Schedules of Controlled Substances: Placement of Indiplon Into Schedule IV
This proposed rule is issued by the Deputy Administrator of the Drug Enforcement Administration (DEA) to place the substance indiplon (N-methyl-N-[3-[3-(2-thienylcarbonyl)-pyrazolo[1,5- a]pyrimidin-7- yl]phenyl]acetamide), including its salts, and all products containing indiplon into schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (DHHS) and an evaluation of the relevant data by DEA. This scheduling of indiplon in schedule IV will not be finalized until a New Drug Application (NDA) for an indiplon product is approved by the Food and Drug Administration (FDA). If finalized, this action will impose the regulatory controls and criminal sanctions applicable to schedule IV non-narcotics on those who handle indiplon and products containing indiplon.
Solicitation for a Cooperative Agreement: Strategic Planning Coordinator, Kansas Evidence Based Practices Implementation Effort
The National Institute of Corrections (NIC) solicits proposals from organizations or individuals for a 12-month cooperative agreement to provide coaching on executive leadership and complex project management to achieve the implementation of evidence based practices (EBP) on offender risk reduction in the Kansas Department of Corrections (KDOC) Community Corrections Act oversight unit and a limited number of local community corrections agencies. The project is jointly supported by NIC and the JEHT Foundation. This Request for Proposals seeks a successful applicant to facilitate the strategic change process at both the KDOC oversight and selected local community corrections agencies levels. The coaching will include evidence based policy and practice related to decision making by criminal justice officials and stakeholders; organizational development knowledge and strategies; and assessment, case management and behavioral interventions for the State's adult felony probation population. The selected applicant will need to be available for on site facilitation and off site coaching beginning early April, 2008, and continuing for twelve months thereafter. An initial site visit including NIC and JEHT representation will be scheduled upon award of the cooperative agreement.
Meeting of the Department of Justice's (DOJ's) Global Justice Information Sharing Initiative Federal Advisory Committee
This is an announcement of a meeting of DOJ's Global Justice Information Sharing Initiative (Global) Federal Advisory Committee (GAC) to discuss the Global Initiative, as described at http:// www.it.ojp.gov/global.
Registration Requirements for Importers and Manufacturers of Prescription Drug Products Containing Ephedrine, Pseudoephedrine, or Phenylpropanolamine
The Combat Methamphetamine Epidemic Act of 2005 (CMEA), which was enacted on March 9, 2006, requires DEA to establish an assessment of annual need for the importation and manufacture of ephedrine, pseudoephedrine, and phenylpropanolamine. Because of the new CMEA mandates for importation, import quotas, and production quotas for these chemicals, DEA must revise its registration provisions. The changes made by the CMEA render current DEA regulations inadequate for two reasons. First, although DEA registers bulk manufacturers of the three chemicals in the United States and importers of the bulk chemicals, some of those chemicals are distributed to non-registered companies that process them into prescription drugs. Under the Controlled Substances Act, section 826, production quotas are available only to registered manufacturers. DEA cannot meet the CMEA mandate to establish annual need and import quotas, and then issue individual quotas for each of the chemicals unless all manufacturers manufacturing or procuring the chemicals and manufacturing drug products that contain the chemicals are registered as manufacturers, even if the distribution of the final drug products is not regulated. DEA also must know the quantity of prescription drug products containing the three chemicals being imported. Without this information, DEA would not be able to determine an assessment of annual need for these chemicals. Any person importing prescription drug products containing any of the three chemicals must register although the distribution of these products would not be subject to DEA regulation. Second, persons currently registered to import, distribute, or dispense controlled substances who manufacture drug products using ephedrine, pseudoephedrine, or phenylpropanolamine, are not necessarily registered to do so. This must also be changed so that controlled substance registrants will only receive a waiver from the requirement of separate chemical registration if they engage in the same activity for both lawfully marketed drug products containing List I chemicals and controlled substances (as is already the case for bulk manufacture, imports, and exports.) In this way, any registrant that must obtain a quota to manufacture or procure one or more of the chemicals will be a registered manufacturer, as required by the CSA. Were DEA not to issue this rule, it would have no mechanism to issue production or import quotas for persons handling prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine. If these persons were not required to register, there would be no mechanism by which they would be permitted to apply for production or import quotas. Therefore, these persons would have no means by which to acquire the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine necessary for them to conduct business. Accordingly, DEA is proposing to amend its registration regulations to ensure that every location that manufactures or imports one of these chemicals or drug products that contain ephedrine, pseudoephedrine, or phenylpropanolamine is a DEA registered manufacturer or importer. These amendments will make it possible to establish the system of quotas and assessment of annual needs for the manufacturing that Congress mandated for ephedrine, pseudoephedrine, and phenylpropanolamine.
Technical Amendments to the Regulations Providing Whistleblower Protection for Federal Bureau of Investigation Employees
This rule makes several technical amendments to the Department of Justice regulations that provide whistleblower protection for Federal Bureau of Investigation (FBI) employees.