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.     

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.     

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.     

Privacy Act of 1974; systems of records--PHS

In accordance with the requirements of the Privacy Act and the Debt Collection Act of 1932 (Pub. L. 97-365), the Public Health Service (PHS) is publishing a notice of a proposal to add three routine uses and a "special disclosure" statement to four systems of records in the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). PHS invites interested persons to submit comments on the proposed routine uses on or before February 27, 1984.     

Privacy Act of 1974; new system of records--Department of Health and Human Services. Notification of new system of records. Mental Health Epidemiologic and Biometric Research Data

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing a notice of a proposal to initiate a new system of records in the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA), National Institute of Mental Health (NIMH), entitled, "Mental Health Epidemiologic and Biometric Research Data, HHS/ADAMHA/NIMH." The purpose of the new system will be to maintain a data base for biometric and epidemiologic research in the area of mental health and mental illness. This system will allow the statistical analysis of research data to test hypotheses about relationships among the various items of information and generate new hypotheses to guide future research.     

Privacy Act of 1974; system of records--PHS. Notification of a proposal to add routine uses

In accordance with the requirements of the Privacy Act and the Debt Collection Art of 1982 ( Pub . L. 97-365), the Public Health Service (PHS) is publishing a notice of a proposal to expand one routine use and to add one routine use to three systems of records in the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). We are adding a further routine use to system of records 09-30-0031 only. PHS invites interested persons to submit comments on the proposed routine uses on or before July 2, 1984.     

Establishment, maintenance, and availability of records: amendment to record availability requirements. Interim final rule; request for comments

The Food and Drug Administration (FDA) is amending its regulations on establishment, maintenance, and availability of records. FDA is issuing this interim final rule (IFR) to amend FDA's regulation on the record availability requirements to implement the amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by the FDA Food Safety Modernization Act (FSMA). The FSMA amendment expands FDA's former records access authority beyond records relating to the specific suspect article of food to records relating to any other article of food that the Secretary of Health and Human Services (the Secretary) reasonably believes is likely to be affected in a similar manner. In addition, the FSMA amendment permits FDA to access records relating to articles of food for which the Secretary believes that there is a reasonable probability that the use of or exposure to the article of food, and any other article of food that the Secretary reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals. This expanded records access authority will further help improve FDA's ability to respond to, and further contain threats of serious adverse health consequences or death to humans or animals.     

Changes to patient limitation for dispensing or prescribing approved narcotic controlled substances for maintenance or detoxification treatment by qualified individual practitioners. Final rule

On September 20, 2007, the Drug Enforcement Administration (DEA) published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (72 FR 53734) proposing to conform its regulations to recent statutory amendments to the Controlled Substances Act that changed certain patient limitations for practitioners who dispense or prescribe certain narcotic drugs for maintenance or detoxification treatment. DEA received one comment in support of this rulemaking. DEA is finalizing the rule as proposed.     

Iron-containing supplements and drugs; label warning statements and unit-dose packaging requirements; removal of regulations for unit-dose packaging requirements for dietary supplements and drugs. Final rule; removal of regulatory provisions in response to court order

The Food and Drug Administration (FDA) is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.     

Quality assurance in nuclear medicine facilities; availability of final recommendations--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of final recommendations prepared by its Center for Devices and Radiological Health (CDRH) on quality assurance programs in nuclear medicine facilities. The final recommendations include the agency's rationale for the recommendations as well as references that can be used as well as references that can be used as guides in conducting quality control monitoring. These final recommendations are available as a technical report in CDRH's radiation recommendations series. They are intended to encourage and promote the development of voluntary quality assurance programs in nuclear medicine facilities.     

Medical devices; general hospital and personal use devices; classification of the filtering facepiece respirator for use by the general public in public health medical emergencies. Final rule

The Food and Drug Administration (FDA) is classifying the filtering facepiece respirator for use by the general public in public health medical emergencies into class II (special controls). The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of these devices and is specifying what those special controls are. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled, "Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies." This guidance document will serve as one of the special controls, along with certification of the respirator by the National Institute for Occupational Safety and Health (NIOSH) in accordance with its regulations for non-powered air-purifying particulate respirators, found in 42 CFR part 84, as specified in the classification regulation.     

Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).     

Biological products regulated under Section 351 of the Public Health Service Act; implementation of biologics license; elimination of establishment license and product license; public workshop--FDA. Proposed rule; notice of workshop

The Food and Drug Administration (FDA) is announcing a public workshop to present issues related to the agency's proposed rule entitled "Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License" issued recently in the Federal Register. The purpose of the public workshop is to provide interested persons an opportunity to more clearly understand the proposed rule and its effect on industry and the public.     

Privacy Act of 1974; proposed major alterations to an existing system of records--Public Health Service. Notice of proposed major alterations

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing a notice proposing major alterations in the Privacy Act system of records entitled "Grants Act system of records entitled "Grants: Research, Research Training, Research Scientist Development, Education, Demonstration, Fellowships, Clinical Training, Community Services, Cooperation Agreements, "HHS/ADAMHA/OA, 09-03-0027. The system contains the official documentation of the grant programs of the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). The proposed alterations are necessary to ensure compliance with recently added provisions in the Public Health Service Act (PHSA). Section 303 (42 U.S.C 242a), concerning clinical training awardees' payback obligations.     

Regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing regulations on the evaluation and approval of in vivo radiopharmaceuticals used in the diagnosis and monitoring of diseases. FDA is issuing these regulations in accordance with the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). These regulations are intended to clarify existing regulations applicable to the approval of radiopharmaceutical drugs and biologics under the Federal Food, Drug, and Cosmetic Act (the act) and the Public Health Service Act (the PHS Act).     

International Conference on Harmonisation; final recommendation for the revision of the permitted daily exposure for the solvent cumene according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a final recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C Impurities: Residual Solvents.' The recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).     

Medical devices; general hospital and personal use devices; classification of implantable radiofrequency transponder system for patient identification and health information. Final rule

The Food and Drug Administration (FDA) is classifying the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.     

International Conference on Harmonisation; final recommendations on the revision of the permitted daily exposures for two solvents, n-methylpyrrolidone and tetrahydrofuran, according to the maintenance procedures for the guidance Q3C Impurities: Residual Solvents; Availability. Notice

The Food and Drug Administration (FDA) is announcing final recommendations to revise the permitted daily exposures (PDEs) for two solvents, n-methylpyrrolidone (NMP) and tetrahydrofuran (THF), according to the maintenance procedures for the guidance for industry entitled "Q3C Impurities: Residual Solvents." The final recommendations were reached under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).