[Congressional Record Volume 142, Number 36 (Friday, March 15, 1996)]
[Senate]
[Pages S2203-S2206]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




             THE 1996 BALANCED BUDGET DOWN PAYMENT ACT, II

                                 ______


                HATFIELD (AND WYDEN) AMENDMENT NO. 3536

  Mr. HATFIELD (for himself and Mr. Wyden) proposed an amendment to 
amendment No. 3466 proposed by Mr. Hatfield to the bill (H.R. 3019) 
making appropriations for fiscal year 1996 to make a further 
downpayment toward a balanced budget, and for other purposes; as 
follows:

       On page 577 of the pending amendment, strike lines 14 
     through the period on line 23.
                                 ______


                  BOND (AND HARKIN) AMENDMENT NO. 3537

  Mr. HATFIELD (for Mr. Bond, for himself, Mr. Simon, Mr. Grassley, Ms. 
Moseley-Braun, and Mr. Harkin) proposed an amendment to amendment No. 
3466 proposed by him to the bill H.R. 3019, supra; as follows:

       Insert the following at the appropriate place under Title 
     III of the Committee amendment:
       ``Sec.   . Any funds heretofore appropriated and made 
     available in Public Law 102-104 and Public Law 102-377 to 
     carry out the provisions for the project for navigation, St. 
     Louis Harbor, Missouri and Illinois; may be utilized by the 
     Secretary of the Army in carrying out the Upper Mississippi 
     and Illinois Waterway System Navigation Study, Iowa, 
     Illinois, Missouri, Wisconsin, Minnesota, in Fiscal Year 1996 
     or until expended.''
                                 ______


                   SPECTER AMENDMENTS NOS. 3538-3539

  Mr. HATFIELD (for Mr. Specter) proposed two amendments to amendment 
No. 3466 proposed by him to the bill H.R. 3019, supra; as follows:

                           Amendment No. 3538

       On page 546, line 21 of the pending amendment, increase the 
     rescission amount by $1,000,000.

[[Page S2204]]

       On page 572, line 16 of the pending amendment, strike 
     ``$129,499,000'' and insert in lieu thereof ``$130,499,000''.
                                                                    ____


                           Amendment No. 3539

       On page 590, after the word ``for'' on line 19, strike all 
     up to the word ``payment'' on line 23.
       On page 590, after the word ``education'' on line 25, 
     strike all up to the period on page 591, line 3.
                                 ______


                      JEFFORDS AMENDMENT NO. 3540

  Mr. HATFIELD (for Mr. Jeffords) proposed an amendment to amendment 
No. 3466 proposed by Mr. Hatfield to the bill H.R. 3019, supra; as 
follows:

       At the end of title III, on page 771 after line 17, add the 
     following new section:
       Sec.  . The Secretary of Health and Human Services shall 
     grant a waiver of the requirements set forth in section 
     1903(m)(2)(A)(ii) of the Social Security Act to D.C. 
     Chartered Health Plan, Inc. of the District of Columbia: 
     Provided, That such waiver shall be deemed to have been in 
     place for all contract periods from October 1, 1991 through 
     the current contract period or October 1, 1999, whichever 
     shall be later.
                                 ______


                COCHRAN (AND BUMPERS) AMENDMENT NO. 3541

  Mr. HATFIELD (for Mr. Cochran, for himself and Mr. Bumpers) proposed 
an amendment to amendment No. 3466 proposed by Mr. Hatfield to the bill 
H.R. 3019, supra; as follows:

       At the appropriate place insert the following:
       Sec.  . Of the funds appropriated by Public Law 104-37 or 
     otherwise made available to the Food Safety and Inspection 
     Service for Fiscal Year 1996, not less than $363,000,000 
     shall be available for salaries and benefits of in-plant 
     personnel: Provided, That this limitation shall not apply if 
     the Secretary of Agriculture certifies to the House and 
     Senate Committees on Appropriations that a lesser amount will 
     be adequate to fully meet in-plant inspection requirements 
     for the fiscal year.
                                 ______


