81 FR 7810 - Bioequivalence Recommendations for Cyclosporine; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 30 (February 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 30 (February 16, 2016)
| Page Range | 7810-7811 | |
| FR Document | 2016-02975 |
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)] [Notices] [Pages 7810-7811] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-02975] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0369] Bioequivalence Recommendations for Cyclosporine; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on cyclosporine ophthalmic emulsion entitled ``Draft Guidance on Cyclosporine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for cyclosporine ophthalmic emulsion. This draft guidance is a revised version of a previously issued draft guidance on the same subject. 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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 18, 2016.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 [[Page 7811]] 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-P-0369 for ``Draft Guidance on Cyclosporine.'' 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. 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, ``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 as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of revised draft BE recommendations for cyclosporine ophthalmic emulsion. FDA initially approved new drug application 050790 for RESTASIS (cyclosporine ophthalmic emulsion), 0.05% in December 2002. There are no approved ANDAs for this product. In June 2013, we issued a draft guidance for industry on BE recommendations for generic cyclosporine ophthalmic emulsion. Allergan, Inc., manufacturer of the reference listed drug, RESTASIS, submitted a citizen petition in February 2014 challenging the Agency's initial BE recommendations for generic cyclosporine ophthalmic emulsion. We responded to that petition on November 20, 2014 (Docket No. FDA-2014-P-0304). The following month, Allergan submitted a second citizen petition challenging the Agency's initial BE recommendations. In April 2015, FDA received a third citizen petition on its initial BE recommendations from Physical Pharmaceutica LLC. FDA has reviewed the issues raised by Allergan and Physical Pharmaceutica and is responding to their petitions (Docket Nos. FDA-2015-P-0065 and FDA-2015-P-1404). In addition, we are now issuing a revised draft guidance for industry on BE recommendations for generic cyclosporine ophthalmic emulsion (``Draft Guidance on Cyclosporine''). 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 cyclosporine ophthalmic emulsion. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach 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: February 9, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-02975 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
![7810 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
comments only as a written/paper include: (1) First and last name, (2) Information office address is available
submission. You should submit two contact phone or email address, (2) live on the Agency’s Web site at http://
copies total. One copy will include the attendance or via Webcast, (4) indicate www.fda.gov.
information you claim to be confidential if you plan to attend day 1, day 2, or Dated: February 9, 2016.
with a heading or cover note that states both days. Registration closes on April Leslie Kux,
‘‘THIS DOCUMENT CONTAINS 8, 2016. For those without Internet
Associate Commissioner for Policy.
CONFIDENTIAL INFORMATION.’’ The access, please contact Denise Pica-
Branco or Denise Johnson-Lyles (see FOR [FR Doc. 2016–02967 Filed 2–12–16; 8:45 am]
Agency will review this copy, including
the claimed confidential information, in FURTHER INFORMATION CONTACT) to BILLING CODE 4164–01–P
its consideration of comments. The register. Onsite registration will not be
second copy, which will have the available.
If you need special accommodations DEPARTMENT OF HEALTH AND
claimed confidential information
due to a disability, please contact HUMAN SERVICES
redacted/blacked out, will be available
for public viewing and posted on http:// Denise Pica-Branco or Denise Johnson-
Food and Drug Administration
www.regulations.gov. Submit both Lyles (see FOR FURTHER INFORMATION
copies to the Division of Dockets CONTACT) at least 7 days in advance. [Docket No. FDA–2007–D–0369]
Management. If you do not wish your SUPPLEMENTARY INFORMATION:
name and contact information to be Bioequivalence Recommendations for
I. Background Cyclosporine; Draft Guidance for
made publicly available, you can
provide this information on the cover FDA has engaged with regulatory, Industry; Availability
sheet and not in the body of your academic, and industry experts to
AGENCY: Food and Drug Administration,
comments and you must identify this discuss the current state and future
HHS.
information as ‘‘confidential.’’ Any directions of the collection of data on
the potential risks to breastfed infants ACTION: Notice of availability.
information marked as ‘‘confidential’’
will not be disclosed except in with maternal use of medications during SUMMARY: The Food and Drug
accordance with 21 CFR 10.20 and other lactation. The first day of the workshop Administration (FDA) is announcing the
applicable disclosure law. For more will focus on review and discussion of availability of a draft guidance for
information about FDA’s posting of current approaches for the collection of industry on cyclosporine ophthalmic
comments to public dockets, see 80 FR data, and review and discussion of gaps emulsion entitled ‘‘Draft Guidance on
56469, September 18, 2015, or access in our present knowledge. The second Cyclosporine.’’ The recommendations
the information at: http://www.fda.gov/ day of the workshop will focus on provide specific guidance on the design
regulatoryinformation/dockets/ consideration of novel approaches to of bioequivalence (BE) studies to
default.htm. improve the quality and quantity of data support abbreviated new drug
Docket: For access to the docket to available to assess the safety of applications (ANDAs) for cyclosporine
read background documents or the medications used during lactation as
ophthalmic emulsion. This draft
well as a review and discussion of
electronic and written/paper comments guidance is a revised version of a
strategies to communicate safety
received, go to http:// previously issued draft guidance on the
information related to maternal use of
www.regulations.gov and insert the same subject.
