81 FR 4916 - Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

Page Range		4916-4917
FR Document		2016-01683

The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lamotrigine extended-release tablets entitled ``Draft Guidance on Lamotrigine.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lamotrigine extended-release tablets.

Federal Register, Volume 81 Issue 18 (Thursday, January 28, 2016)

[Federal Register Volume 81, Number 18 (Thursday, January 28, 2016)]
[Notices]
[Pages 4916-4917]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-01683]

[[Page 4916]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Bioequivalence Recommendations for Lamotrigine; Draft Guidance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availability of a revised draft guidance for industry on lamotrigine
extended-release tablets entitled ``Draft Guidance on Lamotrigine.''
The recommendations provide specific guidance on the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs) for lamotrigine extended-release tablets.

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this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 28, 2016.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 Lamotrigine.'' 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 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 revised
draft BE recommendations for lamotrigine extended-release tablets.
On May 29, 2009, FDA initially approved new drug application 022115
for LAMICTAL (lamotrigine) extended-release tablets. There are eight
approved ANDAs for this product. In April 2010, we issued a draft
guidance for industry on BE recommendations for lamotrigine extended-
release tablets, which we subsequently revised in May 2010; July 2010;
and August 2010. We are now issuing a further revised draft guidance
for industry on BE recommendations for generic lamotrigine extended-
release tablets (``Draft Guidance on Lamotrigine'').
In October 2006, UCB, Inc., submitted a citizen petition requesting
that FDA

[[Page 4917]]

take several actions with respect to anti-epileptic drugs (AEDs),
including that FDA narrow the bioequivalence range for all such drugs
(Docket No. FDA-2006-P-0461). FDA is reviewing the issues raised in the
petition. Although lamotrigine is not the sole focus of the petition,
lamotrigine is discussed and it is indicated for use as an AED;
therefore, FDA will consider any comments on the draft guidance on
lamotrigine 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 lamotrigine extended-release
tablets. It does not create or confer any rights for or on any person
and does 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: January 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01683 Filed 1-27-16; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 4917

