105610 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Notices 

Authority: 8 U.S.C. 412(a)(4). 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–31044 Filed 12–26–24; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Unaccompanied Children 

Bureau Incident Reporting (Office of 

Management and Budget #: 0970– 

NEW) 

AGENCY: Office of Refugee Resettlement, 

Administration for Children and 

Families, U.S. Department of Health and 

Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Refugee 

Resettlement (ORR), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services, is inviting public comments 

on the proposed information collection, 

including proposed changes. The 

request consists of several forms that 

will allow the Unaccompanied Children 

Bureau (UCB) to ensure that serious 

issues are elevated to ORR and that all 

incidents and the response to such 

incidents are documented and resolved 

in a way that protects the interests of 

children. 

DATES: Comments due February 25, 

2025. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: ORR UCB is in the 

process of reorganizing its information 

collections to create more unique 

information collections that will contain 

fewer forms under each OMB control 

number. This will promote operational 

efficiency for UCB by decreasing the 

burden associated with renewing large 

collections and enabling UCB to create 

more purpose-specific information 

collections. In addition, this will 

facilitate OMB review by ensuring the 

scope of the collection is targeted and 

narrower than existing collections, 

resulting in clearer requests. As part of 

that reorganization effort, ORR plans to 

move the following forms into this new 

information collection: 

• Child-Level Event (Form A–9A) 

• Emergency Significant Incident 

Report (eSIR) (Form A–9B) 

• Non-Emergency Significant Incident 

Report (non-eSIR)(Form A–9C) 

• Historical Disclosure (Form A–9D) 

• Behavioral Note (Form A–9E) 

• Program-Level Event (PLE) Report 

(Form A–10) 

In addition, ORR plans to revise the 

forms as follows to better align the 

forms with related reporting 

requirements and processes found in 

ORR agency guidance (i.e., regulations, 

policies, and procedures), as well as 

improve the forms’ organization, clarity, 

and functionality: 

Child-Level Event (Form A–9A) 

• Adjust the dropdown options for 

the ‘‘Location of Event’’ field to remove 

duplication and improve accuracy by: 

Æ Removing ‘‘Group Home’’ and ‘‘Foster 

Home’’ 

Æ Rewording ‘‘Community (field trip or 

outside the foster home)’’ to 

‘‘Community’’ 

Æ Rewording ‘‘U.S. Interior, not DHS or 

ORR custody’’ to ‘‘U.S. Interior 

(before entering DHS or ORR 

custody)’’ 

• Adjust the dropdown options for 

‘‘Specify Location’’ for accuracy by: 

Æ Rewording options to clarify when 

they are referring to locations inside 

the care provider facility 

Æ Adding an option for ‘‘Individual 

Foster Home’’ 

Æ Adding the following options to 

select from if ‘‘Community’’ is 

selected in the ‘‘Location of Event’’ 

field 

D Hospital or other healthcare facility 

D School 

D Field Trip 

D Other 

• Add the following fields: 

Æ Level of Care 

Æ Specify Out-of-Network Facility 

Æ Specify Out-of-Network Level of Care 

• Reword the Date/Time Event 

Reported to Care Provider fields as 

follows since provider staff may have 

directly witnessed the event, as opposed 

to having it reported to them by a thirdparty: 

Æ Date Care Provider Became Aware of 

Event 

Æ Time Care Provider Became Aware of 

Event 

Emergency Significant Incident Report 

(Form A–9B) 

• Reword the subcategory 

‘‘Molestation (penetration or touching 

unrelated to official job duties of a 

child’s buttocks, breasts, or anal, oral, or 

genital area by a body part or object’’ to 

‘‘Molestation (intentional penetration or 

touching unrelated to official job duties 

of a child’s genitalia, anus, groin, breast, 

inner thigh, buttocks, or mouth by a 

body part or object, including kissing, 

with intent to abuse, arouse, or gratify 

sexual desire)’’ for added clarity. 

• Remove the option of ‘‘UC and UC 

consensual’’ from the ‘‘Type of 

Allegation’’ dropdown field to align 

with the related regulation. 

