46066 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Sam 

Raney, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 4706, Silver Spring, 

MD 20993, 240–402–7967, email: 

Sameersingh.Raney@fda.hhs.gov; or 

Markham Luke, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 4712, 

Silver Spring, MD 20993, 301–796– 

5556, email: Markham.Luke@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The conventional approach to 

establish bioequivalence (BE) for most 

topical dermatological generic drug 

products relies upon clinical endpoint 

BE studies. The risk of failing to 

demonstrate BE due to the relative 

insensitivity of these clinical endpoint 

studies, combined with their burden 

and length, may represent a barrier to 

generic drug development and may 

adversely impact patient access to some 

topical dermatological generic drug 

products. FDA is evaluating alternative 

BE approaches for topical 

dermatological generic drug products, 

using methods that are more efficient, 

and also more sensitive and 

reproducible. FDA believes that these 

BE approaches would benefit from 

public discussion. 

II. Topics for Discussion at the Public 

Workshop 

This public workshop will focus on a 

discussion of current regulatory science 

initiatives intended to foster the 

development of topical dermatological 

generic drug products, examining 

alternative BE approaches that may be 

more efficient and less risky than 

traditional approaches. FDA is also 

interested in receiving public input 

about any barriers that may limit the use 

of such alternative BE approaches in the 

development of topical dermatological 

generic drug products. Public input is 

also sought about strategies to overcome 

these barriers. 

III. Participating in the Public 

Workshop 

Registration: Persons interested in 

attending this public workshop must 

register online at https://

survey.co1.qualtrics.com/jfe/form/SV_

9YQDLZJRjXtYiXz. Please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email, and 

telephone. 

Registration is free and based on 

space availability, with priority given to 

early registrants. Persons interested in 

attending this public workshop must 

register by October 13, 2017, midnight, 

Eastern Time. Early registration is 

recommended because seating is 

limited; therefore, FDA may limit the 

number of participants from each 

organization. 

If you need special accommodations 

due to a disability, please contact Sam 

Raney (see FOR FURTHER INFORMATION

CONTACT) no later than October 13, 2017. 

Requests for Oral Presentations: 

During online registration you may 

indicate if you wish to present during a 

public comment session, and which 

topic(s) you wish to address. We will do 

our best to accommodate requests to 

make public comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and to request time for a 

joint presentation, or to submit requests 

for designated representatives to 

participate in the focused sessions. 

Following the close of registration, we 

will determine the amount of time 

allotted to each presenter and the 

approximate time each oral presentation 

is to begin, and will select and notify 

participants by October 16, 2017. All 

requests to make oral presentations 

must be received by the close of 

registration on October 9, 2017. If 

selected for presentation, any 

presentation materials must be emailed 

to GDUFARegulatoryScience@

fda.hhs.gov no later than October 13, 

2017. No commercial or promotional 

material will be permitted to be 

presented or distributed at the public 

workshop. 

Streaming webcast of the public 

workshop: This public workshop will 

also be webcast. A live webcast of this 

workshop will be viewable at https://

collaboration.fda.gov/ogddermaldrug/ 

on the day of the workshop. 

If you have never attended a Connect 

Pro event before, test your connection at 

https://collaboration.fda.gov/common/ 

help/en/support/meeting_test.htm. To 

get a quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the Web site addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

Web sites are subject to change over 

time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

workshop is available, it will be 

accessible at https://

www.regulations.gov. It may be viewed 

at the Dockets Management Staff (see 

ADDRESSES). A link to the transcript will 

also be available on the internet at 

https://www.fda.gov/Drugs/NewsEvents/ 

ucm557252.htm. 

Dated: September 28, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21186 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5670] 

Abbreviated New Drug Applications 

Submissions—Amendments To 

Abbreviated New Drug Applications 

Under the Generic Drug User Fee Act; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled ‘‘ANDA 

Submissions—Amendments to 

Abbreviated New Drug Applications 

Under GDUFA.’’ This draft guidance is 

intended to explain to applicants how 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46067 

the review goals established as part of 

the Generic Drug User Fee Amendments 

Reauthorization of 2017 (GDUFA II) 

apply to amendments to abbreviated 

new drug applications (ANDAs) and 

prior approval supplements (PASs) to 

FDA under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). This draft 

guidance describes amendment 

classifications and categories and 

explains how amendment submissions 

may affect an application’s review goal 

dates. The draft guidance also describes 

how FDA will review amendments 

submitted to ANDAs and PASs received 

prior to October 1, 2017, the effective 

date to implement the GDUFA II review 

goals. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 4, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2017–D–5670 for ‘‘ANDA 

