80 FR 66009 - Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 208 (October 28, 2015)

Page Range		66009-66011
FR Document		2015-27420

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.

Federal Register, Volume 80 Issue 208 (Wednesday, October 28, 2015)

[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Notices]
[Pages 66009-66011]
From the Federal Register Online [www.thefederalregister.org]
[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.

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

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, 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/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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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, 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
---------------------------------------------------------------------------------------------
Total................................................. .............. .............. .............. .............. 54,253
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

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
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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\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
Activity/21 CFR section respondents per disclosures burden per Total hours
respondent 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.

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

Federal Register / Vol. 80, No. 208 / Wednesday, October 28, 2015 / Notices 66011

investigators and sponsors. FDA the study, records of shipment and sponsors’ recordkeeping and reporting
requires this information for tracking disposition, signed investigator burden is reduced. Pertinent records on
and oversight purposes. Investigators agreements, adverse device effects the study must be maintained by both
are required to maintain records, information, and, for a nonsignificant parties, and reports are made to
including correspondence and reports risk device study, an explanation of the sponsors and institutional review
concerning the study, records of receipt, nonsignificant risk determination, boards (IRBs). Reports are made to FDA
use or disposition of devices, records of records of device name and intended only in certain circumstances, e.g.,
each subject’s case history and exposure use, study objectives, investigator recall of the device, the occurrence of
to the device, informed consent information, investigational review unanticipated adverse effects, and as a
documentation, study protocol, and board information, and statement on the consequence of certain IRB actions. The
documentation of any deviation from extent that good manufacturing estimate of the burden is based on the
the protocol. Sponsors are required to practices will be followed. number of IDEs received in recent years.
maintain records including For a nonsignificant risk device FDA estimates the burden of this
correspondence and reports concerning investigation, the investigators’ and collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response

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

Total .............................................................................. ........................ ........................ ........................ ........................ 54,253
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section records per burden per Total Hours
recordkeepers records
recordkeeper 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

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

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.

Dated: October 22, 2015. DEPARTMENT OF HEALTH AND guidance for industry entitled ‘‘Product
Leslie Kux, HUMAN SERVICES Development Under the Animal Rule.’’
Associate Commissioner for Policy. When human efficacy studies are not
Food and Drug Administration ethical and field trials are not feasible,
[FR Doc. 2015–27420 Filed 10–27–15; 8:45 am]
BILLING CODE 4164–01–P [Docket No. FDA–2009–D–0007] FDA may rely on adequate and well-
controlled animal efficacy studies to
Product Development Under the support approval of a drug or licensure
Animal Rule; Guidance for Industry; of a biological product under the
Availability Animal Rule. This guidance finalizes
mstockstill on DSK4VPTVN1PROD with NOTICES

the 2014 revised draft guidance for
AGENCY: Food and Drug Administration,
industry ‘‘Product Development Under
HHS.
the Animal Rule.’’ It is intended to help
ACTION: Notice of availability. potential stakeholders (industry,
SUMMARY: The Food and Drug academia, and government) understand
Administration (FDA or Agency) is FDA’s expectations for product
announcing the availability of a development under the Animal Rule.

VerDate Sep<11>2014 19:16 Oct 27, 2015 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\28OCN1.SGM 28OCN1

Document Created: 2018-02-27 08:57:55
Document Modified: 2018-02-27 08:57:55

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		Submit either electronic or written comments on the collection of information by December 28, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 66009

80 FR 66009 - Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 208 (October 28, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration