Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 96655 

TABLE 1—DRUG PRODUCTS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS—Continued 

Application No. Drug name Active ingredient(s) Dosage form/route Strength(s) Applicant 

NDA 020837 ............ XOPENEX ........................ Levalbuterol Hydrochloride.Solution; Inhalation .......... EQ 0.0103% Base; EQ 

0.021% Base; EQ 

0.042% Base; EQ 

0.25% Base.

Hikma. 

NDA 020857 ............ COMBIVIR ....................... Lamivudine; Zidovudine ... Tablet; Oral ...................... 150 mg; 300 mg ............... Viiv Health Care. 

NDA 020977 ............ ZIAGEN ............................ Abacavir Sulfate ............... Tablet; Oral ...................... EQ 300 mg Base ............. Viiv Health Care. 

NDA 021205 ............ TRIZIVIR .......................... Abacavir Sulfate, 

Lamivudine, Zidovudine.

Tablet; Oral ...................... EQ 300 mg Base, 150 

mg, 300 mg.

Viiv Health Care. 

NDA 021223 ............ ZOMETA .......................... Zoledronic Acid ................ Injectable; Intravenous ..... EQ 4 mg Base/100 mL; 

EQ 4 mg Base/5 mL.

Novartis. 

NDA 021548 ............ LEXIVA ............................. Fosamprenavir Calcium ... Tablet; Oral ...................... EQ 700 mg Base ............. Viiv Health Care. 

NDA 021695 ............ ANTARA (MICRONIZED) Fenofibrate ....................... Capsule; Oral ................... 90 mg ............................... Lupin. 

NDA 021738 ............ EXTINA ............................ Ketoconazole ................... Aerosol, Foam; Topical .... 2% .................................... Mylan. 

NDA 021861 ............ PATANASE ...................... Olopatadine Hydrochloride Spray, Metered; Nasal ..... 0.665 mg/Spray ................ Novartis. 

NDA 022128 ............ SELZENTRY .................... Maraviroc ......................... Tablet; Oral ...................... 25 mg; 75 mg ................... Viiv Health Care. 

NDA 022350 ............ ONGLYZA ........................ Saxagliptin Hydrochloride Tablet; Oral ...................... EQ 2.5 mg Base; EQ 5 

mg Base.

AstraZeneca AB. 

NDA 050440 ............ KEFLET ............................ Cephalexin ....................... Tablet; Oral ...................... EQ 250 mg Base; EQ 500 

mg Base.

Eli Lilly and Company. 

NDA 050558 ............ ZINACEF .......................... Cefuroxime Sodium ......... Injectable; Intramuscular, 

Intravenous.

EQ 750 mg Base/Vial; EQ 

1.5 g Base/Vial; EQ 7.5 

g Base/Vial.

PAI Pharma. 

NDA 050567 ............ POLYTRIM ....................... Polymyxin B Sulfate, 

Trimethoprim Sulfate.

Solution/Drops; Ophthalmic.10,000 Units/mL, EQ 1 

mg Base/mL.

Allergan. 

NDA 050588 ............ CEFOTAN ........................ Cefotetan Disodium ......... Injectable; Injection .......... EQ 10 g Base/Vial ........... PAI Pharma. 

NDA 050795 ............ DORYX ............................ Doxycycline Hyclate ......... Tablet, Delayed Release; 

Oral.

EQ 75 mg Base; EQ 150 

mg Base.

Mayne Pharma. 

NDA 200678 ............ KOMBIGLYZE XR ............ Metformin Hydrochloride, 

Saxagliptin Hydrochloride.

Tablet, Extended Release; 

Oral.

500 mg, EQ 5 mg Base; 1 

g, EQ 5 mg Base; 1 g, 

EQ 2.5 mg Base.

AstraZeneca AB. 

NDA 201194 ............ OXYCODONE HYDROCHLORIDE.Oxycodone Hydrochloride Solution; Oral ................... 5 mg/5 mL ........................ VistaPharm, LLC. 

NDA 204427 ............ KERYDIN ......................... Tavaborole ....................... Solution; Topical .............. 5% .................................... Anacor Pharmaceuticals, 

Inc. 

NDA 204592 ............ ZORVOLEX ...................... Diclofenac ........................ Capsule; Oral ................... 35 mg ............................... Zyla. 

NDA 204790 ............ TIVICAY ........................... Dolutegravir Sodium ........ Tablet; Oral ...................... EQ 10 mg Base; EQ 25 

mg Base.

Viiv Health Care. 

