Document ID: FDA-2018-D-2310-0004
Agency: fda
Document Type: Notice
Title: Process To Request a Review of the 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Decision Not To Issue Certain Export Certificates for Devices; Draft
Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period
Posted Date: 2018-10-04T04:00Z

[Federal Register Volume 83, Number 193 (Thursday, October 4, 2018)]
[Notices]
[Pages 50109-50110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21597]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Process To Request a Review of the 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Decision Not To Issue Certain Export Certificates for Devices; Draft 
Guidance for Industry and Food and Drug Administration Staff; 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; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
extending the comment period for the notice of availability that 
appeared in the Federal Register of August 17, 2018. FDA requested 
comments on the draft guidance for industry and FDA staff entitled 
``Process To Request a Review of FDA's Decision Not To Issue Certain 
Export Certificates for Devices.'' The Agency is taking this action in 
response to a request for an extension to allow interested persons 
additional time to submit comments.

DATES: FDA is extending the comment period on the document published 
August 17, 2018 (83 FR 41078). Submit either electronic or written 
comments on the draft guidance by November 15, 2018, to ensure that the 
Agency considers your comment on this draft guidance before it begins 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 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

[[Page 50110]]

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 document 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], 301-796-6836; 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

    In the Federal Register of August 17, 2018, FDA published a notice 
of availability with a 60-day comment period to request comments on the 
draft guidance for industry and FDA staff entitled ``Process to Request 
a Review of FDA's Decision Not to Issue Certain Export Certificates for 
Devices.''
    The Agency has received a request for a 30-day extension of the 
comment period. The request conveyed concern that the current 60-day 
comment period does not allow sufficient time to develop a meaningful 
or thoughtful response.
    FDA has considered the request and is extending the comment period 
for the notice of availability for 30 days, until November 15, 2018. 
The Agency believes that a 30-day extension allows adequate time for 
interested persons to submit comments without significantly delaying 
guidance on these important issues.

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 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. 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 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.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 of the Federal Food, Drug and Cosmetic Act (21 
U.S.C. 381(e) and 382) 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: September 28, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21597 Filed 10-3-18; 8:45 am]
 BILLING CODE 4164-01-P