28240 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 

website: https://www.fda.gov/ 

Food/NewsEvents/WorkshopsMeetings

Conferences/default.htm. 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 meeting must 

register by July 5, 2018. Early 

registration is recommended because 

seating is limited; therefore, FDA may 

limit the number of participants from 

each organization. Registrants will 

receive confirmation when they have 

been accepted. 

If you need special accommodations 

due to a disability, please contact 

Juanita Yates (see FOR FURTHER

INFORMATION CONTACT) no later than June 

28, 2018. 

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 request time for a 

joint presentation. 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 

July 3, 2018. Speakers will be limited to 

making oral remarks; there will not be 

an opportunity to display materials such 

as slide shows, videos, or other media 

during the meeting. All requests to make 

oral presentations must be received by 

June 28, 2018. No commercial or 

promotional material will be permitted 

to be presented or distributed at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. Webcast participants are 

asked to preregister at https://

www.fda.gov/ 

Food/NewsEvents/WorkshopsMeetings

Conferences/default.htm. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting 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/ 

Food/NewsEvents/WorkshopsMeetings

Conferences/default.htm. 

Other Issues for Consideration: A 

summary of key information on 

participating in the meeting follows: 

TABLE 1—INFORMATION ON PARTICIPATION IN THE MEETING

Date Address Preregister Electronic address 

Request to 

make an oral 

presentation 

Special 

accommodations 

Submit either electronic or written 

comments 

July 12, 2018, 

from 8:30 a.m. 

until 3 p.m. EDT.

Food and Drug Administration, Center 

for Food Safety and 

Applied Nutrition, 

Wiley Auditorium, 

5001 Campus 

Drive, College Park, 

MD 20740.

July 5, 2018: 

Closing date 

for registration.

https://www.fda.gov/ 

Food/NewsEvents/ 

WorkshopsMeetings

Conferences/default.htm.

June 28, 2018 June 28, 2018: Closing date to request 

special accommodations due to a 

disability.

Submit Comments by September 

25, 2018 to: https://

www.regulations.gov, or Dockets Management Staff (HFA– 

305), Food and Drug Administration, 5630 Fishers Lane, 

Rm. 1061, Rockville, MD 

20852. 

Dated: June 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12939 Filed 6–15–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2016] 

Epidermolysis Bullosa: Developing 

Drugs for Treatment of Cutaneous 

Manifestations; 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 

‘‘Epidermolysis Bullosa: Developing 

Drugs for Treatment of Cutaneous 

Manifestations.’’ The purpose of this 

draft guidance is to assist sponsors with 

the development of drugs for treatment 

or prevention of the serious cutaneous 

manifestations of the heterogeneous 

group of disorders collectively known as 

epidermolysis bullosa (EB). There is an 

unmet medical need for EB patients due 

to the paucity of effective treatment 

options. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 17, 2018 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28241 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–2016 for ‘‘Epidermolysis 

Bullosa: Developing Drugs for 

Treatment of Cutaneous Manifestations; 

Draft Guidance for Industry.’’ 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: 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, or Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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: 

Barbara Gould, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5166, 

Silver Spring, MD 20993–0002, 301– 

796–4224; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Epidermolysis Bullosa: Developing 

Drugs for Treatment of Cutaneous 

Manifestations.’’ The purpose of this 

draft guidance is to assist sponsors with 

the development of drugs for treatment 

or prevention of the serious cutaneous 

manifestations of the heterogeneous 

group of disorders collectively known as 

EB. There is an unmet medical need for 

EB patients due to the paucity of 

effective treatment options. 

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 ‘‘Epidermolysis Bullosa: Developing 

Drugs for Treatment of Cutaneous 

Manifestations.’’ 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 that 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 

part 312 have been approved under 

OMB control number 0910–0014. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, https://www.fda.gov/ 

BiologicsBloodVaccines/ 

GuidanceCompliance

RegulatoryInformation/default.htm, or 

https://www.regulations.gov. 

Dated: June 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12976 Filed 6–15–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2569] 

S9 Nonclinical Evaluation for 

Anticancer Pharmaceuticals— 

Questions and Answers; International 

Council for Harmonisation; 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 final 

guidance for industry entitled ‘‘S9 

Nonclinical Evaluation for Anticancer 

Pharmaceuticals—Questions and 

Answers.’’ The guidance was prepared 

under the auspices of the International 

Council for Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use (ICH), formerly the 

International Conference on 

Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use. The 

guidance consists of questions and 

answers that were developed to provide 

additional clarity about anticancer 

pharmaceutical development described 

in the ICH guidance ‘‘S9 Nonclinical 

Evaluation for Anticancer 

Pharmaceuticals’’ that was published in 

2010 (ICH S9 (2010)), as well as to 

continue progress in the 3Rs of 

Reduction, Refinement, and 

Replacement in the use of animals. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on June 18, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 


amozie on DSK3GDR082PROD with NOTICES1