NDA 215868 ............ MIDAZOLAM IN 0.8% 

SODIUM CHLORIDE.

Midazolam ........................ Solution; Intravenous ....... 50 mg/50 mL (1 mg/mL) .. Exela Pharma. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed were not 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

Agency will continue to list the drug 

products in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

drug products listed are unaffected by 

the discontinued marketing of the 

products subject to these applications. 

Additional ANDAs that refer to these 

products may also be approved by the 

Agency if they comply with relevant 

legal and regulatory requirements. If 

FDA determines that labeling for these 

drug products should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: November 27, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28433 Filed 12–4–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0604] 

Yong Sheng Jiao; Denial of Hearing; 

Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

denying a request for a hearing 

submitted by Yong Sheng Jiao, also 

known as Yongsheng Jiao and Wilson 

Jiao (Jiao), and is issuing an order under 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) debarring Jiao for 5 

years from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. FDA bases this order on a 

finding that Jiao was convicted of a 

felony under Federal law for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance under the FD&C Act. In 

determining the appropriateness and 

period of Jiao’s debarment, FDA 

considered the relevant factors listed in 

the FD&C Act. Jiao submitted a request 

for hearing but failed to file with the 

Agency information and analyses 

sufficient to create a basis for a hearing. 

DATES: The order is applicable 

December 5, 2024. 

ADDRESSES: Any application for 

termination of debarment by Jiao under 

section 306(d) of the FD&C Act (21 

U.S.C. 335a(d)) (application) may be 

submitted as follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application does not include any 


khammond on DSK9W7S144PROD with NOTICES
96656 Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 

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 

application, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application 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 a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All applications must 

include the Docket No. FDA–2024–N– 

0604. An application will be placed in 

the docket and, unless 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 an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application 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 your application. 

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 application 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, 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 between 9 a.m. 

and 4 p.m., Monday through Friday, 

240–402–7500. Publicly available 

submissions may be seen in the docket. 

FOR FURTHER INFORMATION CONTACT: 

Karen Fikes, Office of Scientific 

Integrity, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4232, Silver Spring, 

MD 20993, 301–796–9603. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(D) of the FD&C Act 

permits FDA to debar an individual if 

the Agency finds that the individual has 

been convicted of a felony under 

Federal law for conduct relating to the 

importation into the United States of 

any drug or controlled substance. On 

January 24, 2023, Jiao, the owner and 

operator of Santec Chemicals 

Corporation and Syntec Pharma 

Corporation, pled guilty to a Felony 

count of Causing the Delivery of 

Misbranded Drugs into Interstate 

Commerce in violation of sections 

301(a), 303(a)(2), and 502(a) of the FD&C 

Act (21 U.S.C. 331(a), 333(a)(2), and 

352(a)). Then, on January 8, 2024, the 

U.S. District Court for the Eastern 

District of New York entered a 

judgement convicting and sentencing 

Jiao to 2 years of probation and fines. 

Jiao’s conviction stemmed from 

conduct, occurring between on or about 

November 30, 2017, and April 30, 2020, 

relating to the importation of a drug, 

dipyrone, which is not approved for use 

in the United States. Jiao imported 

dipyrone from suppliers located in 

China into the United States, addressed 

to one of his businesses, Santec 

Chemicals Corporation. The shipments 

of dipyrone were misbranded in that 

they were either not labeled or they 

were falsely labeled as sebacic acid. Jiao 

pled guilty to knowingly and 

intentionally introducing into interstate 

commerce, with the intent to defraud 

and mislead the Federal Government, 

the misbranded drug dipyrone. 

By letter dated March 18, 2024, FDA’s 

Office of Regulatory Affairs (ORA) 

notified Jiao of its proposal to debar him 

for a period of 5 years (Proposal). As 

explained in the Proposal, Jiao’s 

conviction stemmed from conduct 

relating to the importation of any drug 

or controlled substance into the United 

States by illegally importing and 

introducing misbranded dipyrone, an 

unapproved drug, into interstate 

commerce in violation of 301(a), 

303(a)(2), and 502(a) of the FD&C Act. 

An individual convicted of a felony for 

conduct related to the importation into 

the United States of any drug or 

controlled substance may be subject to 

debarment as set forth in section 

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

ORA found, on the basis of Jiao’s 

conviction, that Jiao is subject to 

debarment under 306(b)(1)(D) of the 

FD&C Act. 

