Approved as
amended by HHS/SAMHSA's 11/12/98 memoranda to OMB. Approval is
conditional on the following terms, which shall be addressed before
the project proceeds to ensure that the usefulness of the
information is maximized. OMB recommends that SAMHSA meet with OMB
and the Office of National Drug Control Policy as soon as possible
to address these conditions. 1) The project should be retitled as
"Development and Implemen- tation of Opioid Treatment Program
Accreditation". Regardless of the medication, there should be
uniformity in treatment delivery sytems across all
hospitals/clinics treating persons addicated to opiates. 2) The
standards developed by CARF (and under development by JCAHO) should
be subjected to rigorous testing to establish the viability of
accreditation and its impact on programs, including study of the
MTQAS criteria in participating programs. 3) During the period of
evaluation there should be drug testing (i.e., through urinalysis)
of most drugs of abuse. Other studies may follow on the main study,
and the utility of those studies should not be limited by the
number of drugs screened. As the data are assessed appropriate
changes can be made. 4) The conditions of approval regarding the
evaluation of the accreditation project are integrally linked to
this study. At the meeting to address these conditions, SAMHSA will
discuss the status of addressing those conditions and related
concerns regarding the study and project design. 5) SAMHSA will
provide the examples of JCAHO forms promised in its 11/12/98
memorandum as soon as possible. 6) SAMHSA will continue to promote
the use of electronic transfer of information between MTPs,
accreditors and SAMHSA, for implementation as soon as practical. 7)
The listing of patient's rights in Section XVI of the Guidelines
should be revised as necessary to be consistent with the
Administration's Patient's Bill of Rights. 8) SAMHSA will take all
necessary measures to ensure that the target response rate of the
CARF survey feedback questionnaire (Att. 4D) equals or exceeds
80%.
Inventory as of this Action
Requested
Previously Approved
02/28/2002
02/28/2002
769,095
0
0
20,784
0
0
599,000
0
0
This project implements a limited
"test" of an accreditation-based regulatory system (which will
include regulations) to replace FDA's existing
regulation/inspection program. The project, which does not supplant
current FDA regulations, will permit assessment of a national
accreditation-based oversight system to be administered by SAMHSA.
This request includes treatment guidelines that are implemented in
accreditation standards by national accreditation entities through
an application and site visit process. A separate evaluation
project has been approved by OMB.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.
Development and Implementation of Methadone/LAAM Treatment Program Accreditation