[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66009-66011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27420]


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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 of availability.

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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 December 28, 2015.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-N-0477 for Agency Information Collection Activities; Proposed 
Collection; Comment Request; Investigational Device Exemptions Reports 
and Records. Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the

[[Page 66010]]

claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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/reinstatement] 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. 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

[[Page 66011]]

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.
    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, and 812.27...............             356               1             356              80          28,480
Supplements--812.35 and 812.150...........................             356              12           4,272               6          25,632
Treatment IDE Applications--812.36(c).....................               1               1               1             120             120
Treatment IDE Reporting--812.36(f)........................               1               1               1              20              20
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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.


                               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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    Total.......................  ..............  ..............  ..............  ..............           9,968
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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
                                     Number of      disclosures    Total annual       Average
     Activity/21 CFR section        respondents         per         disclosures     burden per      Total hours
                                                    respondent                      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.


    Dated: October 22, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-27420 Filed 10-27-15; 8:45 am]
 BILLING CODE 4164-01-P