Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 62089 

for the Treatment of Alzheimer’s 

Disease; Use: CMS Office of Minority 

Health (OMH) is going to announce a 

call for nominations for the 2024 CMS 

Health Equity Award. This award will 

recognize organizations who 

demonstrate they have advanced health 

equity by designing, implementing, and 

operationalizing policies and programs 

that support health for all the people 

served by our programs, reducing 

avoidable differences in health 

outcomes experienced by people who 

are underserved, and provided the care 

and support that CMS enrollees need to 

thrive. 

The goals of the award are to 

encourage organizations to identify and 

address their health disparities, to 

disseminate best practices, and to show 

that progress is possible by having a 

results-oriented focus. By identifying 

organizations who are successfully 

closing gaps and reducing disparities, 

CMS can show our stakeholders how 

health equity work can be initiated, 

targeted, measured, and successfully 

reduce disparities among communities 

nationwide. 

CMS Representatives collect 

Company Name, Point of Contact 

Information (email, phone# & name) 

along with information from the 

organizations regarding their programs 

to improve the health quality, outcomes, 

and access to care for the communities 

that they serve. The CMS selection 

committee uses a scoring rubric to score 

the applicants on demonstrated 

measurable results in reducing a 

disparity in one or more of the CMS 

priority populations. Form Number: 

CMS–10866 (OMB control number: 

0938–NEW); Frequency: Annually; 

Affected Public: Federal Government, 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 50; Number of Responses: 

50; Total Annual Hours: 100. (For 

policy questions regarding this 

collection, contact Ashley PeddicordAustin at 410–786–0757.) 

Dated: September 1, 2023. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2023–19359 Filed 9–7–23; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Announcing the Intent To Award a 

Single-Source Supplement for the 

Alternatives to Guardianship Youth 

Resource Center Cooperative 

Agreement 

ACTION: Notice. 

SUMMARY: The Administration for 

Community Living (ACL) announces the 

intent to award a single-source 

supplement to the current cooperative 

agreement held by the University of 

Massachusetts for the Alternatives to 

Guardianship Youth Resource Center 

cooperative agreement. The purpose of 

this project is to divert high school 

students with intellectual and 

developmental disabilities (I/DD) away 

from guardianship to less restrictive 

decisional supports. The target audience 

for this information includes youth with 

I/DD, families, and caregivers of high 

school students with I/DD, teachers, 

education administrators, advocates, 

vocational rehabilitation counselors, 

guidance counselors, and school district 

officials. The administrative supplement 

for FY 2023 will amount to $200,000, 

bringing the total award for FY 2023 to 

$500,000. 

FOR FURTHER INFORMATION CONTACT: For 

further information or comments 

regarding this program supplement, 

contact Dana Fink, U.S. Department of 

Health and Human Services, 

Administration for Community Living, 

Administration on Disabilities, (202) 

795–7604 or via email dana.fink@

acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: This 

supplementary funding will expand the 

Alternatives to Guardianship Youth 

Resource Center’s engagement and 

education efforts around diverting high 

school students with I/DD away from 

guardianship to less restrictive 

decisional supports. As a result of 

funding this Center, ACL expects that: 

• More students with I/DD will have 

more decisional options, such as Powers 

of Attorney, supported-decision-making, 

joint bank accounts, bill paying services, 

and medical or educational release 

forms, on completion of high school; 

• Fewer young adults with I/DD will 

be subject to guardianship; 

• The public will become more 

knowledgeable of alternatives to 

guardianship; and 

• Youth will become more 

independent by gaining job experience 

and personal responsibilities. 

This supplement will fund: 

• Support to enhance the engagement 

of youth advisory board members, 

including (1) a dedicated staff member 

for facilitation and administrative 

coordination and support and; (2) paid 

opportunities for youth advisory board 

members to be more deeply engaged in 

project activities. 

• Continued support for two 

additional staff members from grant 

partner Self-Advocates Becoming 

Empowered who have joined the youth 

ambassador training team. 

• Additional training for project staff 

and partners on allyship and 

augmentative and alternative 

communication (AAC) to support a state 

team of AAC users. 

• Support for travel for youth 

ambassadors and youth advisors to 

participate in conference presentations. 

• Supervisory support for the new 

youth trainer position that will begin 

August 2023. This youth trainer will 

join the Youth Ambassador workgroup 

and be part of the training team that 

facilitates the third cohort of youth 

ambassadors from Texas, California, and 

New York. 

• Continued enhancement to the 

project website, which includes a 

dedicated page for each of the 40+ youth 

ambassadors, youth-friendly products 

and videos, and plain language 

documents. 

The administrative supplement for FY 

2023 will amount to $200,000, bringing 

the total award for FY 2023 to $500,000. 

Program Name: Center for Youth 

Voice Youth Choice (CYVYC) 

Alternatives to Guardianship Youth 

Resource Center. 

Recipient: University of 

Massachusetts, Boston. 

Period of Performance: The 

supplement award will be issued for the 

fourth year of the five-year project 

period of September 1, 2023, through 

August 31, 2024. 

Total Supplement Award Amount: 

$200,000. 

Award Type: Cooperative Agreement. 

Statutory Authority: This program is 

authorized under the Developmental 

Disabilities Assistance and Bill of Rights 

Act of 2000 Pub. L. 106–402, Section 

161(2) (B), (C) and (D). 

Basis for Award: 

The University of Massachusetts is 

currently funded to carry out the 

CYVYC Project for the period of 

September 1, 2020 through August 31, 

2025. Much work has already been 

completed and further tasks are 

currently being accomplished. It would 

be unnecessarily time consuming and 

disruptive to the CYVYC project and the 

beneficiaries being served for ACL to 

establish a new grantee at this time 


lotter on DSK11XQN23PROD with NOTICES1
62090 Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 

when critical services are presently 

being provided in an efficient manner. 

Dated: September 4, 2023. 

Alison Barkoff, 

Senior official performing the duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2023–19391 Filed 9–7–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3518] 

Endogenous Cushing’s Syndrome: 

Developing Drugs for Treatment; 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 

‘‘Endogenous Cushing’s Syndrome: 

Developing Drugs for Treatment.’’ The 

purpose of this guidance is to provide 

recommendations to sponsors regarding 

clinical trial designs for drugs intended 

for the treatment of adults with 

endogenous Cushing’s syndrome for 

whom surgery is not an option or has 

not been curative. This draft guidance is 

intended to focus continued discussions 

among FDA’s Division of General 

Endocrinology, pharmaceutical 

sponsors, the academic community, and 

the public. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 7, 2023 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– 

2023–D–3518 for ‘‘Endogenous 

Cushing’s Syndrome: Developing Drugs 

for Treatment.’’ 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, 240–402–7500. 

• 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.govinfo.gov/content/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, 240–402–7500. 

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. 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: 

Naomi Lowy, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, 301–796–0692. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Endogenous Cushing’s Syndrome: 

Developing Drugs for Treatment.’’ The 

purpose of this guidance is to provide 

recommendations to sponsors regarding 

clinical trial designs for drugs intended 

for the treatment of adults with 

endogenous Cushing’s syndrome for 

whom surgery is not an option or has 

not been curative. This draft guidance is 

intended to focus continued discussions 

among FDA’s Division of General 

Endocrinology, pharmaceutical 

sponsors, the academic community, and 

the public. This is the first guidance 

drafted by FDA on this topic. 

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 ‘‘Endogenous Cushing’s Syndrome: 


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