34770 Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 

requested that FDA determine the 

product’s regulatory review period. 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

POLIVY is 3,050 days. Of this time, 

2,876 days occurred during the testing 

phase of the regulatory review period, 

while 174 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355(i)) 

became effective: February 4, 2011. FDA 

has verified the applicant’s claims that 

the date the investigational new drug 

application became effective was on 

February 4, 2011. 

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): December 19, 2018. FDA 

has verified the applicant’s claim that 

the biologics license application (BLA) 

for POLIVY (BLA 761121) was initially 

submitted on December 19, 2018. 

3. The date the application was 

approved: June 10, 2019. FDA has 

verified the applicant’s claim that BLA 

761121 was approved on June 10, 2019. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the USPTO applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 1,032 days, 1,127 

days, or 1,445 days of patent term 

extension. 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

Must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: June 23, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13949 Filed 6–29–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0424] 

Medical Devices; Exemption From 

Premarket Notification: Powered 

Patient Transport, All Other Powered 

Patient Transport 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice announcing receipt of a petition 

requesting exemption from the 

premarket notification requirements. 

The document was published with an 

incorrect docket number. This 

document corrects that error. 

FOR FURTHER INFORMATION CONTACT: Dan 

Reed, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1526, Silver Spring, 

MD 20993–0002, 240–402–4717. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of June 15, 2021 (86 FR 

31722), in FR Doc. 2021–12505, on page 

31722, the following correction is made: 

On page 31722, in the second column, 

in the header of the document, and, also 

on page 31723, in the first column 

under ‘‘Instructions,’’ ‘‘Docket No. 

FDA–2021–N–0493’’ is corrected to read 

‘‘Docket No. FDA–2021–P–0424’’. 

Dated: June 25, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13967 Filed 6–29–21; 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 10(d) 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: Center for Scientific 

Review Special Emphasis Panel; PAR Panel: 

Transgender People: Immunity, Prevention, 

and Treatment of HIV and STIs. 

Date: July 26, 2021. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: David C. Chang, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, MD 

20892, (301) 451–0290, changdac@

mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: AIDS and AIDS-Related 

Applications. 

Date: July 27, 2021. 

Time: 11:00 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 (Virtual Meeting). 

Contact Person: Kristen Prentice, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3112, 

MSC 7808, Bethesda, MD 20892, (301) 496– 

0726, prenticekj@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; UNITE 

Transformative Research to Address Health 

Disparities and Advance Health Equity (U01). 

Date: July 27, 2021. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Bukhtiar H. Shah, DVM, 

Ph.D., Scientific Review Officer, Vascular 

and Hematology IRG, Center for Scientific 


jbell on DSKJLSW7X2PROD with NOTICES
Federal Register / Vol. 86, No. 123 / Wednesday, June 30, 2021 / Notices 34771 

Review, National Institutes of Health, 6701 

Rockledge Drive, Room 4120, MSC 7802, 

Bethesda, MD 20892, (301) 806–7314, 

shahb@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Topics in Virology. 

Date: July 28, 2021. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Marci Scidmore, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3192, 

MSC 7808, Bethesda, MD 20892, 301–435– 

1149, marci.scidmore@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: HIV Molecular Virology, Cell 

Biology, Immune and Therapeutic-Focused 

Application. 

Date: July 28, 2021. 

Time: 10:00 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 (Virtual Meeting). 

Contact Person: Audrey O. Lau, MPH, 

Ph.D., Chief Center for Scientific Review, 

6701 Rockledge Drive, Bethesda, MD 20892, 

(301) 594–4088, audrey.lau@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

Fellowships: Endocrinology, Metabolism, 

Nutrition and Reproductive Sciences. 

Date: July 28, 2021. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Elaine Sierra-Rivera, Ph.D., 

IRG Chief, EMNR IRG, Center for Scientific 

Review, National Institutes of Health, 6701 

Rockledge Drive, Room 6182, MSC 7892, 

Bethesda, MD 20892, 301–435–2514, 

riverase@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Social Sciences and Chronic and 

Infectious Disease Epidemiology. 

Date: July 28, 2021. 

Time: 11:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Lisa Steele, Ph.D., 

Scientific Review Officer, PSE IRG, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3139, 

MSC 7770, Bethesda, MD 20892, 301–594– 

6594, steeleln@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Social 

Sciences and Chronic and Infectious Disease 

Epidemiology. 

Date: July 28, 2021. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Denise Wiesch, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3138, 

MSC 7770, Bethesda, MD 20892, (301) 437– 

3478, wieschd@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; UNITE 

Transformative Research to Address Health 

Disparities and Advance Health Equity at 

Minority Serving Institutions (U01). 

Date: July 29–30, 2021. 

Time: 10:00 a.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Aruna K. Behera, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4211, 

MSC 7814, Bethesda, MD 20892, 301–435– 

6809, beheraak@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Topics in Mycology, Parasitology 

and Pathogenesis. 

Date: July 29, 2021. 

Time: 10:00 a.m. to 6:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Kenneth M. Izumi, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3204, 

MSC 7808, Bethesda, MD 20892, 301–496– 

6980, izumikm@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Topics in Endocrinology and 

Metabolism. 

Date: July 29, 2021. 

Time: 10:30 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Liliana N. Berti-Mattera, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, RM 6158, 

MSC 7890, Bethesda, MD 20892, (301) 827– 

7609, liliana.berti-mattera@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Program 

Project: Endocannabinoids as Therapeutic 

Targets. 

Date: July 29, 2021. 

Time: 1:00 p.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 (Virtual Meeting). 

Contact Person: Peter B. Guthrie, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4142, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

1239, guthriep@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Innate and Adaptive Immunology. 

Date: July 30, 2021. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Kenneth A. Roebuck, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5214, 

MSC 7852, Bethesda, MD 20892, (301) 435– 

1166, roebuckk@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Topics in 

Innate and Adaptive Immunology. 

Date: July 30, 2021. 

Time: 10:00 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Neerja Kaushik-Basu, 

Ph.D., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3198, 

MSC 7808, Bethesda, MD 20892, (301) 435– 

1742, kaushikbasun@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: June 24, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–13942 Filed 6–29–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Scientific Advisory Committee on 

Alternative Toxicological Methods; 

Announcement of Meeting; Request 

for Comments 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

next meeting of the Scientific Advisory 

Committee on Alternative Toxicological 

Methods (SACATM). SACATM is a 

federally chartered external advisory 

group of scientists from the public and 

private sectors, including 


jbell on DSKJLSW7X2PROD with NOTICES