[Congressional Record Volume 143, Number 122 (Monday, September 15, 1997)]
[Senate]
[Pages S9338-S9345]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                          AMENDMENTS SUBMITTED

                                 ______
                                 

 THE FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT 
    OF 1997 PRESCRIPTION DRUG USERS FEE REAUTHORIZATION ACT OF 1997

                                 ______
                                 

                 HARKIN (AND OTHERS) AMENDMENT NO. 1137

  (Ordered to lie on the table.)
  Mr. HARKIN (for himself, Mr. Hatch, Mr. Daschle, and Ms. Mikulski) 
submitted an amendment intended to be proposed by them to the bill (S. 
830) to amend the Federal Food, Drug, and Cosmetic Act and the Public 
Health Service Act to improve the regulation of food, drugs, devices, 
and biological products, and for other purposes; as follows:

       At the appropriate place, insert the following new section:

     SEC. ___. ESTABLISHMENT OF NATIONAL CENTER FOR COMPLEMENTARY 
                   AND ALTERNATIVE MEDICINE.

       (a) In General.--Title IV of the Public Health Service Act 
     (42 U.S.C. 281 et seq.) is amended--
       (1) by striking section 404E; and
       (2) in part E, by amending subpart 4 to read as follows:

``Subpart 4--National Center for Complementary and Alternative Medicine

     ``SEC. 485C. PURPOSE OF CENTER.

       ``(a) In General.--The general purposes of the National 
     Center for Complementary and

[[Page S9339]]

     Alternative Medicine (in this subpart referred to as the 
     `Center') are--
       ``(1) the conduct and support of basic and applied research 
     (including both intramural and extramural research), research 
     training, the dissemination of health information, and other 
     programs, including prevention programs, with respect to 
     identifying, investigating, and validating complementary and 
     alternative treatment, prevention, and diagnostic systems, 
     modalities, and disciplines; and
       ``(2) carrying out the functions specified in sections 485D 
     (relating to dietary supplements).

     The Center shall be headed by a director, who shall be 
     appointed by the Secretary. The Director of the Center shall 
     report directly to the Director of NIH.
       ``(b) Advisory Council.--The Secretary shall establish an 
     advisory council for the Center in accordance with section 
     406, except that the members of the advisory council who are 
     not ex officio members shall include one or more 
     practitioners from each of the disciplines and systems with 
     which the Center is concerned, and at least 3 individuals 
     representing the interests of individual consumers of 
     complementary and alternative medicine.
       ``(c) Complement to Conventional Medicine.--In carrying out 
     subsection (a), the Director of the Center shall, as 
     appropriate, study the integration of alternative medical 
     treatment and diagnostic systems, modalities, and disciplines 
     into the practice of conventional medicine as a complement to 
     such medicine and into health care delivery systems in the 
     United States.
       ``(d) Appropriate Scientific Expertise.--The Director of 
     the Center, after consultation with the advisory council for 
     the Center and the division of research grants, shall ensure 
     that scientists with appropriate expertise in research on 
     complementary and alternative medicine are incorporated into 
     the review, oversight, and management processes of all 
     research projects and other activities funded by the Center. 
     In carrying out this subsection, the Director of the Center, 
     as necessary, may establish review groups with appropriate 
     scientific expertise.
       ``(e) Evaluation of Various Disciplines and Systems.--In 
     carrying out subsection (a), the Director of the Center shall 
     identify and evaluate alternative medical treatment and 
     diagnostic modalities in each of the disciplines and systems 
     with which the Center is concerned, including each discipline 
     and system in which accreditation, national certification, or 
     a State license is available.
       ``(f) Ensuring High Quality, Rigorous Scientific Review.--
     In order to ensure high quality, rigorous scientific review 
     of complementary and alternative medical and diagnostic 
     systems, modalities, and disciplines, the Director of the 
     Center shall conduct or support the following activities:
       ``(1) Outcomes research and investigations.
       ``(2) Epidemiological studies.
       ``(3) Health services research.
       ``(4) Basic science research.
       ``(5) Clinical trials.
       ``(6) Other appropriate research and investigational 
     activities.
       ``(g) Data System; Information Clearinghouse.--
       ``(1) Data system.--The Director of the Center shall 
     establish a bibliographic system for the collection, storage, 
     and retrieval of worldwide research relating to complementary 
     and alternative medical treatment and diagnostic systems, 
     modalities, and disciplines. Such a system shall be regularly 
     updated and publicly accessible.
       ``(2) Clearinghouse.--The Director of the Center shall 
     establish an information clearinghouse to facilitate and 
     enhance, through the effective dissemination of information, 
     knowledge and understanding of alternative medical treatment 
     and diagnostic systems and disciplines by health 
     professionals, patients, industry, and the public.
       ``(h) Research Centers.--
       ``(1) In general.--The Director of the Center, after 
     consultation with the advisory council for the Center, shall 
     provide support for the development and operation of 
     multipurpose centers to conduct research and other activities 
     described in subsection (a)(1) with respect to complementary 
     and alternative medical treatment and diagnostic systems, 
     modalities, and disciplines.
       ``(2) Requirements.--Each center assisted under paragraph 
     (1) shall use the facilities of a single entity, or be formed 
     from a consortium of cooperating entities, and shall meet 
     such requirements as may be established by the Director of 
     the Center. Each such center shall--
       ``(A) be established as an independent entity; or
       ``(B) be established within or in affiliation with an 
     entity that conducts research or training described in 
     subsection (a)(1).
       ``(3) Duration of support.--Support of a center under 
     paragraph (1) may be for a period not exceeding 5 years. Such 
     period may be extended for one or more additional periods not 
     exceeding 5 years if the operations of such center have been 
     reviewed by an appropriate technical and scientific peer 
     review group established by the Director of the Center and if 
     such group has recommended to the Director that such period 
     should be extended.
       ``(i) Biennial Report.--The Director of the Center shall 
     prepare biennial reports on the activities carried out or to 
     be carried out by the Center, and shall submit each such 
     report to the Director of NIH for inclusion in the biennial 
     report under section 403.
       ``(j) Availability of Resources.--After consultation with 
     the Director of the Center, the Director of NIH shall ensure 
     that resources of the National Institutes of Health, 
     including laboratory and clinical facilities, fellowships 
     (including research training fellowship and junior and senior 
     clinical fellowships), and other resources are sufficiently 
     available to enable the Center to appropriately and 
     effectively carry out its duties as described in subsection 
     (a).
       ``(k) Authorization of Appropriations.--For the purpose of 
     carrying out this subpart, there are authorized to be 
     appropriated such sums as may be necessary for each of the 
     fiscal years 1998 through 2002. Amounts appropriated under 
     this subsection for fiscal year 1998 are available for 
     obligation through September 30, 2000. Amounts appropriated 
     under this subsection for fiscal year 1999 are available for 
     obligation through September 30, 2000.