Non-Emergency Significant Incident 

Report (Form A–9C) 

• For the ‘‘Staff Code of Conduct & 

Boundary Violation’’ category: 

Æ Reworded the subcategory ‘‘Failing to 

report any knowledge, suspicion, or 

information about sexual abuse, 

sexual harassment, or inappropriate 

sexual behavior’’ to ‘‘Failing to 

report any knowledge, suspicion, or 

information about sexual abuse, 

sexual harassment, inappropriate 

sexual behavior, or any other form 

of abuse/neglect’’ to clarify that 

other forms of abuse/neglect are 

also reportable 

Æ Added the following subcategories to 

better align with ORR agency 

guidance: 

D Failing to report a code of conduct 

violation 

D Engaging in sexual contact with 

anyone while on duty or while 

acting in the official capacity of 

their position 

D Threatening a child with incident 

reporting or behavioral notes to 

regulate their behavior or for any 

other reason 

D Threatening a child with legal, 

immigration, sponsor unification, or 

asylum case consequences to 

regulate their behavior or for any 

other reason 

Historical Disclosure (Form A–9D) 

• Reword the ‘‘Abuse Neglect in DHS 

Custody’’ category to ‘‘Violation of Civil 

Rights/Liberties in DHS Custody’’ and 

replace the current subcategories with 

the following options to better reflect 

the types of reportable incidents: 

Æ Conditions of detention 

Æ Disability accommodation 

Æ Excessive force or inappropriate use 

of force 

Æ Fourth Amendment (confiscation of 

documents/property) 

Æ Intimidation, threat, or improper 

coercion 


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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Notices 105611 

Æ Legal access/due process rights 

Æ Undocumented separation from 

parent/legal guardian 

Æ Undocumented separation from 

minor sibling 

Æ Medical/mental health care 

Æ Privacy Violation 

Æ Religious Accommodation 

Æ Retaliation 

Æ Restraints or isolation 

Æ Sexual abuse, sexual harassment, or 

inappropriate sexual behavior 

Æ Previous enrollment in the U.S. 

Department of Homeland Security 

(DHS) Migrant Protection Protocols 

program 

• Add a ‘‘Notifications’’ section to 

document notifications made to parties 

other than ORR. 

Behavioral Note (Form A–9E) 

• Change the title of the ‘‘Incident 

Information’’ section to ‘‘Behavior 

Information’’ and added the following 

fields: 

Æ Type of Behavior, with the 

following options: 

D Positive behavior, habit, resilience, 

personal growth, skill-building, or 

another meritorious action/trait 

D Behavior that merits monitoring in 

the event a behavioral pattern 

emerges that requires intervention 

or support 

Æ Is the behavior part of an 

established behavioral pattern? 

Æ Is intervention or support required? 

• In the Actions Taken section: 

Æ Reword ‘‘Staff Response and 

Intervention’’ to ‘‘Staff Response (if 

applicable)’’ 

Æ Reword ‘‘Follow-up and/or 

Resolution’’ to ‘‘Potential 

Consequence(s) of Continued 

Behavior’’ 

Æ Reword ‘‘Recommendations’’ to ‘‘Staff 

Intervention or Support’’ 

Program-Level Event Report (Form A– 

10) 

• Reword ‘‘Program/Facility’’ to 

‘‘Specify Program’’. 

• Add a field for ‘‘Level of Care’’. 

• Reword ‘‘Synopsis of Event’’ to 

‘‘Short Synopsis’’. 

• Remove the category for ‘‘Other’’. 

• Reword the category ‘‘Death (nonUC)’’ to ‘‘Death of an Adult or non-UC 

Child’’. 

• Reword the category ‘‘Major 

Disturbance’’ to ‘‘Threats to Safety’’ and 

replace the current subcategories with: 

Æ Trespassing/Intruder 

Æ Threats to Children or Staff 

Æ Weapon Found 

Æ Vehicle Accident 

Æ Cyber Breech, Attack, or Threat 

• Reword the category ‘‘Natural 

Disaster’’ to ‘‘Natural Disaster or 

Weather Event’’ and replace the ‘‘Other’’ 

subcategory with ‘‘Storm’’. 

