
[Federal Register Volume 77, Number 101 (Thursday, May 24, 2012)]
[Notices]
[Pages 31022-31024]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-12590]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, 
daniel.gittleson@fda.hhs.gov.

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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
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)......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          54,253
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of      records per    Total annual     burden per      Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    Totals......................  ..............  ..............  ..............  ..............           9,968
----------------------------------------------------------------------------------------------------------------
\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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
     Activity/21 CFR section         Number of      disclosures    Total annual     burden per      Total hours
                                    respondents   per respondent    disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Reports for Nonsignificant Risk                1               1               1               6               6
 Studies/812.150................
----------------------------------------------------------------------------------------------------------------
\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