                     LAUTENBERG AMENDMENT NO. 3542

  Mr. HATFIELD (for Mr. Lautenberg) proposed an amendment to amendment 
No. 3466 proposed by Mr. Hatfield to the bill H.R. 3019, supra; as 
follows:

       On page 769, line 24, delete the word ``Of'' and insert 
     ``Notwithstanding any other provision of law, of''
       On page 770, line 4, after the word ``available'', insert 
     the words ``for operating expenses''.
                                 ______


                 GREGG (AND OTHERS) AMENDMENT NO. 3543

  Mr. HATFIELD (for Mr. Gregg, for himself, Mr. Kennedy, Mr. Hatch, and 
Mrs. Kassebaum) proposed an amendment to amendment No. 3466 proposed by 
Mr. Hatfield to the bill H.R. 3019, supra; as follows:

       At the appropriate place in the bill, insert the following:

                  TITLE  --FOOD AND DRUG EXPORT REFORM

     SEC.  01. SHORT TITLE, REFERENCE.

       (a) Short Title.--This title may be cited as the ``FDA 
     Export Reform and Enhancement Act of 1996''.
       (b) Reference.--Wherever in this title (other than in 
     section   04) an amendment or repeal is expressed in terms of 
     an amendment to, or repeal of, a section or other provision, 
     the reference shall be considered to be made to a section or 
     other provision of the Federal Food. Drug, and Cosmetic Act. 
     (21 U.S.C. 321 et seq.)

                SEC.   02. EXPORT OF DRUGS AND DEVICES.

       (a) Export and Imports.--Section 801 (21 U.S.C. 381) is 
     amended--
       (1) In subsection (d), by adding at the end thereof the 
     following new paragraphs:
       ``(3) No component, part, or accessory of a drug, 
     biological product, or device, including a drug in bulk 
     inform, shall be excluded from importation into the United 
     States under subsection (a) if--
       ``(A) the importer affirms at the time of initial 
     importation that such component, part, or accessory is 
     intended to be incorporated by the initial owner or consignee 
     into a drug, biological product, or device that will be 
     exported by such owner or consignee from the United States in 
     accordance with subsection 801(e) or section 802 of this Act 
     or section 351(h) of the Public Health Service Act;
       ``(B) the initial owner or consignee responsible for such 
     imported articles maintains records that identify the use of 
     such imported articles and upon request of the Secretary 
     submits a report that provides an accounting of the 
     exportation or the disposition of the imported articles, 
     including portions that have been destroyed, and the manner 
     in which such person complied with the requirements of this 
     paragraph; and
       ``(C) any imported component, part or accessory not so 
     incorporated is destroyed or exported by the owner or 
     consignee.''
       ``(4) The importation into the United States of blood, 
     blood components, source plasma, and source leukocytes, is 
     not permitted pursuant to paragraph (3) unless the 
     importation complies with section 351(a) of the Public Health 
     Service Act. The importation of tissue is not permitted 
     pursuant to paragraph (3) unless the importation complies 
     with section 361 of the Public Health Service Act.'';
       ``(2) in subsection (e)(1), by striking the second 
     sentence;
       ``(3) in subsection (e)(2)--
       ``(A) by striking ``the Secretary'' and inserting ``either 
     (i) the Secretary''; and
       ``(B) by inserting before the period at the end thereof the 
     following: ``or (ii) the device is eligible for export under 
     section 802''; and
       ``(4) in subsection (e), by adding at the end thereof the 
     following new paragraph:;
       ``(3) A new animal drug that requires approval under 
     section 512 shall not be exported pursuant to paragraph (1) 
     if such drug has been banned in the United States.''.
       ``(b) Export of Certain Unapproved Drugs and Devices.--
     Section 802 (21 U.S.C. 382) is amended to read as follows:


                ``EXPORTS OF CERTAIN UNAPPROVED PRODUCTS

       ``Sec. 802. (a) A drug (including a biological product) 
     intended for human use or a device for human use--
       ``(1) which, in the case of a drug--
       ``(A)(i) requires approval by the Secretary under section 
     505 before such drug may be introduced or delivered for 
     introduction into interstate commerce; or
       ``(ii) requires licensing by the Secretary under section 
     351 of the Public Health Service Act or by the Secretary of 
     Agriculture under the Act of March 4, 1913 (known as the 
     Virus-Serum Toxin Act) before it may be introduced or 
     delivered for introduction into interstate commerce; and
       ``(B) does not have such approval or license, is not exempt 
     from such sections or Act, and is introduced or delivered for 
     introduction into interstate commerce; or
       ``(2) which, in the case of a device--
       ``(A) does not comply with an applicable requirement under 
     section 514 or 515;
       ``(B) under section 520(g) is exempt from either such 
     section; or
       ``(C) is a banned device under section 516,

     is adulterated, misbranded, and in violation of such sections 
     or Act unless the export of the drug or device is authorized 
     under subsection (b), (c), (d), or (e), or under section 
     801(e)(2). If a drug (including a biological product) or 
     device described in paragraphs (1) and (2) may be exported 
     under subsection (b) and if an application for such drug or 
     device under section 505 or 514 or section 351 of the Public 
     Health Service Act was disapproved, the Secretary shall 
     notify the appropriate public health official of the country 
     to which such drug will be exported of such disapproval.
       ``(b)(1) Except as otherwise provided in this section, a 
     drug (including a biological product) or device may be 
     exported to any country, if the drug or device complies with 
     the laws of that country and has valid marketing 
     authorization by the appropriate approval authority--
       ``(A) in Australia, Canada, Israel, Japan, New Zealand, 
     Switzerland, or South Africa; or
       ``(B) in the European Union or a country in the European 
     Economic Area (the countries in the European Union and the 
     European Free Trade Association) if the drug or device is 
     marketed in that country or the drug or device is authorized 
     for general marketing in the European Economic Area.
       ``(2) The Secretary may designate an additional country or 
     countries to be included in the list of countries described 
     in subparagraphs (A) and (B) of paragraph (1). The Secretary 
     shall not delegate the authority granted under this 
     paragraph.
       ``(3) An appropriate country official, manufacturer, or 
     exporter may request the Secretary to designate an additional 
     country or countries to be included in the list of countries 
     described in subparagraphs (A) and (B) of paragraph (1) by 
     submitting documentation to the Secretary in support of such 
     designation. Any person other than a country requesting such 
     designation shall include along with the request a letter 
     from the country indicating the desire of such country to be 
     designated.
       ``(4) The Secretary shall designate a country or countries 
     to be included in the list of countries described in 
     subparagraphs (A) and (B) of paragraph (1) of the Secretary 
     finds that the valid marketing authorization system in such 
     country or countries is equivalent to the systems in the 
     countries described in subparagraphs (A) and (B) of paragraph 
     (1).
       ``(c) A drug or device intended for investigational use in 
     any country described in subsection (b) may be exported in 
     accordance with the laws of that country and shall be exempt 
     from regulation under section 505(i) or 520(g).
       ``(d) A drug or device intended for formulation, filling, 
     packaging, labeling, or further processing in anticipation of 
     market authorization in any country described in paragraph 
     (1)(A) or (B) of subsection (b) may be exported to those 
     countries for use in accordance with the laws of that 
     country.
       ``(e)(1) A drug (including a biological product) or device 
     which is to be used in the prevention or treatment of a 
     tropical disease or other disease not prevalent in the United 
     States and which does not otherwise qualify for export under 
     this section may, upon approval of an application submitted 
     under paragraph (2), be exported if--

[[Page S2205]]