     ``SEC. 485D. OFFICE OF DIETARY SUPPLEMENTS.

       ``(a) In General.--There is established within the Center 
     an office to be known as the Office of Dietary Supplements 
     (in this section referred to as the `Office'). The Office 
     shall be headed by a director, who shall be appointed by the 
     Director of the Center. The Director of the Center shall 
     carry out the functions specified in this section acting 
     through the Director of the Office.
       ``(b) Duties.--
       ``(1) In general.--The Director of the Office shall--
       ``(A) expand the activities of the national research 
     institutes with respect to the potential role of dietary 
     supplements as a significant part of the efforts of the 
     United States to improve health care; and
       ``(B) promote scientific study of the benefits of dietary 
     supplements in maintaining health and preventing chronic 
     disease and other health-related conditions.
       ``(2) Certain duties.--The Director of the Office shall--
       ``(A) conduct and coordinate scientific research within the 
     National Institutes of Health relating to dietary supplements 
     and the extent to which the use of dietary supplements can 
     limit or reduce the risk of diseases such as heart disease, 
     cancer, birth defects, osteoporosis, cataracts, or 
     prostatism;
       ``(B) collect and compile the results of scientific 
     research relating to dietary supplements, including 
     scientific data from foreign sources or other offices of the 
     Center;
       ``(C) serve as the principal advisor to the Secretary and 
     to the Assistant Secretary for Health and provide advice to 
     the Director of NIH, the Director of the Centers for Disease 
     Control and Prevention, and the Commissioner of Food and 
     Drugs on issues relating to dietary supplements including--
       ``(i) dietary intake regulations;
       ``(ii) the safety of dietary supplements;
       ``(iii) claims characterizing the relationship between 
     dietary supplements and the prevention of disease or other 
     health-related conditions;
       ``(iv) claims characterizing the relationship between 
     dietary supplements and the maintenance of health; and
       ``(v) scientific issues arising in connection with the 
     labeling and composition of dietary supplements;
       ``(D) compile a database of scientific research on dietary 
     supplements and individual nutrients; and
       ``(E) coordinate funding relating to dietary supplements 
     for the National Institutes of Health.
       ``(c) Biennial Report.--The Director of the Office shall 
     prepare biennial reports on the activities carried out or to 
     be carried out by the Office, and shall submit each such 
     report to the Director of the Center for inclusion in the 
     biennial report under section 485C(i).
       ``(d) Definition.--For purposes of this section, the term 
     `dietary supplement' has the meaning given such term in 
     section 201(ff) of the Federal Food, Drug, and Cosmetic 
     Act.''.
       (b) Savings Provisions.--
       (1) National center for complementary and alternative 
     medicine.--All officers and employees employed in the Office 
     of Alternative Medicine on the day before the date of the 
     enactment of this Act (pursuant to section 404E of the Public 
     Health Service Act, as in effect on such day) are transferred 
     to the National Center for Complementary and Alternative 
     Medicine. Such transfer does not affect the status of any 
     such officer or employee (except to the extent that the 
     amendments made by subsection (a) affect the authority to 
     make appointments to employment positions). All funds 
     available on such day for such Office are transferred to such 
     Center, and the transfer does not affect the availability of 
     funds for the purposes for which the funds were appropriated 
     (except that such purposes shall apply with respect to the 
     Center to the same extent and in the same manner as the 
     purposes applied with respect to the Office). All other legal 
     rights and duties with respect to the Office are transferred 
     to the Center, and continue in effect in accordance with 
     their terms.
       (2) Office of dietary supplements.--With respect to the 
     Office of Dietary Supplements established in section 485D of 
     the Public Health Service Act (as added by subsection (a)), 
     such establishment shall be construed to constitute a 
     transfer of such Office to the National Center for 
     Complementary and Alternative Medicine from the Office of the 
     Director of the National Institutes of Health (in which the 
     Office of Dietary Supplements was located pursuant to section 
     485C of the Public Health Service Act, as such section