Submissions—Amendments to 

Abbreviated New Drug Applications 

Under GDUFA.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff 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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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: at: https://

www.gpo.gov/fdsys/pkg/FR-2015-09-18/ 

pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 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: 

Elizabeth Giaquinto Friedman, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1670, 

Silver Spring, MD 20993–0002, 240– 

402–7930, elizabeth.giaquinto@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘ANDA Submissions—Amendments to 

Abbreviated New Drug Applications 

Under GDUFA.’’ This guidance is 

intended to assist applicants preparing 

to submit amendments to ANDAs or 

PASs to FDA under section 505(j) of the 

FD&C Act (21 U.S.C. 355(j)) by 

explaining how the review goals 

established as part of GDUFA II apply 

to these submissions. In accordance 

with the ‘‘GDUFA Reauthorization 

Performance Goals and Program 

Enhancements Fiscal Years 2018–2022’’ 

(GDUFA II Commitment Letter, 

available at: https://www.fda.gov/

downloads/ForIndustry/UserFees/ 

GenericDrugUserFees/UCM525234.pdf), 

FDA agreed to certain review goals and 

procedures for the review of 

amendments pending as of or received 

on or after the GDUFA II effective date. 

The GDUFA II Commitment Letter 

reflects significant changes in the 

classification of and review goals for 

amendments to ANDAs and PASs under 

the Generic Drug User Fee Amendments 

of 2012 (GDUFA I). Under GDUFA I, 

amendments were classified into a 

complex tier system based on the 

following factors: 

• Whether the amendment was 

solicited (submitted in response to a 

complete response letter) or unsolicited 

(submitted on the applicant’s own 

initiative). 

• Whether the amendment was major 

or minor. 

• The number of amendments 

submitted to the ANDA or PAS. 

• Whether an inspection was 

necessary to support the information 

contained in the amendment. 

GDUFA II simplified the amendment 

review goals and no longer subjects 

them to a tier system; however, review 


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46068 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

goals are still dependent on several 

factors. In general, under GDUFA II, 

amendments will be designated as 

either standard or priority, will be 

classified as major or minor, and will 

receive a goal date based on the factors 

discussed in the draft guidance, 

including whether a preapproval 

inspection is needed. When finalized, 

this draft guidance will replace the 

December 2001 guidance for industry 

‘‘Major, Minor, and Telephone 

Amendments to Abbreviated New Drug 

Applications.’’ This draft guidance 

supersedes the July 2014 draft guidance 

for industry ‘‘ANDA Submissions— 

Amendments and Easily Correctable 

Deficiencies Under GDUFA.’’ 

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 ‘‘ANDA Submissions—Amendments 

to Abbreviated New Drug Applications 

Under GDUFA.’’ 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. This guidance 

is not subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR 314.96 have 

been approved under OMB control 

number 0910–0001. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: September 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21175 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5891] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Endocrinologic and Metabolic Drugs 

Advisory Committee. The general 

function of the committee is to provide 

advice and recommendations to the 

Agency on FDA’s regulatory issues. The 

meeting will be open to the public. FDA 

is establishing a docket for public 

comment on this document. 

DATES: The public meeting will be held 

on October 18, 2017, from 8 a.m. to 5 

p.m. 

ADDRESSES: Tommy Douglas Conference 

Center, the Ballroom, 10000 New 

Hampshire Ave., Silver Spring, MD 

20903. The conference center’s 

telephone number is 240–645–4000. 

Answers to commonly asked questions 

about FDA Advisory Committee 

meetings may be accessed at https://

www.fda.gov/AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm408555.htm. Information about the 

Tommy Douglas Conference Center can 

be accessed at: http://

www.tommydouglascenter.com/. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–5891. 

The docket will close on October 17, 

2017. Submit either electronic or 

written comments on this public 

meeting by October 17, 2017. Late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 17, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 17, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Comments received on or before 

October 11, 2017, will be provided to 

the committee. Comments received after 

that date will be taken into 

consideration by the Agency. You may 

submit comments as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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– 

2017–N–5891for ‘‘Endocrinologic and 

Metabolic Drugs Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES