[Federal Register Volume 85, Number 133 (Friday, July 10, 2020)]
[Notices]
[Pages 41593-41594]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-14880]


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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: Submit written comments (including recommendations) on the 
collection of information by August 10, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0767. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

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 (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 to comply with the order of an 
individual physician or dentist;
     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 February 21, 2020 (85 FR 10175), we 
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 devices................................              34                1               34               40            1,360
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 41594]]

    Our estimated burden for the information collection reflects an 
overall increase of 40 hours and a corresponding increase of one 
response/record. We attribute this adjustment to an increase in the 
number of submissions we received over the last few years.

    Dated: July 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14880 Filed 7-9-20; 8:45 am]
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