[[Page S9340]]

     was in effect on the day before the date of the enactment of 
     this Act). Such transfer does not affect the status of any 
     individual as an officer or employee in the Office of Dietary 
     Supplements (except to the extent that the amendments made by 
     subsection (a) affect the authority to make appointments to 
     employment positions), does not affect the availability of 
     funds of the Office for the purposes for which the funds were 
     appropriated, and does not affect any other rights or duties 
     with respect to the Office.
       (c) Technical and Conforming Amendments.--Part A of title 
     IV of the Public Health Service Act (42 U.S.C. 281 et seq.), 
     as amended by subsection (a), is amended--
       (1) in section 401(b)(2), by amending subparagraph (E) to 
     read as follows:
       ``(E) The National Center for Complementary and Alternative 
     Medicine.''; and
       (2) in section 402, by redesignating subsections (g) 
     through (k) as subsections (f) through (j), respectively.
                                 ______
                                 

                    DURBIN AMENDMENTS NOS. 1138-1141

  (Ordered to lie on the table.)
  Mr. DURBIN submitted four amendments intended to be proposed by him 
to the bill, S. 830, supra; as follows:

                           Amendment No. 1138

       Strike subsection (c) of section 404 and insert the 
     following:
       (c) Rule of Construction.--Nothing in this Act or any 
     amendment made by this Act shall be construed to alter any 
     authority of the Secretary of Health and Human Services to 
     regulate any tobacco product, or any additive or ingredient 
     of a tobacco product.
                                  ____


                           Amendment No. 1139

       Strike sections 605 and 606.
                                  ____


                           Amendment No. 1140

       In section 523 of the Federal Food, Drug, and Cosmetic Act, 
     as added by section 204, strike subsection (b) and insert the 
     following:
       ``(b) Accreditation.--
       ``(1) In general.--Within 180 days after the date of 
     enactment of this section, the Secretary shall adopt methods 
     of accreditation that ensure that entities or individuals who 
     conduct reviews and make recommendations under this section 
     are qualified, properly trained, knowledgeable about handling 
     confidential documents and information, and free of conflicts 
     of interest.
       ``(2) Standards.--In adopting the methods of accreditation, 
     the Secretary shall ensure that the entities and 
     individuals--
       ``(A) are subject to--
       ``(i) the conflict of interest standards applicable to 
     employees of the Food and Drug Administration under subparts 
     E, H, and I of part 73 of title 45, Code of Federal 
     Regulations (as in effect on January 1, 1996); or
       ``(ii) if the standards described in clause (i) would be 
     inappropriate for the entities and individuals, conflict of 
     interest standards developed by the Secretary that are--
       ``(I) based on the standards described in clause (i); and
       ``(II) modified, as appropriate, to apply to the entities 
     and individuals; and
       ``(B) are not subject to the conflict of interest standards 
     under supbart J of such part.
       ``(3) Publication.--The Secretary shall publish the methods 
     of accreditation in the Federal Register on the adoption of 
     the methods.''.
                                  ____


                           Amendment No. 1141

       At the end of title VIII, add the following:

     SEC. __. NOTIFICATION OF DISCONTINUANCE OF A LIFE SAVING 
                   PRODUCT.

       Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
     811, is further amended by adding at the end the following:

  ``Subchapter H--Notification of the Discontinuance of a Life Saving 
                                Product

     ``SEC. 781. DISCONTINUANCE OF A LIFE SAVING PRODUCT.

       ``(a) In General.--A manufacturer that is the sole 
     manufacturer of a drug (including a biological product) or 
     device--
       ``(1) that is--
       ``(A) life supporting;
       ``(B) life sustaining; or
       ``(C) intended for use in the prevention of a debilitating 
     disease or condition; and
       ``(2) for which an application has been approved under 
     section 505(b), 505(j), or 515(d),

     shall notify the Secretary of a discontinuance of the 
     manufacture of the drug or device at least 6 months prior to 
     the date of the discontinuance.
       ``(b) Reduction in Notification Period.--On application of 
     a manufacturer, the Secretary may reduce the notification 
     period required under subsection (a) for the manufacturer if 
     good cause exists for the reduction, such as a situation in 
     which--
       ``(1) a public health problem may result from continuation 
     of the manufacturing for the 6-month period;
       ``(2) a biomaterials shortage prevents the continuation of 
     the manufacturing for the 6-month period;
       ``(3) a liability problem may exist for the manufacturer if 
     the manufacturing is continued for the 6-month period;
       ``(4) continuation of the manufacturing for the 6-month 
     period may cause substantial economic hardship for the 
     manufacturer; or
       ``(5) the manufacturer has filed for bankruptcy under 
     chapter 7 or 11 of title 11, United States Code.
       ``(c) Distribution.--To the maximum extent practicable, the 
     Secretary shall distribute information on the discontinuation 
     of the drugs and devices described in subsection (a) to 
     appropriate physician and patient organizations.''.
                                 ______
                                 

                   KENNEDY AMENDMENTS NOS. 1142-1155

  (Ordered to lie on the table.)
  Mr. KENNEDY submitted 14 amendments intended to be proposed by him in 
the bill, S. 830, supra; as follows:

                           Amendment No. 1142

       Strike section 404.
                                  ____


                           Amendment No. 1143

       On age 30, strike lines 1 through 16, and insert the 
     following:
       (b) Premarket Notification.--Section 513(i)(1) (21 U.S.C. 
     360c(i)(1)) is amended by adding at the end the following:
       ``(C) Whenever the Secretary requests information to 
     demonstrate that the devices with differing technological 
     characteristics are substantially equivalent, the Secretary 
     shall only request information that is necessary to make a 
     substantial equivalence determination. In making such a 
     request, the Secretary shall consider the least burdensome 
     means of demonstrating substantial equivalence and shall 
     request information accordingly.
       ``(D) The determination of the Secretary under this 
     subsection and section 513(f)(1) with respect to the intended 
     use of a device shall be based on the intended use included 
     in the proposed labeling of the device submitted in a report 
     under section 510(k), except that nothing in this 
     subparagraph may be construed to limit what the Secretary may 
     consider in determining whether a device is substantially 
     equivalent to a predicate device under subparagraph 
     (A)(ii).''.
                                  ____


