http://www.scribd.com/people/view/199069-fda This a feed for documents on Scribd written by FDA 30 Wed, 23 Jan 2008 22:19:14 GMT Wed, 23 Jan 2008 22:19:14 GMT http://www.scribd.com/doc/1441846/US-Food-and-Drug-Administration-medwatchonline Wed, 23 Jan 2008 22:19:14 GMT http://www.scribd.com/doc/1441846/US-Food-and-Drug-Administration-medwatchonline http://www.scribd.com/doc/1441838/US-Food-and-Drug-Administration-VaersDataEntryintro Wed, 23 Jan 2008 22:19:09 GMT http://www.scribd.com/doc/1441838/US-Food-and-Drug-Administration-VaersDataEntryintro http://www.scribd.com/doc/1441825/US-Food-and-Drug-Administration-wer7741 2002, 77, 341–348 No. 41 Weekly epidemiological record Relevé épidémiologique hebdomadaire 11 OCTOBER 2002, 77th YEAR / 11 OCTOBRE 2002, 77e ANNÉE No. 41, 2002, 77, 341–348 http://www.who.int/wer Contents 341 Outbreak news 341 Limited measles outbreak, Tunisia, 2002 344 Recommended composition of influenza virus vaccines for use in the 2003 influenza season 348 International Health Regulations Q OUTBREAK NEWS Yellow fever, Senegal The Ministry of Health has officially confirmed a total of 12 cases of yellow fever in the department of Mbacké, which includes the city of Touba with 8 Wed, 23 Jan 2008 22:19:02 GMT http://www.scribd.com/doc/1441825/US-Food-and-Drug-Administration-wer7741 http://www.scribd.com/doc/1441823/US-Food-and-Drug-Administration-wer7608 2001, 76, 57–64 No. 8 Weekly epidemiological record Relevé épidémiologique hebdomadaire 23 FEBRUARY 2001, 76th YEAR / 23 FÉVRIER 2001, 76e ANNÉE No. 8, 2001, 76, 57–64 http://www.who.int/wer Contents 57 Outbreak news 58 Recommended composition of influenza virus vaccines for use in the 2001-2002 season 61 Revision of the International Health Regulations 64 Influenza 64 Global SalmSurv External Quality Assurance System 64 International Health Regulations Q OUTBREAK NEWS Meningococcal disease, African meningitis belt. The highest number of cases and the highest burden of this diseas Wed, 23 Jan 2008 22:19:00 GMT http://www.scribd.com/doc/1441823/US-Food-and-Drug-Administration-wer7608 http://www.scribd.com/doc/1441821/US-Food-and-Drug-Administration-WHO2 Report to the World Health Organization (WHO) on a Plan for International Registration of Controlled Trials Draft This document represents a draft of a position paper on this topic. It is a work-in-progress and aims to signal the important issues related to the topic. We emphasize that the final document will be developed based on perspectives, comments and suggestions from the various regional consultations to enable critical inputs from regional and country perspectives to be included in the final version. SEND COMMENTS AND SUGGESTIONS TO: Kay_Dickersin@brown.edu The need for registers of Wed, 23 Jan 2008 22:18:58 GMT http://www.scribd.com/doc/1441821/US-Food-and-Drug-Administration-WHO2 http://www.scribd.com/doc/1441819/US-Food-and-Drug-Administration-ictrp-sag-meeting-april2005-conclusions ocixeM ,ytiC ocixeM ,4002 rebmevoN 02-61 1 .stnemeerga eseht ezi lanoitarepo ot stnapicitrap eht htiw krow l liw dna stnemmoc gnitcelloc si tairaterceS ehT .”tfard“ sa dedrager eb dluohs dna gniteem eht gnirud deerga sa detneserp yltnerruc era esehT :etoN noitatlusnoC eht fo semoctuO .II .noisses yranelp eht ta noissucsid rof snoitadnemmocer etalumrof ot deksa saw dna ksat a dna evitcejbo na nevig saw puorg hcaE eloR OHW dna retsigeR ot erehW :4 PUORG sdradnatS erusolcsiD stluseR :3 PUORG )tes atad mum iniM( scitsiretcarahC slairT :2 PUORG )retsiger ot slairt hcihW( sdradnatS noitartsig Wed, 23 Jan 2008 22:18:57 GMT http://www.scribd.com/doc/1441819/US-Food-and-Drug-Administration-ictrp-sag-meeting-april2005-conclusions http://www.scribd.com/doc/1441817/US-Food-and-Drug-Administration-who-fao-expert-report This report contains the collective views of an international group of experts and does not necessarily represent the decisions or the stated policy of the World Health Organization or of the Food and Agriculture Organization of the United Nations WHO Technical Report Series 916 DIET, NUTRITION AND THE PREVENTION OF CHRONIC DISEASES Report of a Joint WHO/FAO Expert Consultation World Health Organization Geneva 2003 *WHO Library Cataloguing-in-Publication Data Joint WHO/FAO Expert Consultation on Diet, Nutrition and the Prevention of Chronic Diseases (2002 : Geneva, Switzerland) Diet, nutr Wed, 23 Jan 2008 22:18:55 GMT http://www.scribd.com/doc/1441817/US-Food-and-Drug-Administration-who-fao-expert-report http://www.scribd.com/doc/1441808/US-Food-and-Drug-Administration-GIP-2005-5Eweb WHO/CDS/CSR/GIP/2005.5 EPIDEMIC ALERT & RESPONSE WHO global influenza preparedness plan The role of WHO and recommendations for national measures before and during pandemics Department of Communicable Disease Surveillance and Response Global Influenza Programme *© World Health Organization 2005 All rights reserved. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or co Wed, 23 Jan 2008 22:18:48 GMT http://www.scribd.com/doc/1441808/US-Food-and-Drug-Administration-GIP-2005-5Eweb http://www.scribd.com/doc/1441802/US-Food-and-Drug-Administration-2007northreport 2006-02-14 16:28:04 Recommended composition of influenza virus vaccines for use in the 2006–2007 influenza season This recommendation relates to the composition of vaccines for the forthcoming influenza season in the northern hemisphere (November 2006 to April 2007). A recommendation will be made in September 2006 relating to vaccines that will be used for the influenza season in the southern hemisphere (May to September 2007). Epidemiological considerations will influence which recommendation (February or September) is more appropriate for countries in equatorial regions. Influenza activi Wed, 23 Jan 2008 22:18:45 GMT http://www.scribd.com/doc/1441802/US-Food-and-Drug-Administration-2007northreport http://www.scribd.com/doc/1441799/US-Food-and-Drug-Administration-prescrip-fs REDUCING PRESCRIPTION DRUG ABUSE Non-medical use of addictive prescription drugs has been increasing throughout the United States at alarming rates. According to the National Survey on Drug Use and Health, in 2002, an estimated 6.2 million Americans reported past month use of prescription drugs for non-medical purposes. Nearly 14 percent of youth between the ages of 12 and 17 have used such drugs, which include pain relievers, sedatives/tranquilizers, or stimulants, for non-medical purposes at some point in their lives. Emergency room visits associated with narcotic pain relievers have increas Wed, 23 Jan 2008 22:18:43 GMT http://www.scribd.com/doc/1441799/US-Food-and-Drug-Administration-prescrip-fs http://www.scribd.com/doc/1441787/US-Food-and-Drug-Administration-nspi-implementation N at i o n a l S t r at e g y f o r pandemic influenza implementation plan homeland security council m ay 2006 *N at i o n a l S t r at e g y f o r pandemic influenza implementation plan homeland security council m ay 2006 **Table of Contents PREFACE .................................................................................................................................................................................................vii CHAPTER 1 - EXECUTIVE SUMMARY......................................................................................................... Wed, 23 Jan 2008 22:18:38 GMT http://www.scribd.com/doc/1441787/US-Food-and-Drug-Administration-nspi-implementation http://www.scribd.com/doc/1441776/US-Food-and-Drug-Administration-vaers-form WEBSITE: www.vaers.hhs.gov E-MAIL: info@vaers.org FAX: 1-877-721-0366 VACCINE ADVERSE EVENT REPORTING SYSTEM 24 Hour Toll-Free Information 1-800-822-7967 P.O. Box 1100, Rockville, MD 20849-1100 PATIENT IDENTITY KEPT CONFIDENTIAL Patient Name: Last Address For CDC/FDA Use Only VAERS Number Date Received Form completed by (Name): Relation Vaccine Provider Patient/Parent to Patient Manufacturer Other Address (if different from patient or provider) Vaccine administered by (Name): First M.I. Responsible Physician Facility Name/Address City State Zip City State Zip City State Zip Tele Wed, 23 Jan 2008 22:18:30 GMT http://www.scribd.com/doc/1441776/US-Food-and-Drug-Administration-vaers-form http://www.scribd.com/doc/1441775/US-Food-and-Drug-Administration-VAERS-folleto ¿Qué es VAERS? El Sistema para Reportar Reacciones Adversas a las Vacunas (VAERS, por sus siglas en inglés) es un programa nacional para vigilar la seguridad de las vacunas después que son aprobadas. Este programa es supervisado por los Centros para el Control y la Prevención de