The Proposal explained that the 

maximum period of debarment for a 

Felony under section 306(c)(2)(A)(iii) of 

the FD&C Act is 5 years. The Proposal 

also outlined findings concerning the 

three relevant factors that ORA 

considered in determining the 

appropriateness and period of 

debarment, as provided in section 

306(c)(3) of the FD&C Act: (1) the nature 

and seriousness of any offense involved; 

(2) the nature and extent of voluntary 

steps to mitigate the impact on the 

public of any offense involved; and (3) 

prior convictions under the FD&C Act or 

under other Acts involving matters 

within the jurisdiction of FDA. ORA 

found that the nature and seriousness of 

the offense and the nature and extent of 

voluntary steps to mitigate the effect on 

the public are unfavorable factors for 

Jiao. ORA found the lack of prior 

convictions involving matters within 

FDA jurisdiction as a favorable factor for 

Jiao. ORA concluded that the facts 

supporting the unfavorable factors 

outweigh those supporting the favorable 

factor, thereby warranting a 5-year 

period of debarment. The Proposal also 

informed Jiao of an opportunity to 

request a hearing under section 306(i) of 

the FD&C Act and part 12 (21 CFR part 

12). 

In response to the Proposal, Jiao 

submitted a timely request for a hearing, 

which included a notice of appearance 

and a statement of intent to prepare and 

submit materials in support of the 

hearing request. In a letter submitted to 

the Dockets Management Staff dated 

May 12, 2024, Jiao submitted 

information in support of his request for 

a hearing (Response). Jiao’s Response 

included multiple documents meant to 


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Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 96657 

address the two unfavorable factors 

identified in ORA’s Proposal. 

Under the authority delegated to him 

by the Commissioner of Food and 

Drugs, the Director, Office of Scientific 

Integrity (OSI Director) has considered 

Jiao’s request for a hearing. Hearings are 

granted only if there is a genuine and 

substantial issue of fact. A request for a 

hearing may not rest upon mere 

allegations or denials but must present 

specific facts showing that there is a 

genuine and substantial issue of fact 

that justifies a hearing. Hearings will not 

be granted on issues of policy or law, on 

mere allegations, denials or general 

descriptions of positions and 

contentions, or on data and information 

insufficient to justify the factual 

determination urged (see 21 CFR 

12.24(b)). The OSI Director has 

considered Jiao’s arguments and 

concluded that they are unpersuasive 

and fail to raise a genuine and 

substantial issue of fact requiring a 

hearing. 

II. Argument in Support of a Hearing 

Jiao’s Response included documents 

and claims that challenge ORA’s 

proposed findings in determining the 

appropriateness and period of 

permissive debarment. Specifically, Jiao 

argues that he should not be ‘‘punished’’ 

for wrongdoing by his company’s 

supplier in China and that he 

incorrectly signed the plea agreement 

due to a misunderstanding, contending 

that FDA approved bulk importation of 

dipyrone during the time of his illegal 

importation. As a preliminary matter, 

debarment, under section 306 of the 

FD&C Act, is a remedial measure to 

protect public health, not a punishment. 

(See DiCola v. FDA, 77 F.3d 504, 507 

(D.C. Cir. 1996) (permanent debarment 

of convicted individual is not 

punishment, but instead is a remedy to 

protect the integrity of the drug industry 

and public confidence in that industry)). 

Insofar as Jiao is arguing that he is 

actually innocent of the offense to 

which he pled guilty, under section 

306(l) of the FD&C Act a person is 

convicted of a criminal offense, inter 

alia, when a Federal court enters a 

judgment of conviction or when a 

Federal court accepts a plea of guilty. 

The administrative record, including 

Jiao’s supporting documents, establishes 

that he pled guilty in Federal court on 

January 24, 2023. After accepting Jiao’s 

guilty plea, the Federal court entered a 

judgment of conviction. Jiao does not 

dispute the court’s judgment of 

conviction or acceptance of his guilty 

plea based on his admission to 

knowingly and intentionally importing 

misbranded dipyrone with an intent to 

defraud or mislead the Federal 

Government. Jiao cannot now dispute 

the facts to which he admitted in 

support of his guilty plea during the 

criminal proceedings against him. 

Federal court is the proper venue for 

any challenge to Jiao’s guilty plea based 

on a claim of actual innocence, not this 

remedial proceeding. 

