Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5913 

Based on updated data, we have 

revised our estimate for sections 905(b), 

905(c), 905(d), 905(h), or 905(i) of the 

FD&C Act. ‘‘Tobacco Product 

Establishment Initial Registration and 

Listing’’; Form FDA 3741: ‘‘Registration 

and Product Listing for Owners and 

Operators of Domestic Establishments’’; 

Form FDA 3741a: ‘‘Registration and 

Listing for Owners and Operators of 

Domestic Deemed Tobacco Product 

Establishments’’ (Electronic and Paper 

submissions) reflects a reduction from 

200 to 75 respondents and ‘‘Tobacco 

Product Establishment Renewal 

Registration and Listing’’; Form FDA 

3741: ‘‘Registration and Product Listing 

for Owners and Operators of Domestic 

Establishments’’; Form FDA 3741a: 

‘‘Registration and Listing for Owners 

and Operators of Domestic Deemed 

Tobacco Product Establishments’’ 

(Electronic and Paper submissions) 

reflects a reduction from 2,572 to 1,003 

respondents. 

Under sections 905(b), 905(c), 905(d), 

905(h), or 905(i) of the FD&C Act, FDA 

estimates up to 75 new establishments 

will submit one initial establishment 

registration and product listing report 

each year. These estimates reflect the 

burden that will be associated with this 

information collection upon OMB 

approval of the revision and 

implementation of the proposed 

updates. The Agency estimates that up 

to 75 tobacco establishments will each 

submit 1 initial establishment 

registration and product listing report 

each year using the new Form FDA 

3741, ‘‘Registration and Product Listing 

of Tobacco Product Manufacturing 

Establishments’’, which is expected to 

take 1.5 hours, for a total 113 burden 

hours. 

FDA estimates up to 75 

establishments will submit one initial 

listing of tobacco products report each 

year. These estimates reflect the burden 

that will be associated with this 

information collection upon OMB 

approval of the revision and 

implementation of the proposed 

updates. The Agency estimates that up 

to 75 tobacco establishments will each 

submit 1 initial product list and 

material file information spreadsheet 

each year using the new Form FDA 

3741b, which is expected to take 2 

hours, for a total 150 burden hours. 

FDA estimates that the confirmation 

or updating of establishment registration 

and product listing information as 

required by section 905 of the FD&C Act 

will take 20 minutes annually per 

confirmation or update per 

establishment. These estimates reflect 

the burden that will be associated with 

this information collection upon OMB 

approval of the revision and 

implementation of the proposed 

updates. Based on FDA’s experience 

with current establishment registration 

and product listings submitted to the 

Agency, the Agency estimates that on 

average 1,003 establishments will each 

submit one confirmation or updated 

report each year, using the new Form 

FDA 3741, which is expected to take 

0.33 hour (20 minutes) for a total 331 

burden hours. 

FDA estimates that the confirmation 

or updating of listing of tobacco 

products will take 30 minutes annually 

per confirmation or update per 

establishment. These estimates reflect 

the burden that will be associated with 

this information collection upon OMB 

approval of the revision and 

implementation of the proposed 

updates. Based on FDA’s experience 

with current establishment registration 

and product listings submitted to the 

Agency, the Agency estimates that on 

average 1,003 establishments will each 

submit one confirmation or updated 

report each year, using the new Form 

FDA 3741b, which is expected to take 

0.5 hour (30 minutes) for a total 502 

burden hours. 

FDA estimates that the submission of 

ingredient listings required by section 

904(a)(1) of the FD&C Act for each 

establishment will take 2 hours initially. 

Ingredients may be submitted 

electronically through the CTP portal or 

if unable to submit ingredients 

electronically then by mail using Form 

FDA 3742. FDA estimates that 16 

establishments will initially submit one 

report annually at 2 hours per report, for 

a total of 32 hours. 

Based on FDA’s experience and the 

number of new products authorized to 

be introduced or delivered for 

introduction into interstate commerce 

submitted over the past 3 years, FDA 

estimates that 37 establishments will 

each submit 10 reports (one every 6 

months). FDA also estimates that the 

confirmation or updating of product 

(ingredient) listing information required 

by section 904(c) of the FD&C Act is 

expected to take 0.40 hour (24 minutes) 

for a total 148 burden hours. FDA 

estimates that obtaining a DUNS (data 

universal numbering system) number 

will take 30 minutes. FDA assumes that 

all new establishment facilities that will 

be required to initially register under 

section 905 of the FD&C Act would 

obtain a DUNS number. FDA estimates 

that up to 100 establishments that 

would need to obtain this number each 

year. The total industry burden to obtain 

a DUNS number is 50 hours. 

Our estimated burden for the 

information collection reflects an 

overall increase of 655 hours and a 

decrease of 616 responses. We attribute 

this adjustment to the proposed 

revisions to this information collection 

to add the updated and comprehensive 

Form FDA 3741, ‘‘Registration and 

Product Listing of Tobacco Product 

Manufacturing Establishments’’ and add 

Form FDA 3741b, ‘‘Product List and 

Material File Information Spreadsheet’’. 

