[Federal Register Volume 65, Number 130 (Thursday, July 6, 2000)]
[Notices]
[Pages 41676-41678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16974]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1226]


Agency Information Collection Activities; Submission for OMB 
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 the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
August 7, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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 No. 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 FDA 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, those 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, those 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 IDE's. 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

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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 ensure 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, institutional review 
board (IRB) information, and a 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 April 13, 2000 (65 FR 19912), the agency 
requested comments on the proposed collection of information. No 
significant comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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812.10                                  1               1               1               1               1
812.20,812.25, and 812.27             600               0.5           300              80          24,000
812.35 and 812.150 (Significant)      600               7           4,200               6          25,200
812.150 (Nonsignificant)              600               0.017          10               6              60
812.36(c)                               6               1               6             120             720
812.36(f)                               6               2              12              20             240
Total                                                                                                  50.221
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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 Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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812.40                                600               0.5           300              10           3,000
Original Supplemental                 600               7           4,200               1           4,200
Nonsignificant                        600               1             600               6           3,600
Total                                                                                             10,800
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

I. Reporting

    Section 812.10 estimates are based on the fact that FDA has 
received very few, if any, waiver requests in the past, and estimates 
that very few will be submitted in the future. Therefore, FDA estimates 
a minimal burden to account for waiver requests.
    Sections 812.20, 812.25, and 812.27 estimates are based on the 
average of IDE's submitted from fiscal years 1995 through 1999. FDA 
estimates the annual reporting burden for one IDE original application 
to be approximately 80 hours, and the annual reporting burden for one 
IDE supplement to be approximately 6 hours.
    Sections 812.35 and 812.150 estimates are based on the average of 
IDE supplements submitted from fiscal years 1995 through 1999 for 
significant risk device studies. FDA estimates the annual reporting 
burden for one IDE supplement to be approximately 6 hours.
    The reporting burden for nonsignificant risk device studies 
(Sec. 812.150) is negligible. Nonsignificant risk device studies are 
not reported to FDA unless a problem is reported such as an 
unanticipated adverse device reaction, failure to obtain informed 
consent, withdrawal of IRB approval, or a recall of a device. In the 
past, an average of 10 incidences or less annually have been reported 
to FDA. Section 812.36(c) and (f) estimates are based on FDA's 
experience with the treatment use of drugs and knowledge of the types 
of devices that may meet the treatment use criteria. FDA estimates that 
an average of six treatment use applications will be submitted each 
year. FDA estimates that it will take approximately 120 hours to 
prepare a treatment IDE and the total annual burden for preparing 
applications will be 720 hours. FDA also estimates that it will take 
approximately 20 hours to prepare a semiannual report, resulting in a 
total annual burden of 240 hours for annual reports.

II. Recordkeeping

    Section 812.40 estimates are based on conversations with 
manufacturers, industry trade association groups, and

[[Page 41678]]

businesses over the last 3 years. For significant risk device 
investigations, FDA has estimated that the recordkeeping burden for 
preparing an original IDE submission averages 10 hours for each 
original IDE submission. Similarly, through the same conversations 
mentioned above, FDA has estimated recordkeeping for each supplement 
requires 1 hour. The recordkeeping burden for nonsignificant risk 
device investigations is difficult to estimate because nonsignificant 
risk device investigations are not required to be submitted to FDA. The 
IDE staff estimates that the number of recordkeepers for nonsignificant 
risk device investigations is equal to the number for active 
significant risk device investigations. The recordkeeping burden, 
however, is reduced for nonsignificant risk device studies. It is 
estimated that 600 recordkeepers will spend 6 hours each in maintaining 
these records.

    Dated: June 27, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-16974 Filed 7-5-00; 8:45 am]
BILLING CODE 4160-01-F