Jiao next challenges the proposed 

period of debarment, arguing that the 

two considerations in section 306(c)(3) 

of the FD&C Act deemed unfavorable in 

the Proposal should be treated as 

favorable in light of the arguments and 

documents submitted by him in support 

of his hearing request. Relying on the 

Presentence Investigation Report, Plea 

Agreement, and Mitigation Letter from 

his criminal proceedings, Jiao first 

challenges ORA’s findings regarding the 

nature and seriousness of his offense 

under section 306(c)(3)(A) of the FD&C 

Act. Jiao contends that, as reflected in 

the documents from his criminal 

proceedings, his supplier in China is the 

cause of shipping the dipyrone as 

sebacic acid to avoid the ‘‘unreasonable 

testing requirement in China’’ and that 

he relabeled the product before 

shipment to customers. As noted above, 

however, Jiao pled guilty to causing the 

introduction of an unapproved and 

misbranded drug into the United States. 

The basis for his guilty plea was his 

misbranding the product upon entry 

into the United States, not the 

subsequent shipment to customers. 

Without FDA premarket review, such 

illegally imported drugs pose a 

significant risk to patients because they 

lack findings of safety and effectiveness, 

manufacturing quality standards, and 

appropriate labeling for use. Inasmuch 

as Jiao admitted, as part of his guilty 

plea, to ‘‘knowingly, intentionally, and 

voluntarily’’ causing the introduction of 

such drugs into the United States with 

an intent to defraud or mislead the 

Federal Government, Jiao’s attempts to 

mitigate the nature and seriousness of 

his offense by placing some 

responsibility on his suppliers and 

claiming that he relabeled the product 

before further shipment fail to raise a 

genuine and substantial issue of fact 

regarding the consideration under 

306(c)(3)(A) of the FD&C Act, which the 

OSI Director will treat as unfavorable. 

Jiao also argues that FDA should treat 

as favorable the consideration under 

section 306(c)(3)(C) of the FD&C Act, 

which requires the Agency to consider 

‘‘the nature and extent of voluntary 

steps to mitigate the impact on the 

public of any offense involved’’ in 

determining the appropriateness and 

period of his debarment. Citing a 

Federal Register document from 2019 

(84 FR 64080, November 20, 2019), Jiao 

argues that FDA ‘‘approved’’ dipyrone 

for bulk importation and that, therefore, 

his company’s sales after 2019 should 

not have created a negative ‘‘impact on 

the public.’’ Jiao’s reading of this 

Federal Register document is incorrect. 

FDA did not indicate in this Federal 

Register document that the Agency was 

either approving, or exercising 

enforcement discretion with respect to 

bulk dipyrone for use in compounding 

under limited circumstances. 

Regardless, as discussed above, Jiao 

admitted to knowingly and intentionally 

importing a misbranded drug with an 

intent to defraud or mislead the Federal 

Government. Any change in FDA’s 

enforcement policies with respect to 

that drug would not qualify as a 

voluntary step taken by Jiao to mitigate 

the impact of his offense on the public, 

nor does he provide information 

regarding any additional steps he took 

to mitigate the effects of his offense on 

the public under section 306(c)(3)(C) of 

the FD&C Act. Accordingly, Jiao has 

failed to raise a genuine and substantial 

issue of fact with respect to ORA’s 

proposed finding that he did not to take 

any voluntary steps to mitigate the 

potential impact on the public under 

section 306(c)(3)(C) of the FD&C Act, 

and thus the OSI Director will treat this 

consideration as unfavorable. 

Additionally, as FDA’s enforcement 

policies with respect to dipyrone remain 

unchanged, Jiao’s argument would not 

affect the nature and seriousness of his 

offense, under 306(c)(3)(A) of the FD&C 

Act or alter the OSI Director’s treatment 

of this consideration as unfavorable. 

Based on the undisputed record, 

including the facts to which Jiao pled 

guilty in his criminal proceedings, a 5- 

year debarment period is appropriate. 

Although it is undisputed that Jiao has 

no previous criminal convictions related 

to matters within the jurisdiction of 

FDA, this single favorable factor does 

not counterbalance the nature and 

seriousness of his offense and lack of 

voluntary steps promptly taken to 

mitigate the impact of his offense on the 

public. Therefore, the OSI Director 

agrees with ORA’s conclusion that ‘‘the 

facts supporting the unfavorable factors 

outweigh those supporting the favorable 

factor, and therefore warrant imposition 

of a five-year period of debarment.’’ 

III. Findings and Order 

Therefore, the OSI Director, under 

section 306(b)(1)(D) of the FD&C Act 

and authority delegated to him by the 

Commissioner of Food and Drugs, finds 

that Jiao has been convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 


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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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