66456 Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices 

[FR Doc. 2023–21045 Filed 9–26–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Community Living 

Announcing the Intent To Award a 

Single-Source Supplement the Link 

Center: Bridging Intellectual and/or 

Developmental Disabilities (I/DD) and 

Mental Health Systems 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 National 

Association for State Directors of 

Developmental Disabilities Services 

(NASDDDS) for the Link Center: 

Bridging I/DD and Mental Health 

Systems cooperative agreement. The 

purpose of this project is to improve the 

quality of life for people with 

intellectual and/or developmental 

disabilities (I/DD) and mental health 

conditions by supporting state agencies 

with policy development, service 

design, and service coordination 

resources, and sharing resources to 

individuals, families, direct support 

professionals, clinicians, and other 

policymakers. The administrative 

supplement for FY 2023 will amount to 

$540,000, bringing the total award for 

FY 2023 to $1,214,978. 

FOR FURTHER INFORMATION CONTACT: For 

further information or comments 

regarding this program supplement, 

contact Allison Cruz, U.S. Department 

of Health and Human Services, 

Administration for Community Living, 

Administration on Disabilities, (202) 

795–7334 or via email allison.cruz@

acl.hhs.gov. 

SUPPLEMENTARY INFORMATION: This 

supplementary funding from the 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will expand The Link Center: Bridging 

I/DD and Mental Health Systems by 

coordinating, planning, and 

implementing activities to support 988 

call centers to support people with I/DD 

and mental health conditions. A key 

activity will be the 988 Policy Academy. 

As a result of this funding, ACL and 

SAMHSA expect that: 

• Up to 6 States will improve their 

systems to more effectively address the 

needs of individuals with I/DD and 

mental health conditions. 

• Targeted State teams will have 

engaged in six (6) virtual learning 

engagements and participated in a twoday session to finalize actions steps. 

These States will receive follow-along 

supports towards implementations and 

sustainability activities to more 

effectively address the needs of 

individuals with I/DD and mental 

health conditions. 

This supplement will fund the 

following. 

Academy Structure 

Membership 

The policy academy will be open to 

5–6 states. Each state will bring a team 

of partners, including: 

• SAMHSA 988 Office and CMHS 

leadership and/or key staff, including 

the representatives from the Lifeline 

network administrator 

• State mental health authority 

leadership and core staff involved in 

988 and Crisis Response 

• State I/DD authority leadership and 

core staff involved in supporting 

individuals with complex support 

needs 

• State Medicaid leader(s) with 

knowledge and oversight of MH and/ 

or LTSS 

• State Head Injury Administrators/core 

staff or partner organizations 

• People with lived experience 

• One or more State DD Act Partner 

organizations (DD Councils, UCEDDs, 

Protection and Advocacy 

Organizations) 

• Leadership from the National 

Association of County Behavioral 

Health & Developmental Disability 

Directors 

Optional: 

• Child welfare officials, especially 

those supporting children with 

complex support needs 

• Law enforcement 

• Other partners as determined by the 

state 

Each team should be led by 2–3 

individuals from State Mental Health, 

988/Lifeline and I/DD Agencies. Each 

state team may consist of 8–10 

individuals. Team composition should 

reflect a lens toward ensuring that the 

state-level solutions will be informed by 

diversity, equity, and inclusion. States 

may include team members that are key 

to building a responsive network of 

information sharing, potential warm 

hand-offs, and available supports. 

Approach 

Exploratory survey/Environmental 

scan: 

• Prior to selection of state participants, 

collect information related to general 

areas of need that will inform and 

give an aggregate scope of focus for 

succeeding academy activities 

State Tailored Interventions: 

• State specific planning meetings with 

state leads 

• Convene state-level (virtual) town hall 

discussions to provide landscape 

information on areas of need 

• Develop target areas for state team 

Virtual Learning Opportunities: 

• Based on state target areas, develop 

series of six (6) virtual learning 

engagements for cross-state 

participation (identifying peers for 

both elevation of good practice and 

group solution identification) 

In Person Academy: 

• Convene a two-day symposium in the 

Washington DC area focused on 

cultivating sustainable networks and 

ongoing information sharing (Strongly 

encourage in-person participation, 

accommodate virtual if needed). Will 

include group learning and statespecific breakout sessions to optimize 

learning, sharing and action plan 

development. 

