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pd01de97 Exchange With Reporters Prior to Discussions With President Jiang Zemin...
<DOC> [Weekly Compilation of Presidential Documents] [frwais.access.gpo.gov] [Page i-ii] Monday, December 1, 1997 Volume 33--Number 48 Pages 1885-1930 Contents [[Page i]] Weekly Compilation of Presidential Documents [[Page ii]] Addresses and Remarks Canada, U.S. Consulate staff in Vancouver--1913 Colorado Arrival in Denver--1888 Democratic National Committee luncheon in Denver--1890 Democratic National Committee reception in Denver--1894 Radio address--1887 Thanksgiving turkey presentation ceremony--1924 Washington Dinner for Senator Patty Murray in Medina--1899 Reception for Senator Patty Murray in Seattle--1903 Bill Signings Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act, 1998, statement--1926 Food and Drug Administration Modernization Act of 1997, statement-- 1885 Foreign Operations, Export Financing, and Related Programs Appropriations Act, 1998, statement--1925 Communications to Congress Iran, letter reporting--1922 Executive Orders Closing of Government Departments and Agencies on Friday, December 26, 1997--1922 Interviews With the News Media Exchanges with reporters Canada, Vancouver--1911, 1912 Colorado, Denver--1888 Rose Garden--1924 News conference with Prime Minister Chretien of Canada in Vancouver, November 23 (No. 153)--1905 Joint Statements APEC Economic Leaders' Declaration: Connecting the APEC Community-- 1915 Vancouver Framework for Enhanced Public-Private Partnerships in Infrastructure Development--1920 Meetings With Foreign Leaders APEC leaders--1915, 1920 Canada, Prime Minister Chretien--1905 China, President Jiang--1911 Japan, Prime Minister Hashimoto--1912 Proclamations National Family Caregivers Week--1898 National Family Week--1887 National Farm-City Week--1886 Statements by the President See also Bill Signings Death of Jorge Mas Canosa--1910 Effectiveness of anticrime measures--1911 Supplementary Materials Acts approved by the President--1930 Checklist of White House press releases--1929 Digest of other White House announcements--1928 Nominations submitted to the Senate--1929 WEEKLY COMPILATION OF ------------------------------ PRESIDENTIAL DOCUMENTS Published every Monday by the Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408, the Weekly Compilation of Presidential Documents contains statements, messages, and other Presidential materials released by the White House during the preceding week. The Weekly Compilation of Presidential Documents is published pursuant to the authority contained in the Federal Register Act (49 Stat. 500, as amended; 44 U.S.C. Ch. 15), under regulations prescribed by the Administrative Committee of the Federal Register, approved by the President (37 FR 23607; 1 CFR Part 10). Distribution is made only by the Superintendent of Documents, Government Printing Office, Washington, DC 20402. The Weekly Compilation of Presidential Documents will be furnished by mail to domestic subscribers for $80.00 per year ($137.00 for mailing first class) and to foreign subscribers for $93.75 per year, payable to the Superintendent of Documents, Government Printing Office, Washington, DC 20402. The charge for a single copy is $3.00 ($3.75 for foreign mailing). There are no restrictions on the republication of material appearing in the Weekly Compilation of Presidential Documents. [[Page 1885]] <DOC> [Weekly Compilation of Presidential Documents] [frwais.access.gpo.gov] [Page 1885-1886] Monday, December 1, 1997 Volume 33--Number 48 Pages 1885-1930 Week Ending Friday, November 28, 1997 Statement on Signing the Food and Drug Administration Modernization Act of 1997 November 21, 1997 I am pleased to sign into law S. 830, the ``Food and Drug Administration Modernization Act of 1997.'' This bipartisan legislation culminates several years of work by my Administration and the Congress on steps to streamline and rationalize the process by which the Food and Drug Administration (FDA) approves new drugs and medical devices, while ensuring that these products, on which the American people rely, are safe and effective. The Act represents the most comprehensive reform of our Nation's drug, medical device, and food laws in decades. I believe that it is a good compromise on a difficult set of issues and am pleased that the Congress and my Administration were able to work through these issues and enact a bipartisan bill. Most importantly, I am pleased that S. 830 addresses my key concern that any FDA legislation maintain our high standards to protect the American people from dangerous drugs, devices, and foods. This legislation will extend through Fiscal Year 2002, the Prescription Drug User Fee Act, which requires drug companies to help underwrite the cost of FDA reviews of their products' safety and efficacy. This measure has enabled the FDA to eliminate backlogs and significantly shorten the review time of new human drug applications without compromising quality standards. Supported by the drug industry, the Prescription Drug User Fee Act illustrates the true benefits of a public-private partnership. Certainly, FDA reform did not start with this bill. The Vice President has been working on reforming and reinventing the FDA since 1993. This bill codifies many of the reforms proposed by the Vice President's Reinventing Government Initiative. For example, it modernizes the regulations of biological products, eliminates the batch certification