Agency for International Development 2015 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services and the other Federal Departments and Agencies listed in this document are extending the comment period on the Federal Policy for the Protection of Human Subjects notice of proposed rulemaking. The NPRM requests comment on proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. The NPRM was published in the Federal Register on September 8, 2015.

The U.S. Agency for International Development (USAID) seeks public comment on a proposed rule that would revise the Agency for International Development Acquisition Regulation (AIDAR) to maintain consistency with Federal and Agency regulations and incorporate current and new USAID clauses into the regulation.

USAID is issuing a final rule adopting with amendments the ``Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards,'' issued by the Office of Management and Budget and published in Federal Register on December 26, 2013. Consistent with the OMB rule, USAID's rule supersedes USAID's ``Administration of Assistance Awards to U.S. Non-Governmental Organizations.'' Parts of this final rule apply to for-profit entities in limited circumstances and to foreign organizations as described in this guidance.

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration removes [\123\I]ioflupane from the schedules of the Controlled Substances Act. This action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after an opportunity for a hearing through formal rulemaking. Prior to the effective date of this rule, [\123\I]ioflupane was, by definition, a schedule II controlled substance because it is derived from cocaine via ecgonine, both of which are schedule II controlled substances. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle [\123\I]ioflupane.

Patheon Pharmaceuticals, Inc. applied to be registered as a manufacturer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Patheon Pharmaceuticals, Inc. registration as a manufacturer of this controlled substance.

Cody Laboratories, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as a manufacturer of those controlled substances.

Cayman Chemicals Company applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cayman Chemicals Company registration as a manufacturer of those controlled substances.

Sigma-Aldrich International GMBH, Sigma Aldrich Co., LLC applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Sigma-Aldrich International GMBH, Sigma Aldrich Co., LLC registration as an importer of those controlled substances.

Almac Clinical Services Inc. (ACSI) applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Almac Clinical Services Inc. (ACSI) registration as an importer of those controlled substances.

Hospira applied to be registered as an importer of certain basic class of controlled substances. The Drug Enforcement Administration (DEA) grants Hospira registration as an importer of this controlled substance.

Pharmacore, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Pharmacore, Inc. registration as a manufacturer of those controlled substances.