30952 Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices 

drug application became effective was 

on December 29, 2009. 

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): April 30, 2019. FDA has 

verified the applicant’s claim that the 

biologics license application (BLA) for 

SARCLISA (BLA 761113) was initially 

submitted on April 30, 2019. 

3. The date the application was 

approved: March 2, 2020. FDA has 

verified the applicant’s claim that BLA 

761113 was approved on March 2, 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 86 or 1,596 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 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12189 Filed 6–9–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2014–N–1031, FDA– 

2013–N–0878, FDA–2014–N–0998, FDA– 

2014–N–1076, FDA–2013–N–0520, FDA– 

2017–N–6397, FDA–2014–N–1030, and FDA– 

2020–N–1228] 

Agency Information Collection 

Activities; Announcement of Office of 

Management and Budget Approvals 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of information collections that have 

been approved by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

following is a list of FDA information 

collections recently approved by OMB 

under section 3507 of the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507). 

The OMB control number and 

expiration date of OMB approval for 

each information collection are shown 

in table 1. Copies of the supporting 

statements for the information 

collections are available on the internet 

at http://www.reginfo.gov/public/do/ 

PRAMain. An Agency may not conduct 

or sponsor, and a person is not required 

to respond to, a collection of 

information unless it displays a 

currently valid OMB control number. 

TABLE 1—LIST OF INFORMATION

COLLECTIONS APPROVED BY OMB 

Title of collection 

OMB 

control 

number 

Date 

approval 

expires 

FDA recall regulations ................. 0910–0249 5/31/2024 

Premarket Notification for a New 

Dietary Ingredient ................. 0910–0330 5/31/2024 

Regulations for In 

Vivo Radiopharmaceuticals 

Used for Diagnosis and Monitoring ................ 0910–0409 5/31/2024 

TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB— 

Continued 

Title of collection 

OMB 

control 

number 

Date 

approval 

expires 

Formal Dispute 

Resolution; Scientific and 

Technical 

Issues Related 

to Pharmaceutical Current 

Good Manufacturing Practice .. 0910–0563 5/31/2024 

Substances Prohibited From 

Use in Animal 

Food or Feed ... 0910–0627 5/31/2024 

Food Labeling; 

Calorie Labeling 

of Articles of 

Food in Vending 

Machines and 

Nutrition Labeling of Standard 

Menu Items in 

Restaurants and 

Similar Retail 

Food Establishments ............... 0910–0782 5/31/2024 

Food Allergen Labeling and Reporting .............. 0910–0792 5/31/2024 

Study of Multiple 

Indications in 

Direct-to-Consumer Television Advertisements ............... 0910–0897 5/31/2024 

Dated: June 4, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–12156 Filed 6–9–21; 8:45 am] 

BILLING CODE 4164–01–P 


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