• Add the following categories and 

subcategories: 

Æ Facilities Issues, with subcategories 

for: 

D Environmental 

D Mechanical Malfunction 

D Imminent Risk to Safety 

D Maintenance 

D Staffing Shortage 

Æ Video Monitoring Disruption 

Æ Infectious Disease/Health and Safety 

Incident 

Æ Power Outage/Disruption of Utilities 

(External) 

Æ Incident Involving Unidentified 

Child, with subcategories for: 

D Code of Conduct Violation 

D Safety or Abuse/Neglect Concern 

Æ Code of Conduct Violation Not 

Involving a Child, with 

subcategories for: 

D Failing to disclose staff misconduct 

witnessed on or off duty 

D Failing to self-disclose misconduct 

occurring on or off duty 

Æ Unauthorized Photography, Video, or 

Surveillance 

Æ Media Requests/External Questions 

Æ IT Disruption/internet Outage 

Æ Records Issues, with subcategories 

for: 

D Damaged Records 

D Unauthorized Destruction of 

Records 

D Lost Records 

• Remove the following fields from 

the Incident Information section: 

Æ Location of Incident (and Specify) 

Æ Was the UAC or Anyone Else Injured? 

(If Yes, SIR must be created) (and 

Specify) 

Æ Internal Investigation? 

Æ Results/Findings of Investigation 

• Reword the following fields from 

the Incident Information section: 

Æ ‘‘Description of Incident’’ to 

‘‘Describe the event and explain the 

effect on the program’s operations.’’ 

Æ ‘‘Was the UAC or Anyone Else 

Evacuated?’’ to ‘‘Were or are 

children being evacuated?’’ 

Æ ‘‘Staff Response and Intervention’’ to 

‘‘Describe actions taken to mitigate 

the impact on children in care’’ 

• Reword the field ‘‘Follow-up and/or 

Resolution’’ to ‘‘Updates, Follow-up, 

and/or Resolution’’ and move it into a 

new ‘‘Addendum’’ section. 

• Add the following fields from the 

Incident Information section: 

Æ Does the program need immediate 

guidance or resources? 

Æ Was or is the facility locked down or 

sheltered in place? 

Æ Has or will the program’s ability to 

provide healthcare services be 

affected? 

Æ Does the program have adequate 

resources to provide care for 

children for duration of the event? 

Æ Did or will the event affect the 

program’s bed capacity? 

Æ Specify Effect on Bed Capacity, with 

options for: 

D Beds need to come offline 

D Unable to receive additional 

children 

D Children need to be transferred to 

another program 

• Add new areas to document 

reporting to and the outcome of 

investigations conducted by the 

following parties: 

Æ Child Protective Services 

Æ Office of the Inspector General (OIG) 

Æ Department of Homeland Security 

(DHS) 

Æ Office on Trafficking in Persons 

Revisions Applied to Multiple Forms 

• Change ‘‘UC’’ to ‘‘child’’ or 

‘‘children’’ where possible [all forms]. 

• Update the field in the ‘‘UC Basic 

Information’’ section as follows to align 

with how information is currently 

displayed [all forms]: 

Æ Remove the following fields: 

D LOC 

D Age 

D Current Location 

Æ Add system-generated ‘‘Portal ID’’ 

field 

Æ Reword fields as follows: 

D ‘‘A No.’’ to ‘‘A#’’ 

D ‘‘Child’s Country of Birth’’ to 

‘‘Country of Birth’’ 

D ‘‘LOS’’ to ‘‘Length of Stay’’ 

Æ Reorganized the order in which the 

fields appear 

• Add a field for ‘‘Physical Location 

of the Child’’ in the ‘‘UC Basic 

Information Section’’. 

• For the ‘‘How was this child 

involved?’’ and ‘‘Were other 

unaccompanied children involved’’ 

fields [eSIR and non-eSIR]: 

Æ Use terms better aligned with child 

welfare best practices for incidents 

involving children by rewording 

‘‘Victim’’ to ‘‘Impacted’’ and 

‘‘Perpetrator’’ to ‘‘Exhibiting.’’ 

Æ Allow users to select multiple options 

since a child may play multiple 

roles in an incident. This includes 

situations where the child is both 

exhibiting problematic behaviors 

and impacted due to past trauma or 

victimization. 