       ``(A) the Secretary finds, based on credible scientific 
     evidence, including clinical investigations, that the drug or 
     device is safe and effective in the country to which the drug 
     or device is to be exported in the prevention or treatment of 
     a tropical disease or other disease not prevalent in the 
     United States in such country.
       ``(B) the drug or device is manufactured, processed, 
     packaged, and held in conformity with current good 
     manufacturing practice and is not adulterated under 
     subsection (a)(1), (a)(2)(A), (a)(3), (c), or (d) of section 
     501;
       ``(C) the outside of the shipping package is labeled with 
     the following statement: `This drug or device may be sold or 
     offered for sale only in the following countries: ______', 
     the blank space being filled with a list of the countries to 
     which export of the drug or device is authorized under this 
     subsection;
       ``(D) the drug or device is not the subject of a notice by 
     the Secretary or the Secretary of Agriculture of a 
     determination that the manufacture of the drug or device in 
     the United States for export to a country is contrary to the 
     public health and safety of the United States; and
       ``(E) the requirements of subparagraphs (A) through (D) of 
     section 801(e)(1) have been met.
       ``(2) Any person may apply to have a drug or device 
     exported under paragraph (1). The application shall--
       ``(A) describe the drug or device to be exported;
       ``(B) list each country to which the drug or device is to 
     be exported;
       ``(C) contain a certification by the applicant that the 
     drug or device will not be exported to a country for which 
     the Secretary cannot make a finding described in paragraph 
     (1)(A);
       ``(D) identify the establishments in which the drug or 
     device is manufactured; and
       ``(E) demonstrate to the Secretary that the drug or device 
     meets the requirements of paragraph (1).
       ``(3) The holder of an approved application for the export 
     of a drug or device under this subsection shall report to the 
     Secretary--
       ``(A) the receipt of any information indicating that the 
     drug or device is being or may have been exported from a 
     country for which the Secretary made a finding under 
     paragraph (1)(A) to a country for which the Secretary cannot 
     make such a finding; and
       ``(B) the receipt of any information indicating any adverse 
     reactions to such drug.
       ``(4)(A) If the Secretary determines that--
       ``(i) a drug or device for which an application is approved 
     under paragraph (2) does not continue to meet the 
     requirements of paragraph (1);
       ``(ii) the holder of such application has not made the 
     report required by paragraph (3); or
       ``(iii) the manufacture of such drug or device in the 
     United States for export is contrary to the public health and 
     safety of the United States and an application for the export 
     of such drug or device has been approved under paragraph (2).

     then before taking action against the holder of an 
     application for which a determination was made under clause 
     (i), (ii), or (iii), the Secretary shall notify the holder in 
     writing of the determination and provide the holder 30 days 
     to take such action as may be required to prevent the 
     Secretary from taking action against the holder under this 
     subparagraph. If the Secretary takes action against such 
     holder because of such a determination, the Secretary shall 
     provide the holder a written statement specifying the reasons 
     for such determination and provide the holder, on request, an 
     opportunity for an informal hearing with respect to such 
     determination.
       ``(B) If at any time the Secretary, or in the absence of 
     the Secretary, the official designated to act on behalf of 
     the Secretary, determines that--
       ``(i) the holder of an approved application under paragraph 
     (2) is exporting a drug or device from the United States to 
     an importer;
       ``(ii) such importer is exporting the drug or device to a 
     country for which the Secretary cannot make a finding under 
     paragraph (1)(A); and
       ``(iii) such export presents an imminent hazard to the 
     public health in such country,

