Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records, 71601-71603 [2012-29095]
Download as PDF
<![CDATA[
emcdonald on DSK67QTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Notices
We are looking for suggested topic
areas and publicly available instruments
in which—(1) The source of information
is from consumers and patients who
directly received care at an emergency
department or caregivers who were
directly involved in the care (for
example, parents of young children);
and (2) patients or caregivers identified
the information as important to them in
evaluating emergency department care
(for example, wait time, medical staff
and physician communication). Existing
instruments that have been tested, have
a high degree of reliability and validity,
and evidence of wide use is preferred.
The following information would be
especially helpful in any comments
responding to this request for
information:
• A brief cover letter summarizing the
information requested above for
submitted instruments and topic areas,
respectively, and how the submission
will help fulfill the intent of the patient
experiences survey;
• (Optional) Information about the
person submitting the material for the
purposes of follow up questions about
the submission which includes the
following:
++ Name.
++ Title.
++ Organization.
++ Mailing address.
++ Telephone number.
++ Email address.
++ Indication that the topic area or
instrument is publicly available.
• When submitting topic areas, we
encourage including to the extent
available the following information:
++ Detailed descriptions of the
suggested topic area(s) and specific
purpose(s).
++ Relevant peer-reviewed journal
articles or full citations.
• When submitting publicly available
instruments or survey questions, we
encourage including to the extent
available the following information:
++ Name of the instrument.
++ Copies of the full instrument in all
available languages.
++ Topic areas included in the
instrument.
++ Measures derived from the
instrument. Instrument reliability
(internal consistency, test-retest, etc)
and validity (content, construct,
criterion-related).
++ Results of cognitive testing.
++ Results of field testing.
++ Current use of the instrument
(who is using it, what it is being used
for, what population it is being used
with, how instrument findings are
reported, and by whom the findings are
used).
VerDate Mar<15>2010
14:30 Nov 30, 2012
Jkt 229001
++ Relevant peer-reviewed journal
articles or full citations.
++ CAHPS® trademark status.
++ Survey administration
instructions.
++ Data analysis instructions.
++ Guidelines for reporting survey
data.
We are developing this survey and
plan to submit it to AHRQ for
recognition as a Consumer Assessment
of Healthcare Providers and Systems
(CAHPS®) survey. The survey will be
developed in accordance with CAHPS®
Survey Design Principles and
implementation instructions will be
based on those for CAHPS® instruments
(https://www.cahps.AHRQ.gov/AboutCAHPS/Principles.aspx).
(Catalog of Federal Domestic Assistance
Program No. 93.773, Medicare—Hospital
Insurance; and Program No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: October 2, 2012.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2012–29104 Filed 11–30–12; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0477]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
Device Exemptions Reports and
Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 January 2,
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
oira_submission@omb.eop.gov. All
comments should be identified with the
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
71601
OMB control number 0910–0078. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
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.
Investigational Device Exemptions
Reports and Records—(OMB Control
Number 0910–0078)—Extension
Section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
(21 U.S.C. 360j(g)) establishes the
statutory authority to collect
information regarding investigational
devices, and establishes rules under
which new medical devices may be
tested using human subjects in a clinical
setting. The Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) added section
520(g)(6) to the FD&C Act and permitted
changes to be made to either the
investigational device or to the clinical
protocol without FDA approval of an
investigational device exemption (IDE)
supplement. An IDE allows a device,
which would otherwise be subject to
provisions of the FD&C Act, such as
premarket notification or premarket
approval, to be used in investigations
involving human subjects in which the
safety and effectiveness of the device is
being studied. The purpose of part 812
(21 CFR part 812) is to encourage, to the
extent consistent with the protection of
public health and safety and with
ethical standards, the discovery and
development of useful devices intended
for human use. The IDE regulation is
designed to encourage the development
of useful medical devices and allow
investigators the maximum freedom
possible, without jeopardizing the
health and safety of the public or
violating ethical standards. To do this,
the regulation provides for different
levels of regulatory control, depending
on the level of potential risk the
investigational device presents to
human subjects. Investigations of
significant risk devices, ones that
present a potential for serious harm to
the rights, safety, or welfare of human
subjects, are subject to the full
requirements of the IDE regulation.
