Authority for practitioners to dispense or prescribe approved narcotic controlled substances for maintenance or detoxification treatment. Final rule

DEA is amending its regulations to allow qualified practitioners not otherwise registered as a narcotic treatment program to dispense and prescribe to narcotic dependent persons Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. This Final Rule is in response to amendments to the Controlled Substances Act by the Drug Addiction Treatment Act of 2000 (DATA) that are designed to expand and improve treatment of narcotic addiction. This Final Rule is intended to accomplish the goals of DATA while preventing the diversion of Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for maintenance / detoxification treatment.     

Clarification of registration requirements for individual practitioners. Final rule

The Drug Enforcement Administration (DEA) is amending its registration regulations to make it clear that when an individual practitioner practices in more than one State, he or she must obtain a separate DEA registration for each State. This amendment will make it easier for practitioners to understand the requirements of the Controlled Substances Act and its implementing regulations.     

Grants to states for operation of qualified high risk pools. Final rule

This rule finalizes the interim final rule with comment period that was published on July 27, 2007, regarding extended funding for seed and operational grants for State High Risk Pools under the Public Health Service Act.     

Grants to states for operation of qualified high risk pools. Final rule

This final rule implements a provision of the Trade Adjustment Assistance Reform Act of 2002 by providing $40 million in Federal fiscal year 2003 and $40 million in Federal fiscal year 2004 to States that have incurred losses in connection with the operation of qualified high risk pools that meet certain criteria. This final rule also addresses comments received in response to the interim final rule that was published on May 2, 2003. This grant program implements section 2745 of the Public Health Service Act, as added by the Trade Adjustment Assistance Reform Act of 2002.     

Hazardous materials: revision to standards for infectious substances. Final rule

RSPA is revising transportation requirements for infectious substances, including regulated medical waste, to: adopt defining criteria and packaging requirements consistent with international standards; revise the current broad exceptions for diagnostic specimens and biological products; and authorize bulk packaging options for regulated medical waste consistent with requirements in international standards and DOT exemptions. These revisions will assure an acceptable level of safety for the transportation of infectious substances, and facilitate domestic and international transportation.     

Methadone in maintenance treatment of narcotic addicts; joint revision of conditions for use; interim maintenance treatment; human immunodeficiency virus disease counseling--FDA and SAMHSA. Final rule

The Food and Drug Administration (FDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) formerly the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA) are revising the conditions for the use of methadone in the maintenance treatment of narcotic addicts. The final rule allows, contingent on FDA and State approval, public and nonprofit private narcotic treatment programs to provide interim maintenance treatment to patients awaiting placement in comprehensive maintenance treatment and to require all narcotic treatment programs to provide counseling on preventing exposure to, and the transmission of, human immunodeficiency virus (HIV) disease.     

Schedules of controlled substances: rescheduling of buprenorphine from schedule V to schedule III. Final rule

This final rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to reschedule buprenorphine from a Schedule V narcotic to a Schedule III narcotic under the Controlled Substances Act (CSA). This action is based on a rescheduling recommendation by the Department of Health and Human Services (DHHS) and a DEA review indicating that buprenorphine meets the criteria of a Schedule III narcotic. The DEA published a proposed rule to reschedule buprenorphine on March 21, 2002 (67 FR 13114). The comment period was extended for an additional 30 days until May 22, 2002 (67 FR 20072). The DEA received ten comments but no requests for hearings. This final action will impose the regulatory controls and criminal sanctions of a Schedule III narcotic on those persons who handle buprenorphine or products containing buprenorphine     

Grants to states for operation of qualified high risk pools. Final rule with comment period

This final rule with comment period implements a provision of the Trade Assistance Reform Act of 2002 by providing $40 million in Federal fiscal year 2003 and $40 million in Federal fiscal year 2004 to States that have incurred losses in connection with the operation of qualified high risk pools that meet certain criteria. This grant program implements section 2745 of the Public Health Service Act, as added by the Trade Adjustment Assistance Reform Act of 2002.     

Opioid drugs in maintenance and detoxification treatment of opiate addiction; addition of buprenorphine and buprenorphine combination to list of approved opioid treatment medications. Interim final rule

This interim final rule amends the Federal opioid treatment program regulations by adding buprenorphine and buprenorphine combination products to the list of approved opioid treatment medications that may be used in federally certified and registered opioid treatment programs. The Food and Drug Administration (FDA) recently approved Subutex[reg] (buprenorphine) and Suboxone[reg] (buprenorphine in fixed combination with naloxone) for the treatment of opiate dependence. These two products will join methadone and ORLAAM[reg] as medications that may be used in opioid treatment programs for the maintenance and detoxification treatment of opioid dependence. Opioid treatment programs that choose to use these new products in the treatment of opioid dependence will adhere to the same Federal treatment standards established for methadone and ORLAAM[reg]. The Secretary invites public comments on this action.     

Opioid drugs in maintenance and detoxification treatment of opiate addiction; Substance Abuse and Mental Health Services Administration, HHS. Final rule

The Department of Health and Human Services and the Substance Abuse and Mental Health Services Administration (SAMHSA) are issuing final regulations for the use of narcotic drugs in maintenance and detoxification treatment of opioid addiction. This final rule repeals the existing narcotic treatment regulations enforced by the Food and Drug Administration (FDA), and creates a new regulatory system based on an accreditation model. In addition, this final rule shifts administrative responsibility and oversight from FDA to SAMHSA. This rulemaking initiative follows a study by the Institute of Medicine (IOM) and reflects recommendations by the IOM and several other entities to improve opioid addiction treatment by allowing for increased medical judgment in treatment.     

