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Federal Register / Vol. 77, No. 186 / Tuesday, September 25, 2012 / Notices

sequences in their devices, and
incorporate the result of these analyses
into their quality management system,
as required by 21 CFR 820.100(a)(1).
These analyses will be evaluated against
the device design validation and risk
analysis required by 21 CFR 820.30(g),
to determine if any design changes may
be necessary.

FDA estimates that 10 respondents
will be affected annually. Each
respondent will collect this information
twice per year; each response is
estimated to take 15 hours. This results
in a total data collection burden of 300
hours. The guidance also refers to
previously approved information
collections found in FDA regulations.
The collections of information in 21

CFR 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 807 subpart E have been approved
under OMB control number 0910–0120;
and the collections of information in 21
CFR part 820 have been approved under
OMB control number 0910–0073.
FDA estimates the burden of this
collection of information as follows:

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
FD&C Act section

Number of
recordkeepers

Number of
records per
recordkeeper

Total annual
records

Average
burden per
recordkeeping

513(g) ...................................................................................

10

2

20

15

1 There

Availability.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
7726, [email protected].
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.

[FR Doc. 2012–23544 Filed 9–24–12; 8:45 am]
BILLING CODE 4160–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0597]

Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Draft Guidance for
Industry: Oversight of Clinical
Investigations: A Risk-Based
Approach to Monitoring
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 October 25,
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
[email protected]. All
comments should be identified with the
OMB control number 0910–New and
title ‘‘Draft Guidance for Industry on
Oversight of Clinical Investigations: A
Risk-Based Approach to Monitoring;
SUMMARY:

emcdonald on DSK67QTVN1PROD with NOTICES

300

are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: September 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.

AGENCY:

Total hours

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14:15 Sep 24, 2012

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Draft Guidance for Industry: Oversight
of Clinical Investigations: A Risk-Based
Approach to Monitoring—(OMB
Control Number 0910–New)
Description of Respondents:
Respondents to this collection of
information are sponsors that monitor
clinical investigations.
Burden Estimate: The draft guidance
is intended to assist sponsors of clinical
investigations in developing risk-based
monitoring strategies and plans for
investigational studies of medical
products, including human drug and
biological products, medical devices,
and combinations thereof. The guidance
is intended to make clear that sponsors
can use a variety of approaches to fulfill
their responsibilities related to
monitoring investigator conduct and the
progress of investigational new drug
(IND) or investigational device
exemption (IDE) studies. The guidance
describes strategies for monitoring
activities performed by a sponsor, or
contract research organizations (CROs),
that focus on the conduct, oversight,
and reporting of findings of an
investigation by clinical investigators.
The guidance recommends strategies
that reflect a risk-based approach to
monitoring that focuses on critical study
parameters and relies on a combination
of monitoring activities to oversee a

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study effectively. The guidance
specifically encourages greater reliance
on centralized monitoring methods,
where appropriate.
Sponsors are required to provide
appropriate oversight of their clinical
investigations to ensure adequate
protection of the rights, welfare, and
safety of human subjects and the quality
and integrity of the resulting data
submitted to FDA.1 As part of this
oversight, sponsors of clinical
investigations are required to monitor
the conduct and progress of their
clinical investigations.2 3 The
regulations are not specific about how
sponsors are to conduct monitoring of
clinical investigations and, therefore,
are compatible with a range of
approaches to monitoring. FDA
currently has OMB approval for the
information collection required under
part 812 (OMB control number 0910–
0078) and part 312, including certain
provisions under subpart D (OMB
control number 0910–0014).
However, the collections of
information associated with this draft
guidance that are not currently
approved under OMB control numbers
0910–0014 or 0910–0078 are as follows:
Development of Comprehensive
Monitoring Plan: Section IV.D of the
draft guidance recommends that
sponsors develop a prospective, detailed
monitoring plan that describes the
monitoring methods, responsibilities,
1 Part 312 (21 CFR part 312), subpart D, generally
(Responsibilities of Sponsors and Investigators) and
part 812 (21 CFR part 812), subpart C, generally
(Responsibilities of Sponsors).
2 Section 312.50 requires a sponsor to, among
other things, ensure ‘‘proper monitoring of the
investigation(s)’’ and ‘‘that the investigation(s) is
conducted in accordance with the general
investigational plan and protocols contained in the
IND.’’
3 Also see §§ 312.53(d), 312.56(a), 812.40, and
812.43(d).