Enfermedades de EE.UU. (CDC, por sus siglas en inglés) y la Administración de Medicinas y Alimentos de EE.UU. (FDA, por sus siglas en inglés). VAERS es parte de un sistema mayor, el cual asegura que las vacunas no causen daño y que funcionen según se diseñaron. Para esto, se toman medidas antes y después qu Wed, 23 Jan 2008 22:18:29 GMT http://www.scribd.com/doc/1441775/US-Food-and-Drug-Administration-VAERS-folleto http://www.scribd.com/doc/1441773/US-Food-and-Drug-Administration-VAERS-brochure What Is VAERS? The Vaccine Adverse Event Reporting System (VAERS) is a national program that monitors the safety of vaccines after they are licensed. VAERS is managed by the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS is part of a larger system that makes sure that vaccines are safe and work as intended. Steps to make sure that vaccines are safe begin before a vaccine is licensed and continue afterward. Before a vaccine is licensed, FDA requires that it go through extensive safety testing. After a vaccine is licensed,VAERS is use Wed, 23 Jan 2008 22:18:27 GMT http://www.scribd.com/doc/1441773/US-Food-and-Drug-Administration-VAERS-brochure http://www.scribd.com/doc/1441764/US-Food-and-Drug-Administration-trackandconfirm Wed, 23 Jan 2008 22:18:23 GMT http://www.scribd.com/doc/1441764/US-Food-and-Drug-Administration-trackandconfirm http://www.scribd.com/doc/1441758/US-Food-and-Drug-Administration-receivemailinotherplaces Wed, 23 Jan 2008 22:18:18 GMT http://www.scribd.com/doc/1441758/US-Food-and-Drug-Administration-receivemailinotherplaces http://www.scribd.com/doc/1441753/US-Food-and-Drug-Administration-moversguide Wed, 23 Jan 2008 22:18:15 GMT http://www.scribd.com/doc/1441753/US-Food-and-Drug-Administration-moversguide http://www.scribd.com/doc/1441749/US-Food-and-Drug-Administration-poboxrentals Wed, 23 Jan 2008 22:18:12 GMT http://www.scribd.com/doc/1441749/US-Food-and-Drug-Administration-poboxrentals http://www.scribd.com/doc/1441739/US-Food-and-Drug-Administration-holdmail-redirect Wed, 23 Jan 2008 22:18:02 GMT http://www.scribd.com/doc/1441739/US-Food-and-Drug-Administration-holdmail-redirect http://www.scribd.com/doc/1441733/US-Food-and-Drug-Administration-18usc207 WAIS Document RetrievalFrom the U.S. Code Online via GPO Access [wais.access.gpo.gov] [Laws in effect as of January 7, 2003] [Document not affected by Public Laws enacted between January 7, 2003 and February 12, 2003] [CITE: 18USC207] TITLE 18--CRIMES AND CRIMINAL PROCEDURE PART I--CRIMES CHAPTER 11--BRIBERY, GRAFT, AND CONFLICTS OF INTEREST Sec. 207. Restrictions on former officers, employees, and elected officials of the executive and legislative branches (a) Restrictions on All Officers and Employees of the Executive Branch and Certain Other Agencies.-(1) Permanent restrictions on represent Wed, 23 Jan 2008 22:17:59 GMT http://www.scribd.com/doc/1441733/US-Food-and-Drug-Administration-18usc207 http://www.scribd.com/doc/1441730/US-Food-and-Drug-Administration-rfsoc-02 Standards of Ethical Conduct for Employees of the Executive Branch October 2002 *STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE EXECUTIVE BRANCH Final Regulation Issued by the U.S. Office of Government Ethics Codified in 5 C.F.R. Part 2635 (1/1/02 Edition), as amended at 67 FR 61761-61762 (Oct. 2, 2002) OGE 10/02/02 *TABLE OF CONTENTS SUBPART A - GENERAL PROVISIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 § 2635.101 Basic obligation of public service. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 § 2 Wed, 23 Jan 2008 22:17:58 GMT http://www.scribd.com/doc/1441730/US-Food-and-Drug-Administration-rfsoc-02 http://www.scribd.com/doc/1441725/US-Food-and-Drug-Administration-fog-v3 Field Operations Guide for Disaster Assessment and Response U.S. Agency for International Development Bureau for Humanitarian Response Office of Foreign Disaster Assistance In cooperation with and produced by the USDA Forest Service International Programs Disaster Assistance Support Program Version 3.0 *CONTENTS Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii Policy Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix Chapter I. General Responsibilities and Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Individua Wed, 23 Jan 2008 22:17:54 GMT http://www.scribd.com/doc/1441725/US-Food-and-Drug-Administration-fog-v3 http://www.scribd.com/doc/1441718/US-Food-and-Drug-Administration-EPAJAN Framework for Environmental Health Risk Management The Presidential/Congressional Commission on Risk Assessment and Risk Management Final Report Volume 1 1997 *The Presidential/Congressional Commission on Risk Assessment and Risk Management Gilbert S. Omenn (Chairman), Dean, School of Public Health and Community Medicine, University of Washington, Seattle, WA Alan C. Kessler (Vice-Chairman), Partner, Buchanan Ingersoll, Philadelphia, PA Norman T. Anderson, Director of Research, American Lung Association of Maine, Augusta, ME Peter Y. Chiu, Senior Physician, Kaiser Permanente, Milpitas, CA Jo Wed, 23 Jan 2008 22:17:48 GMT http://www.scribd.com/doc/1441718/US-Food-and-Drug-Administration-EPAJAN http://www.scribd.com/doc/1441713/US-Food-and-Drug-Administration-newlabel ***** Wed, 23 Jan 2008 22:17:42 GMT http://www.scribd.com/doc/1441713/US-Food-and-Drug-Administration-newlabel http://www.scribd.com/doc/1441711/US-Food-and-Drug-Administration-sherman-22 Preclinica A BioTechniques® Publication Volume 2, No. 2 ™ March/April, 2004 Looking Through a Window of the Food and Drug Administration: FDA's Advisory Committee System Linda Ann Sherman Director, Advisory Committee Oversight & Management Staff, Food and Drug Administration, Rockville, MD, USA Reprinted with permission from Preclinica 2(2): 99-102 (March/April 2004) The U.S. FDA is one of the most recognized and respected federal agencies in the world. It is responsible for food safety policy and for the regulation of more than 150,000 marketed medical products. Not only does the Agen Wed, 23 Jan 2008 22:17:40 GMT http://www.scribd.com/doc/1441711/US-Food-and-Drug-Administration-sherman-22 http://www.scribd.com/doc/1441707/US-Food-and-Drug-Administration-ceq-ostp-study5 CASE STUDY No. IV FARM ANIMAL (GOAT) THAT PRODUCES HUMAN DRUGS Overview This case study examines in a general way the proposed use of genetically engineered animals to produce protein biologics for use in human therapy, referred to herein as “human biologics1,” “human proteins,” or “transgenic proteins,” including the disposition of those animals. The case study uses the example of a goat engineered to express a human protein in its milk. The protein is then extracted and purified for therapeutic use in humans. While there are products under review, because no such product has comp Wed, 23 Jan 2008 22:17:37 GMT http://www.scribd.com/doc/1441707/US-Food-and-Drug-Administration-ceq-ostp-study5 http://www.scribd.com/doc/1441706/US-Food-and-Drug-Administration-ceq-ostp-study2 CASE STUDY No. I GROWTH-ENHANCED SALMON Overview This case study concerns the potential aquaculture production or importation of Atlantic salmon (Salmo salar L.) genetically engineered to contain an additional fish growth hormone gene that is intended to make the Atlantic salmon grow faster and use feed more efficiently. In general, brood stocks of such fish would be raised in conventional inland hatcheries, where brood stock would be treated to produce 100% genetically female eggs. The eggs would then be treated to cause reproductive sterility (triploidy). The reproductively sterile, all-fem Wed, 23 Jan 2008 22:17:37 GMT http://www.scribd.com/doc/1441706/US-Food-and-Drug-Administration-ceq-ostp-study2 http://www.scribd.com/doc/1441705/US-Food-and-Drug-Administration-ceq-ostp-study1 CEQ and OSTP Assessment: Case Studies of Environmental Regulations for Biotechnology I. Introduction On May 3, 2000, President Clinton directed the Council on Environmental Quality (CEQ) and the Office of Science and Technology Policy (OSTP) to “conduct a six month interagency assessment of Federal environmental regulations pertaining to agricultural biotechnology and, if appropriate, make recommendations to improve them.” The assessment was undertaken as part of a larger set of policy measures intended to build consumer confidence and ensure that U.S. regulations keep pace with the lates Wed, 23 Jan 2008 22:17:36 GMT http://www.scribd.com/doc/1441705/US-Food-and-Drug-Administration-ceq-ostp-study1 http://www.scribd.com/doc/1441704/US-Food-and-Drug-Administration-oei019800400 Department of Health and Human