Schedules of controlled substances: placement of 5-methoxy-N,N-dimethyltryptamine into Schedule I of the Controlled Substances Act. Final rule

With the issuance of this final rule, the Deputy Administrator of the Drug Enforcement Administration (DEA) places the substance 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), including its salts, isomers and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act (CSA). This action by the DEA Deputy Administrator is based on a scheduling recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and a DEA review indicating that 5-MeO-DMT meets the criteria for placement in schedule I of the CSA. This final rule will impose the criminal sanctions and regulatory controls of schedule I substances under the CSA on the manufacture, distribution, dispensing, importation, exportation, and possession of 5-MeO-DMT.     

Schedules of controlled substances: placement of alpha-methyltryptamine and 5-methoxy-N,N-diisopropyltryptamine into schedule I of the Controlled Substances Act. Final rule

This final rulemaking is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place alpha-methyltryptamine (AMT) and 5-methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT) into Schedule I of the Controlled Substances Act (CSA). This action by the DEA Deputy Administrator is based on a scheduling recommendation by the Department of Health and Human Services (DHHS) and a DEA review indicating that AMT and 5-MeO-DIPT meet the criteria for placement in Schedule I of the CSA. This final rule will continue to impose the regulatory controls and criminal sanctions of Schedule I substances on the manufacture, distribution, and possession of AMT and 5-MeO-DIPT.     

Implementation of the Equal Access to Justice Act in agency proceedings--HHS. Final rule

These regulations implement the Equal Access to Justice Act, 5 U.S.C. 504 and 504 note, for the Department of Health and Human Services. They describe the circumstances under which the Department may award attorney fees and certain other expenses to eligible individuals and entities who prevail over the Department in specified administrative proceedings where the Department's position in the proceeding was not substantially justified.     

Schedules of controlled substances; placement of 2,5-dimethoxy-4-(n)-propylthiophenethylamine and N-benzylpiperazine into Schedule I of the Controlled Substances Act. Final rule

This final rulemaking is issued by the Acting Deputy Administrator of the Drug Enforcement Administration (DEA) to place 2,5-dimethoxy-4-(n)-propylthiophenethylamine (2C-T-7) and N-benzylpiperazine (BZP) into Schedule I of the Controlled Substances Act (CSA). This action by the DEA Acting Deputy Administrator is based on a scheduling recommendation by the Department of Health and Human Services (DHHS) and a DEA review indicating that 2C-T-7 and BZP meet the criteria for placement in Schedule I of the CSA. This final rule will continue to impose the regulatory controls and criminal sanctions of Schedule I substances on the manufacture, distribution, and possession of 2C-T-7 and BZP.     

Beneficiary travel under 38 U.S.C. 111 within the Unites. Final rule

This document amends the beneficiary travel regulations of the Department of Veterans Affairs (VA) that provide a mechanism for payment of travel expenses within the United States under 38 U.S.C. 111 to help veterans and other persons obtain care and services from VA's Veterans Health Administration (VHA). The amended regulations more fully implement the statutory provisions governing such payments.     

National Medical Support Notice. Office of Child Support Enforcement, Administration for Children and Families, HHS. Final rule

This rule implements provisions of the Child Support Performance and Incentives Act of 1998 (CSPIA), Public Law 105-200, that require State child support enforcement agencies, under title IV-D of the Social Security Act (the Act), to enforce the health care coverage provision in a child support order through the use of the National Medical Support Notice (NMSN). A proposed rule was published in the Federal Register on November 15, 1999 (64 FR 62074). After consideration of the written comments received, changes have been made in this final regulation, including changes to the NMSN found in the Appendix.     

Gastroenterology-urology devices: reclassification of the penile rigidity implant. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is reclassifying the penile rigidity implant from class III to class II when intended to provide penile rigidity in men diagnosed as having erectile dysfunction. The special control is the FDA guidance document entitled "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants." This action is taken on FDA's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.     

Special surveillance list of chemicals, products, materials and equipment used in the clandestine production of controlled substances or listed chemicals. Drug Enforcement Administration (DEA), Justice. Final notice

On October 3, 1996, the Comprehensive Methamphetamine Control Act of 1996 (MCA) was signed into law. The MCA makes it unlawful for any person to distribute a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, with reckless disregard for the illegal uses to which such laboratory supply will be put. Individuals who violate this provision are subject to a civil penalty of not more than $25,000; businesses which violate this provision are subject to a civil penalty of not more than $250,000. The term "laboratory supply" is defined as "a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General, which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals." This final notice contains the list of "laboratory supplies" which constitutes the Special Surveillance List that was required to be published by the Attorney General pursuant to Title 21, United States Code, Section 842(a).     

