Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, 79689-79691 [2011-32776]
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Federal Register / Vol. 76, No. 246 / Thursday, December 22, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0908]
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.
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 either electronic or
written comments on the collection of
information by February 21, 2012.
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: Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
7726, Ila.Mizrachi@fda.hhs.gov.
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.
jlentini on DSK4TPTVN1PROD with NOTICES
SUMMARY:
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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
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 referenced in
this 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
PO 00000
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79689
the DMC regarding waivers, (2) DMC
reports based on meeting minutes to the
sponsor, (3) sponsor reports to 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
certain serious and unexpected adverse
events in drugs and biologics trials
(§ 312.32 (21 CFR 312.32)) and
unanticipated adverse device effects in
the case of device trials (§ 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 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.
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.’’
4. 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;
• 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;
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Federal Register / Vol. 76, No. 246 / Thursday, December 22, 2011 / Notices
• 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.
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)).
a. Description of Respondents: The
submission and data collection
recommendations described in this
document affect sponsors of clinical
trials and DMCs.
b. 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.
c. 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 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 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. 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 §§ 312.30, 312.32,
312.38, 312.55, and 312.56 have been
approved under OMB control number
0910–0014; § 314.50 has been approved
under OMB control number 0910–0001;
and §§ 812.35 and 812.150 have been
approved under OMB control number
0910–0078.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of respondents
Section of guidance/reporting activity
Number of responses per
respondent
1
1
1
370
2
740
37
1
37
4.4.1.2. Sponsor notification to the DMC regarding waivers. ..................................................................................
4.4.3.2. DMC reports of meeting minutes to the sponsor
5. Sponsor reporting to FDA on DMC recommendations
related to safety ..............................................................
Total ............................................................................
1 There
........................
Average
burden per
response
Total annual
responses
........................
........................
Total hours
0.25
(15 min.)
1
0.25
740
0.50
(30 min.)
18.5
........................
758.75
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
jlentini on DSK4TPTVN1PROD with NOTICES
Section of guidance/recordkeeping activity
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
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.
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79691
Federal Register / Vol. 76, No. 246 / Thursday, December 22, 2011 / Notices
Dated: December 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
collection of information to OMB for
review and clearance.
[FR Doc. 2011–32776 Filed 12–21–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0508]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Blood
Establishment Registration and
Product Listing, Food and Drug
Administration Form 2830
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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: Fax written comments on the
collection of information by January 23,
2012.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax:
(202) 395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0052. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Ila
S. Mizrachi, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, (301) 796–
7726, Ila.Mizrachi@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
FOR FURTHER INFORMATION CONTACT:
Blood Establishment Registration and
Product Listing, FDA Form 2830—21
CFR Part 607 (OMB Control Number
0910–0052)—Extension
Under section 510 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
360), any person owning or operating an
establishment that manufactures,
prepares, propagates, compounds, or
processes a drug or device must register
with the Secretary of Health and Human
Services, on or before December 31 of
each year, his or her name, place of
business, and all such establishments,
and must submit, among other
information, a listing of all drug or
device products manufactured,
prepared, propagated, compounded, or
processed by him or her for commercial
distribution. In part 607 (21 CFR part
607), FDA has issued regulations
implementing these requirements for
manufacturers of human blood and
blood products.
Section 607.20(a), in brief, requires
owners or operators of certain
establishments that engage in the
manufacture of blood products to
register and to submit a list of every
blood product in commercial
distribution. Section 607.21, in brief,
requires the owners or operators of
establishments entering into the
manufacturing of blood products to
register within 5 days after beginning
such operation and to submit a list of
every blood product in commercial
distribution at the time. If the owner or
operator of the establishment has not
previously entered into such operation
for which a license is required,
registration must follow within 5 days
after the submission of a biologics
license application. In addition, owners
or operators of all establishments so
engaged must register annually between
November 15 and December 31 and
must update their blood product listing
information every June and December.