                           Amendment No. 1144

       On page 30, line 16, after the first period, insert the 
     following: ``Nothing in the preceding sentence shall be 
     construed to prohibit the Secretary from determining that a 
     new device is not substantially equivalent to a predicate 
     device because changes in the technological characteristics 
     of the new device demonstrate that the device is intended for 
     a different use than the use stated in the labeling of the 
     device.''.
                                  ____


                           Amendment No. 1145

       On page 30, line 16, insert before the first period the 
     following: ``If the proposed labeling is neither false nor 
     misleading''.
                                  ____


                           Amendment No. 1146

       Strike section 406.
                                  ____


                           Amendment No. 1147

       Amend section 406 to read as follows:

     SEC. 406. LIMITATIONS ON INITIAL CLASSIFICATION 
                   DETERMINATIONS.

       Section 510(21 U.S.C. 360) is amended by adding at the end 
     the following:
       ``(m) The Secretary may not withhold a determination of the 
     initial classification of a device under section 513(f)(1) 
     because of a failure to comply with any provision of this Act 
     that is unrelated to a substantial equivalence decision, 
     including a failure to comply with the requirements relating 
     to good manufacturing practices under section 520(f), if such 
     failure is unrelated to a substantial equivalence 
     decision.''.
                                  ____


                           Amendment No. 1148

       Amend section 406 to read as follows:

     SEC. 406. LIMITATIONS ON INITIAL CLASSIFICATION 
                   DETERMINATIONS.

       Section 510 (21 U.S.C. 360) is amended by adding at the end 
     the following:
       ``(m) The Secretary may not withhold a determination of the 
     initial classification of a device under section 513(f)(1) 
     because of a failure to comply with any provision of this Act 
     that is unrelated to a substantial equivalence decision, 
     including a failure to comply with the requirements relating 
     to good manufacturing practices under section 520(f), unless 
     such failure could result in harm to human health.''.
                                  ____


                           Amendment No. 1149

       Strike section 602.
                                  ____


                           Amendment No. 1150

       Strike section 602 and insert the following:

     SEC. 602. ENVIRONMENTAL IMPACT REVIEW.

       Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
     402, is further amended by adding at the end the following:

     ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.

       ``Notwithstanding any other provision of law, an 
     environmental impact statement prepared in accordance with 
     the regulations published in part 25 of title 21, Code of 
     Federal Regulations (as in effect on August 31, 1997) in 
     connection with an action carried out under (or a 
     recommendation or report relating to) this Act, shall be 
     considered to meet the requirements for a detailed statement 
     under section 102(2)(C) of the National Environmental Policy 
     Act of 1969 (42 U.S.C. 4332(2)(C)).''.
                                  ____


                           Amendment No. 1151

       On page 26, line 9, strike ``1999'' and insert ``2000''.
                                  ____


                           Amendment No. 1152

       On page 24, line 19, strike ``is'' and insert ``could be''.

[[Page S9341]]

     
                                  ____
                           Amendment No. 1153

       On page 31, strike lines 13 through 15 and insert the 
     following: ``a major amendment to an application.''.
                                  ____


                           Amendment No. 1154

       On page 38, line 12, strike ``120'' and insert ``240''.
                                  ____


                           Amendment No. 1155

       On page 43, line 12, strike ``30'' and insert ``180''.
                                 ______
                                 

                  WELLSTONE AMENDMENTS NOS. 1156-1159

  (Ordered to lie on the table.)
  Mr. WELLSTONE submitted four amendments intended to be proposed by 
him to the bill, S. 830, supra; as follows:

                           Amendment No. 1156

       Strike section 612 and insert the following:

     SEC. 612. HEALTH CARE ECONOMIC INFORMATION.

       (a) In General.--Section 502(a) (21 U.S.C. 352(a)) is 
     amended by adding at the end the following: ``Health care 
     economic information provided to a formulary committee, or 
     other similar entity, in the course of the committee or the 
     entity carrying out its responsibilities for the selection of 
     drugs for managed care or other similar organizations, shall 
     not be considered to be false or misleading if the health 
     care economic information directly relates to an indication 
     approved under section 505 or 507 or section 351(a) of the 
     Public Health Service Act (42 U.S.C. 262(a)) for such drug 
     and is based on competent and reliable scientific evidence. 
     The requirements set forth in section 505(a), 507, or section 
     351(a) of the Public Health Service Act (42 U.S.C. 262(a)) 
     shall not apply to health care economic information provided 
     to such a committee or entity in accordance with this 
     paragraph. Information that is relevant to the substantiation 
     of the health care economic information presented pursuant to 
     this paragraph shall be made available to the Secretary upon 
     request. In this paragraph, the term `health care economic 
     information' means any analysis that identifies, measures, or 
     compares the economic consequences, including the costs of 
     the represented health outcomes, of the use of a drug to the 
     use of another drug, to another health care intervention, or 
     to no intervention.''.
       (b) Study and Report.--The Comptroller General of the 
     United States shall conduct a study of the implementation of 
     the provisions added by the amendment made by subsection (a). 
     Not later than 4 years and 6 months after the date of 
     enactment of this Act, the Comptroller General of the United 
     States shall prepare and submit to Congress a report 
     containing the findings of the study.
                                  ____


                           Amendment No. 1157

       Strike section 602.
                                  ____


                           Amendment No. 1158

       At the appropriate place, insert the following:

     SEC.   . PARKINSON'S DISEASE RESEARCH.

