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Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices FOR FURTHER INFORMATION CONTACT:

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Jonathan Resnick, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3160, Silver Spring, MD 209930002, 301
7967997, 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 209930002, 2404027911.

Food and Drug Administration Docket No. FDA2021N0356

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Establishment and Operation of Clinical Trial Data Monitoring Committees AGENCY:

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 745Aa 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.

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SUPPLEMENTARY INFORMATION:

Dated: August 18, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202118303 Filed 82421; 8:45 am BILLING CODE 416401P

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Food and Drug Administration,
HHS.
ACTION:

Notice.

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 ReviewOpen for Public Comments or by using the search function. The OMB
control number for this information collection is 09100581. Also include the FDA docket number found in brackets in the heading of this document.
SUMMARY:

FOR FURTHER INFORMATION CONTACT:

Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017965733, PRAStaff@
fda.hhs.gov.
In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.

SUPPLEMENTARY INFORMATION:

Establishment and Operation of Clinical Trial Data Monitoring Committees OMB Control Number 09100581
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

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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 312.32c 21 CFR 312.32c 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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