

offices to assess the progress achieved in 

key MCH priority areas and to 

document MCH Block Grant program 

accomplishments. 

By legislation (section 505(a) and 

506(a) of title V of the Social Security 

Act), the MCH Block Grant Application/ 

Annual Report must be developed by, or 

in consultation with, the State MCH 

health agency. In establishing State 

reporting requirements, HRSA considers 

the availability of national data from 

Federal agencies. Data for the National 

Performance and Outcome Measures are 

pre-populated for States in the Title V 

Information System. Such national data 

sources often do not include data from 

the title V jurisdiction grantees, with the 

exception of the District of Columbia. 

As a result, the eight remaining 

jurisdictions (i.e., American Samoa, 

Guam, the Commonwealth of the 

Northern Mariana Islands, the Republic 

of Palau, Puerto Rico, the Republic of 

the Marshall Islands, the Federated 

States of Micronesia, and U.S. Virgin 

Islands) have limited access to 

significant data and MCH indicators, 

with limited resources for collecting 

these data. 

Sponsored by HRSA, the MCH 

Jurisdictional Survey is designed to 

produce data on the physical and 

emotional health of mothers and 

children under 18 years of age in the 

following eight jurisdictions—American 

Samoa, Guam, the Commonwealth of 

the Northern Mariana Islands, the 

Republic of Palau, Puerto Rico, the 

Republic of the Marshall Islands, the 

Federated States of Micronesia, and U.S. 

Virgin Islands. More specifically, the 

MCH Jurisdictional Survey collects 

information on factors related to the 

well-being of children, including health 

status, visits to health care providers, 

health care costs, and health insurance 

coverage. In addition, the MCH 

Jurisdictional Survey collects 

information on factors related to the 

well-being of mothers, including health 

risk behaviors, health conditions, and 

preventive health practices. Collecting 

these data will enable the jurisdictions 

to meet Federal performance reporting 

requirements and demonstrate the 

impact of MCH Block Grant funding on 

MCH outcomes. 

The MCH Jurisdictional Survey was 

designed based on informationgathering activities with title V 

leadership and program staff in the 

jurisdictions, Federal experts, and 

organizations with relevant data 

collection experience. Survey items are 

based on the National Survey of 

Children’s Health; the Behavioral Risk 

Factor Surveillance System; the Youth 

Behavior Surveillance System; and 

selected other Federal studies. The 

Survey is designed as a core 

questionnaire to be administered across 

all jurisdictions with a supplemental set 

of survey questions customized to the 

needs of each jurisdiction. 

The MCH Jurisdictional Survey has 

been conducted annually since 2019, 

with several modifications to address 

emerging issues and challenges related 

to survey questions and methods. The 

2022 extension (ICR 202203–0906–002) 

enhanced the detail in collecting 

demographic data through race and 

ethnicity survey questions in response 

to jurisdictional feedback. Since the 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 211 / Thursday, October 31, 2024 / Notices 86823 

1Office of Management and Budget, ‘‘Revisions to 

OMB’s Statistical Policy Directive No. 15: Standards 

for Maintaining, Collecting, and Presenting Federal 

Data on Race and Ethnicity,’’ 89 FR 22182–22190 

(March 29, 2024), https://www.federalregister.gov/ 

documents/2024/03/29/2024-06469/revisions-toombs-statistical-policy-directive-no-15-standardsfor-maintaining-collecting-and/. 

2For the purposes of this table, numbers are 

rounded to the nearest hundredth decimal place. 

2022 extension, two non-substantive 

change requests (ICRs: 202211–0906– 

001, and 202404–0906–002) allowed for 

adjustments, such as refining hurricanerelated questions, to make them more 

general and increasing sample sizes. 

Need and Proposed Use of the 

Information: There is an ongoing need 

for future data collections, as data from 

the MCH Jurisdictional Survey is used 

to measure progress on national 

performance and outcome measures 

under the Title V MCH Services Block 

Grant Program. This survey instrument 

is critical to collect information on 

factors related to the well-being of all 

mothers, children, and their families in 

the jurisdiction MCH Block Grant 

programs, which address their unique 

MCH needs. 