       (a) Short Title.--This section may be cited as the ``Morris 
     K. Udall Parkinson's Research Act of 1997''.
       (b) Findings and Purpose.--
       (1) Finding.--Congress finds that to take full advantage of 
     the tremendous potential for finding a cure or effective 
     treatment, the Federal investment in Parkinson's must be 
     expanded, as well as the coordination strengthened among the 
     National Institutes of Health research institutes.
       (2) Purpose.--It is the purpose of this Section to provide 
     for the expansion and coordination of research regarding 
     Parkinson's, and to improve care and assistance for afflicted 
     individuals and their family caregivers.
       (c) Parkinson's Research.--Part B of title IV of the public 
     Health Service Act (42 U.S.C. 284 et seq.) is amended by 
     adding at the end the following:


                         ``parkinson's disease

       ``Sec. 409B. (a) In General. --The Director of NIH shall 
     establish a program for the conduct and support of research 
     and training with respect to Parkinson's disease with funding 
     for such program allocated to the extent authorized.
       ``(b) Inter-institute Coordination.--
       ``(1) In general.--The Director of NIH shall provide for 
     the coordination of the program established under subsection 
     (a) among all of the national research institutes conducting 
     Parkinson's research.
       ``(2) Conference.--Coordination under paragraph (1) shall 
     include the convening of a research planning conference not 
     less frequently than once every 2 years. Each such conference 
     shall prepare and submit to the Committee on Appropriations 
     and the Committee on Labor and Human Resources of the Senate 
     and the Committee on Appropriations and the Committee on 
     Commerce of the House of Representatives a report concerning 
     the conference.
       ``(c) Morris K. Udall Research Centers.--
       ``(1) In general.--The Director of NIH shall award Core 
     Center Grants to encourage the development of innovative 
     multidisciplinary research and provide training concerning 
     Parkinson's. The Director shall award not more than 10 Core 
     Center Grants and designate each center funded under such 
     grants as a Morris K. Udall Center for Research on 
     Parkinson's Disease.
       ``(2) Requirements.--
       ``(A) In general.--With respect to Parkinson's, each center 
     assisted under this subsection shall--
       ``(i) use the facilities of a single institution or a 
     consortium of cooperating institutions, and meet such 
     qualifications as may be prescribed by the Director of the 
     NIH; and
       ``(ii) conduct basic and clinical research.
       ``(B) Discretionary requirements.--With respect to 
     Parkinson's, each center assisted under this subsection may--
       ``(i) conduct training programs for scientists and health 
     professionals;
       ``(ii) conduct programs to provide information and 
     continuing education to health professionals;
       ``(iii) conduct programs for the dissemination of 
     information to the public;
       ``(iv) develop and maintain, where appropriate, a bank to 
     collect specimens related to the research and treatment of 
     Parkinson's;
       ``(v) separately or in collaboration with other centers, 
     establish a nationwide data system derived from patient 
     populations with Parkinson's, and where possible, comparing 
     relevant data involving general populations;
       ``(vi) separately or in collaboration with other centers, 
     establish a Parkinson's Disease Information Clearinghouse to 
     facilitate and enhance knowledge and understanding of 
     Parkinson's disease; and
       ``(vii) separately or in collaboration with other centers, 
     establish a national education program that fosters a 
     national focus on Parkinson's and the care of those with 
     Parkinson's.
       ``(3) Stipends regarding training programs.--A center may 
     use funds provided under paragraph (1) to provide stipends 
     for scientists and health professionals enrolled in training 
     programs under paragraph (2)(B).
       ``(4) Duration of support.--Support of a center under this 
     subsection may be for a period not exceeding five years. Such 
     period may be extended by the Director of NIH for one or more 
     additional periods of not more than five years if the 
     operations of such center have been reviewed by an 
     appropriate technical and scientific peer review group 
     established by the Director and if such group has recommended 
     to the Director that such period should be extended.
       ``(d) Morris K. Udall Awards for Excellence in Parkinson's 
     Disease Research.--The Director of NIH shall establish a 
     grant program to support investigators with a proven record 
     of excellence and innovation in Parkinson's research and who 
     demonstrate potential for significant future breakthroughs in 
     the understanding of the pathogenesis, diagnosis, and 
     treatment of Parkinson's. Grants under this subsection shall 
     be available for a period of not to exceed 5 years.
       ``(e) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $100,000,000 for fiscal year 1998, and such sums 
     as may be necessary for each of the fiscal years 1999 and 
     2000.''.
                                  ____


                           Amendment No. 1159

       In section 613, strike subsection (b) and insert the 
     following:
       (b) Civil Money Penalties.--Section 303(g)(1) (21 U.S.C. 
     333(g)(1)) is amended--
       (1) in subparagraph (A), by inserting ``or a requirement of 
     section 561 that relates to conducting post-approval studies 
     for fast track drugs'' after ``devices''; and
       (2) by adding at the end the following:
       ``(C) The Secretary may waive the application of 
     subparagraph (A) to a person who fails to conduct post-
     approval studies for fast track drugs, as required in section 
     561, if the Secretary determines that the failure was due to 
     circumstances beyond the control of the person, or for other 
     good cause.''.
       (c) Guidance.--Within 1 year after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     issue guidance for fast track drugs that describes the 
     policies and procedures that pertain to section 561 of the 
     Federal Food, Drug, and Cosmetic Act.
                                 ______
                                 

                    MURRAY AMENDMENTS NOS. 1160-1161

  (Ordered to lie on the table.)
  Mrs. MURRAY submitted two amendments intended to be proposed by her 
to the bill, S. 830, supra; as follows:

