[Federal Register Volume 84, Number 220 (Thursday, November 14, 2019)]
[Notices]
[Pages 61913-61915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24717]


-----------------------------------------------------------------------

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; Guidance 
for Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance entitled ``Process to Request a 
Review of FDA's Decision Not to Issue Certain Export Certificates for 
Devices.'' FDA is issuing this 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), which specifies the process 
afforded to persons denied a Certificate to Foreign Government (CFG) 
for a device. This guidance describes the information that the Center 
for Devices and Radiological Health (CDRH) and the Center for Biologics 
Evaluation and Research (CBER), in collaboration with the Office of 
Regulatory Affairs (ORA), 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.

DATES: The announcement of the guidance is published in the Federal 
Register on November 14, 2019.

ADDRESSES: You may submit either electronic or written comments on

[[Page 61914]]

Agency guidances 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.'' 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 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 guidance document entitled 
``Process to Request a Review of FDA's Decision Not to Issue Certain 
Export Certificates for Devices'' to the Office of Policy, 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 to the Office of Communication, 
Outreach and Development, Center for Biologics Evaluation and Research 
(CBER), 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. 1463, 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 guidance to comply with section 704 of FDARA 
(Pub. L. 115-52), which amended section 801(e)(4) of the FD&C Act (21 
U.S.C. 381(e)(4)), to specify the process afforded to persons denied a 
CFG for a device. This guidance describes the information that CDRH and 
CBER, in collaboration with ORA, 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 guidance applies to the process for persons denied 
CFGs requested pursuant to section 801(e)(4)(A) of the FD&C Act 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 
guidance supplements the FDA's guidance ``FDA Export Certificates,'' 
which is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-export-certificates. FDA considered 
comments received on the draft guidance that appeared in the Federal 
Register of August 17, 2018 (83 FR 41078). FDA revised the guidance as 
appropriate in response to the comments.

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 
current thinking of FDA on ``Process to Request a Review of FDA's 
Decision Not to Issue Certain Export Certificates for Devices.'' 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.

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

[[Page 61915]]

Center for Devices and Radiological Health guidance documents is 
available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This 
guidance document is also available at https://www.regulations.gov or 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. 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'' 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 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. 3501-3521). The collections of information in 
the following FDA regulations and guidance have been approved by OMB as 
listed in the following table:

------------------------------------------------------------------------
 FD&C Act section; 21 CFR part; or                          OMB control
             guidance                       Topic               No.
------------------------------------------------------------------------
FD&C Act sections 801(e) and 802    Export certificates        0910-0498
 (21 U.S.C. 382).                    for FDA regulated
                                     products.
21 CFR part 820...................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
21 CFR part 807, subparts A         Electronic                 0910-0625
 through E.                          Submission of
                                     Medical Device
                                     Registration and
                                     Listing.
``Center for Devices and            Appeals process.....       0910-0738
 Radiological Health Appeals
 Processes``.
------------------------------------------------------------------------


    Dated: November 5, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-24717 Filed 11-13-19; 8:45 am]
 BILLING CODE 4164-01-P