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Draft Guidance for Industry.’’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
28242 Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 

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– 

2016–D–2569 for ‘‘S9 Nonclinical 

Evaluation for Anticancer 

Pharmaceuticals—Questions and 

Answers.’’ 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 office 

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 this 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 the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), 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. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: John K. 

Leighton, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2204, Silver Spring, 

MD 20993–0002, 301–796–1398; or 

Anne M. Pilaro, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 4023, 

Silver Spring, MD 20993–0002, 240– 

402–8341. 

Regarding the ICH: Amanda Roache, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1176, Silver Spring, 

MD 20993–0002, 301–796–4548. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, regulatory authorities 

and industry associations from around 

the world have participated in many 

important initiatives to promote 

international harmonization of 

regulatory requirements under the ICH. 

FDA has participated in several ICH 

meetings designed to enhance 

harmonization and FDA is committed to 

seeking scientifically-based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and reduce 

differences in technical requirements for 

drug development among regulatory 

agencies. 

ICH was established to provide an 

opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products for human use 

among regulators around the world. The 

six founding members of the ICH are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; FDA; the Japanese 

Ministry of Health, Labour, and Welfare; 

the Japanese Pharmaceutical 

Manufacturers Association; and the 

Pharmaceutical Research and 

Manufacturers of America. The 

Standing Members of the ICH 

Association include Health Canada and 

Swissmedic. Any party eligible as a 

Member in accordance with the ICH 

Articles of Association can apply for 

membership in writing to the ICH 

Secretariat. The ICH Secretariat, which 

coordinates the preparation of 

documentation, operates as an 

international nonprofit organization and 

is funded by the Members of the ICH 

Association. 

The ICH Assembly is the overarching 

body of the ICH Association and 

includes representatives from each of 

the ICH members and observers. The 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 117 / Monday, June 18, 2018 / Notices 28243 

ICH Assembly is responsible for the 

endorsement of draft guidelines and 

adoption of final guidelines. FDA 

publishes ICH guidelines as FDA 

guidances. 

ICH S9 (2010) was a significant 

advance in harmonizing anticancer drug 

development. Implementation of ICH S9 

(2010) has revealed areas that are open 

to broad and divergent interpretation by 

both regulatory authorities and industry. 

For this reason, an Implementation 

Working Group (IWG) was formed in 

October 2014 to provide additional 

clarity about anticancer pharmaceutical 

development. The questions and 

answers developed by the IWG are 

intended to facilitate the 

implementation of ICH S9 (2010), as 

well as to continue progress in the 3Rs 

of Reduction, Refinement, and 

Replacement in the use of animals. 

In the Federal Register of September 

19, 2016 (81 FR 64178), FDA published 

a notice announcing the availability of 

a draft guidance entitled ‘‘S9 

Nonclinical Evaluation for Anticancer 

Pharmaceuticals—Questions and 

Answers.’’ The notice gave interested 

persons an opportunity to submit 

comments by November 18, 2016. 

After consideration of the comments 

received and revisions to the guideline, 

a final draft of the guideline was 

submitted to the ICH Assembly and 

endorsed by the regulatory agencies in 

June 2016. 

The guidance provides 

recommendations on development of 

anticancer pharmaceuticals, including 

small molecule and biotechnologyderived products. The questions and 

answers are intended to provide clarity 

and to facilitate a harmonized approach 

to the implementation of ICH S9 (2010). 

Since the publication of the draft 

questions and answers and receipt of 

public comments, some questions were 

combined for brevity and clarity or were 

deleted as redundant or due to lack of 

harmonization. Several areas of 

particular importance include 

additional clarity around the scope of 

the guidance, additional 

recommendations regarding 

development of antibody-drug 

conjugates, and the need for recovery 

animals in general toxicology studies. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on ‘‘S9 Nonclinical 

Evaluation for Anticancer 

Pharmaceuticals—Questions and 

Answers.’’ 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. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.regulations.gov, https://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Dated: June 12, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–12975 Filed 6–15–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Immunity in the Elderly 

(R01). 

Date: July 9–10, 2018. 

Time: 9:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, LD30, 

5601 Fishers Lane, Rockville, MD 20892. 

Contact Person: Julio Aliberti, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, DEA/NIAID/NIH/DHHS, 5601 

Fishers Lane, MSC–9823, Rockville, MD 

20852, 301–761–7322, alibertijc@

niaid.nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; Maintaining Immunity after 

Immunization (U01). 

Date: July 11–12, 2018. 

Time: 8:30 a.m. to 2:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892. 

Contact Person: Geetanjali Bansal, Ph.D., 

Scientific Review Officer, Scientific Review 

Program, Division of Extramural Activities, 

Room 3G49, National Institutes of Health/ 

NIAID, 5601 Fishers Lane, MSC 9834, 

Bethesda, MD 20892–9834, (240) 669–5073, 

geetanjali.bansal@nih.gov. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID Investigator Initiated 

Program Project (P01). 

Date: July 11, 2018. 

Time: 1:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Raymond R. Schleef, 

Ph.D., Senior Scientific Review Officer, 

Scientific Review Program, Division of 

Extramural Activities, Room 3E61, National 

Institutes of Health/NIAID, 5601 Fishers 

Lane, MSC 9823, Bethesda, MD 20892–9823, 

(240) 669–5019, schleefrr@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: June 12, 2018. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–12921 Filed 6–15–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR: 

Selected Topics in Transfusion Medicine. 

Date: June 28–29, 2018. 

Time: 10:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 


amozie on DSK3GDR082PROD with NOTICES1