                           Amendment No. 1160

       On page 118, strike lines 6 through 10, and insert the 
     following:
       ``(2) would not cause any drug to be in violation of any 
     applicable requirement or prohibition under Federal law;
       ``(3) would not unduly burden interstate commerce; or
       ``(4) provides that the label or labeling of a drug shall 
     include written information, or a symbol, to warn or educate 
     children and the parents of the children with respect to any 
     harm that may result from the use of the drug by the 
     children.''
                                  ____


                           Amendment No. 1161

       Beginning on page 117, strike line 24 and all that follows 
     through page 118, line 10, and insert the following:
       ``(b) Exemption.--
       ``(1) In general.--Upon application of a State or political 
     subdivision thereof, the

[[Page S9342]]

     Secretary may by regulation, after notice and opportunity for 
     written and oral presentation of views, exempt from 
     subsection (a), under such conditions as may be prescribed in 
     such regulation, a State or political subdivision requirement 
     that--
       ``(A) protects an important public interest that would 
     otherwise be unprotected, including the health and safety of 
     children;
       ``(B) would not cause any drug to be in violation of any 
     applicable requirement or prohibition under Federal law; and
       ``(C) would not unduly burden interstate commerce.
       ``(2) Timely action.--The Secretary shall make a decision 
     on the exemption of a State or political subdivision 
     requirement under paragraph (1) not later than 120 days after 
     receiving the application of the State or political 
     subdivision under paragraph (1).''
                                 ______
                                 

                    BIDEN AMENDMENTS NOS. 1162-1167

  (Ordered to lie on the table.)
  Mr. BIDEN submitted six amendments intended to be proposed by him to 
the bill, S. 830, supra; as follows:

                           Amendment No. 1162

       At the appropriate place in title VIII, insert the 
     following:

     SEC.   . REAUTHORIZATION FOR MEDICATION DEVELOPMENT PROGRAM.

       Section 464P(e) of the Public Health Service Act (42 U.S.C. 
     285o-4(e)) is amended to read as follows:
       ``(e) Authorization of Appropriations.--There is authorized 
     to be appropriated to carry out this section such sums as may 
     be necessary for each of the fiscal years 1998 through 2002 
     of which the following amount may be appropriated from the 
     Violent Crime Reduction Trust Fund:
       ``(1) $100,000,000 for fiscal year 2001; and
       ``(2) $100,000,000 for fiscal year 2002.''.
                                  ____


                           Amendment No. 1163

       At the appropriate place insert the following:

           TITLE   --PATENT PROTECTIONS FOR PHARMACOTHERAPIES

     SEC.   01. RECOMMENDATION FOR INVESTIGATION OF DRUGS.

       Section 525(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360aa(a)) is amended--
       (1) by striking ``States'' each place it appears and 
     inserting ``States, or for treatment of an addiction to 
     illegal drugs''; and
       (2) by striking ``such disease or condition'' each place it 
     appears and inserting ``such disease, condition, or treatment 
     of such addiction''.

     SEC.   02. DESIGNATION OF DRUGS.

       Section 526(a) of the Federal, Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360bb(a)) is amended--
       (1) in paragraph (1)--
       (A) by inserting before the period in the first sentence 
     the following: ``or for treatment of an addiction to illegal 
     drugs'';
       (B) in the third sentence, by striking ``rare disease or 
     condition'' and inserting ``rare disease or condition, or for 
     treatment of an addiction to illegal drugs,''; and
       (C) by striking ``such disease or condition'' each place it 
     appears and inserting ``such disease, condition, or treatment 
     of such addiction''; and
       (2) in paragraph (2)--
       (A) by striking ``(2) For'' and inserting ``(2)(A) For'';
       (B) by striking ``(A) affects'' and inserting ``(i) 
     affects'';
       (C) by striking ``(B) affects'' and inserting ``(ii) 
     affects''; and
       (D) by adding at the end the following:
       ``(B) Treatment of an addiction to illegal drugs.--The term 
     `treatment of an addiction to illegal drugs' means any 
     pharmacological agent or medication that--
       ``(i) reduces the craving for an illegal drug for an 
     individual who--
       ``(I) habitually uses the illegal drug in a manner that 
     endangers the public health, safety, or welfare; or
       ``(II) is so addicted to the use of the illegal drug that 
     the individual is not able to control the addiction through 
     the exercise of self-control;
       ``(ii) blocks the behavioral and physiological effects of 
     an illegal drug for an individual described in clause (i);
       ``(iii) safely serves as a replacement therapy for the 
     treatment of drug abuse for an individual described in clause 
     (i);
       ``(iv) moderates or eliminates the process of withdrawal 
     for an individual described in clause (i);
       ``(v) blocks or reverses the toxic effect of an illegal 
     drug on an individual described in clause (i); or
       ``(vi) prevents, where possible, the initiation of drug 
     abuse in individuals at high risk.
       ``(C) Illegal drug.--The term `illegal drug' means a 
     controlled substance identified under schedules I, II, III, 
     IV, and V in section 202(c) of the Controlled Substance Act 
     (21 U.S.C. 812(c)).''.

     SEC.   03. PROTECTION FOR DRUGS.

       Section 527 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360cc) is amended--
       (1) by striking ``rare disease or condition' each place it 
     appears and inserting ``rare disease or condition or for 
     treatment of an addiction to illegal drugs'';
       (2) by striking ``such disease or condition'' each place it 
     appears and inserting ``such disease, condition, or treatment 
     of the addiction''; and
       (3) in subsection (b)(1), by striking ``the disease or 
     condition'' and inserting ``the disease, condition, or 
     addiction''.

