[Federal Register Volume 64, Number 201 (Tuesday, October 19, 1999)]
[Proposed Rules]
[Pages 56294-56296]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-27299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 8

[Docket No. 98N-0617]


Narcotic Drugs in Maintenance and Detoxification Treatment of 
Narcotic Dependence; Repeal of Current Regulations and Proposal To 
Adopt New Regulations; Notice of Public Hearing

AGENCIES: Substance Abuse and Mental Health Services Administration.

ACTION: Notice of public hearing.

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SUMMARY: The Substance Abuse and Mental Health Services Administration 
(SAMHSA) Center for Substance Abuse Treatment (CSAT) in conjunction 
with the Food and Drug Administration and other Federal agencies will 
convene a public hearing on proposed regulations for opioid drugs in 
the treatment of narcotic addiction. The purpose of the hearing is to 
provide an opportunity for interested parties to convey comments on the 
proposed rule to a panel composed of representatives from Federal 
agencies.

DATES: The hearing will be held on November 1, 1999, from 9 a.m. to 5 
p.m. Written notice of participation should be filed by October 26, 
1999.

ADDRESSES: The public hearing will be held in Conference Room D, 6001 
Executive Blvd., Rockville, MD 20852. Written notices of participation 
and any comments are to be sent to CSAT

[[Page 56295]]

(Proposed Rule Public Hearing), Office of Pharmacological and 
Alternative Therapies, Rockwall II, 5515 Security Lane, Rockville, MD 
20857. Notices can also be faxed to 301-480-3045. Transcripts of the 
public hearing may be requested in writing from the Freedom of 
Information Office, SAMHSA, 5600 Fishers Lane, rm. 13C-05, Rockville, 
MD 20857, approximately 15 working days after the hearing, at a cost of 
10 cents per page. The transcript of the public hearing, copies of data 
and information submitted during the hearing, and any written comments 
will be available for review at the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20857 between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Lubran, Center for 
Substance Abuse Treatment (CSAT), SAMHSA, Rockwall II, 5515 Security 
Lane, Rockville, MD 20857, 301-443-0744, FAX 301-480-3045, e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a Federal Register notice published July 22, 1999, (64 FR 39809) 
the Secretary of the Department of Health and Human Services (HHS) 
proposed to revise the conditions for the use of narcotic drugs in 
maintenance and detoxification treatment of opioid addiction. The 
proposal included the repeal of the existing narcotic treatment 
regulations enforced by the Food and Drug Administration (FDA), the 
creation of a new regulatory system based on an accreditation model 
under new 42 CFR Part 8, and a shift in administrative responsibility 
and oversight from FDA to the Substance Abuse and Mental Health 
Services Administration (SAMHSA). It must be stressed, however that in 
the interim, until the proposal is finalized and effective, treatment 
programs will remain subject to FDA oversight and monitoring.
    Several entities representing treatment providers, patients, State 
regulatory authorities, and others have approached SAMHSA and FDA to 
request an opportunity to present comments to Federal representatives 
in the forum of a public hearing. SAMHSA and FDA have determined that 
it would be valuable to convene a public hearing on the proposed rule.

II. Public Hearing Topics

    The public hearing is intended to provide an opportunity for public 
comment on the proposed rule in its entirety. Participants are 
encouraged to review and comment upon any portion of the proposal. The 
July 22, 1999, proposal, however, identified and solicited comments on 
a few specific issues. These issues are restated below for emphasis, 
but are not intended to preclude participants from providing public 
hearing comments on any issue relating to any aspect of the proposal:

1. Accreditation Impact Study

    The July 22, 1999, notice described in detail a SAMHSA/CSAT study 
of 180 randomly selected, volunteer OTPs. The study is designed to 
provide useful information for refining the accreditation model. 
Importantly, no OTP participating in the study will be prohibited by 
the FDA or the Drug Enforcement Administration (DEA) from operating 
because of failure to meet the standards for accreditation. It was also 
noted that an external advisory group, established as part of SAMHSA's 
CSAT National Advisory Council will assist in the evaluation of the 
study data. Ultimately, the Council will provide recommendations to 
SAMHSA on the accreditation project. These recommendations will be 
reviewed and discussed among Federal agencies represented in the 
Interagency Narcotic Treatment Policy Review Board, which includes 
ONDCP. SAMHSA and FDA request specific comments on this review process.

