[Federal Register Volume 66, Number 53 (Monday, March 19, 2001)]
[Rules and Regulations]
[Pages 15347-15348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6745]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

21 CFR Part 291

42 CFR Part 8

RIN 0910-AA52


Opioid Drugs in Maintenance and Detoxification Treatment of 
Opiate Addiction; Repeal of Current Regulations and Issuance of New 
Regulations: Delay of Effective Date and Resultant Amendments to the 
Final Rule

AGENCY: Substance Abuse and Mental Health Services Administration, 
Department of Health and Human Services.

ACTION: Final rule; delay of effective date and resultant amendments to 
the final rule.

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SUMMARY: In accordance with the memorandum of January 20, 2001, from 
the Assistant to the President and Chief of Staff, entitled 
``Regulatory Review Plan,'' published in the Federal Register on 
January 24, 2001, this action temporarily delays for 60 days the 
effective date of the rule entitled ``Opioid Drugs in Maintenance and 
Detoxification Treatment of Opiate Addiction; Repeal of Current 
Regulations and Issuance of New Regulations'' published in the Federal 
Register on January 17, 2001 (66 FR 4076). It also amends the final 
rule published on January 17 to extend by 60 days the dates outlines in 
the rule for transitional certification of opioid treatment programs so 
as to be consistent with extending the effective date by that amount of 
time. That rule repealed the existing narcotic treatment regulations 
enforced by the Food and Drug Administration (FDA), and created a new 
regulatory system based on an accreditation model. It also shifted 
administrative responsibility and oversight of the program from FDA to 
SAMHSA.

DATES: This rule is effective March 18, 2001. The effective date of the 
``Opioid Drugs in Maintenance and Detoxification Treatment of Opiate 
Addiction'' published in the Federal Register on January 17, 2001 (66 
FR 4076), is delayed for 60 days, from March 19, 2001 to a new 
effective date of May 18, 2001.

FOR FURTHER INFORMATION CONTACT: Nicholas Reuter, Center for Substance 
Abuse Treatment (CSAT), SAMHSA, Rockwell II, 5600 Fishers Lane, Rm 12-
05, Rockville, MD 20857, 301-443-0457, email: [email protected].

SUPPLEMENTARY INFORMATION: To the extent that 5 U.S.C. section 553 
applies to this action, it is exempt from notice and comment because it 
constitutes a rule of procedure under 5 U.S.C. section 553(b)(A). 
Alternatively, the Department's implementation of this rule without 
opportunity for public comment, effective immediately upon publication 
today in the Federal Register, is based on the good cause exceptions in 
5 U.S.C. section 553(b)(B) and 553(b)(3). Seeking public comment is 
impracticable, unnecessary and contrary to the public interest. The 
temporary 60-day delay in effective date is necessary to give 
Department officials the opportunity for further review and 
consideration of new regulations, consistent with the Assistant to the 
President's memorandum of January 20, 2001. Given the imminence of the 
effective date, seeking prior public comment on this temporary delay 
would have been impractical, as well as contrary to the public interest 
in the orderly promulgation and implementation of regulations.

List of Subjects in 42 CFR Part 8

    Health professions, Levo-Alpha-Acetyl-Methadol (LAAM), Methadone, 
Reporting and recordkeeping requirements.

    Dated: January 14, 2001.
Tommy G. Thompson,
Department of Health and Human Services.

    For the reasons set forth above, Part 8 of Title 42 of the Code of 
Federal Regulations is amended as follows:
    1. The authority citation for Part 8 continue to read as follows:
    21 U.S.C. 823; Sections 301(d), 543, and 1976 of the 42 U.S.C. 
257a, 290aa(d), 290 dd-2, 300x-23, 300x-27(a), 300y-11.

    2. Section 8.11(d) is revised to read as follows:


Sec. 8.11  Opioid treatment program certification.

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[[Page 15348]]

    (d) Transitional certification. OTPs that before May 18, 2001 were 
the subject of a current, valid approval by FDA under 21 CFR, part 291 
(contained in the 21 CFR parts 200 to 299 edition, revised as of July 
1, 2000), are deemed to be the subject of a current valid certification 
for purposes of paragraph (a)(11) of this section. Such ``transitional 
certification'' will expire on August 17, 2001 unless the OTP submits 
the information required by paragraph (b) of this section to SAMHSA on 
or before August 17, 2001. In addition to this application, OTPs must 
certify with a written statement signed by the program sponsor, that 
they will apply for accreditation within 90 days of the date SAMHSA 
approves the second accreditation body. Transitional certification, in 
that case, will expire on May 19, 2003. SAMHSA may extend the 
transitional certification of an OTP for up to one additional year 
provided the OTP demonstrates that it has applied for accreditation, 
that an accreditation survey has taken place or is scheduled to take 
place, and that an accreditation decision is expected within a 
reasonable period of time (e.g., within 90 days from the date of 
survey). Transitional certification under this section may be suspended 
or revoked in accordance with Sec. 8.14.
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[FR Doc. 01-6745 Filed 3-16-01; 8:45 am]
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