41494 Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices 

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, the 

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 on (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 through the use 

of automated collection techniques or 

other forms of information technology. 

Proposed Project: Opioid Drugs in 

Maintenance and Detoxification 

Treatment of Opioid Dependence—42 

CFR Part 8 (OMB No. 0930–0206) and 

Opioid Treatment Programs (OTPs)— 

Extension 

42 CFR part 8 establishes a 

certification program managed by 

SAMHSA’s Center for Substance Abuse 

Treatment (CSAT). The regulation 

requires that Opioid Treatment 

Programs (OTPs) be certified. 

‘‘Certification’’ is the process by which 

SAMHSA determines that an OTP is 

qualified to provide opioid treatment 

under the Federal opioid treatment 

standards established by the Secretary 

of Health and Human Services. To 

become certified, an OTP must be 

accredited by a SAMHSA-approved 

accreditation body. The regulation also 

provides standards for such services as 

individualized treatment planning, 

increased medical supervision, and 

assessment of patient outcomes. This 

submission seeks continued approval of 

the information collection requirements 

in the regulation and of the forms used 

in implementing the regulation. 

SAMHSA currently has approval for 

the Application for Certification to Use 

Opioid Drugs in a Treatment Program 

Under 42 CFR 8.11 (Form SMA–162); 

the Application for Approval as 

Accreditation Body Under 42 CFR 8.3(b) 

(Form SMA–163); and the Exception 

Request and Record of Justification 

Under 42 CFR 8.12 (Form SMA–168), 

which may be used on a voluntary basis 

by physicians when there is a patient 

care situation in which the physician 

must make a treatment decision that 

differs from the treatment regimen 

required by the regulation. Form SMA– 

168 is a simplified, standardized form to 

facilitate the documentation, request, 

and approval process for exceptions. 

SAMHSA believes that the 

recordkeeping requirements in the 

regulation are customary and usual 

practices within the medical and 

rehabilitative communities and has not 

calculated a response burden for them. 

The recordkeeping requirements set 

forth in 42 CFR 8.4, 8.11 and 8.12 

include maintenance of the following: 5- 

year retention by accreditation bodies of 

certain records pertaining to 

accreditation; documentation by an OTP 

of the following: A patient’s medical 

examination when admitted to 

treatment, A patient’s history, a 

treatment plan, any prenatal support 

provided the patient, justification of 

unusually large initial doses, changes in 

a patient’s dosage schedule, justification 

of unusually large daily doses, the 

rationale for decreasing a patient’s clinic 

attendance, and documentation of 

physiologic dependence. 

The tables that follows summarizes 

the annual reporting burden associated 

with the regulation, including burden 

associated with the forms. There are no 

changes being made to the forms. 

Form Number of 

respondents 

Responses/ 

respondent 

Total 

responses 

Hours/ 

response Total hours 

Estimated Annual Reporting Requirement Burden for Accreditation Bodies 

SMA–163 ............................................................................. 54 26.055 1,407 0.28 394 

Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs 

SMA–162 ............................................................................. 651.33 17.976 11,708.91 

SMA–168 ............................................................................. 1,302.67 17.977 23,418.09 

Subtotal ......................................................................... 1,954 17.977 35,127 0.08 2,902 

Total ....................................................................... ........................ ........................ 36,534 ........................ 3,296 

Send comments to Carlos Graham, 

SAMHSA Reports Clearance Officer, 

Room 15–E57A, 5600 Fishers Lane, 

Rockville, MD 20850 OR email him a 

copy at carlos.graham@samhsa.hhs.gov. Written comments should be received 

within 60 days of this notice. 

Carlos Graham, 

Statistician. 

[FR Doc. 2021–16402 Filed 7–30–21; 8:45 am] 

BILLING CODE 4162–20–P 


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