Agency Information Collection Activities: Proposed Collection; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application, 13067-13068 [2013-04422]
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Federal Register / Vol. 78, No. 38 / Tuesday, February 26, 2013 / Notices
description section of the FOA, will
more effectively guide applicants and
panel reviewers on what ANA believes
are critical components of a project’s
application. (Legal authority: Section
803(c) of NAPA, as amended.)
I. Objective Review and Results:
ANA’s FOA currently states ‘‘Results of
the competitive objective review are
taken into consideration by ACF in the
selection of projects for funding;
however, objective review scores and
rankings are not binding. They are one
element in the decision-making
process.’’ ANA will clarify the scoring
process in this section by stating that
ANA will have the discretion to Use
either the actual ‘‘raw’’ score or a
normalized score in order to determine
the ranking of applications after the
panel review has been completed. The
raw score is the average of the actual
scores given by the three panelists that
served as peer reviewers for the
application. A normalized score is a
statistical method that accounts for the
variability and relative nature of
individual reviewers’ scoring
tendencies. Normalized scores are used
to counteract any possible
predisposition or scoring biases of
individual reviewers and panels in
order to make the outcome fairer for all
applications. The use of a normalized
score is allowable and authorized by
HHS grants administration policy.
Lillian A. Sparks,
Commissioner, Administration for Native
American.
[FR Doc. 2013–04383 Filed 2–25–13; 8:45 am]
BILLING CODE 4184–34–P
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.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
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
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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 https://
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
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13067
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 § 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 § 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
§ 314.126; (6) the name and address of
the IEC that reviewed the study and a
statement that the IEC meets the
definition in § 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,
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13068
Federal Register / Vol. 78, No. 38 / Tuesday, February 26, 2013 / Notices
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 § 312.120(a)(1) and (b). Under
§ 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 § 314.90 sets
forth requirements for applicants who
request waivers from FDA for
compliance with §§ 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
§ 312.120(d) stating how long sponsors
and applicants must retain records
required by § 312.120. In addition,
§ 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 IECrelated information. Under § 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 § 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
§ 312.120 would take sponsors between
18 and 32 hours annually for each nonIND foreign clinical trial, totaling 37,920
hours (32 × 1,185).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
312.120 ................................................................................
237
5
1,185
32
37,920
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.
[Docket No. FDA–2012–N–0714]
335a(l)(1)(B)), of three felony counts
under Federal law for conduct relating
to the importation into the United States
of an article of food. Mr. Stowell was
given notice of the proposed debarment
and an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of December 14, 2012,
Mr. Stowell had not responded. Mr.
Stowell’s failure to respond constitutes
a waiver of his right to a hearing
concerning this action.
Richard Stowell: Debarment Order
DATES:
[FR Doc. 2013–04422 Filed 2–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
AGENCY:
Food and Drug Administration,
tkelley on DSK3SPTVN1PROD with NOTICES
Submit applications for
termination of debarment to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
ADDRESSES:
HHS.
ACTION:
This order is effective February
26, 2013.
Notice.
SUMMARY: The U.S. Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Richard Stowell for a period of 3 years
from importing articles of food or
offering such articles for importation
into the United States. FDA bases this
order on a finding that Mr. Stowell was
convicted, as defined in section
306(l)(1)(B) of the FD&C Act (21 U.S.C.
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FOR FURTHER INFORMATION CONTACT:
Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD
20857, 301–796–4640.
SUPPLEMENTARY INFORMATION:
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I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act (21 U.S.C.
335a(b)(3)(A)), that the individual has
been convicted of a felony for conduct
relating to the importation into the
United States of any food.
On July 27, 2011, Mr. Stowell was
convicted, as defined in section
306(l)(1)(B) of the FD&C Act, when the
U.S. District Court for the Southern
District of Florida accepted his plea of
guilty and entered judgment against him
for the following offenses: One count of
conspiracy to falsely label and misbrand
seafood, in violation of 18 U.S.C. 371;
one count of false labeling of seafood
under the Lacey Act, in violation of 16
U.S.C. 3372(d)(2) and 3373(d)(3)(A)(ii);
and one count of misbranding food, in
violation of 21 U.S.C. 331(a), 343(a)(1),
and 333(a)(2).
FDA’s finding that debarment is
appropriate is based on the felony
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
312.120............................................................ 237 5 1,185 32 37,920
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
