4916 Federal Register / Vol. 81, No. 18 / Thursday, January 28, 2016 / Notices 

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Lamotrigine; Draft Guidance for 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availability of a revised draft guidance 

for industry on lamotrigine extendedrelease tablets entitled ‘‘Draft Guidance 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on the draft guidance by March 28, 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 productspecific BE recommendations available 

to the public on FDA’s Web site at 

http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/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) extendedrelease 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 


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

take several actions with respect to antiepileptic 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/

GuidanceCompliance

RegulatoryInformation/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–0044] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Recommended 

Recordkeeping for Exempt Infant 

Formula Production 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by February 

29, 2016. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or emailed to oira_

submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910—NEW. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Recommended Recordkeeping for 

Exempt Infant Formula Production— 

OMB Control Number 0910—NEW 

I. Background 

Section 412(h)(1) (21 U.S.C. 

350a(h)(1)) of the Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) 

exempts an infant formula which is 

represented and labeled for use by an 

infant with an inborn error of 

metabolism, low birth weight, or who 

otherwise has an unusual medical or 

dietary problem from the requirements 

of section 412(a), (b), and (c) of the 

FD&C Act (21 U.S.C. 350a(a), (b), and 

(c)). These formulas are customarily 

referred to as ‘‘exempt infant formulas.’’ 

In the Federal Register of June 10, 2014 

(79 FR 33057), we published a final rule 

that adopted, with some modifications, 

an interim final rule published on 

February 10, 2014 (79 FR 7934), that 

established requirements for quality 

factors for infant formulas and current 

good manufacturing practices (CGMPs), 

including quality control procedures, 

under section 412 of the FD&C Act. The 

final rule will help prevent the 

manufacture of adulterated infant 

formula, ensure the safety of infant 

formula, and ensure that the nutrients in 

infant formula are present in a form that 

is bioavailable. 

In the Federal Register of February 

10, 2014 (79 FR 7610), we published a 

notice of availability of the draft 

guidance document entitled, ‘‘Guidance 

for Industry: Exempt Infant Formula 

Production: Current Good 

Manufacturing Practices, Quality 

Control Procedures, Conduct of Audits, 

and Records and Reports’’ (the draft 

guidance). The draft guidance, when 

finalized, will describe our current 

thinking on the manufacturing of 

exempt infant formula in relation to the 

requirements in part 106 (21 CFR part 

106) for CGMPs, quality control 

procedures, conduct of audits, and 

records and reports that apply to 

nonexempt infant formulas. Persons 

with access to the Internet may obtain 

the draft guidance at http://

www.fda.gov/FoodGuidances. 

II. Analysis of the Proposed 

Information Collection 

The proposed information collection 

seeks OMB approval of the 

recordkeeping recommendations of the 

draft guidance. Our estimate of the 

burden of the recordkeeping 

recommendations includes the one-time 

burden of developing production and 

in-process control systems and the 

annual burdens of developing and 

maintaining production aggregate 

production and control records, records 

pertaining to the distribution of infant 

formula, and records pertaining to 

regularly scheduled audits. Included in 

the burden estimate is the time for 

reviewing instructions, searching 

existing data sources, gathering and 

maintaining the data needed, and 

completing and reviewing each 

collection of information. 

Description of Respondents: The 

respondent recordkeepers are 

manufacturers of exempt infant formula. 

Description: The records 

recommended, to the extent practicable, 

in the draft guidance include records 

required by part 106, subparts A, B, C, 

D, and F for non-exempt infant 

formulas. Because the records and 

reporting requirements related to part 

106 subparts E and G are not generally 

applicable to exempt infant formula 

manufacturers, FDA is not 

recommending in the draft guidance 

that exempt infant formula 

manufacturers follow these 

requirements. As such, the records and 

reporting requirements in part 106 

subparts E and G are not part of this new 

information collection. 

In the Federal Register of March 18, 

2015 (80 FR 14134), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. We received one letter 

responsive to the notice, which 

contained comments. 

(Comment 1) One comment suggested 

that we clarify the action level for endof-shelf-life verification testing and how 

this testing differs for exempt infant 

formulas as compared to non-exempt 

infant formulas. 

(Response) We appreciate the 

concerns discussed in the comment. 


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