80 FR 81339 - Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 249 (December 29, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 249 (December 29, 2015)
| Page Range | 81339-81340 | |
| FR Document | 2015-32723 |
[Federal Register Volume 80, Number 249 (Tuesday, December 29, 2015)] [Notices] [Pages 81339-81340] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32723] ----------------------------------------------------------------------- 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Food and Drug Administration [Docket No. FDA-2007-D-0369] Bioequivalence Recommendations for Paliperidone Palmitate; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on paliperidone palmitate extended-release injectable suspension entitled ``Draft Guidance on Paliperidone Palmitate.''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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 29, 2016.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
![Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices 81339
DeviceRegulationandGuidance/ Electronic Submissions with a heading or cover note that states
GuidanceDocuments/UCM427866.pdf. ‘‘THIS DOCUMENT CONTAINS
4. American Glaucoma Society/Food and Submit electronic submissions in the
following way: CONFIDENTIAL INFORMATION.’’ The
Drug Administration Workshop on Agency will review this copy, including
Supporting Innovation for Safe and • Federal eRulemaking Portal: http://
Effective Minimally Invasive Glaucoma www.regulations.gov. Follow the the claimed confidential information, in
Surgery; Public Workshop, available at instructions for submitting comments. its consideration of comments. The
http://www.fda.gov/MedicalDevices/ Comments submitted electronically, second copy, which will have the
NewsEvents/WorkshopsConferences/ including attachments, to http:// claimed confidential information
ucm382508.htm. www.regulations.gov will be posted to redacted/blacked out, will be available
5. Regulatory Science Considerations for for public viewing and posted on http://
Medical Countermeasure Radiation
the docket unchanged. Because your
comment will be made public, you are www.regulations.gov. Submit both
Biodosimetry Devices, available at http:// copies to the Division of Dockets
www.fda.gov/MedicalDevices/ solely responsible for ensuring that your
comment does not include any Management. If you do not wish your
NewsEvents/WorkshopsConferences/
ucm308079.htm. confidential information that you or a name and contact information to be
6. Information to Support a Claim of third party may not wish to be posted, made publicly available, you can
Electromagnetic Compatibility (EMC) of such as medical information, your or provide this information on the cover
Electrically-Powered Medical Devices, anyone else’s Social Security number, or sheet and not in the body of your
available at http://www.fda.gov/ucm/ confidential business information, such comments and you must identify this
groups/fdagov-public/@fdagov-meddev- information as ‘‘confidential.’’ Any
gen/documents/document/
as a manufacturing process. Please note
that if you include your name, contact information marked as ‘‘confidential’’
ucm470201.pdf. will not be disclosed except in
information, or other information that
Dated: December 7, 2015. identifies you in the body of your accordance with 21 CFR 10.20 and other
Leslie Kux, comments, that information will be applicable disclosure law. For more
Associate Commissioner for Policy. posted on http://www.regulations.gov. information about FDA’s posting of
[FR Doc. 2015–32726 Filed 12–28–15; 8:45 am] • If you want to submit a comment comments to public dockets, see 80 FR
BILLING CODE 4164–01–P with confidential information that you 56469, September 18, 2015, or access
do not wish to be made available to the the information at: http://www.fda.gov/
public, submit the comment as a regulatoryinformation/dockets/
DEPARTMENT OF HEALTH AND written/paper submission and in the default.htm.
HUMAN SERVICES manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
Food and Drug Administration electronic and written/paper comments
received, go to http://
[Docket No. FDA–2007–D–0369]
Written/Paper Submissions www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
Bioequivalence Recommendations for follows: heading of this document, into the
Paliperidone Palmitate; Draft Guidance • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts
for Industry; Availability written/paper submissions): Division of and/or go to the Division of Dockets
Dockets Management (HFA–305), Food Management, 5630 Fishers Lane, rm.