     the Secretary shall immediately prohibit the export of the 
     drug or device to such importer, provide the person exporting 
     the drug or device from the United States prompt notice of 
     the determination, and afford such person an opportunity for 
     an expedited hearing. A determination by the Secretary under 
     this subparagraph may not be stayed pending final action by a 
     reviewing court. The authority conferred by this subparagraph 
     shall not be delegated by the Secretary.
       ``(C) If the Secretary, or in the absence of the Secretary, 
     the official designated to act on behalf of the Secretary, 
     determines that the holder of an approved application under 
     paragraph (2) is exporting a drug or device to a country for 
     which the Secretary cannot make a finding under paragraph 
     (1)(A), and that the export of the drug or device presents an 
     imminent hazard, the Secretary shall immediately prohibit the 
     export of the drug or device to such country, give the holder 
     prompt notice of the determination, and afford the holder an 
     opportunity for an expedited hearing. A determination by the 
     Secretary under this subparagraph may not be stayed pending 
     final action by a reviewing court. The authority conferred by 
     this subparagraph shall not be delegated by the Secretary.
       ``(D) If the Secretary receives credible evidence that the 
     holder of an application approved under paragraph (2) is 
     exporting a drug or device to a country for which the 
     Secretary cannot make a finding under paragraph (1)(A), the 
     Secretary shall give the holder 60 days to provide 
     information to the Secretary respecting such evidence and 
     shall provide the holder an opportunity for an informal 
     hearing on such evidence. Upon the expiration of such 60 
     days, the Secretary shall prohibit the export of such drug or 
     device to such country if the Secretary determines the holder 
     is exporting the drug or device to a country for which the 
     Secretary cannot make a finding under paragraph (1)(A).
       ``(E) If the Secretary receives credible evidence that an 
     importer is exporting a drug or device to a country for which 
     the Secretary cannot make a finding under paragraph (1)(A), 
     the Secretary shall notify the holder of the application 
     authorizing the export of such drug or device of such 
     evidence and shall require the holder to investigate the 
     export by such importer and to report to the Secretary within 
     14 days of the receipt of such notice the findings of the 
     holder. If the Secretary determines that the importer has 
     exported a drug or device to such a country, the Secretary 
     shall prohibit such holder from exporting such drug or device 
     to the importer unless the Secretary determines that the 
     export by the importer was unintentional.
       ``(f) A drug or device may not be exported under this 
     section if--
       ``(1) the drug or device is not manufactured, processed, 
     packaged, and held in conformity with current good 
     manufacturing practice or is adulterated under paragraph (1), 
     (2)(A), or (3) of section 501(a) or subsection (c) or (d) of 
     section 501;
       ``(2) the requirements of subparagraphs (A) through (d) of 
     section 801(e)(1) have not been met;
       ``(3)(A) the drug or device is the subject of a notice by 
     the Secretary or the Secretary of Agriculture of a 
     determination that the possibility of reimportation of the 
     exported drug or device would present an imminent hazard to 
     the public health and safety of the United States and the 
     only means of limiting the hazard is to prohibit the export 
     of the drug or device;
       ``(B) the drug or device presents an imminent hazard to the 
     public health of the country to which the drug or device 
     would be exported; or
       ``(4) the drug or device is not lableld or promoted--
       ``(A) in accordance with the requirements and conditions 
     for use in--
       ``(i) the country in which the drug or device received a 
     valid marketing authorization under subsection (b)(2); and
       ``(ii) the country to which the drug or device would be 
     exported; and
       ``(B) in the language of the country or designated by the 
     country to which the drug or device would be exported.

     ``In making a finding under paragraph (37)(B), the Secretary 
     shall, to the maximum extent possible, consult with the 
     appropriate public health official in the affected country.
       ``(g) The exporter of a drug or device exported under this 
     section shall provide a simple notification to the Secretary 
     when the exporter first begins to export such drug or device 
     to a country and shall maintain records of all products 
     exported pursuant to this section.
       ``(h) For purposes of this section--
       ``(1) a reference to the Secretary shall in the case of a 
     biological product which is required to be licensed under the 
     Act of March 4, 1913 (37 Stat. (832-833) (commonly known as 
     the Virus-Serum Toxin Act) be considered to be a reference to 
     the Secretary of Agriculture, and
       ``(2) the term ``drug'' includes drugs for human use as 
     well as biological under section 351 of the Public Health 
     Service Act or the Act of March 4, 1913 (37 Stat. 832-833) 
     (commonly known as the Virus-Serum Toxin Act).''

     SEC.  03. PROHIBITED ACT.