and monograph requirements for insulin and antibiotics, and streamlines the approval process for drug manufacturing changes. This Act also codifies reforms proposed by the FDA's Center for Devices and Radiological Health that will significantly improve both the rigor and timeliness of its premarket review of medical devices. Notably, S. 830 will expand FDA's current program to streamline the filing and approval of new therapies for serious or life-threatening conditions. It will also codify FDA regulations and practices designed to ensure that patients will have access to therapies for serious and life-threatening conditions before they are approved for marketing. The Act requires the Department of Health and Human Services to establish a databank, providing information to the public on clinical trials of experimental treatments for serious and life-threatening conditions. In addition, S. 830 includes a provision that eliminates certain health information dissemination restrictions, while maintaining public health protections. For example, product sponsors, manufacturers, or distributors will now be permitted to furnish to health professionals, providers, and others, peer- reviewed journal articles on an ``off- label'' use of an approved or cleared drug or device, so long as the manufacturers commit to completing the research needed to approve such use and meet other specified conditions. Drug manufacturers will also be able to give cost data to health maintenance organizations and other institutional purchasers of prescription drugs, so long as it is based on competent and reliable scientific evidence. The Act will also resolve the issue of pharmacy compounding--the process of making customized medicines--so that legitimate pharmacy compounding is allowed, while the manufacture of unapproved drugs is not. While I am satisfied with the resolution of the issues in this legislation, I am also [[Page 1886]] pleased that the Congress included sunsets to certain of the Act's provisions so that, at the appropriate time, we can evaluate whether the proper compromises were reached. As FDA reform did not start with this bill, it will not end with this bill. Even with the streamlining provided in S. 830, the FDA will continue to face the challenge of fulfilling its many responsibilities and requirements within available resources. The Vice President and I look forward to continuing our work with patient groups, industry, and the Congress to make sure that the FDA is meeting the challenges of the future and providing safe and effective products to all Americans. William J. Clinton The White House, November 21, 1997. Note: S. 830, approved November 21, was assigned Public Law No. 105-115. This item was not received in time for publication in the appropriate issue. <DOC> [Weekly Compilation of Presidential Documents] [frwais.access.gpo.gov] [Page 1886] Monday, December 1, 1997 Volume 33--Number 48 Pages 1885-1930 Week Ending Friday, November 28, 1997 Proclamation 7053--National Farm-City Week, 1997 November 21, 1997 By the President of the United States of America A Proclamation When Americans sit down to a meal each day, we sometimes take for granted the quality and variety of the food we eat. Our grocery stores, supermarkets, and restaurants offer us an enormous volume and selection of fruits, vegetables, meats, dairy products, and other food items, but we too often forget the hardworking men and women whose skill and effort put that food on our tables. Strengthening our economy and providing food for people around the world, American agriculture is a leading global industry and a source of pride for our Nation. While producing an abundance of safe and affordable food and fiber, America's farmers and ranchers also provide a rich source of jobs in the United States. American agriculture employs more than 21 million people today, and agriculture-related industries continue to expand, pumping a trillion dollars into the American economy each year. During the earliest days of our Nation, most of the crops farmers grew were used to feed their families or local consumers. Today, through advances in technology and marketing and through partnerships with agribusiness industries, research scientists, carriers, shippers, and retail distributors, America's farmers produce enough food and fiber to help meet the needs of people around the globe. This week, as Americans gather with family and friends around the dinner table to give thanks for their many blessings, it is fitting that we count amount those blessings the vital farm-city partnerships that have done so much to improve the quality of our lives. Rural and urban communities, working together to make the most of America's rich agricultural resources, continue to contribute immensely to the health and well-being of our people and to the vigor of our national economy. Now, Therefore, I, William J. Clinton, President of the United States of America, by virtue of the authority vested in me by the Constitution and laws of the United States, do hereby proclaim November 21 through November 27, 1997, as National Farm-City Week. I call upon citizens in urban and rural areas throughout the Nation to acknowledge and celebrate the achievements of all those who, working together, produce an abundance of agricultural products that strengthen and enrich our country. In Witness Whereof, I have hereunto set my hand this twenty-first
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