Services OFFICE OF INSPECTOR GENERAL FDA Oversight of State Food Firm Inspections A Call for Greater Accountability JUNE GIBBS BROWN Inspector General JUNE 2000 OEI-01-98-00400 *OFFICE OF INSPECTOR GENERAL The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, is to protect the integrity of the Department of Health and Human Services programs as well as the health and welfare of beneficiaries served by them. This statutory mission is carried out through a nationwide program of audits, investigations, inspections, sanctions, an Wed, 23 Jan 2008 22:17:35 GMT http://www.scribd.com/doc/1441704/US-Food-and-Drug-Administration-oei019800400 http://www.scribd.com/doc/1441702/US-Food-and-Drug-Administration-atp3full National Cholesterol Education Program High Blood Cholesterol NATIONAL NATIONAL HEART, Detection Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Final Report Evaluation Treatment INSTITUTES LUNG, AND OF BLOOD HEALTH INSTITUTE *High Blood Cholesterol *Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) Evaluat Wed, 23 Jan 2008 22:17:32 GMT http://www.scribd.com/doc/1441702/US-Food-and-Drug-Administration-atp3full http://www.scribd.com/doc/1441700/US-Food-and-Drug-Administration-KnowNumbers-Eng If you have diabetes… know your blood sugar numbers! The A1C Test The Best Measure of Long-Term Diabetes Control What is the A1C test? T aking control of your diabetes can help you feel better and stay healthy. Research shows that keeping your blood glucose (blood sugar) close to normal reduces your chances of having eye, kidney, and nerve problems. To control your diabetes, you need to know your blood glucose numbers and your target goals. The A1C test is a simple lab test that reflects your average blood glucose level over the last 3 months. A small blood sample to check your A1C can b Wed, 23 Jan 2008 22:17:31 GMT http://www.scribd.com/doc/1441700/US-Food-and-Drug-Administration-KnowNumbers-Eng http://www.scribd.com/doc/1441699/US-Food-and-Drug-Administration-Food2020Drug Food & Drug Interactions *M edicines can treat and cure many health problems. However, they must be taken properly to ensure that they are safe and effective. Many medicines have powerful ingredients that interact with the human body in different ways, and diet and lifestyle can sometimes have a significant impact on a drug’s ability to work in the body. Certain foods, beverages, alcohol, caffeine, and even cigarettes can interact with medicines. This may make them less effective or may cause dangerous side effects or other problems. When you take medicine, be sure to follow your doctor’s Wed, 23 Jan 2008 22:17:30 GMT http://www.scribd.com/doc/1441699/US-Food-and-Drug-Administration-Food2020Drug http://www.scribd.com/doc/1441696/US-Food-and-Drug-Administration-Food202620Drug Food & Drug Interactions *M edicines can treat and cure many health problems. However, they must be taken properly to ensure that they are safe and effective. Many medicines have powerful ingredients that interact with the human body in different ways, and diet and lifestyle can sometimes have a significant impact on a drug’s ability to work in the body. Certain foods, beverages, alcohol, caffeine, and even cigarettes can interact with medicines. This may make them less effective or may cause dangerous side effects or other problems. When you take medicine, be sure to follow your doctor’s Wed, 23 Jan 2008 22:17:29 GMT http://www.scribd.com/doc/1441696/US-Food-and-Drug-Administration-Food202620Drug http://www.scribd.com/doc/1441676/US-Food-and-Drug-Administration-index Wed, 23 Jan 2008 22:16:59 GMT http://www.scribd.com/doc/1441676/US-Food-and-Drug-Administration-index http://www.scribd.com/doc/1441675/US-Food-and-Drug-Administration-JIFSAN-Impact-05-02-01-05 Fall/Winter Issue J I F S A N i mpact Joint Institute for Food Safety and Applied Nutrition News Inside This Issue Postdoctoral Research Program 2 Acrylamide in Foods 2 Student Internship Program 3 Internal Competitive Research Program 4 CSL/JIFSAN Joint Symposium 5 Good Agricultural Practices Program 6 Food Safety Risk Analysis Program 8 J I FS A N Overview F ood safety and nutrition issues are not limited to any one area of science, but include a web of disciplines from the physical to the social sciences. In addition, programs in information technology, communications, professional Wed, 23 Jan 2008 22:16:56 GMT http://www.scribd.com/doc/1441675/US-Food-and-Drug-Administration-JIFSAN-Impact-05-02-01-05 http://www.scribd.com/doc/1441666/US-Food-and-Drug-Administration-actionplan Action Plan for Import Safety A roadmap for continual improvement A Report to the President Interagency Working Group on Import Safety November 2007 *Interagency Working Group on Import Safety: Department of Health and Human Services Department of State Department of Treasury Department of Justice Department of Agriculture Department of Commerce Department of Transportation Department of Homeland Security Office of Management and Budget United States Trade Representative Environmental Protection Agency Consumer Product Safety Commission We will continually improve the safety of imported Wed, 23 Jan 2008 22:16:45 GMT http://www.scribd.com/doc/1441666/US-Food-and-Drug-Administration-actionplan http://www.scribd.com/doc/1441660/US-Food-and-Drug-Administration-clin-trial Editorial Clinical Trial Registration: A Statement from the International Committee of Medical Journal Editors A ltruism and trust lie at the heart of research on human subjects. Altruistic individuals volunteer for research because they trust that their participation will contribute to improved health for others and that researchers will minimize risks to participants. In return for the altruism and trust that make clinical research possible, the research enterprise has an obligation to conduct research ethically and to report it honestly. Honest reporting begins with revealing the existenc Wed, 23 Jan 2008 22:16:40 GMT http://www.scribd.com/doc/1441660/US-Food-and-Drug-Administration-clin-trial http://www.scribd.com/doc/1441656/US-Food-and-Drug-Administration-topstory4 Wed, 23 Jan 2008 22:16:35 GMT http://www.scribd.com/doc/1441656/US-Food-and-Drug-Administration-topstory4 http://www.scribd.com/doc/1441655/US-Food-and-Drug-Administration-HHSPandemicInfluenzaPlan HHS Pandemic Influenza Plan U.S. Department of Health and Human Services November 2005 **HHS Pandemic Influenza Plan U.S. Department of Health and Human Services November 2005 **HHS Pandemic Influenza Plan TABLE OF CONTENTS Statement by Secretary Leavitt ................................................................................................................1 Preface .........................................................................................................................................................2 Executive Summary ............................................ Wed, 23 Jan 2008 22:16:34 GMT http://www.scribd.com/doc/1441655/US-Food-and-Drug-Administration-HHSPandemicInfluenzaPlan http://www.scribd.com/doc/1441652/US-Food-and-Drug-Administration-fguid Department of Health and Human Services Final Guidance Document Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection This document replaces the “HHS Draft Interim Guidance: Financial Relationships in Clinical Research: Issues for Institutions, Clinical Investigators, and IRBs to Consider when Dealing with Issues of Financial Interests and Human Subject Protection” dated January 10, 2001. This document is intended to provide guidance. It does not create or confer rights for or on any person and does not operate to bind the Departm Wed, 23 Jan 2008 22:16:32 GMT http://www.scribd.com/doc/1441652/US-Food-and-Drug-Administration-fguid http://www.scribd.com/doc/1441651/US-Food-and-Drug-Administration-guidanceallsections OCR HIPAA Privacy December 3, 2002 Revised April 3, 2003 STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION 45 CFR Parts 160 and 164 Introduction Standards for Privacy of Individually Identifiable Health Information http://answers.hhs.gov/cgi-bin/hhs.cfg/php/enduser/std_alp.php The Privacy Rule Standards Addressed l *OCR HIPAA Privacy December 3, 2002 Revised April 3, 2003 GENERAL OVERVIEW OF STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION 45 CFR Part 160 and Subparts A and E of Part 164 Standards for Privacy of Individually Identifiable Health Infor Wed, 23 Jan 2008 22:16:32 GMT http://www.scribd.com/doc/1441651/US-Food-and-Drug-Administration-guidanceallsections