• In the ‘‘Actions Taken’’ section 

[eSIR, non-eSIR, and Historical 

Disclosure]: 

Æ Add the following fields to better 

track compliance with requirements 

in ORR agency guidance: 


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105612 Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Notices 

D Was or will the child be referred to 

the local legal service provider for 

a follow-up legal consultation? 

D Was or will the child be referred for 

appointment of a child advocate? 

Æ Add the following fields to better 

track what healthcare services may 

be required because of the incident 

[eSIR, non-eSIR, and Historical 

Disclosure]: 

D Was the child hospitalized and/or 

receive serious medical services? 

[eSIR only] 

D Was or will the child be referred for 

healthcare services? 

D Specify Type(s) of Healthcare 

Services (with options for Medical, 

Mental Health/Behavioral, and 

Dental) 

D Describe the healthcare services that 

were or will be provided 

Æ Replace the ‘‘Follow-up Regarding 

Individuals Involved’’ field, which 

is duplicative of other fields in the 

section, with ‘‘Actions Taken for 

Witnesses’’ [eSIR and non-eSIR] 

• Add a new ‘‘Immediate Phone Call 

Notifications’’ section to better track 

compliance with policy requirements 

[eSIR and PLE Report]. 

• In the Reporting section: 

Æ Replace the yes/no radio button 

options for fields that ask if the 

incident was investigated with a 

dropdown field that includes the 

following options: ‘‘Yes,’’ ‘‘No,’’ 

‘‘To Be Determined,’’ ‘‘Unknown’’ 

[eSIR, non-eSIR, Historical 

Disclosure, and PLE Report] 

Æ Add a ‘‘Disposition of Investigation’’ 

field for reports made to state 

licensing, child protective services, 

and local law enforcement to better 

track outcomes when the incident is 

investigated by those parties [eSIR, 

non-eSIR, Historical Disclosure, and 

PLE Report] 

Æ Add a new area to document reports 

to and the outcome of investigations 

conducted by the ORR Division of 

Child Protection Investigations 

(DCPI) [eSIR, non-eSIR, Historical 

Disclosure, and PLE Report] 

Æ Add a new area to document when an 

Incident Review form (currently 

approved under OMB# 0970–0564) 

must be completed and a place to 

upload the completed form [eSIR 

and non-eSIR] 

• Update the auto-populated 

information in the ‘‘ORR Notifications’’ 

table to align with policy and replace 

the ‘‘Email’’ and ‘‘Phone’’ columns with 

columns for ‘‘Method of Notification’’ 

and ‘‘Specify’’ (for when ‘‘Other’’ is 

selected) [eSIR and PLE Report]. 

• Remove the ‘‘ORR Notifications’’ 

table since notifications are made by 

ORR’s SIR Triage Team, not the care 

provider [non-eSIR and Historical 

Disclosure]. 

• Update the auto-populated 

information in the ‘‘Other Notifications’’ 

table to align with policy and add 

options for ‘‘Messaging app’’ and ‘‘Mail’’ 

for the ‘‘Method of Notification’’ field 

[eSIR and non-eSIR]. 

Revisions to Burden Estimates 

• Child-Level Event (Form A–9A): 

Revise the burden estimate to account 

for an increase in the number of care 

provider facilities and to align with the 

actual number of forms submitted per 

year. The annual number of respondents 

increased from 216 to 300 and the 

annual number of responses per 

response increased from 160 to 262. 

• Emergency Significant Incident 

Report (eSIR) (Form A–9B): Revise the 

burden estimate to account for an 

increase in the number of care provider 

facilities and to align with the actual 

number of forms submitted per year. 

The annual number of respondents 

increased from 216 to 300 and the 

annual number of responses per 

response decreased from 26 to 10. 

• Non-Emergency Significant 

Incident Report (non-eSIR)(Form A–9C): 

Revise the burden estimate to account 

for an increase in the number of care 

provider facilities and to align with the 

actual number of forms submitted per 

year. The annual number of respondents 

increased from 216 to 300 and the 

annual number of responses per 

response decreased from 261 to 62. 

• Historical Disclosure (Form A–9D): 

Revise the burden estimate to account 

for an increase in the number of care 

provider facilities and to align with the 

actual number of forms submitted per 

year. The annual number of respondents 

increased from 216 to 300 and the 

annual number of responses per 

response decreased from 163 to 139. 

