81 FR 40335 - Agency Information Collection Activities: Submission for OMB Review; Comment Request
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Substance Abuse and Mental Health Services Administration Federal Register Volume 81, Issue 119 (June 21, 2016)
Substance Abuse and Mental Health Services Administration
Federal Register Volume 81, Issue 119 (June 21, 2016)
| Page Range | 40335-40337 | |
| FR Document | 2016-14586 |
[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)] [Notices] [Pages 40335-40337] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-14586] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276-1243. Project: Opioid Drugs in Maintenance and Detoxification Treatment of Opioid Dependence--42 CFR Part 8 (OMB No. 0930-0206) and Opioid Treatment Programs (OTPs)--Revision 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 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, and 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 to 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 rule also includes requirements that OTPs and accreditation organizations disclose information. For example, 42 CFR 8.12(e)(1) requires that a physician explain the facts concerning the use of opioid drug treatment to each patient. This type of disclosure is considered to be consistent with the common medical practice and is not considered an additional burden. Further, the rule requires, under section 8.4(i)(1) that accreditation organizations shall make public their fee structure; this type of disclosure is standard business practice and is not considered a burden. A number of changes have been made to the forms. Forms have been reworded for clarification, updated with current SAMHSA mailing and web-submission information, and a few additional fields have been provided for clarity and for providers to best explain their services (e.g., expanding the former global patient census in the SMA-162 to request patient census by drug type--methadone, buprenorphine, naltrexone, or other) and the needs of their patients (e.g., including urinalysis results on the SMA-168 and adding ``weather crisis'' as a standard option for physician justification of the requested exception). Amendments also include the removal of information pertaining to faxing the forms to SAMHSA, as this is no longer an acceptable form of submission. The burden hours have increased slightly (by 28% or approximately 639 hours) due to an increase in the number of facilities accredited and certified by SAMHSA since the previous submissions of these forms. The forms are available online with a unique feature for both the SMA-162 and SMA-168 that pre-populates certain information within the form. This in turn reduces the program's time spent [[Page 40336]] filling out the forms as well as the staff time spent on processing it. The tables that follow summarize the annual reporting burden associated with the regulation, including burden associated with the forms. Estimated Annual Reporting Requirement Burden for Accreditation Bodies -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Responses/ Total Hours/ 42 CFR Citation Purpose respondents respondent responses response Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- 8.3(b)(1-11).......................... Initial approval (SMA-163)...... 1 1 1 6.00 6.00 8.3(c)................................ Renewal of approval (SMA-163)... 2 1 2 1.00 2.00 8.3(e)................................ Relinquishment notification..... 1 1 1 0.50 0.50 8.3(f)(2)............................. Non-renewal notification to 1 90 90 0.10 9.00 accredited OTPs. 8.4(b)(1)(ii)......................... Notification to SAMHSA for 2 2 4 1.00 4.00 seriously noncompliant OTPs. 8.4(b)(1)(iii)........................ Notification to OTP for serious 2 10 20 1.00 20.00 noncompliance. 8.4(d)(1)............................. General documents and 6 5 30 0.50 15.00 information to SAMHSA upon request. 8.4(d)(2)............................. Accreditation survey to SAMHSA 6 75 450 0.02 9.00 upon request. 8.4(d)(3)............................. List of surveys, surveyors to 6 6 36 0.20 7.20 SAMHSA upon request. 8.4(d)(4)............................. Report of less than full 6 5 30 0.50 15.00 accreditation to SAMHSA. 8.4(d)(5)............................. Summaries of Inspections........ 6 50 300 0.50 150.00 8.4(e)................................ Notifications of Complaints..... 12 6 72 0.50 36.00 8.6(a)(2) and (b)(3).................. Revocation notification to 1 185 185 0.30 55.50 Accredited OTPs. 8.6(b)................................ Submission of 90-day corrective 1 1 1 10.00 10.00 plan to SAMHSA. 8.6(b)(1)............................. Notification to accredited OTPs 1 185 185 0.30 55.50 of Probationary Status. ------------------------------------------------------------------------------- Subtotal.......................... ................................ 54 .............. 1,407 .............. 394.70 -------------------------------------------------------------------------------------------------------------------------------------------------------- Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Responses/ Total Hours/ 42 CFR Citation Purpose respondents respondent responses response Total hours -------------------------------------------------------------------------------------------------------------------------------------------------------- 8.11(b)............................... Renewal of approval (SMA-162)... 