Federal Register / Vol. 89, No. 30 / Tuesday, February 13, 2024 / Notices 10087 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Section of guidance; 

recordkeeping activity 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total 

hours 

Sections VI and VII; Charters and 

SOPs for DMCs .................................. 74 1 74 8 592 

Section VI.6.C.4.b.; DMC meeting 

records ............................................... 740 1 740 2 1,480 

Total ................................................ .............................. .............................. .............................. .............................. 2,072 

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

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Section of guidance; 

disclosure activity 

Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total 

hours 

Section VI.C.4.; DMC reports of meeting minutes to the 

sponsor ............................................................................. 740 2 1,480 1 1,480 

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

Reporting, Recordkeeping, and ThirdParty Disclosure Burdens: Based on our 

experience and the anticipated increase 

in DMC use, FDA estimates that there 

are approximately 1,480 clinical trials 

with DMCs regulated by the Center for 

Biologics Evaluation and Research, the 

Center for Drug Evaluation and 

Research, and the Center for Devices 

and Radiological Health. FDA estimates 

that the average length of a clinical trial 

is 2 years, resulting in an annual 

estimate of 740 clinical trials. For the 

purposes of this information collection, 

FDA estimates that each sponsor is 

responsible for approximately 10 trials, 

resulting in an estimated 74 sponsors 

that are affected by the guidance 

annually. 

Based on information provided to 

FDA by sponsors that have typically 

used DMCs for the kinds of studies for 

which this guidance recommends using 

a DMC, FDA estimates that the majority 

of sponsors have already prepared SOPs 

for DMCs, and only a minimum amount 

of time is necessary to revise or update 

them for use for other clinical studies. 

Based on FDA’s experience with clinical 

trials using DMCs, FDA estimates that 

the sponsor on average would issue two 

interim reports per clinical trial to the 

DMC. FDA estimates that the DMCs 

would hold two meetings per year per 

clinical trial, resulting in the issuance of 

two DMC reports of meeting minutes 

(closed and open meeting sessions) to 

the sponsor. One set of both of the 

meeting records should be maintained 

per clinical trial. 

Based on a review of the information 

collection since our last request for 

OMB approval, our estimated burden for 

the information collection reflects an 

overall increase in burden of 1,183 

hours and a corresponding increase of 

1,794 responses. We attribute this 

increase generally to an adjustment in 

respondents based on our experience 

and the anticipated increase in DMC 

use. In table 3, since we removed the 

language in this draft guidance 

regarding waivers, we removed the 

‘‘sponsor notification to the DMC 

regarding waivers’’ task from the burden 

table, resulting in a decrease of 1 

response. In addition, the sections in the 

draft guidance were changed; therefore, 

we updated the section numbers in the 

burden tables in accordance with the 

draft guidance. 

This draft guidance also refers to 

previously approved FDA collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR parts 50 and 56 have been 

approved under OMB control number 

0910–0130. The collections of 

information in 21 CFR part 312 have 

been approved under OMB control 

number 0910–0014. The collections of 

information in 21 CFR part 314 have 

been approved under OMB control 

number 0910–0001. The collections of 

information pertaining to good clinical 

practice have been approved under 

OMB control number 0910–0843. The 

collections of information in 21 CFR 

part 812 have been approved under 

OMB control number 0910–0078. The 

collections of information in 21 CFR 

part 54 pertaining to financial 

disclosure by clinical investigators have 

been approved under OMB control 

number 0910–0396. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

draft guidance at https://www.fda.gov/ 

drugs/guidance-compliance-regulatoryinformation/guidances-drugs, https:// 

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

medical-devices/device-advicecomprehensive-regulatory-assistance/ 

guidance-documents-medical-devicesand-radiation-emitting-products, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// 

www.regulations.gov. 

Dated: February 6, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–02849 Filed 2–12–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Update to the Bright Futures 

Periodicity Schedule as Part of the 

HRSA-Supported Preventive Services 

Guidelines for Infants, Children, and 

Adolescents; Correction 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notices; correction. 

SUMMARY: HRSA published documents 

in the Federal Register of October 24, 


lotter on DSK11XQN23PROD with NOTICES1
10088 Federal Register / Vol. 89, No. 30 / Tuesday, February 13, 2024 / Notices 

2023, and January 5, 2024, concerning 

updates to the Bright Futures 

Periodicity Schedule as part of the 

HRSA-supported preventive services 

guidelines for infants, children, and 

adolescents. These documents 

contained minor errors related to 

updates to two footnotes, including an 

error in the text of footnote 15 and an 

error in the description of footnote 21. 

These minor corrections align with 

information provided to the public on 

the Bright Futures web page and 

referenced by HRSA in the October 24, 

2023, Federal Register notice that 

sought public comment on the proposed 

updates to the Bright Futures 

Periodicity Schedule. These corrections 

do not change the clinical 

recommendations in the Bright Futures 

Periodicity Schedule or the associated 

requirement for certain group health 

plans and health insurance issuers to 

provide coverage without cost-sharing 

under section 2713 of the Public Health 

Service Act. 