Definition of "positional isomer" as it pertains to the control of schedule I controlled substances. Final rule

On May 25, 2006, DEA published a Notice of Proposed Rulemaking which proposed the addition of a specific definition for the term "positional isomer" to allow for the systematic determination of which isomers of schedule I substances would be considered to be "positional," and therefore, subject to schedule I control. This rulemaking finalizes that definition. The Controlled Substances Act (CSA) and its implementing regulations specify which hallucinogenic substances are considered schedule I controlled substances. The CSA states that all salts, isomers, and salts of isomers of these substances are also schedule I controlled substances. In non-technical terms, an isomer of a substance is a different compound, but a compound which has the same number and kind of atoms. The terms "optical isomer" and "geometric isomer" are specific scientific terms and it is easy to determine whether one substance is an optical or geometric isomer of another. The term "positional isomer," however, is subject to scientific interpretation. The addition of a definition for the term "positional isomer" will assist legitimate research[ers] and industry in determining the control status of materials that are "positional isomers" of schedule I hallucinogens. While the DEA will remain the authority for ultimately determining the control status of a given material, providing a specific definition for "positional isomer" will ensure consistent criteria are utilized in making these determinations. This rule does not change existing laws, regulations, policies, processes, and procedures regarding the determination of control status for schedule I hallucinogenic substances. This rule merely makes available to the public the longstanding definition of "positional isomer" which DEA has used when making these scheduling determinations. This rule is relevant only to specialized forensic or research chemists. Most of these individuals are existing DEA registrants who are authorized by the DEA to handle schedule I hallucinogenic substances.     

Exceptions or alternatives to labeling requirements for products held by the Strategic National Stockpile. Final rule

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the interim final rule that issued regulations permitting FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). FDA is taking this action to complete the rulemaking initiated with the interim final rule.     

Payment of reimbursement for emergency treatment furnished by non-VA providers in non-VA facilities to certain veterans with service-connected or nonservice-connected disabilities. Final rule

This document amends the Department of Veterans Affairs (VA) medical regulations concerning emergency hospital care and medical services provided to eligible veterans at non-VA facilities. The amendments are required by section 402 of the Veterans' Mental Health and Other Care Improvements Act of 2008. Among other things, the amendments authorize VA to pay for emergency treatment provided to a veteran at a non-VA facility up to the time the veteran can be safely transferred to a VA or other Federal facility and such facility is capable of accepting the transfer, or until such transfer was actually accepted, so long as the non-VA facility made and documented reasonable attempts to transfer the veteran to a VA or other Federal facility.     

Medicare program; changes to the ambulatory surgical centers patient rights conditions for coverage. Final rule

This final rule revises the ambulatory surgical centers (ASCs) conditions for coverage (CfC) to allow patient rights information to be provided to the patient, the patient's representative, or the patient's surrogate prior to the start of the surgical procedure. In addition, we made minor changes to the CfC for patient rights requirements, as specified in the proposed rule. This final rule reflects the Centers for Medicare and Medicaid Services' (CMS') commitment to the general principles of the President's Executive Order 13563 released January 18, 2011, entitled "Improving Regulation and Regulatory Review.'     

Additional disability or death due to hospital care, medical or surgical treatment, examination, or training and rehabilitation services--VA. Final rule

This document amends the Department of Veterans Affairs (VA) adjudication regulations concerning awards of compensation or dependency and indemnity compensation for additional disability or death due to VA hospital care, medical or surgical treatment, examination, or training and rehabilitation services. Under this final rule, benefits are payable for additional disability or death caused by VA hospital care, medical or surgical treatment, or examination only if VA fault or "an event not reasonably foreseeable" proximately caused the disability or death. Benefits are also payable for additional disability or death proximately caused by VA's provision of training and rehabilitation services. This final rule is necessary to reflect Congress' recent amendment of 38 U.S.C. 1151, the statutory authority for such benefits.     

Infectious substances (etiologic agents); revisions to transitional provisions--Department of Transportation. Final rule; partial response to petition for reconsideration

This amendment extends the transition provisions in 49 CFR 171.14 concerning the regulations for the transportation of infectious substances (etiologic agents), which were published under Docket No. HM-142A (56 FR 197, January 3, 1991, and which was incorporated into Docket HM-181 in a final rule published September 18, 1991 (56 FR 47158). The September 18, 1991, final rule extended the effective date for certain quantities of infectious substances, partially in response to a petition for reconsideration. This further revision to the transition provisions in section 171.14 is necessary because RSPA anticipates issuing a further response to the petition for reconsideration in a forthcoming corrections document. This amendment also makes a minor technical correction to section 171.14(b)(4)(ii).     

Medicare program; allowing certifications and recertification by nurse practitioners and clinical nurse specialists for certain services--HCFA. Final rule with comment period

This final rule with comment period authorizes nurse practitioners and clinical nurse specialists, working in collaboration with a physician, to certify and recertify that extended care services are needed or continue to be needed. In addition, it sets forth the qualification requirements that a nurse practitioner or clinical nurse specialist must meet in order to sign certification or recertification statements. This final rule is necessary to implement section 6028 of the Omnibus Budget Reconciliation Act of 1989.