[Federal Register: May 26, 2006 (Volume 71, Number 102)]
[Notices]
[Page 30425-30426]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26my06-93]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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