[Federal Register: June 16, 2003 (Volume 68, Number 115)]
[Notices]               
[Page 35677-35679]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16jn03-70]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0050]

 
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 or electronic comments on the collection of 
information by July 16, 2003.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. 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: Fumie Yokota, Desk 
Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, 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 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 either to 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. The 
safety and effectiveness of the device involving human subjects 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 distribution of the device is in the interests of the public 
health. Section

[[Page 35678]]

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 March 12, 2003 (68 FR 11868), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                Annual Frequency per
             21 CFR Section                No. of Respondents         Response        Total Annual Responses   Hours per 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                  300                     80                24,000
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812.35 and 812.150 (significant)                 600                     7                  4,200                      6                25,200
812.150 (nonsignificant)                         600                     0.017                 10                      6                    60
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812.36(c)                                          6                     1                      6                    120                   720
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812.36(f)                                          6                     2                     12                     20                   240
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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 Burden\1\
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                                                                 Annual Frequency of
             21 CFR Section               No. of Recordkeepers      Recordkeeping      Total Annual Records     Hours per Record         Total Hours
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812.140
  Original                                       600                     0.5                  300                     10                 3,000
  Supplemental                                   600                     7                  4,200                      1                 4,200
  Nonsignificant                                 600                     1                    600                      6                 3,600
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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.

II. 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 IDEs submitted from fiscal years 1995 through 2002. 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 2002 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

[[Page 35679]]

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.

III. Recordkeeping

    Section 812.40 estimates are based on conversations with 
manufacturers, industry trade association groups, and 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 previously mentioned, 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 
device nonsignificant risk studies. It is estimated that 600 
recordkeepers will spend 6 hours each in maintaining these records.

    Dated: June 9, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-15059 Filed 6-13-03; 8:45 am]

BILLING CODE 4160-01-S