Dated: January 14, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–01217 Filed 1–16–25; 8:45 am] 

BILLING CODE 4164–01–P 

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 

Jurisdictional Survey Instrument for 

the Title V MCH Block Grant Program 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than February 18, 

2025. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 


KHAMMOND on DSK9W7S144PROD with NOTICES
5914 Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 

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,’’ Federal Register, 89 

FR 22182 through 22190 (March 29, 2024), https:// 

www.federalregister.gov/documents/2024/03/29/ 

2024-06469/revisions-to-ombs-statistical-policydirective-no-15-standards-for-maintainingcollecting-and/. 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

Maternal and Child Health 

Jurisdictional Survey Instrument for the 

Title V MCH Block Grant Program, OMB 

No. 0906–0042—Revision. 

Abstract: The purpose of the Title V 

Maternal and Child Health (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. Using a threetiered 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 

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. 

A 60-day notice published in the 

Federal Register on October 31, 2024, 

89 FR 86822 and 86823. There were no 

public comments. 

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 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 


KHAMMOND on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 90, No. 11 / Friday, January 17, 2025 / Notices 5915 

2For the purposes of this table, we have rounded 

to the nearest hundredth decimal place, which may 

result in slight discrepancies in the total burden 

hours. 

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 

Adults—Puerto Rico ........................ Screener ......................

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

5,205 

1,250 

1 

1 

5,205 

1,250 

0.03 

0.75 

156.15 

937.50 

1,093.65 

Adults—U.S. Virgin Islands ............. Screener ......................

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

1,457 

350 

1 

1 

1,457 

350 

0.03 

0.70 

43.71 

245 

288.71 

Adults—Guam ................................. Screener ......................

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

1,334 

450 

1 

1 

1,334 

450 

0.03 

0.66 

40.02 

297 

337.02 

Adults—American Samoa ............... Screener ......................

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

564 

450 

1 

1 

564 

450 

0.03 

0.73 

16.92 

328.50 

345.42 

Adults—Federated States of Micronesia.Screener ......................

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

625 

450 

1 

1 

625 

450 

0.03 

0.68 

18.75 

306.00 

324.75 

Adults—Republic of the Marshall Islands.Screener ......................

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

360 

300 

1 

1 

360 

300 

0.03 

0.65 

10.80 

195.00 

205.80 

Adults—Commonwealth 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 ......................

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

285 

250 

1 

1 

285 

250 

0.03 

0.70 

8.55 

175 

183.55 

Total ......................................... Screener ......................

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

10,500 

4,000 

1 

1 

10,500 

4,000 

0.03 

0.71 

315.00 

2,840.00 

2 3,155 

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. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2025–01150 Filed 1–16–25; 8:45 am] 

BILLING CODE 4165–15–P 

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; Environmental Information 

and Documentation (EID), OMB No. 

0915–0324, Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, 

HRSA submitted an Information 

Collection Request (ICR) to the Office of 

Management and Budget (OMB) for 

review and approval. Comments 

submitted during the first public review 

of this ICR will be provided to OMB. 

OMB will accept further comments from 

the public during the review and 

approval period. OMB may act on 

HRSA’s ICR only after the 30-day 

comment period for this notice has 

closed. 

DATES: Comments on this ICR should be 

received no later than February 18, 

2025. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under Review—Open for 

Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request a copy of the clearance requests 

submitted to OMB for review, email 

Joella Roland, the HRSA Information 

Collection Clearance Officer, at 

paperwork@hrsa.gov or call (301) 443– 

3983. 

SUPPLEMENTARY INFORMATION: 

Information Collection Request Title: 

HRSA Environmental Information and 

Documentation, OMB No. 0915–0324— 

Extension. 

Abstract: HRSA proposes an 

extension of the Paperwork Reduction 

Act approval for the Environmental 

Information and Documentation (EID) 

checklist, which consists of information 

that the agency is required to obtain to 

comply with the National 

Environmental Policy Act (NEPA) of 

1969 as amended by the Fiscal 

Responsibility Act of 2023. NEPA 

establishes the federal government’s 

national policy for protection of the 

environment. The EID checklist must be 

completed and submitted by applicants 

for HRSA funds that plan to engage in 

construction or other projects that will 

potentially impact the environment. 

HRSA uses the checklist to ensure that 

decision-making processes are 

consistent with NEPA and other related 

environmental and historic preservation 

laws. The extension will support 

HRSA’s implementation of programs 

with capital improvements that have the 

potential to significantly affect the 

human environment, such as 

construction/expansion and alteration/ 

renovation activities, as defined in the 

associated HRSA program guidance, or 

installation of fixed equipment. 

A 60-day notice published in the 

Federal Register on October 24, 2024, 

89 FR 84898, No. 2024–24732; pp. 

84898 and 84899. There were no public 

comments. 

Need and Proposed Use of the 

Information: Applicants for HRSA funds 

must provide information and assurance 

of compliance with NEPA on the EID 

checklist. This information is reviewed 

during the Pre-Award stage (and/or 

prior to the implementation of the 

project). The information is reviewed in 

the Post Award stage for project changes 

and the information is reviewed before 

the implementation of the project 

changes. 


KHAMMOND on DSK9W7S144PROD with NOTICES