Draft Guidance for Industry on Providing Submissions in Electronic Format-Summary Level Clinical Site Data for Center for Drug Evaluation and Research's Inspection Planning; Availability, 75174-75176 [2012-30510]
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Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices
contract with FDA, capable of
performing the technical analysis,
management assessment, and program
evaluation tasks required to address the
assessment as described in the MDUFA
III Commitment Letter. For Phase 1,
FDA will award the contract no later
than the end of the second quarter of
FY2013. Findings on high-priority
recommendations (i.e., those likely to
have a significant impact on review
times) will be published within 6
months of award; final comprehensive
findings and recommendations will be
published within 1 year of contract
award. FDA will publish an
implementation plan within 6 months
of receipt of each set of
recommendations. For Phase 2 of the
independent assessment, the contractor
will evaluate the implementation of
recommendations and publish a written
assessment no later than February 1,
2016.
The assessment will address FDA’s
premarket review process using an
assessment framework that draws from
appropriate quality system standards,
including, but not limited to,
management responsibility, document
controls and records management, and
corrective and preventive action.
The assessment will include, but not
be limited to, the following areas:
1. Identification of process
improvements and best practices for
conducting predictable, efficient, and
consistent premarket reviews that meet
regulatory review standards.
2. Analysis of elements of the review
process (including the presubmission
process, and investigational device
exemption, premarket notification
(510(k)), and premarket approval
application reviews) that consume or
save time to facilitate a more efficient
process. This includes analysis of root
causes for inefficiencies that may affect
review performance and total time to
decision. This will also include
recommended actions to correct any
failures to meet MDUFA goals. Analysis
of the review process will include the
impact of combination products,
companion diagnostic products, and
laboratory developed tests on the review
process.
3. Assessment of FDA methods and
controls for collecting and reporting
information on premarket review
process resource use and performance.
4. Assessment of effectiveness of
FDA’s Reviewer Training Program
implementation.
5. Recommendations for ongoing
periodic assessments and any
additional, more detailed or focused
assessments.
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16:35 Dec 18, 2012
Jkt 229001
FDA will incorporate findings and
recommendations, as appropriate, into
its management of the premarket review
program. FDA will analyze the
recommendations for improvement
opportunities identified in the
assessment, develop and implement a
corrective action plan, and assure its
effectiveness. FDA also will incorporate
the results of the assessment into a Good
Review Management Practices (GRMP)
guidance document. FDA’s
implementation of the GRMP guidance
will include initial and ongoing training
of FDA staff, and periodic audits of
compliance with the guidance.
FDA is seeking public comment now
on the proposed statement of work for
the assessment, available at https://
www.fda.gov/downloads/
MedicalDevices/
DeviceRegulationandGuidance/
Overview/MDUFAIII/UCM331516.pdf.
III. Comments
Interested persons may submit either
written comments regarding the
statement of work to the Division of
Dockets Management (see ADDRESSES) or
electronic comments to https://
www.regulations.gov. 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.
Dated: December 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–30511 Filed 12–18–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–1168]
Draft Guidance for Industry on
Providing Submissions in Electronic
Format—Summary Level Clinical Site
Data for Center for Drug Evaluation
and Research’s Inspection Planning;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Providing
Submissions in Electronic Format—
SUMMARY:
PO 00000
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Sfmt 4703
Summary Level Clinical Site Data for
CDER’s Inspection Planning.’’ The draft
guidance is intended to assist applicants
in the voluntary submission of a clinical
dataset that describes and summarizes
the characteristics and outcomes of
clinical investigations at the level of the
individual study site (summary level
clinical site dataset). The summary level
clinical site dataset is intended to
facilitate use of a risk-based approach to
timely identification of clinical
investigator sites for onsite inspection
by FDA during the review of marketing
applications. This draft guidance
describes a recommended electronic
format for the summary level clinical
site dataset to be submitted voluntarily
in new drug applications (NDAs),
biologics licensing applications (BLAs),
and NDA and BLA supplemental
applications submitted to FDA’s Center
for Drug Evaluation and Research
(CDER).
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 19,
2013.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul
Okwesili, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 5353, Silver Spring,
MD 20993–0002, 301–796–0173.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Providing Submissions in Electronic
Format—Summary Level Clinical Site
Data for CDER’s Inspection Planning.’’