AGENCY: Food and Drug Administration, and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
HHS. Lane, rm. 1061, Rockville, MD 20852. Submit written requests for single
ACTION: Notice of availability. • For written/paper comments copies of the draft guidance to the
submitted to the Division of Dockets Division of Drug Information, Center for
SUMMARY: The Food and Drug Management, FDA will post your Drug Evaluation and Research, Food
Administration (FDA) is announcing the comment, as well as any attachments, and Drug Administration, 10001 New
availability of a revised draft guidance except for information submitted, Hampshire Ave., Hillandale Building,
for industry on paliperidone palmitate marked and identified, as confidential, 4th Floor, Silver Spring, MD 20993–
extended-release injectable suspension if submitted as detailed in 0002. Send one self-addressed adhesive
entitled ‘‘Draft Guidance on ‘‘Instructions.’’ label to assist that office in processing
Paliperidone Palmitate.’’ The Instructions: All submissions received your requests. See the SUPPLEMENTARY
recommendations provide specific must include the Docket No. FDA– INFORMATION section for electronic
guidance on the design of 2007–D–0369 for ‘‘Draft Guidance on access to the draft guidance document.
bioequivalence (BE) studies to support Paliperidone Palmitate.’’ Received FOR FURTHER INFORMATION CONTACT:
abbreviated new drug applications comments will be placed in the docket Xiaoqiu Tang, Center for Drug
(ANDAs) for paliperidone palmitate and, except for those submitted as Evaluation and Research, Food and
extended-release injectable suspension. ‘‘Confidential Submissions,’’ will be Drug Administration, 10903 New
publicly viewable at http:// Hampshire Ave., Bldg. 75, rm. 4730,
DATES: Although you can comment on
www.regulations.gov or at the Division Silver Spring, MD 20993–0002, 301–
any guidance at any time (see 21 CFR
of Dockets Management between 9 a.m. 796–5850.
10.115(g)(5)), to ensure that the Agency
and 4 p.m., Monday through Friday.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
considers your comments on this draft SUPPLEMENTARY INFORMATION:
guidance before it begins work on the • Confidential Submissions: To
submit a comment with confidential I. Background
final version of the guidance, submit
either electronic or written comments information that you do not wish to be In the Federal Register of June 11,
on the draft guidance by February 29, made publicly available, submit your 2010 (75 FR 33311), FDA announced the
2016. comments only as a written/paper availability of a guidance for industry
submission. You should submit two entitled ‘‘Bioequivalence
ADDRESSES: You may submit comments copies total. One copy will include the Recommendations for Specific
as follows: information you claim to be confidential Products,’’ which explained the process
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![81340 Federal Register / Vol. 80, No. 249 / Tuesday, December 29, 2015 / Notices
that would be used to make product- Guidances/default.htm or http:// Written/Paper Submissions
specific BE recommendations available www.regulations.gov. Submit written/paper submissions as
to the public on FDA’s Web site at Dated: December 23, 2015. follows:
http://www.fda.gov/Drugs/Guidance Leslie Kux, • Mail/Hand delivery/Courier (for
ComplianceRegulatoryInformation/ Associate Commissioner for Policy. written/paper submissions): Division of
Guidances/default.htm. Dockets Management (HFA–305), Food
[FR Doc. 2015–32723 Filed 12–28–15; 8:45 am]
As described in that guidance, FDA and Drug Administration, 5630 Fishers
BILLING CODE 4164–01–P
adopted this process to develop and Lane, rm. 1061, Rockville, MD 20852.
disseminate product-specific BE • For written/paper comments
recommendations and to provide a DEPARTMENT OF HEALTH AND submitted to the Division of Dockets
meaningful opportunity for the public to HUMAN SERVICES Management, FDA will post your
consider and comment on those comment, as well as any attachments,
recommendations. This notice Food and Drug Administration except for information submitted,
announces the availability of draft BE marked and identified, as confidential,
[Docket No. FDA–2015–N–4170]
recommendations for paliperidone if submitted as detailed in
palmitate extended-release injectable Establishment of a Public Docket; ‘‘Instructions.’’
suspension. FDA initially approved new Clinical Trial Designs in Emerging Instructions: All submissions received
drug application 022264 for INVEGA Infectious Diseases must include the Docket No. FDA–
SUSTENNA (paliperidone palmitate) 2015–N–4170 for ‘‘Clinical Trial Designs
extended-release injectable suspension. AGENCY: Food and Drug Administration, in Emerging Infectious Diseases.’’
