Notice: Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Investigational 
Device Exemptions Reports and Records

Federal Register: January 19, 2010 (Volume 75, Number 11)              
                  Page 2869-2871

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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 
February 18, 2010.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0078. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-5156, 
Daniel.Gittleson@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--21 CFR Part 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 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. 
Non-significant 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 of the act, 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

[[Page 2870]]

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 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. 
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 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 
non-significant risk device study, an explanation of the non-
significant 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.
    In the Federal Register of October 23, 2009 (74 FR 54824), 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:

                                 Table 1. --Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                No. of       Annual Frequency   Total Annual      Hours per
      21 CFR Section          Respondents      per Response       Responses       Response        Total  Hours
----------------------------------------------------------------------------------------------------------------
812.10                                   1                  1               1               1                  1
----------------------------------------------------------------------------------------------------------------
812.20, 812.25, and 812.27             465                0.5             233              80             18,640
----------------------------------------------------------------------------------------------------------------
812.35 and 812.150                     465                7.8           3,627               6             21,762
 (reports for significant
 risk studies)
----------------------------------------------------------------------------------------------------------------
812.150 (reports for non-              465              0.017               8               6                 48
 significant risk studies)
----------------------------------------------------------------------------------------------------------------
812.36(c)                                1                  1               1             120                120
----------------------------------------------------------------------------------------------------------------
812.36(f)                                1                  2               2              20                 40
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     40,611
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information. Due to a reevaluation of the burden, the burden hours and annual responses which appeared in a
  notice issued in the Federal Register of October 23, 2009 (74 FR 54824) have been adjusted.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                             Annual Frequency
      21 CFR Section            No. of             per          Total Annual      Hours per       Total  Hours
                             Recordkeepers    Recordkeeping        Records         Record
----------------------------------------------------------------------------------------------------------------
812.140 Original                       465                0.5             233              10              2,330
----------------------------------------------------------------------------------------------------------------
812.140 Supplemental                   465                  7           3,255               1              3,255
----------------------------------------------------------------------------------------------------------------
812.140 Non-significant                465                  1             465               6              2,790
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      8,375
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information. The estimate of the burden is based on the number of IDEs received in the last 3 years.



[[Page 2871]]

    Dated: January 12, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-793 Filed 1-15-10; 8:45 am]
BILLING CODE 4160-01-S