http://www.scribd.com/doc/1441649/US-Food-and-Drug-Administration-combinedregtext U.S. Department of Health and Human Services Office for Civil Rights Standards for Privacy of Individually Identifiable Health Information Security Standards for the Protection of Electronic Protected Health Information General Administrative Requirements Including, Civil Money Penalties: Procedures for Investigations, Imposition of Penalties, and Hearings Regulation Text (Unofficial Version) (45 CFR Parts 160 and 164) December 28, 2000 as amended: May 31, 2002, August 14, 2002, February 20, 2003, and April 17, 2003 *OC R/HIP AA Privacy/Secur ity/Enforcement R egulation Text August 2003 St Wed, 23 Jan 2008 22:16:31 GMT http://www.scribd.com/doc/1441649/US-Food-and-Drug-Administration-combinedregtext http://www.scribd.com/doc/1441647/US-Food-and-Drug-Administration-appealsrpt REPORT TO CONGRESS March 2004 PLAN FOR THE TRANSFER OF RESPONSIBILITY FOR MEDICARE APPEALS Developed under section 931 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), Pub. L. No. 108-173, 117 Stat. 2066 (2003) Submitted by: The Secretary of Health and Human Services and The Commissioner of Social Security *Introduction This plan was developed in response to section 931 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), Pub. L. No. 108-173, 117 Stat. 2066 (2003) (Appendix A) and includes information as compiled and ag Wed, 23 Jan 2008 22:16:29 GMT http://www.scribd.com/doc/1441647/US-Food-and-Drug-Administration-appealsrpt http://www.scribd.com/doc/1441643/US-Food-and-Drug-Administration-med-ingred-full-public Created on 2/16/2006 6:44:00 PM -1- med_ingred_full_publicv1.1.doc Consolidated Health Care Informatics Standards Adoption Recommendation Medications Subdomain: Active Ingredients Index 1. Part I – Sub-team & Domain Scope Identification – basic information defining the team and the scope of its investigation. 2. Part II – Standards Adoption Recommendation – team-based advice on standard(s) to adopt. 3. Part III – Adoption & Deployment Information – supporting information gathered to assist with deployment of the standard (may be partial). *Created on 2/16/2006 6:44:00 PM -2- Wed, 23 Jan 2008 22:16:24 GMT http://www.scribd.com/doc/1441643/US-Food-and-Drug-Administration-med-ingred-full-public http://www.scribd.com/doc/1441639/US-Food-and-Drug-Administration-19Nutrition 19 Nutrition and Overweight Co-Lead Agencies: Food and Drug Administration National Institutes of Health Contents Goal.......................................................................................................................Page 19-3 Overview ...............................................................................................................Page 19-3 Issues and Trends.............................................................................................Page 19-3 Disparities.......................................................................................... Wed, 23 Jan 2008 22:16:19 GMT http://www.scribd.com/doc/1441639/US-Food-and-Drug-Administration-19Nutrition http://www.scribd.com/doc/1441637/US-Food-and-Drug-Administration-HG-Patient-Safety-Study-Final HealthGrades Quality Study Patient Safety in American Hospitals July 2004 *Patient Safety in American Hospitals Study Released by HealthGrades July 2004 Introduction Policymakers, providers, and consumers have made the safety of patients in United States hospitals a top priority. The need to monitor, track, assess, and improve the safety of inpatient care is at the top of many stakeholders’ agendas. Despite the shocking and widely publicized statistics on preventable deaths due to medical errors in America’s hospitals, there is little evidence that patient safety has improved in the last Wed, 23 Jan 2008 22:16:18 GMT http://www.scribd.com/doc/1441637/US-Food-and-Drug-Administration-HG-Patient-Safety-Study-Final http://www.scribd.com/doc/1441623/US-Food-and-Drug-Administration-gpraqu United States General Accounting Office GAO May 1997 Version 1 GeneralGovernmentDivision Agencies’ StrategicPlans UnderGPRA: Key Questions to Facilitate Congressional Review GAo/GGD-lo.l.16 **Preface Under the Government Performance and Results Act (GPRA) of 1993, every major federal agency must now ask itself some basic questions: What is our mission? What are our goals and how will we achieve them? How can we measure our performance? How will we use that information to make improvements? GPRA forces a shift in the focus of federal agencies–away from such traditional concerns as staf Wed, 23 Jan 2008 22:16:08 GMT http://www.scribd.com/doc/1441623/US-Food-and-Drug-Administration-gpraqu http://www.scribd.com/doc/1441620/US-Food-and-Drug-Administration-gg10120 United States General Accounting Office GAO April 1998 Version 1 General Government Division The Results Act An Evaluator’s Guide to Assessing Agency Annual Performance Plans GAO/GGD-10.1.20 **Preface As Congress seeks to reduce the cost and improve the performance of the federal government, holding agencies accountable for results is believed to be key to better management of programs. However, Congress found that the lack of adequate information on federal agencies’ performance was handicapping congressional policymaking, spending decisions, and oversight and diminishing federal ac Wed, 23 Jan 2008 22:16:06 GMT http://www.scribd.com/doc/1441620/US-Food-and-Drug-Administration-gg10120 http://www.scribd.com/doc/1441618/US-Food-and-Drug-Administration-rc00255 United States General Accounting Office GAO September 2000 Report to the Honorable Richard J. Durbin, United States Senate FOOD SAFETY Controls Can Be Strengthened to Reduce the Risk of Disease Linked to Unsafe Animal Feed GAO/RCED-00-255 **Contents Letter Appendixes Appendix I: Comments From the Food and Drug Administration 3 20 23 27 11 Appendix II: Comments From the Centers for Disease Control and Prevention Appendix III: Comments From the President's Council on Food Safety Tables Table 1: Types of Firms Inspected Abbreviations BSE CDC FDA HACCP bovine spongiform encephalopathy C Wed, 23 Jan 2008 22:16:05 GMT http://www.scribd.com/doc/1441618/US-Food-and-Drug-Administration-rc00255 http://www.scribd.com/doc/1441617/US-Food-and-Drug-Administration-d04820 United States General Accounting Office GAO June 2004 Report to the Chairman, Permanent Subcommittee on Investigations, Committee on Governmental Affairs, U.S. Senate INTERNET PHARMACIES Some Pose Safety Risks for Consumers GAO-04-820 a *June 2004 INTERNET PHARMACIES Some Pose Safety Risks for Consumers Highlights of GAO-04-820, a report to the Chairman, Permanent Subcommittee on Investigations, Committee on Governmental Affairs, U.S. Senate As the demand for and the cost of prescription drugs rise, many consumers have turned to the Internet to purchase drugs. However, the global natur Wed, 23 Jan 2008 22:16:04 GMT http://www.scribd.com/doc/1441617/US-Food-and-Drug-Administration-d04820 http://www.scribd.com/doc/1441615/US-Food-and-Drug-Administration-d02586 United States General Accounting Office GAO June 2002 Report to Congressional Requesters INFORMATION MANAGEMENT Challenges in Managing and Preserving Electronic Records GAO-02-586 a *United States General Accounting Office June 2002 GAO Accountability Integrity Reliability Highlights Why GAO Did This Study In the wake of the transition from paper-based to electronic processes, federal agencies are producing vast and rapidly growing volumes of electronic records. The difficulties of managing, preserving, and providing access to these records represent challenges for the National Archiv Wed, 23 Jan 2008 22:16:02 GMT http://www.scribd.com/doc/1441615/US-Food-and-Drug-Administration-d02586 http://www.scribd.com/doc/1441609/US-Food-and-Drug-Administration-d02183 United States General Accounting Office GAO January 2002 Report to Congressional Requesters MAD COW DISEASE Improvements in the Animal Feed Ban and Other Regulatory Areas Would Strengthen U.S. Prevention Efforts GAO-02-183 *Contents Letter Results in Brief Background Weaknesses Exist in Federal BSE Prevention and Detection Efforts The Economic Impacts of a U.S. Outbreak Could Be Severe, and the Health Risks Are Uncertain The United States Set Controls on Importing Animals and Met BSE Testing Goals Earlier Than Many Countries, but Its Feed Ban Is More Permissive Conclusions Recomme Wed, 23 Jan 2008 22:15:53 GMT http://www.scribd.com/doc/1441609/US-Food-and-Drug-Administration-d02183 http://www.scribd.com/doc/1441606/US-Food-and-Drug-Administration-d05760t This is the accessible text file for GAO report number GAO-05-760T entitled 'Influenza Pandemic: Challenges Remain in Preparedness' which was released on May 26, 2005. This text file was formatted by the U.S. Government Accountability Office (GAO) to be accessible to users with visual impairments, as part of a longer term project to improve GAO products' accessibility. Every attempt has been made to maintain the structural and data integrity of the original printed product. Accessibility features, such as text descriptions of tables, consecutively numbered footnotes placed at the end of the fi Wed, 23 Jan 2008 22:15:50 GMT http://www.scribd.com/doc/1441606/US-Food-and-Drug-Administration-d05760t http://www.scribd.com/doc/1441605/US-Food-and-Drug-Administration-060927surfreport925 H HII Multimedia SPANIC Surf A Report by the FTC’s Division of Enforcement September 27, 2006 **Table of Contents I. Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 II. Methodology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 A. Media Surfed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 B. Advertisement Categories . . . . . . . . . . . . . . . Wed, 23 Jan 2008 22:15:49 GMT http://www.scribd.com/doc/1441605/US-Food-and-Drug-Administration-060927surfreport925 http://www.scribd.com/doc/1441604/US-Food-and-Drug-Administration-JFP0998 ************** Wed, 23 Jan 2008 22:15:49 GMT http://www.scribd.com/doc/1441604/US-Food-and-Drug-Administration-JFP0998 http://www.scribd.com/doc/1441598/US-Food-and-Drug-Administration-foodRecovery ................... Comprehensive Guidelines for Food Recovery Programs ................... Developed by the Food Recovery Committee Council 1 2000 Conference for Food Protection Food Recovery 1 *TABLE of CONTENTS Page Definitions..................................................................................... Introduction to Food Recovery.................................................... Food Recovery Activities............................................................. Legal Issues................................................................................. Implementing a Fo Wed, 23 Jan 2008 22:15:43 GMT http://www.scribd.com/doc/1441598/US-Food-and-Drug-Administration-foodRecovery http://www.scribd.com/doc/1441597/US-Food-and-Drug-Administration-dmdcia * Public Law 104-134 104th Congress An Act Making appropriations for fiscal year 1996 to make a further downpayment toward a balanced budget, and for other purposes. <<NOTE: Apr. 26, 1996 - [H.R. 3019]>> Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, <<NOTE: Omnibus Consolidated Rescissions and Appropriations Act of 1996.>> Section 101. For programs, projects or activities in the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1996, provided as follows, to be effective as if it Wed, 23 Jan 2008 22:15:42 GMT http://www.scribd.com/doc/1441597/US-Food-and-Drug-Administration-dmdcia http://www.scribd.com/doc/1441589/US-Food-and-Drug-Administration-fswomen DIABETES FACTS WOMEN AND DIABETES What Is Diabetes? Diabetes is a disease that affects the body's ability to produce or respond to insulin, a hormone that allows blood glucose (blood sugar) to enter the cells of the body and be used for energy. Diabetes falls into two main categories: type 1, which usually occurs during childhood or adolescence, and type 2, the most common form of the disease, which usually occurs after age 45, but is increasingly being diagnosed in children and adolescents. How Does It Affect Women? Approximately 9.1 million or 8.9% of all women in the United States have diab Wed, 23 Jan 2008 22:15:32 GMT http://www.scribd.com/doc/1441589/US-Food-and-Drug-Administration-fswomen http://www.scribd.com/doc/1441587/US-Food-and-Drug-Administration-fsprediabetes DIABETES FACTS DIABETES AND PRE-DIABETES AMONG AMERICANS Prevalence of Diabetes Total: 17.0 million people – 6.2 % of the population – have diabetes. Diagnosed: 11.1 million people Undiagnosed: 5.9 million people Prevalence of diabetes among people 20 years or older:: Age 65 years or older: 7.0 million. 20.1% of all people in this age group have diabetes. Men: 7.8 million. 8.3% of all men have diabetes. Women: 9.1 million. 8.9% of all women have diabetes. Non-Hispanic whites: 11.4 million. 7.8% of all non-Latino whites have diabetes. African Americans: 2.8 million. 13.0% of all African Ame Wed, 23 Jan 2008 22:15:31 GMT http://www.scribd.com/doc/1441587/US-Food-and-Drug-Administration-fsprediabetes http://www.scribd.com/doc/1441585/US-Food-and-Drug-Administration-diabetes-broc-span Back Cover Diabetes en la mujer • En los Estados Unidos hay 9,1 millones de personas que tienen diabetes; 3 millones de ellas ni siquiera lo saben. • Las mujeres con diabetes corren mayor riesgo de perder al bebé durante el embarazo o de tener un bebé con defectos de nacimiento. • Las mujeres con diabetes suelen ser pobres, lo cual hace que sea más difícil manejar la enfermedad. ¿Corre riesgo de tener diabetes? ¿Tiene sobrepeso? ¿Hace poco o nada de ejercicio? ¿Tiene la presión sanguínea alta (130/80 o más)? ¿Tiene un hermano o hermana con diabetes? ¿Tiene diabetes su mad Wed, 23 Jan 2008 22:15:30 GMT http://www.scribd.com/doc/1441585/US-Food-and-Drug-Administration-diabetes-broc-span http://www.scribd.com/doc/1441584/US-Food-and-Drug-Administration-diabetes-broc-eng Women and Diabetes • In the U.S., 9.1 million women have diabetes and 3 million of them don't even know it. • Women who have diabetes are more likely to have a miscarriage or a baby with birth defects. • Women with diabetes are more likely to be poor which makes it harder to manage the disease. Are You at Risk for Diabetes? Are you overweight? Do you get little or no exercise? Do you have high blood pressure (130/80 or higher)? Do you have a brother or sister with diabetes? Do you have a parent with diabetes? Are you a woman who had diabetes when you were pregnant OR have you had a baby Wed, 23 Jan 2008 22:15:29 GMT http://www.scribd.com/doc/1441584/US-Food-and-Drug-Administration-diabetes-broc-eng http://www.scribd.com/doc/1441582/US-Food-and-Drug-Administration-vietnamese Beänh tieåu ñöôøng laø gì? • Boä maùy tieâu hoùa bieán cheá phaàn lôùn thöùc aên thaønh moät loaïi ñöôøng vaø ñöôïc ñöa vaøo heä thoáng maùu trong cô theå chuùng ta. Chaát insulin, moät loaïi kích thích toá do tuïy taïng laøm ra, chuyeån chaát ñöôøng ñoù thaønh naêng löôïng ñeå nuoâi döôõng caùc teá baøo cuûa cô theå. Caùch tieâu hoùa caùc thöùc aên seõ bò aûnh höôûng neáu chuùng ta maéc beänh tieåu ñöôøng. Khi tuïy taïng khoâng laøm ra ñöôïc insulin hay cô theå khoâng söû duïng ñ Wed, 23 Jan 2008 22:15:29 GMT http://www.scribd.com/doc/1441582/US-Food-and-Drug-Administration-vietnamese http://www.scribd.com/doc/1441581/US-Food-and-Drug-Administration-tongan ‘Oku Ke Ngali Mo’ua Nai ‘I he Mahaki Suka ? Kakai Fefine Pea Mo e Suka • ‘Oku fakafuofua ki he 9.1 miliona ‘o e kakai fefine ‘i ‘Amelika ni ‘oku nau mo’ua ‘i he suka pea ko e toko 3 miliona ‘o kinautolu ‘oku ‘ikai te nau ‘ilo ‘oku nau mo’ua ai. ‫‘ ڤ‬Oku ke fu’u sino ? ‫‘ ڤ‬Oku ke fakamalohisino pe ‘ikai ke ‫ڤ‬ ‫ڤ‬ ‫ڤ‬ ‫ڤ‬ fakamalohisino ? ‘Oku ma’olunga ho toto ? (130/80 pe ma’olunga ange ? ) ‘Oku ‘i ai hao tokoua pe tuonga’ane oku suka ? Oku suka ha taha ‘o ho’o ongo matu’a? Na’a ke suka nai ‘i he Wed, 23 Jan 2008 22:15:28 GMT http://www.scribd.com/doc/1441581/US-Food-and-Drug-Administration-tongan http://www.scribd.com/doc/1441580/US-Food-and-Drug-Administration-thai โรคเบาหวานคืออะไร โรคเบาหวานเปลี่ยนแปลงวิธีที่ร่างกายนำ อาหารไปใช้ËÅѧ¨Ò¡อาหารที่รับประทานเข้าไป¶Ù¡ เปลี่ยนเป็นน้ำตาล • เลือดนำน้ำตาลเข้าสู่à«Åร่างกายâ´ÂÁÕอินซูลิน à»ç¹ตัวช่วยนำน้ำตาลจากเลือด ไปหล่อเลี้ยง ร่างกาย Wed, 23 Jan 2008 22:15:27 GMT http://www.scribd.com/doc/1441580/US-Food-and-Drug-Administration-thai http://www.scribd.com/doc/1441579/US-Food-and-Drug-Administration-taglish ANO ANG DIABETES? • Binabago ng diabetes ang paraan ng paggamit ng katawan sa pagkain. Ang pagkain ay nagiging asukal sa loob ng katawan. Dinadala ng dugo ang asukal na ito sa buong katawan. Ang insulin ay tumutulong na kunin ang asukal sa dugo para maging enerhiya ng katawan. Kapag ang inyong katawan ay nagkukulang sa enerhiya, ang inyong blood sugar ay nananatiling mataas. Ang mataas na blood sugar ay maaaring maging sanhi ng komplikasyon sa puso at kidney, pagkabulag, atake sa puso o amputasyon ng paa o hita o maari ring maging sanhi ng kamatayan. ________________________ ANG MAGANDANG BA Wed, 23 Jan 2008 22:15:26 GMT http://www.scribd.com/doc/1441579/US-Food-and-Drug-Administration-taglish