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Federal Register / Vol. 77, No. 186 / Tuesday, September 25, 2012 / Notices
and requirements for each clinical trial.
The plan should provide those involved
in monitoring with adequate
information to effectively carry out their
duties. All sponsor and CRO personnel
who may be involved with monitoring,
including those who review and/or
determine appropriate action regarding
potential issues identified through
monitoring, should review the
monitoring plan. The components of a
monitoring plan are described in the
draft guidance, including monitoring
plan amendments (i.e., the review and
revision of monitoring plans and
processes for timely updates). FDA
understands that sponsors currently
develop monitoring plans; however, not
all monitoring plans contain all the
elements described in the guidance.
Therefore, our following burden
estimate provides the additional time
that a sponsor would expend in
developing a comprehensive monitoring
plan based on the recommendations in
the guidance. We estimate that
approximately 88 sponsors will develop
approximately 132 comprehensive
monitoring plans in accordance with the
draft guidance, and that the added
burden for each plan will be
approximately 4 hours to develop,
including the time needed for preparing
monitoring plan amendments when
appropriate (a total of 528 hours).
Voluntary Submission of Monitoring
Plans to FDA: Section IV.D of the draft
guidance permits sponsors to
voluntarily and prospectively submit
their monitoring plans to the
appropriate Center for Drug Evaluation
and Research (CDER) review division
and request input from the division’s

clinical trial oversight component
(sponsors of significant risk device
studies are already required under
§ 812.25(e) to submit and maintain
written procedures for monitoring). We
estimate that approximately 22 sponsors
will submit approximately 33
monitoring plans to CDER for feedback
and that each submission will take
approximately 2 hours to complete (a
total of 66 hours).
In the Federal Register of August 29,
2011 (76 FR 53683), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. The following is a
summary of the comments and FDA’s
response to the comments for the two
collections of information associated
with the draft guidance that are not
currently approved by OMB.
Development of Comprehensive
Monitoring Plan:
FDA received comments that the
guidance lacks specific information on
development and initialization of risk
assessment plans, appropriate
mitigation plans, and execution of
mitigation plans through the monitoring
plan. Addition of use of risk
management tools, along with potential
applications for using risk-based
monitoring strategies would help
facilitate implementation.
In response to the comments, FDA
included additional detail in the final
guidance in an effort to enhance the
quality, utility, and clarity of the
information collected. Specifically, FDA
included additional detail on the
development of a monitoring plan,
which focuses on the important and
likely risks, identified by the risk

58999

assessment, to critical data and
processes. In addition, FDA included
additional guidance on the steps
involved in performing a risk
assessment and references to tools and
methodologies that can be used to
perform a risk assessment. FDA clarified
that the guidance does not provide
comprehensive detail on how to
perform a risk assessment.
FDA received several comments that
the guidance should specify that it is
acceptable for monitoring plans to
reference existing standard operating
procedures (SOPs) or other documents.
The draft guidance specifies that a
monitoring plan may reference existing
policies and procedures in order to
minimize the burden of the collection of
information.
Voluntary Submission of Monitoring
Plans to FDA:
FDA received numerous comments
that the lack of specific details about
FDA review of the monitoring plans
early enough in the IND process could
delay startup of clinical trials. In
addition, numerous comments
requested a detailed process or
procedure.
Although the draft guidance stated
that CDER was considering establishing
processes through which sponsors could
voluntarily submit monitoring plans for
CDER feedback, CDER has concluded
that CDER does not have the resources
necessary to commit to such a review at
this time. CDER is exploring the
possibility of a pilot program in this
area in the future.
FDA estimates the burden of this
collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Draft guidance on monitoring clinical investigations

Number of
respondents

Number of
responses per
respondent

Total annual
responses

Average
burden per
response

Total hours

Development of Comprehensive Monitoring Plan ...............

88

1.5

132

4

528

1 There

are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: September 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–23545 Filed 9–24–12; 8:45 am]

emcdonald on DSK67QTVN1PROD with NOTICES

BILLING CODE 4160–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0938]

Draft Guidance for Industry on
Abbreviated New Drug Applications:
Stability Testing of Drug Substances
and Products; Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

VerDate Mar<15>2010

14:15 Sep 24, 2012

Jkt 226001

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Notice.

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The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘ANDAs: Stability
Testing of Drug Substances and
Products.’’ FDA is recommending that
generic drug manufacturers follow the
stability testing recommendations in the
International Conference on
Harmonisation (ICH) guidances
Q1A(R2) through Q1E. The use of these
ICH recommendations will standardize
FDA’s stability testing policies, which
will help make the abbreviated new

SUMMARY:

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