Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Investigational Device Exemptions Reports and Records, 2869-2871 [2010-793]
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2869
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
recordkeeping burden of 2,800 hours
(700 x 4 = 2,800). FDA estimates that the
cost of developing standard operating
procedures for each recordkeeper is
$300 (6 hours of work at $50/hour (h)).
This results in a total cost to industry of
$210,000 ($300 x 700 recordkeepers).
FDA estimates that operating costs for
collecting this information is $300 per
recordkeeper (6 hours of work at $50/h).
This results in a total operational and
maintenance cost to industry of
$210,000 ($300 x 700 recordkeepers).
The total cost of this recordkeeping,
capital plus operational and
maintenance cost is estimated to be
$420,000.
In the Federal Register of October 20,
2009 (74 FR 53749), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
Section of the Act
520(g)
Annual Frequency
per Recordkeeping
700
Total Annual
Records
1
Hours per
Record
700
Total Hours
4
2,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information. Due to a clerical error, the capital costs and operating and maintenance costs that appeared in a notice issued in the FEDERAL REGISTER of October 20, 2009 (74 FR 53749 at
53750) were incorrect. The costs were actually salary costs; Table 1 of this document contains the correct cost burden.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 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.
[FR Doc. 2010–791 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0480]
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.
jlentini on DSKJ8SOYB1PROD with NOTICES
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 February
18, 2010.
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 e-mailed 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.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
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 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 added
section 520(g)(6) to the 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 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
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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,
ones 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 of the act, 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
E:\FR\FM\19JAN1.SGM
19JAN1
2870
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
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
which 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
interests 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 non-significant
risk device study, an explanation of the
non-significant 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.
In the Federal Register of October 23,
2009 (74 FR 54824), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1. —ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
812.10
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total
Hours
1
1
1
1
1
812.20, 812.25, and 812.27
465
0.5
233
80
18,640
812.35 and 812.150 (reports for significant risk
studies)
465
7.8
3,627
6
21,762
812.150 (reports for non-significant risk studies)
465
0.017
8
6
48
812.36(c)
1
1
1
120
120
812.36(f)
1
2
2
20
40
Total
40,611
1 There
are no capital costs or operating and maintenance costs associated with this collection of information. Due to a reevaluation of the burden, the burden hours and annual responses which appeared in a notice issued in the FEDERAL REGISTER of October 23, 2009 (74 FR 54824)
have been adjusted.
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of Recordkeepers
Annual Frequency
per
Recordkeeping
812.140 Original
465
0.5
233
10
2,330
812.140 Supplemental
465
7
3,255
1
3,255
812.140 Non-significant
465
1
465
6
2,790
21 CFR Section
Total Annual
Records
Hours per
Record
Total
Total
Hours
8,375
1 There
jlentini on DSKJ8SOYB1PROD with NOTICES
are no capital costs or operating and maintenance costs associated with this collection of information. The estimate of the burden is
based on the number of IDEs received in the last 3 years.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
PO 00000
Frm 00027
Fmt 4703
Sfmt 9990
E:\FR\FM\19JAN1.SGM
19JAN1
2871
Federal Register / Vol. 75, No. 11 / Tuesday, January 19, 2010 / Notices
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
[FR Doc. 2010–793 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0474]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Inspection by
Accredited Persons Program Under
the Medical Device User Fee and
Modernization Act of 2002
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0510. 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 (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 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.
ADDRESSES:
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 February
18, 2010.
Inspection by Accredited Persons
Program Under the Medical Device
User Fee and Modernization Act of
2002—(OMB Control Number 0910–
0510)—Extension
The Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Public Law 107–250) was signed into
law on October 26, 2002. Section 201 of
MDUFMA adds a new paragraph ‘‘g’’ to
section 704 of the Federal, Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
374), directing FDA to accredit third
parties (accredited persons) to conduct
inspections of eligible manufacturers of
class II or class III devices. This is a
voluntary program. FDA has a guidance
document that provides information for
those interested in participating in this
program. The guidance is entitled
‘‘Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria.’’
FDA based these estimates on
conversations with industry, trade
association representatives, and internal
FDA estimates. Once an organization is
accredited, it will not be required to
reapply.
In the Federal Register of October 22,
2009 (74 FR 54570), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of the Act
704(g)
No. of
Respondents
Item
Request for Accreditation
Annual Frequency
per Response
3
Total Annual
Responses
1
3
Hours per
Response
Total Hours
80
Total Hours
1 There
240
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy,
Planning and Budget.
ACTION:
[FR Doc. 2010–796 Filed 1–15–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
jlentini on DSKJ8SOYB1PROD with NOTICES
[Docket No. FDA–2009–N–0475]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Administrative
Detention and Banned Medical Devices
AGENCY:
240
Food and Drug Administration,
HHS.
VerDate Nov<24>2008
16:28 Jan 15, 2010
Jkt 220001
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 February
18, 2010.
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 e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0114. Also
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–5156,
Daniel.Gittleson@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Administrative Detention and Banned
Medical Devices—(OMB Control
Number 0910–0114)—Extension
FDA has the statutory authority under
section 304(g) of the Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C.
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 75, Number 11 (Tuesday, January 19, 2010)]
[Notices]
[Pages 2869-2871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-793]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0480]
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
February 18, 2010.
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 e-mailed 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 (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 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--21 CFR Part 812
(OMB Control Number 0910-0078)--Extension
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the
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 added section 520(g)(6) to the 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 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.
Non-significant risk device investigations, ones 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 of the act, 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
[[Page 2870]]
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 which 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 interests 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
non-significant risk device study, an explanation of the non-
significant 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.
In the Federal Register of October 23, 2009 (74 FR 54824), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1. --Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
812.10 1 1 1 1 1
----------------------------------------------------------------------------------------------------------------
812.20, 812.25, and 812.27 465 0.5 233 80 18,640
----------------------------------------------------------------------------------------------------------------
812.35 and 812.150 465 7.8 3,627 6 21,762
(reports for significant
risk studies)
----------------------------------------------------------------------------------------------------------------
812.150 (reports for non- 465 0.017 8 6 48
significant risk studies)
----------------------------------------------------------------------------------------------------------------
812.36(c) 1 1 1 120 120
----------------------------------------------------------------------------------------------------------------
812.36(f) 1 2 2 20 40
----------------------------------------------------------------------------------------------------------------
Total 40,611
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information. Due to a reevaluation of the burden, the burden hours and annual responses which appeared in a
notice issued in the Federal Register of October 23, 2009 (74 FR 54824) have been adjusted.
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency
21 CFR Section No. of per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Record
----------------------------------------------------------------------------------------------------------------
812.140 Original 465 0.5 233 10 2,330
----------------------------------------------------------------------------------------------------------------
812.140 Supplemental 465 7 3,255 1 3,255
----------------------------------------------------------------------------------------------------------------
812.140 Non-significant 465 1 465 6 2,790
----------------------------------------------------------------------------------------------------------------
Total 8,375
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information. The estimate of the burden is based on the number of IDEs received in the last 3 years.
[[Page 2871]]
Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-793 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S
