Agency Information Collection Activities; Proposed Collection; Comment Request: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, 35283-35284 [2013-13904]
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Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Notices
Food and Drug Administration
[Docket No. FDA–2013–N–0663]
Agency Information Collection
Activities; Proposed Collection;
Comment Request: Investigational
New Drug Safety Reporting
Requirements for Human Drug and
Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans
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
extension 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 resulting
from investigational new drug (IND)
safety reporting requirements and safety
reporting requirements for
bioavailability and bioequivalence
studies.
Submit either electronic or
written comments on the collection of
information by August 12, 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.
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DATES:
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16:32 Jun 11, 2013
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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 extension 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.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Investigational New Drug Safety
Reporting Requirements for Human
Drug and Biological Products and
Safety Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans—(OMB Control
Number 0910–0672)—Extension
In the Federal Register of September
29, 2010 (75 FR 59935), FDA published
a document entitled ‘‘Investigational
New Drug Safety Reporting
Requirements for Human Drug and
Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans.’’ The document
clarified the Agency’s expectations for
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35283
timely review, evaluation, and
submission of relevant and useful safety
information and implemented
internationally harmonized definitions
and reporting standards for IND safety
reports. The document also required
safety reporting for bioavailability and
bioequivalence studies. The document
was intended to improve the utility of
IND safety reports, expedite FDA’s
review of critical safety information,
better protect human subjects enrolled
in clinical trials, and harmonize safety
reporting requirements internationally.
The rulemaking included the
following information collection under
the PRA that was not already included
in 21 CFR 312.32 and approved under
OMB control number 0910–0014.
Section 312.32(c)(1)(ii) and (c)(1)(iii)
requires reporting to FDA, in an IND
safety report, of potential serious risks
from clinical trials within 15 calendar
days for findings from epidemiological
studies, pooled analyses of multiple
studies, or other clinical studies that
suggest a significant risk in humans
exposed to the drug.
Section 312.32(c)(1)(iii) specifies the
requirements for reporting to FDA in an
IND safety report potential serious risks
from clinical trials within 15 calendar
days for findings from in vitro testing
that suggest a significant risk to humans.
FDA estimates that approximately 100
sponsors spend a total of approximately
12 hours per report to prepare and
submit approximately 600 reports
annually.
Section 312.32(c)(1)(iv) requires
reporting to FDA in an IND safety report
within 15 calendar days of any
clinically important increase in the rate
of occurrence of serious suspected
adverse reactions over that listed in the
protocol or investigator brochure. FDA
estimates that approximately 10
sponsors spend a total of approximately
12 hours per report to prepare and
submit approximately 10 reports
annually.
The rulemaking also included new
information collection under the PRA
by requiring safety reporting for
bioavailability and bioequivalence
studies (21 CFR 320.31(d)). FDA
estimates that approximately 10
sponsors spend a total of approximately
14 hours per report to prepare and
submit approximately 200 reports
annually.
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35284
Federal Register / Vol. 78, No. 113 / Wednesday, June 12, 2013 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
320.31(d) Bioavailability and Bioequivalence Safety Reports ..................................................................................
312.32(c)(1)(ii) and (c)(1)(iii) IND Safety Reports ...............
312.32(c)(1)(iv) IND Safety Reports ....................................
Number of
responses per
respondent
10
100
10
Total annual
responses
20
6
1
Average
burden per
response
200
600
10
Total hours
14
12
12
2,800
7,200
120
Total ..............................................................................
1 There
Dated: June 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
Agency’s Division of Dockets
Management.
Submit written requests for
copies of summaries of safety and
effectiveness data to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Please cite the appropriate docket
number as listed in table 1 of this
document when submitting a written
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the summaries of safety and
effectiveness.
ADDRESSES:
[FR Doc. 2013–13904 Filed 6–11–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–M–0036, FDA–
2013–M–0205, FDA–2013–M–0255, FDA–
2013–M–0281, FDA–2013–M–0282, and
FDA–2013–M–0343]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
10,120
are no capital costs or operating and maintenance costs associated with this collection of information.
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) that have been approved. This
list is intended to inform the public of
the availability of safety and
effectiveness summaries of approved
PMAs through the Internet and the
FOR FURTHER INFORMATION CONTACT:
Nicole Wolanski, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6570.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is placed on the
Internet. Section 10.33(b) provides that
FDA may, for good cause, extend this
30-day period. Reconsideration of a
denial or withdrawal of approval of a
PMA may be sought only by the
applicant; in these cases, the 30-day
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly list of available
safety and effectiveness summaries of
PMA approvals and denials that were
announced during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
Internet from January 1, 2013, through
March 31, 2013. There were no denial
actions during this period. The list
provides the manufacturer’s name, the
product’s generic name or the trade
name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2013, THROUGH MARCH 31, 2013
Applicant
Trade name
Approval date
P110014, FDA–2013–M–0036 ..............