       Section 301 (21 U.S.C. 331) is amended--
       (1) by redesignating the second subsection (u) as 
     subsection (v); and
       (2) by adding at the end thereof the following new 
     subsection:
       ``(w)(1) The failure to maintain records as required by 
     section 801(d)(3), the making of a knowing false statement in 
     any record or report required or requested under section 
     801(d)(3), the release into interstate commerce of any 
     article imported into the United States under section 
     801(d)(3) or any finished product made from such article 
     (except for export in accordance with subsection 801(e) or 
     section 802 of the Act or section 351(h) of the Public Health 
     Service Act), or the failure to export or destroy any 
     component, part or accessory not incorporated into a drug, 
     biological product or device that will be exported in 
     accordance with subsection 801(e) or section 802 of this Act 
     or section 351(h) of the Public Health Service Act.''

     SEC.  04. PARTIALLY PROCESSED BIOLOGICAL PRODUCTS.

       Subsection (h) of section 351 of the Public Health Service 
     Act (42 U.S.C. 262) is amended to read as follows:
       ``(h) A partially processed biological product which--
       ``(1) is not in a form applicable to the prevention, 
     treatment, or cure of diseases or injuries of man;
       ``(2) is not intended for sale in the United States; and
       ``(3) is intended for further manufacture into final dosage 
     form outside the United States,


[[Page S2206]]


     shall be subject to no restriction on the export of the 
     product under this Act or the Federal Food, Drug, and 
     cosmetic Act (21 U.S.C. 321 et seq.) if the product is 
     manufactured, processed, packaged, and held in conformity 
     with current good manufacturing practice and meets the 
     requirements in section 801(e)(1) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 381(e)).''.
                                 ______


            GRAMM (AND HUTCHISON) AMENDMENTS NOS. 3544-3545

  Mr. HATFIELD (for Mr. Gramm, for himself and Mrs. Hutchison) proposed 
two amendments to amendment No. 3466 proposed by Mr. Hatfield to the 
bill H.R. 3019, supra; as follows:

                           Amendment No. 3544

       On page 577, line 14 of the committee substitute, insert:
       ``Sec. 213. If the Secretary fails to approve the 
     application for waivers related to the Achieving Change for 
     Texans, a comprehensive reform of the Texas Aid To Families 
     With Dependent Children program designed to encourage work 
     instead of welfare, a request under section 1115(a) of the 
     Social Security Act submitted by the Texas Department of 
     Human Services on September 30, 1995, by the date of 
     enactment of this Act, notwithstanding the Secretary's 
     authority to approve the applications under such section, the 
     applications shall be deemed approved.''
                                                                    ____


                           Amendment No. 3545

       Section 223B of the amendment is amended to read as 
     follows:
       ``Sec. 223B. Section 415 of the Department of Housing and 
     Urban Development--Independent Agencies Appropriations Act, 
     1988 (Public Law 100-202; 101 Stat. 1329-213) is repealed 
     effective the date of enactment of Public Law 104-19. The 
     Secretary is authorized to demolish the structures identified 
     in such section. The Secretary is also authorized to 
     compensate those local governments which, due to this 
     provision, expended local revenues demolishing the 
     developments identified in such provision.''.
                                 ______


                       GORTON AMENDMENT NO. 3546

  Mr. HATFIELD (for Mr. Gorton) proposed an amendment to amendment No. 
3466 proposed by Mr. Hatfield to the bill H.R. 3019, supra; as follows:

       To the amendment numbered 3466: On page 406, line 8, strike 
     ``$567,152,000'' and insert in lieu thereof ``$567,753,000''.
                                 ______


                HATFIELD (AND OTHERS) AMENDMENT NO. 3547

  Mr. HATFIELD (for himself, Mr. Hollings, Mr. Pell, Mr. Daschle, and 
Mr. Kerry) proposed an amendment to amendment No. 3466 proposed by Mr. 
Hatfield to the bill H.R. 3019, supra; as follows:

       At the appropriate place, insert the following:
       The appropriation for the Arms Control and Disarmament 
     Agency in Public Law 103-317 (108 STAT. 1768) is amended by 
     deleting after ``until expended'' the following: ``only for 
     activities related to the implementation of the Chemical 
     Weapons Convention'' : Provided, That amounts made available 
     shall not be used to undertake new programs or to increase 
     employment above levels on board at the time of enactment of 
     this Act.

                          ____________________