[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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