[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)]
[Notices]
[Pages 41078-41079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17796]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2310]


Process To Request a Review of Food and Drug Administration's 
Decision Not To Issue Certain Export Certificates for Devices; Draft 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the draft guidance entitled ``Process to Request a 
Review of FDA's Decision Not to Issue Certain Export Certificates for 
Devices; Draft Guidance for Industry and Food and Drug Administration 
Staff.'' FDA is issuing this draft guidance to comply with changes to 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the 
FDA Reauthorization Act of 2017 (FDARA), to specify the process 
afforded to persons denied a Certificate to Foreign Government (CFG) 
for a device. This draft guidance describes the information that the 
Center for Devices and Radiological Health (CDRH) and the Center for 
Biologics Evaluation and Research (CBER) will provide to a person whose 
request for a CFG for a device is denied, and the process for seeking 
review of such a denial. This draft guidance is not final nor is it in 
effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by October 16, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-D-2310 for ``Process to Request a Review of FDA's Decision Not 
to Issue Certain Export Certificates for Devices; Draft Guidance for 
Industry and Food and Drug Administration Staff.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9

[[Page 41079]]

a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    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 draft guidance entitled 
``Process to Request a Review of FDA's Decision Not to Issue Certain 
Export Certificates for Devices; Draft Guidance for Industry and Food 
and Drug Administration Staff '' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002 or the Office of 
Communication, Outreach, and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.

FOR FURTHER INFORMATION CONTACT: Joann Belt, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3658, Silver Spring, MD 20993-0002, 
[email protected], 301-796-7400, option 3; or Stephen Ripley, 
Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this draft guidance to comply with section 704 of 
FDARA (Pub. L. 115-52), which amended section 801 of the FD&C Act, to 
specify the process afforded to persons denied a CFG for a device. This 
draft guidance describes the information that CDRH and CBER will 
provide to a person whose request for a CFG for a device is denied, and 
the process for seeking review of such a denial. This draft guidance 
applies to the process for persons denied CFGs requested pursuant to 
section 801(e)(4)(A) of the FD&C Act (21 U.S.C. 381(e)(4)(A) for 
devices manufactured in an establishment registered under section 510 
of the FD&C Act (21 U.S.C. 360) (i.e., FDA-approved, cleared, or 
exempted devices) that are exported from the United States. This draft 
guidance supplements the FDA's guidance ``FDA Export Certificates,'' 
which is available at: https://www.fda.gov/RegulatoryInformation/Guidances/ucm125789.htm. This draft guidance is not final nor is it in 
effect at this time.

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 current thinking of FDA on the process 
for persons denied a certificate to foreign government for a device. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by downloading an electronic copy from the internet. A search 
capability for all CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available 
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download an electronic copy of 
``Process to Request a Review of FDA's Decision Not to Issue Certain 
Export Certificates for Devices; Draft Guidance for Industry and Food 
and Drug Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 17044 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. 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 
sections 801(e) and 802 (21 U.S.C. 382) of the FD&C Act have been 
approved under OMB control number 0910-0498; the collections of 
information in 21 CFR part 807, subparts A through E, have been 
approved under OMB control number 0910-0625; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; and the collections of information in the guidance 
``Center for Devices and Radiological Health Appeals Processes'' have 
been approved under OMB control number 0910-0738.

    Dated: August 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17796 Filed 8-16-18; 8:45 am]
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