386 1 386 0.15 57.90 8.11(b)............................... Relocation of Program (SMA-162). 35 1 35 1.17 40.95 8.11(e)(1)............................ Application for provisional 42 1 42 1.00 42.00 certification. 8.11(e)(2)............................ Application for extension of 30 1 30 0.25 7.50 provisional certification. 8.11(f)(5)............................ Notification of sponsor or 60 1 60 0.10 6.00 medical director change (SMA- 162). 8.11(g)(2)............................ Documentation to SAMHSA for 1 1 1 1.00 1.00 interim maintenance. 8.11(h)............................... Request to SAMHSA for Exemption 1,325 25 33,125 0.07 2,318.75 from 8.11 and 8.12 (including SMA-168). 8.11(i)(1)............................ Notification to SAMHSA Before 10 1 10 0.25 2.50 Establishing Medication Units (SMA-162). 8.12(j)(2)............................ Notification to State Health 1 20 20 0.33 6.60 Officer When Patient Begins Interim Maintenance. 8.24.................................. Contents of Appellant Request 2 1 2 0.25 .50 for Review of Suspension. 8.25(a)............................... Informal Review Request......... 2 1 2 1.00 2.00 8.26(a)............................... Appellant's Review File and 2 1 2 5.00 10.00 Written Statement. 8.28(a)............................... Appellant's Request for 2 1 2 1.00 2.00 Expedited Review. 8.28(c)............................... Appellant Review File and 2 1 2 5.00 10.00 Written Statement. ------------------------------------------------------------------------------- Subtotal.......................... ................................ 1,900 .............. 33,719 .............. 2,507.70 ------------------------------------------------------------------------------- Total......................... ................................ 1,954 .............. 35,126 .............. 2,902.40 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 40337]] Written comments and recommendations concerning the proposed information collection should be sent by July 21, 2016 to the SAMHSA Desk Officer at the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). To ensure timely receipt of comments, and to avoid potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, commenters are encouraged to submit their comments to OMB via email to: [email protected]. Although commenters are encouraged to send their comments via email, commenters may also fax their comments to: 202-395-7285. Commenters may also mail them to: Office of Management and Budget, Office of Information and Regulatory Affairs, New Executive Office Building, Room 10102, Washington, DC 20503. Summer King, Statistician. [FR Doc. 2016-14586 Filed 6-20-16; 8:45 am] BILLING CODE 4162-20-P
![Federal Register / Vol. 81, No. 119 / Tuesday, June 21, 2016 / Notices 40335
Knowledge Management database and their information from either system at There are no changes to the burden or
places email subscription information any time. the forms.
into a database maintained by a third- The respondents are behavioral health SAMHSA estimates the burden of this
party vendor that serves multiple professionals, researchers, parents, information collection as follows:
Federal agencies and the White House.
caregivers, and the general public.
Customers can change, add, or delete
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Annual
Number of Total annual
frequency Hours per response Total hours
respondents responses
per response
Website Registration ............................................. 38,605 1 38,605 .033 (2 min.) ................ 1,286
Email Update Subscription .................................... 21,138 1 21,138 .017 (1 min.) ................ 359
Total ................................................................ 59,743 ........................ 59,743 ...................................... 1,645
Send comments to Summer King, accredited by a SAMHSA-approved attendance, and documentation of
SAMHSA Reports Clearance Officer, accreditation body. The regulation also physiologic dependence.
5600 Fishers Lane, Room 15E57–B, provides standards for such services as The rule also includes requirements
Rockville, Maryland 20857, OR email a individualized treatment planning, that OTPs and accreditation
copy to summer.king@samhsa.hhs.gov. increased medical supervision, and organizations disclose information. For
Written comments should be received assessment of patient outcomes. This example, 42 CFR 8.12(e)(1) requires that
by August 22, 2016. submission seeks continued approval of a physician explain the facts concerning
Summer King, the information collection requirements the use of opioid drug treatment to each
Statistician. in the regulation and of the forms used patient. This type of disclosure is
[FR Doc. 2016–14581 Filed 6–20–16; 8:45 am]
in implementing the regulation. considered to be consistent with the
BILLING CODE 4162–20–P SAMHSA currently has approval for common medical practice and is not
the Application for Certification to Use considered an additional burden.
Opioid Drugs in a Treatment Program Further, the rule requires, under section
DEPARTMENT OF HEALTH AND Under 42 CFR 8.11 (Form SMA–162); 8.4(i)(1) that accreditation organizations
HUMAN SERVICES the Application for Approval as shall make public their fee structure;
Accreditation Body Under 42 CFR 8.3(b) this type of disclosure is standard
Substance Abuse and Mental Health (Form SMA–163); and the Exception business practice and is not considered
Services Administration Request and Record of Justification a burden.
