Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records, 66009-66011 [2015-27420]
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66009
Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
Tribal Maternal, Infant, and Early Childhood Home Visiting Program Needs
Assessment and Plan for Responding to Identified Needs .........................
25
1
100
2,500
Estimated Total Annual Burden Hours .....................................................
........................
........................
........................
2,500
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–27416 Filed 10–27–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0477]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Investigational
Device Exemptions Reports and
Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
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
investigational device exemptions
reports and records.
DATES: Submit either electronic or
written comments on the collection of
information by December 28, 2015.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
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that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0477 for Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Investigational Device Exemptions
Reports and Records. Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
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66010
Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
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/
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
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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 Device Exemptions
Reports and Records—21 CFR Part
812—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
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present a potential for serious harm, are
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
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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 investigators’ and
sponsors’ 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 recent years.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity/21 CFR section
Average
burden per
response
Total annual
responses
Total hours
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.
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
Reports for Nonsignificant Risk Studies—812.150 .............
1 There
1
Average
burden per
disclosure
Total annual
disclosures
1
1
Total hours
6
6
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–27420 Filed 10–27–15; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0007]
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Number of
disclosures
per
respondent
Number of
respondents
Activity/21 CFR section
Product Development Under the
Animal Rule; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
SUMMARY:
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guidance for industry entitled ‘‘Product
Development Under the Animal Rule.’’
When human efficacy studies are not
ethical and field trials are not feasible,
FDA may rely on adequate and wellcontrolled animal efficacy studies to
support approval of a drug or licensure
of a biological product under the
Animal Rule. This guidance finalizes
the 2014 revised draft guidance for
industry ‘‘Product Development Under
the Animal Rule.’’ It is intended to help
potential stakeholders (industry,
academia, and government) understand
FDA’s expectations for product
development under the Animal Rule.
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]]>Agencies
[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66009-66011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27420]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0477]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Investigational Device Exemptions Reports and Records
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
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 investigational device
exemptions reports and records.
DATES: Submit either electronic or written comments on the collection
of information by December 28, 2015.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0477 for Agency Information Collection Activities; Proposed
Collection; Comment Request; Investigational Device Exemptions Reports
and Records. Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
[[Page 66010]]
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@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/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.
Investigational Device Exemptions Reports and Records--21 CFR Part
812--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 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
[[Page 66011]]
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 investigators'
and sponsors' 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 recent years.
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, and 812.27............... 356 1 356 80 28,480
Supplements--812.35 and 812.150........................... 356 12 4,272 6 25,632
Treatment IDE Applications--812.36(c)..................... 1 1 1 120 120
Treatment IDE Reporting--812.36(f)........................ 1 1 1 20 20
---------------------------------------------------------------------------------------------
Total................................................. .............. .............. .............. .............. 54,253
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity/21 CFR section Number of records per Total annual burden 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
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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
Number of disclosures Total annual Average
Activity/21 CFR section respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
Reports for Nonsignificant Risk 1 1 1 6 6
Studies--812.150...............
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27420 Filed 10-27-15; 8:45 am]
BILLING CODE 4164-01-P
