96658 Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 

of any drug or controlled substance and 

is subject to debarment, as set forth in 

section 306(b)(3)(C) of the FD&C Act. 

FDA has considered the applicable 

factors listed in section 306(c)(3) of the 

FD&C Act and determined that a 

debarment period of 5 years is 

appropriate. 

As a result of the foregoing findings, 

Jiao is debarred for 5 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under sections 

505, 512, or 802 of the FD&C Act (21 

U.S.C. 355, 360b, or 382), or under 

section 351 of the Public Health Service 

Act (42 U.S.C. 262), effective December 

5, 2024 (see 21 U.S.C. 335a(c)(1)(B) and 

(c)(2)(A)(iii) and 21 U.S.C. 321(dd)). 

Any person with an approved or 

pending drug product application, who 

knowingly uses the services of Jiao, in 

any capacity during his period of 

debarment, will be subject to civil 

money penalties (section 307(a)(6) of the 

FD&C Act (21 U.S.C. 335b(a)(6))). If Jiao, 

during his period of debarment, 

provides services in any capacity to a 

person with an approved or pending 

drug product application, he will be 

subject to civil money penalties (section 

307(a)(7) of the FD&C Act). In addition, 

FDA will not accept or review any 

abbreviated new drug applications 

submitted by or with the assistance of 

Jiao during his period of debarment 

(section 306(c)(1)(B) of the FD&C Act). 

Dated: November 27, 2024. 

George M. Warren, 

Director, Office of Scientific Integrity. 

[FR Doc. 2024–28452 Filed 12–4–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

In compliance with section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995 concerning 

opportunity for public comment on 

proposed collections of information, 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

will publish periodic summaries of 

proposed projects. To request more 

information on the proposed projects or 

to obtain a copy of the information 

collection plans, call the SAMHSA 

Reports Clearance Officer at (240) 276– 

0361. Comments are invited on: (a) 

whether the proposed collections of 

information are necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) ways to enhance the 

quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including leveraging 

automated data collection techniques or 

other forms of information technology. 

Proposed Project: Revision to the 

Community Mental Health Services 

Block Grant and Substance Use 

Prevention, Treatment, and Recovery 

Services Block Grant FY 2026–2027 

Application Plan and Report Guide 

(OMB No. 0930–0168) 

SAMHSA is requesting approval from 

the Office of Management and Budget 

(OMB) to revise the 2026–2027 

Community Mental Health Services 

Block Grant (MHBG) and Substance Use 

Prevention, Treatment, and Recovery 

Services (SUPTRS) Block Grant 

Application Plan and Report Guide. 

Currently, the SUPTRS BG and the 

MHBG differ on a number of their 

practices (e.g., data collection at 

individual or aggregate levels) and 

statutory authorities (e.g., method of 

calculating MOE, stakeholder input 

requirements for planning, set asides for 

specific populations or programs, etc.). 

Historically, the Centers within 

SAMHSA that administer these block 

grants have had different approaches to 

application requirements and reporting. 

To compound this variation, states have 

different structures for accepting, 

planning, and accounting for the block 

grants and the prevention set aside 

within the SUPTRS BG. As a result, how 

these dollars are spent and what is 

known about the services and clients 

that receive these funds varies by block 

grant and by State. 

SAMHSA has conveyed that block 

grant funds must be directed toward 

four purposes: (1) to fund priority 

treatment and support services for 

individuals without insurance or who 

cycle in and out of health insurance 

coverage; (2) to fund those priority 

treatment and support services not 

covered by Medicaid, Medicare, or 

private insurance offered through the 

exchanges and that demonstrate success 

in improving outcomes and/or 

supporting recovery; (3) to fund 

universal, selective and indicated 

prevention activities and services that 

align with SAMHSA’s six prevention 

strategies; and (4) to collect performance 

and outcome data to determine the 

ongoing effectiveness of behavioral 

health prevention, treatment and 

recovery support services and to plan 

the implementation of new services on 

a nationwide basis. 

States will need help to meet future 

challenges associated with, the 

implementation and management of an 

integrated physical health, mental 

health, and substance use disorder 

service system. SAMHSA has 

established standards and expectations 

that will lead to an improved system of 

care for individuals with or at risk of 

mental and substance use disorders. 

Therefore, this application package 

continues to fully exercise SAMHSA’s 

existing authority regarding states, U.S. 

territories, freely associated states, and 

the Red Lake Band of Chippewa 

Indians’ (subsequently referred to as 

‘‘states’’) use of block grant funds as 

they fully integrate behavioral health 

services into the broader health care 

continuum. 

Consistent with previous 

applications, the FY 2026–2027 

application has required sections and 

other sections where additional 

information is requested. The FY 2026– 

2027 application requires states to 

submit a face sheet, a table of contents, 

a behavioral health assessment and 

plan, reports of expenditures and 

persons served, an executive summary, 

and funding agreements and 

certifications. In addition, SAMHSA is 

requesting information on key areas that 

are critical to the states’ success in 

addressing health care equity. 

Therefore, as part of this block grant 

planning process, states should identify 

promising or effective strategies as well 

as technical assistance needed to 

implement the strategies identified in 

their plans for FYs 2026 and 2027. 

SAMHSA has made changes to the 

Block Grant Plan and Report 

requirements for FFY 2026 and 2027. 

These changes are necessary to ensure 

that funds are spent in an appropriate 

and timely manner. Adjustments were 

made to pre-existing tables in the plan 

and report. 

On the BG narrative portion of the 

Block Grant Plan document changes 

include editorial changes and minor 

language clarifications throughout the 

document. Examples include changing 

‘‘call centers’’ to ‘‘contact centers’’ and 

‘‘paraprofessionals’’ to ‘‘peer support 

specialists and recovery coaches, 

prevention specialists’’ as appropriate 

throughout the document. In addition, 

updated guidance on best practices and 

conditions under which states may use 

BG funds for improvements to their 

health information technology (IT) and 

systems have been made. On the MHBG 


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Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 96659 

application, one new planning table has 

been added (Table 4a) to collect planned 

MHBG budget for direct services, other 

capacity building/systems development, 

and administrative costs. In addition, a 

new data section has been added to the 

Environmental Factors and Plan section. 

Both MHBG and SUPTRS BG reports 

adopted HHS recommended Sexual 

Orientation and Gender Identity (SOGI) 

measures for reporting. Key 

modifications included the addition of 

‘‘Two-Spirit’’ for both sexual orientation 

and gender identity for individuals who 

identify as American Indian or Alaska 

Native, and an update of terms used. 

Changes to these measures were applied 

to MHBG Tables: 8A–8D, 9, 10A–10B, 

13A–13B, 14, 15A–15B, 18, 19A–9B, 21, 

22 23A–23B, and 24; and SUPTRS BG 

Tables: 10B, 11A, 11B, 11C. 

On the MHBG report there are 

changes with the addition of one new 

table to the state agency expenditures 

section (Table 4b on the MHBG). With 

the addition of this new table, the 

original MHBG table 4 has been 

relabeled 4a. In addition, an appendix 

with a list of definitions have been 

added to the aid states in reporting data. 

The additional tables should not require 

excessive effort as all data will already 

be collected by the states on how MHBG 

funds are spent on direct and system 

development. Minor revisions were 

made for clarification to other sections. 

Proposed revisions for substance use 

disorder treatment services in the FY 

26–27 SUPTRS BG Plan and Report 

include revisions related to removal of 

stigmatizing language, with the deletion 

of the term ‘abuse’, and replacement 

with the term ‘use’, per the 

Consolidated Appropriations Act, 2023. 

The Plan and Report also include the 

universal adoption of ‘Recovery Support 

Services’ as a stand-alone category for 

SUPTRS BG Plan and Report tables. 

These changes affect Plan Tables 1, 2b, 

4b, and 6b, and Report Tables 1, 2, 4, 

6, 7. 

Editorial and minor stylistic changes 

have been made to tables and language. 

Footnotes have been revised that define 

the COVID–19 and ARP Supplemental 

Funding expenditure periods, including 

the addition of explicit instructions on 

the second No Cost Extension (NCE) for 

the COVID–19 funding, and the 

expiration date for the ARP funding. 

Finally, the SUPTRS BG Report Table 

11c has been revised to reflect the 

Number of Persons Admitted to 

Treatment by Sexual Orientation and 

Race/Ethnicity, in a reporting format 

that is compatible with the format and 

content of the comparable CMHS table 

for the MHBG. 

Similarly, modifications to SUPTRS 

BG reports were made to allow for the 

accurate capture of information for the 

FY 2026/2027 reporting period and 

SUPTRS BG priorities. 

Proposed revisions for prevention 

services in the FY 26–27 SUPTRS BG 

Plan include those revisions that are 

related to a more intentional use of 

language, with strengthened statements 

with the addition of statistics, and 

added language to reinforce the 

interrelatedness between mental health 

and substance use. There is also 

reinforcement of SUPTRS BG primary 

prevention set-aside funds to support 

universal, selective, and/or indicated 

substance use prevention strategies. 

Updated tables ensure consistency in 

Tables 5a–5c for both Plans and Reports, 

and updated language for substances in 

Table 5c. Table 5b (Primary Prevention 

Expenditures by IOM Categories) was 

added to align with Table 5b (Primary 

Prevention Planned Expenditures by 

IOM Categories) in the application. 

The term ‘abstinence’ has been 

removed from the Prevention National 

Outcome Measures (NOMs) to better 

reflect current terminology. Report 

Tables 31 and 32 have been combined 

into a new Report Table 31, which 

reduces burden for grantees and 

removes redundant, obsolete reporting 

requirements. Gender categories in 

Table 31 have been updated to align 

with CSAT gender categories. 

While the statutory deadlines and 

block grant award periods remain 

unchanged, SAMHSA encourages states 

to turn in their application as early as 

possible to allow for a full discussion 

and review by SAMHSA. Applications 

for the MHBG-only are due no later than 

September 2, 2025. The application for 

SUPTRS BG-only is due no later than 

October 1, 2025. A single application for 

MHBG and SUPTRS BG combined is 

due no later than September 2, 2025. 

Estimates of Annualized Hour Burden 

The estimated annualized burden for 

the uniform application will remain 

33,493 hours, since most revisions have 

been made for clarification and the 

combining of tables will not change the 

burden. Burden estimates are broken out 

in the following tables showing burden 

separately for Year 1 and Year 2. Year 

1 includes the estimates of burden for 

the uniform application and annual 

reporting. Year 2 includes the estimates 

of burden for the recordkeeping and 

annual reporting. The reporting burden 

remains constant for both years. 

TABLE 1—ESTIMATES OF APPLICATION AND REPORTING BURDEN FOR YEAR 1 

Substance Use Prevention, Treatment, and Recovery Services (SUPTRS BG) and Community Mental Health Services (MHBG) Block Grants

Authorizing statute 

SUPTRS BG 

Authorizing statute 

MHBG Implementing regulation Number of respondent 

Number of 

responses 

per year 

Number of 

hours per 

response 

Total 

hours 

Reporting .................. Standard Form and Content ............................................. ............................................. .................... .................. .................. ............

42 U.S.C. 300x–32(a) ......... ............................................. ............................................. .................... .................. .................. ............

SUPTRS BG ............ Annual Report ..................... ............................................. ............................................. .................... .................. .................. 11,190 

42 U.S.C. 300x–52(a) ......... ............................................. 45 CFR 96.122(f) ................ 60 1 .................. ............

42 U.S.C. 300x–30–b ......... ............................................. ............................................. 5 1 .................. ............

42 U.S.C. 300x–30(d)(2) ..... ............................................. 45 CFR 96.134(d) ............... 60 1 .................. ............

MHBG ....................... Annual Report ..................... ............................................. ............................................. .................... .................. .................. 11,003 

42 U.S.C. 300x–6(a) ........... ............................................. 59 1 .................. ............

42 U.S.C. 300x–52(a) ......... ............................................. .................... .................. .................. ............

42 U.S.C. 300x–4(b)(3)B .... ............................................. 59 1 .................. ............

State Plan (Covers 2 years) ............................................. ............................................. .................... .................. .................. ............

SUPTRS BG elements.42 U.S.C. 300x–22(b) ......... ............................................. 45 CFR 96.124(c)()1) .......... 60 1 .................. ............

42 U.S.C. 300x–23 ............. ............................................. 45 CFR 96.126(f) ................ 60 1 .................. ............

42 U.S.C. 300x–27 ............. ............................................. 45 CFR 96.131(f) ................ 60 1 .................. ............

42 U.S.C. 300x–32(b) ......... ............................................. 45 CFR 96.122(g) ............... 60 1 120 7,230 

MHBG elements ....... ............................................. 42 U.S.C. 300x–1(b) ........... ............................................. 59 1 120 7,109 

42 U.S.C. 300x–1(b)(2) ....... ............................................. 59 1 .................. ............

42 U.S.C. 300x–2(a) ........... ............................................. 59 1 .................. ............

Waivers ............................... ............................................. ............................................. .................... .................. .................. 3,240 

42 U.S.C. 300x–24(b)(5)(B) ............................................. ............................................. 20 1 .................. ............


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96660 Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 

TABLE 1—ESTIMATES OF APPLICATION AND REPORTING BURDEN FOR YEAR 1—Continued 

Substance Use Prevention, Treatment, and Recovery Services (SUPTRS BG) and Community Mental Health Services (MHBG) Block Grants

Authorizing statute 

SUPTRS BG 

Authorizing statute 

MHBG Implementing regulation Number of respondent 

Number of 

responses 

per year 

Number of 

hours per 

response 

Total 

hours 

42 U.S.C. 300x–28(d) ......... ............................................. 45 CFR 96.132(d) ............... 5 1 .................. ............

42 U.S.C. 300x–30(c) ......... ............................................. 45 CFR 96.134(b) ............... 10 1 .................. ............

42 U.S.C. 300x–31(c) ......... ............................................. ............................................. 1 1 .................. ............

42 U.S.C. 300x–32(c) ......... ............................................. ............................................. 7 1 .................. ............

42 U.S.C. 300x–32(e) ......... ............................................. ............................................. 10 .................. .................. ............

42 U.S.C. 300x–2(a)(2) ....... ............................................. 10 .................. .................. ............

42 U.S.C 300x–4(b)(3) ........ ............................................. 10 .................. .................. ............

42 U.S.C 300x–6(b) ............ ............................................. 7 .................. .................. ............

Recordkeeping ......... 42 U.S.C. 300x–23 ............. 42 U.S.C. 300x–3 ............... 45 CFR 96.126(c) ............... 60/59 1 20 1,200 

42 U.S.C. 300x–25 ............. ............................................. 45 CFR 96.129(a)(13) ......... 10 1 20 200 

42 U.S.C 300x–65 .............. ............................................. 42 CFR part 54 ................... 60 1 20 1,200 

Combined Burden.............................................. ............................................. ............................................. .................... .................. .................. 42,373 

Report. 

300x–52(a)—Requirement of Reports and Audits by States—Report. 

300x–30(b)—Maintenance of Effort (MOE) Regarding State Expenditures—Exclusion of Certain Funds (SUPTRS BG). 

300x–30(d)(2)—MOE—Noncompliance—Submission of Information to Secretary (SUPTRS BG). 

State Plan—SUPTRS BG. 

300x–22(b)—Allocations for Women. 

300x–23—Intravenous Substance Abuse. 

300x–27—Priority in Admissions to Treatment. 

300x–29—Statewide Assessment of Need. 

300x–32(b)—State Plan. 

State Plan—MHBG. 

42 U.S.C. 300x–1(b)—Criteria for Plan. 

42 U.S.C. 300x–1(b)(2)—State Plan for Comprehensive Community Mental Health Services for Certain Individuals—Criteria for Plan—Mental Health System Data 

and Epidemiology. 

42 U.S.C. 300x–2(a)—Certain Agreements—Allocations for Systems Integrated Services for Children. 

Waivers—SUPTRS BG. 

300x–24(b)(5)(B)—Human Immunodeficiency Virus—Requirement Regarding Rural Areas. 

300x–28(d)—Additional Agreements. 

300x–30(c)—MOE. 

300x–31(c)—Restrictions on Expenditure of Grant—Waiver Regarding Construction of Facilities. 

300x–32(c)—Certain Territories. 

300x–32(e)—Waiver Amendment for 1922, 1923, 1924 and 1927. 

Waivers—MHBG. 

300x–2(a)(2)—Allocations for Systems Integrated Services for Children. 

300x–6(b)—Waiver for Certain Territories. 

Recordkeeping. 

300x–23—Waiting list. 

300x–25—Group Homes for Persons in Recovery From Substance Use Disorders. 

300x–65—Charitable Choice. 

TABLE 2—ESTIMATES OF APPLICATION AND REPORTING BURDEN FOR YEAR 2 

Number of 

respondent 

Number of 

responses 

per year 

Number of 

hours per 

response 

Total hours 

Reporting: 

SUPTRS BG ............................................................................................. 60 1 187 11,220 

MHBG ....................................................................................................... 59 1 187 11,033 

Recordkeeping ................................................................................................. 60/59 1 40 2,360 

Combined Burden ............................................................................. ........................ ........................ ........................ 24,613 

The total annualized burden for the 

application and reporting is 33,493 

hours (42,373 + 24,613 = 66,986/2 years 

= 33,493). 

Link for the application: http://

www.samhsa.gov/grants/block-grants. 

Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

Krishna Palipudi, 

Social Science Analyst. 

[FR Doc. 2024–28440 Filed 12–4–24; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HOMELAND 

SECURITY 

Transportation Security Administration 

Intent To Request Extension From 

OMB of One Current Public Collection 

of Information: Generic Clearance for 

the Collection of Qualitative Feedback 

on Agency Service Delivery 

AGENCY: Transportation Security 

Administration, DHS. 

ACTION: 60-Day notice. 

SUMMARY: The Transportation Security 

Administration (TSA) invites public 


khammond on DSK9W7S144PROD with NOTICES