Department of Health and Human Services April 5, 2012 – Federal Register Recent Federal Regulation Documents
Results 1 - 13 of 13
Jose Concepcion: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Jose Concepcion for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on findings that Mr. Concepcion was convicted of conspiracy to commit an offense against the United States, that the conduct that served as the basis for the felony conspiracy conviction relates to the development or approval, including the process for development or approval, of any drug product and relates to the regulation of drug products under the FD&C Act, and that the type of conduct underlying the conviction undermines the process for the regulation of drugs. Mr. Concepcion was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Concepcion failed to request a hearing. Mr. Concepcion's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Activities; Proposed Collection; Comment Request; OAA Title III-C Evaluation
The Administration on Aging (AoA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to
Determination of Regulatory Review Period for Purposes of Patent Extension; FLECTOR
The Food and Drug Administration (FDA) has determined the regulatory review period for FLECTOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Ashish Macwan: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Ashish Macwan for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Macwan was convicted of one count of conspiracy to commit an offense against the United States for conduct relating to the development and approval, including the process for development and approval, of a drug product and to the regulation of drug products under the FD&C Act. In addition, the type of conduct underlying the conviction undermined the process for the regulation of drugs. Mr. Macwan was given notice of the proposed debarment and an opportunity to request a hearing within the time frame prescribed by regulation. Mr. Macwan failed to request a hearing, which constitutes a waiver of his right to a hearing concerning this action.
Shashikant Shah: Debarment Order
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Shashikant Shah for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Shah was convicted of one count of conspiracy to commit an offense against the United States for conduct relating to the development and approval, including the process for development and approval, of a drug product and to the regulation of drug products under the FD&C Act. In addition, the type of conduct underlying the conviction undermined the process for the regulation of drugs. Mr. Shah was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Shah failed to request a hearing, which constitutes a waiver of his right to a hearing concerning this action.
Request for Information on Prescription Medication Adherence
The Office of the Assistant Secretary for Health is seeking information about causes, impact and potential solutions associated with the public health problem of prescription medication non-adherence in adults with chronic conditions. The purpose of this notice is to provide individuals and organizations with the opportunity to identify issues relevant to all levels of government, as well as individuals, health care providers, and industry and private organizations in efforts to improve medication adherence in adults with chronic conditions. Comments that provide input on and evidence from interventions that improve adherence are particularly encouraged. Comments must be in writing and should not exceed 500 words. All comments will receive careful consideration. However, persons and organizations submitting comments will not receive individual responses.
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