Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability, 43209-43210 [2016-15663]
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Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
indicate in your registration if you plan
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Docket Comments: Regardless of if
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Transcripts: As soon as a transcript is
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ucm501389.htm.
Dated: June 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–15662 Filed 6–30–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2007–D–0369]
Bioequivalence Recommendations for
Paliperidone Palmitate; Draft Guidance
for Industry; Availability
Food and Drug Administration,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a revised draft guidance
for industry on generic paliperidone
palmitate extended-release injectable
suspension, entitled ‘‘Draft Guidance on
Paliperidone Palmitate.’’ The
recommendations provide specific
SUMMARY:
VerDate Sep<11>2014
19:05 Jun 30, 2016
Jkt 238001
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
Food and Drug Administration
AGENCY:
guidance on the design of
bioequivalence (BE) studies to support
abbreviated new drug applications
(ANDAs) for paliperidone palmitate
extended-release injectable suspension.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 6,
2016.
ADDRESSES: You may submit comments
as follows:
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 ‘‘Draft Guidance on
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
43209
Paliperidone Palmitate.’’ 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 Division of Dockets
Management 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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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
Division of Dockets Management, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
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.
E:\FR\FM\01JYN1.SGM
01JYN1
43210
Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
FOR FURTHER INFORMATION CONTACT:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD–600),
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 June 11,
2010 (75 FR 33311), FDA announced the
availability of a guidance for industry
entitled ‘‘Bioequivalence
Recommendations for Specific
Products,’’ which explained the process
that would be used to make productspecific BE recommendations available
to the public on FDA’s Web site at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm. As described in
that guidance, FDA adopted this process
to develop and disseminate productspecific BE recommendations and to
provide a meaningful opportunity for
the public to consider and comment on
those recommendations. This notice
announces the availability of draft BE
recommendations for generic
paliperidone palmitate extended-release
injectable suspension.
FDA initially approved new drug
application 022264 for INVEGA
SUSTENNA (paliperidone palmitate)
extended-release injectable suspension
in July 2009. Currently, there are no
approved ANDAs for this product. In
August 2011, we issued a draft guidance
for industry on BE recommendations for
paliperidone palmitate extended-release
injectable suspension, which we
subsequently revised in December 2013
and December 2015. We are now issuing
a further revised draft guidance for
industry on BE recommendations for
generic paliperidone palmitate
extended-release injectable suspension
(‘‘Draft Guidance on Paliperidone
Palmitate’’).
In May 2013, Janssen Research and
Development, LLC, manufacturer of the
reference listed drug, INVEGA
SUSTENNA, submitted a citizen
petition requesting that FDA require
that any ANDA referencing INVEGA
SUSTENNA meet certain conditions
related to demonstrating BE (Docket No.
FDA–2013–P–0608). FDA is reviewing
the issues raised in the petition. FDA
will consider any comments on the draft
guidance on paliperidone palmitate in
responding to the petition.
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 design of BE studies to support
VerDate Sep<11>2014
19:05 Jun 30, 2016
Jkt 238001
ANDAs for paliperidone palmitate
extended-release injectable suspension.
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.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–15663 Filed 6–30–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1504]
Recurrent Herpes Labialis: Developing
Drugs for Treatment and Prevention;
Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Recurrent Herpes Labialis: Developing
Drugs for Treatment and Prevention.’’
The purpose of this guidance is to assist
sponsors in all phases of development
of treatments for recurrent herpes
labialis. The guidance also addresses
prevention of recurrent herpes labialis.
The guidance outlines the types of
nonclinical studies and clinical trials
recommended throughout the drug
development process to support
approval of antiviral drug products for
the treatment or prevention of recurrent
herpes labialis.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 29,
2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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. [Docket
No. FDA–2016–D–1504 ] for ‘‘Recurrent
Herpes Labialis: Developing Drugs for
Treatment and Prevention.’’. 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 Division of Dockets
Management 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
E:\FR\FM\01JYN1.SGM
01JYN1
Agencies
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)]
[Notices]
[Pages 43209-43210]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15663]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Bioequivalence Recommendations for Paliperidone Palmitate; Draft
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised draft guidance for industry on generic
paliperidone palmitate extended-release injectable suspension, entitled
``Draft Guidance on Paliperidone Palmitate.'' The recommendations
provide specific guidance on the design of bioequivalence (BE) studies
to support abbreviated new drug applications (ANDAs) for paliperidone
palmitate extended-release injectable suspension.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 6, 2016.
ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 ``Draft Guidance on Paliperidone Palmitate.''
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 Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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.
[[Page 43210]]
FOR FURTHER INFORMATION CONTACT: Xiaoqiu Tang, Center for Drug
Evaluation and Research (HFD-600), 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 June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products,'' which
explained the process that would be used to make product-specific BE
recommendations available to the public on FDA's Web site at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As described in that guidance, FDA adopted this process to
develop and disseminate product-specific BE recommendations and to
provide a meaningful opportunity for the public to consider and comment
on those recommendations. This notice announces the availability of
draft BE recommendations for generic paliperidone palmitate extended-
release injectable suspension.
FDA initially approved new drug application 022264 for INVEGA
SUSTENNA (paliperidone palmitate) extended-release injectable
suspension in July 2009. Currently, there are no approved ANDAs for
this product. In August 2011, we issued a draft guidance for industry
on BE recommendations for paliperidone palmitate extended-release
injectable suspension, which we subsequently revised in December 2013
and December 2015. We are now issuing a further revised draft guidance
for industry on BE recommendations for generic paliperidone palmitate
extended-release injectable suspension (``Draft Guidance on
Paliperidone Palmitate'').
In May 2013, Janssen Research and Development, LLC, manufacturer of
the reference listed drug, INVEGA SUSTENNA, submitted a citizen
petition requesting that FDA require that any ANDA referencing INVEGA
SUSTENNA meet certain conditions related to demonstrating BE (Docket
No. FDA-2013-P-0608). FDA is reviewing the issues raised in the
petition. FDA will consider any comments on the draft guidance on
paliperidone palmitate in responding to the petition.
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 design of
BE studies to support ANDAs for paliperidone palmitate extended-release
injectable suspension. 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.
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: June 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15663 Filed 6-30-16; 8:45 am]
BILLING CODE 4164-01-P