Document ID: FDA-2017-N-1066-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Annual Reporting for Custom Device Exemption
Posted Date: 2017-06-26T04:00Z

[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Pages 28860-28861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13245]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1066]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Annual Reporting for 
Custom Device Exemption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 July 
26, 2017.

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 emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0767. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@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.

Annual Reporting for Custom Device Exemption OMB Control Number 0910-
0767--Extension

    The custom device exemption is set forth at section 520(b)(2)(B) of 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
360j(b)(2)(B)). A custom device is in a narrow category of device that, 
by virtue of the rarity of the patient's medical condition or 
physician's special need the device is designed to treat, it would be 
impractical for the device to comply with premarket review regulations 
and performance standards.
    The Food and Drug Administration Safety and Innovation Act (FDASIA) 
implemented changes to the custom device exemption contained in section 
520(b) of the FD&C Act. The new provision amended the existing custom 
device exemption and introduced new concepts and procedures for custom 
devices, such as:
     Devices created or modified in order to comply with the 
order of an individual physician or dentist;

[[Page 28861]]

     The potential for multiple units of a device type (limited 
to no more than five units per year) qualifying for the custom device 
exemption; and
     Annual reporting requirements by the manufacturer to FDA 
about devices manufactured and distributed under section 520(b) of the 
FD&C Act.
    Under FDASIA, ``devices'' that qualify for the custom device 
exemption contained in section 520(b) of the FD&C Act were clarified to 
include no more than ``five units per year of a particular device 
type'' that otherwise meet all the requirements necessary to qualify 
for the custom device exemption.
    In the Federal Register of September 24, 2014 (79 FR 57112), FDA 
announced the availability of the guidance entitled ``Custom Device 
Exemption.'' FDA has developed this document to provide guidance to 
industry and FDA staff about implementation of the custom device 
exemption contained in the FD&C Act. The intent of the guidance is to 
define terms used in the custom device exemption, explain how to 
interpret the ``five units per year of a particular device type'' 
language contained in the FD&C Act, describe information that FDA 
proposes manufacturers should submit in the custom device annual 
report, and provide recommendations on how to submit an annual report 
for devices distributed under the custom device exemption.
    In the Federal Register of March 21, 2017 (82 FR 14518), 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\
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                                                     Number of
            Activity                 Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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Annual reporting for custom                   33               1              33              40           1,320
 devices........................
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13245 Filed 6-23-17; 8:45 am]
 BILLING CODE 4164-01-P