[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Notices]
[Pages 19714-19715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-07577]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0051]


User Fees and Refunds for Premarket Approval Applications and 
Device Biologics License Applications; 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 ``User Fees and Refunds for 
Premarket Approval Applications (PMAs) and Device Biologics License 
Applications (BLAs).'' The purpose of this guidance document is to 
identify the types of PMAs and BLAs subject to device user fees, 
including supplements and other submissions, as well as those that do 
not have an associated user fee. The guidance also identifies industry 
and FDA actions on these submissions that may result in a refund of the 
fee. The draft of this document was issued on March 16, 2009.

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: Submit written requests for single copies of the guidance 
document entitled ``User Fees and Refunds for Premarket Approval 
Applications and Device Biologics License Applications'' 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 Office of Communication, Outreach and 
Development (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, 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 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

[[Page 19715]]

docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570; 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.

SUPPLEMENTARY INFORMATION:

I. Background

    The Medical Device User Fee Amendments of 2012 (MDUFA III), amended 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize 
FDA to collect user fees for the review of certain premarket 
submissions received on or after October 1, 2012, including PMAs and 
device BLAs. The additional funds obtained from user fees will enable 
FDA, with the cooperation of industry, to improve the medical device 
review process to meet certain performance goals and implement 
improvements for the medical device review process.

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 user fees and refunds for PMAs and device 
BLAs. 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 
using 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 http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. To receive ``User Fees and Refunds for Premarket Approval 
Applications and Device Biologics License Applications,'' 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 1681 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 814 have been approved under 
OMB control number 0910-0231.

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: March 27, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07577 Filed 4-1-13; 8:45 am]
BILLING CODE 4160-01-P