40250 Federal Register / Vol. 87, No. 128 / Wednesday, July 6, 2022 / Notices 

biologics license application (BLA) for 

VYEPTI (BLA 761119) was initially 

submitted on February 21, 2019. 

3. The date the application was 

approved: February 21, 2020. FDA has 

verified the applicant’s claim that BLA 

761119 was approved on February 21, 

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 637 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 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14350 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1768] 

Advisory Committee; Pharmacy 

Compounding Advisory Committee; 

Renewal 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice; renewal of federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Pharmacy Compounding 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Pharmacy 

Compounding Advisory Committee for 

an additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until the April 25, 2024, 

expiration date. 

DATES: Authority for the Pharmacy 

Compounding Advisory Committee will 

expire on April 25, 2024, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Takyiah Stevenson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 240– 

402–2507, PCAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3, FDA is announcing 

the renewal of the Pharmacy 

Compounding Advisory Committee (the 

Committee). The Committee is a nondiscretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to compounding drugs for human 

use and, as required, any other product 

for which FDA has regulatory 

responsibility. 

The Committee shall provide advice 

on scientific, technical, and medical 

issues concerning drug compounding 

under sections 503A and 503B of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 353a and 353b), and, as 

required, any other product for which 

FDA has regulatory responsibility, and 

make appropriate recommendations to 

the Commissioner of Food and Drugs. 

The Committee shall consist of a core 

of 12 voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

pharmaceutical compounding, 

pharmaceutical manufacturing, 

pharmacy, medicine, and related 

specialties. These members will include 

representatives from the National 

Association of Boards of Pharmacy, the 

U.S. Pharmacopeia, pharmacists with 

current experience and expertise in 

compounding, physicians with 

background and knowledge in 

compounding, and patient and public 

health advocacy organizations. Members 

will be invited to serve for overlapping 

terms of up to 4 years. Non-Federal 

members of this committee will serve as 

Special Government Employees, 

representatives, or Ex-Officio members. 

Federal members will serve as Regular 

Government Employees or Ex-Officios. 

The core of voting members may 

include one or more technically 

qualified members, selected by the 

Commissioner or designee, who are 

identified with consumer interests and 

are recommended by either a 

consortium of consumer-oriented 

organizations or other interested 

persons. In addition to the voting 

members, the Committee may include 

one or more non-voting representative 

members who are identified with 

industry interests. There may also be an 

alternate industry representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

pharmacy-compounding-advisorycommittee/pharmacy-compoundingadvisory-committee-charter or by 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: June 24, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14346 Filed 7–5–22; 8:45 am] 

BILLING CODE 4164–01–P 


jspears on DSK121TN23PROD with NOTICES1