Alcohol, Tobacco, Firearms, and Explosives Bureau August 20, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Agency Information Collection Activities; Proposed Collection; Comment Request; Comment Request; Interstate Shellfish Dealers Certificate
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on our 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 provisions of the Interstate Shellfish Dealers Certificate.
Lisa Marie Coroniti: Debarment Order
The U.S. Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Lisa Coroniti 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 Ms. Coroniti was convicted of a felony under Federal law for conduct relating to the regulation of a drug product. Ms. Coroniti was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Ms. Coroniti failed to request a hearing. Ms. Coroniti's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.
Technical Document for Using the Inactive Ingredient Database; Establishment of a Public Docket
The Food and Drug Administration (FDA, or the Agency) is announcing the establishment of a public docket to receive comments from interested parties on enhancing the utility and usability of the Inactive Ingredient Database (IID) (also known as the Inactive Ingredient Guide). These comments will help FDA identify best practices to assist Agency staff in designing the IID and maintaining the information contained therein. We intend to identify and further develop these best practices in a technical guide or draft guidance to be issued at a later date.
Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered to be tropical diseases for purposes of obtaining PRVs, and also provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' as set forth in the FD&C Act. FDA has determined that Chagas disease and neurocysticercosis satisfy this definition, and therefore is adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain applications for the treatment of Chagas disease and neurocysticercosis may be eligible to receive a PRV if such applications are approved by FDA.
Pediatric Advisory Committee; Notice of Meeting; Correction
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of August 12, 2015 (80 FR 48325). Phenylephrine Hydrochloride was incorrectly linked to DUREZOL (difluprednate ophthalmic emulsion) 0.05% because they were both listed as item number 1 in the numbered list of products to be discussed at the meeting. Phenylephrine Hydrochloride Ophthalmic Solution is a separate stand-alone drug that will be reviewed by the committee and should be listed as item number 2. The other drugs in the numbered list should be renumbered accordingly. This document corrects that error.
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