2. Accreditation, Conflicts of Interest

    Proposed Sec. 8.3(b)(6) and Sec. 8.4(g) address the policies and 
procedures established by the accreditation bodies to avoid conflicts 
of interest, or the appearance of conflicts of interest, by the 
applicant's board members, commissioners, professional personnel, 
consultants, administrative personnel, and other representatives. The 
proposal requested comments on the types of financial conflicts that 
should be prohibited, or on the amount of financial interest that may 
be considered de minimus such that it would not rise to a conflict of 
interest.

3. States as Accreditation Bodies

    Proposed Sec. 8.3(a) defines the term ``accreditation body'' to 
mean a body that has been approved by SAMHSA under proposed Sec. 8.3 to 
accredit OTPs. Under the proposal, private nonprofit organizations as 
well as State governmental entities, including a political subdivision 
of a State (such as a county) may apply to serve as an accreditation 
body. However, proposed Sec. 8.3 would limit eligibility to those 
applicants (including States and political subdivisions of a State) who 
demonstrate that they will be able to accredit at least 50 OTPs per 
year. The proposed rule specifically requested comment on this 
requirement, which was proposed to ensure the quality of the 
accreditation services performed by accreditation bodies and to 
minimize the variability in the standards used by accrediting 
organizations.

4. Procedures for Suspension/Revocation of Certification and 
Accreditation Body Approval

    Proposed Secs. 8.21-8.34 addresses the process and procedures for 
revoking approval or certification, including the procedures for a 
hearing. The proposal noted that DEA also has a process for review when 
a registration is revoked or suspended consistent with the requirements 
of 21 U.S.C. Sec. 824(c). The notice discussed possibilities for 
consolidating hearings under the lead of one agency. The Secretary, 
while proposing a separate hearing process, seeks comment on the 
proposed process.

5. Federal Opioid Treatment Standards, Criteria for Admission to 
Treatment

    Under proposed Sec. 8.12(e)(2) and (e)(4) the Secretary proposed a 
waiting period of no less than 7 days between detoxification treatment 
episodes. However, the Secretary tentatively concluded that 7 days is 
more time than is needed for this purpose, and may unnecessarily expose 
addicts to increased risks from HIV and other infectious diseases. The 
proposal requested comments on a shorter period, perhaps 2 days, as a 
waiting period between detoxification admissions.

6. Office-Based Treatment

    The preamble to the proposed rule discussed the growing interest in 
providing treatment outside the traditional treatment program setting 
as a way to increase access to treatment in general. In addition, the 
notice specifically requested comments on how the Federal opioid 
treatment standards might be modified to accommodate office-based 
treatment and on whether a separate set of Federal opioid treatment 
standards should be included in this rule for office-based treatment.

7. Medications Dispensed for Unsupervised Use (``Take-Homes'')

    In the July 22, 1999, notice, the Secretary proposed four options 
for determining whether OTPs comply with standards respecting the 
quantities of opioid drugs which may be provided to patients for 
unsupervised use. The

[[Page 56296]]

Secretary specifically requested comment on these approaches, as well 
as the optimal combination of regulatory requirements, accreditation 
elements, and oversight procedures to reduce the risks of diversion.

8. Analysis of Impacts

    The July 22, 1999, proposal included an extensive review and 
analysis of the estimated cost to affected opioid treatment programs 
for complying with the new regulations and the estimated cost to SAMHSA 
for enforcing the proposed regulations. The average annual net cost of 
this regulation was estimated to be $4.4 million. The notice requested 
comments and information to further assess or estimate the costs for 
programs to meet the requirements of the current regulations. In 
addition, the proposal requested comments on how to address the impact 
of the estimated costs on small entities.

