Department of Health and Human Services November 22, 2006 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry on Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Sinusitis: Designing Clinical Development Programs of Nonantimicrobial Drugs for Treatment.'' Sinusitis is a common disease affecting an estimated 16 percent of the adult U.S. population annually. At present, other than antimicrobials, the treatment options for sinusitis are limited. This guidance is intended to assist the pharmaceutical industry in designing clinical development programs for nonantimicrobial drug products for the treatment of sinusitis.
Children's Hospitals Graduate Medical Education Payment Program (CHGME PP)
This document announces a scheduled CHGME PP conference call for Federal fiscal year (FY) 2007. The purpose of this conference call is to discuss new annual reporting requirements as required under Public Law (Pub. L.) 109-307 for children's hospitals participating in the CHGME PP.
Notification and Obligation of the Federal Employee Antidiscrimination and Retaliation Act of 2002
This notice announces the notification and obligation of the Federal Employee Antidiscrimination and Retaliation Act of 2002 (No Fear Act). This notice is in compliance with the notification provisions set forth in Title II of the Notification and Federal Employee Antidiscrimination and Retaliation Act of 2002. The No FEAR Act requires that all Federal agencies publish an initial notice in the Federal Register informing Federal employees, former Federal employees, and applicants of the rights and protections available to them under Federal antidiscrimination and whistleblower protection laws.
Guidance for Industry and Food and Drug Administration Staff; Saline, Silicone Gel, and Alternative Breast Implants; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Saline, Silicone Gel, and Alternative Breast Implants.'' This version of the guidance document updates preclinical, clinical, and labeling recommendations described in ``Guidance for Saline, Silicone Gel, and Alternative Breast Implants,'' dated January 13, 2004. The update is based on the latest scientific and medical information on breast implants, and clarifies the type and amount of scientific data that should be submitted to allow FDA to evaluate whether these devices are safe and effective.
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