[Federal Register: October 31, 2006 (Volume 71, Number 210)]
[Notices]
[Page 63766-63768]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31oc06-60]
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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