[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]


-----------------------------------------------------------------------

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.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   No. of                                                                               
      Information collection requirement           No. of        responses/                 Average hour burden per response               Total burden 
                                                 respondents     respondent                                                                    hours    
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Recordkeeping                                                                     
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.                                                                                                                                              
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       Disclosure                                                                       
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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