http://www.scribd.com/doc/1441577/US-Food-and-Drug-Administration-samoan Ituaiaga Ma'i Suka Eseese O Le Ā Le Ma'i Suka? • O le ma'i suka e suia ai le fa'aaogaina o meataumafa e lou tino. E fa'aliliuina e lou tino au meata'umafa i le suka. • E fe’avea'iina e lou toto le suka i totonu o lou tino. O le inisulini e fesoasoani e aumai le suka mai lou toto ma fa'aliliuina e maua ai le malosi. E le mauaina e le tino se malosi pe ‘a tumau pea le maualuga o le suka i totonu o le toto. • Ga'o (Fats) Ituaiga Muamua (Type I) - O le ituaiga lea ua le mafai lava e lou tino ona gaosia se inisulini. O tagata ua maua i le ituaiga ma'i suka lea e tatau lava ona faia a lat Wed, 23 Jan 2008 22:15:26 GMT http://www.scribd.com/doc/1441577/US-Food-and-Drug-Administration-samoan http://www.scribd.com/doc/1441575/US-Food-and-Drug-Administration-marshallese Kora im naminmej in tonal • Ilo US in ewor 9.1 million kora 3 million ian kora rein rojjab jela ke ewor ak emoj an jino naninmej in tonal ilo enbwinier. • Kora ro im rej naninmej in tonal Ekka an mej lojeer im wor jorren Ak utamwe ilo ajri ro nejier. • Ekka an wor jeramol im jerata Ibwiljin kora ro im roj naninmej In tonal, kin men in ekoman bwe Enjab bolel wewin kejbarok tonal Ko aer. NANINMEJ IN MENONO IM MEJREJOT ARMEJ (stroke) • Kora ro im rej dri tonal, ekka aer Bok naninmej in metak uob ilo Yio ko roman dred. • Kobed ke ilo kauotata ko an naninmej in tonal? ‫ ڤ‬Kokileb ke Wed, 23 Jan 2008 22:15:24 GMT http://www.scribd.com/doc/1441575/US-Food-and-Drug-Administration-marshallese http://www.scribd.com/doc/1441574/US-Food-and-Drug-Administration-laotian c,jospa’7nrpkfg[qks;koL • rpkfg[qks;koxjPo;ymIk’dkpmjko.-hvkskoD uj vkskomumkodyo 9txjPolrk[,kgxaooE8ko jj 16.oIjk’dkp0v’mjkoD j • • xtgrf8jk’M0v’rpkfg[qks;ko xtgrf 1 – Ijk’dkpz]yfvyol5]o[+wfhD r;dmuj y vyol5]om5dM,Ngrnv.sh,-;f168wxD y j uuy j+ • gxaog[qks;koxtgrfob’ 8hv’wfhld s]n dyo1k j a xtgrf 2 – Ijk’dkpz]yfvyol5]o[+rP’r=F y ,adgxao g[qks;koxtgrflv’oUD • • vkskomugIqkdyoxtdv[fh;p mkf8jk’Mgs]qkoUG j j 7k3[wIftgif Xzq]w,hF zadF g0Qk9uF j w0,ao oE\kdw,hF oq,F -ui3v] c]t 0v’s;ko? y 3xi8uo cmdg[y’oE8ko.og]nvf c]t j IPoI6[oskl50trk[djP;0hv’8jk Wed, 23 Jan 2008 22:15:24 GMT http://www.scribd.com/doc/1441574/US-Food-and-Drug-Administration-laotian http://www.scribd.com/doc/1441573/US-Food-and-Drug-Administration-korean 당뇨병이란 무엇입니까? • 당뇨병은 체내에 음식 섭취 방식을 바꿔 놓습니다. 섭취된 음식이 체내에서 당으로 변합니다. • 체내 에서 혈액은 이 당을 골고루 흡수되게 만듭니다. 인슐린이 혈액의 당을 체내의 에너지로 되게 도와 줍니다. • 그 연료 공급이 부족하게 되면 체내의 혈당이 높아지게 됩니다. 당뇨병의 유형 • 1번 타입 – 이 타입은 체내에서 전혀 인슐린이 만들어 지지 않습니다. 그래서 1번 타입 당뇨병이 있는 분은 인슐린을 매일 복용 Wed, 23 Jan 2008 22:15:23 GMT http://www.scribd.com/doc/1441573/US-Food-and-Drug-Administration-korean http://www.scribd.com/doc/1441572/US-Food-and-Drug-Administration-khmerace etIGICaeraKTwkenamEpí m? à ¨bePT« neraKTwkenamEpí m • GaharEdleyIgjSumanCatiÐ • ¨bYlenArebobxç n¨VNG~ke¨ bI  eraKTwkenamEpí meFI[mankarE¨ b à • ¨Vs’cMNIGahar. cMNIGahar enAk~¬ gx n Â ç ¨VNG~k. EdlG~kbriePaKkayCaCatisr  û GiunsUlin ral’« f edImºIrs’enA. © eraKTwkenamEpí m¨bePT1¨tUvTTYl linTal’Etes ê. mnus§Edlman ¨bePT1-xç n¨VNminplitGiunsU  karbUGéß ¨dat(Ep eQI bEn nMb&ug TwkEp eQI    x aj’  TwkedaHeKa esoerol nig bEgí m) Binit´emIlCatis rk~¬ g û Qam ehIydwgBI ABC rbs’G~k • karrk§a[Catis rmancMnYnl m û µ Wed, 23 Jan 2008 22:15:22 GMT http://www.scribd.com/doc/1441572/US-Food-and-Drug-Administration-khmerace http://www.scribd.com/doc/1441570/US-Food-and-Drug-Administration-japanese *’ * Wed, 23 Jan 2008 22:15:21 GMT http://www.scribd.com/doc/1441570/US-Food-and-Drug-Administration-japanese http://www.scribd.com/doc/1441569/US-Food-and-Drug-Administration-chinese 什麼是糖尿病 • 糖尿病的類型 • • 我們所吃食物的成份包括﹕ 碳㈬化合物 （㈬果、蔬菜、麵 包、果汁、牛奶、穀類及甜食） 脂肪 蛋白質 膽固醇 纖維素 （㈬果、蔬菜、豆類、 麵包及穀類） 檢測血糖、血壓和膽固醇 • 糖尿病改變㆟體利用食物的方 式。㆒般㆟吃進的食物會在體 內轉換成糖份。 血液將此糖份送到全身各處。 胰島素幫助將血㆗的糖份傳送 入體內，以提供熱能。 糖尿病患者無法製造足夠的胰 島素，或無法充分使用體內胰 島素 Wed, 23 Jan 2008 22:15:20 GMT http://www.scribd.com/doc/1441569/US-Food-and-Drug-Administration-chinese http://www.scribd.com/doc/1441568/US-Food-and-Drug-Administration-alert-card-span back Tómese el tiempo para cuidarse de... front Tarjeta de alerta de diabetes Diabetes Alert 1-800-DIABETES (1-800-342-2383) asistencia en inglés y español La Diabetes FDA-022250S www.fda.gov/womens La diabetes es algo serio. Para evitar problemas del corazón y de los riñones, ceguera, problemas cerebrovasculares o la pérdida de un pie o una pierna: Nombre (Name) Seguro Nº (Insurance #) Médico (Doctor) Teléfono (Telephone) Farmacia (Pharmacy) 1. Cuide su dieta y haga ejercicio. 2. Sepa usar los medicamentos. 3. Vigile el nivel de azúcar en la sangre. inside left fold inside Wed, 23 Jan 2008 22:15:20 GMT http://www.scribd.com/doc/1441568/US-Food-and-Drug-Administration-alert-card-span http://www.scribd.com/doc/1441567/US-Food-and-Drug-Administration-alert-card-eng back Take Time To Care… About Diabetes front Diabetes Alert 1-800-DIABETES (1-800-342-2383) www.fda.gov/womens FDA-022250 Diabetes is serious. To avoid heart and kidney problems, blindness, stroke, the loss of a foot or leg: 1. Watch what you eat and get exercise. 2. Use medicines wisely. 3. Check your blood sugar. Name Insurance # Doctor Telephone Pharmacy inside left fold inside right *Diabetes is serious. To avoid heart and kidney problems, blindness, stroke, the loss of a foot or leg: 1. Watch what you eat and get exercise. 2. Use medicines wisely. 3. Check your blood sugar. Nam Wed, 23 Jan 2008 22:15:19 GMT http://www.scribd.com/doc/1441567/US-Food-and-Drug-Administration-alert-card-eng http://www.scribd.com/doc/1441563/US-Food-and-Drug-Administration-Meds-Spn Este documento fue desarrollado por la Oficina de la Salud de la Mujer de la Administración Federal de Alimentos y Drogas (FDA) y la Asociación Nacional de Cadena de Farmacias. Muchas gracias a todas las organizaciones participantes que han ayudado en su reproducción y distribución. Salud de la mujer: Tiempo para cuidar su salud por usted...y por los que la necesitan is Medicinas M S E PA U SAR LOS M E DICAM E NTOS Alrededor del 30% al 50% de la gente que usa medicamentos no los usa en la forma indicada. Esto resulta en más visitas al médico o al hospital y cambios en las recetas. Todo Wed, 23 Jan 2008 22:15:18 GMT http://www.scribd.com/doc/1441563/US-Food-and-Drug-Administration-Meds-Spn http://www.scribd.com/doc/1441562/US-Food-and-Drug-Administration-Meds-Eng This document was developed by FDA's Office of Women's Health (OWH) and the National Association of Chain Drug Stores (NACDS). The OWH and NACDS thank all of the participating organizations that have assisted in its reproduction and distribution. y Medicines M U S E M E DIC I N E S WI S E LY About 30% to 50% of those who use medicines do not use them as directed. This causes more doctor visits, hospital stays, lost wages and changed prescriptions. All this costs Americans as much as $76.6 billion each year. Women often take care of medicines for the whole family, as well as themselves. So we Wed, 23 Jan 2008 22:15:17 GMT http://www.scribd.com/doc/1441562/US-Food-and-Drug-Administration-Meds-Eng http://www.scribd.com/doc/1441560/US-Food-and-Drug-Administration-report0306 Protecting and Advancing Women’s Health The FDA Office of Women’s Health U.S. Food and Drug Administration 10 Years and Beyond… *OWH Mission OWH Mission The FDA Office of Women’s Health Mission (OWH) is to: • Protect and advance the health of women through policy, science and outreach • Advocate for the inclusion of women in clinical trials as well as sex/gender and subpopulation analyses i *Table of Contents Table of Contents 1. 2. 3. 4. 5. 6. 7. 8. 