
[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12735-12737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05385]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0477]


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 April 
11, 2016.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0078. 
Also

[[Page 12736]]

include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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-- 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. 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.
    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.
    For a nonsignificant risk device investigation, the investigators' 
and sponsors' 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. The estimate of the burden is based 
on the number of IDEs received in recent years.
    In the Federal Register of October 28, 2015 (80 FR 66009), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 12737]]



                                 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,             219               1             219              80          17,520
 and 812.27.....................
Supplements--812.35 and 812.150.             579               6           3,474               6          20,844
Treatment IDE Applications--                   1               1               1             120             120
 812.36(c)......................
Treatment IDE Reporting--                      1               1               1              20              20
 812.36(f)......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          38,505
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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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                                                    Number of                         Average
    Activity/21 CFR section         Number of      records per     Total annual     burden per      Total hours
                                  recordkeepers    recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Original--812.140..............             219                1             219              10           2,190
Supplemental--812.140..........             579                6           3,747               1           3,474
Nonsignificant--812.140........             356                1             356               6           2,136
                                --------------------------------------------------------------------------------
    Total......................  ..............  ...............  ..............  ..............           7,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                      Activity/21 CFR section                          Number of      disclosures per    Total annual   Average  burden    Total hours
                                                                      respondents       respondent       disclosures     per disclosure
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Reports for Nonsignificant Risk Studies--812.150..................               1                 1                1                6                6
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated annual reporting burden for this extension has 
decreased to 38,505 hours (previously 54,253 hours) as the result of a 
decrease in the average number of applications and supplements 
submitted. For the same reason, the recordkeeping burden has decreased 
to 7,800 hours (previously 9,968). The previous approved total burden 
hours of 64,227, have therefore decreased by 17,916 to 46,311.

    Dated: March 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05385 Filed 3-9-16; 8:45 am]
 BILLING CODE 4164-01-P