Medical devices; revocation of cardiac pacemaker registry. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to revoke a regulation requiring a cardiac pacemaker registry. The registry, which was mandated by the Deficit Reduction Act of 1984, requires any physician and any provider of services who requests or receives Medicare payment for an implantation, removal, or replacement of permanent cardiac pacemaker devices and pacemaker leads to submit certain information to the registry. The information is used by FDA to track the performance of permanent cardiac pacemakers and pacemaker leads and by the Health Care Finance Administration (HCFA) to administer its Medicare payment program for these devices. This action is being taken to implement an act to Repeal An Unnecessary Medical Device Reporting Requirement passed by Congress in 1996 to remove the cardiac pacemaker registry to eliminate duplicative and unnecessary reporting.     

Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its classification regulations to designate class I devices that are exempt from the premarket notification requirements, subject to certain limitations, and to designate those class I devices that remain subject to premarket notification requirements under the new statutory criteria for premarket notification requirements. The devices FDA is designating as exempt do not include class I devices that have been previously exempted by regulation from the premarket notification requirements. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in order to implement a requirement of FDAMA. Elsewhere in this issue of the Federal Register, FDA is announcing that it is withdrawing proposed rules to revoke existing exemptions from premarket notification for two devices.     

Prescriptions; dispensing controlled substances in institutional practitioner emergency rooms--Drug Enforcement Administration, Justice. Withdrawal of proposed rule

A Notice of Proposed Rulemaking published on September 17, 1982, would have amended Part 1306 of Title 21 of the Code of Federal Regulations to permit hospital emergency room personnel to dispense controlled substances to nonpatients when alternate pharmacy services were not available. This proposed action was initiated in response to requests from various state agencies and hospitals. After assessing the comments and objections to the proposal, the Drug Enforcement Administration (DEA) has determined that the need for the proposed rule change has not been established at this time and the proposal is therefore withdrawn for further study.     

Obstetrical and gynecological devices; classification of female condoms. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the preamendments female condom intended for contraceptive and prophylactic purposes. Under this rule, the preamendments female condom is being classified into class III (premarket approval). This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the FDA Modernization Act of 1997.     

Classification of two steroids, prostanozol and methasterone, as Schedule III anabolic steroids under the Controlled Substance Act. Final rule

With the issuance of this Final Rule, the Administrator of the DEA classifies the following two steroids as "anabolic steroids' under the Controlled Substances Act (CSA): prostanozol (17[beta]-hydroxy-5[alpha]-androstano[3,2-c]pyrazole) and methasterone (2[alpha],17[alpha]-dimethyl-5[alpha]-androstan-17[beta]-ol-3-one). These steroids and their salts, esters, and ethers are Schedule III controlled substances subject to the regulatory control provisions of the CSA.     

Immunology and Microbiology Devices; Classification of Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Test Systems. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is classifying the Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test system into class II (special controls). The special control that will apply to this device is a guidance document entitled "Guidance for Industry and FDA Reviewers: Class II Special Control Guidance Document for Anti-Saccharomyces cerevisiae (S. cerevisiae) Antibody (ASCA) Premarket Notifications." Elsewhere in this issue of the Federal Register. FDA is announcing the availability of this guidance document. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the devices.     

List of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness. Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending its regulations to include a list of drug products that may not be used for pharmacy compounding under the exemptions under section 503A of the Federal Food, Drug, and Cosmetic Act (the act) because they have had their approval withdrawn or were removed from the market because the drug product or its components have been found to be unsafe or not effective. The list has been compiled under the new statutory requirements of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).     

Regulations implementing the Federal Coal Mine Health and Safety Act of 1969, as amended. Employment Standards Administration, Labor. Final rule

On January 22, 1997, the Department issued a proposed rule to amend the regulations implementing the Black Lung Benefits Act. 62 FR 3338-3435 (Jan. 22, 1997). When the comment period closed on August 21, 1997, the Department had received written submissions from almost 200 interested persons, including coal miners, coal mine operators, insurers, physicians, and attorneys. The Department also held hearings in Charleston, West Virginia, and Washington, D.C. at which over 50 people testified. The Department carefully reviewed the testimony and the comments and, on October 8, 1999, issued a second notice of proposed rulemaking. 64 FR 54966-55072 (Oct. 8, 1999). In its second notice, the Department proposed changing several of the most important provisions in its initial proposal. The Department also explained its decision not to alter the original proposal with respect to other key regulations based on the comments received to date. Finally, the Department prepared an initial regulatory flexibility analysis. In order to ensure that small businesses that could be affected by the Department's proposal received appropriate notice of the Department's proposed changes, the Department mailed a copy of the second notice of proposed rulemaking to all coal mine operators contained in the databases maintained by the Mine Safety and Health Administration. The Department initially allowed interested parties until December 7, 1999 to file comments to its second proposal, but extended that period until January 6, 2000. The Department received 37 written submissions before the close of the comment period, from groups representing both coal miners and coal mine operators. The Department also received comments from individual miners, various coal mining and insurance companies, as well as from claims processing organizations, attorneys, and various professional organizations. The Department has carefully reviewed all of the comments, and is issuing its final rule. The rule contains a final regulatory flexibility analysis as required by the Regulatory Flexibility Act.