FDA is responsible for making
regulatory decisions about drugs and
E:\FR\FM\19DEN1.SGM
19DEN1
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices
biological products after reviewing
clinical safety and efficacy data
submitted in support of NDAs, BLAs,
and NDA and BLA supplements
submitted to CDER (BLAs submitted to
and reviewed by CDER as described in
the Federal Register of June 26, 2003
(68 FR 38067), available at https://
www.fda.gov/downloads/AboutFDA/
CentersOffices/
OfficeofMedicalProductsandTobacco/
CBER/UCM186799.pdf). CDER’s
Bioresearch Monitoring Program has
specific responsibility for verifying the
integrity of data submitted to FDA in
support of new NDAs and BLAs and
supplements, and for determining
whether clinical trials are conducted in
compliance with applicable FDA
regulations and statutory requirements,
including those intended to ensure the
rights and welfare of human research
subjects.
sroberts on DSK5SPTVN1PROD with
A. Site Inspections
As part of the application review
process, FDA may conduct onsite
inspections of clinical investigators,
sponsors, contract research
organizations, and institutional review
boards. The study-related information in
applications is critical to FDA’s
selection of clinical investigator sites for
inspection. However, the current
submission format for the data does not
facilitate efficient site selection. Thus,
CDER is requesting submission of a
structured, summary-level clinical site
dataset.
B. Summary Level Clinical Site Dataset
CDER recently initiated a pilot
program evaluating a risk-based model
for selecting clinical investigators for
inspection. This model permits
evaluation of an array of risk parameters
across clinical investigator sites
associated with marketing applications.
The summary level clinical site
dataset:
• Contains data from all relevant
studies used to support evaluation of
the application, including studies
supportive of various treatment
indications; and
• Presents the characteristics and
outcomes of the study at the site level.
The data requested in the summary
level clinical site dataset comprise data
elements currently collected under
regulations in 21 CFR part 312 and
maintained, tabulated, and submitted
under regulations in 21 CFR part 314,
specifically § 314.50(d)(5) Clinical data
section and § 314.50(f) Case report
forms and tabulations or in 21 CFR part
601, specifically § 601.2 Applications
for biologic licenses; procedures for
filing.
VerDate Mar<15>2010
16:35 Dec 18, 2012
Jkt 229001
The electronic submission of a
summary level clinical site dataset is
intended to facilitate FDA’s timely
selection of clinical investigator sites for
inspection to evaluate the integrity of
the data submitted in the application or
supplement.
This 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 Agency’s current thinking
on this topic. It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Comments
Interested persons may submit either
written comments regarding this
document to the Division of Dockets
Management (see ADDRESSES) or
electronic comments regarding to https://
www.regulations.gov. 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.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (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 that 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 for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this draft
guidance, FDA invites comments on the
following topics: (1) Whether the
proposed information collected is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
PO 00000
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75175
burden of the proposed information
collected, including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information collected; and
(4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
The draft guidance recommends an
electronic format for a summary level
clinical site dataset to be submitted
voluntarily in NDAs, BLAs, and NDA
and BLA supplemental applications
submitted to CDER. The summary level
clinical site dataset is intended to
facilitate use of a risk-based approach to
timely identification of clinical
investigator sites for on-site inspection
by FDA during the review of marketing
applications.
The summary level dataset comprises
information required in parts 312, 314,
or 601, including case histories
(§ 312.62(b)), information regarding
foreign clinical studies not conducted
under an investigational new drug
application (IND) (§ 312.120), and the
clinical data section (§ 314.50(d)(5)) and
case report forms and tabulations
(§ 314.50(f)), or in part 601 (§ 601.2
Applications for biologic licenses;
procedures for filing) in an NDA, BLA,
or supplement. The draft guidance
recommends that the data be submitted
electronically in a format that will
facilitate site selection. The variables
described in the format are elements
currently used in other submissions;
some of the variable names are new. The
financial disclosure information is
currently reported in Module 1 (region
specific information) of the electronic
common technical document, but is
new as a variable in a dataset. In
addition, identifying that a study has
been conducted under an IND is new as
a request in a dataset. Initial preparation
of the summary level clinical site
dataset and the development of new
standard operating procedures (SOPs)
would require additional time. Once
SOPs have been established, generation
of the dataset should not involve
significant additional work. The
applicant would likely perform
additional quality assurance, which may
add time to preparation and review of
the submission.
Based on CDER’s data on the number
of applications, including supplements,
that would be covered by the draft
guidance, we estimate that each year
approximately 75 applicants will
voluntarily submit for 96 applications
the summary level clinical site dataset
in electronic format as recommended by
E:\FR\FM\19DEN1.SGM
19DEN1
75176
Federal Register / Vol. 77, No. 244 / Wednesday, December 19, 2012 / Notices
the draft guidance. We estimate that the
submission of each summary level
clinical site dataset will take
approximately 26 hours to prepare.
