Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records, 54824-54826 [E9-25539]
Download as PDF
<![CDATA[
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
54824
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
minimize the information collection
burden.
1. Type of Information Collection
Request: Extension of the currently
approved collection; Title of
Information Collection: Indirect Medical
Education (IME) and Supporting
Regulations at 42 CFR 412.105; Direct
Graduate Medical Education (GME) and
Supporting Regulations at 42 CFR
413.75 through 413.83; Use: The
information collected on interns and
residents (IRs) is used by the Medicare
Part A fiscal intermediaries (FI) and Part
A Medicare Administrative Contractors
(MAC) to verify the number of IRs used
in the calculation of Medicare program
payments for indirect medical education
(IME) as well as direct graduate medical
education (GME). The IR data collected
from the hospitals is processed through
computers at FIs/MACs to identify any
duplicated time based upon the
accumulated time of each individual
that worked at one or more hospitals.
The identification of duplicate IRs is
necessary to ensure that no IR is
counted more than once.
The FIs/MACs use the information
collected on IRs to help ensure that all
program payments for IME and GME are
based upon an accurate number of FTE–
IRs, determined in accordance with
Medicare regulations. The IR data
submitted by the hospitals are used by
the FIs/MACs during their audits of the
providers’ cost reports. The audit
procedures help assure that the
information reported was correct, and
that IRs who should not have been
reported by the hospitals (or portions of
the IRs’ time) are not included in the
FTE count. The FIs/MACs also use
reports of duplicate IRs to prevent
improper payment for IME and GME.
Form Number: CMS–R–64 (OMB#:
0938–0456); Frequency: Reporting—
Yearly; Affected Public: Business or
other for-profit and Not-for-profit
institutions; Number of Respondents:
1,190; Total Annual Responses: 1,190;
Total Annual Hours: 2,380. (For policy
questions regarding this collection
contact Milton Jacobson at 410–786–
7553. For all other issues call 410–786–
1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
VerDate Nov<24>2008
15:24 Oct 22, 2009
Jkt 220001
In commenting on the proposed
information collections please reference
the document identifier or OMB control
number. To be assured consideration,
comments and recommendations must
be submitted in one of the following
ways by December 22, 2009:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) accepting comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: October 16, 2009.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E9–25572 Filed 10–22–09; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0480]
Agency Information Collection
Activities; Proposed Collection;
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 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 written or electronic
comments on the collection of
information by December 22, 2009.
ADDRESSES: Submit electronic
comments on the collection of
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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 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
E:\FR\FM\23OCN1.SGM
23OCN1
54825
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
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.
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 are 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 of
the act 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; Section 812.25 lists the
contents of the investigational plan; and
Section 812.27 lists the data relating to
previous investigations or testing. The
information in this 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 the FDA, a sponsor must submit
certain requests and reports. Under
Section 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 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Total Annual
Responses
Hours per
Response
Total Hours
1
1
1
1
1
812.20, 812.25, and 812.27
600
0.5
300
80
24,000
812.35 and 812.150 (reports for significant risk studies)
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
812.10
Annual Frequency
per Response
600
7.8
4,700
6
28,200
812.150 (reports for non-significant risk
studies)
600
0.017
10
6
60
812.36(c)
1
1
1
120
120
812.36(f)
1
2
2
20
40
Total
1 There
52,421
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Nov<24>2008
15:24 Oct 22, 2009
Jkt 220001
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
E:\FR\FM\23OCN1.SGM
23OCN1
54826
Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices
TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
No. of
Recordkeepers
21 CFR Section
Annual Frequency
of Recordkeeping
Total Annual
Records
Hours per
Recordkeeper
Total Hours
812.140 Original
600
0.5
300
10
3,000
812.140 Supplemental
600
7
4,200
1
4,200
812.140 Non-significant
600
1
600
6
3,600
Total
10,800
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.
Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25539 Filed 10–22–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0486]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry, FDA, and Foreign
Governments: Fiscal Year 2010
Medical Device User Fee Small
Business Qualification and
Certification
AGENCY:
Food and Drug Administration,
HHS.
CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
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
FDA Forms 3602 and FDA Form 3602A
which will allow domestic and foreign
applicants to certify that they qualify as
a ‘‘small business’’ and pay certain
medical device user fees at reduced
rates.
DATES: Submit written or electronic
comments on the collection of
information by December 22, 2009.
ADDRESSES: Submit electronic
comments on the collection of
VerDate Nov<24>2008
15:24 Oct 22, 2009
Jkt 220001
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:
Denver Presley, Jr., Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3793.
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
practicalutility; (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
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
burden of the collection of information
on respondents, including through the
use of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry, FDA, and
Foreign Governments: FY 2010 Medical
Device User Fee Small Business
Qualification and Certification FD&C
Act Section 738 (OMB Control Number
0910–0508)—Extension
Section 101 of the Medical Device
User Fee and Modernization Act
(MDUFMA) amends the Federal Food,
Drug, and Cosmetic Act (the act) to
provide for user fees for certain medical
device applications. FDA published a
Federal Register notice on August 3,
2009 (74 FR 38444), announcing fees for
fiscal year (FY) 2010. To avoid harming
small businesses, MDUFMA provides
for reduced or waived fees for
applicants who qualify as a ‘‘small
business.’’ This means there are two
levels of fees, a standard fee, and a
reduced or waived small business fee.
FDA From 3602— For Domestic Small
Business Applicants
For FY 2010, you can qualify for a
small business fee discount under
MDUFMA if you reported gross receipts
or sales of no more than $100 million
on your Federal income tax return for
the most recent tax year. If you have any
affiliates, partners, or parent firms, you
must add their gross receipts or sales to
yours and the total must be no more
than $100 million. If your gross receipts
or sales are no more than $30 million,
including all of your affiliates, partners,
and parent firms, you will also qualify
for a waiver of the fee for your first
(ever) premarket application, (product
development protocol, biologics
licensing application, or Premarket
Report). An applicant must pay the full
standard fee unless it provides evidence
demonstrating to FDA that it meets the
‘‘small business’’ criteria. The evidence
required by MDUFMA is a copy of the
most recent Federal income tax return of
the applicant, and any affiliate, partner,
or parent firm. FDA will review these
E:\FR\FM\23OCN1.SGM
23OCN1
]]>Agencies
[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54824-54826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25539]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0480]
Agency Information Collection Activities; Proposed Collection;
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 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 written or electronic comments on the collection of
information by December 22, 2009.
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: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3793.
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 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
[[Page 54825]]
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. 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 are 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 of the act 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; Section 812.25 lists the
contents of the investigational plan; and Section 812.27 lists the data
relating to previous investigations or testing. The information in this
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 the FDA, a sponsor must
submit certain requests and reports. Under Section 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 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.
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, 600 0.5 300 80 24,000
and 812.27
----------------------------------------------------------------------------------------------------------------
812.35 and 600 7.8 4,700 6 28,200
812.150 (reports
for significant
risk studies)
----------------------------------------------------------------------------------------------------------------
812.150 (reports 600 0.017 10 6 60
for non-
significant risk
studies)
----------------------------------------------------------------------------------------------------------------
812.36(c) 1 1 1 120 120
----------------------------------------------------------------------------------------------------------------
812.36(f) 1 2 2 20 40
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 52,421
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 54826]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section Recordkeepers of Recordkeeping Records Recordkeeper Total Hours
----------------------------------------------------------------------------------------------------------------
812.140 Original 600 0.5 300 10 3,000
----------------------------------------------------------------------------------------------------------------
812.140 600 7 4,200 1 4,200
Supplemental
----------------------------------------------------------------------------------------------------------------
812.140 Non- 600 1 600 6 3,600
significant
----------------------------------------------------------------------------------------------------------------
Total ................. ................. ................. ................. 10,800
----------------------------------------------------------------------------------------------------------------
\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.
Dated: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25539 Filed 10-22-09; 8:45 am]
BILLING CODE 4160-01-S
