[Federal Register Volume 63, Number 181 (Friday, September 18, 1998)]
[Notices]
[Pages 49919-49920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25032]
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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 list 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 (301)443-7978.
Proposed Project: Development and Implementation of Methadone/LAAM
Treatment Program (MTP) Accreditation Project
New--OMB approval is sought for information collections related to
the development and implementation of the methadone/LAAM accreditation
program by the Center for Substance Abuse Treatment (CSAT), SAMHSA. The
project implements a limited test of an accreditation-based model which
may form the basis for a new Department of Health and Human Services
regulatory/accreditation program for MTPs. The project does not
supplant FDA regulations and is designed in compliance with current FDA
treatment regulations set forth under 21 CFR 291.505. The project will
operate under an FDA exemption from certain specific existing
regulatory requirements. MTPs participating in this project will be
exempt from certain FDA regulatory requirements and paperwork burden
and will be required to meet requirements specified for this project.
This project, developed in conjunction with FDA and other Federal
agencies, is based on ``Guidelines for the Accreditation of Methadone/
LAAM Treatment Programs'' which were developed by experts in the
substance abuse treatment field. In this project, two accrediting
organizations will incorporate the Guidelines into their own
accreditation standards so that the specific accreditation standards
used by each accrediting body are built on the accreditation
``Guidelines'' and are crafted to be consonant with each accreditation
body's existing philosophy and mode of operation. The project is
designed to provide experience with the processes and costs associated
with implementing an accreditation-based oversight system in the
nation's MTPs. A separate evaluation of the project has been approved
by the Office of
[[Page 49920]]
Management and Budget under control number 0930-0190.
Approval is sought for the specific record keeping and disclosure
language in the Guidelines and for the following separate information
collections to be used by each accrediting organization: (1) an
Accreditation Application: (2) Site Visit Feedback Questionnaire; (3)
Performance Improvement Plan. Most of the record keeping and reporting
requirements describe procedures that would be employed in any MTP in
conformance with existing state and federal requirements and with
standard, quality clinical practice. The estimated annualized burden
for this four-year project is summarized below.
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No. of
Information collection requirement No. of responses/ Average hour burden per response Total burden
respondents respondent hours
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Recordkeeping
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II., p. 3: documentation of compliance with 300 \1\ 1.33 0.08 (5 minutes)......................................... 32
all local & state safety & environmental
codes.
X., p. 17: documentation every 90 days of 300 \2\ 150 0.05 (3 minutes)......................................... 2,250
physician's decision on continuing patient's
``take-home'' medication.
XI. D. 4., p. 21: documentation of steps 300 \3\ 100 0.03 (2 minutes)......................................... 900
taken to avoid discharge when patient
requests discharge.
XIV. F. 2., p. 26: ``on-call'' staff access 300 \4\ 52 0.33 (20 minutes)........................................ 5,150
to roster of patients & medication dosages,
for emergency use.
XV. B. 1., p. 28: documentation of reason for 300 \5\ 50 0.02 (1 minute).......................................... 300
denial of admission to pregnant applicants.
XVI. B. 3, p. 31: obtain written 300 \6\1020 .02 (1 minute)........................................... 6,120
acknowledgment of receipt of program rules,
regulations & patient rights &
responsibilities.
XVII. A.1., p. 34: medical record must 300 \7\ 1020 0.02 (1 minutes)......................................... 6,120
contain patient identifying data & unique
identifier.
XVIII. 6., p. 38: requirement to document 300 \8\ 6 1.00..................................................... 1,800
community relations efforts & community
contacts.
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Disclosure
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III. B.3, p. 5: must post names & phone 300 \9\ 6 0.08 (5 minutes)......................................... 144
numbers of individuals to notify in
emergency.
X. C. 2, p. 19: requirement to inform 300 \10\ 150 0.03 (2 minutes)......................................... 1,350
patients of rights & responsibilities
regarding take-home medications.
XVI. F.3., p. 32: program must display 300 \11\ 3 0.2...................................................... 80
policies & patient grievance procedures in
patient care areas.
MTP Review of Accreditation Standards........ 300 \12\ 1.33 90.0..................................................... 35,910
Application Form............................. 300 \13\ 1.33 2.0...................................................... 800
Site Visit Questionnaire..................... 300 \14\ 1.33 0.5...................................................... 200
Quality Improvement Plan..................... 300 \15\ 1.33 3.0...................................................... 1,197
3-Year Total................................. 300 .............. ......................................................... 62,353
Annualized Burden............................ 300 .............. ......................................................... 20,784
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\1\ It is anticipated that of the total of 300 MTPs being asked to participate, 222 will receive one site visit, 46 will receive two site visits and 30
will receive three site visits, for a total of about 400 visits. On average, each program will receive 1.33 site visits (400/300 = 1.33).
\2\ Based on the assumption that the average program of 140-capacity will require an average of 150 quarterly physician notes regarding ``take home''
medication over a 3-year period.
\3\ Based on the assumption that the average program will have 100 discharge requests over a 3-year period.
\4\ Based on the assumption that the average program will update the roster weekly.
\5\ Based on the assumption that the average program of 140-patient capacity will deny admission to 50 pregnant applicants in a 3-year period.
\6\ Based on the assumption that the average program of 140-patient capacity will admit 1020 patients in a 3-year period.
\7\ Based on the assumption that the average program of 140-patient capacity will admit 1020 patients in a 3-year period.
\8\ Assumes there will be 6 community relations activities (e.g., community advisory board meeting) held every three years and 1 hour to document each
with written minutes.
\9\ Based on the assumption that the average program will update this information twice per year.
\10\ Based on the assumption that the average program will have 150 patients with take-home privileges over a 3 year period.
\11\ Assumes each program updates these materials on an annual basis.
\12\ It is anticipated that of the total of 300 MTPs being asked to participate, 222 will receive one site visit, 46 will receive two site visits and 30
will receive three site visits, for a total of about 400 visits. On average, each program will receive 1.33 site visits (400/300 = 1.33).
\13\ It is anticipated that of the total of 300 MTPs being asked to participate, 222 will receive one site visit, 46 will receive two site visits and 30
will receive three site visits, for a total of about 400 visits. On average, each program will receive 1.33 site visits (400/300 = 1.33).
\14\ It is anticipated that of the total of 300 MTPs being asked to participate, 222 will receive one site visit, 46 will receive two site visits and 30
will receive three site visits, for a total of about 400 visits. On average, each program will receive 1.33 site visits (400/300 = 1.33).
\15\ It is anticipated that of the total of 300 MTPs being asked to participate, 222 will receive one site visit, 46 will receive two site visits and 30
will receive three site visits, for a total of about 400 visits. On average, each program will receive 1.33 site visits (400/300 = 1.33).
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to:
Daniel Chenok, Human Resources and Housing Branch, Office of Management
and Budget, New Executive Office Building, Room 10235, Washington, D.C.
20503.
Dated: September 14, 1998.
Richard Kopanda,
Executive Officer, SAMHSA.
[FR Doc. 98-25032 Filed 9-17-98; 8:45 am]
BILLING CODE 4162-20-P
