
[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11654-11655]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03652]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry and Food and Drug Administration 
Staff; Providing Information About Pediatric Uses of Medical Devices 
Under Section 515A of the Federal Food, Drug, and Cosmetic Act; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Draft Guidance for 
Industry and Food and Drug Administration Staff: Providing Information 
About Pediatric Uses of Medical Devices Under Section 515A of the 
Federal Food, Drug, and Cosmetic Act.'' FDA is issuing this guidance 
document to describe how to compile and submit the readily available 
pediatric use information required under the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it 
in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 22, 2013. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 by April 22, 2013, 
(see the ``Paperwork Reduction Act of 1995'' section of this document).

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and Food and 
Drug Administration Staff: Providing Information About Pediatric Uses 
of Medical Devices Under Section 515A of the Federal Food, Drug, and 
Cosmetic Act'' to the Division of Small Manufacturers, International, 
and Consumer Assistance, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
4613, Silver Spring, MD 20993-0002; or the Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research (CBER), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 301-847-8149. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
With regard to the guidance: Sheila Brown, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993-0002, 301-796-6563; 
or
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), 
Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852, 301-827-6210.

    With regard to the proposed collection of information: Daniel 
Gittleson, Office of Information Management, Food and Drug 
Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-
796-5156, daniel.gittleson@fda.hhs.gov.

I. Background

    On September 27, 2007, the Food and Drug Administration Amendments 
Act of 2007 (FDAAA) \1\ (Pub. L. 110-85) amended the FD&C Act by 
adding, among other things, a new section 515A (21 U.S.C. 360e-1) of 
the FD&C Act. Section 515A(a) of the FD&C Act requires persons who 
submit certain medical device applications to include, if readily 
available:
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    \1\ Title III of FDAAA, which includes new section 515A, is also 
known as the Pediatric Medical Device Safety and Improvement Act of 
2007.
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    1. A description of any pediatric subpopulations that suffer from 
the disease or condition that the device is intended to treat, 
diagnose, or cure; and
    2. The number of affected pediatric patients.
    The purpose of this guidance document is to describe the type of 
information that FDA believes is readily available to the applicant, 
and the information FDA believes should be included in a submission to 
meet the requirements of section 515A(a) of the FD&C Act.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the 
requirements relating to the submission of information on pediatric 
subpopulations that suffer from the disease or condition that a device 
is intended to treat, diagnose, or cure. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov or from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``Draft 
Guidance for Industry and Food and Drug Administration Staff: Providing 
Information About Pediatric Uses of Medical Devices Under Section 515A 
of the Federal Food, Drug, and Cosmetic Act,'' you may either send an 
email request to dsmica@fda.hhs.gov to receive an electronic copy of 
the document or send a fax request to 301-847-8149 to receive a hard 
copy. Please use the document number 1801 to identify the guidance you 
are requesting.

IV. Paperwork Reduction Act of 1995

    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 that they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320(c) and 
includes Agency requests or requirements that members of the public

[[Page 11655]]

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 before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing this 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 on 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.

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

    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 FD&C Act;
    2. Any premarket approval application (PMA) or supplement to a PMA 
submitted under section 515 of the FD&C Act;
    3. Any product development protocol submitted under section 515 of 
the FD&C Act.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
           Description               Number of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       responses
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Uses outside approved indication             148               1             148              .5              74
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    Totals......................             148  ..............             148  ..............              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.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a proposed rule that requires, under section 515A of the FD&C Act, the 
submission of readily available information on any pediatric 
subpopulations that suffer from the disease or condition that the 
device is intended to treat, diagnose, or cure, and the number of 
affected pediatric patients.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: February 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03652 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P


