[Federal Register Volume 71, Number 210 (Tuesday, October 31, 2006)]
[Notices]
[Pages 63766-63768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18200]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0184]


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.

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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 
November 30, 2006.

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: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Denver Presley, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1472.

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 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

[[Page 63767]]

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 allows 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 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.
    Once FDA approves an IDE application, 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. Under Sec.  812.150, a 
sponsor is required 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 on device name and intended 
use, study objectives, investigator information, investigational review 
board (IRB) information, and statement on the extent that good 
manufacturing practices will be followed.
    The most likely respondents to this information collection will 
primarily be medical device manufacturers, investigators, hospitals, 
health maintenance organizations, and businesses.
    In the Federal Register of May 26, 2006 (71 FR 30425), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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                  275                 80             22,000
 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
 nonsignificant
 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                                                                                                     50,421
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                               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                275                 10              2,750
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812.140                          600                7                4,700                  1              4,700
 Supplemental
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[[Page 63768]]

 
812.140                          600                1                  600                  6              3,600
 Nonsignificant
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Total                                                                                                     11,050
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: October 24, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18200 Filed 10-30-06; 8:45 am]
BILLING CODE 4160-01-S