Department of Health and Human Services April 21, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representatives; Reopening of Notification Period
The Food and Drug Administration (FDA) is reopening the period for industry organizations interested in participating in the selection of nonvoting industry representatives to represent the interests of the pharmaceutical manufacturing industry and the pharmacy compounding industry on the Pharmacy Compounding Advisory Committee for the Center for Drug Evaluation and Research to notify FDA of such interest. FDA announced a request for notification of interest in selection of industry representatives and for nominations in the Federal Register on January 13, 2014. This notice requested industry organizations that were interested in participation in the selection process to notify FDA in writing by February 12, 2014, and stated that nominations would be accepted for the two nonvoting vacancies by the same date. Industry organizations that did not notify FDA by the deadline of their interest in participating in the selection of nonvoting pharmacy compounding and pharmaceutical manufacturing industry representatives have now expressed interest in participating. Therefore, FDA is reopening the notification period for an additional two weeks so that any interested industry organizations wanting to participate can notify the Agency of their interest.
Agency Information Collection Activities; Proposed Collection; Comment Request; Risk and Benefit Perception Scale Development
The Food and Drug Administration (FDA) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study, Risk and Benefit Perception Scale Development. The study is designed to test different ways of measuring consumers' benefit and risk perceptions after exposure to direct-to-consumer (DTC) prescription drug advertising.
Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight
The Food and Drug Administration (FDA or Agency) is classifying the eyelid weight into class II (special controls). The Agency is exempting the external eyelid weight from premarket notification, but continuing to require premarket notification for implantable eyelid weights in order to provide a reasonable assurance of safety and effectiveness of the device. Both external and implantable eyelid weight devices are subject to special controls. The eyelid weight may be adhered to the outer skin of the upper eyelid (external eyelid weight) or implanted into the upper eyelid (implantable eyelid weight), and is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).
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