Nonsignificant risk device
investigations, i.e., devices that do not
present a potential for serious harm, are
E:\FR\FM\03DEN1.SGM
03DEN1
71602
Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Notices
subject to the reduced burden of the
abbreviated requirements. The
regulation also includes provisions for
treatment IDEs. The purpose of these
provisions is to facilitate the
availability, as early in the device
development process as possible, of
promising new devices to patients with
life-threatening or serious conditions for
which no comparable or satisfactory
alternative therapy is available. Section
812.10 permits the sponsor of the IDE to
request a waiver to all of the
requirements of part 812. This
information is needed for FDA to
determine if waiver of the requirements
of part 812 will impact the public’s
health and safety. Sections 812.20,
812.25, and 812.27 consist of the
information necessary to file an IDE
application with FDA. The submission
of an IDE application to FDA is required
only for significant risk device
investigations.
Section 812.20 lists the data
requirements for the original IDE
application; § 812.25 lists the contents
of the investigational plan; and § 812.27
lists the data relating to previous
investigations or testing. The
information in the original IDE
application is evaluated by the Center
for Devices and Radiological Health to
determine whether the proposed
investigation will reasonably protect the
public health and safety, and for FDA to
make a determination to approve the
IDE.
Upon approval of an IDE application
by FDA, a sponsor must submit certain
requests and reports. Under § 812.35, a
sponsor who wishes to make a change
in the investigation that affects the
scientific soundness of the study or the
rights, safety, or welfare of the subjects,
is required to submit a request for the
change to FDA. Section 812.150 requires
a sponsor to submit reports to FDA.
These requests and reports are
submitted to FDA as supplemental
applications. This information is needed
for FDA to assure protection of human
subjects and to allow review of the
study’s progress. Section 812.36(c)
identifies the information necessary to
file a treatment IDE application. FDA
uses this information to determine if
wider distribution of the device is in the
interest of the public health. Section
812.36(f) identifies the reports required
to allow FDA to monitor the size and
scope of the treatment IDE, to assess the
sponsor’s due diligence in obtaining
marketing clearance of the device, and
to ensure the integrity of the controlled
clinical trials.
Section 812.140 lists the
recordkeeping requirements for
investigators and sponsors. FDA
requires this information for tracking
and oversight purposes. Investigators
are required to maintain records,
including correspondence and reports
concerning the study, records of receipt,
use or disposition of devices, records of
each subject’s case history and exposure
to the device, informed consent
documentation, study protocol, and
documentation of any deviation from
the protocol. Sponsors are required to
maintain records including
correspondence and reports concerning
the study, records of shipment and
disposition, signed investigator
agreements, adverse device effects
information, and, for a nonsignificant
risk device study, an explanation of the
nonsignificant risk determination,
records of device name and intended
use, study objectives, investigator
information, investigational review
board information, and statement on the
extent that good manufacturing
practices will be followed.
For a nonsignificant risk device
investigation, the investigator’s and
sponsor’s recordkeeping and reporting
burden is reduced. Pertinent records on
the study must be maintained by both
parties, and reports are made to
sponsors and institutional review
boards (IRBs). Reports are made to FDA
only in certain circumstances, e.g.,
recall of the device, the occurrence of
unanticipated adverse effects, and as a
consequence of certain IRB actions.
The estimate of the burden is based
on the number of IDEs received in the
last 3 years. In the Federal Register of
May 24, 2012 (77 FR 31022), FDA
published a 60-day notice requesting
public comment on the proposed
collection of information. FDA received
two comments, one of which was
outside the scope of the four collection
of information topics on which the
notice solicited comments and will not
be discussed in this document. The
other comment recommends
streamlining the annual IDE report
requirements to focus on the reporting
of safety information only, rather than
both safety and effectiveness. The
comment notes that the effectiveness
information is ‘‘reviewed during FDA
clinical site GCP compliance
inspections’’ and at the time of
premarket application. FDA recognizes
that part 812 provides limited
information on the content of IDE
annual reports; however, we believe that
the specific content requirements for
IDE annual reports are outside the scope
of this PRA renewal notice. Section
812.150(b)(10) provides broad authority
for FDA to request information
regarding ongoing IDEs, and FDA will
consider the need for additional
guidance to IDE sponsors regarding the
content of annual reports.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity/21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
emcdonald on DSK67QTVN1PROD with NOTICES
Waivers—812.10 ..................................................................
IDE Application—812.20, 812.25, and 812.27 ....................
Supplements—812.35 and 812.150 ....................................
Treatment IDE Applications—812.36(c) ..............................
Treatment IDE Reporting—812.36(f) ...................................
1
356
356
1
1
1
1
12
1
1
1
356
4,272
1
1
1
80
6
120
20
1
28,480
25,632
120
20
Total ..............................................................................
