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Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices
provide disclosure to all DMC
members of any potential conflicts that are not thought to impede objectivity and, thus, would not preclude service on the DMC;
identify and disclose any concurrent service of any DMC member on other DMCs of the same, related, or competing products;
ensure separation, and designate a different statistician to advise on the management of the trial, if the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC; and minimize the risks of bias that are associated with an arrangement under which the primary trial statistician takes on the responsibility for interim analysis and reporting to the DMC, if it appears infeasible or highly impractical for any other statistician to take over responsibilities related to trial management.
3. DMC Meeting Records The Agency recommends in the guidance that the DMC or the group preparing the interim reports to the DMC maintain all meeting records. This information should be submitted to FDA
with the clinical study report 21 CFR
314.50d5ii.
4. Sponsor Notification to the DMC
Regarding Waivers The sponsor must report to FDA
certain serious and unexpected adverse events in drugs and biologics trials 312.32 and unanticipated adverse device effects in the case of device trials 21 CFR 812.150b1. The Agency recommends in the guidance that sponsors notify DMCs about any waivers granted by FDA for expedited reporting of certain serious events.
5. DMC Reports of Meeting Minutes to the Sponsor The Agency recommends in the guidance that DMCs should issue a written report to the sponsor based on the DMC meeting minutes. Reports to the sponsor should include only those data generally available to the sponsor.

The sponsor may convey the relevant information in this report to other interested parties, such as study investigators. Meeting minutes or other information that include discussion of confidential data would not be provided to the sponsor.
Description of the Respondents: The submission and data collection recommendations described in this document affect sponsors of clinical trials and DMCs.
Burden Estimate: Table 1 of this document provides the burden estimate of the annual reporting burden for the information to be submitted in accordance with the guidance. Table 2
of this document provides the burden estimate of the annual recordkeeping burden for the information to be maintained in accordance with the guidance. Table 3 of this document provides the burden estimate of the annual third-party disclosure burden for the information to be submitted in accordance with the guidance.
Reporting, Recordkeeping, and ThirdParty Disclosure Burdens: Based on information from FDA review divisions, FDA estimates that there are approximately 740 clinical trials with DMCs regulated by the Center for Biologics Evaluation and Research, the Center for Drugs Evaluation and Research, and the Center for Devices and Radiological Health. FDA estimates that the average length of a clinical trial is 2 years, resulting in an annual estimate of 370 clinical trials. Because FDA has no information on which to project a change in the use of DMCs, FDA estimates that the number of clinical trials with DMCs will not change significantly. For purposes of this information collection, FDA
estimates that each sponsor is responsible for approximately 10 trials, resulting in an estimated 37 sponsors that are affected by the guidance annually.
Based on information provided to FDA by sponsors that have typically used DMCs for the kinds of studies for which this guidance recommends them, FDA estimates that the majority of
sponsors have already prepared SOPs for DMCs, and only a minimum amount of time is necessary to revise or update them for use for other clinical studies.
FDA receives very few requests for waivers regarding expedited reporting of certain serious events; therefore, FDA
has estimated one respondent per year to account for the rare instance a request may be made. Based on FDAs experience with clinical trials using DMCs, FDA estimates that the sponsor on average would issue two interim reports per clinical trial to the DMC.
FDA estimates that the DMCs would hold two meetings per year per clinical trial resulting in the issuance of two DMC reports of meeting minutes to the sponsor. One set of both of the meeting records should be maintained per clinical trial.
The Average Burden per Response and Average Burden per Recordkeeping are based on FDAs experience with comparable recordkeeping and reporting provisions applicable to FDA regulated industry.
The Average Burden per Response includes the time the respondent would spend reviewing, gathering, and preparing the information to be submitted to the DMC, FDA, or the sponsor. The Average Burden per Recordkeeping includes the time to record, gather, and maintain the information.
The information collection provisions in the guidance for 21 CFR 312.30, 312.32, 312.38, 312.55, and 312.56 have been approved under OMB control number 09100014; 21 CFR 314.50 has been approved under OMB control number 09100001; and 21 CFR 812.35
and 812.150 have been approved under OMB control number 09100078.
In the Federal Register of April 29, 2021 86 FR 22690, we published a 60day notice requesting public comment on the proposed collection of information. No comments were received.
We estimate the burden of the information collection as follows:

TABLE 1ESTIMATED ANNUAL REPORTING BURDEN 1

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Section of guidance/reporting activity
Number of respondents
Number of responses per respondent
Total annual responses
Average burden per response
Total hours
5.Sponsor reporting to FDA on DMC recommendations related to safety.

37

1

37

0.50 30 minutes

18.5

Total

18.5

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

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