Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 39531 

affiliation with and/or active 

participation in consumer or 

community-based organizations, (2) be 

able to analyze technical data, (3) 

understand research design, (4) discuss 

benefits and risks, and (5) evaluate the 

safety and efficacy of products under 

review. The consumer representative 

should be able to represent the 

consumer perspective on issues and 

actions before the advisory committee; 

serve as a liaison between the 

committee and interested consumers, 

associations, coalitions, and consumer 

organizations; and facilitate dialogue 

with the advisory committees on 

scientific issues that affect consumers. 

III. Selection Procedures 

Selection of members representing 

consumer interests is conducted 

through procedures that include the use 

of organizations representing the public 

interest and public advocacy groups. 

These organizations recommend 

nominees for the Agency’s selection. 

Representatives from the consumer 

health branches of Federal, State, and 

local governments also may participate 

in the selection process. Any consumer 

organization interested in participating 

in the selection of an appropriate voting 

or nonvoting member to represent 

consumer interests should send a letter 

stating that interest to FDA (see 

ADDRESSES) within 30 days of 

publication of this document. 

Within the subsequent 45 days, FDA 

will compile a list of consumer 

organizations that will participate in the 

selection process and will forward to 

each such organization a ballot listing at 

least two qualified nominees selected by 

the Agency based on the nominations 

received, together with each nominee’s 

current curriculum vitae or re ́sume ́. 

Ballots are to be filled out and returned 

to FDA within 30 days. The nominee 

receiving the highest number of votes 

ordinarily will be selected to serve as 

the member representing consumer 

interests for that particular advisory 

committee or panel. 

IV. Nomination Procedures 

Any interested person or organization 

may nominate one or more qualified 

persons to represent consumer interests 

on the Agency’s advisory committees or 

panels. Self-nominations are also 

accepted. Nominations must include a 

current, complete re ́sume ́ or curriculum 

vitae for each nominee and a signed 

copy of the Acknowledgement and 

Consent form available at the FDA 

Advisory Nomination Portal (see 

ADDRESSES section of this document), 

and a list of consumer or communitybased organizations for which the 

candidate can demonstrate active 

participation. 

Nominations must also specify the 

advisory committee(s) or panel(s) for 

which the nominee is recommended. In 

addition, nominations must also 

acknowledge that the nominee is aware 

of the nomination unless selfnominated. FDA will ask potential 

candidates to provide detailed 

information concerning such matters as 

financial holdings, employment, and 

research grants and/or contracts to 

permit evaluation of possible sources of 

conflicts of interest. Members will be 

invited to serve for terms of up to 4 

years. 

FDA will review all nominations 

received within the specified 

timeframes and prepare a ballot 

containing the names of qualified 

nominees. Names not selected will 

remain on a list of eligible nominees 

and be reviewed periodically by FDA to 

determine continued interest. After 

selecting qualified nominees for the 

ballot, FDA will provide those 

consumer organizations that are 

participating in the selection process 

with the opportunity to vote on the 

listed nominees. Only organizations 

vote in the selection process. Persons 

who nominate themselves to serve as 

voting or nonvoting consumer 

representatives will not participate in 

the selection process. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: June 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14135 Filed 6–30–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2021–E–0452; FDA– 

2021–E–0453] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; IMCIVREE 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for IMCIVREE and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see the 

SUPPLEMENTARY INFORMATION section) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by August 30, 2022. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

December 28, 2022. See ‘‘Petitions’’ in 

the SUPPLEMENTARY INFORMATION section 

for more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

August 30, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 


khammond on DSKJM1Z7X2PROD with NOTICES
39532 Federal Register / Vol. 87, No. 126 / Friday, July 1, 2022 / Notices 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket Nos. FDA– 

2021–E–0452; FDA–2021–E–0453 for 

‘‘Determination of Regulatory Review 

Period for Purposes of Patent Extension; 

IMCIVREE.’’ Received comments, those 

filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with § 10.20 (21 

CFR 10.20) and other applicable 

disclosure law. For more information 

about FDA’s posting of comments to 

public dockets, see 80 FR 56469, 

September 18, 2015, or access the 

information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

Rm. 6250, Silver Spring, MD 20993, 

301–796–3600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Drug Price Competition and 

Patent Term Restoration Act of 1984 

(Pub. L. 98–417) and the Generic 

Animal Drug and Patent Term 

Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug or biologic product, animal drug 

product, medical device, food additive, 

or color additive) was subject to 

regulatory review by FDA before the 

item was marketed. Under these acts, a 

product’s regulatory review period 

forms the basis for determining the 

amount of extension an applicant may 

receive. 

A regulatory review period consists of 

two periods of time: a testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of USPTO may award (for 

example, half the testing phase must be 

subtracted as well as any time that may 

have occurred before the patent was 

issued), FDA’s determination of the 

length of a regulatory review period for 

a human drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(1)(B). 

FDA has approved for marketing the 

human drug product, IMCIVREE 

(setmelanotide acetate) indicated for 

chronic weight management in adult 

and pediatric patients 6 years of age and 

older with obesity due to 

proopiomelanocortin (POMC), 

proprotein convertase subtilisin/kexin 

type 1 (PCSK1), or leptin receptor 

(LEPR) deficiency confirmed by genetic 

testing demonstrating variants in POMC, 

PCSKI, or LEPR genes that are 

interpreted as pathogenic, likely 

pathogenic, or of uncertain significance. 

Subsequent to this approval, the USPTO 

received patent term restoration 

applications for IMCIVREE (U.S. Patent 

Nos. 8,039,435; 9,458,195) from 

RHYTHM PHARMACEUTICALS, INC. 

and the USPTO requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated June 8, 2021, FDA advised 

the USPTO that this human drug 

product had undergone a regulatory 

review period and that the approval of 

IMCIVREE represented the first 

permitted commercial marketing or use 

of the product. Thereafter, the USPTO 

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 

IMCIVREE is 3,304 days. Of this time, 

3,060 days occurred during the testing 

phase of the regulatory review period, 

while 244 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: November 11, 

2011. The applicant claims November 

12, 2011, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

November 11, 2011, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: March 27, 2020. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

IMCIVREE (NDA 213793) was initially 

submitted on March 27, 2020. 

3. The date the application was 

approved: November 25, 2020. FDA has 

verified the applicant’s claim that NDA 

213793 was approved on November 25, 

2020. 

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 879 days or 1,774 

days of patent term extension. 


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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] 

BILLING CODE 4164–01–P 

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] 

BILLING CODE 4150–05–P 


khammond on DSKJM1Z7X2PROD with NOTICES