Section 607.22 requires the use of FDA
Form 2830 (Blood Establishment
Registration and Product Listing) for
initial registration, subsequent annual
registration, and for blood product
listing information. Section 607.25 sets
forth the information required for
establishment registration and blood
product listing. Section 607.26, in brief,
requires certain changes to be submitted
on FDA Form 2830 as an amendment to
establishment registration within 5 days
of such changes. Section 607.30(a), in
brief, sets forth the information required
from owners or operators of
establishments when updating their
blood product listing information every
June and December, or at the discretion
of the registrant at the time the change
occurs. Section 607.31 requires that
additional blood product listing
information be provided upon FDA
request. Section 607.40, in brief,
requires certain foreign blood product
establishments to comply with the
establishment registration and blood
product listing information
requirements discussed earlier in this
document and to provide the name and
address of the establishment and the
name of the individual responsible for
submitting establishment registration
and blood product listing information as
well as the name, address, and phone
number of its U.S. agent.
Among other uses, this information
assists FDA in its inspections of
facilities, and its collection is essential
to the overall regulatory scheme
designed to ensure the safety of the
Nation’s blood supply. FDA Form 2830
is used to collect this information.
Respondents to this collection of
information are human blood and
plasma donor centers, blood banks,
certain transfusion services, other blood
product manufacturers, and
independent laboratories that engage in
quality control and testing for registered
blood product establishments.
FDA estimates the burden of this
collection of information based upon
information obtained from FDA’s Center
for Biologics Evaluation and Research’s
database and FDA experience with the
blood establishment registration and
product listing requirements.
In the Federal Register of August 8,
2011 (76 FR 48167), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
jlentini on DSK4TPTVN1PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
49
1
49
1
49
2,589
1
2,589
0.5
(30 min.)
1,295
Number of
respondents
21 CFR Section
FDA Form 2830
607.20(a), 607.21, 607.22,
607.25, and 607.40.
607.21, 607.22, 607.25, 607.26,
607.31, and 607.40.
Initial registration ........................
Re-registration ............................
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]]>Agencies
[Federal Register Volume 76, Number 246 (Thursday, December 22, 2011)]
[Notices]
[Pages 79689-79691]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-32776]
[[Page 79689]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0908]
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 either electronic or written comments on the collection
of information by February 21, 2012.
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: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850, (301) 796-7726, Ila.Mizrachi@fda.hhs.gov.
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 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 referenced in this 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 based on meeting minutes to
the sponsor, (3) sponsor reports to 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 certain serious and unexpected
adverse events in drugs and biologics trials (Sec. 312.32 (21 CFR
312.32)) and unanticipated adverse device effects in the case of device
trials (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 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.
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. 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;
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;
[[Page 79690]]
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.
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)).
a. Description of Respondents: The submission and data collection
recommendations described in this document affect sponsors of clinical
trials and DMCs.
b. 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.
c. 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 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 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. 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
Sec. Sec. 312.30, 312.32, 312.38, 312.55, and 312.56 have been
approved under OMB control number 0910-0014; Sec. 314.50 has been
approved under OMB control number 0910-0001; and Sec. Sec. 812.35 and
812.150 have been approved under OMB control number 0910-0078.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Section of guidance/reporting Number of responses per Total annual burden per Total hours
activity respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
4.4.1.2. Sponsor notification to 1 1 1 0.25 0.25
the DMC regarding waivers...... (15 min.)
4.4.3.2. DMC reports of meeting 370 2 740 1 740
minutes to the sponsor.........
5. Sponsor reporting to FDA on 37 1 37 0.50 18.5
DMC recommendations related to (30 min.)
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\
----------------------------------------------------------------------------------------------------------------
Number of Average
Section of guidance/ Number of records per Total annual burden 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.
[[Page 79691]]
Dated: December 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32776 Filed 12-21-11; 8:45 am]
BILLING CODE 4160-01-P
