77868 Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Notices 

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, OJJAARA 

(momelotinib). OJJAARA is indicated 

for the treatment of intermediate or 

high-risk myelofibrosis (MF), including 

primary MF or secondary MF [postpolycythemia vera and post-essential 

thrombocythemia], in adults with 

anemia. Subsequent to this approval, 

the USPTO received patent term 

restoration applications for OJJAARA 

(U.S. Patent Nos. 8,486,941 and 

RE48,285) from GlaxoSmithKline LLC, 

and the USPTO requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated January 30, 2024, FDA 

advised the USPTO that this human 

drug product had undergone a 

regulatory review period and that the 

approval of OJJAARA 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 

OJJAARA is 5,127 days. Of this time, 

4,670 days occurred during the testing 

phase of the regulatory review period, 

while 457 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: September 3, 

2009. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on September 3, 2009. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: June 16, 2022. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

OJJAARA (NDA 216873) was initially 

submitted on June 16, 2022. 

3. The date the application was 

approved: September 15, 2023. FDA has 

verified the applicant’s claim that NDA 

216873 was approved on September 15, 

2023. 

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 828 days or 5 years 

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: September 18, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21844 Filed 9–23–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–E–2584] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; QUVIVIQ 

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 QUVIVIQ and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of an application 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 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by November 25, 2024. 

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 

March 24, 2025. 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 

November 25, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

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’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Notices 77869 

• 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 No. FDA– 

2023–E–2584 for ‘‘Determination of 

Regulatory Review Period for Purposes 

of Patent Extension; QUVIVIQ.’’ 

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. 6200, 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 biological 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, QUVIVIQ 

(daridorexant hydrochloride) indicated 

for the treatment of adult patients with 

insomnia characterized by difficulties 

with sleep onset and/or sleep 

maintenance. Subsequent to this 

approval, the USPTO received a patent 

term restoration application for 

QUVIVIQ (U.S. Patent No. 9,732,075) 

from Idorsia Pharmaceuticals Ltd. and 

the USPTO requested FDA’s assistance 

in determining the patent’s eligibility 

for patent term restoration. In a letter 

dated September 28, 2023, FDA advised 

the USPTO that this human drug 

product had undergone a regulatory 

review period and that the approval of 

QUVIVIQ 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 

QUVIVIQ is 2,115 days. Of this time, 

1,660 days occurred during the testing 

phase of the regulatory review period, 

while 455 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 24, 2016. FDA has 

verified the applicant’s claim that the date 

the investigational new drug application 

became effective was on June 24, 2016. 

2. The date the application was initially 

submitted with respect to the human drug 

product under section 505 of the FD&C Act: 

January 8, 2021. FDA has verified the 

applicant’s claim that the new drug 

application (NDA) for QUVIVIQ (NDA 

214985) was initially submitted on January 8, 

2021. 

3. The date the application was approved 

or the date of issuance of the interim final 

rule controlling the drug under section 201(j) 

of the Controlled Substances Act: April 7, 

2022. FDA has verified the applicant’s claim 

that NDA 214985 was approved by FDA on 

January 7, 2022. However, the Drug 

Enforcement Agency issued an interim final 

rule controlling the product under section 

201(j) of the Controlled Substances Act on 

April 7, 2022. 

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 1,030 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 


lotter on DSK11XQN23PROD with NOTICES1
77870 Federal Register / Vol. 89, No. 185 / Tuesday, September 24, 2024 / Notices 

§ 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: September 19, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–21836 Filed 9–23–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Building Interdisciplinary Research 

Careers in Women’s Health (BIRCWH) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The Building 

Interdisciplinary Research Careers in 

Women’s Health (BIRCWH) is an 

institutional mentored careerdevelopment program designed to 

connect junior faculty, known as 

BIRCWH Scholars, to senior faculty 

mentors with shared interest in 

women’s health and sex differences 

research. The BIRCWH Annual Meeting 

is a gathering of senior and junior 

faculty that provides an opportunity to 

network and share scientific advances. 

DATES: The meeting will be held on 

October 1, 2024, from 8 a.m. to 5 p.m. 

EDT. 

