Department of Health and Human Services August 3, 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of aerosolized antimicrobials for the management and/or treatment of patients with cystic fibrosis. Aerosolized antimicrobials are used to treat chronic bacterial infection in the lungs and thus improve the respiratory symptoms in patients with cystic fibrosis. This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of the design of clinical trials of aerosolized antimicrobials in patients with cystic fibrosis. The input from this public workshop will help in developing topics for further discussion.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Residual Drug in Transdermal and Related Drug Delivery Systems.'' This draft guidance provides recommendations to developers and manufacturers of transdermal drug delivery systems (TDDS), transmucosal drug delivery systems (TMDS), and topical patch products regarding use of an appropriate scientific approach during product design and developmentas well as during manufacturing and product lifecycle managementto ensure that the amount of residual drug substance at the end of the labeled use period is minimized. The draft guidance is applicable to investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental new drug applications (sNDAs) for TDDS, TMDS, and topical patch products.

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for certain establishments subject to registration. The FY 2011 fee rates are provided in this document. These fees apply from October 1, 2010, through September 30, 2011. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This document provides information on how the fees for FY 2011 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.

The Office of Public Health and Science, Office on Women's Health, HHS, is seeking nominations of qualified candidates to be considered for appointment as a member of the Chronic Fatigue Syndrome Advisory Committee (CFSAC). CFSAC provides science-based advice and recommendations to the Secretary of Health and Human Services, through the Assistant Secretary for Health, on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS). CFSAC, which was formerly known as the Chronic Fatigue Syndrome Coordinating Committee, was established by the Secretary of Health and Human Services on September 5, 2002. Several Committee member appointments are scheduled to end on April 1, 2011. Nominations of qualified candidates are being sought to fill future vacancies.

This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) to implement applicable statutory requirements and changes arising from our continuing experience with this system and to implement certain provisions of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (Affordable Care Act). In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These proposed changes would be applicable to services furnished on or after January 1, 2011.

This document corrects technical errors that appeared in the final rule with comment period found in the Federal Register (FR) on November 20, 2009, entitled ``Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment Rates'' and in the correction document found in the Federal Register on December 31, 2009, entitled ``Medicare Program: Changes to the Hospital Outpatient Prospective Payment System and CY 2010 Payment Rates; Changes to the Ambulatory Surgical Center Payment System and CY 2010 Payment Rates.''