The Federal Register

Phenylpropanolamine-Containing Drug Products for Over-the-Counter Human Use; Tentative Final Monographs

Thu, Dec 22 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is issuing a notice of proposed rulemaking (notice) for overthecounter (OTC) nasal decongestant and weight control drug products containing
phenylpropanolamine preparations. This proposed rule reclassifies phenylpropanolamine preparations from their previously proposed monograph status (Category I) for these uses to nonmonograph (Category II)
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status based on safety concerns. FDA is issuing this proposed rule after considering new data and information on the safety of phenylpropanolamine as part of its ongoing review of OTC drug products.

Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Public

Thu, Dec 22 2005 11:00:00 GMT

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, 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 FDA Public Health Notification (formerly known as Safety Alert/Public Health Advisory) Readership Survey.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Thu, Dec 22 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Advisory Committees; Tentative Schedule of Meetings for 2006

Thu, Dec 22 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2006. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (the IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of the IOM's recommendations was for the agency to publish an annual tentative schedule of its meetings in the Federal Register. This publication implements the IOM's recommendation.

Hand-Held, Doppler Ultrasound Prenatal Listening Devices

Thu, Dec 22 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing a public workshop to discuss scientific information bearing on whether handheld Doppler ultrasound prenatal listening devices should be made available for use overthecounter (OTC). This 1day workshop is intended to provide members of the academic, scientific, and clinical communities; industry; consumer, and patient advocacy groups; and others with a forum for presenting their perspectives about available scientific literature and clinical studies relating to handheld Doppler ultrasound prenatal listening devices. Written comments submitted to the docket before the workshop and information gathered at the workshop will be used by FDA to further identify and evaluate the risks and benefits associated with possible OTC availability of handheld prenatal Doppler ultrasound listening devices.

Date and Time: The public workshop will be held on Wednesday, March 29, 2006, from 9 a.m. to 3:30 p.m. The deadline for registration is Friday, Marc