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Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices 5,503 INDs from 3,717 sponsors; 142
NDAs from 111 applicants; 3,285
supplements to NDAs from 516
applicants; 35 biologic license applications BLAs from 32 applicants;
777 supplements to BLAs from 89
applicants; 743 ANDAs from 239
applicants; and 11,438 supplements to
applicants approximately 8 hours to prepare a claim for a categorical exclusion and approximately 3,400
hours to prepare an EA. Based on recent numbers, we now estimate a total of 21,936 annual responses and 219,584
hours for human drugs an increase of 6,489 responses and 62,088 hours.

ANDAs from 482 applicants. FDA
estimates that it receives approximately 21,923 claims for categorical exclusions as required under 25.15a and d and 13 EAs as required under 25.40a and c. Based on information provided by the pharmaceutical industry, FDA
estimates that it takes sponsors or
TABLE 1ESTIMATED ANNUAL REPORTING BURDEN FOR HUMAN DRUGS 1
Number of respondents
21 CFR section
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
25.15a andd
25.40a and c

5,186
14

4.2273
0.9285

21,923
13

8
3,400

175,384
44,200

Total

219,584

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.

III. Estimated Annual Reporting Burden for Medical Devices Under 814.20b11 21 CFR
814.20b11, premarket approval applications PMAs original PMAs and supplements must contain a claim for categorical exclusion under 25.30 or 25.34 21 CFR 25.34 or an EA under
25.40. In 2020, FDA received an average of 62 claims original PMAs and supplements for categorical exclusions as required under 25.15a and d, and 0 EAs as required under 25.40a and c. FDA estimates that approximately 62 respondents will submit an average of 1 application for categorical exclusion annually. Based on
information provided by sponsors, FDA
estimates that it takes approximately 6
hours to prepare a claim for a categorical exclusion. Based on recent numbers, we now estimate a total of 62
annual responses and 372 hours for medical devices an increase of 12
responses and 72 hours.

TABLE 2ESTIMATED ANNUAL REPORTING BURDEN FOR MEDICAL DEVICES 1
21 CFR section
Number of respondents
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
25.15a and d

62

1

62

6

372

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.

IV. Estimated Annual Reporting Burden for Biological Products, Drugs, and Medical Devices in the Center for Biologics Evaluation and Research Under 21 CFR 601.2a, BLAs as well as INDs 312.23, NDAs 314.50, ANDAs 314.94, and PMAs 814.20
must contain either a claim of categorical exclusion under 25.30 or 25.32 21 CFR 25.32 or an EA under 25.40. Annually, FDA receives approximately 11 BLAs from 11
applicants, 1,080 BLA supplements to license applications from 160
applicants, 7,017 INDs from 2,087

sponsors, 1 NDA from 1 applicant, 16
supplements to NDAs from 6 applicants, 1 ANDA from 1 applicant, 3
supplements to ANDAs from 2
applicants, 1 PMA from 1 applicant, and 79 PMA supplements from 19
applicants. FDA estimates that approximately 10 percent of these supplements would be submitted with a claim for categorical exclusion or an EA.
FDA estimates that it has received approximately 7,150 claims for categorical exclusion as required under 25.15a and d annually and 4 EAs as required under 25.40a and c annually. Therefore, FDA estimates that
approximately 3,575 respondents will submit an average of 2 applications for categorical exclusion, and 4 respondents will submit an average of 1 EA. Based on information provided by industry, FDA estimates that it takes sponsors and applicants approximately 8 hours to prepare a claim of categorical exclusion and approximately 3,400 hours to prepare an EA for a biological product.
Based on recent numbers, we now estimate a total of 7,154 annual responses and 70,800 hours for biological products an increase of 6,658
responses and 60,048 hours.

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TABLE 3ESTIMATED ANNUAL REPORTING BURDEN FOR BIOLOGICAL PRODUCTS 1
Number of respondents
21 CFR section
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
25.15a and d
25.40a andc

3,575
4

2
1

7,150
4

8
3,400

57,200
13,600

Total

70,800

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.

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