
[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]


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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Draft Guidance for Industry on Providing Submissions in 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.

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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availability of a draft guidance for industry entitled ``Providing 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 The draft guidance is intended to assist 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 This draft guidance 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 19, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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access to the draft guidance document.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 http://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 
http://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 http://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 http://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

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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\
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                                                     Number of
                                     Number of     responses per
            Activity                respondents     respondent         Total         Hours per      Total hours
                                       (i.e.          (i.e.,         responses       response
                                    applicants)    applications)
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Summary Level Clinical Site                   75             1.3              96              26           2,496
 Dataset Submissions............
Dataset Quality Assurance.......              75             1.3              96               1              96
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    Total.......................  ..............  ..............  ..............  ..............           2,592
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.


                                   Table 2--Estimated Recordkeeping Burden \1\
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                                                     Number of
            Activity                 Number of      records per    Total records     Hours per      Total hours
                                   recordkeepers   recordkeeper                    recordkeeper
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Develop Initial SOP(s)..........              75               1              75              12             900
Maintain and Update SOP(s)......              75               1              75               1              75
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    Total.......................  ..............  ..............  ..............  ..............             975
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\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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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