Æ Will include pre-planning with each 

state (two meetings) 

Æ Will include post-meeting follow up 

activities, including plan for 

implementation and sustainability 

Post Meeting Activities and FollowAlong Technical Assistance: 

• TA Collaborative will meet with 

state teams to finalize action steps 

developed from in person meeting; 

• TA Collaborative will meet monthly 

with state teams to provide follow-along 

support toward implementation and 

sustainability activities. 

• A post convening synthesis will be 

developed as a resource for partners 

engaged in this work. 

Program Name: The Link Center: 

Bridging I/DD and Mental Health 

Systems. 

Recipient: The National Association 

of State Directors of Developmental 

Disabilities Services. 

Period of Performance: The 

supplement award will be issued for the 

second year of the five-year project 

period of September 30, 2023, through 

August 31, 2024. 

Total Supplement Award Amount: 

$540,000. 

Award Type: Cooperative Agreement. 

Statutory Authority: This program is 

authorized under the Developmental 

Disabilities Assistance and Bill of Rights 

Act of 2000 Public Law 106–402, 

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

Basis for Award: The National 

Association of State Directors of 

Developmental Disabilities Services is 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 186 / Wednesday, September 27, 2023 / Notices 66457 

currently funded to carry out The Link 

Center Project for the period of 

September 1, 2022, through August 31, 

2027. Much work has already been 

completed and further tasks are 

currently being accomplished. It would 

be unnecessarily time consuming and 

disruptive to the Link Center project 

and the beneficiaries being served for 

ACL to establish a new grantee at this 

time when critical services are presently 

being provided in an efficient manner. 

SAMHSA also has determined that the 

award of another contract or grant to 

provide these services would duplicate 

the activities carried out under this 

cooperative agreement. SAMHSA has 

further determined that a grant 

supplement to support the 988 State 

Policy Academy through this 

cooperative agreement is likely to be 

less expensive than a separate 

arrangement. This agreement promotes 

government efficiency and reduces the 

possibility of costly duplication of 

effort. 

Dated: September 21, 2023. 

Alison Barkoff, 

Senior Official Performing the Duties of the 

Administrator and the Assistant Secretary for 

Aging. 

[FR Doc. 2023–21046 Filed 9–26–23; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–2343] 

Hazard Analysis and Risk-Based 

Preventive Controls for Human Food; 

Draft Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the availability of 

two additional draft chapters of a 

multichapter draft guidance for industry 

entitled ‘‘Hazard Analysis and RiskBased Preventive Controls for Human 

Food.’’ This multichapter draft 

guidance, when finalized, will explain 

FDA’s current thinking on how to 

comply with the requirements for 

hazard analysis and risk-based 

preventive controls under FDA’s 

regulation entitled ‘‘Current Good 

Manufacturing Practice, Hazard 

Analysis, and Risk-Based Preventive 

Controls for Human Food.’’ The newly 

available draft chapters are entitled 

‘‘Chapter 11—Food Allergen Program’’ 

and ‘‘Chapter 16—Acidified Foods.’’ 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by March 25, 2024 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– 

2016–D–2343 for ‘‘Hazard Analysis and 

Risk-Based Preventive Controls for 

Human Food.’’ 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 Office 

of Food Safety (HFS–300), Center for 

Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed adhesive labels 

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: 

Linda Kahl, Center for Food Safety and 

Applied Nutrition (HFS–300), Food and 

Drug Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2784. 


ddrumheller on DSK120RN23PROD with NOTICES1