[Federal Register Volume 78, Number 241 (Monday, December 16, 2013)]
[Notices]
[Pages 76150-76151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-29796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 Under Section 515A of the 
Federal Food, Drug, and Cosmetic Act

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

[[Page 76151]]

(OMB) for review and clearance under the Paperwork Reduction Act of 
1995.

DATES: Fax written comments on the collection of information by January 
15, 2014.

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-New and 
title ``Providing Information About Pediatric Uses of Medical Devices 
Under Section 515A of the Federal Food, Drug, and Cosmetic Act''. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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.

Medical Devices; Pediatric Uses of Devices; Requirement for Submission 
of Information on Pediatric Subpopulations That Suffer From a Disease 
or Condition That a Device Is Intended To Treat, Diagnose, or Cure--
(OMB Control Number 0910--New)

    The draft guidance suggests that applicants who submit certain 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 in order 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);
    3. Any product development protocol submitted under section 515 of 
the FD&C Act.
    In the Federal Register of February 19, 2013, (78 FR 11654), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. However, only one comment was interpreted as 
being related to the proposed collection of information.
    One comment stated that FDA should not require all readily 
available information on pediatric uses of devices because it is unduly 
burdensome, but rather applicants should be required to perform a 
reasonable search. FDA disagrees with the comment. In order for FDA to 
be provided useful, comprehensive information and to fulfill the 
statutory mandate, all readily available information should be 
submitted to FDA. Moreover, the requirement is not unduly burdensome 
because FDA is only requiring all information that is readily 
available, not all information in general.
    FDA estimates the burden of this collection of information as 
follows:

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

    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 
so.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in part 814 (21 CFR part 814), subpart B have been approved under OMB 
control number 0910-0231, and the collections of information in part 
814, subpart H have been approved under OMB control number 0910-0332.

    Dated: December 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-29796 Filed 12-13-13; 8:45 am]
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