Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32301 

indicate acceptability of the hearing date that 

has been scheduled and provide names of the 

individuals who will represent the State at 

the hearing. If the hearing date is not 

acceptable, Mr. Cohen can set another date 

mutually agreeable to the parties. The 

hearing will be governed by the procedures 

prescribed by federal regulations at 42 CFR 

Part 430. 

This SPA requested CMS approval to add 

coverage and reimbursement of services 

provided by Dental Health Aide Therapists 

(DHATs) under the Other Licensed 

Practitioner (OLP) benefit. Specifically, SPA 

17–0027 proposed the coverage and 

reimbursement of services provided by 

DHATs only when furnished in a practice 

setting within the boundaries of a tribal 

reservation and only when operated by an 

Indian health program, and proposed to make 

coverage of DHAT services available only to 

members of a federally recognized tribe or 

those otherwise eligible for services under 

Indian Health Service criteria. Washington 

would, therefore, not permit Medicaid 

beneficiaries to receive Medicaid coverage for 

DHAT services if they are not members of a 

federally recognized tribe or otherwise 

eligible for services under Indian Health 

Service criteria. 

The issues to be considered at the hearing 

are whether Washington SPA 17–0027 is 

inconsistent with the requirements of: 

• Section 1902(a)(23) of the Social Security 

Act (the Act) because it would restrict access 

to services provided by a DHAT to a limited 

group of beneficiaries, and it would also 

prevent beneficiaries from receiving DHAT 

services from similarly qualified dental 

services providers that provide services 

outside the boundaries of a tribal reservation 

or that are not Indian health programs. 

• Section 1902(a)(10)(A) of the Act because 

it was unclear whether DHATs must be 

supervised by a licensed professional 

consistent with the requirements of the OLP 

benefit, and because CMS was therefore 

unable to determine whether DHAT services 

are ‘‘medical assistance’’ consistent with 

1902(a)(10)(A) and 1905 of the Act. 

In the event that CMS and the State come 

to agreement on resolution of the issues 

which formed the basis for disapproval, this 

SPA may be moved to approval prior to the 

scheduled hearing. 

Sincerely, 

Seema Verma 

Administrator 

Section 1116 of the Social Security Act (42 

U.S.C. section 1316; 42 CFR section 430.18) 

(Catalog of Federal Domestic Assistance 

program No. 13.714. Medicaid Assistance 

Program.) 

Dated: July 6, 2018. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2018–14876 Filed 7–6–18; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2642] 

Advisory Committee; Science Advisory 

Board to the National Center for 

Toxicological Research; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Science Advisory Board 

(the Board) to the National Center for 

Toxicological Research (NCTR) by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Board to the NCTR 

for an additional 2 years beyond the 

charter expiration date. The new charter 

will be in effect until June 2, 2020. 

DATES: Authority for the Board to the 

NCTR expired on June 2, 2018; 

however, the Commissioner formally 

determined that renewal is in the public 

interest. 

FOR FURTHER INFORMATION CONTACT: 

Donna L. Mendrick, National Center for 

Toxicological Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 2208, Silver Spring, 

MD 20993–0002, 301–796–8892, 

donna.mendrick@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 

Board to the NCTR. The Board is a 

discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Board to the 

NCTR 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 

Board advises the NCTR Director in 

establishing, implementing, and 

evaluating the research programs that 

assist the Commissioner in fulfilling 

regulatory responsibilities. The Board 

provides an extra-agency review in 

ensuring that the research programs at 

NCTR are scientifically sound and 

pertinent. 

The Board 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 

toxicological research. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Almost all non-Federal 

members of this Board 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. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/AdvisoryCommittees/ 

CommitteesMeetingMaterials/ 

ToxicologicalResearch/ucm148166.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. 2018–14943 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–N–2565] 

Advisory Committee; 

Psychopharmacologic Drugs Advisory 

Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of advisory 

committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Psychopharmacologic 

Drugs Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the 

Psychopharmacologic Drugs Advisory 

Committee for an additional 2 years 

beyond the charter expiration date. The 

new charter will be in effect until June 

4, 2020. 


amozie on DSK3GDR082PROD with NOTICES1
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