medications during lactation.
docket number, found in brackets in the This workshop includes a public DATES: Although you can comment on
heading of this document, into the comment session. If you would like to any guidance at any time (see 21 CFR
‘‘Search’’ box and follow the prompts present during this session, please 10.115(g)(5)), to ensure that the Agency
and/or go to the Division of Dockets identify the topic(s) you will address considers your comments on this draft
Management, 5630 Fishers Lane, Rm. during the registration. FDA will do its guidance before it begins work on the
1061, Rockville, MD 20852. best accommodate requests to speak. final version of the guidance, submit
FOR FURTHER INFORMATION CONTACT: For FDA urges individuals and either electronic or written comments
questions regarding the workshop, organizations with common interests to on the draft guidance by April 18, 2016.
contact Denise Pica-Branco, Center for coordinate and give a joint, consolidated ADDRESSES: You may submit comments
Drug Evaluation and Research, Food presentation. Following the close of as follows:
and Drug Administration, 10903 New registration, FDA will allot time for each
Hampshire Ave., Silver Spring, MD Electronic Submissions
presentation and notify presenters by
20993–0002, 301–796–1732, FAX: 301– April 21, 2016. Do not present or Submit electronic comments in the
796–9858, denise.picabranco@ distribute commercial or promotional following way:
fda.hhs.gov; or Denise Johnson-Lyles, material during the workshop. • Federal eRulemaking Portal: http://
Center for Drug Evaluation and Registered presenters should check in www.regulations.gov. Follow the
Research, Food and Drug before the workshop begins. instructions for submitting comments.
Administration, 10903 New Hampshire Comments submitted electronically,
Ave., Silver Spring, MD 20993–0002, II. Transcripts including attachments, to http://
301–796–6169; FAX: 301–796–9858, Please be advised that as soon as a www.regulations.gov will be posted to
denise.johnson-lyles@fda.hhs.gov. transcript is available, it will be the docket unchanged. Because your
Registration: Participation can be accessible at http:// comment will be made public, you are
mstockstill on DSK4VPTVN1PROD with NOTICES
either in person attendance or by www.regulations.gov. It may be viewed solely responsible for ensuring that your
Webcast. There is no fee to attend the at the Division of Dockets Management, comment does not include any
public workshop, but attendees must Food and Drug Administration, 5630 confidential information that you or a
register in advance. Space is limited, Fishers Lane, Rm. 1061, Rockville, MD third party may not wish to be posted,
and registration will be on a first-come, 20857. A transcript will also be such as medical information, your or
first-served basis. Persons interested in available in either hardcopy or on CD– anyone else’s Social Security number, or
attending this workshop must register ROM, after submission of a Freedom of confidential business information, such
online at lactation@fda.hhs.gov. Please Information request. The Freedom of as a manufacturing process. Please note
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![Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7811
that if you include your name, contact accordance with 21 CFR 10.20 and other for industry on BE recommendations for
information, or other information that applicable disclosure law. For more generic cyclosporine ophthalmic
identifies you in the body of your information about FDA’s posting of emulsion.
comments, that information will be comments to public dockets, see 80 FR Allergan, Inc., manufacturer of the
posted on http://www.regulations.gov. 56469, September 18, 2015, or access reference listed drug, RESTASIS,
• If you want to submit a comment the information at: http://www.fda.gov/ submitted a citizen petition in February
with confidential information that you regulatoryinformation/dockets/ 2014 challenging the Agency’s initial BE
do not wish to be made available to the default.htm. recommendations for generic
public, submit the comment as a Docket: For access to the docket to cyclosporine ophthalmic emulsion. We
written/paper submission and in the read background documents or the responded to that petition on November
manner detailed (see ‘‘Written/Paper electronic and written/paper comments 20, 2014 (Docket No. FDA–2014–P–
Submissions’’ and ‘‘Instructions’’). received, go to http:// 0304). The following month, Allergan
www.regulations.gov and insert the submitted a second citizen petition
Written/Paper Submissions
docket number, found in brackets in the challenging the Agency’s initial BE
Submit written/paper submissions as heading of this document, into the recommendations. In April 2015, FDA
follows: ‘‘Search’’ box and follow the prompts received a third citizen petition on its
• Mail/Hand delivery/Courier (for and/or go to the Division of Dockets initial BE recommendations from
written/paper submissions): Division of Physical Pharmaceutica LLC. FDA has
Management, 5630 Fishers Lane, rm.