........................
........................
........................
........................
54,253
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Mar<15>2010
14:30 Nov 30, 2012
Jkt 229001
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
E:\FR\FM\03DEN1.SGM
03DEN1
71603
Federal Register / Vol. 77, No. 232 / Monday, December 3, 2012 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/21 CFR Section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Original—812.140 ................................................................
Supplemental—812.140 .......................................................
Nonsignificant—812.140 ......................................................
356
356
356
1
12
1
356
4,272
356
10
1
6
3,560
4,272
2,136
Total ..............................................................................
........................
........................
........................
........................
9,968
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity/21 CFR Section
Number of
respondents
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Reports for Nonsignificant Risk Studies—812.150 .............
1
1
1
6
6
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
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:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
410B, Rockville, MD 20850, 301–796–
3784,
JonnaLynn.capezzuto@fda.hhs.gov.
[FR Doc. 2012–29095 Filed 11–30–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0307]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Antiparasitic Drug
and Resistance Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
FDA’s ‘‘Antiparasitic Drug and
Resistance Survey.’’
DATES: Submit either electronic or
written comments on the collection of
information by February 1, 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
emcdonald on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:30 Nov 30, 2012
Jkt 229001
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
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
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
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.
Antiparasitic Drug and Resistance
Survey—21 CFR Part 514.4 (OMB
Control Number 0910–NEW)
Resistance of parasites to one or more
of the major classes of FDA approved
antiparasitic drugs is a documented
problem in cattle, horses, sheep, and
goats in the United States. The results
from this survey will provide FDA
information that can be used to make
decisions about future approaches to
antiparasitic drugs. FDA will make the
results of the survey publicly available.
FDA plans to survey members of
veterinary professional organizations
using an Internet-based survey
instrument. The questions in the survey
are designed to elicit professional
opinions regarding the use of
antiparasitic drugs and the awareness of
antiparasitic drug resistance. The survey
will query subjects on topics including:
(1) Awareness of the issues related to
antiparasitic resistance, (2) methods
currently being used to detect and/or
monitor for antiparasitic resistance, (3)
management practices being used or
recommended to manage or reduce
antiparasitic resistance, and (4) labeling
and marketing considerations for
antiparasitic drugs.
FDA published a 60-day notice in the
Federal Register on July 13, 2010 (75 FR
39948), requesting public comment on
the proposed survey, and published a
30-day notice on May 23, 2011 (76 FR
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 77, Number 232 (Monday, December 3, 2012)]
[Notices]
[Pages 71601-71603]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29095]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0477]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Investigational
Device Exemptions Reports and Records
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
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 January
2, 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 oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0078.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
Daniel.Gittleson@fda.hhs.gov.
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.
Investigational Device Exemptions Reports and Records--(OMB Control
Number 0910-0078)--Extension
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360j(g)) establishes the statutory authority to
collect information regarding investigational devices, and establishes
rules under which new medical devices may be tested using human
subjects in a clinical setting. The Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105-115) added section 520(g)(6) to
the FD&C Act and permitted changes to be made to either the
investigational device or to the clinical protocol without FDA approval
of an investigational device exemption (IDE) supplement. An IDE allows
a device, which would otherwise be subject to provisions of the FD&C
Act, such as premarket notification or premarket approval, to be used
in investigations involving human subjects in which the safety and
effectiveness of the device is being studied. The purpose of part 812
(21 CFR part 812) is to encourage, to the extent consistent with the
protection of public health and safety and with ethical standards, the
discovery and development of useful devices intended for human use. The
IDE regulation is designed to encourage the development of useful
medical devices and allow investigators the maximum freedom possible,
without jeopardizing the health and safety of the public or violating
ethical standards. To do this, the regulation provides for different
levels of regulatory control, depending on the level of potential risk
the investigational device presents to human subjects. Investigations
of significant risk devices, ones that present a potential for serious
harm to the rights, safety, or welfare of human subjects, are subject
to the full requirements of the IDE regulation. Nonsignificant risk
device investigations, i.e., devices that do not present a potential
for serious harm, are
[[Page 71602]]
subject to the reduced burden of the abbreviated requirements. The
regulation also includes provisions for treatment IDEs. The purpose of
these provisions is to facilitate the availability, as early in the
device development process as possible, of promising new devices to
patients with life-threatening or serious conditions for which no
comparable or satisfactory alternative therapy is available. Section
812.10 permits the sponsor of the IDE to request a waiver to all of the
requirements of part 812. This information is needed for FDA to
determine if waiver of the requirements of part 812 will impact the
public's health and safety. Sections 812.20, 812.25, and 812.27 consist
of the information necessary to file an IDE application with FDA. The
submission of an IDE application to FDA is required only for
significant risk device investigations.