ADDRESSES: The meeting will be in 

person; registration is at https://

www.eventbrite.com/e/2024-bircwhannual-meeting-tickets-893884130497. 

The meeting is viewable at https://

videocast.nih.gov/watch=55110. 

FOR FURTHER INFORMATION CONTACT: For 

information concerning this meeting, 

visit https://orwh.od.nih.gov/about/ 

newsroom/events/2024-buildinginterdisciplinary-research-careers-inwomens-health-bircwh-annual-meeting, 

or contact Dr. Marquitta White, Senior 

Research Program Officer, Careers 

Section, in the Office of Research on 

Women’s Health (ORWH), 6707 

Democracy Boulevard, Suite 400, 

Bethesda, MD 20817, telephone: 301– 

402–1770; email: marquitta.white@

nih.gov. 

SUPPLEMENTARY INFORMATION: This 

notice is in accordance with 42 U.S.C. 

287d of the Public Health Service Act, 

as amended. Created by the ORWH in 

partnership with NIH Institutes, 

Centers, and Offices. 

This year, the BIRCWH abstracts have 

been grouped into nine categories with 

the following number of abstracts, from 

highest to lowest: Public Health (12), 

Reproductive Health (10), Sex and 

Gender Differences (9), Health 

Disparities (9), Cancer (9), Neuroscience 

(8), Clinical Research (7), Basic Research 

(6), and Bioengineering/Bioinformatics 

(3). The number and quality of abstracts 

centered on Public Health and Basic 

Research has increased this year, 

indicating a growing focus on women’s 

health and the influence of biological 

sex on health and disease in these 

important areas. Specifically, several 

abstracts in these categories focus on 

maternal morbidity, perinatal health, 

and how biological sex and gender 

transition impact health and disease. 

The meeting will include the 2024 Ruth 

L. Kirschstein Memorial Lecture by 

Abbey B. Berenson M.D., MMS, Ph.D., 

and the 2024 Legacy of Leadership 

Lecture by Nina F. Schor, M.D., Ph.D. 

Individuals interested in in-person 

attendance can register online at https:// 

www.eventbrite.com/e/2024-bircwhannual-meeting-tickets-893884130497. 

More information about the speakers 

and agenda can be found at https://

orwh.od.nih.gov/about/newsroom/ 

events/2024-building-interdisciplinaryresearch-careers-in-womens-healthbircwh-annual-meeting. 

This event is free. 

Dated: September 16, 2024. 

Lawrence A. Tabak, 

Principal Deputy Director, National Institutes 

of Health. 

[FR Doc. 2024–21717 Filed 9–23–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 30-Day 

Comment Request; Public Health 

Service (PHS) Applications and PreAward Reporting Requirements (Office 

of the Director) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995, the National 

Institutes of Health (NIH) has submitted 

to the Office of Management and Budget 

(OMB) a request for review and 

approval of the information collection 

listed below. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 30-days of the date of this 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project, 

contact: Ms. Mikia P. Currie, Program 

Analyst, Office of Policy for Extramural 

Research Administration, 6705 

Rockledge Drive, Suite 350, Bethesda, 

Maryland 20892, or call a non-toll-free 

number 301–435–0941 or email your 

request, including your address to 

ProjectClearanceBranch@mail.nih.gov. 

Formal requests for additional plans and 

instruments must be requested in 

writing. 

SUPPLEMENTARY INFORMATION: This 

proposed information collection was 

previously published in the Federal 

Register on May 22, 2024, pages 45001– 

45003 (89 FR 45001) and allowed 60 

days for public comment. No public 

comments were received. The purpose 

of this notice is to allow an additional 

30 days for public comment. 

The Office of the Director (OD), Office 

of Extramural Research (OER), National 

Institutes of Health (NIH), may not 

conduct or sponsor, and the respondent 

is not required to respond to, an 

information collection that has been 

extended, revised, or implemented on or 

after October 1, 1995, unless it displays 

a currently valid Office of Management 

and Budget (OMB) control number. 

In compliance with Section 

3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, NIH has 

submitted to OMB a request for review 

and approval of the information 

collection listed below. 

Proposed Collection Title: Public 

Health Service (PHS) Applications and 


lotter on DSK11XQN23PROD with NOTICES1