40852 Federal Register / Vol. 87, No. 130 / Friday, July 8, 2022 / Notices 

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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological product becomes effective 

and runs until the approval phase 

begins. The approval phase starts with 

the initial submission of an application 

to market the human biological product 

and continues until FDA grants 

permission to market the biological 

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 biological 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 biologic product UPLIZNA 

(inebilizumab-cdon). UPLIZNA is 

indicated for the treatment of 

neuromyelitis optica spectrum disorder 

in adult patients who are antiaquaporin-4 antibody positive. 

Subsequent to this approval, the USPTO 

received a patent term restoration 

application for UPLIZNA (U.S. Patent 

No. 8,323,653) from Viela Bio, Inc., and 

the USPTO requested FDA’s assistance 

in determining this patent’s eligibility 

for patent term restoration. In a letter 

dated December 14, 2020, FDA advised 

the USPTO that this human biological 

product had undergone a regulatory 

review period and that the approval of 

UPLIZNA 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 

UPLIZNA is 4,033 days. Of this time, 

3,666 days occurred during the testing 

phase of the regulatory review period, 

while 367 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: May 29, 2009. The 

applicant claims July 5, 2009, as the 

date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was May 29, 2009, 

which was the first date after receipt of 

an earlier IND that the investigational 

studies were allowed to proceed. 

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): June 11, 2019. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

UPLIZNA (BLA 761142) was initially 

submitted on June 11, 2019. 

3. The date the application was 

approved: June 11, 2020. FDA has 

verified the applicant’s claim that BLA 

761142 was approved on June 11, 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 application for patent extension, 

this applicant seeks 1,557 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: July 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14539 Filed 7–7–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Advisory Committee on 

Seniors and Disasters and National 

Advisory Committee on Individuals 

With Disabilities and Disasters Public 

Meeting 

AGENCY: Office of the Assistant 

Secretary for Preparedness and 

Response (ASPR), Department of Health 

and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the Office of 

the Assistant Secretary for Preparedness 

and Response, Department of the Health 

and Humans Services is hereby giving 

notice that the National Advisory 

Committee on Seniors and Disasters 

(NACSD) and the National Advisory 

Committee on Individuals with 

Disabilities and Disasters (NACIDD) will 

hold public meetings on August 4, 2022. 

DATES: The NACSD and the NACIDD 

will conduct a joint virtual inaugural 

public meeting on August 4, 2022. The 

NACSD and the NACIDD will vote on 

possible recommendations for national 

public health and medical 

preparedness, response, and recovery, 

specific to the needs of older adults and 

people with disabilities in disasters. A 

more detailed agenda and meeting 

registration link will be available on the 

NACSD and the NACIDD meeting 

websites which are located at https://

www.phe.gov/nacsd and at https://

www.phe.gov/nacidd, respectively. 

ADDRESSES: Members of the public may 

attend the meetings via a toll-free phone 

number or Zoom teleconference, which 

requires pre-registration. The meeting 

links to pre-register will be posted on 

https://www.phe.gov/nacsd and https:// 

www.phe.gov/nacidd. Members of the 

public may provide written comments 

or submit questions for consideration by 

the NACSD and NACIDD at any time via 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 130 / Friday, July 8, 2022 / Notices 40853 

email to NACSD@hhs.gov and 

NACIDD@hhs.gov, respectively. 

Members of the public are also 

encouraged to provide comments after 

the meeting. 

FOR FURTHER INFORMATION CONTACT: Dr. 

Maxine Kellman, NACSD Designated 

Officer, 202–260–0447, NACSD@

hhs.gov and Tabinda Burney, NACIDD 

Designated Federal Officer, 202–699– 

1779, NACIDD@hhs.gov; Office of the 

Assistant Secretary for Preparedness 

and Response (ASPR), Department of 

Health and Human Services (HHS), 

Washington, DC. 

