Department of Health and Human Services September 12, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 4 of 4
Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, and Implications for Dosing and Labeling; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Drug Interaction StudiesStudy Design, Data Analysis, and Implications for Dosing and Labeling.'' This document is intended to provide recommendations to sponsors of new drug applications (NDAs), and biologic license applications (BLAs) for therapeutic biologics (drugs) on carrying out in vitro or in vivo drug-drug interaction studies. The draft guidance reflects the current view that the metabolism and transport of a new drug should be defined during drug development and that its interactions with other drugs should be explored as part of an adequate assessment of the safety and effectiveness of the drug.
Training of Latin American Health Care Workers; Cooperative Agreement
This project will support the Gorgas Memorial Institute (GMI) to: (a) Develop a regional training center in Panam[aacute] and (b) train community health workers and clinicians (physicians, nurses, and auxiliary medical workers) and select public-health professionals from Central and South America, (c) facilitate partnerships (``twinning'') between U.S. universities and their Latin American counterparts to develop human resources for health in Latin America, and (d) harness the energies of U.S. and other non-governmental organizations by partnering with them to advance community health training and program efforts in Latin America. These efforts will contribute to improved and expanded provision of prevention and primary health care, and they will help engage significantly more areas of these countries to prepare for and respond to public health emergencies such as pandemic influenza. The training efforts of this project will place greater emphasis on the training of nurses and community health workers, rather than physicians, to reap the greatest improvement in expanded coverage and improved access to community, preventive and primary health care in underserved parts of Latin America (i.e., underserved rural and poor urban communities). In addition, as a result, the healthcare work force will be better prepared to respond to public health emergencies such as pandemic influenza. Key to the selection of recipients for this training will be their availability and willingness to commit to providing their health and medical care skills in underserved areas within the region. In addition to all appropriate medical care and health education or communication subjects, training supported by this project will emphasize infectious diseases, epidemiology, disease surveillance and outbreak response, among other subjects so graduates of training programs will be prepared to play contributing roles to any pandemic preparation and response.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection project: ``Eisenberg Center Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on July 5, 2006 and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
