Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 77533 

for those products intended to be 

licensed under section 351(k) of the 

PHS Act and being developed as a 

proposed biosimilar to a reference 

product. 

FDA estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

FDA form; survey Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Biosimilar User Fee Cover Sheet (Form FDA 3792) ............ 30 2 60 0.5 (30 minutes) ..... 30 

Request for discontinuation from BPD program or to move 

products to discontinued section of Biosimilar List.

6 1 6 1 ............................. 6 

Biosimilar product & interchangeable product applications 

(351(k)); patent infringement notifications (351(l)).

16 ∼1.94 31 ∼610.90 .................. 18,938 

Formal meeting requests as recommended in FDA guidance.135 2.30 311 21.42 ...................... 6,661 

Submission of Pediatric Assessment; iPSP template information, including deferrals of pediatric assessments for 

proposed biosimilar products; iPSP amendments as recommended in FDA guidance.

11 1 11 ∼38.18 .................... 420 

Total ................................................................................ .................... ........................ 419 ................................ 26,055 

Our estimated burden for the 

information collection reflects an 

overall increase of 13,069 hours and 105 

responses annually. Although part of 

the increase may be attributed to the 

inclusion of burden associated with the 

submission of pediatric study plans, we 

regard the majority of adjustments as 

nominal fluctuations consistent with the 

number of applications and submissions 

we are receiving. 

Dated: September 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21671 Filed 9–20–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Adult Lifespan Psychopathology 

Study Section. 

Date: October 17–18, 2024. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Benjamin G. Shapero, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3182, 

MSC 7848, Bethesda, MD 20892, (301) 402– 

4786, shaperobg@mail.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group; Gene 

Regulation in Cancer Study Section. 

Date: October 21–22, 2024. 

Time: 9:30 a.m. to 7:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Manzoor A. Zarger, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6208, 

MSC 7804, Bethesda, MD 20892, (301) 435– 

2477, zargerma@csr.nih.gov. 

Name of Committee: Biobehavioral and 

Behavioral Processes Integrated Review 

Group; Biobehavioral Regulation, Learning 

and Ethology Study Section. 

Date: October 21–22, 2024. 

Time: 9:30 a.m. to 7:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Sara Louise Hargrave, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institute of 

Health, 6701 Rockledge Drive, Room 3170, 

Bethesda, MD 20892, (301) 443–7193, 

hargravesl@mail.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group; Basic 

Cancer Immunobiology Study Section. 

Date: October 22–23, 2024. 

Time: 8:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Meeting Format: In Person. 

Contact Person: Sarita Kandula Sastry, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20782, 301–402–4788, sarita.sastry@nih.gov. 

Name of Committee: Applied Therapeutics 

for Cancer Integrated Review Group; 

Mechanisms of Cancer Therapeutics C Study 

Section. 

Date: October 22–23, 2024. 

Time: 8:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Darcy Hotel, 1515 Rhode Island 

Ave, NW, Washington, DC 20005. 

Meeting Format: In Person. 

Contact Person: Gloria Huei-Ting Su, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, 301–496–0465, gloria.su@nih.gov. 

Name of Committee: Musculoskeletal, Oral 

and Skin Sciences Integrated Review Group; 

Skeletal Muscle and Exercise Physiology 

Study Section. 

Date: October 22–23, 2024. 

Time: 8:00 a.m. to 10:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road NW, 

Washington, DC 20015. 

Meeting Format: In Person. 

Contact Person: Carmen Bertoni, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 805B, 


khammond on DSKJM1Z7X2PROD with NOTICES
77534 Federal Register / Vol. 89, No. 184 / Monday, September 23, 2024 / Notices 

Bethesda, MD 20892, (301) 867–5309, 

bertonic2@csr.nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group; Macromolecular Structure 

and Function B Study Section. 

Date: October 22–23, 2024. 

Time: 8:30 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: In Person and Virtual 

Meeting. 

Contact Person: Alexei A. Yeliseev, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 443–0552, yeliseeva@

mail.nih.gov. 

Name of Committee: Population Sciences 

and Epidemiology Integrated Review Group; 

Analytics and Statistics for Population 

Research Panel; A Study Section. 

Date: October 22–23, 2024. 

Time: 9:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892. 

Meeting Format: Virtual Meeting. 

Contact Person: Lisa Steele, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3139, 

MSC 7770, Bethesda, MD 20892, (301) 257– 

2638, steeleln@csr.nih.gov. 

Name of Committee: Social and 

Community Influences on Health Integrated 

Review Group; Social Sciences and 

Population Studies A Study Section. 

Date: October 22–23, 2024. 

Time: 9:00 a.m. to 7:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle NW, Washington, DC 20005. 

Meeting Format: In Person. 

Contact Person: Suzanne Ryan, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3139, 

MSC 7770, Bethesda, MD 20892, (301) 435– 

1712, ryansj@csr.nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group; Neurodifferentiation, 

Plasticity, Regeneration and Rhythmicity 

Study Section. 

Date: October 22–23, 2024. 

Time: 9:00 a.m. to 8:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hilton Washington/Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Meeting Format: In Person. 

Contact Person: Jacek Topczewski, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 1002A1, 

Bethesda, MD 20892, (301) 594–7574, 

topczewskij2@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: September 17, 2024. 

Victoria E. Townsend, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–21617 Filed 9–20–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health & Human 

Development; Amended Notice of 

Meeting 

Notice is hereby given of a change in 

the meeting of the Eunice Kennedy 

Shriver National Institute of Child 

Health and Human Development Initial 

Review Group, Population Sciences 

Study Section, October 25, 2024, 09:00 

a.m. to 05:00 p.m., Hyatt Regency 

Bethesda, 7400 Wisconsin Avenue, 

Bethesda, MD 20814, which was 

published in the Federal Register on 

June 17, 2024, FR Doc. No. 2024–13310, 

89 FR 51537. 

This notice is being amended to 

change the start time of the meeting 

from 9:00 a.m. to 10:00 a.m. E.T. The 

meeting is closed to the public. 

Dated: September 18, 2024. 

Lauren A. Fleck, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–21662 Filed 9–20–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

Notice of Closed Meeting 

Pursuant to section 1009 of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Mental Health Initial Review Group; Mental 

Health Services Study Section. 

Date: October 21–22, 2024. 

Time: 2:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency, Bethesda, One 

Bethesda Metro Center, Bethesda, MD 20814 

(Hybrid Meeting). 

Contact Person: Aileen Schulte, Ph.D., 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, National Institutes of Health, 

Neuroscience Center, 6001 Executive Blvd., 

Bethesda, MD 20852, 301–443–1225, email: 

aschulte@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program No. 93.242, Mental Health Research 

Grants, National Institutes of Health, HHS) 

Dated: September 18, 2024. 

Bruce A. George, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2024–21663 Filed 9–20–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; National Institutes 

of Health NeuroBioBank Tissue 

Access Request and Progress Report 

Forms (National Institute of Mental 

Health) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act of 1995, the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30-days of the date of this 

publication. 

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 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 


khammond on DSKJM1Z7X2PROD with NOTICES