Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, 58970-58972 [E8-23833]
Download as PDF
<![CDATA[
58970
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices
ANNUAL BURDEN ESTIMATES
45 CFR Part 1301 ...........................................................................
Estimated Total Annual Burden
Hours: 10,000.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. E-mail address:
infocollection@acf.hhs.gov. All requests
should be identified by the title of the
information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Dated: October 3, 2008.
Janean Chambers,
Reports Clearance Officer.
[FR Doc. E8–23798 Filed 10–7–08; 8:45 am]
jlentini on PROD1PC65 with NOTICES
BILLING CODE 4184–01–P
VerDate Aug<31>2005
18:10 Oct 07, 2008
Jkt 217001
Number of
responses per
respondent
Number of
respondents
Instrument
2,500
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0521]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Clinical Trial Sponsors: Establishment
and Operation of Clinical Trial Data
Monitoring Committees
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information concerning
the establishment and operation of
clinical trial data monitoring
committees.
Submit written or electronic
comments on the collection of
information by December 8, 2008.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
DATES:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Average burden
hours per
response
2
2
Total burden
hours
10,000
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Clinical Trial Sponsors:
Establishment and Operation of
Clinical Trial Data Monitoring
Committees—(OMB Control Number
0910–0581)—Extension
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 an
E:\FR\FM\08OCN1.SGM
08OCN1
jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices
ongoing clinical trial. The DMC advises
the sponsor regarding the continuing
safety of current participants and those
yet to be recruited, as well as the
continuing validity and scientific merit
of the trial.
FDA’s guidance document 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. The
guidance addresses the roles,
responsibilities, and operating
procedures of DMCs, describes certain
reporting and recordkeeping
responsibilities, including the
following: (1) Sponsor notification to
the DMC regarding waivers, (2) DMC
reports of meeting minutes to the
sponsor, (3) sponsor reports to the FDA
on DMC recommendations related to
safety, (4) standard operating
procedures (SOPs) for DMCs, and (5)
DMC meeting records.
1. Sponsor Notification to the DMC
Regarding Waivers
The sponsor must report to FDA
serious unexpected adverse events in
drugs and biologics trials (§ 312.32 (21
CFR 312.32)) and unanticipated adverse
events in the case of device trials under
(§ 812.150(b)(1) (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.
2. DMC Reports of Meeting Minutes to
the Sponsor
The agency recommends in the
guidance that the DMC 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.
3. 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)) 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.’’
VerDate Aug<31>2005
18:10 Oct 07, 2008
Jkt 217001
4. Standard Operating Procedures for
DMCs
In the guidance, we recommend 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;
• 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
study statistician takes on the
responsibility for interim analysis and
reporting to the DMC; and
• Minimize the risks of bias that arise
when the primary study 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.
5. 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
(§ 314.50(d)(5)(ii) (21 CFR
314.50(d)(5)(ii))).
Description of 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.
Reporting and Recordkeeping Burdens
Based on information from FDA
review divisions, FDA estimates there
are approximately 740 clinical trials
with DMCs regulated by the Center for
Biologics Evaluation and Research, the
Center for Drug 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
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
58971
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 in the next few
years. 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. 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. 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 meeting
records should be maintained per
clinical trial.
The ‘‘Hours per Response’’ and
‘‘Hours per Record’’ are based on FDA’s
experience with comparable
recordkeeping and reporting provisions
applicable to FDA regulated industry.
The ‘‘Hours per Response’’ include the
time the respondent would spend
reviewing, gathering, and preparing the
information to be submitted to the DMC,
FDA, or the sponsor. The ‘‘Hours per
Record’’ include the time to record,
gather, and maintain the information.
The information collection provisions
in the guidance for §§ 312.30 (21 CFR
312.30), 312.32, 312.38 (21 CFR 312.38),
312.55 (21 CFR 312.55), and 312.56
have been approved under OMB Control
No. 0910–0014; § 314.50 has been
approved under OMB Control No. 0910–
0001; and §§ 812.35 (21 CFR 812.35)
and 812.150 have been approved under
OMB Control No. 0910–0078.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\08OCN1.SGM
08OCN1
58972
Federal Register / Vol. 73, No. 196 / Wednesday, October 8, 2008 / Notices
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of Guidance/Reporting
Activity
No. of
Respondents
Annual Frequency per
Response
4.4.1.2. Sponsor notification to
the DMC regarding waivers
Total Annual
Responses
Hours Per
Response
Total Hours
1
1
1
.25
.25
4.4.3.2. DMC reports of meeting
minutes to the sponsor
370
2
740
1
740
5. Sponsor reporting to FDA on
DMC recommendations related
to safety
37
1
37
.5
18.5
Total
758.75
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Recordkeeping Activity
Annual Frequency
per Recordkeeping
Total Annual
Records
Hours Per
Record
Total Hours
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 There
1,036
are no capital costs or operating and maintenance costs associated with this collection of information.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
Dated: September 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–23833 Filed 10–7–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jlentini on PROD1PC65 with NOTICES
Proposed Collection; Comment
Request; Information Program on
Clinical Trials: Maintaining a Registry
and Results Databank
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995 to
provide opportunity for public comment
on proposed data collection projects, the
National Library of Medicine (NLM), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
VerDate Aug<31>2005
18:10 Oct 07, 2008
Jkt 217001
Proposed Collection: Title:
Information Program on Clinical Trials:
Maintaining a Registry and Results
Databank; Type of Information
Collection Request: Revision of
currently approved collection [OMB No.
0925–0586, expiration date 01/31/2009],
Form Number: NA; Need and Use of
Information Collection: The National
Institutes of Health is modifying the
clinical trial registry databank
established under previous law
[FDAMA, Section 113] to comply with
provisions of Title VIII of Public Law
110–85 (Food and Drug Administration
Amendments Act of 2007). The
databank collects specified registration
and results information on certain
clinical trials identified in the law, with
the objective of enhancing patient
enrollment and providing a mechanism
for tracking subsequent progress of
clinical trials, to the benefit of public
health. The databank is widely used by
patients, physicians, and medical
researchers; in particular those involved
in clinical research studies. Public Law
110–85 expands the scope of clinical
trials that must be registered in
ClinicalTrials.gov, increases the clinical
trial information that must be submitted
as part of each registration, and requires
the submission of basic results
information for registered trials of
approved drugs, biologics and devices.
Frequency of Response: Responsible
parties must submit the required
registration information not later than
21 days after enrolling the first subject.
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
Results information is to be reported not
later than 12 months after the
completion date (as defined in the law),
but can be delayed under certain
circumstances. Updates to submitted
information are required at least once a
year, unless there are no changes to
report. Changes in recruitment status
and completion of a trial must be
reported not later than 30 days after
such events. Description of
Respondents: Respondents are referred
to in the law as ‘‘responsible parties,’’
and are defined as: (1) The sponsor of
the clinical trial (as defined in 21 CFR
50.3) or (2) the principal investigator of
such clinical trial if so designated by a
sponsor, grantee, contractor, or awardee,
provided that ‘‘the principal investigator
is responsible for conducting the trial,
has access to and control over the data
from the clinical trial, has the right to
publish the results of the trial, and has
the ability to meet all of the
requirements’’ for submitting
information under the law. Estimate of
Burden: The burden associated with this
information collection consists of two
parts: the burden associated with
registration of clinical trials; and the
burden associated with the reporting of
results information. In both cases, the
burden includes the time necessary to
extract information from the study
protocol or results record, reformat it,
enter it into the databank, and provide
necessary updating over the course of
the study. It is estimated that
registration information will be required
E:\FR\FM\08OCN1.SGM
08OCN1
]]>Agencies
[Federal Register Volume 73, Number 196 (Wednesday, October 8, 2008)]
[Notices]
[Pages 58970-58972]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23833]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0521]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Clinical Trial Sponsors: Establishment
and Operation of Clinical Trial Data Monitoring Committees
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the collection of information
concerning the establishment and operation of clinical trial data
monitoring committees.
