[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24731-24732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09897]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0458]


Providing Information About Pediatric Uses of Medical Devices; 
Guidance for Industry and Food and Drug Administration Staff; 
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 guidance entitled ``Providing Information about 
Pediatric Uses of Medical Devices.'' 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).

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Providing Information About Pediatric Uses of Medical Devices'' to 
the Office of the Center Director, Guidance and Policy Development, 
Center for Devices and Radiological Health (CDRH), Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002 or 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.
    Submit electronic comments on the 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: 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.

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: (1) A description of any pediatric subpopulations that 
suffer from the disease or condition that the device is intended to 
treat, diagnose, or

[[Page 24732]]

cure and (2) the number of affected pediatric patients.
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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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    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. The draft 
version of this guidance was issued on February 19, 2013 (78 FR 11654).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents 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 guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health 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. Persons unable to 
download an electronic copy of ``Providing Information about Pediatric 
Uses of Medical Devices,'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1801 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    On January 9, 2014, the Agency submitted a proposed collection of 
information entitled ``Providing Information About Pediatric Uses of 
Medical Devices Under Section 515A of the Federal Food, Drug and 
Cosmetic Act'' to OMB for review and clearance under 44 U.S.C. 3507. An 
Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless it displays a currently 
valid OMB control number. OMB has now approved the information 
collection and has assigned OMB control number 0910-0762. The approval 
expires on March 31, 2017. A copy of the supporting statement for this 
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.
    This guidance also refers to previously approved collections of 
information found in FDA regulations. The collections of information in 
21 CFR part 814, subpart B have been approved under OMB control number 
0910-0231 and the collections of information in 21 CFR part 814, 
subpart H have been approved under OMB control number 0910-0332.

V. Comments

    Interested persons may submit either written 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: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09897 Filed 4-30-14; 8:45 am]
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