Agency Information Collection Under 42 CFR 8.12 (Form SMA–168), A number of changes have been made
Activities: Submission for OMB which may be used by physicians when to the forms. Forms have been reworded
Review; Comment Request there is a patient care situation in which for clarification, updated with current
the physician must make a treatment SAMHSA mailing and web-submission
Periodically, the Substance Abuse and decision that differs from the treatment information, and a few additional fields
Mental Health Services Administration regimen required by the regulation. have been provided for clarity and for
(SAMHSA) will publish a summary of Form SMA–168 is a simplified, providers to best explain their services
information collection requests under standardized form to facilitate the (e.g., expanding the former global
OMB review, in compliance with the documentation, request, and approval
Paperwork Reduction Act (44 U.S.C. patient census in the SMA–162 to
process for exceptions. request patient census by drug type—
chapter 35). To request a copy of these
documents, call the SAMHSA Reports SAMHSA believes that the methadone, buprenorphine, naltrexone,
Clearance Officer on (240) 276–1243. recordkeeping requirements in the or other) and the needs of their patients
regulation are customary and usual (e.g., including urinalysis results on the
Project: Opioid Drugs in Maintenance practices within the medical and SMA–168 and adding ‘‘weather crisis’’
and Detoxification Treatment of Opioid rehabilitative communities and has not as a standard option for physician
Dependence—42 CFR Part 8 (OMB No. calculated a response burden for them. justification of the requested exception).
0930–0206) and Opioid Treatment The recordkeeping requirements set Amendments also include the removal
Programs (OTPs)—Revision forth in 42 CFR 8.4, 8.11, and 8.12 of information pertaining to faxing the
42 CFR part 8 establishes a include maintenance of the following: 5- forms to SAMHSA, as this is no longer
certification program managed by year retention by accreditation bodies of an acceptable form of submission. The
SAMHSA’s Center for Substance Abuse certain records pertaining to burden hours have increased slightly
Treatment (CSAT). The regulation accreditation, and documentation by an (by 28% or approximately 639 hours)
requires that Opioid Treatment OTP of the following: A patient’s due to an increase in the number of
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Programs (OTPs) be certified. medical examination when admitted to facilities accredited and certified by
‘‘Certification’’ is the process by which treatment, a patient’s history, a SAMHSA since the previous
SAMHSA determines that an OTP is treatment plan, any prenatal support submissions of these forms. The forms
qualified to provide opioid treatment provided to the patient, justification of are available online with a unique
under the Federal opioid treatment unusually large initial doses, changes in feature for both the SMA–162 and
standards established by the Secretary a patient’s dosage schedule, justification SMA–168 that pre-populates certain
of Health and Human Services. To of unusually large daily doses, the information within the form. This in
become certified, an OTP must be rationale for decreasing a patient’s clinic turn reduces the program’s time spent
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Written comments and services provided to suicidal SAMHSA’s desire to expand this
recommendations concerning the individuals through the National process and impacts evaluation to assess
proposed information collection should Suicide Prevention Lifeline Crisis follow-up with clients referred to the
be sent by July 21, 2016 to the SAMHSA Center Follow-Up (NSPL Follow-Up) Lifeline from partnering inpatient
Desk Officer at the Office of Information program. hospitals and EDs and continue to
and Regulatory Affairs, Office of The NSPL, or Lifeline, is SAMHSA’s improve the methods and standards of
Management and Budget (OMB). To 24-hour crisis hotline (1–800–273– service delivery to suicidal individuals
ensure timely receipt of comments, and TALK [8255]) that serves as a central receiving crisis center services. This
to avoid potential delays in OMB’s switchboard, seamlessly connecting effort will build on information
receipt and processing of mail sent callers from anywhere in the U.S. to the collected through previous and ongoing
through the U.S. Postal Service, closest of its 165 crisis centers within NSPL evaluations; expand our
commenters are encouraged to submit the Lifeline network. Since its understanding of the outcomes
their comments to OMB via email to: inception, the Lifeline has helped more associated with the NSPL Follow-Up
OIRA_Submission@omb.eop.gov. than 6 million people. In 2008, program; and continue to contribute to
Although commenters are encouraged to SAMHSA launched the NSPL Follow- the evidence base.
send their comments via email, up program and began awarding This revision requests approval for
commenters may also fax their cooperative agreements to crisis centers the removal of one previously-approved
comments to: 202–395–7285. in the Lifeline network to reconnect instrument and the continuation and
Commenters may also mail them to: with suicidal callers to offer emotional renaming of five previously-approved
Office of Management and Budget, support and ensure they followed up activities. Six crisis centers funded
Office of Information and Regulatory with referrals to treatment. In 2013, the through the NSPL Follow-Up program
Affairs, New Executive Office Building, program was expanded to include crisis in FY 2016 will participate in this effort.
