47504 Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices 

V. Estimated Annual Reporting Burden 

for Animal Drugs 

Under 21 CFR 514.1(b)(14), new 

animal drug applications (NADAs) and 

abbreviated new animal drug 

applications (ANADAs); supplemental 

NADAs and ANADAs (21 CFR 

514.8(a)(1)); investigational new animal 

drug applications (INADs) and generic 

investigational new animal drug 

applications (JINADs) (21 CFR 

511.1(b)(10)); and food additive 

petitions (21 CFR 571.1(c)) must contain 

a claim for categorical exclusion under 

§ 25.30 or § 25.32 or an EA under 

§ 25.40. Annually, FDA’s Center for 

Veterinary Medicine has received 

approximately 1,140 claims for 

categorical exclusion as required under 

§ 25.15(a) and (d) and 9 EAs as required 

under § 25.40(a) 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 4—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

25.15(a) and (d) ................................................................... 114 10 1,140 3 3,420 

25.40(a) and (c) ................................................................... 9 1 9 2,160 19,440 

Total .............................................................................. ........................ ........................ ........................ ........................ 22,860 

1There 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 0910–0673; the burden 

for PMTAs are currently approved 

under OMB control number 0910–0768; 

the burden for SE exemptions are 

currently approved under OMB control 

number 0910–0684. 

FDA’s 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 FDA’s 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 5—ESTIMATED 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 

25.40(a) and (c) ................................................................... 14 1 14 80 1,120 

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

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. 2021–18239 Filed 8–24–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–1216] 

Electronic Common Technical 

Document; Data Standards; 

Specifications for the Electronic 

Common Technical Document 

Validation Criteria 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (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.’’ 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices 47505 

FOR FURTHER INFORMATION CONTACT: 

Jonathan Resnick, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, Rm. 3160, 

Silver Spring, MD 20993–0002, 301– 

796–7997, 

Jonathan.Resnick@fda.hhs.gov: or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: FDA is 

issuing this Federal Register notice to 

announce that eCTD validations 1306 

and 1323, described in ‘‘Specifications 

for eCTD Validation Criteria,’’ have been 

raised to high validation errors. 

Beginning March 1, 2022, FDA will 

reject submissions that fail either of 

these validations. 

According to the guidance for 

industry entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Certain Human Pharmaceutical Product 

Applications and Related Submissions 

Using the eCTD Specifications,’’ 

submissions subject to section 745A(a) 

of the Federal Food, Drug, and Cosmetic 

Act must be submitted in eCTD format 

using the version of eCTD currently 

supported by FDA (unless such 

submission is exempt from the 

electronic submission requirements or if 

FDA has granted a waiver). The version 

of eCTD currently supported by FDA is 

specified in the Data Standards Catalog. 

eCTD submissions must follow FDA 

eCTD technical specification entitled 

‘‘The Comprehensive Table of Contents 

Headings and Hierarchy.’’ Documents 

which are not properly referenced in the 

eCTD backbone as described in the ‘‘M2 

eCTD: Electronic Common Technical 

Document Specification’’ and ‘‘The 

eCTD Backbone Files Specification for 

Module 1,’’ result in content that is not 

accessible within FDA eCTD technical 

specification ‘‘The Comprehensive 

Table of Contents Headings and 

Hierarchy.’’ eCTD validations 1306 (‘‘No 

leaf element for file’’) and 1323 (‘‘No file 

for leaf element’’), within the 

‘‘Specifications for eCTD Validation 

Criteria,’’ describe parts of the eCTD 

specifications which were not followed 

correctly. Rejection for failing to pass 

either eCTD validations 1306 or 1323 

will begin on March 1, 2022. 

Dated: August 18, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–18303 Filed 8–24–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0356] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Establishment and 

Operation of Clinical Trial Data 

Monitoring Committees 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by September 

24, 2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0581. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Establishment and Operation of 

Clinical Trial Data Monitoring 

Committees 

OMB Control Number 0910–0581— 

Extension 

This collection of information 

supports Agency regulations and 

associated Agency guidance. Sponsors 

are required to monitor studies 

evaluating new drugs, biologics, and 

devices (21 CFR 312.50 and 312.56 for 

drugs and biologics, and 21 CFR 812.40 

and 812.46 for devices). Various 

individuals and groups play different 

roles in clinical trial monitoring. One 

such group is a data monitoring 

committee (DMC), appointed by a 

sponsor to evaluate the accumulating 

outcome data in some trials. A clinical 

trial DMC is a group of individuals with 

pertinent expertise that reviews on a 

regular basis accumulating data from 

one or more ongoing clinical trials. The 

DMC advises the sponsor regarding the 

continuing safety of current trial 

subjects and those yet to be recruited to 

the trial, as well as the continuing 

validity and scientific merit of the trial. 

The guidance document entitled 

‘‘Guidance for Clinical Trial Sponsors: 

Establishment and Operation of Clinical 

Trial Data Monitoring Committees’’ 

(March 2006) is intended to assist 

sponsors of clinical trials in determining 

when a DMC is needed for monitoring 

a study and how such committees 

should operate and is available from our 

website at: https://www.fda.gov/media/ 

75398/download. The guidance 

addresses the roles, responsibilities, and 

operating procedures of DMCs and 

describes certain reporting and 

recordkeeping responsibilities, 

including the following: (1) Sponsor 

reporting to FDA on DMC 

recommendations related to safety; (2) 

standard operating procedures (SOPs) 

for DMCs; (3) DMC meeting records; (4) 

sponsor notification to the DMC 

regarding waivers; and (5) DMC reports 

based on meeting minutes to the 

sponsor. 

1. Sponsor Reporting to FDA on DMC 

Recommendations Related to Safety 

The requirement of the sponsor to 

report DMC recommendations related to 

serious adverse events in an expedited 

manner in clinical trials of new drugs 

(§ 312.32(c)) (21 CFR 312.32(c)) would 

not apply when the DMC 

recommendation is related to an excess 

of events not classifiable as serious. 

Nevertheless, the Agency recommends 

in the guidance that sponsors inform 

FDA about all recommendations related 

to the safety of the investigational 

product whether or not the adverse 

event in question meets the definition of 

‘‘serious.’’ 

2. SOPs for DMCs 

In the guidance, FDA recommends 

that sponsors establish procedures to do 

the following things: 

• Assess potential conflicts of interest 

of proposed DMC members; 

• ensure that those with serious 

conflicts of interest are not included in 

the DMC; 


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