This revision enables continued data 

collection for Federal reporting and to 

show the impact of MCH Block Grant 

funding on jurisdiction MCH priorities. 

The current request proposes further 

updates to survey questions to align 

with new Federal data standards, 

including updated guidance from OMB 

on collecting information on race and 

ethnicity.1 Updates also reflect program 

oversight and administration needs. 

To continue improving the precision 

of the data in all jurisdictions, HRSA 

also seeks to increase the sample size. 

Given the varying populations of 

children in each jurisdiction, the 

increased sample size varies for each 

jurisdiction. While the target number of 

interviews for each jurisdiction may be 

limited by funding, the maximum 

number of completed interviews 

possible for each jurisdiction is as 

follows: American Samoa, 450; Guam, 

450; Commonwealth of the Northern 

Mariana Islands, 500; Republic of Palau, 

250; Puerto Rico, 1,250; Republic of the 

Marshall Islands, 300; Federated States 

of Micronesia, 450; and U.S. Virgin 

Islands, 350. 

Likely Respondents: The respondent 

universe is women age 18 or older who 

live in one of the eight targeted 

jurisdictions (American Samoa, Guam, 

the Commonwealth of the Northern 

Mariana Islands, the Republic of Palau, 

Puerto Rico, the Republic of the 

Marshall Islands, the Federated States of 

Micronesia, and U.S. Virgin Islands) and 

who are mothers or guardians of at least 

one child aged 0–17 years living in the 

same household. 

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

Type of 

respondent Form name Number of respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

(in hours) 

Burden 

hours per 

form 

Total 

burden 

hours 2

Adults—Puerto Rico ..................................................... Screener ............. 5,205 1 5,205 0.03 156.15 1,093.65 

Core .................... 1,250 1 1,250 0.75 937.50 

Adults—U.S. Virgin Islands .......................................... Screener ............. 1,457 1 1,457 0.03 43.71 288.71 

Core .................... 350 1 350 0.70 245 

Adults—Guam .............................................................. Screener ............. 1,334 1 1,334 0.03 40.02 337.02 

Core .................... 450 1 450 0.66 297 

Adults—American Samoa ............................................ Screener ............. 564 1 564 0.03 16.92 345.42 

Core .................... 450 1 450 0.73 328.50 

Adults—Federated States of Micronesia ..................... Screener ............. 625 1 625 0.03 18.75 324.75 

Core .................... 450 1 450 0.68 306.00 

Adults—Republic of the Marshall Islands .................... Screener ............. 360 1 360 0.03 10.80 205.80 

Core .................... 300 1 300 0.65 195.00 

Adults—Common-wealth of the Northern Mariana Islands.Screener .............

Core ....................

670 

500 

1 

1 

670 

500 

0.03 

0.75 

20.10 

375 

395.10 

Adults—Republic of Palau ........................................... Screener ............. 285 1 285 0.03 8.55 183.55 

Core .................... 250 1 250 0.70 175 

Total ...................................................................... Screener ............. 10,500 1 10,500 0.03 315.00 3,155 

Core .................... 4,000 1 4,000 0.71 2,840.00 

The table above shows a total annual 

burden of 3,155 hours, a decrease from 

the previously estimated 3,480.52 hours 

in ICR 202404–0906–002. Although the 

total number of interviews has 

increased, the burden hours have 

declined due to two factors: (1) survey 

timings have been adjusted to reflect 

actual survey times from the three 

completed rounds of data collection, 

rather than prior estimates, and (2) 

eligibility assumptions and response 

rates have been updated based on actual 

results from the same three rounds of 

data collection experience. 

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. 2024–25246 Filed 10–30–24; 8:45 am] 

BILLING CODE 4165–15–P 


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