Document ID: FDA-2012-N-0477-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
Posted Date: 2019-06-11T04:00Z

[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27139-27141]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12266]

[[Page 27139]]

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

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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 August 12, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before August 12, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 12, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff 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 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@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)

[[Page 27140]]

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

OMB Control Number 0910-0078--Extension

    Section 520(g) of the Federal Food, Drug, and Cosmetic Act (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 of any of the requirements of part 812. 
Sections 812.20, 812.25, and 812.27 describe 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.
    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.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Activity/21 CFR section         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Waivers--812.10.................               1               1               1               1               1
IDE Application--812.20, 812.25,             229               1             229              80          18,320
 and 812.27.....................
Supplements--812.35 and 812.150.             654               5           3,270               6          19,620
Treatment IDE Applications--                   1               1               1             120             120
 812.36(c)......................
Treatment IDE Reporting--                      1               1               1              20              20
 812.36(f)......................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          38,081
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 27141]]

                                Table 2--Estimated Annual Recordkeeping Burden 1
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
     Activity/21 CFR section         Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Original--812.140...............             229               1             229              10           2,290
Supplemental--812.140...........             654               5           3,270               1           3,270
Nonsignificant--812.140.........             356               1             356               6           2,136
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           7,696
----------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                      Activity/21 CFR section                           Number of     disclosures per    Total annual    Average burden    Total hours
                                                                       respondents       respondent      disclosures     per disclosure
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reports for Nonsignificant Risk Studies--812.150...................               1                1                1                6                6
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimated burden for the information collection reflects an 
overall decrease of 528 hours. We attribute this adjustment to a 
decrease in the number of submissions we received over the last few 
years.

    Dated: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12266 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P