[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13067-13068]
From the Federal Register Online via the Government Publishing 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, [email protected].
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