[Federal Register Volume 71, Number 102 (Friday, May 26, 2006)]
[Notices]
[Pages 30425-30426]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8125]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0184]


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 July 25, 2006.

ADDRESSES:  Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. 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, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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 812 (OMB 
Control Number 0910-0078)

    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. 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

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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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                Annual Frequency per      Total Annual        Hours per
             21 CFR Section               No. of Respondents          Response             Responses           Response              Total Hours
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812.10                                                      1            1                             1                  1               1
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812.20, 812.25, and 812.27                                600            0.5                         275                 80          22,000
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812.35 and 812.150 (reports for                           600            7.8                        4700                  6          28,200
 significant risk studies)
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812.150 (reports for non-significant                      600            0.017                        10                  6              60
 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 per                               Hours per
              21 CFR Section                  Recordkeepers         Recordkeeping       Total Annual Records      Recordkeeper          Total Hours
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812.140 Original                                          600            0.5                   275                            10        2,750
812.140 Supplemental                                      600            7                   4,700                             1        4,700
812.140 Non-significant                                   600            1                     600                             6        3,600
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: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-8125 Filed 5-25-06; 8:45 am]
BILLING CODE 4160-01-S