DATES: Submit written or electronic comments on the collection of
information by December 8, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Clinical Trial Sponsors: Establishment and Operation of
Clinical Trial Data Monitoring Committees--(OMB Control Number 0910-
0581)--Extension
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 an
[[Page 58971]]
ongoing clinical trial. The DMC advises the sponsor regarding the
continuing safety of current participants and those yet to be
recruited, as well as the continuing validity and scientific merit of
the trial.
FDA's guidance document 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. The guidance addresses the roles,
responsibilities, and operating procedures of DMCs, describes certain
reporting and recordkeeping responsibilities, including the following:
(1) Sponsor notification to the DMC regarding waivers, (2) DMC reports
of meeting minutes to the sponsor, (3) sponsor reports to the FDA on
DMC recommendations related to safety, (4) standard operating
procedures (SOPs) for DMCs, and (5) DMC meeting records.
1. Sponsor Notification to the DMC Regarding Waivers
The sponsor must report to FDA serious unexpected adverse events in
drugs and biologics trials (Sec. 312.32 (21 CFR 312.32)) and
unanticipated adverse events in the case of device trials under (Sec.
812.150(b)(1) (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.
2. DMC Reports of Meeting Minutes to the Sponsor
The agency recommends in the guidance that the DMC 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.
3. 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)) 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.''
4. Standard Operating Procedures for DMCs
In the guidance, we recommend 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;
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 study
statistician takes on the responsibility for interim analysis and
reporting to the DMC; and
Minimize the risks of bias that arise when the primary
study 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.
5. 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 (Sec. 314.50(d)(5)(ii) (21 CFR 314.50(d)(5)(ii))).
Description of 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.
Reporting and Recordkeeping Burdens
Based on information from FDA review divisions, FDA estimates there
are approximately 740 clinical trials with DMCs regulated by the Center
for Biologics Evaluation and Research, the Center for Drug 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 in the next few years. 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. 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. 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 meeting records should be maintained
per clinical trial.
The ``Hours per Response'' and ``Hours per Record'' are based on
FDA's experience with comparable recordkeeping and reporting provisions
applicable to FDA regulated industry. The ``Hours per Response''
include the time the respondent would spend reviewing, gathering, and
preparing the information to be submitted to the DMC, FDA, or the
sponsor. The ``Hours per Record'' include the time to record, gather,
and maintain the information.
The information collection provisions in the guidance for
Sec. Sec. 312.30 (21 CFR 312.30), 312.32, 312.38 (21 CFR 312.38),
312.55 (21 CFR 312.55), and 312.56 have been approved under OMB Control
No. 0910-0014; Sec. 314.50 has been approved under OMB Control No.
0910-0001; and Sec. Sec. 812.35 (21 CFR 812.35) and 812.150 have been
approved under OMB Control No. 0910-0078.
FDA estimates the burden of this collection of information as
follows:
[[Page 58972]]
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours Per
Section of Guidance/Reporting Activity Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
4.4.1.2. Sponsor notification to the DMC regarding 1 1 1 .25 .25
waivers
--------------------------------------------------------------------------------------------------------------------------------------------------------
4.4.3.2. DMC reports of meeting minutes to the sponsor 370 2 740 1 740
--------------------------------------------------------------------------------------------------------------------------------------------------------
5. Sponsor reporting to FDA on DMC recommendations 37 1 37 .5 18.5
related to safety
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 758.75
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Recordkeeping Activity Recordkeepers per Recordkeeping Records Hours Per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
Dated: September 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-23833 Filed 10-7-08; 8:45 am]
BILLING CODE 4160-01-S