Initial preparation of the summary
level clinical site dataset would involve
the development of new SOPs for the
preparation of the summary level
clinical site dataset. We estimate that 75
applicants would take approximately 12
hours to develop and subsequently 1
hour annually to maintain and update
the SOP(s). The summary level clinical
site dataset submitted with each
application would likely involve
additional quality assurance procedures,
which would add approximately 1 hour
for each submission.
This draft guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in part
312 have been approved under OMB
control number 0910–0014; the
collections of information in part 314
have been approved under OMB control
number 0910–0001.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1
Number of
respondents
(i.e.
applicants)
Activity
Number of responses per
respondent
(i.e., applications)
Total
responses
Hours per
response
Total hours
Summary Level Clinical Site Dataset Submissions .............
Dataset Quality Assurance ..................................................
75
75
1.3
1.3
96
96
26
1
2,496
96
Total ..............................................................................
........................
........................
........................
........................
2,592
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Number of
records per
recordkeeper
Total records
Hours per
recordkeeper
Total hours
Develop Initial SOP(s) .........................................................
Maintain and Update SOP(s) ...............................................
75
75
1
1
75
75
12
1
900
75
Total ..............................................................................
........................
........................
........................
........................
975
1 There
are no capital costs or operating and maintenance costs associated with this information collection.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either http:
//www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–30510 Filed 12–18–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0548]
Drug Safety and Risk Management
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSK5SPTVN1PROD with
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public. This meeting is being
VerDate Mar<15>2010
18:26 Dec 18, 2012
Jkt 229001
rescheduled due to the postponement of
the October 29–30, 2012, Drug Safety
and Risk Management Advisory
Committee meeting due to
unanticipated weather conditions
caused by Hurricane Sandy.
Name of Committee: Drug Safety and
Risk Management Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on January 24, 2013, from 8 a.m.
to 6 p.m., and January 25, 2013, from 8
a.m. to 5 p.m. This meeting is a
reschedule of a postponed meeting
announced in the Federal Register of
June 8, 2012 (77 FR 34051–34052),
originally scheduled for October 29–30,
2012.
ADDRESSES: FDA has opened a docket
for public comment on this meeting.
The docket number is FDA–2012–N–
0548. The docket opened for public
comment on June 8, 2012. The docket
will close on February 1, 2013.
Interested persons may submit either
electronic or written comments
regarding this meeting. Submit
electronic comments to https://
www.regulations.gov. Submit written
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments received will be posted
without change, including any personal
information provided. 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.
Comments received on or before January
9, 2013, will be provided to the
committee before the meeting. Any
comments received for the originally
scheduled October 29 and 30, 2012,
Drug Safety and Risk Management
Advisory Committee meeting will be
provided to the committee. It is not
necessary to resubmit any comments
previously submitted to the docket. If a
comment originally submitted to the
docket is resubmitted prior to January 9,
2013, both comments will be provided
to the committee.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD, 20993–
E:\FR\FM\19DEN1.SGM
19DEN1
]]>Agencies
[Federal Register Volume 77, Number 244 (Wednesday, December 19, 2012)]
[Notices]
[Pages 75174-75176]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30510]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-1168]
Draft Guidance for Industry on Providing Submissions in
Electronic Format--Summary Level Clinical Site Data for Center for Drug
Evaluation and Research's Inspection Planning; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Providing
Submissions in Electronic Format--Summary Level Clinical Site Data for
CDER's Inspection Planning.'' The draft guidance is intended to assist
applicants in the voluntary submission of a clinical dataset that
describes and summarizes the characteristics and outcomes of clinical
investigations at the level of the individual study site (summary level
clinical site dataset). The summary level clinical site dataset is
intended to facilitate use of a risk-based approach to timely
identification of clinical investigator sites for onsite inspection by
FDA during the review of marketing applications. This draft guidance
describes a recommended electronic format for the summary level
clinical site dataset to be submitted voluntarily in new drug
applications (NDAs), biologics licensing applications (BLAs), and NDA
and BLA supplemental applications submitted to FDA's Center for Drug
Evaluation and Research (CDER).
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by February 19, 2013.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Paul Okwesili, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5353, Silver Spring, MD 20993-0002, 301-
796-0173.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Submissions in Electronic Format--Summary Level
Clinical Site Data for CDER's Inspection Planning.'' FDA is responsible
for making regulatory decisions about drugs and
[[Page 75175]]
biological products after reviewing clinical safety and efficacy data
submitted in support of NDAs, BLAs, and NDA and BLA supplements
submitted to CDER (BLAs submitted to and reviewed by CDER as described
in the Federal Register of June 26, 2003 (68 FR 38067), available at
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/UCM186799.pdf). CDER's
Bioresearch Monitoring Program has specific responsibility for
verifying the integrity of data submitted to FDA in support of new NDAs
and BLAs and supplements, and for determining whether clinical trials
are conducted in compliance with applicable FDA regulations and
statutory requirements, including those intended to ensure the rights
and welfare of human research subjects.