9. An Invitation Champion on Many Fronts Opening Doors to Clinical Trials OWH Science Program At the Forefront of Stu Wed, 23 Jan 2008 22:15:16 GMT http://www.scribd.com/doc/1441560/US-Food-and-Drug-Administration-report0306 http://www.scribd.com/doc/1441559/US-Food-and-Drug-Administration-mayjune2005 …Protecting & Advancing the Health of Women UPDATE May/June 2005 Dear Abby Features FDA OWH Take Time To Care Information Series Dear Abby: Your readers have a history of responding enthusiastically to the good advice you share with them. Because of that, I'm writing on behalf of the Food and Drug Administration's Office of Women's Health and the Federal Citizen Information Center to offer our new, free Women's Health Information Kit. It contains some of Uncle Sam's best advice on more than a dozen health topics that concern today's women. All of these materials are part of the Take Time t Wed, 23 Jan 2008 22:15:15 GMT http://www.scribd.com/doc/1441559/US-Food-and-Drug-Administration-mayjune2005 http://www.scribd.com/doc/1441557/US-Food-and-Drug-Administration-march2006 …Protecting & Advancing the Health of Women UPDATE March 2006 “ASK FDA”: Public Session at FDA Science Forum The Food and Drug Administration (FDA) will conduct a free public session called "ASK FDA" on April 18, 2006 from 1:30-5:30 p.m. at the Washington, DC Convention Center. The session will allow the public to get answers from top FDA scientists on important health questions. Dr. Janet Woodcock, FDA Deputy Commissioner for Operations, will moderate a panel of FDA scientists who will answer, in plain language, consumer questions on FDA-regulated products. The session is free but att Wed, 23 Jan 2008 22:15:14 GMT http://www.scribd.com/doc/1441557/US-Food-and-Drug-Administration-march2006 http://www.scribd.com/doc/1441556/US-Food-and-Drug-Administration-fall2007 OWH eUpdate www.fda.gov/womens Fall 2007 In This Issue • OWH Research • Hot Topics • Update Extras • Outreach Initiatives Message from the Director Throughout 2007, OWH has worked diligently to promote women's health by facilitating high quality science and developing partnerships to deliver consumer health messages. In this final update for 2007, you will find articles on the outcomes of several OWH research and outreach programs including a nationwide outreach initiative and new publications. Explore the articles below as well as the links to upcoming FDA meetings and information o Wed, 23 Jan 2008 22:15:13 GMT http://www.scribd.com/doc/1441556/US-Food-and-Drug-Administration-fall2007 http://www.scribd.com/doc/1441553/US-Food-and-Drug-Administration-august2005 …Protecting & Advancing the Health of Women UPDATE August/September 2005 FDA Commissioner Confirmed On July 18, 2005, Lester M. Crawford D.V.M., Ph.D. was confirmed by the Senate as Commissioner of the FDA. Dr. Crawford has served as the Acting Commissioner for the past year. Previously, he served as Deputy Commissioner of the FDA and as Director of the Center for Food and Nutrition Policy at Georgetown University and Virginia Tech. Dr. Crawford has demonstrated a continued commitment to working with OWH. In one of his first acts in his new position, Dr. Crawford announced the establishmen Wed, 23 Jan 2008 22:15:11 GMT http://www.scribd.com/doc/1441553/US-Food-and-Drug-Administration-august2005 http://www.scribd.com/doc/1441552/US-Food-and-Drug-Administration-Winter2006 OWH eUpdate www.fda.gov/womens Winter 2006 In This Issue • OWH Research • Hot Topics • Update Extras • Outreach Initiatives Message from the Director As another year comes to a close, the FDA Office of Women’s Health has begun to take stock of the many initiatives we’ve undertaken in 2006. The OWH research and development team has strengthened its commitment to fund research that will advance the understanding and treatment of conditions in women, as well as, advance knowledge of sex and gender differences in diagnosis and treatment. The outreach program has continued to make gre Wed, 23 Jan 2008 22:15:10 GMT http://www.scribd.com/doc/1441552/US-Food-and-Drug-Administration-Winter2006 http://www.scribd.com/doc/1441550/US-Food-and-Drug-Administration-Summer2007 OWH eUpdate www.fda.gov/womens Summer 2007 In This Issue • OWH Research • Hot Topics • Update Extras • Outreach Initiatives Message from the Director OWH continues to seek innovative scientific and outreach opportunities to promote and advance the health of women nationwide. On the research front, OWH recently selected the recipients of the FY07 intramural funding awards. OWH is also embarking on a new partnership with the Agency for Healthcare Research and Quality (AHRQ) and the FDA Center for Devices and Radiological Health (CDRH) to study the long term health outcomes in patients Wed, 23 Jan 2008 22:15:07 GMT http://www.scribd.com/doc/1441550/US-Food-and-Drug-Administration-Summer2007 http://www.scribd.com/doc/1441547/US-Food-and-Drug-Administration-Summer2006 OWH eUpdate http://www.fda.gov/womens Summer 2006 In This Issue • OWH Research • Hot Topics • Update Extras • Outreach Initiatives Message from the Director Over the years, the FDA Office of Women’s Health (OWH) has sent periodic e-blasts to update our partners and stakeholders on FDA actions and activities. This summer we are making some changes to our electronic outreach as we work to find innovative ways to provide you with timely information from OWH, FDA, and HHS. The new look of this quarterly, online update reflects these efforts. The new format provides snapshots of OWH res Wed, 23 Jan 2008 22:15:06 GMT http://www.scribd.com/doc/1441547/US-Food-and-Drug-Administration-Summer2006 http://www.scribd.com/doc/1441546/US-Food-and-Drug-Administration-Spring2007 OWH eUpdate www.fda.gov/womens Spring 2007 In This Issue • OWH Research • Hot Topics • Update Extras • Outreach Initiatives Message from the Director OWH is continuing to find innovative methods to promote women’s health through research and outreach. Last month, OWH announced the availability of our new medicine booklets that provide consumers with easy-to-read information on all FDA-approved products for HIV, elevated cholesterol, smoking cessation, hypertension, depression, and menopause. With the release of this update, OWH is pleased to announce another milestone - the availab Wed, 23 Jan 2008 22:15:06 GMT http://www.scribd.com/doc/1441546/US-Food-and-Drug-Administration-Spring2007 http://www.scribd.com/doc/1441545/US-Food-and-Drug-Administration-Fall2006 OWH eUpdate www.fda.gov/womens Fall 2006 In This Issue • OWH Research • Hot Topics • Update Extras • Outreach Initiatives Message from the Director In line with our ongoing mission to provide the public with up-to-date health information, OWH has several new projects. First, we have restructured the OWH website to provide the public with easier access to health and safety information from the FDA and elsewhere in the U.S. Department of Health and Human Services. We have added several new features including links to drug information and women’s health statistics on the OWH Home Page Wed, 23 Jan 2008 22:15:05 GMT http://www.scribd.com/doc/1441545/US-Food-and-Drug-Administration-Fall2006 http://www.scribd.com/doc/1441543/US-Food-and-Drug-Administration-purseSpan ¡Infórmese! El Centro Federal de Información para Cuidadanos La Administración de Servicios Generales de Los Estados Unidos www.pueblo.gsa.gov 1-888-878-3256 Administración de Medicamentos y Alimentos (FDA), DHHS www.fda.gov/womens www.fda.gov/cder Centro Nacional de Información sobre la Salud de la Mujer Departamento de Salud y Servicios Humanos de los Estados Unidos (DHHS) www.4woman.gov Institutos Nacionales de la Salud (NIH), DHHS www.nih.gov/PHTindex.htm Agencia de Investigación sobre la Calidad de los Servicios de Salud, DHHS www.ahrq.gov ¿Qué podemos creer? Este documento fue Wed, 23 Jan 2008 22:15:04 GMT http://www.scribd.com/doc/1441543/US-Food-and-Drug-Administration-purseSpan http://www.scribd.com/doc/1441541/US-Food-and-Drug-Administration-purseEng Federal Citizen Information Center US General Services Administration www.pueblo.gsa.gov 1-888-878-3256 Food and Drug Administration US Department of Health and Human Services www.fda.gov/womens www.fda.gov/cder National Women’s Health Information Center US Department of Health and Human Services www.4woman.gov National Institutes of Health US Department of Health and Human Services www.nih.gov/PHTindex.htm Agency for Healthcare Research Quality US Department of Health and Human Services www.ahrq.gov/ppip/healthywom.htm What Can You Believe? This document was developed by FDA and other ag Wed, 23 Jan 2008 22:15:02 GMT http://www.scribd.com/doc/1441541/US-Food-and-Drug-Administration-purseEng http://www.scribd.com/doc/1441539/US-Food-and-Drug-Administration-PurseEng Federal Citizen Information Center US General Services Administration www.pueblo.gsa.gov 1-888-878-3256 Food and Drug Administration US Department of Health and Human Services www.fda.gov/womens www.fda.gov/cder National Women’s Health Information Center US Department of Health and Human Services www.4woman.gov National Institutes of Health US Department of Health and Human Services www.nih.gov/PHTindex.htm Agency for Healthcare Research Quality US Department of Health and Human Services www.ahrq.gov/ppip/healthywom.htm What Can You Believe? This document was developed by FDA and other ag Wed, 23 Jan 2008 22:15:01 GMT