FOR FURTHER INFORMATION CONTACT: 

Savannah Kidd, M.S. MFT, Sr. Public 

Health Advisor, Division of Child, 

Adolescent and Family Health, Maternal 

and Child Health Bureau, HRSA, 

telephone: (301) 287–2601, email: 

SKidd@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

Correction 

In the Federal Register of January 5, 

2024, FR Doc. 2024–00024, on page 790, 

column 3, paragraph 2, correct the text 

of updated footnote 15 to read as 

follows: ‘‘A recommended tool to assess 

use of alcohol, tobacco and nicotine, 

and marijuana and other substances, 

including opioids, is available at http:// 

crafft.org.’’ The document incorrectly 

omitted the phrase, ‘‘and other 

substances, including opioids,’’ in this 

sentence. 

In the Federal Register of January 5, 

2024, FR Doc. 2024–00024, on page 790, 

column 3, paragraph 3, correct the 

description of the update to footnote 21 

to read as follows: ‘‘This updated 

reference aligns with the Bright Futures 

recommendation for universal bilirubin 

screening for all newborn infants 

between 24 and 48 hours after birth.’’ 

The document incorrectly included the 

phrase ‘‘between 24 and 28 hours after 

birth’’ in this sentence. 

In the Federal Register of October 24, 

2023, FR Doc. 2023–23396, on page 

73035, column 3, paragraph 3, correct 

the description of the proposed update 

to footnote 21 to read as follows: ‘‘This 

reference aligns with the Bright Futures 

recommendation for universal bilirubin 

screening for all newborn infants 

between 24 and 48 hours after birth.’’ 

The document incorrectly included the 

phrase ‘‘between 24 and 28 hours after 

birth.’’ 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2024–02959 Filed 2–12–24; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Advisory Child Health and 

Human Development Council Task 

Force on Research Specific to 

Pregnant Women and Lactating 

Women (PRGLAC) Implementation 

Working Group Meeting 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The Eunice Kennedy Shriver 

National Institute of Child Health and 

Human Development (NICHD) PRGLAC 

Implementation Working Group of 

Council is charged with monitoring and 

reporting on implementation of the 

recommendations from the PRGLAC. 

This includes monitoring and reporting 

on implementation, updating 

regulations, and guidance, as applicable, 

regarding the inclusion of pregnant 

women and lactating women in clinical 

trials. 

DATES: The in-person meeting will be 

held on March 22, 2024, from 8:30 a.m. 

to 4:30 p.m. EST. 

ADDRESSES: The in-person meeting will 

be held on the NIH Campus, 1 Center 

Dr., Building 31/6C, Room A, Bethesda, 

MD 20892. 

FOR FURTHER INFORMATION CONTACT: For 

information concerning this meeting, 

Dr. Emma Carpenter, Health Science 

Policy Analyst, Legislation and Public 

Policy Branch, Office of Legislation, 

Public Policy, and Ethics, NICHD, NIH, 

6710B Rockledge Drive, Bethesda, MD 

20892–7510, emma.carpenter@nih.gov, 

301–594–2572. 

SUPPLEMENTARY INFORMATION: This 

notice is pursuant to 42 U.S.C. 285g. 

The National Advisory Child Health and 

Human Development Council Task 

Force on Research Specific to Pregnant 

Women and Lactating Women 

(PRGLAC) Implementation Working 

Group meeting will be open to the 

public as a virtual meeting. Individuals 

who need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed in 

advance of the meeting. 

Any interested person may file 

written comments with the committee 

by forwarding the statement to the 

Contact Person listed on this notice. The 

statement should include the name, 

address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: https://

www.nichd.nih.gov/about/advisory, 

where an agenda and any additional 

information for the meeting will be 

posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS). 

Alison N. Cernich, 

Deputy Director, Eunice Kennedy Shriver 

National Institute of Child Health and Human 

Development, National Institutes of Health. 

[FR Doc. 2024–02904 Filed 2–12–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

[Docket No. USCG–2023–0672] 

Collection of Information Under 

Review by Office of Management and 

Budget; OMB Control Number 1625– 

0031 

AGENCY: Coast Guard, DHS. 

ACTION: Thirty-day notice requesting 

comments. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995 the 

U.S. Coast Guard is forwarding an 

Information Collection Request (ICR), 

abstracted below, to the Office of 

Management and Budget (OMB), Office 

of Information and Regulatory Affairs 

(OIRA), requesting an extension of its 

approval for the following collection of 

information: 1625–0031, Plan Approval 

and Records for Electrical Engineering 

Regulations—Title 46 CFR Subchapter J; 

without change. 

Our ICR describes the information we 

seek to collect from the public. Review 

and comments by OIRA ensure we only 

impose paperwork burdens 

commensurate with our performance of 

duties. 

DATES: You may submit comments to 

the Coast Guard and OIRA on or before 

March 14, 2024. 


lotter on DSK11XQN23PROD with NOTICES1