[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Pages 14224-14225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05302]



Food and Drug Administration

[Docket No. FDA-2013-D-0117]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Providing Information 
About Pediatric Uses of Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 April 
17, 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 [email protected]. All 
comments should be identified with the OMB control number 0910-0762. 
Also include the FDA docket number found in brackets in the heading of 
this document.

Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, [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.

Providing Information About Pediatric Uses of Medical Devices Under 
Section 515A of the Federal Food, Drug, and Cosmetic Act

OMB Control Number 0910-0762--Extension

    The guidance document entitled ``Providing Information About 
Pediatric Uses of Medical Devices--Guidance for Industry and Food and 
Drug Administration Staff'' suggests that applicants who submit certain 
medical device applications include, if readily available, pediatric 
use information for diseases or conditions that the device is being 
used to treat, diagnose, or cure that are outside the device's approved 
or proposed indications for use, as well as an estimate of the number 
of pediatric patients with such diseases or conditions. The information 
submitted will allow FDA to identify pediatric uses of devices outside 
their approved or proposed indication for use to determine areas where 
further pediatric device development could be useful. This 
recommendation applies to applicants who submit the following 
applications: (1) Any request for a humanitarian device exemption 
submitted under section 520(m) of the Federal Food, Drug, and Cosmetic 
Act (the FD&C Act) (21 U.S.C. 360j(m)); (2) any premarket approval 
application (PMA) or supplement to a PMA submitted under section 515 of 
the FD&C Act (21 U.S.C. 360e); and (3) any product development protocol 
submitted under section 515 of the FD&C Act.
    Respondents are permitted to submit information relating to uses of 
the device outside the approved or proposed indication if such uses are 
described or acknowledged in acceptable sources of readily available 
information. We estimate that 20 percent of respondents submitting 
information required by section 515A of the FD&C Act will choose to 
submit this information and that it will take 30 minutes for them to do 
    In the Federal Register of December 5, 2016 (81 FR 87575), 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 

[[Page 14225]]

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                   Number of
                 Description                      Number of      responses per     Total annual        Average burden per response         Total hours
                                                 respondents       respondent       responses
Uses outside approved indication.............             148                1              148   0.5 (30 minutes).....................              74
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05302 Filed 3-16-17; 8:45 am]