Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices 32951 

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 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, TURALIO 

(pexidartinib), indicated for treatment of 

adult patients with symptomatic 

tenosynovial giant cell tumor associated 

with severe morbidity or functional 

limitations and not amenable to 

improvement with surgery. Subsequent 

to this approval, the USPTO received 

patent term restoration applications for 

TURALIO (U.S. Patent Nos. 7,893,075; 

8,461,169; and 9,169,250) from 

Plexxikon Inc. and the USPTO 

requested FDA’s assistance in 

determining the patents’ eligibility for 

patent term restoration. In a letter dated 

May 8, 2020, FDA advised the USPTO 

that this human drug product had 

undergone a regulatory review period 

and that the approval of TURALIO 

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 

TURALIO is 3,637 days. Of this time, 

3,394 days occurred during the testing 

phase of the regulatory review period, 

while 243 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: August 19, 

2009. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on August 19, 2009. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 505 

of the FD&C Act: December 3, 2018. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

TURALIO (NDA 211810) was initially 

submitted on December 3, 2018. 

3. The date the application was 

approved: August 2, 2019. FDA has 

verified the applicant’s claim that NDA 

211810 was approved on August 2, 

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 1,664 days, 1,244 

days or 810 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 16, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–13186 Filed 6–22–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings 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, 


jbell on DSKJLSW7X2PROD with NOTICES
32952 Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Small 

Business: SBIR/STTR Commercialization 

Readiness Pilot (CRP) Program. 

Date: July 15, 2021. 

Time: 9:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Allen Richon, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6184, 

MSC 7892, Bethesda, MD 20892, 301–379– 

9351, allen.richon@nih.hhs.gov. 

Name of Committee: Infectious Diseases 

and Immunology B Integrated Review Group; 

HIV Coinfections and HIV Associated 

Cancers Study Section. 

Date: July 15, 2021. 

Time: 9:30 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Jingsheng Tuo, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3196, 

Bethesda, MD 20892, 301–451–5953, tuoj@

csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Fellowship: 

Infectious Diseases and Immunology Panel C. 

Date: July 15–16, 2021. 

Time: 9:30 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Shahrooz Vahedi, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 810G, 

Bethesda, MD 20892, (301) 496–9322, 

vahedis@mail.nih.gov. 

Name of Committee: Infectious Diseases 

and Immunology B Integrated Review Group; 

HIV Immunopathogenesis and Vaccine 

Development Study Section. 

Date: July 15–16, 2021. 

Time: 10:00 a.m. to 8:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Shiv A. Prasad, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5220, 

MSC 7852, Bethesda, MD 20892, 301–443– 

5779, prasads@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Topics in Reproductive Biology. 

Date: July 16, 2021. 

Time: 11:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Yunshang Piao, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6184, 

Bethesda, MD 20892, (301) 402–8402, 

piaoy3@mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Infectious 

Diseases and Immunology Research 

Enhancement Review. 

Date: July 19, 2021. 

Time: 9:30 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Liangbiao Zheng, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3202, 

MSC 7808, Bethesda, MD 20892, 301–996– 

5819, zhengli@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Human Complex Mental Function. 

Date: July 19, 2021. 

Time: 1:00 p.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Pamela Jeter, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 10J08, 

Bethesda, MD 20892, (301) 435–2591, 

pamela.jeter@nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Topics in infectious diseases 

vaccines, therapeutics and vector biology. 

Date: July 20, 2021. 

Time: 9:30 a.m. to 7:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Rockledge II, 6701 Rockledge Drive, 

Bethesda, MD 20892 (Virtual Meeting). 

Contact Person: Gagan Pandya, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, RM 3200, 

MSC 7808, Bethesda, MD 20892, 301–435– 

1167, pandyaga@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: June 17, 2021. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2021–13184 Filed 6–22–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Center for Substance Abuse 

Treatment; Notice of Meeting 

Pursuant to Public Law 92–463, 

notice is hereby given that the 

Substance Abuse and Mental Health 

Services Administration’s (SAMHSA) 

Center for Substance Abuse Treatment 

(CSAT) National Advisory Council 

(NAC) will meet on August 12, 2021, 

1:00 p.m.–4:30 p.m. (EDT). 

The meeting is open to the public and 

will include consideration of minutes 

from the SAMHSA CSAT NAC meeting 

of March 31, 2021; an update on CSAT 

activities; a discussion with SAMHSA 

leadership; and discussion of recovery 

and recovery support. Interested 

persons may present data, information, 

or views, orally or in writing, on issues 

pending before the Council. Written 

submissions should be forwarded to the 

contact person on or before August 6, 

2021. Oral presentations from the public 

will be scheduled at the conclusion of 

the meeting. Individuals interested in 

making oral presentations must notify 

the contact person on or before August 

6, 2021. Five minutes will be allotted for 

each presentation. 

The meeting will be conducted via 

WebEx and telephone only, and 

registration is required to participate 

during this me. To attend virtually, or 

to obtain the call-in number and access 

code, submit written or brief oral 

comments, or request special 

accommodations for persons with 

disabilities, please register on-line at 

http://snacregister.samhsa.gov/ 

MeetingList.aspx, or communicate with 

the CSAT National Advisory Council 

Designated Federal Officer; Tracy Goss 

(see contact information below). 

Meeting information and a roster of 

Council members may be obtained by 

accessing the SAMHSA Committee 

website at http://www.samhsa.gov/ 

about-us/advisory-councils/csatnational-advisory-council or by 

contacting the CSAT National Advisory 

Council Designated Federal Officer. 

Council Name: SAMHSA’s Center for 

Substance Abuse Treatment National 

Advisory Council. 

Date/Time/Type: August 12, 2021, 

1:00 p.m.–4:30 p.m. EDT, OPEN. 

Place: SAMHSA, 5600 Fishers Lane, 

Rockville, Maryland 20857. 

Contact: Tracy Goss, Designated 

Federal Officer, CSAT National 

Advisory Council, 5600 Fishers Lane, 

Rockville, Maryland 20857 (mail), 


jbell on DSKJLSW7X2PROD with NOTICES