• Behavioral Note (Form A–9E): 

Revise the burden estimate to account 

for an increase in the number of care 

provider facilities and to align with the 

actual number of forms submitted per 

year. The annual number of respondents 

increased from 216 to 300 and the 

annual number of responses per 

response decreased from 137 to 90. 

• Program-Level Event (PLE) Report 

(Form A–10): Revise the burden estimate 

to account for an increase in the number 

of care provider facilities and to align 

with the actual number of forms 

submitted per year. The annual number 

of respondents increased from 216 to 

300 and the annual number of responses 

per response decreased from 7 to 6. 

Respondents: Care provider programs. 

Annual Burden Estimates 

ESTIMATED TOTAL ANNUAL BURDEN HOURS

Form 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Annual 

total 

burden 

hours 

Child-Level Event (Form A–9A) ........................................................................... 300 262.0 0.17 13,362 

Emergency Significant Incident Report (Form A–9B) ......................................... 300 10.0 1.50 4,500 

Non-Emergency Significant Incident Report (Form A–9C) ................................. 300 62.0 1.50 27,900 

Historical Disclosure (Form A–9D) ...................................................................... 300 139.0 1.50 62,550 

Behavioral Note (Form A–9E) ............................................................................. 300 90.0 0.50 13,500 

Program Level Event (Form A–10D) ................................................................... 300 6.0 1.00 1,800 

Estimated Annual Burden Hours Total ......................................................... ........................ ........................ ........................ 123,612 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is 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) 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 through the 

use of automated collection techniques 


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Federal Register / Vol. 89, No. 248 / Friday, December 27, 2024 / Notices 105613 

1For the purposes of this notice, the terms opioid 

dependence and opioid use disorder are used 

interchangeably. 

2 21 CFR 1308.13(e). 

3Approvals of Subutex and Suboxone sublingual 

tablets were withdrawn on September 15, 2022 (87 

FR 50337, August 16, 2022). 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 6 U.S.C. 279; 8 U.S.C. 

1232; 45 CFR 410; 45 CFR 411. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–30851 Filed 12–26–24; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5381] 

Modifications to Labeling of 

Buprenorphine-Containing 

Transmucosal Products for the 

Treatment of Opioid Dependence 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing that we have concluded 

that certain statements set forth in the 

FDA-approved labeling for 

buprenorphine-containing transmucosal 

products for the treatment of opioid 

dependence (BTODs) related to the 

recommended maintenance dosage and 

dosage adjustments during pregnancy 

can be modified. We believe that certain 

statements in BTOD labeling can be 

modified because the labeling for these 

products may be misinterpreted by 

some as establishing a maximum dosage 

when none exists. FDA is concerned 

that misinterpretation of these labeling 

statements may be adversely impacting 

patients’ access to BTODs. We 

encourage sponsors of approved 

applications for BTODs to submit 

supplemental new drug applications 

(NDAs) (labeling supplements) to 

modify these labeling statements as 

described in this notice. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Compton, Center for Drug 

Evaluation and Research (HFD–170), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 22, Rm. 

3168, Silver Spring, MD 20993, 301– 

796–1191, kimberly.compton@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. FDA-Approved BTODs 

Buprenorphine is a mu-opioid 

receptor partial agonist and a kappaopioid receptor antagonist. BUPRENEX 

(buprenorphine hydrochloride (HCl)) 

injection (under NDA 018401) is a 

schedule III controlled substance under 

the Controlled Substances Act (CSA) 

and was the first buprenorphine product 

to be approved in the United States 

(approved in 1981) for management of 

moderate to severe pain. Other 

buprenorphine products were 

subsequently approved for the treatment 

of opioid use disorder (OUD) 1 and are 

also controlled under schedule III of the 

CSA.2 BTODs have been approved by 

FDA since 2002. BTODs are available 

both as products containing 

buprenorphine alone and as fixed 

combination drug products containing 

buprenorphine and naloxone. BTODs 

include ZUBSOLV (buprenorphine HCl 

and naloxone HCl) sublingual tablets; 

SUBOXONE (buprenorphine HCl and 

naloxone HCl) sublingual film (for 

sublingual or buccal use); 

Buprenorphine and Naloxone 

Sublingual Film; and Buprenorphine 

and Naloxone Sublingual Tablets. 

