[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54113-54115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-23386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Product-Specific Guidance; Revised Draft Guidance for Industry on 
Sucralfate; Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period for a

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revised draft product-specific guidance on Sucralfate that appeared in 
a notice of availability, published in the Federal Register of October 
20, 2017. In that notice, FDA requested comments on the revised draft 
guidance for industry on Sucralfate, as well as comments on other 
product-specific guidances. FDA is reopening the comment period for the 
Draft Guidance on Sucralfate (revised October 2017) to facilitate 
submission of comments pertaining to this draft guidance following an 
FDA response to two citizen petitions. The petition response suggests 
that the petitioners submit to the docket comments relating to the 
guidance.

DATES: Submit either electronic or written comments on the draft 
guidance by December 26, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2007-D-0369 for ``Product-Specific Guidance; Revised Draft Guidance 
for Industry on Sucralfate; Reopening of Comment Period.'' 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)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 20, 2017 (82 FR 48826), FDA 
published a notice of availability with a 60-day comment period to 
request comments on the revised draft guidance for industry on 
Sucralfate, as well as comments on other product-specific guidances. 
This draft guidance includes recommendations pertaining to abbreviated 
new drug applications seeking approval of sucralfate oral suspension 
products, 1 gram/10 milliliters.
    The comment period for all draft guidances identified in that 
notice ended on December 19, 2017.
    On December 18, 2017, FDA received a citizen petition from Haynes 
and Boone, LLP (Docket No. FDA-2017-P-6922), requesting that FDA deny 
approval to any abbreviated new drug application for a sucralfate oral 
suspension drug product that relies on patient-based clinical endpoint 
studies to establish bioequivalence with the reference listed drug. On 
March 28, 2018, FDA received a citizen petition from Vertice Pharma 
(Docket No. FDA-2018-P-1310) requesting specific changes to the 
recommendations made in the ``Draft Guidance on Sucralfate'' (revised 
October 2017), available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM573202.pdf.
    FDA denied both petitions in a joint response dated May 17, 2018. 
However, given the interest in this guidance, FDA is reopening the 
comment period until December 26, 2018. The Agency believes that an 
additional 60 days will allow adequate time for interested persons to 
submit comments without compromising the timely publication of the 
final version of the guidance.

[[Page 54115]]

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-23386 Filed 10-25-18; 8:45 am]
 BILLING CODE 4164-01-P