Document ID: FDA-2013-N-0172-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application
Posted Date: 2013-02-26T05:00Z

[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13067-13068]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04422]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0172]

Agency Information Collection Activities: Proposed Collection; 
Comment Request; Foreign Clinical Studies Not Conducted Under an 
Investigational New Drug Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the information collection 
contained in FDA's regulations on foreign clinical studies not 
conducted under an investigational new drug application (IND).

DATES: Submit either electronic or written comments on the collection 
of information by April 29, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane., Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B, 
Rockville, MD 20850, 301-796-7726, Ila.mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed reinstatement of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Foreign Clinical Studies Not Conducted Under an IND--(OMB Control 
Number 0910-0622)--Reinstatement

    Under 312.120 (21 CFR 312.120), FDA accepts foreign clinical 
studies not conducted under an IND as support for an IND or application 
for marketing approval for a drug or biological product if the studies 
are conducted in accordance with good clinical practices (GCP), 
including review and approval by an independent ethics committee (IEC).
    Under Sec.  312.120(a), FDA accepts as support for an IND or 
application for marketing approval a well-designed and well-conducted 
foreign clinical study not conducted under an IND if the study is 
conducted in accordance with GCP, and we are able to validate the data 
from the study through an onsite inspection if necessary. GCP includes 
review and approval by an IEC before initiating a study, continuing 
review of an ongoing study by an IEC, and obtaining and documenting the 
freely given informed consent of the subject before initiating a study.
    Under Sec.  312.120(b), a sponsor of a non-IND foreign study who 
wants to rely on that study as support for an IND or application for 
marketing approval must provide the following information to FDA: (1) 
The investigator's qualifications; (2) a description of the research 
facilities; (3) a detailed summary of the protocol and results of the 
study and, should FDA request, case records maintained by the 
investigator or additional background data such as hospital or other 
institutional records; (4) a description of the drug substance and drug 
product used in the study, including a description of the components, 
formulation, specifications, and, if available, bioavailability of the 
specific drug product used in the clinical study; (5) if the study is 
intended to support the effectiveness of a drug product, information 
showing that the study is adequate and well controlled under Sec.  
314.126; (6) the name and address of the IEC that reviewed the study 
and a statement that the IEC meets the definition in Sec.  312.3; (7) a 
summary of the IEC's decision to approve or modify and approve the 
study, or to provide a favorable opinion; (8) a description of how 
informed consent was obtained; (9) a description of what incentives, if 
any,

[[Page 13068]]

were provided to subjects to participate in the study; (10) a 
description of how the sponsor(s) monitored the study and ensured that 
the study was carried out consistently with the study protocol; and 
(11) a description of how investigators were trained to comply with GCP 
and to conduct the study in accordance with the study protocol, and a 
statement on whether written commitments by investigators to comply 
with GCP and the protocol were obtained.
    Section 312.120(c) specifies how sponsors or applicants can request 
a waiver for any of the requirements under Sec.  312.120(a)(1) and (b). 
Under Sec.  312.120(c)(1), a waiver request must contain at least one 
of the following: (1) An explanation why the sponsor's or applicant's 
compliance with the requirement is unnecessary or cannot be achieved, 
(2) a description of an alternative submission or course of action that 
satisfies the purpose of the requirement, or (3) other information 
justifying a waiver. A waiver request may be submitted in an IND or in 
an information amendment to an IND, or in an application or in an 
amendment or supplement to an application submitted under 21 CFR part 
314 or 601. Section 312.10 sets forth requirements for sponsors who 
request waivers from FDA for compliance with any of the provisions in 
part 312, and Sec.  314.90 sets forth requirements for applicants who 
request waivers from FDA for compliance with Sec. Sec.  314.50 through 
314.81.
    FDA has approval for the submission of these waiver requests under 
OMB control numbers 0910-0014 for part 312 and 0910-0001 for part 314. 
In addition to the reporting requirements set forth in table 1 of this 
document, there is also a recordkeeping provision in Sec.  312.120(d) 
stating how long sponsors and applicants must retain records required 
by Sec.  312.120. In addition, Sec.  312.120(b) states that any signed 
written commitments by investigators must be maintained by the sponsor 
or applicant and made available for Agency review upon request, and 
also specifies sponsor recordkeeping of IEC-related information. Under 
Sec.  312.120(d), if a study is submitted in support of an application 
for marketing approval, records must be retained for 2 years after an 
Agency decision on that application; if a study is submitted in support 
of an IND but not an application for marketing approval, records must 
be retained for 2 years after the submission of the IND. The retention 
requirements in Sec.  312.57(c) for records and reports required under 
part 312 apply to these provisions, and are approved under OMB control 
number 0910-0014.
    We estimate that 237 companies will submit a total of approximately 
1,185 non-IND foreign clinical studies in support of an IND or 
application for marketing approval for a drug or biological product. 
Hour burden estimates vary due to differences in size, complexity, and 
duration across studies, and we estimate that complying with Sec.  
312.120 would take sponsors between 18 and 32 hours annually for each 
non-IND foreign clinical trial, totaling 37,920 hours (32 x 1,185).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                           21 CFR Section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
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312.120............................................................             237                5            1,185               32           37,920
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: February 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04422 Filed 2-25-13; 8:45 am]
BILLING CODE 4160-01-P