There are no approved ANDAs for this HHS. Received comments will be placed in
product. In August 2011, we issued a ACTION: Notice; establishment of docket; the docket and, except for those
draft guidance for industry on BE request for comments. submitted as ‘‘Confidential
recommendations for paliperidone Submissions,’’ publicly viewable at
palmitate extended-release injectable SUMMARY: The Food and Drug
Administration (FDA) is establishing a http://www.regulations.gov or at the
suspension, which we subsequently Division of Dockets Management
revised in December 2013. We are now public docket to receive input on
clinical trial designs in emerging between 9 a.m. and 4 p.m., Monday
issuing a further revised draft guidance through Friday.
infectious diseases. Interested parties
for industry on BE recommendations for
are invited to submit comments, • Confidential Submissions—To
generic paliperidone palmitate submit a comment with confidential
supported by research and data,
extended-release injectable suspension information that you do not wish to be
regarding clinical trial designs.
(‘‘Draft Guidance on Paliperidone made publicly available, submit your
Palmitate’’). DATES: Submit either electronic or
comments only as a written/paper
In May 2013, Janssen Research and written comments on the collection of
information by January 28, 2016. submission. You should submit two
Development, LLC, manufacturer of the copies total. One copy will include the
reference listed drug, INVEGA ADDRESSES: You may submit comments
information you claim to be confidential
SUSTENNA, submitted a citizen as follows: with a heading or cover note that states
petition requesting that FDA require Electronic Submissions ‘‘THIS DOCUMENT CONTAINS
that any ANDA referencing INVEGA CONFIDENTIAL INFORMATION.’’ The
Submit electronic comments in the
SUSTENNA extended-release injectable Agency will review this copy, including
following way:
suspension meet certain conditions • Federal eRulemaking Portal: http:// the claimed confidential information, in
related to demonstrating BE (Docket No. www.regulations.gov. Follow the its consideration of comments. The
FDA–2013–P–0608). FDA is reviewing instructions for submitting comments. second copy, which will have the
the issues raised in the petition. FDA Comments submitted electronically, claimed confidential information
will consider any comments on the including attachments, to http:// redacted/blacked out, will be available
Draft Guidance on Paliperidone www.regulations.gov will be posted to for public viewing and posted on http://
Palmitate in responding to the petition. the docket unchanged. Because your www.regulations.gov. Submit both
This draft guidance is being issued comment will be made public, you are copies to the Division of Dockets
consistent with FDA’s good guidance solely responsible for ensuring that your Management. If you do not wish your
practices regulation (21 CFR 10.115). comment does not include any name and contact information to be
The draft guidance, when finalized, will confidential information that you or a made publicly available, you can
represent the Agency’s current thinking third party may not wish to be posted, provide this information on the cover
on the design of BE studies to support such as medical information, your or sheet and not in the body of your
ANDAs for paliperidone palmitate anyone else’s Social Security number, or comments and you must identify this
extended-release injectable suspension. confidential business information, such information as ‘‘confidential.’’ Any
It does not create or confer any rights for as a manufacturing process. Please note information marked as ‘‘confidential’’
or on any person and do not operate to that if you include your name, contact will not be disclosed except in
bind FDA or the public. You can use an information, or other information that accordance with 21 CFR 10.20 and other
alternative approach if it satisfies the identifies you in the body of your applicable disclosure law. For more
requirements of the applicable statutes information about FDA’s posting of
asabaliauskas on DSK5VPTVN1PROD with NOTICES
comments, that information will be
and regulations. posted on http://www.regulations.gov. comments to public dockets, see 80 FR
• 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/
II. Electronic Access
do not wish to be made available to the regulatoryinformation/dockets/
Persons with access to the Internet public, submit the comment as a default.htm.
may obtain the document at either written/paper submission and in the Docket: For access to the docket to
http://www.fda.gov/Drugs/Guidance manner detailed (see ‘‘Written/Paper read background documents or the
ComplianceRegulatoryInformation/ Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
VerDate Sep<11>2014 19:17 Dec 28, 2015 Jkt 238001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1](https://thefederalregister.org/doc/80_FR_81588/page/2.svg)
Document Created: 2015-12-29 10:15:28
Document Modified: 2015-12-29 10:15:28
| 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 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. | |
| 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. | |
| FR Citation | 80 FR 81339 |
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