E9-14554. 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 [phone].

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) Mortality Reporting Form—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 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 developed an OTP mortality report form to be utilized by OTPs in response to the increasing methadone associated mortality around the country. This form also assists SAMHSA with regulatory oversight of methadone for use in opioid addiction treatment because it is not clear whether and to what extent the increase in methadone-associated deaths may be related to treatment in OTPs. A system within SAMHSA to gather information directly relevant to the agency's mission of overseeing and ensuring safe and effective treatment for patients with opioid dependence provides an additional layer of oversight.

SAMHSA currently has approval for the Opioid Treatment Programs (OTPs) Mortality Reporting Form. The data collected from the form is used by SAMHSA to increase understanding of the factors contributing to these deaths, identify preventable causes of deaths, and ultimately, take appropriate action to minimize risk and help improve the quality of care. SAMHSA recently received OMB approval for the voluntary collection of data regarding OTP mortality, which expires October 2011. The consolidation of the OMB packages for the mortality form with the regulatory forms SMA-162, SMA-163, and SMA-168 reduces agency and staff burden.

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

42 CFR citation	Purpose	No. of respondents	Responses/ respondent	Hours/ response	Total hours
8.3(b)(1-11)	Initial approval (SMA-163)	1	1	6.0	6
8.3(c)	Renewal of approval (SMA-163)	2	1	1.0	2
8.3(e)	Relinquishment notification	1	1	0.5	0.5
8.3(f)(2)	Non-renewal notification to accredited OTPs	1	90	0.1	9
8.4(b)(1)(ii)	Notification to SAMHSA for seriously noncompliant OTPs	2	2	1.0	4
8.4(b)(1)(iii)	Notification to OTP for serious noncompliance	2	10	1.0	20
8.4(d)(1)	General documents and information to SAMHSA upon request	6	5	0.5	15
8.4(d)(2)	Accreditation survey to SAMHSA upon request	6	75	0.02	9
8.4(d)(3)	List of surveys, surveyors to SAMHSA upon request	6	6	0.2	7.2
8.4(d)(4)	Report of less than full accreditation to SAMHSA	6	5	0.5	15
8.4(d)(5)	Summaries of Inspections	6	50	0.5	150
8.4(e)	Notifications of Complaints	12	6	0.5	3.6
8.6(a)(2) and (b)(3)	Revocation notification to Accredited OTPs	1	185	0.3	55.5
8.6(b)	Submission of 90-day corrective plan to SAMHSA	1	1	10	10.0
8.6(b)(1)	Notification to accredited OTPs of Probationary Status	1	185	0.3	55.0
TOTAL		6			361.80

Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs

42 CFR citation	Purpose	No. of respondents	Responses/ respondent	Hours/ response	Total hours
8.11(b)	Renewal of approval (SMA-162)	386	1	0.15	57.9
8.11(b)	Relocation of Program (SMA-162)	35	1	1.17	40.95
8.11(e)(1)	Application for provisional certification	42	1	1	42.00
8.11(e)(2)	Application for extension of provisional certification	30	1	0.25	7.50
8.11(f)(5)	Notification of sponsor or medical director change (SMA-162)	60	1	0.1	6.00
8.11(g)(2)	Documentation to SAMHSA for interim maintenance	1	1	1	1.00
8.11(h)	Request to SAMHSA for Exemption from 8.11 and 8.12 (including SMA-168)	1,200	25	0.7	2135.0
8.11(i)(1)	Notification to SAMHSA Before Establishing Medication Units (SMA-162)	10	1	0.25	2.5
8.12(j)(2)	Notification to State Health Officer When Patient Begins Interim Maintenance	1	20	0.33	6.6
8.24	Contents of Appellant Request for Review of Suspension	2	1	0.25	.50
8.25(a)	Informal Review Request	2	1	1.00	2.00
8.26(a)	Appellant's Review File and Written Statement	2	1	5.00	10.00
8.28(a)	Appellant's Request for Expedited Review	2	1	1.00	2.00
8.28(c)	Appellant Review File and Written Statement	2	1	5.00	10.00
TOTAL		1,200			2323.95

Estimated Annual Reporting Requirement Burden for OTPs

Form name	Number of facilities (OTPs)	Responses per facility	Burden/ response (hours) to OTP	Annual burden (hours) to OTPs
SAMHSA OTP Mortality Form	1,200	2 per year	0.5	1200.00

Estimated Annual Reporting Requirement Burden for Medical Examiner (ME)

Form name	Number of ME follow-ups	Responses per ME	Burden/ response (hours) for ME	Annual burden (hours) for ME
SAMHSA OTP mortality form	230	1 per year	0.1	2.3

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 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 Sec. 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.

The information requested from OTPs on mortality report form should be readily available to any OTP that has met accreditation standards. The OTP should not find any need to otherwise analyze or synthesize new data in order to complete this form.

Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 7-1044, One Choke Cherry Road, Rockville, MD 20857 and e-mail her a copy at [e-mail]. Written comments should be received within 60 days of this notice.

Dated: June 15, 2009.

Elaine Parry,

Director, Office of Program Services.