Section 812.20 lists the data requirements for the original IDE
application; Sec. 812.25 lists the contents of the investigational
plan; and Sec. 812.27 lists the data relating to previous
investigations or testing. The information in the original IDE
application is evaluated by the Center for Devices and Radiological
Health to determine whether the proposed investigation will reasonably
protect the public health and safety, and for FDA to make a
determination to approve the IDE.
Upon approval of an IDE application by FDA, a sponsor must submit
certain requests and reports. Under Sec. 812.35, a sponsor who wishes
to make a change in the investigation that affects the scientific
soundness of the study or the rights, safety, or welfare of the
subjects, is required to submit a request for the change to FDA.
Section 812.150 requires a sponsor to submit reports to FDA. These
requests and reports are submitted to FDA as supplemental applications.
This information is needed for FDA to assure protection of human
subjects and to allow review of the study's progress. Section 812.36(c)
identifies the information necessary to file a treatment IDE
application. FDA uses this information to determine if wider
distribution of the device is in the interest of the public health.
Section 812.36(f) identifies the reports required to allow FDA to
monitor the size and scope of the treatment IDE, to assess the
sponsor's due diligence in obtaining marketing clearance of the device,
and to ensure the integrity of the controlled clinical trials.
Section 812.140 lists the recordkeeping requirements for
investigators and sponsors. FDA requires this information for tracking
and oversight purposes. Investigators are required to maintain records,
including correspondence and reports concerning the study, records of
receipt, use or disposition of devices, records of each subject's case
history and exposure to the device, informed consent documentation,
study protocol, and documentation of any deviation from the protocol.
Sponsors are required to maintain records including correspondence and
reports concerning the study, records of shipment and disposition,
signed investigator agreements, adverse device effects information,
and, for a nonsignificant risk device study, an explanation of the
nonsignificant risk determination, records of device name and intended
use, study objectives, investigator information, investigational review
board information, and statement on the extent that good manufacturing
practices will be followed.
For a nonsignificant risk device investigation, the investigator's
and sponsor's recordkeeping and reporting burden is reduced. Pertinent
records on the study must be maintained by both parties, and reports
are made to sponsors and institutional review boards (IRBs). Reports
are made to FDA only in certain circumstances, e.g., recall of the
device, the occurrence of unanticipated adverse effects, and as a
consequence of certain IRB actions.
The estimate of the burden is based on the number of IDEs received
in the last 3 years. In the Federal Register of May 24, 2012 (77 FR
31022), FDA published a 60-day notice requesting public comment on the
proposed collection of information. FDA received two comments, one of
which was outside the scope of the four collection of information
topics on which the notice solicited comments and will not be discussed
in this document. The other comment recommends streamlining the annual
IDE report requirements to focus on the reporting of safety information
only, rather than both safety and effectiveness. The comment notes that
the effectiveness information is ``reviewed during FDA clinical site
GCP compliance inspections'' and at the time of premarket application.
FDA recognizes that part 812 provides limited information on the
content of IDE annual reports; however, we believe that the specific
content requirements for IDE annual reports are outside the scope of
this PRA renewal notice. Section 812.150(b)(10) provides broad
authority for FDA to request information regarding ongoing IDEs, and
FDA will consider the need for additional guidance to IDE sponsors
regarding the content of annual reports.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR Section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Waivers--812.10................. 1 1 1 1 1
IDE Application--812.20, 812.25, 356 1 356 80 28,480
and 812.27.....................
Supplements--812.35 and 812.150. 356 12 4,272 6 25,632
Treatment IDE Applications-- 1 1 1 120 120
812.36(c)......................
Treatment IDE Reporting-- 1 1 1 20 20
812.36(f)......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 54,253
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 71603]]
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Original--812.140............... 356 1 356 10 3,560
Supplemental--812.140........... 356 12 4,272 1 4,272
Nonsignificant--812.140......... 356 1 356 6 2,136
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 9,968
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR Section Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports for Nonsignificant Risk Studies--812.150................... 1 1 1 6 6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29095 Filed 11-30-12; 8:45 am]
BILLING CODE 4160-01-P