http://www.scribd.com/doc/1441539/US-Food-and-Drug-Administration-PurseEng http://www.scribd.com/doc/1441537/US-Food-and-Drug-Administration-MHTenglish What is menopause? Menopause is a normal change in a woman’s life when her period stops. That’s why some people call menopause “the change of life” or “the change.” During menopause a woman’s body slowly produces less of the hormones estrogen and progesterone. This often happens between the ages of 45 and 55 years old. A woman has reached menopause when she has not had a period for 12 months in a row. What is hormone therapy for menopause? How do hormones help with menopause? Hormone therapy for menopause has also been called hormone replacement therapy (HRT). Lower hormone leve Wed, 23 Jan 2008 22:15:00 GMT http://www.scribd.com/doc/1441537/US-Food-and-Drug-Administration-MHTenglish http://www.scribd.com/doc/1441534/US-Food-and-Drug-Administration-FSspan ¿Qué es la menopausia? La menopausia es un cambio normal en la vida de la mujer por el cual deja de tener su período menstrual. Por eso algunas personas llaman a la menopausia “el cambio” o “edad crítica”. Durante la menopausia, el cuerpo de la mujer produce cada vez menos cantidad de las hormonas llamadas estrógeno y progesterona. Esto suele ocurrir entre los 45 y 55 años de edad. La menopausia se produce cuando la mujer no tiene su período menstrual por 12 meses seguidos. ¿Qué es el tratamiento con hormonas para la menopausia? El tratamiento con hormonas para la menopausia t Wed, 23 Jan 2008 22:14:57 GMT http://www.scribd.com/doc/1441534/US-Food-and-Drug-Administration-FSspan http://www.scribd.com/doc/1441532/US-Food-and-Drug-Administration-FSeng What is menopause? Menopause is a normal change in a woman’s life when her period stops. That’s why some people call menopause “the change of life” or “the change.” During menopause a woman’s body slowly produces less of the hormones estrogen and progesterone. This often happens between the ages of 45 and 55 years old. A woman has reached menopause when she has not had a period for 12 months in a row. What is hormone therapy for menopause? How do hormones help with menopause? Hormone therapy for menopause has also been called hormone replacement therapy (HRT). Lower hormone leve Wed, 23 Jan 2008 22:14:56 GMT http://www.scribd.com/doc/1441532/US-Food-and-Drug-Administration-FSeng http://www.scribd.com/doc/1441531/US-Food-and-Drug-Administration-smoking Medicines To Help You Smoking Read this guide... even if you are not ready to quit now. Learn more about products and medicines to help you quit smoking. Use this guide to help you talk to your doctor, pharmacist, or nurse about the benefits and risks of taking products to help you quit smoking. FDA Office of Women’s Health http://www.fda.gov/womens To Learn More: Smokefree.gov http://www.smokefree.gov Phone: 1-800-QUITNOW (1-800-784-8669) TTY/TDD: 1-800-332-8615 This guide should not be used in place of talking to your doctor or reading the product label. The drug and risk information Wed, 23 Jan 2008 22:14:54 GMT http://www.scribd.com/doc/1441531/US-Food-and-Drug-Administration-smoking http://www.scribd.com/doc/1441530/US-Food-and-Drug-Administration-menopause Medicines To Help You Menopause Use this guide to help you talk to your doctor, pharmacist, or nurse about your hormone medicines. The guide lists all of the FDA-approved products now available to treat this condition. You will also find some general information to help you use your medicines wisely. FDA Office of Women’s Health http://www.fda.gov/womens To Learn More: FDA Office of Women’s Health Menopause and Hormone Therapy Information http://www.fda.gov/womens/menopause/default.htm This guide should not be used in place of talking to your doctor or reading the label on your medi Wed, 23 Jan 2008 22:14:53 GMT http://www.scribd.com/doc/1441530/US-Food-and-Drug-Administration-menopause http://www.scribd.com/doc/1441529/US-Food-and-Drug-Administration-hiv Medicines To Help You HIV and AIDS Use this guide to help you talk to your doctor, pharmacist, or nurse about your HIV medicines. The guide lists all of the FDA-approved products now available to treat this condition. You will also find some general information to help you use your medicines wisely. FDA Office of Women’s Health http://www.fda.gov/womens To Learn More: FDA Office of Special Health Issues FDA HIV/AIDS Info http://www.fda.gov/oashi/aids/virals.html AIDSinfo US Department of Health and Human Services http://www.aidsinfo.nih.gov Phone: 1-800-448-0440 TTY/TTD: 888-480-3739 U Wed, 23 Jan 2008 22:14:52 GMT http://www.scribd.com/doc/1441529/US-Food-and-Drug-Administration-hiv http://www.scribd.com/doc/1441526/US-Food-and-Drug-Administration-highbloodpressure Medicines To Help You High Blood Pressure Use this guide to help you talk to your doctor, pharmacist, or nurse about your blood pressure medicines. The guide lists all of the FDA-approved products now available to treat this condition. You will also find some general information to help you use your medicines wisely. FDA Office of Women’s Health http://www.fda.gov/womens To Learn More: FDA Heart Health Online http://www.fda.gov/hearthealth/treatments/ medications.html Federal Relay Service Phone: 1-800-877-8339 National Heart, Lung, and Blood Institute Health Information Center http://www Wed, 23 Jan 2008 22:14:50 GMT http://www.scribd.com/doc/1441526/US-Food-and-Drug-Administration-highbloodpressure http://www.scribd.com/doc/1441525/US-Food-and-Drug-Administration-depression Medicines To Help You Depression Use this guide to help you talk to your doctor, pharmacist, or nurse about your medicines for depression. The guide lists all of the FDA-approved products now available to treat this condition. You will also find some general information to help you use your medicines wisely. FDA Office of Women’s Health http://www.fda.gov/womens To Learn More: National Institute of Mental Health (NIMH) http://www.nimh.nih.gov Phone: 1-866-615-6464 TTY/TDD: 1-866-415-8051 This guide should not be used in place of talking to your doctor or reading the label on your medic Wed, 23 Jan 2008 22:14:49 GMT http://www.scribd.com/doc/1441525/US-Food-and-Drug-Administration-depression http://www.scribd.com/doc/1441523/US-Food-and-Drug-Administration-cholesterol Medicines To Help You Cholesterol Use this guide to help you talk to your doctor, pharmacist, or nurse about your cholesterol medicines. The guide lists all of the FDA-approved products now available to treat this condition. You will also find some general information to help you use your medicines wisely. FDA Office of Women’s Health http://www.fda.gov/womens To Learn More: National Heart, Lung, and Blood Institute Health Information Center Phone: 301-592-8573 http://www.nhlbi.nih.gov/health/infoctr/ index.htm The National Women’s Health Information Center Phone: 1-800-994-WOMAN (1-8 Wed, 23 Jan 2008 22:14:48 GMT http://www.scribd.com/doc/1441523/US-Food-and-Drug-Administration-cholesterol http://www.scribd.com/doc/1441517/US-Food-and-Drug-Administration-birthcontrolguide Medicines To Help You Birth Control Guide This guide gives the basic facts about the different kinds of FDA-approved medicines and devices for birth control. Ask your doctor to tell you about all of the risks and benefits of using these products. *To learn more: http://www.fda.gov/womens/healthinformation/birthcontrol.html For the most recent information: Go to http://www.accessdata.fda.gov/scripts/cder/drugsatfda and type in the name of your drug. Or http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/LSTSimpleSearch.cfm and type in the name of your device. 2007 2 *If you do not want Wed, 23 Jan 2008 22:14:42 GMT http://www.scribd.com/doc/1441517/US-Food-and-Drug-Administration-birthcontrolguide http://www.scribd.com/doc/1441514/US-Food-and-Drug-Administration-Birth20Control20Chart Medicines To Help You Birth Control Guide Methods Number of pregnancies expected per 100 women How to use it Some Risks Most Effective Sterilization Surgery for Women 1 One-time procedure; nothing to do or remember • Pain • Bleeding • Infection or other complications after surgery • Ectopic (tubal) pregnancy Surgical Sterilization Implant for Women 1 One-time procedure; nothing to do or remember • Mild to moderate pain after insertion • Ectopic (tubal) pregnancy Sterilization Surgery for Men 1 One-time procedure; nothing to do or remember • Pain • Bleeding • I Wed, 23 Jan 2008 22:14:41 GMT http://www.scribd.com/doc/1441514/US-Food-and-Drug-Administration-Birth20Control20Chart