Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46065 

Type of 

respondent Form name Estimated number of respondents 

Number of responses 

per respondent 

Average 

time per 

response 

(in hours) 

Total 

burden 

hours 

(annual) 

Project staff ............................... Semi-annual Performance Report ..................... 18 ................................ Twice a year ............................. 8 288 

Local agency leaders ................ Program Information Cover Sheet/Participant 

Information Form/Attendance Log/Post Program Survey.

700 leaders ................. Twice a year (one set per program)..50 700 

Local data entry staff ................ 46 data entry staff ...... Once per program x 1400 programs..50 700 

Local organization staff and 

local database entry staff.

Host Organization Data Form ........................... 700 staff ...................... 1 ............................................... .05 35 

Program participants ................. Participant Information Form ............................. 16,390 ......................... 1 ............................................... .10 1,639 

Program participants ................. Post Program Survey ........................................ 983 .............................. 1 ............................................... .10 983 

Total Burden Hours ........... ............................................................................ ..................................... ................................................... ................ 4,345 

Dated: September 20, 2017. 

Mary Lazare, 

Principal Deputy Administrator. 

[FR Doc. 2017–21179 Filed 10–2–17; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5437] 

Topical Dermatological Generic Drug 

Products: Overcoming Barriers to 

Development and Improving Patient 

Access; Public Workshop; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

workshop entitled ‘‘Topical 

Dermatological Generic Drug Products: 

Overcoming Barriers to Development 

and Improving Patient Access.’’ The 

purpose of the public workshop is to 

provide an overview of current 

regulatory science initiatives related to 

generic topical dermatological drug 

products, solicit public input on 

scientific barriers that may limit patient 

access to such drug products, and 

discuss approaches to overcome/address 

any such barriers. FDA is seeking public 

input from a variety of stakeholders, 

including industry, academia, patient 

advocates, and professional 

associations. 

DATES: The public workshop will be 

held on October 20, 2017, from 8:30 

a.m. to 4:30 p.m., Eastern Standard 

Time. Submit either electronic or 

written comments on this public 

workshop by November 20, 2017. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public workshop will 

be held at FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503A), Silver Spring, MD 20993–0002. 

Entrance for the public workshop 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/Workingat

FDA/BuildingsandFacilities/WhiteOak

CampusInformation/ucm241740.htm. 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before November 20, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of November 20, 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. 

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–5437 for ‘‘Topical 

Dermatological Generic Drug Products: 

Overcoming Barriers to Development 

and Improving Patient Access.’’ 

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 

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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
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 


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