81 FR 43209 - Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 127 (July 1, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 127 (July 1, 2016)
| Page Range | 43209-43210 | |
| FR Document | 2016-15663 |
[Federal Register Volume 81, Number 127 (Friday, July 1, 2016)] [Notices] [Pages 43209-43210] From the Federal Register Online [www.thefederalregister.org] [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Food and Drug Administration [Docket No. FDA-2007-D-0369] Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on generic paliperidone palmitate extended-release injectable suspension, entitled ``Draft Guidance on Paliperidone Palmitate.''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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 6, 2016.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: 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,'' 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. [[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 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 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 http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://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
![Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices 43209
indicate in your registration if you plan guidance on the design of Paliperidone Palmitate.’’ Received
to attend in person or via the Webcast. bioequivalence (BE) studies to support comments will be placed in the docket
Seating will be limited, so early abbreviated new drug applications and, except for those submitted as
registration is recommended. (ANDAs) for paliperidone palmitate ‘‘Confidential Submissions,’’ publicly
Registration is free and will be on a first- extended-release injectable suspension. viewable at http://www.regulations.gov
come, first-served basis. However, FDA DATES: Although you can comment on or at the Division of Dockets
may limit the number of participants any guidance at any time (see 21 CFR Management between 9 a.m. and 4 p.m.,
from each organization based on space 10.115(g)(5)), to ensure that the Agency Monday through Friday.
limitations. Registrants will receive considers your comment on this draft • Confidential Submissions—To
confirmation once they have been guidance before it begins work on the submit a comment with confidential
accepted. Onsite registration on the day final version of the guidance, submit information that you do not wish to be
of the workshop will be based on space either electronic or written comments made publicly available, submit your
availability. If you need special on the draft guidance by September 6, comments only as a written/paper
accommodations because of a disability, 2016. submission. You should submit two
please contact Meghana Chalasani (see ADDRESSES: You may submit comments copies total. One copy will include the
FOR FURTHER INFORMATION CONTACT) at information you claim to be confidential
as follows:
least 7 days before the workshop. with a heading or cover note that states
FDA will hold an open public Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
comment period to give the public an Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
opportunity to comment. Registration following way: Agency will review this copy, including
for open public comment will occur at • Federal eRulemaking Portal: http:// the claimed confidential information, in
the registration desk on the day of the www.regulations.gov. Follow the its consideration of comments. The
workshop on a first-come, first-served instructions for submitting comments. second copy, which will have the
basis. Comments submitted electronically, claimed confidential information
Docket Comments: Regardless of if including attachments, to http:// redacted/blacked out, will be available
you attend the public workshop, you www.regulations.gov will be posted to for public viewing and posted on http://
can submit electronic or written the docket unchanged. Because your www.regulations.gov. Submit both
responses for consideration to the comment will be made public, you are copies to the Division of Dockets
public docket (see ADDRESSES) by solely responsible for ensuring that your Management. If you do not wish your
December 24, 2016. Received comments comment does not include any name and contact information to be
may be seen in the Division of Dockets confidential information that you or a made publicly available, you can
Management between 9 a.m. and 4 p.m., third party may not wish to be posted, provide this information on the cover
Monday through Friday, and will be such as medical information, your or sheet and not in the body of your
posted to the docket at http:// anyone else’s Social Security number, or comments and you must identify this
www.regulations.gov. confidential business information, such information as ‘‘confidential.’’ Any
Transcripts: As soon as a transcript is as a manufacturing process. Please note information marked as ‘‘confidential’’
available, FDA will post it at http:// that if you include your name, contact will not be disclosed except in
www.fda.gov/Drugs/NewsEvents/ information, or other information that accordance with 21 CFR 10.20 and other
ucm501389.htm. identifies you in the body of your applicable disclosure law. For more
Dated: June 27, 2016. comments, that information will be information about FDA’s posting of
Leslie Kux, posted on http://www.regulations.gov. comments to public dockets, see 80 FR
Associate Commissioner for Policy. • If you want to submit a comment 56469, September 18, 2015, or access
with confidential information that you the information at: http://www.fda.gov/
[FR Doc. 2016–15662 Filed 6–30–16; 8:45 am]
do not wish to be made available to the regulatoryinformation/dockets/
BILLING CODE 4164–01–P
public, submit the comment as a default.htm.
written/paper submission and in the Docket: For access to the docket to
DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper read background documents or the
HUMAN SERVICES Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
received, go to http://www.regulations.
Written/Paper Submissions gov and insert the docket number, found
Food and Drug Administration
Submit written/paper submissions as in brackets in the heading of this
[Docket No. FDA–2007–D–0369] follows: document, into the ‘‘Search’’ box and
• Mail/Hand delivery/Courier (for follow the prompts and/or go to the
Bioequivalence Recommendations for
written/paper submissions): Division of Division of Dockets Management, 5630
Paliperidone Palmitate; Draft Guidance
Dockets Management (HFA–305), Food Fishers Lane, Rm. 1061, Rockville, MD
for Industry; Availability
and Drug Administration, 5630 Fishers 20852.
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single
HHS. • For written/paper comments copies of the draft guidance to the
ACTION: Notice of availability. submitted to the Division of Dockets Division of Drug Information, Center for
Management, FDA will post your Drug Evaluation and Research, Food
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY: The Food and Drug comment, as well as any attachments, and Drug Administration, 10001 New
Administration (FDA) is announcing the except for information submitted, Hampshire Ave., Hillandale Building,
availability of a revised draft guidance marked and identified, as confidential, 4th Floor, Silver Spring, MD 20993–
for industry on generic paliperidone if submitted as detailed in 0002. Send one self-addressed adhesive
palmitate extended-release injectable ‘‘Instructions.’’ label to assist that office in processing
suspension, entitled ‘‘Draft Guidance on Instructions: All submissions received your requests. See the SUPPLEMENTARY
Paliperidone Palmitate.’’ The must include the Docket No. FDA– INFORMATION section for electronic
recommendations provide specific 2007–D–0369 for ‘‘Draft Guidance on access to the draft guidance document.
VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1](https://thefederalregister.org/doc/81_FR_43336/page/1.svg)
![43210 Federal Register / Vol. 81, No. 127 / Friday, July 1, 2016 / Notices
FOR FURTHER INFORMATION CONTACT: ANDAs for paliperidone palmitate Electronic Submissions
Xiaoqiu Tang, Center for Drug extended-release injectable suspension. Submit electronic comments in the
Evaluation and Research (HFD–600), It does not establish any rights for any following way:
Food and Drug Administration, 10903 person and is not binding on FDA or the • Federal eRulemaking Portal: http://
New Hampshire Ave., Bldg. 75, Rm. public. You can use an alternative www.regulations.gov. Follow the
4730, Silver Spring, MD 20993–0002, approach if it satisfies the requirements instructions for submitting comments.
301–796–5850. of the applicable statutes and Comments submitted electronically,
SUPPLEMENTARY INFORMATION: regulations. including attachments, to http://
I. Background II. Electronic Access www.regulations.gov will be posted to
the docket unchanged. Because your
In the Federal Register of June 11, Persons with access to the Internet
comment will be made public, you are
2010 (75 FR 33311), FDA announced the may obtain the draft guidance at either
solely responsible for ensuring that your
availability of a guidance for industry http://www.fda.gov/Drugs/Guidance
comment does not include any
entitled ‘‘Bioequivalence ComplianceRegulatoryInformation/
confidential information that you or a
Recommendations for Specific Guidances/default.htm or http://
third party may not wish to be posted,
Products,’’ which explained the process www.regulations.gov.
that would be used to make product- such as medical information, your or
Dated: June 28, 2016. anyone else’s Social Security number, or
specific BE recommendations available
to the public on FDA’s Web site at
Leslie Kux, confidential business information, such
http://www.fda.gov/Drugs/Guidance Associate Commissioner for Policy. as a manufacturing process. Please note
ComplianceRegulatoryInformation/ [FR Doc. 2016–15663 Filed 6–30–16; 8:45 am] that if you include your name, contact
Guidances/default.htm. As described in BILLING CODE 4164–01–P information, or other information that
that guidance, FDA adopted this process identifies you in the body of your
to develop and disseminate product- comments, that information will be
specific BE recommendations and to DEPARTMENT OF HEALTH AND posted on http://www.regulations.gov.
