[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31022-31024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-12590]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0477]
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 either electronic or written comments on the collection
of information by July 23, 2012.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
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 Part 812
(OMB Control Number 0910-0078)--Extension
Section 520(g) of the Federal Food, Drug, and Cosmetic Act (the
FD&C 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 (Pub. L. 105-115) added section 520(g)(6) to
the FD&C 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 FD&C
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, i.e., devices 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 permits 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 the 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.
Upon approval of an IDE application by FDA, a sponsor must submit
certain requests and reports. Under Sec. 812.35, a sponsor who wishes
to make a change in the investigation that 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.
Section 812.150 requires a sponsor to submit reports to FDA.
[[Page 31023]]
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 interest 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
Activity/21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Waivers/812.10.................. 1 1 1 1 1
IDE application/812.20, 812.25, 356 1 356 80 28,480
and 812.27.....................
Supplements/812.35 and 812.150.. 356 12 4,272 6 25,632
Treatment IDE applications/ 1 1 1 120 120
812.36(c)......................
Treatment IDE reporting/ 1 1 1 20 20
812.36(f)......................
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Total....................... .............. .............. .............. .............. 54,253
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
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 of device name and intended
use, study objectives, investigator information, investigational review
board information, and statement on the extent that good manufacturing
practices will be followed.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average
Activity/21 CFR section Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
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Original/812.140................ 356 1 356 10 3,560
Supplemental/812.140............ 356 12 4,272 1 4,272
Nonsignificant/812.140.......... 356 1 356 6 2,136
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Totals...................... .............. .............. .............. .............. 9,968
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
For a nonsignificant risk device investigation, the investigator's
and sponsor's recordkeeping and reporting burden is reduced. Pertinent
records on the study must be maintained by both parties, and reports
are made to sponsors and institutional review boards (IRBs). Reports
are made to FDA only in certain circumstances, e.g., recall of the
device, the occurrence of unanticipated adverse effects, and as a
consequence of certain IRB actions.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of Average
Activity/21 CFR section Number of disclosures Total annual burden per Total hours
respondents per respondent disclosures disclosure
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Reports for Nonsignificant Risk 1 1 1 6 6
Studies/812.150................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 31024]]
The estimate of the burden is based on the number of IDEs received
in the last 3 years.
Dated: May 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12590 Filed 5-23-12; 8:45 am]
BILLING CODE 4160-01-P