Page:United States Statutes at Large Volume 114 Part 3.djvu/348

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114 STAT. 1654A-306 PUBLIC LAW 106-398—APPENDIX shall be established by regulation. Any such criteria are effective only for 3 years after the date on which the criteria are promulgated, but may be extended for such additional discrete 3-year periods as the Secretary considers appropriate for purposes of this subclause. Such an extension of criteria may only be effectuated through a statement published in the Federal Register by the Secretary during the 30-day period preceding the end of the 3-year period involved. "(H)(i) In consultation with the Administrator of the Drug Enforcement Administration, the Administrator of the Substance Abuse and Mental Health Services Administration, the Director of the National Institute on Drug Abuse, and the Commissioner of Food and Drugs, the Secretary shall issue regulations (through notice and comment rulemaking) or issue practice guidelines to address the following: "(I) Approval of additional credentialing bodies and the responsibilities of additional credentialing bodies. "(II) Additional exemptions from the requirements of this paragraph and any regulations under this paragraph. Nothing in such regulations or practice guidelines may authorize any Federal official or employee to exercise supervision or control over the practice of medicine or the manner in which medical services are provided. "(ii) Not later than 120 days after the date of the enactment of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001, the Secretary shall issue a treatment improvement protocol containing best practice guidelines for the treatment and maintenance of opiate-dependent patients. The Secretary shall develop the protocol in consultation with the Director of the National Institute on Drug Abuse, the Administrator of the Drug Enforcement Administration, the Commissioner of Food and Drugs, the Administrator of the Substance Abuse and Mental Health Services Administration, and other substance abuse disorder professionals. The protocol shall be guided by science. "(I) During the 3-year period beginning on the date of the enactment of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001, a State may not preclude a practitioner from dispensing or prescribing drugs in schedule III, IV, or V or combinations of such drugs, to patients for maintenance or detoxification treatment in accordance with this paragraph unless, before the expiration of that 3-year period, the State enacts a law prohibiting a practitioner from dispensing such drugs or combinations of drug. "(J)(i) This paragraph takes effect on the date of the enactment of the Floyd D. Spence National Defense Authorization Act for Fiscal Year 2001, and remains in effect thereafter except as provided in clause (iii) (relating to a decision by the Secretary or the Attorney General that this paragraph should not remain in effect). "(ii) For purposes relating to clause (iii), the Secretary and the Attorney General may, during the 3-year period beginning on the date of the enactment of the Floyd D. Spence Nationgd Defense Authorization Act for Fiscal Year 2001, make determinations in accordance with the following: "(I) The Secretary may make a determination of whether treatments provided under waivers under subparagraph (A)