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[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]]




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[Weekly Compilation of Presidential Documents]
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[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.


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[Weekly Compilation of Presidential Documents]
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[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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