take several actions with respect to anti- ADDRESSES: To ensure that comments on finalized, will describe our current
epileptic drugs (AEDs), including that the information collection are received, thinking on the manufacturing of
FDA narrow the bioequivalence range OMB recommends that written exempt infant formula in relation to the
for all such drugs (Docket No. FDA– comments be faxed to the Office of requirements in part 106 (21 CFR part
2006–P–0461). FDA is reviewing the Information and Regulatory Affairs, 106) for CGMPs, quality control
issues raised in the petition. Although OMB, Attn: FDA Desk Officer, FAX: procedures, conduct of audits, and
lamotrigine is not the sole focus of the 202–395–7285, or emailed to oira_ records and reports that apply to
petition, lamotrigine is discussed and it submission@omb.eop.gov. All nonexempt infant formulas. Persons
is indicated for use as an AED; comments should be identified with the with access to the Internet may obtain
therefore, FDA will consider any OMB control number 0910—NEW. Also the draft guidance at http://
comments on the draft guidance on include the FDA docket number found www.fda.gov/FoodGuidances.
lamotrigine in responding to the in brackets in the heading of this
II. Analysis of the Proposed
petition. document.
This draft guidance is being issued Information Collection
FOR FURTHER INFORMATION CONTACT: FDA
consistent with FDA’s good guidance The proposed information collection
PRA Staff, Office of Operations, Food
practices regulation (21 CFR 10.115). seeks OMB approval of the
and Drug Administration, 8455
The draft guidance, when finalized, will recordkeeping recommendations of the
Colesville Rd., COLE–14526, Silver
represent the Agency’s current thinking draft guidance. Our estimate of the
Spring, MD 20993–0002, PRAStaff@
on the design of BE studies to support burden of the recordkeeping
fda.hhs.gov.
ANDAs for lamotrigine extended-release recommendations includes the one-time
tablets. It does not create or confer any SUPPLEMENTARY INFORMATION: In burden of developing production and
rights for or on any person and does not compliance with 44 U.S.C. 3507, FDA in-process control systems and the
operate to bind FDA or the public. You has submitted the following proposed annual burdens of developing and
can use an alternative approach if it collection of information to OMB for maintaining production aggregate
satisfies the requirements of the review and clearance. production and control records, records
applicable statutes and regulations. Recommended Recordkeeping for pertaining to the distribution of infant
Exempt Infant Formula Production— formula, and records pertaining to
II. Electronic Access regularly scheduled audits. Included in
OMB Control Number 0910—NEW
Persons with access to the Internet the burden estimate is the time for
may obtain the document at either I. Background reviewing instructions, searching
http://www.fda.gov/Drugs/ Section 412(h)(1) (21 U.S.C. existing data sources, gathering and
GuidanceCompliance 350a(h)(1)) of the Federal Food, Drug, maintaining the data needed, and
RegulatoryInformation/Guidances/ and Cosmetic Act (the FD&C Act) completing and reviewing each
default.htm or http:// exempts an infant formula which is collection of information.
www.regulations.gov. represented and labeled for use by an Description of Respondents: The
Dated: January 22, 2016. infant with an inborn error of respondent recordkeepers are
Leslie Kux, metabolism, low birth weight, or who manufacturers of exempt infant formula.
Associate Commissioner for Policy. otherwise has an unusual medical or Description: The records
dietary problem from the requirements recommended, to the extent practicable,
[FR Doc. 2016–01683 Filed 1–27–16; 8:45 am]
of section 412(a), (b), and (c) of the in the draft guidance include records
BILLING CODE 4164–01–P
FD&C Act (21 U.S.C. 350a(a), (b), and required by part 106, subparts A, B, C,
(c)). These formulas are customarily D, and F for non-exempt infant
DEPARTMENT OF HEALTH AND referred to as ‘‘exempt infant formulas.’’ formulas. Because the records and
HUMAN SERVICES In the Federal Register of June 10, 2014 reporting requirements related to part
(79 FR 33057), we published a final rule 106 subparts E and G are not generally
Food and Drug Administration that adopted, with some modifications, applicable to exempt infant formula
an interim final rule published on manufacturers, FDA is not
[Docket No. FDA–2014–D–0044] February 10, 2014 (79 FR 7934), that recommending in the draft guidance
Agency Information Collection established requirements for quality that exempt infant formula
Activities; Submission for Office of factors for infant formulas and current manufacturers follow these
Management and Budget Review; good manufacturing practices (CGMPs), requirements. As such, the records and
Comment Request; Recommended including quality control procedures, reporting requirements in part 106
Recordkeeping for Exempt Infant under section 412 of the FD&C Act. The subparts E and G are not part of this new
final rule will help prevent the information collection.
Formula Production
manufacture of adulterated infant In the Federal Register of March 18,
AGENCY: Food and Drug Administration, formula, ensure the safety of infant 2015 (80 FR 14134), FDA published a
HHS. formula, and ensure that the nutrients in 60-day notice requesting public
ACTION: Notice. infant formula are present in a form that comment on the proposed collection of
is bioavailable. information. We received one letter
SUMMARY: The Food and Drug In the Federal Register of February responsive to the notice, which
Administration (FDA) is announcing 10, 2014 (79 FR 7610), we published a contained comments.
that a proposed collection of notice of availability of the draft (Comment 1) One comment suggested
wgreen on DSK2VPTVN1PROD with NOTICES

information has been submitted to the guidance document entitled, ‘‘Guidance that we clarify the action level for end-
Office of Management and Budget for Industry: Exempt Infant Formula of-shelf-life verification testing and how
(OMB) for review and clearance under Production: Current Good this testing differs for exempt infant
the Paperwork Reduction Act of 1995. Manufacturing Practices, Quality formulas as compared to non-exempt
DATES: Fax written comments on the Control Procedures, Conduct of Audits, infant formulas.
collection of information by February and Records and Reports’’ (the draft (Response) We appreciate the
29, 2016. guidance). The draft guidance, when concerns discussed in the comment.

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Document Created: 2018-02-02 12:40:56
Document Modified: 2018-02-02 12:40:56

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 March 28, 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		81 FR 4916

81 FR 4916 - Bioequivalence Recommendations for Lamotrigine; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 18 (January 28, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration