32302 Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 

DATES: Authority for the 

Psychopharmacologic Drugs Advisory 

Committee will expire on June 4, 2020, 

unless the Commissioner formally 

determines that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Kalyani Bhatt, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, email: PDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services pursuant to 45 CFR part 11 and 

by the General Services Administration, 

FDA is announcing the renewal of the 

Psychopharmacologic Drugs Advisory 

Committee (the Committee). The 

Committee is a discretionary Federal 

advisory committee established to 

provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the practice of psychiatry and 

related fields and makes appropriate 

recommendations to the Commissioner. 

The Committee shall consist of a core 

of nine voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

psychopharmacology, psychiatry, 

epidemiology or statistics, and related 

specialties. Members will be invited to 

serve for overlapping terms of up to 4 

years. Almost all non-Federal members 

of this committee serve as Special 

Government Employees. The core of 

voting members may include one 

technically qualified member, selected 

by the Commissioner or designee, who 

is identified with consumer interests 

and is recommended by either a 

consortium of consumer-oriented 

organizations or other interested 

persons. In addition to the voting 

members, the Committee may include 

one non-voting member who is 

identified with industry interests. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/Drugs/ 

PsychopharmacologicDrugs

AdvisoryCommittee/default.htm or by 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). In light of the fact that no 

change has been made to the committee 

name or description of duties, no 

amendment will be made to 21 CFR 

14.100. 

This document is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please check https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: July 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14934 Filed 7–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2236] 

Human Gene Therapy for Retinal 

Disorders; 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 

document entitled ‘‘Human Gene 

Therapy for Retinal Disorders; Draft 

Guidance for Industry.’’ The draft 

guidance provides recommendations to 

stakeholders developing human gene 

therapy (GT) products for retinal 

disorders affecting adult and pediatric 

patients. The draft guidance focuses on 

issues specific to GT products for retinal 

disorders and provides 

recommendations related to product 

development, preclinical testing, and 

clinical trial design for such GT 

products. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 10, 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 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2018–D–2236 for ‘‘Human Gene 

Therapy for Retinal Disorders; 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 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32303 

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 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 the office in processing your 

requests. The draft 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 draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Angela Moy, 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 document entitled ‘‘Human Gene 

Therapy for Retinal Disorders; Draft 

Guidance for Industry.’’ The draft 

guidance provides recommendations to 

stakeholders developing GT products 

for retinal disorders affecting adult and 

pediatric patients. These disorders vary 

in etiology, prevalence, diagnosis, and 

management, and include genetic as 

well as age-related diseases. These 

disorders manifest with central or 

peripheral visual impairment and often 

with progressive visual loss. The draft 

guidance focuses on issues specific to 

GT products for retinal disorders and 

provides recommendations related to 

product development, preclinical 

testing, and clinical trial design for such 

GT products. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

availability of two other human gene 

therapy draft guidance documents 

entitled ‘‘Human Gene Therapy for 

Hemophilia; Draft Guidance for 

Industry’’ and ‘‘Human Gene Therapy 

for Rare Diseases; Draft Guidance for 

Industry.’’ 

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 ‘‘Human Gene Therapy for Retinal 

Disorders.’’ 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 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 50 have been approved under OMB 

control number 0910–0755; the 

collections of information in 21 CFR 

part 58 have been approved under OMB 

control number 0910–0119; the 

collections of information in 21 CFR 

part 211 have been approved under 

OMB control number 0910–0139; the 

collections of information in 21 CFR 

part 312 have been approved under 

OMB control number 0910–0014; the 

collections of information in 21 CFR 

part 601 have been approved under 

OMB control number 0910–0338; the 

collections of information in the 

guidance entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics’’ have been approved under 

OMB control number 0910–0765; and 

the collections of information in the 

guidance entitled ‘‘Formal Meetings 

Between the FDA and Sponsors or 

Applicants’’ have been approved under 

OMB control number 0910–0429. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 

Dated: July 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14870 Filed 7–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2258] 

Human Gene Therapy for Rare 

Diseases; 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 

document entitled ‘‘Human Gene 

Therapy for Rare Diseases; Draft 

Guidance for Industry.’’ The draft 

guidance document provides 

recommendations to stakeholders 

developing a human gene therapy (GT) 

product intended to treat a rare disease 

in adult and/or pediatric patients 

regarding the manufacturing, 

preclinical, and clinical trial design 

issues for all phases of the clinical 

development program. Such 

information is intended to assist 

sponsors in designing clinical 

development programs for such 

products, where there may be limited 

study population size and potential 

feasibility and safety issues as well as 

issues relating to the interpretability of 

bioactivity/efficacy outcomes that may 

be unique to rare diseases or to the 

nature of the GT product itself. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 10, 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 


amozie on DSK3GDR082PROD with NOTICES1