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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices TABLE 2ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of recordkeepers
Awardee activity
Number of records per recordkeeper
Total annual records
Average burden per recordkeeping
Total hours
Records related to Initial Report
Records related to Progress Reports Records related to Supplement or Followup Report if applicable.

400
400
100

1
2 1

400
800
100

0.5 hour 30 minutes
0.5 hour 30 minutes
0.5 hour 30 minutes

200
400
50

Total

650

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

Recordkeeping activities include storing and maintaining records related to submitting a request to participate in the project and compiling reports.
Respondents should use current record
retention capabilities for electronic or paper storage to achieve these activities.
We assume it will take 0.5 hour/year to ensure the documents related to submitting a request to participate in the
program are retained properly according to their existing recordkeeping policies, but no less than 3 years, as recommended by FDA table 2.

TABLE 3ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of respondents
Awardee activity
Coordination with partnering entities related to Initial Report
Coordination with partnering entities related to Progress Reports
Coordination with partnering entities related to Supplement or Followup Report if applicable
Total
1 There
Total annual disclosures
Average burden per disclosure
Total hours
300

2

600

8

4,800

300

4

1,200

8

9,600

100

2

200

8

1,600

16,000

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

For those pilot projects that involve a participant composed of partnering entities in the program, FDA is taking into consideration the time that partnering entities will spend coordinating with each other in a pilot project. We estimate that 300
respondents will work with their respective partnering entities and the average number of partnering entities will be 2. We assume each respondent will spend 8 hours coordinating with each partnering entity on each response for this pilot. We estimate that seven respondents will need to coordinate with an average of two partnering entities to create progress reports and the final report to submit to FDA table 3.
Dated: July 26, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
jbell on DSKJLSW7X2PROD with NOTICES

Number of disclosures per respondent
FR Doc. 202116192 Filed 72821; 8:45 am
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2018D1216

Electronic Study Data Submission;
Data Standards; Technical Rejection Criteria for Study Data Effective Date AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

The Food and Drug Administrations FDA or Agency Center for Biologics Evaluation and Research CBER and Center for Drug Evaluation and Research CDER are announcing the effective date for Electronic Common Technical Document eCTD validations referenced in FDAs Technical Rejection Criteria for Study Data TRC.

SUMMARY:

The eCTD validations will become applicable on September 15, 2021.

DATES:

BILLING CODE 416401P

You may submit either electronic or written comments at any time as follows:

ADDRESSES:

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Electronic Submissions Submit electronic comments in the following way:
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.

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