Thomas M. Rodgers, Jr.; Denial of Hearing; Debarment Order
The Food and Drug Administration (FDA) is denying Mr. Thomas M. Rodgers, Jr.'s request for a hearing and is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Mr. Thomas M. Rodgers, Jr., for 5 years from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a biologics license application. FDA bases this order on a finding that Mr. Rodgers was convicted of three misdemeanors under Federal law for conduct relating to the regulation of a drug product under the act, and that the type of conduct that served as the basis for the convictions undermines the process for the regulation of drugs. Mr. Rodgers failed to file with FDA information and analyses sufficient to create a basis for a hearing concerning this action. Therefore, FDA finds that there is no genuine and substantial issue of fact to grant a hearing on the debarment.
Proposed Vaccine Information Materials for Hepatitis A and Influenza Vaccines; Interim Vaccine Information Materials for Influenza Vaccines
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for hepatitis A and trivalent influenza vaccines. In addition, to ensure that influenza vaccine information materials are available at the beginning of the upcoming influenza vaccination season, this notice includes interim vaccine information materials covering influenza vaccines for use pending issuance of final influenza materials following completion of the formal NCVIA development process.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZUBRIN
The Food and Drug Administration (FDA) has determined the regulatory review period for ZUBRIN 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 animal drug product.