A. Site Inspections
As part of the application review process, FDA may conduct onsite
inspections of clinical investigators, sponsors, contract research
organizations, and institutional review boards. The study-related
information in applications is critical to FDA's selection of clinical
investigator sites for inspection. However, the current submission
format for the data does not facilitate efficient site selection. Thus,
CDER is requesting submission of a structured, summary-level clinical
site dataset.
B. Summary Level Clinical Site Dataset
CDER recently initiated a pilot program evaluating a risk-based
model for selecting clinical investigators for inspection. This model
permits evaluation of an array of risk parameters across clinical
investigator sites associated with marketing applications.
The summary level clinical site dataset:
Contains data from all relevant studies used to support
evaluation of the application, including studies supportive of various
treatment indications; and
Presents the characteristics and outcomes of the study at
the site level.
The data requested in the summary level clinical site dataset comprise
data elements currently collected under regulations in 21 CFR part 312
and maintained, tabulated, and submitted under regulations in 21 CFR
part 314, specifically Sec. 314.50(d)(5) Clinical data section and
Sec. 314.50(f) Case report forms and tabulations or in 21 CFR part
601, specifically Sec. 601.2 Applications for biologic licenses;
procedures for filing.
The electronic submission of a summary level clinical site dataset
is intended to facilitate FDA's timely selection of clinical
investigator sites for inspection to evaluate the integrity of the data
submitted in the application or supplement.
This 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 Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.
II. Comments
Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments regarding to https://www.regulations.gov. 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.
III. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
The draft guidance recommends an electronic format for a summary
level clinical site dataset to be submitted voluntarily in NDAs, BLAs,
and NDA and BLA supplemental applications submitted to CDER. The
summary level clinical site dataset is intended to facilitate use of a
risk-based approach to timely identification of clinical investigator
sites for on-site inspection by FDA during the review of marketing
applications.
The summary level dataset comprises information required in parts
312, 314, or 601, including case histories (Sec. 312.62(b)),
information regarding foreign clinical studies not conducted under an
investigational new drug application (IND) (Sec. 312.120), and the
clinical data section (Sec. 314.50(d)(5)) and case report forms and
tabulations (Sec. 314.50(f)), or in part 601 (Sec. 601.2 Applications
for biologic licenses; procedures for filing) in an NDA, BLA, or
supplement. The draft guidance recommends that the data be submitted
electronically in a format that will facilitate site selection. The
variables described in the format are elements currently used in other
submissions; some of the variable names are new. The financial
disclosure information is currently reported in Module 1 (region
specific information) of the electronic common technical document, but
is new as a variable in a dataset. In addition, identifying that a
study has been conducted under an IND is new as a request in a dataset.
Initial preparation of the summary level clinical site dataset and the
development of new standard operating procedures (SOPs) would require
additional time. Once SOPs have been established, generation of the
dataset should not involve significant additional work. The applicant
would likely perform additional quality assurance, which may add time
to preparation and review of the submission.
Based on CDER's data on the number of applications, including
supplements, that would be covered by the draft guidance, we estimate
that each year approximately 75 applicants will voluntarily submit for
96 applications the summary level clinical site dataset in electronic
format as recommended by
[[Page 75176]]
the draft guidance. We estimate that the submission of each summary
level clinical site dataset will take approximately 26 hours to
prepare.
Initial preparation of the summary level clinical site dataset
would involve the development of new SOPs for the preparation of the
summary level clinical site dataset. We estimate that 75 applicants
would take approximately 12 hours to develop and subsequently 1 hour
annually to maintain and update the SOP(s). The summary level clinical
site dataset submitted with each application would likely involve
additional quality assurance procedures, which would add approximately
1 hour for each submission.
This draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in part 312 have been approved under OMB control number 0910-0014; the
collections of information in part 314 have been approved under OMB
control number 0910-0001.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of responses per
Activity respondents respondent Total Hours per Total hours
(i.e. (i.e., responses response
applicants) applications)
----------------------------------------------------------------------------------------------------------------
Summary Level Clinical Site 75 1.3 96 26 2,496
Dataset Submissions............
Dataset Quality Assurance....... 75 1.3 96 1 96
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,592
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
Table 2--Estimated Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of records per Total records Hours per Total hours
recordkeepers recordkeeper recordkeeper
----------------------------------------------------------------------------------------------------------------
Develop Initial SOP(s).......... 75 1 75 12 900
Maintain and Update SOP(s)...... 75 1 75 1 75
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 975
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: December 13, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-30510 Filed 12-18-12; 8:45 am]
BILLING CODE 4160-01-P