Dune Medical Devices, Inc ..................
MarginProbe System ............................
H110002, FDA–2013–M–0205 ..............
P110032, FDA–2013–M–0282 ..............
P040046, FDA–2013–M–0255 ..............
Second Sight Medical Products, Inc ....
Lombard Medical ..................................
Allergan ................................................
Medtronic Vascular, Inc .......................
P100030, FDA–2013–M–0281 ..............
Tenaxis Medical, Inc ............................
ArgusTM II Retinal Prosthesis System
Aorfix AAA Flexible Stent Graft System
Natrelle® 410 Highly Cohesive Anatomically
Shaped
Silicone-Filled
Breast Implants.
Resolute Integrity Zotarolimus-Eluting
Coronary Stent System.
ArterX Surgical Sealant ........................
December 27,
2012.
February 13, 2013.
February 14, 2013.
February 20, 2013.
P110013/S005, FDA–2013–M–0343 .....
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PMA No., docket No.
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
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DeviceApprovalsandClearances/
PMAApprovals/default.htm.
February 22, 2013.
March 1, 2013.
Dated: June 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–13905 Filed 6–11–13; 8:45 am]
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]]>Agencies
[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35283-35284]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13904]
[[Page 35283]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0663]
Agency Information Collection Activities; Proposed Collection;
Comment Request: Investigational New Drug Safety Reporting Requirements
for Human Drug and Biological Products and Safety Reporting
Requirements for Bioavailability and Bioequivalence Studies in Humans
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 extension 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
resulting from investigational new drug (IND) safety reporting
requirements and safety reporting requirements for bioavailability and
bioequivalence studies.
DATES: Submit either electronic or written comments on the collection
of information by August 12, 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 extension 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.
Investigational New Drug Safety Reporting Requirements for Human Drug
and Biological Products and Safety Reporting Requirements for
Bioavailability and Bioequivalence Studies in Humans--(OMB Control
Number 0910-0672)--Extension
In the Federal Register of September 29, 2010 (75 FR 59935), FDA
published a document entitled ``Investigational New Drug Safety
Reporting Requirements for Human Drug and Biological Products and
Safety Reporting Requirements for Bioavailability and Bioequivalence
Studies in Humans.'' The document clarified the Agency's expectations
for timely review, evaluation, and submission of relevant and useful
safety information and implemented internationally harmonized
definitions and reporting standards for IND safety reports. The
document also required safety reporting for bioavailability and
bioequivalence studies. The document was intended to improve the
utility of IND safety reports, expedite FDA's review of critical safety
information, better protect human subjects enrolled in clinical trials,
and harmonize safety reporting requirements internationally.
The rulemaking included the following information collection under
the PRA that was not already included in 21 CFR 312.32 and approved
under OMB control number 0910-0014.
Section 312.32(c)(1)(ii) and (c)(1)(iii) requires reporting to FDA,
in an IND safety report, of potential serious risks from clinical
trials within 15 calendar days for findings from epidemiological
studies, pooled analyses of multiple studies, or other clinical studies
that suggest a significant risk in humans exposed to the drug.
Section 312.32(c)(1)(iii) specifies the requirements for reporting
to FDA in an IND safety report potential serious risks from clinical
trials within 15 calendar days for findings from in vitro testing that
suggest a significant risk to humans. FDA estimates that approximately
100 sponsors spend a total of approximately 12 hours per report to
prepare and submit approximately 600 reports annually.
Section 312.32(c)(1)(iv) requires reporting to FDA in an IND safety
report within 15 calendar days of any clinically important increase in
the rate of occurrence of serious suspected adverse reactions over that
listed in the protocol or investigator brochure. FDA estimates that
approximately 10 sponsors spend a total of approximately 12 hours per
report to prepare and submit approximately 10 reports annually.
The rulemaking also included new information collection under the
PRA by requiring safety reporting for bioavailability and
bioequivalence studies (21 CFR 320.31(d)). FDA estimates that
approximately 10 sponsors spend a total of approximately 14 hours per
report to prepare and submit approximately 200 reports annually.
[[Page 35284]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
320.31(d) Bioavailability and 10 20 200 14 2,800
Bioequivalence Safety Reports..
312.32(c)(1)(ii) and (c)(1)(iii) 100 6 600 12 7,200
IND Safety Reports.............
312.32(c)(1)(iv) IND Safety 10 1 10 12 120
Reports........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 10,120
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13904 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P
