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Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices
V. Estimated Annual Reporting Burden for Animal Drugs Under 21 CFR 514.1b14, new animal drug applications NADAs and abbreviated new animal drug applications ANADAs; supplemental NADAs and ANADAs 21 CFR
514.8a1; investigational new animal drug applications INADs and generic investigational new animal drug applications JINADs 21 CFR

511.1b10; and food additive petitions 21 CFR 571.1c must contain a claim for categorical exclusion under 25.30 or 25.32 or an EA under 25.40. Annually, FDAs Center for Veterinary Medicine has received approximately 1,140 claims for categorical exclusion as required under 25.15a and d and 9 EAs as required under 25.40a and c. Assuming an average of 10 claims per respondent, FDA estimates that approximately 114

respondents will submit an average of 10 claims for categorical exclusion. FDA
further estimates that nine respondents will submit an average of one EA. FDA
estimates that it takes sponsors/
applicants approximately 3 hours to prepare a claim of categorical exclusion and an average of 2,160 hours to prepare an EA. Based on recent numbers, we now estimate a total of 22,860 hours for animal drugs a decrease of 27,090
hours.

TABLE 4ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 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 and c

114
9

10
1

1,140
9

3
2,160

3,420
19,440

Total

22,860

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

VI. Estimated Annual Reporting Burden for Tobacco Products Under sections 905, 910, and 911 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 387e, 387j, and 387k, product applications and supplements, premarket tobacco applications PMTAs, substantial equivalence SE, exemption from SE, and modified risk tobacco product applications MRTPAs must contain a claim for categorical exclusion or an EA. The majority of the EA burden for tobacco products is covered under already existing
information collections. The burden for SEs is currently approved under OMB
control number 09100673; the burden for PMTAs are currently approved under OMB control number 09100768;
the burden for SE exemptions are currently approved under OMB control number 09100684.
FDAs estimates are based on actual report data from fiscal year FY 2018 to FY 2020. On average, FDA estimated it received approximately 14 MRTPAs from 14 respondents. Based on updated data for this collection, FDA estimates 14 EAs from 14 respondents. A total of
14 respondents will submit an average of one application for environmental assessment. Based on FDAs experience, previous information provided by potential sponsors, and knowledge that part of the EA information has already been produced in one of the tobacco product applications, FDA estimates that it takes approximately 80 hours to prepare an EA. Based on recent MRTPA
numbers, we now estimate a total of 14
annual responses and 1,120 hours for tobacco products a decrease of 13
responses and 1,040 hours.

TABLE 5ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
21 CFR section
Number of respondents
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
25.40a and c

14

1

14

80

1,120

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

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FDA estimates the burden for this information collection to be 30,315
annual responses, and 314,736 hours.
These estimates reflect an overall increase of 13,463 responses and 94,078
hours. These adjustments are attributed to an increase in the number of responses the various centers in FDA
have received over the last few years.
Dated: August 6, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202118239 Filed 82421; 8:45 am BILLING CODE 416401P

VerDate Sep<11>2014

16:54 Aug 24, 2021

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2018D1216

Electronic Common Technical Document; Data Standards;
Specifications for the Electronic Common Technical Document Validation Criteria AGENCY:

Food and Drug Administration,
HHS.
ACTION:

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The Food and Drug Administrations FDA or Agency Center for Drug Evaluation and Research CDER and Center for Biologics Evaluation and Research CBER are announcing the date that FDA will begin rejecting submissions which fail Electronic Common Technical Document eCTD validations 1306 or 1323 that have been raised to high validation errors as described in the Specifications for eCTD Validation Criteria.

SUMMARY:

PO 00000

Notice.

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