Room 10102, Washington, DC 20503. center follow-up with any suicidal
individual referred from a partnering Instrument Removal
Summer King,
emergency department (ED) or inpatient Due to the completion of the
Statistician. hospital. motivational interviewing/safety
[FR Doc. 2016–14586 Filed 6–20–16; 8:45 am] While previous evaluations of the planning (MI/SP) training and the
BILLING CODE 4162–20–P NSPL demonstrated that suicidal callers fulfillment of data collection goals, the
experienced a reduction in hopelessness currently-approved MI/SP Counselor
and suicidal intent after contacting the Attitudes Questionnaire and its
DEPARTMENT OF HEALTH AND Lifeline, 43% of suicidal callers associated burden will be removed.
HUMAN SERVICES participating in follow-up assessments
Instrument and Consent Revisions
reported some recurrence of suicidality
Substance Abuse and Mental Health Each of the five instruments and
(e.g., ideation, plan, or attempt) since
Services Administration consents associated with the Monitoring
their crisis call (Gould et al., 2007).
Agency Information Collection Even so, only about 35% of suicidal of the NSPL was previously approved
Activities: Submission for OMB callers set up an appointment and even by OMB (No. 0930–0274; Expiration,
Review; Comment Request fewer had been seen by the behavioral July 31, 2016). Revisions include the
health care system to which they were following: (1) The term ‘‘caller’’ will be
Periodically, the Substance Abuse and referred (Gould et al., 2007; Kalafat et replaced with ‘‘client’’ to reflect the
Mental Health Services Administration al., 2007). Similarly, while several change in respondent type to clients
(SAMHSA) will publish a summary of randomized, controlled trials have referred from partnering EDs and
information collection requests under demonstrated that following up by inpatient hospitals rather than callers,
OMB review, in compliance with the telephone or letter with patients and (2) MI/SP will be removed from the
Paperwork Reduction Act (44 U.S.C. discharged from inpatient or ED settings titles of all instruments and consents.
Chapter 35). To request a copy of these can reduce rates of repeat suicide No other changes are being made.
documents, call the SAMHSA Reports attempts (Vaiva et al., 2006), as well as D The MI/SP Caller Follow-up
Clearance Officer on (240) 276–1243. completions (Fleischman et al., 2008; Interview will be renamed ‘‘Client
Motto & Bostrom, 2001), suicidal Follow-up Interview.’’
Project: Monitoring of the National D The MI/SP Caller Initial Script will
individuals discharged from EDs rarely
Suicide Prevention Lifeline (OMB No. be renamed ‘‘Client Initial Script.’’
link to ongoing care. As many as 70%
0930–0274) Revision D The MI/SP Caller Follow-up
of suicide attempters either never attend
The Substance Abuse and Mental their first appointment or drop out of Consent Script will be renamed ‘‘Client
Health Services Administration treatment after a few sessions (Knesper Follow-up Consent Script.’’
(SAMHSA) Center for Mental Health et al., 2010). Thus, it is imperative that D The MI/SP Counselor Follow-up
Services (CMHS) is requesting approval EDs and inpatient settings link these Questionnaire will be renamed
for the revision of data collection individuals to follow-up care. ‘‘Counselor Follow-up Questionnaire.’’
associated with the previously-approved SAMHSA is addressing this need D The MI/SP Counselor Consent will
Monitoring of the National Suicide through the NSPL Follow-Up program. be renamed ‘‘Counselor Consent.’’
Prevention Lifeline (OMB No. 0930– The Monitoring of the NSPL will The estimated response burden to
asabaliauskas on DSK3SPTVN1PROD with NOTICES
0274; Expiration, July 31, 2016). The continue to assess whether the NSPL collect this information associated with
current request will continue Follow-Up program achieves its the Monitoring of the NSPL annualized
previously-cleared efforts to evaluate intended goals. This revision of the over the requested 3-year approval
process and impacts of follow-up Monitoring of the NSPL represents period is presented below:
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Document Created: 2016-06-21 01:30:14
Document Modified: 2016-06-21 01:30:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 81 FR 40335 |
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