     SEC.   04. OPEN PROTOCOLS FOR INVESTIGATIONS OF DRUGS.

       Section 528 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360dd) is amended--
       (1) by striking ``rare disease or condition'' and inserting 
     ``rare disease or condition or for treatment of an addiction 
     to illegal drugs''; and
       (2) by striking ``the disease or condition'' each place it 
     appears and inserting ``the disease, condition, or 
     addiction''.
                                  ____


                           Amendment No. 1164

       At the appropriate place in title VIII, insert the 
     following:

     SEC.   . DEVELOPMENT, MANUFACTURE, AND PROCUREMENT OF DRUGS 
                   FOR THE TREATMENT OF ADDICTION TO ILLEGAL 
                   DRUGS.

       Chapter V (21 U.S.C. 351 et seq.), as amended by sections 
     102 and 613(a), is further amended by adding at the end the 
     following:

        ``Subchapter F--Drugs for Cocaine and Heroin Addictions

     ``SEC. 571. CRITERIA FOR AN ACCEPTABLE DRUG TREATMENT FOR 
                   COCAINE AND HEROIN ADDICTIONS.

       ``(a) In General.--Subject to subsections (b) and (c), the 
     Secretary shall, through the Institute of Medicine of the 
     National Academy of Sciences, establish criteria for an 
     acceptable drug for the treatment of an addiction to cocaine 
     and for an acceptable drug for the treatment of an addiction 
     to heroin. The criteria shall be used by the Secretary in 
     making a contract, or entering into a licensing agreement, 
     under section 572.
       ``(b) Requirements.--The criteria established under 
     subsection (a) for a drug shall include requirements--
       ``(1) that the application to use the drug for the 
     treatment of addiction to cocaine or heroin was filed and 
     approved by the Secretary under this Act after the date of 
     enactment of this section;
       ``(2) that a performance based test on the drug--
       ``(A) has been conducted through the use of a randomly 
     selected test group that received the drug as a treatment and 
     a randomly selected control group that received a placebo; 
     and
       ``(B) has compared the long term differences in the 
     addiction levels of control group participants and test group 
     participants;
       ``(3) that the performance based test conducted under 
     paragraph (2) demonstrates that the drug is effective through 
     evidence that--
       ``(A) a significant number of the participants in the test 
     who have an addiction to cocaine or heroin are willing to 
     take the drug for the addiction;
       ``(B) a significant number of the participants in the test 
     who have an addiction to cocaine or heroin and who were 
     provided the drug for the addiction during the test are 
     willing to continue taking the drug as long as necessary for 
     the treatment of the addiction; and
       ``(C) a significant number of the participants in the test 
     who were provided the drug for the period of time required 
     for the treatment of the addiction refrained from the use of 
     cocaine or heroin for a period of 3 years after the date of 
     the initial administration of the drug on the participants; 
     and
       ``(4) that the drug shall have a reasonable cost of 
     production.
       ``(c) Review and Publication of Criteria.--The criteria 
     established under subsection (a) shall, prior to the 
     publication and application of such criteria, be submitted 
     for review to the Committee on the Judiciary and the 
     Committee on Economic and Educational Opportunities of the 
     House of Representatives, and the Committee on the Judiciary 
     and the Committee on Labor and Human Resources of the Senate. 
     Not later than 90 days after notifying each of the 
     committees, the Secretary shall publish the criteria in the 
     Federal Register.

     ``SEC. 572. PURCHASE OF PATENT RIGHTS FOR DRUG DEVELOPMENT.

       ``(a) Application.--
       ``(1) In general.--The patent owner of a drug to treat an 
     addiction to cocaine or heroin, may submit an application to 
     the Secretary--
       ``(A) to enter into a contract with the Secretary to sell 
     to the Secretary the patent rights of the owner relating to 
     the drug; or
       ``(B) in the case in which the drug is approved by the 
     Secretary for more than 1 indication, to enter into an 
     exclusive licensing agreement with the Secretary for the 
     manufacture and distribution of the drug to treat an 
     addiction to cocaine or heroin.
       ``(2) Requirements.--An application described in paragraph 
     (1) shall be submitted at such time and in such manner, and 
     accompanied by such information, as the Secretary may 
     require.
       ``(b) Contract and Licensing Agreements.--
       ``(1) Requirements.--The Secretary may enter into a 
     contract or a licensing agreement with a patent owner who has 
     submitted an application in accordance with (a) if the drug 
     covered under the contract or licensing agreement meets 
     the criteria established by the Secretary under section 
     571(a).
       ``(2) Special rule.--The Secretary may enter into--
       ``(A) not more than 1 contract or exclusive licensing 
     agreement relating to a drug for

[[Page S9343]]

