Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, 54297-54299 [2015-22680]
Download as PDF
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
disputes related to an application for a
user fee product under any of the
available regulatory mechanisms (i.e.,
21 CFR 10.75, 312.48(c), 314.103(c)),
through the formal dispute resolution
process.
This revised draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on formal dispute
resolution requests for appeals above
the division level. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
II. The Paperwork Reduction Act of
1995
AGENCY:
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Lhorne on DSK5TPTVN1PROD with NOTICES
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm, or
https://www.regulations.gov.
14:19 Sep 08, 2015
Jkt 235001
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0908]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Guidance for
Clinical Trial Sponsors: Establishment
and Operation of Clinical Trial Data
Monitoring Committees
Food and Drug Administration,
HHS.
This revised draft guidance refers to
previously approved collections of
information that are subject to review by
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in this draft
guidance have been approved under
OMB control number 0910–0430. This
draft guidance is a revision of an earlier
version of the guidance. The revised
version contains no additional
information collections; therefore, it
continues to be covered under OMB
control number 0910–0430.
VerDate Sep<11>2014
[FR Doc. 2015–22678 Filed 9–8–15; 8:45 am]
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 October 9,
2015.
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 0910–0581. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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.
SUMMARY:
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,
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
54297
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 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
(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;
• 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;
E:\FR\FM\09SEN1.SGM
09SEN1
54298
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / 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.
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 Respondents: The
submission and data collection
recommendations described in this
document affect sponsors of clinical
trials and DMCs.
Burden Estimate: Table 1 provides the
burden estimate of the annual reporting
burden for the information to be
submitted in accordance with the
guidance. Table 2 provides the burden
estimate of the annual recordkeeping
burden for the information to be
maintained in accordance with the
guidance. Table 3 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 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. 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; § 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 March 27,
2015 (80 FR 16402), 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:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
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.
Lhorne on DSK5TPTVN1PROD with NOTICES
Section of guidance/reporting activity
37
1
37
0.5 (30 min.) .........
18.5
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
14:19 Sep 08, 2015
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Fmt 4703
Sfmt 4703
E:\FR\FM\09SEN1.SGM
09SEN1
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
54299
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
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.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
Section of guidance/disclosure activity
Total annual
disclosures
Average burden
per disclosure
Total hours
4.4.1.2. Sponsor notification to the DMC regarding
waivers.
4.4.3.2. DMC reports of meeting minutes to the sponsor.
1
1
1
0.25 (15 minutes) ..
0.25
370
2
740
1 ............................
740
Total ......................................................................
........................
........................
........................
...............................
740.25
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
prevention and care of HIV disease and
AIDS. The functions of the Council are
solely advisory in nature.
DATES: All nominations must be
received no later than 5:00 p.m. (ET) on
October 9, 2015 at the address listed
below.
[FR Doc. 2015–22680 Filed 9–8–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Nominations to the Presidential
Advisory Council on HIV/AIDS
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
The Office of the Assistant
Secretary for Health (OASH) is seeking
nominations of qualified individuals to
be considered for appointment as
members of the Presidential Advisory
Council on HIV/AIDS (PACHA). The
PACHA is a federal advisory committee
within the Department of Health and
Human Services (HHS). Management
support for the activities of this Council
is the responsibility of the OASH. The
qualified individuals will be nominated
to the Secretary of Health and Human
Services for consideration for
appointment as members of the PACHA.
Members of the Council, including the
Chair, are appointed by the Secretary.
Members are invited to serve on the
Council for up to four-year terms. The
Council was established to provide
advice, information, and
recommendations to the Secretary
regarding programs and policies
intended to promote effective
Lhorne on DSK5TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
14:19 Sep 08, 2015
Jkt 235001
All nominations should be
mailed or delivered to Ms. B. Kaye
Hayes, Executive Director, PACHA,
Department of Health and Human
Services, Office of HIV/AIDS and
Infectious Disease Policy, 200
Independence Avenue SW., Room 443–
H, Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: Ms.
Caroline Talev, Public Health Analyst,
Presidential Advisory Council on HIV/
AIDS, Department of Health and Human
Services, 200 Independence Avenue
SW., Room 443–H, Hubert H. Humphrey
Building, Washington, DC 20201; (202)
205–1178. More detailed information
about PACHA can be obtained by
accessing the Council’s page at the
AIDS.gov Web site at www.aids.gov/
pacha.
ADDRESSES:
PACHA
was established by Executive Order
12963, dated June 14, 1995, as amended
by Executive Order 13009, dated June
14, 1996. The Council was established
to provide advice, information, and
recommendations to the Secretary
regarding programs and policies
intended to promote effective
prevention and care of HIV disease and
AIDS. The functions of the Council are
solely advisory in nature.
The Council consists of not more than
25 members. Council members are
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
and AIDS, public health, global health,
philanthropy, marketing or business, as
well as other national leaders held in
high esteem from other sectors of
society. Council members are appointed
by the Secretary or designee, in
consultation with the White House
Office on National AIDS Policy.
Pursuant to advance written agreement,
Council members shall receive no
stipend for the advisory service they
render as members of PACHA. However,
as authorized by law and in accordance
with federal travel regulations, PACHA
members may receive per diem and
reimbursement for travel expenses
incurred in relation to performing duties
for the Council.
This announcement is to solicit
nominations of qualified candidates to
fill current vacancies on the PACHA.
Nominations: In accordance with the
PACHA charter, persons nominated for
appointment as members of the PACHA
should be among prominent community
leaders and authorities with particular
expertise in, or knowledge of, matters
concerning HIV and AIDS, public
health, global health, philanthropy,
marketing or business, as well as other
national leaders held in high esteem
from other sectors of society. The
following information should be
included in the package of material
submitted for each individual being
nominated for consideration of
appointment:
• Name, return address, daytime
telephone number, and affiliation(s) of
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54297-54299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22680]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0908]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 October
9, 2015.
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 0910-0581.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
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 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 (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;
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 54298]]
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 Respondents: The submission and data collection
recommendations described in this document affect sponsors of clinical
trials and DMCs.
Burden Estimate: Table 1 provides the burden estimate of the annual
reporting burden for the information to be submitted in accordance with
the guidance. Table 2 provides the burden estimate of the annual
recordkeeping burden for the information to be maintained in accordance
with the guidance. Table 3 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 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. 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; Sec. 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 March 27, 2015 (80 FR 16402), 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:
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 0.5 (30 min.)......................... 18.5
recommendations related to safety.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 54299]]
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Section of guidance/recordkeeping activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
Number of disclosures Total annual
Section of guidance/disclosure activity respondents per disclosures Average burden per disclosure Total hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 the 370 2 740 1....................................... 740
sponsor.
---------------------------------------------------------------------------------------------------------
Total..................................... .............. .............. .............. ........................................ 740.25
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: September 3, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22680 Filed 9-8-15; 8:45 am]
BILLING CODE 4164-01-P