Dockets Management (HFA–305), Food reviewed the issues raised by Allergan
1061, Rockville, MD 20852.
and Drug Administration, 5630 Fishers and Physical Pharmaceutica and is
Submit written requests for single
Lane, Rm. 1061, Rockville, MD 20852. responding to their petitions (Docket
copies of the draft guidance to the
• For written/paper comments Nos. FDA–2015–P–0065 and FDA–
submitted to the Division of Dockets Division of Drug Information, Center for
Drug Evaluation and Research, Food 2015–P–1404).
Management, FDA will post your In addition, we are now issuing a
comment, as well as any attachments, and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, revised draft guidance for industry on
except for information submitted, BE recommendations for generic
marked and identified, as confidential, 4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive cyclosporine ophthalmic emulsion
if submitted as detailed in (‘‘Draft Guidance on Cyclosporine’’).
‘‘Instructions.’’ label to assist that office in processing
your requests. See the SUPPLEMENTARY This draft guidance is being issued
Instructions: All submissions received consistent with FDA’s good guidance
must include the Docket No. FDA– INFORMATION section for electronic
practices regulation (21 CFR 10.115).
2007–P–0369 for ‘‘Draft Guidance on access to the draft guidance document.
The draft guidance, when finalized, will
Cyclosporine.’’ Received comments will FOR FURTHER INFORMATION CONTACT: represent the Agency’s current thinking
be placed in the docket and, except for Xiaoqiu Tang, Center for Drug on the design of BE studies to support
those submitted as ‘‘Confidential Evaluation and Research (HFD–600), ANDAs for cyclosporine ophthalmic
Submissions,’’ publicly viewable at Food and Drug Administration, 10903 emulsion. It does not create or confer
http://www.regulations.gov or at the New Hampshire Ave., Bldg. 75, Rm. any rights for or on any person and does
Division of Dockets Management 4730, Silver Spring, MD 20993–0002, not operate to bind FDA or the public.
between 9 a.m. and 4 p.m., Monday 301–796–5850. An alternative approach may be used if
through Friday. SUPPLEMENTARY INFORMATION: such approach satisfies the
• Confidential Submissions—To requirements of the applicable statutes
submit a comment with confidential I. Background
and regulations.
information that you do not wish to be In the Federal Register of June 11,
made publicly available, submit your 2010 (75 FR 33311), FDA announced the II. Electronic Access
comments only as a written/paper availability of a guidance for industry, Persons with access to the Internet
submission. You should submit two ‘‘Bioequivalence Recommendations for may obtain the document at either
copies total. One copy will include the Specific Products,’’ which explained the http://www.fda.gov/Drugs/Guidance
information you claim to be confidential process that would be used to make ComplianceRegulatoryInformation/
with a heading or cover note that states product-specific BE recommendations Guidances/default.htm or http://
‘‘THIS DOCUMENT CONTAINS available to the public on FDA’s Web www.regulations.gov.
CONFIDENTIAL INFORMATION.’’ The site at http://www.fda.gov/Drugs/ Dated: February 9, 2016.
Agency will review this copy, including GuidanceCompliance Leslie Kux,
the claimed confidential information, in RegulatoryInformation/Guidances/
Associate Commissioner for Policy.
its consideration of comments. The default.htm. As described in that
[FR Doc. 2016–02975 Filed 2–12–16; 8:45 am]
second copy, which will have the guidance, FDA adopted this process as
BILLING CODE 4164–01–P
claimed confidential information a means to develop and disseminate
redacted/blacked out, will be available product-specific BE recommendations
for public viewing and posted on http:// and provide a meaningful opportunity
DEPARTMENT OF HEALTH AND
www.regulations.gov. Submit both for the public to consider and comment
HUMAN SERVICES
copies to the Division of Dockets on those recommendations. This notice
Management. If you do not wish your announces the availability of revised Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
name and contact information to be draft BE recommendations for
made publicly available, you can cyclosporine ophthalmic emulsion. [Docket No. FDA–2016–D–0236]
provide this information on the cover FDA initially approved new drug
Nonallergic Rhinitis: Developing Drug
sheet and not in the body of your application 050790 for RESTASIS
Products for Treatment; Draft
comments and you must identify this (cyclosporine ophthalmic emulsion),
Guidance for Industry; Availability
information as ‘‘confidential.’’ Any 0.05% in December 2002. There are no
information marked as ‘‘confidential’’ approved ANDAs for this product. In AGENCY: Food and Drug Administration,
will not be disclosed except in June 2013, we issued a draft guidance HHS.
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Document Created: 2016-02-13 03:13:16
Document Modified: 2016-02-13 03:13:16
| 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 April 18, 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 7810 |
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