Product-Specific Guidance; Revised Draft Guidance for Industry on Sucralfate; Reopening of Comment Period, 54113-54115 [2018-23386]
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Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (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/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
khammond on DSK30JT082PROD with NOTICES
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
toward the actual amount of extension
that the Director of USPTO may award
(for example, half the testing phase must
be subtracted as well as any time that
may have occurred before the patent
VerDate Sep<11>2014
18:32 Oct 25, 2018
Jkt 247001
was issued), FDA’s determination of the
length of a regulatory review period for
a human biological product will include
all of the testing phase and approval
phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA has approved for marketing the
human biologic product REBINYN
(Coagulation Factor IX (Recombinant)
GlycoPEGylated). REBINYN is indicated
for use in adults and children with
hemophilia B for: (1) On-demand
treatment and control of bleeding
episodes, and (2) Perioperative
management of bleeding. Subsequent to
this approval, the USPTO received a
patent term restoration application for
REBINYN (U.S. Patent Nos. 7,138,371
and 7,179,617) from Novo Nordisk A/S,
and the USPTO requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated February 6, 2018, FDA
advised the USPTO that this human
biological product had undergone a
regulatory review period and that the
approval of REBINYN represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
REBINYN is 2,793 days. Of this time,
2,412 days occurred during the testing
phase of the regulatory review period,
while 381 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i))
became effective: October 9, 2009. The
applicant claims May 16, 2009, as the
date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was October 9, 2009,
which was the first date after receipt of
the IND that the investigational studies
were allowed to proceed.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): May 16, 2016. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
REBINYN (BLA 125611/0) was initially
submitted on May 16, 2016.
3. The date the application was
approved: May 31, 2017. FDA has
verified the applicant’s claim that BLA
125611/0 was approved on May 31,
2017.
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54113
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 1,660 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: October 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–23437 Filed 10–25–18; 8:45 am]
BILLING CODE 4164–01–P
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.
Notice of availability; reopening
of comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for a
SUMMARY:
E:\FR\FM\26OCN1.SGM
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54114
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
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’’).
khammond on DSK30JT082PROD with NOTICES
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
VerDate Sep<11>2014
18:32 Oct 25, 2018
Jkt 247001
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/201523389.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)).
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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/
GuidanceCompliance
RegulatoryInformation/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.
E:\FR\FM\26OCN1.SGM
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54115
Federal Register / Vol. 83, No. 208 / Friday, October 26, 2018 / Notices
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/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
OMB No.: 0990–0430—Office of the
Assistant Secretary for Financial
Resources, Office of Grants and
Acquisition Policy, and Accountability,
Division of Acquisition.
Abstract: Crime Control Act—
Requirement for Background Checks:
Performance of HHS mission requires
the support of contractors. In some
circumstances, depending on the
requirements of the specific contract,
the contractor is tasked to provide
personnel who will be working with
children under the age of 18. After
contract award, contractor personnel
must undergo a criminal background
check as required by HHS Acquisition
Regulation (HHSAR) 337.103(d)(3) and
the clause at HHSAR 352.237–72 Crime
Control Act—Requirement for
Background Checks before working on
the contract as required by federal law
(Crime Control Act of 1990). The
contractor is therefore required to
provide a list of the names of its
relevant personnel for purposes of
enabling HHS to conduct a criminal
background check.
The Agency is requesting a 3 year
extension to collect this information
from public or private businesses.
Comments on the ICR must be
received on or before November 26,
2018.
DATES:
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
ADDRESSES:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Crime Control
Act—Requirement for Background
Checks.
Type of Collection: Extension.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0430, 0431,
0432, 0433, 0434]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
SUMMARY:
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total burden
hours
Business (contractor) .......................................................................................
160
1
1
160
Total ..........................................................................................................
160
1
1
160
Title of the Collection: Acquisitions
Involving Human Subjects.
Type of Collection: Extension.
OMB No.: 0990–0431—Office of the
Assistant Secretary for Financial
Resources, Office of Grants and
Acquisition Policy, and Accountability,
Division of Acquisition.
Abstract: Acquisitions Involving
Human Subjects: Performance of HHS
mission requires the support of
contractors involving human subjects.
Before awarding a contract to any
khammond on DSK30JT082PROD with NOTICES
Number
responses per
respondent
Subjects), the provision at HHSAR
352.270–10 (Notice to Offerors—
Protection of Human Subjects, Research
Involving Human Subjects Committee
(RIHSC) Approval of Research Protocols
Required), and the clause at HHSAR
352.270–11 (Protection of Human
Subjects—Research Involving Human
Subjects Committee (RIHSC) Approval
of Research Protocols Required).
The Agency is requesting a 3-year
extension to collect this information
from public or private businesses.
contractor that will need to use human
subjects, the Contracting Officer is
required to verify that, the contractor
holds a valid Federal Wide Assurance
(FWA) approved by the Office for
Human Research Protections (OHRP), as
described in HHSAR Subpart 370.3—
Acquisitions Involving Human Subjects.
The provisions are implemented via
contract clauses found at HHSAR
352.270–4a (Protection of Human
Subjects), the clause at HHSAR
352.270–4b (Protection of Human
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Business (contractor) .......................................................................................
VerDate Sep<11>2014
18:32 Oct 25, 2018
Jkt 247001
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
Number
responses per
respondent
90
E:\FR\FM\26OCN1.SGM
4
26OCN1
Average
burden per
response
(in hours)
Total burden
hours
5
1,800
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for a
[[Page 54114]]
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
