36144 Federal Register / Vol. 86, No. 128 / Thursday, July 8, 2021 / Notices 

II. Determination of Regulatory Review 

Period 

FDA has determined that the 

applicable regulatory review period for 

PIQRAY is 3,264 days. Of this time, 

3,106 days occurred during the testing 

phase of the regulatory review period, 

while 158 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 (FD&C Act) (21 U.S.C. 

355(i)) became effective: June 18, 2010. 

FDA has verified the applicant’s claim 

that the date the investigational new 

drug application became effective was 

on June 18, 2010. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: December 18, 2018. 

The applicant claims October 26, 2018, 

as the date the new drug application 

(NDA) for PIQRAY (NDA 212526) was 

initially submitted. However, FDA 

records indicate that NDA 212526 was 

submitted on December 18, 2018. 

3. The date the application was 

approved: May 24, 2019. FDA has 

verified the applicant’s claim that NDA 

212526 was approved on May 24, 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 969 or 1,156 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 22, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14490 Filed 7–7–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Presidential Advisory 

Council on HIV/AIDS 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice of a virtual meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Service is hereby giving notice that the 

Presidential Advisory Council on HIV/ 

AIDS (PACHA or the Council) will be 

holding the 71st full Council meeting 

utilizing virtual technology on Tuesday, 

August 3–Wednesday, August 4, 2021 

from 1:00–5:00 p.m. (ET) on both days. 

The meeting will be open to the public; 

a public comment session will be held 

during the meeting. Pre-registration is 

required to provide public comment 

during the meeting. To pre-register to 

attend or to provide public comment, 

please send an email to PACHA@

hhs.gov and include your name, 

organization, and title by close of 

business Monday, July 26, 2021. If you 

decide you would like to provide public 

comment but do not pre-register, you 

may submit your written statement by 

emailing PACHA@hhs.gov by close of 

business Wednesday, August 11, 2021. 

The meeting agenda will be posted on 

the PACHA page on HIV.gov at https:// 

www.hiv.gov/federal-response/pacha/ 

about-pacha prior to the meeting. 

DATES: The meeting will be held on 

Tuesday, August 3–Wednesday, August 

4, 2021 from 1:00–5:00 p.m. (ET) on 

both days. This meeting will be 

conducted utilizing virtual technology. 

ADDRESSES: Instructions on attending 

this meeting virtually will be posted one 

week prior to the meeting at: https://

www.hiv.gov/federal-response/pacha/ 

about-pacha. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Caroline Talev, MPA, Public Health 

Analyst, Presidential Advisory Council 

on HIV/AIDS, 330 C Street SW, Room 

L609A, Washington, DC 20024; (202) 

795–7622 or PACHA@hhs.gov. 

Additional information can be obtained 

by accessing the Council’s page on the 

HIV.gov site at www.hiv.gov/pacha. 

SUPPLEMENTARY INFORMATION: PACHA 

was established by Executive Order 

12963, dated June 14, 1995, as amended 

by Executive Order 13009, dated June 

14, 1996 and is currently operating 

under the authority given in Executive 

Order 13889, dated September 27, 2019. 

The Council was established to provide 

advice, information, and 

recommendations to the Secretary 

regarding programs and policies 

intended to promote effective 

prevention and care of HIV infection 

and AIDS. The functions of the Council 

are solely advisory in nature. 

The Council consists of not more than 

25 members. Council members are 

selected from prominent community 

leaders with particular expertise in, or 

knowledge of, matters concerning HIV 

and AIDS, public health, global health, 

philanthropy, marketing or business, as 

well as other national leaders held in 

high esteem from other sectors of 

society. Council members are appointed 

by the Secretary or designee, in 

consultation with the White House. 

Dated: June 9, 2021. 

Caroline Talev, 

Management Analyst, Office of Infectious 

Disease and HIV/AIDS Policy, Alternate 

Designated Federal Officer, Presidential 

Advisory Council on HIV/AIDS, Office of the 

Assistant Secretary for Health, Department 

of Health and Human Services. 

[FR Doc. 2021–14496 Filed 7–7–21; 8:45 am] 

BILLING CODE 4150–43–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meeting 

Pursuant to section 10(d) 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 


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