Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 39533 

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 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14134 Filed 6–30–22; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Advisory Council on Alzheimer’s 

Research, Care, and Services; Meeting 

AGENCY: Assistant Secretary for 

Planning and Evaluation, HHS. 

ACTION: Notice of meeting. 

SUMMARY: This notice announces the 

public meeting of the Advisory Council 

on Alzheimer’s Research, Care, and 

Services (Advisory Council). The 

Advisory Council provides advice on 

how to prevent or reduce the burden of 

Alzheimer’s disease and related 

dementias (ADRD) on people with the 

disease and their caregivers. During the 

July 25, 2022 meeting the Advisory 

Council will hear updates from federal 

workgroups on efforts undertaken in the 

last quarter and an overview of the 

National Institutes of Health budget for 

ADRD research. The research, clinical 

care, long-term services and supports, 

and risk reduction subcommittees will 

present recommendations and the 

Council will vote on adopting them. 

DATES: The meeting will be held on July 

25, 2022 from 9:30 a.m. to 4:00 p.m. 

EST. 

ADDRESSES: The meeting will be a 

hybrid meeting that allows both inperson and virtual participation. The 

meeting will be held in Room 800 of the 

Hubert H. Humphrey Building, 200 

Independence Avenue SW, Washington, 

DC 20201. It will also stream live at 

www.hhs.gov/live. 

Comments: Time is allocated on the 

agenda to hear public comments from 

3:30 p.m. to 4:00 p.m. The time for oral 

comments will be limited to two (2) 

minutes per individual. In order to 

provide a public comment, please 

register by emailing your name to 

napa@hhs.gov by Tuesday, July 19. 

Registered commenters may provide 

their comments either in-person or 

virtually. On Friday, July 22, registered 

commenters attending virtually will 

receive both a dial-in number and a link 

to join the meeting virtually; individuals 

will have the choice to either join 

virtually via the link, or to call in only 

by using the dial-in number. Note: 

There may be a 30–45 second delay in 

the livestream video presentation of the 

conference. For this reason, if you have 

pre-registered to submit a public 

comment, it is important to connect to 

the meeting by 3:15 p.m. to ensure that 

you do not miss your name and allotted 

time when called. If you miss your 

name and allotted time to speak, you 

may not be able to make your public 

comment. All participant audio lines 

will be muted for the duration of the 

meeting and only unmuted by the Host 

at the time of the participant’s public 

comment. Should you have questions 

during the session email napa@hhs.gov 

and someone will respond to your 

message as quickly as possible. 

In order to ensure accuracy, please 

submit a written copy of oral comments 

for the record by emailing napa@

hhs.gov by Tuesday, July 26. These 

comments will be shared on the website 

and reflected in the meeting minutes. 

In lieu of oral comments, formal 

written comments may be submitted for 

the record by Tuesday, July 26 to Helen 

Lamont, Ph.D., OASPE, 200 

Independence Avenue SW, Room 424E, 

Washington, DC 20201. Comments may 

also be sent to napa@hhs.gov. Those 

submitting written comments should 

identify themselves and any relevant 

organizational affiliations. 

FOR FURTHER INFORMATION CONTACT: 

Helen Lamont, 202–260–6075, 

helen.lamont@hhs.gov. Note: The 

meeting will be available to the public 

live at www.hhs.gov/live. 

SUPPLEMENTARY INFORMATION: Notice of 

these meetings is given under the 

Federal Advisory Committee Act (5 

U.S.C. App. 2, section 10(a)(1) and 

(a)(2)). Topics of the Meeting: federal 

updates, recommendations. 

Procedure and Agenda: The meeting 

will be webcast at www.hhs.gov/live and 

video recordings will be added to the 

National Alzheimer’s Project Act 

website when available, after the 

meeting. This meeting is open to the 

public. Please allow 30 minutes to go 

through security and walk to the 

meeting room. The meeting will also be 

webcast at www.hhs.gov/live. 

Participants joining in person should 

note that seating may be limited. Those 

wishing to attend the meeting in person 

must send an email to napa@hhs.gov 

and put ‘‘July 25 Meeting Attendance’’ 

in the subject line by Tuesday, July 19 

so that their names may be put on a list 

of expected attendees and forwarded to 

the security officers at the Department 

of Health and Human Services. Any 

interested member of the public who is 

a non-U.S. citizen should include this 

information at the time of registration to 

ensure that the appropriate security 

procedure to gain entry to the building 

is carried out. Although the meeting is 

open to the public, procedures 

governing security and the entrance to 

Federal buildings may change without 

notice. If you wish to make a public 

comment, you must note that within 

your email. 

The Department of Health and Human 

Services follows the CDC COVID–19 

Community Level in determining 

masking and social distancing 

guidelines. Please visit the Safer Federal 

Workforce web page for masking and 

social distancing guidelines for more 

information. 

Authority: 42 U.S.C. 11225; Section 

2(e)(3) of the National Alzheimer’s 

Project Act. The panel is governed by 

provisions of Public Law 92–463, as 

amended (5 U.S.C. Appendix 2), which 

sets forth standards for the formation 

and use of advisory committees. 

Dated: June 28, 2022. 

Benjamin Sommers, 

Senior Official Performing the Duties of the 

Assistant Secretary for Planning and 

Evaluation, Deputy Assistant Secretary for 

Health Policy. 

[FR Doc. 2022–14146 Filed 6–30–22; 8:45 am] 

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