The first BTODs approved were 

SUBUTEX (buprenorphine HCl) 

sublingual tablets (NDA 020732)and 

SUBOXONE (buprenorphine HCl and 

naloxone HCl) sublingual tablets (NDA 

020733).3 Approval of these products 

was based, in part, on clinical studies of 

Buprenorphine Sublingual Tablets with 

and without Naloxone Sublingual 

Tablets, and on studies of sublingual 

administration of a more bioavailable 

ethanolic solution of buprenorphine 

(Ref. 1). Dosing recommendations were 

based on data from one trial of both 

buprenorphine products and two trials 

of the ethanolic solutions. In a doubleblind, parallel-group, 16-week study, 

731 subjects were randomized to receive 

1 of 4 dosages of buprenorphine 

ethanolic solution: 1 milligram (mg), 4 

mg, 8 mg, and 16 mg. For comparison 

purposes 1 mg of solution would be 

equivalent to less than 2 mg of 

buprenorphine in sublingual tablets; 4 

mg, 8 mg, and 16 mg of buprenorphine 

in the solution would be roughly 

equivalent to 6 mg, 12 mg, and 24 mg 

of buprenorphine in sublingual tablets, 

respectively. Buprenorphine 

(administered once daily) was titrated to 

a maintenance dosage over 1 to 4 days 

and continued for 16 weeks. Based on 

retention in treatment and the 

percentage of thrice-weekly urine 

samples negative for non-study opioids, 

the three highest tested dosages of the 

ethanolic solution (i.e., 4 mg, 8 mg, and 

16 mg once daily dosages) were superior 

to the 1 mg once daily dosage. This 

study and the additional information 

submitted to support the approval of 

SUBUTEX and SUBOXONE 

demonstrated Buprenorphine 

Sublingual Tablets are effective from 4 

mg to 24 mg once daily. The ‘‘Dosage 

and Administration’’ section of the 

original labeling for these products in 

describing the appropriate maintenance 

dosage read, in part: 

The dosage of SUBOXONE should be 

progressively adjusted in increments/ 

decrements of 2 mg or 4 mg to a level 

that holds the patient in treatment and 

suppresses opioid withdrawal effects. 

This is likely to be in the range of 4 mg 

to 24 mg per day depending on the 

individual [Ref. 1]. 

In 2011, the Agency took several 

actions including the approval of two 

additional strengths, updates to the 

labeling, and modifications to the risk 

evaluation and mitigation strategy 

(REMS) for SUBUTEX and SUBOXONE 

sublingual tablets (Refs. 2, 3, 4, 5). The 

goals of the REMS for SUBUTEX and 

SUBOXONE were to mitigate the risks 

of accidental overdose, particularly in 

the pediatric population, and to mitigate 

the risks of misuse and abuse, as well 

as to inform patients of the serious risks 

associated with use of these products 

(Refs. 2, 4). It was at this time and 

within the context of addressing these 

concerns that the application holder for 

SUBUTEX and SUBOXONE proposed 

changes to the ‘‘Dosage and 

Administration’’ section of the approved 

labeling. For SUBOXONE, FDA 

approved the following language related 

to the maintenance dosage in the 

‘‘Dosage and Administration’’ section of 

the labeling (SUBUTEX shares similar 

language in its labeling (Ref. 5)): 

• SUBOXONE sublingual tablet is 

indicated for maintenance treatment. 

• The recommended target dosage of 

SUBOXONE sublingual tablet is 16 mg/ 

4 mg buprenorphine/naloxone/day as a 

single daily dose. 

• The dosage of SUBOXONE 

sublingual tablet should be 

progressively adjusted in increments/ 

decrements of 2 mg/0.5 mg or 4 mg/1 

mg buprenorphine/naloxone to a level 

that holds the patient in treatment and 

suppresses opioid withdrawal signs and 

symptoms. 

• The maintenance dose of 

SUBOXONE sublingual tablet is 

generally in the range of 4 mg/1 mg 

buprenorphine/naloxone to 24 mg/6 mg 

buprenorphine/naloxone per day 

depending on the individual patient. 

Dosages higher than this have not been 


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