Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishment and Operation of Clinical Trial Data Monitoring Committees, 47505-47507 [2021-18235]
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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 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.
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:
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.
khammond on DSKJM1Z7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
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
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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
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.
SUMMARY:
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.
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 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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
47505
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;
E:\FR\FM\25AUN1.SGM
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47506
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
314.50(d)(5)(ii)).
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 812.150(b)(1)). 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 FDA’s
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 FDA’s
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 0910–0014; 21 CFR 314.50 has
been approved under OMB control
number 0910–0001; and 21 CFR 812.35
and 812.150 have been approved under
OMB control number 0910–0078.
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 1—ESTIMATED ANNUAL REPORTING BURDEN 1
khammond on DSKJM1Z7X2PROD with NOTICES
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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47507
Federal Register / Vol. 86, No. 162 / Wednesday, August 25, 2021 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Section of guidance/recordkeeping activity
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
4.1. and 6.4—SOPs for DMCs ............................................
4.4.3.2.—DMC meeting records ..........................................
37
370
1
1
37
370
8
2
296
740
Total ..............................................................................
........................
........................
........................
........................
1,036
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
4.4.1.2.—Sponsor notification to the DMC regarding
waivers.
4.4.3.2.—DMC reports of meeting minutes to the
sponsor.
Total ....................................................................
1 There
Total annual
disclosures
Average burden
per disclosure
Total hours
1
1
1
0.25 (15 minutes) ...
0.25
370
2
740
1 .............................
740
........................
..........................
........................
................................
740.25
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: August 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–18235 Filed 8–24–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
[Docket No. TSA–2004–19147]
Intent To Request Revision From OMB
of One Current Public Collection of
Information: Flight Training Security
Transportation Security
Administration, DHS.
ACTION: 60-Day notice.
AGENCY:
The Transportation Security
Administration (TSA) invites public
comment on one currently approved
Information Collection Request (ICR),
Office of Management and Budget
(OMB) control number 1652–0021, that
we will submit to OMB for a revision,
in compliance with the Paperwork
Reduction Act (PRA). The ICR describes
the nature of the information collection
and its expected burden. The collection
involves information necessary to
conduct security threat assessments for
all non-U.S. citizens, non-U.S.
nationals, and other designated
individuals seeking flight instruction
(‘‘candidates’’) from Federal Aviation
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
disclosures per
respondent
Number of
respondents
Section of guidance/disclosure activity
VerDate Sep<11>2014
16:54 Aug 24, 2021
Jkt 253001
Administration (FAA)-certified flight
training providers. Pursuant to statute,
TSA will use the information collected
to determine whether a candidate poses
or is suspected of posing a threat to
aviation or national security, and is thus
prohibited from receiving flight training.
Additionally, flight training providers
are required to conduct a security
awareness training program for their
employees and to maintain records
associated with this training.
DATES: Send your comments by October
25, 2021.
ADDRESSES: Comments may be emailed
to TSAPRA@dhs.gov or delivered to the
TSA PRA Officer, Information
Technology (IT), TSA–11,
Transportation Security Administration,
6595 Springfield Center Drive,
Springfield, VA 20598–6011.
FOR FURTHER INFORMATION CONTACT:
Christina A. Walsh at the above address,
or by telephone (571) 227–2062.
SUPPLEMENTARY INFORMATION:
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid OMB control
number. The ICR documentation will be
available at https://www.reginfo.gov
upon its submission to OMB. Therefore,
in preparation for OMB review and
approval of the following information
collection, TSA is soliciting comments
to—
(1) Evaluate whether the proposed
information requirement is necessary for
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
the proper performance of the functions
of the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including using
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Information Collection Requirement
OMB Control Number 1652–0021,
Flight Training Security. Under 49 CFR
part 1552, TSA conducts security threat
assessments for all non-U.S. citizens,
non-U.S. nationals, and other
designated individuals seeking flight
instruction with Federal Aviation
Administration (FAA)-certified flight
training providers.1 The purpose of this
requirement is to ensure flight training
candidates do not pose a threat to
aviation or national security and thus
can be permitted to receive flight
training. The collection of information
required under 49 CFR part 1552
includes candidates’ biographic
information and fingerprints, which
TSA uses to perform the security threat
assessment.
Additionally, flight training providers
are required to maintain records of
security awareness training provided to
their employees. See subpart B of 49
CFR part 1552. This training, which is
1 See
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also 49 U.S.C. 44939.
25AUN1
]]>Agencies
[Federal Register Volume 86, Number 162 (Wednesday, August 25, 2021)]
[Notices]
[Pages 47505-47507]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18235]
-----------------------------------------------------------------------
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,
[email protected].
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 (Sec. 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;
[[Page 47506]]
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 314.50(d)(5)(ii)).
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 (Sec. 312.32) and
unanticipated adverse device effects in the case of device trials (21
CFR 812.150(b)(1)). 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 Third-Party 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 FDA's 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 FDA's 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 0910-0014; 21 CFR 314.50 has been approved under OMB
control number 0910-0001; and 21 CFR 812.35 and 812.150 have been
approved under OMB control number 0910-0078.
In the Federal Register of April 29, 2021 (86 FR 22690), we
published a 60-day 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 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Section of guidance/reporting activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
5.--Sponsor reporting to FDA on DMC 37 1 37 0.50 (30 minutes)........................ 18.5
recommendations related to safety.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 18.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 47507]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Section of guidance/ Number of records per Total annual per Total hours
recordkeeping activity recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
4.1. and 6.4--SOPs for DMCs..... 37 1 37 8 296
4.4.3.2.--DMC meeting records... 370 1 370 2 740
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 1,036
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Section of guidance/disclosure activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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4.4.1.2.--Sponsor notification to the DMC 1 1 1 0.25 (15 minutes)....................... 0.25
regarding waivers.
4.4.3.2.--DMC reports of meeting minutes to 370 2 740 1....................................... 740
the sponsor.
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Total.................................... .............. ............... .............. ........................................ 740.25
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: August 5, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18235 Filed 8-24-21; 8:45 am]
BILLING CODE 4164-01-P