SUPPLEMENTARY INFORMATION: The 

National Advisory Committee on 

Seniors and Disaster (NACSD) is 

required by section 2811B of the Public 

Health Service Act (42 U.S.C. 300hh– 

10c), as amended, by the Pandemic and 

All-Hazards Preparedness and 

Advancing Innovation Act (PAHPAIA), 

Public Law 116–22. The NACSD is 

governed by the provisions of the 

Federal Advisory Committee Act 

(FACA), Public Law 92–463, as 

amended (5 U.S.C. App.), which sets 

forth standards for the formation and 

use of advisory committees. The NACSD 

shall provide advice and consultation to 

the Secretary of HHS to assist them in 

carrying out these and related activities 

as they pertain to the unique needs of 

older adults in preparation for, 

responses to, and recovery from allhazards emergencies and disasters. The 

Secretary of HHS has formally delegated 

authority to operate the NACSD to 

ASPR. 

The National Advisory Committee on 

Individuals with Disabilities and 

Disasters (NACIDD) is required by 

section 2811C of the PHS Act (42 U.S.C. 

300hh–10d) as amended by the 

Pandemic and All Hazards Preparedness 

and Advancing Innovation Act 

(PAHPAIA) of 2019, Public Law 116–22. 

The Committee is governed by the 

provisions of the Federal Advisory 

Committee Act (FACA) (5 U.S.C. App.) 

and the General Services 

Administration FACA Final Rule. The 

NACIDD shall evaluate issues and 

programs and provide findings, advice, 

and recommendations to the Secretary 

of HHS to support and enhance allhazards public health and medical 

preparedness, response, and recovery 

aimed at meeting the needs of people 

with disabilities (PWD). The Secretary 

of HHS has formally delegated authority 

to operate the NACIDD to ASPR. 

The NACSD and the NACIDD invite 

those who are involved in or represent 

a relevant industry, academia, 

profession, organization, or U.S. state, 

tribal, territorial, or local government to 

request up to four minutes to address 

the committees via Zoom. Requests to 

provide remarks to the NACSD and/or 

the NACIDD during the public meeting 

must be sent to NACSD@hhs.gov and/or 

NACIDD@hhs.gov at least 15 days prior 

to the meeting along with a brief 

description of the topic. We would 

specifically like to request inputs from 

the public on challenges, opportunities, 

and strategic priorities for national 

public health and medical 

preparedness, response, and recovery 

specific to the needs of people with 

disabilities and/or older adults before, 

during, and after disasters. Presenters 

who are selected for the public meeting 

will have audio only for up to four 

minutes during the meeting. Slides, 

documents, and other presentation 

material sent along with the request to 

speak will be provided to the committee 

members separately. Please indicate 

additionally whether the presenter will 

be willing to take questions from the 

committee members (at their discretion) 

immediately following their 

presentation (for up to four additional 

minutes). 

Dawn O’Connell, 

Assistant Secretary for Preparedness and 

Response. 

[FR Doc. 2022–14426 Filed 7–7–22; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

Institute; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Asthma 

Education Prevention Program 

Coordinating Committee. 

The meeting will be open to the 

public. Individuals who plan to attend 

and need special assistance, such as 

sign language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: National Asthma 

Education Prevention Program Coordinating 

Committee. 

Date: August 16, 2022. 

Time: 12:00 p.m. to 4:00 p.m. 

Agenda: Programmatic and Scientific 

Updates 

Place: National Institutes of Health, 

Rockledge II, 6705 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Virtual Access: https://nih.zoomgov.com/j/ 

1603194596?pwd=ZnhJV3BLc

EFOVThvUUdhQnNGOG5xZz09. 

Telephone Access: Meeting ID: 160 319 

4596. Passcode: 748944. +1 669 254 5252 US 

(San Jose). +1 646 828 7666 US (New York). 

+1 551 285 1373 US. +1 669 216 1590 US 

(San Jose). 

Contact Person: Susan Shero, MS, Program 

Officer, CTRIS, Center for Translational 

Research and Implementation Science, 

National Heart, Lung and Blood Institute, 

National Institutes of Health, 6705 Rockledge 

Drive, Bethesda, MD 20892, 301–496–1051, 

susan.shero@nih.gov. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: https://

www.nhlbi.nih.gov/advisory-and-peerreview-committees/national-asthmaeducation-and-prevention-programcoordinating, where an agenda and any 

additional information for the meeting will 

be posted when available. 

Information is also available on the 

Institute’s/Center’s home page: https://

www.nhlbi.nih.gov/advisory-and-peerreview-committees/national-asthmaeducation-and-prevention-programcoordinating, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: July 1, 2022. 

David W Freeman, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–14559 Filed 7–7–22; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences; 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 


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