93308 Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 

3965b once for each submission. We 

assume the submitter could include 

from 1 to 2,000 products in each Form 

FDA 3965b. Entering data for up to 

2,000 rows can take approximately 4 

hours on average per Form FDA 3965b 

for manual data entry. We reflect the 

average time of 60 minutes per response 

based on the assumption that we expect 

to receive an average of 25 bundled 

products per submission. Assuming 60 

minutes per Form FDA 3965b for 1,570 

applications, we estimate a total burden 

of 1,570 hours for this activity. 

The FDA Tobacco Product Grouping 

Spreadsheet Validator (Validator) is a 

free software that validates the content 

of FDA product grouping spreadsheets 

such as ‘‘Form FDA 3965b—SE Unique 

Identification for New and Predicate 

Tobacco Products.’’ The Validator is 

available for voluntary use by the 

tobacco industry (sponsors, 

manufacturers, and importers) prior to 

submitting a product grouping 

spreadsheet to FDA. 

The Validator allows industry users to 

validate product attributes in their 

product grouping spreadsheet with the 

defined and accepted product data 

standards and to make corrections as 

needed. If there are no errors found in 

a spreadsheet, the Validator will 

produce a certificate of completion that 

can be saved locally and included with 

the applicants FDA submission 

voluntarily. If errors are found during 

validation, the Validator will provide 

the applicants with the error at the end 

of each impacted row of the 

spreadsheet, allowing applicants to 

make necessary changes. 

The software and any output files 

reside locally on an applicant’s 

computer, allowing them to work on the 

product grouping spreadsheet offline. 

The Validator does not transmit any 

data across the web to FDA. FDA does 

not have the ability to access, review, or 

supplement the information on local 

computers through this application. We 

estimate that use of the Validator will 

take an average of 5 minutes per 

response. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity; 21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average burden per recordkeeping 

Total hours 

Recordkeeping SE Report under 1107.18–1107.58 ........... 471 1 471 5 2,355 

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

FDA estimates that 30 percent of SE 

Reports or 471 respondents will 

maintain required records related to 

their SE Reports at 5 hours per record 

for a total of 2,355 recordkeeping hours 

(table 2). The first SE Report in a chain 

must use a tobacco product 

commercially marketed (other than for 

test marketing) in the United States as 

of February 15, 2007, as a predicate 

product for the SE Report. Therefore, we 

believe that manufacturers will have 

records on those ‘‘original’’ predicate 

tobacco products from their initial SE 

Reports. 

Our estimated burden for the 

information collection reflects an 

overall increase of 69,010 hours and a 

corresponding increase of 2,905 

responses/records. We attribute this to 

adding a new form, providing the 

validator tool, and reevaluating our 

current estimates. 

Dated: November 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–27654 Filed 11–25–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–4040–0008] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before January 27, 2025. 

ADDRESSES: Submit your comments to 

sagal.musa@hhs.gov or by calling (202) 

205–2634. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 4040–0008–60D 

and project title for reference, to Sagal 

Musa, email: sagal.musa@hhs.gov, or 

call (202) 205–2634 the Reports 

Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (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. 

Title of the Collection: Budget 

Information for Construction Programs 

(SF–424C). 

Type of Collection: Extension. 

OMB No.: 4040–0008. 

Abstract 

Budget Information for Construction 

Programs (SF–424C) is used by 

applicants to apply for Federal financial 

assistance. The Budget Information for 

Construction Programs (SF–424C) form 

allows the applicants to provide budget 

details as part of their grant proposals. 

This form is evaluated by Federal 

agencies as part of the overall grant 

application. This IC expires on February 

28, 2025. Grants.gov seeks a three-year 

clearance of these collections. 


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Federal Register / Vol. 89, No. 228 / Tuesday, November 26, 2024 / Notices 93309 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(if necessary) 

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

Budget Information for Construction 

Programs (SF–424C).

Grant-seeking organizations ............ 239 1 1 239 

Total ........................................... ........................................................... ........................ 1 ........................ 239 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2024–27598 Filed 11–25–24; 8:45 am] 

BILLING CODE 4151–AE–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

[Document Identifier: OS–4040–0007] 

Agency Information Collection 

Request; 60-Day Public Comment 

Request 

AGENCY: Office of the Secretary, HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the Office of the 

Secretary (OS), Department of Health 

and Human Services, is publishing the 

following summary of a proposed 

collection for public comment. 

DATES: Comments on the ICR must be 

received on or before January 27, 2025. 

ADDRESSES: Submit your comments to 

sagal.musa@hhs.gov or by calling (202) 

205–2634. 

FOR FURTHER INFORMATION CONTACT: 

When submitting comments or 

requesting information, please include 

the document identifier 4040–0007–60D 

and project title for reference, to Sagal 

Musa, email: sagal.musa@hhs.gov, or 

call (202) 205–2634 the Reports 

Clearance Officer. 

SUPPLEMENTARY INFORMATION: Interested 

persons are invited to send comments 

regarding this burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (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. 

Title of the Collection: Assurances for 

Non-Construction Programs (SF424B). 

Type of Collection: Extension. 

OMB No.: 4040–0007. 

Abstract 

Assurances for Non-Construction 

Programs (SF–424B) is used by 

applicants to apply for Federal financial 

assistance. The Assurances for NonConstruction Programs (SF–424B) form 

requests that the applicants certify 

specified required assurances as part of 

their grant proposals. This form is 

evaluated by Federal agencies as part of 

the overall grant application. This IC 

expires on February 28, 2025. 

Grants.gov seeks a three-year clearance 

of these collections. 

ANNUALIZED BURDEN HOUR TABLE

Forms 

(if necessary) 

Respondents 

(if necessary) 

Number of 

respondents 

Number of 

responses per 

respondents 

Average 

burden per 

response 

Total burden 

hours 

Assurances for Non-Construction 

Programs (SF–424B).

Grant-seeking organizations ............ 9,772 1 0.5 4,886 

Total ........................................... ........................................................... ........................ 1 ........................ 4,886 

Sherrette A. Funn, 

Paperwork Reduction Act Reports Clearance 

Officer, Office of the Secretary. 

[FR Doc. 2024–27595 Filed 11–25–24; 8:45 am] 

BILLING CODE 4151–AE–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Publication of Common 

Agreement for Nationwide Health 

Information Interoperability (Common 

Agreement) Version 2.1 

AGENCY: Assistant Secretary for 

Technology Policy/Office of the 

National Coordinator for Health 

Information Technology, Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: This notice fulfills an 

obligation under the Public Health 

Service Act (PHSA). The act requires the 

National Coordinator for Health 

Information Technology to publish on 

the Office of the National Coordinator 

for Health Information Technology’s 

public internet website, and in the 

Federal Register, the trusted exchange 

framework and common agreement 

developed under the PHSA. This notice 

is for publishing an updated version of 

the Common Agreement (Version 2.1). 

ADDRESSES: Common Agreement 

Version 2.1 is also available on the 

Office of the National Coordinator for 

Health Information Technology’s public 

internet website at www.HealthIT.gov/ 

TEFCA. 

FOR FURTHER INFORMATION CONTACT: 

Mark Knee, Office of the National 

Coordinator for Health Information 

Technology, 202–664–2058. 

SUPPLEMENTARY INFORMATION: This 

notice fulfills the obligation under 

section 3001(c)(9)(C) of the Public 

Health Service Act (PHSA) to publish 

the trusted exchange framework and 

common agreement, developed under 

section 3001(c)(9)(B) of the PHSA (42 

U.S.C. 300jj–11(c)(9)(B)), in the Federal 

Register. This publication consists of 

the following document: 


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