
[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)]
[Notices]
[Pages 81339-81340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32723]


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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Bioequivalence Recommendations for Paliperidone Palmitate; Draft 
Guidance for Industry; Availability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.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a revised draft guidance for industry on paliperidone 
palmitate extended-release injectable suspension entitled ``Draft 
Guidance on Paliperidone Palmitate.''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 comments 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this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 29, 2016.

ADDRESSES:  You may submit comments as follows:

Electronic Submissions

    Submit electronic submissions in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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,'' will be publicly viewable at 
http://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 http://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: http://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 http://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.

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 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

[[Page 81340]]

that would be used to make product-specific BE recommendations 
available to the public on FDA's Web site at http://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 paliperidone palmitate extended-release injectable 
suspension. FDA initially approved new drug application 022264 for 
INVEGA SUSTENNA (paliperidone palmitate) extended-release injectable 
suspension. 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. 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 extended-release injectable suspension 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 Agency's current thinking on the design 
of BE studies to support ANDAs for paliperidone palmitate extended-
release injectable suspension. It does not create or confer any rights 
for or on any person and do not operate to bind 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 document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: December 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
 [FR Doc. 2015-32723 Filed 12-28-15; 8:45 am]
 BILLING CODE 4164-01-P