provide a meaningful opportunity for HUMAN SERVICES • If you want to submit a comment
the public to consider and comment on with confidential information that you
Food and Drug Administration do not wish to be made available to the
those recommendations. This notice
announces the availability of draft BE public, submit the comment as a
recommendations for generic [Docket No. FDA–2016–D–1504] written/paper submission and in the
paliperidone palmitate extended-release manner detailed (see ‘‘Written/Paper
injectable suspension. Recurrent Herpes Labialis: Developing Submissions’’ and ‘‘Instructions’’).
FDA initially approved new drug Drugs for Treatment and Prevention;
Draft Guidance for Industry; Written/Paper Submissions
application 022264 for INVEGA
SUSTENNA (paliperidone palmitate) Availability Submit written/paper submissions as
extended-release injectable suspension follows:
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
in July 2009. Currently, there are no HHS.
approved ANDAs for this product. In written/paper submissions): Division of
August 2011, we issued a draft guidance ACTION: Notice. Dockets Management (HFA–305), Food
for industry on BE recommendations for and Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852.
paliperidone palmitate extended-release Administration (FDA or Agency) is
injectable suspension, which we • For written/paper comments
announcing the availability of a draft submitted to the Division of Dockets
subsequently revised in December 2013 guidance for industry entitled
and December 2015. We are now issuing Management, FDA will post your
‘‘Recurrent Herpes Labialis: Developing comment, as well as any attachments,
a further revised draft guidance for Drugs for Treatment and Prevention.’’
industry on BE recommendations for except for information submitted,
The purpose of this guidance is to assist marked and identified, as confidential,
generic paliperidone palmitate sponsors in all phases of development
extended-release injectable suspension if submitted as detailed in
of treatments for recurrent herpes ‘‘Instructions.’’
(‘‘Draft Guidance on Paliperidone labialis. The guidance also addresses
Palmitate’’). Instructions: All submissions received
prevention of recurrent herpes labialis. must include the Docket No. [Docket
In May 2013, Janssen Research and
The guidance outlines the types of No. FDA–2016–D–1504 ] for ‘‘Recurrent
Development, LLC, manufacturer of the
nonclinical studies and clinical trials Herpes Labialis: Developing Drugs for
reference listed drug, INVEGA
recommended throughout the drug Treatment and Prevention.’’. Received
SUSTENNA, submitted a citizen
development process to support comments will be placed in the docket
petition requesting that FDA require
approval of antiviral drug products for and, except for those submitted as
that any ANDA referencing INVEGA
the treatment or prevention of recurrent ‘‘Confidential Submissions,’’ publicly
SUSTENNA meet certain conditions
herpes labialis. viewable at http://www.regulations.gov
related to demonstrating BE (Docket No.
FDA–2013–P–0608). FDA is reviewing DATES: Although you can comment on or at the Division of Dockets
the issues raised in the petition. FDA any guidance at any time (see 21 CFR Management between 9 a.m. and 4 p.m.,
will consider any comments on the draft 10.115(g)(5)), to ensure that the Agency Monday through Friday.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
guidance on paliperidone palmitate in considers your comment on this draft • Confidential Submissions—To
responding to the petition. guidance before it begins work on the submit a comment with confidential
This draft guidance is being issued final version of the guidance, submit information that you do not wish to be
consistent with FDA’s good guidance either electronic or written comments made publicly available, submit your
practices regulation (21 CFR 10.115). on the draft guidance by September 29, comments only as a written/paper
The draft guidance, when finalized, will 2016. submission. You should submit two
represent the current thinking of FDA ADDRESSES: You may submit comments copies total. One copy will include the
on the design of BE studies to support as follows: information you claim to be confidential
VerDate Sep<11>2014 19:05 Jun 30, 2016 Jkt 238001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\01JYN1.SGM 01JYN1](https://thefederalregister.org/doc/81_FR_43336/page/2.svg)
Document Created: 2016-07-14 11:37:52
Document Modified: 2016-07-14 11:37:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 81 FR 43209 |
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