III. Scope of Hearing

    The purpose of this hearing is to provide an additional opportunity 
for Federal officials to gather information that will aid in evaluating 
the proposed rule issued on July 22, 1999. In addition, it will provide 
an opportunity for panelists representing Federal agencies with 
interests and responsibilities in this area to question commentors, to 
the extent necessary, to clarify issues. It is not the purpose of this 
hearing to have Federal officials evaluating and making recommendations 
at this hearing on specific elements in the July 22, 1999, proposed 
rule.

IV. Notice of Hearing

    SAMHSA and FDA believe the format and procedures of a public 
hearing, at which interested persons can testify, will provide an 
additional opportunity to elicit the information needed to evaluate 
further the July 22, 1999, proposed rule.
    The public hearing is scheduled to begin at 9 a.m. in Conference 
Room D, Neuroscience Conference Center, 6001 Executive Blvd., 
Rockville, MD, 20852, on November 1, 1999. The presiding officers, H. 
Westley Clark, M.D., J.D., M.P.H., Director, Center for Substance Abuse 
Treatment (CSAT), Substance Abuse and Mental Health Services 
Administration, and David Lepay, M.D., Director, Division of Scientific 
Investigations, Center for Drug Evaluation and Research, Food and Drug 
Administration (FDA), will be accompanied by a panel of FDA, National 
Institutes of Health, DEA, Department of Veterans Affairs, and Office 
of National Drug Control Policy employees with relevant expertise.
     Persons who wish to participate are requested to notify CSAT of 
their intention by writing to CSAT at the address specified above on or 
before October 26, 1999. To ensure timely handling, the outer envelope 
should be clearly marked with Docket No. 98N-0671 and the phrase 
``Proposed Rule Public Hearing.'' The notice of participation should 
contain the interested person's name, address, telephone number, 
facsimile number, any business or organizational affiliation of the 
person desiring to make a presentation, a brief summary of the 
presentation, and the approximate time requested for the presentation. 
CSAT and FDA may ask that groups having similar interests consolidate 
their comments as part of a panel. CSAT and FDA will allocate the time 
available for the hearing among the persons who properly file notices 
of their intent to participate. If time permits, CSAT and FDA will 
allow interested persons attending the hearing who did not submit a 
notice of participation in advance to make an oral presentation at the 
conclusion of the hearing. Finally, CSAT and FDA request that those 
persons interested in attending the hearing, but not intending to 
testify, should also notify CSAT of the their intent to do so.
    Persons who find that there is insufficient time to submit the 
required information in writing may give oral notice of participation 
by calling Mr. Robert Lubran (telephone number above) no later than 
October 29, 1999.
    After reviewing the notices of participation and accompanying 
information, CSAT and FDA will schedule each appearance and notify each 
participant by mail or telephone of the time allotted to the persons 
and the approximate time the person's oral presentation is scheduled to 
begin. The hearing schedule will be available at the hearing.
    It should be noted that there are other opportunities for all 
interested persons to submit data, information, or views on the July 
22, 1999, proposed rule. As noted in July 22, 1999, notice, the 
administrative record will remain open until November 19, 1999. Persons 
who wish to provide additional materials for consideration are to file 
these materials in accordance with the instructions provided in that 
notice.
    The hearing is informal, and the rules of evidence do not apply. No 
participant may interrupt the presentation of another participant. Only 
the presiding officers and panel members may question any person during 
or at the conclusion of a presentation.

    Dated: October 12, 1999.
Nelba Chavez,
Administrator, Substance Abuse and Mental Health Services 
Administration.
[FR Doc. 99-27299 Filed 10-18-99; 8:45 am]
BILLING CODE 4160-17-P