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Federal Register / Vol. 86, No. 208 / Monday, November 1, 2021 / Notices
we will also code and compare responses across types of drug names.

FDA estimates the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
Activity
Number of responses per respondent
Average burden per response
Total annual responses
Total hours
General Consumer Population Pretest 1 screener assumes 80% eligible
Pretest 1 survey
Pretest 2 screener assumes 80% eligible
Pretest 2 survey
Main study screener completes assumes 80%
eligible.
Main study survey completes

22
15 + 10% 2 = 17
22
15 + 10% 2 = 17
413

1
1 1
1 1

22
15 + 10% 2 = 17
22
15 + 10% 2 = 17
413

0.08
0.33
0.08
0.33
0.08

5 minutes
20 minutes
5 minutes
20 minutes
5 minutes

1.8
5.6
1.8
5.6
33

300 + 10% 2 = 330

1

300 + 10% 2 = 330

0.33 20 minutes

108.9

PCP Population Pretest 1 screener assumes 30% eligible
Pretest 1 survey
Pretest 2 screener assumes 30% eligible
Pretest 2 survey
Main study screener completes assumes 30%
eligible.
Main study survey completes

57
15 + 10% 2 = 17
57
15 + 10% 2 = 17
1,100

1
1 1
1 1

57
15 + 10% 2 = 17
57
15 + 10% 2 = 17
1,100

0.08
0.33
0.08
0.33
0.08

5 minutes
20 minutes
5 minutes
20 minutes
5 minutes

4.6
5.6
4.6
5.6
88

300 + 10% 2 = 330

1

300 + 10% 2 = 330

0.33 20 minutes

108.9

Total

374

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 As with most online and mail surveys, it is always possible that some participants are in the process of completing the survey when the target number is reached and that those surveys will be completed and received before the survey is closed out. To account for this, we have estimated approximately 10 percent overage for both samples in the study.
Dated: October 22, 2021.
Lauren K. Roth, Associate Commissioner for Policy.

patent which claims that human drug product.

BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket Nos. FDA2020E1318, FDA
2020E1319, FDA2020E1320, FDA
2020E1321, FDA2020E1322, and FDA
2020E1323

Determination of Regulatory Review Period for Purposes of Patent Extension; VYONDYS 53
AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administration FDA or the Agency has determined the regulatory review period for VYONDYS 53 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office USPTO, Department of Commerce, for the extension of a
lotter on DSK11XQN23PROD with NOTICES1

SUMMARY:

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18:03 Oct 29, 2021

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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 January 3, 2022.
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 May 2, 2022. 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. Electronic comments must be submitted on or before January 3, 2022. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 3, 2022. Comments received by mail/hand delivery/courier for written/paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
DATES:

FR Doc. 202123731 Filed 102921; 8:45 am
Electronic Submissions Submit electronic comments in the following way:

PO 00000

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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 elses 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:
Mail/Hand Delivery/Courier for written/paper submissions: Dockets Management Staff HFA305, Food and
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