[Federal Register Volume 74, Number 204 (Friday, October 23, 2009)]
[Notices]
[Pages 54824-54826]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25539]


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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.

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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 http://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\
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                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
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812.10                             1                  1                  1                  1                  1
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812.20, 812.25,                  600                0.5                300                 80             24,000
 and 812.27
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812.35 and                       600                7.8              4,700                  6             28,200
 812.150 (reports
 for significant
 risk studies)
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812.150 (reports                 600              0.017                 10                  6                 60
 for non-
 significant risk
 studies)
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812.36(c)                          1                  1                  1                120                120
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812.36(f)                          1                  2                  2                 20                 40
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Total              .................  .................  .................  .................             52,421
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\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\
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                         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
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812.140                          600                  7              4,200                  1              4,200
 Supplemental
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812.140 Non-                     600                  1                600                  6              3,600
 significant
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Total              .................  .................  .................  .................             10,800
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\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