[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33847-33848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13246]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 July 5, 
2013.

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 0910-0622. 
Also include the FDA 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., 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.

Foreign Clinical Studies Not Conducted Under an Investigational New 
Drug Application--(OMB Control Number 0910-0622)--Reinstatement

    Under Sec.  312.120 (21 CFR 312.120), FDA accepts foreign clinical 
studies not conducted under an investigational new drug application 
(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

[[Page 33848]]

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, 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).
    In the Federal Register of February 26, 2013 (78 FR 13067), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received that pertained to 
the collection of information.
    FDA estimates the burden for 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: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13246 Filed 6-4-13; 8:45 am]
BILLING CODE 4160-01-P