[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11654-11655]
From the Federal Register Online via the Government Publishing 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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Draft Guidance for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 This draft guidance is not final nor is it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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 22, 2013.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ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and Food and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, [email protected].
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 [email protected] 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