
[Federal Register Volume 78, Number 96 (Friday, May 17, 2013)]
[Notices]
[Pages 29140-29141]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-11708]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0501]


Center for Devices and Radiological Health Appeals Processes: 
Questions and Answers About 517A; Draft Guidance for Industry and Food 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availability of the draft guidance entitled ``Center for Devices and 
Radiological Health (CDRH) Appeals Processes: Questions and Answers 
About 517A.'' This draft document provides CDRH's proposed 
interpretation of key provisions of the Federal Food Drug and Cosmetic 
Act

[[Page 29141]]

(FD&C Act), which were added by the FDA Safety and Innovation Act 
(FDASIA), as those provisions pertain to requests for documentation of 
rationales for significant decisions and requests for supervisory 
review of regulatory decisions and actions taken by CDRH. This draft 
guidance is not final nor is it in effect at this time.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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by August 15, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Center for Devices and Radiological Health 
Appeals Processes: Questions and Answers About 517A'' 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. 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: David S. Buckles, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G470, Silver Spring, MD 20993-0002, 301-
796-5447.

I. Background

    In July of 2012, section 517A of the FD&C Act (21 U.S.C. 360g-1) 
was added by section 603 of FDASIA (Pub. L. 112-114). CDRH developed 
this draft guidance as a companion document to the guidance entitled 
``Center for Devices and Radiological Health Appeals Processes,'' 
(Appeals Guidance) which is also announced in this issue of the Federal 
Register, to provide proposed interpretations of the new law. This 
document provides interpretations of the terms ``significant 
decisions'' and ``substantive summary.'' It also addresses who may 
request documentation of significant decisions under section 517A of 
the FD&C Act, and how this provision relates to requests under the 
Freedom of Information Act. When this guidance is finalized, CDRH 
intends to include the questions and answers in this draft guidance as 
an appendix to the Appeals Guidance.

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 CDRH's 
appeals processes. 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. To receive 
``Center for Devices and Radiological Health Appeals Processes: 
Questions and Answers About 517A'' 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 1821 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    The draft guidance refers to collections of information that 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 the guidance document ``Center for 
Devices and Radiological Health Appeals Processes'' are approved under 
OMB control number 0910-0738 (expires April 30, 2016). The draft 
guidance also refers to currently approved information collections 
found in FDA regulations. The collections of information in 21 CFR part 
807 subpart E are approved under OMB control number 0910-0120; the 
collections of information in 21 CFR part 812 are approved under OMB 
control number 0910-0078; the collections of information in 21 CFR part 
814 are approved under OMB control number 0910-0231; and the 
collections of information in 21 CFR part 814 subpart H are approved 
under OMB control number 0910-0332.

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: May 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11708 Filed 5-16-13; 8:45 am]
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