     the treatment of an addiction to cocaine; and
       ``(B) not more than 1 contract or licensing agreement 
     relating to a drug for the treatment of an addiction to 
     heroin.
       ``(3) Coverage.--A contract or licensing agreement 
     described in subparagraph (A) or (B) of paragraph (2) shall 
     cover not more than 1 drug.
       ``(4) Purchase amount.--Subject to amounts provided in 
     advance in appropriations Acts--
       ``(A) the amount to be paid to a patent owner who has 
     entered into a contract or licensing agreement under this 
     subsection relating to a drug to treat an addiction to 
     cocaine shall not exceed $100,000,000; and
       ``(B) the amount to be paid to a patent owner who has 
     entered into a contract or licensing agreement under this 
     subsection relating to a drug to treat an addiction to heroin 
     shall not exceed $50,000,000.
       ``(c) Transfer of Rights Under Contracts and Licensing 
     Agreement.--
       ``(1) Contracts.--A contract under subsection (b)(1) to 
     purchase the patent rights relating to a drug to treat 
     cocaine or heroin addiction shall transfer to the Secretary--
       ``(A) the exclusive right to make, use, or sell the 
     patented drug within the United States for the term of the 
     patent;
       ``(B) any foreign patent rights held by the patent owner;
       ``(C) any patent rights relating to the process of 
     manufacturing the drug; and
       ``(D) any trade secret or confidential business information 
     relating to the development of the drug, process for 
     manufacturing the drug, and therapeutic effects of the drug.
       ``(2) Licensing agreements.--A licensing agreement under 
     subsection (b)(1) to purchase an exclusive license relating 
     to manufacture and distribution of a drug to treat an 
     addiction to cocaine or heroin shall transfer to the 
     Secretary--
       ``(A) the exclusive right to make, use, or sell the 
     patented drug for the purpose of treating an addiction to 
     cocaine or heroin within the United States for the term of 
     the patent;
       ``(B) the right to use any patented processes relating to 
     manufacturing the drug; and
       ``(C) any trade secret or confidential business information 
     relating to the development of the drug, process for 
     manufacturing the drug, and therapeutic effects of the drug 
     relating to use of the drug to treat an addiction to cocaine 
     or heroin.

     ``SEC. 573. PLAN FOR MANUFACTURE AND DEVELOPMENT.

       ``(a) In General.--Not later than 90 days after the date on 
     which the Secretary purchases the patent rights of a patent 
     owner, or enters into a licensing agreement with a patent 
     owner, relating to a drug under section 571, the Secretary 
     shall develop a plan for the manufacture and distribution of 
     the drug.
       ``(b) Plan Requirements.--The plan shall set forth--
       ``(1) procedures for the Secretary to enter into licensing 
     agreements with private entities for the manufacture and the 
     distribution of the drug;
       ``(2) procedures for making the drug available to nonprofit 
     entities and private entities to use in the treatment of a 
     cocaine or heroin addiction;
       ``(3) a system to establish the sale price for the drug; 
     and
       ``(4) policies and procedures with respect to the use of 
     Federal funds by State and local governments or nonprofit 
     entities to purchase the drug from the Secretary.
       ``(c) Applicability of Procurement and Licensing Laws.--The 
     procurement and licensing laws of the United States shall be 
     applicable to procurements and licenses covered under the 
     plan described in subsection (a).
       ``(d) Review of Plan.--
       ``(1) In general.--Upon completion of the plan under 
     subsection (a), the Secretary shall notify the Committee on 
     the Judiciary and the Committee on Economic and Educational 
     Opportunities of the House of Representatives, and the 
     Committee on the Judiciary and the Committee on Labor and 
     Human Resources of the Senate, of the development of the plan 
     and publish the plan in the Federal Register. The Secretary 
     shall provide an opportunity for public comment on the plan 
     for a period of not more than 30 days after the date of the 
     publication of the plan in the Federal Register.
       ``(2) Final plan.--Not later than 60 days after the date of 
     the expiration of the comment period described in paragraph 
     (1), the Secretary shall publish in the Federal Register a 
     final plan. The implementation of the plan shall begin on the 
     date of the final publication of the plan.
       ``(e) Construction.--The development, publication, or 
     implementation of the plan, or any other agency action with 
     respect to the plan, shall not be considered agency action 
     subject to judicial review.
       ``(f) Regulations.--The Secretary may promulgate 
     regulations to carry out this section.

     ``SEC. 574. AUTHORIZATION OF APPROPRIATIONS.

       ``There is authorized to be appropriated to carry out this 
     subchapter, such sums as may be necessary in each of the 
     fiscal years 1998 through 2000.''.
                                  ____


                           Amendment No. 1165

       At the end of title VIII, add the following:

     SEC. 8  . AUTHORITY TO RESCHEDULE CERTAIN CONTROLLED 
                   SUBSTANCES POSING IMMINENT HAZARD TO PUBLIC 
                   SAFETY.

       Section 201(h) of the Controlled Substances Act (21 U.S.C. 
     811(h)) is amended--
       (1) in paragraph (1)--
       (A) by inserting ``, or the rescheduling of a scheduled 
     substance,'' after ``the scheduling of a substance''; and
       (B) by striking ``if the substance is not listed in any 
     other schedule in section 202 or''; and
       (2) in paragraph (2), by inserting ``or rescheduling'' 
     after ``scheduling'' each place that term appears.
                                  ____


                           Amendment No. 1166

       At the end of title VIII, add the following:

     SEC. 8  . CLASSIFICATION OF KETAMINE HYDROCHLORIDE.

       Notwithstanding section 201 or subsection (a) or (b) of 
     section 202 of the Controlled Substances Act (21 U.S.C. 811, 
     812(a), 812(b)) respecting the scheduling of controlled 
     substances, the Attorney General shall, by order, add 
     ketamine hydrochloride to schedule III of such Act.
                                  ____


                           Amendment No. 1167

       At the end of title VIII, add the following:

     SEC. 8  . RESCHEDULING OF ROHYPNOL.

       Notwithstanding section 201 or subsection (a) or (b) of 
     section 202 of the Controlled Substances Act (21 U.S.C. 811, 
     812(a), 812(b)) respecting the scheduling of controlled 
     substances, the Attorney General shall, by order, transfer 
     flunitrazepam from schedule IV of such Act to schedule I of 
     such Act.
                                 ______
                                 

                       BREAUX AMENDMENT NO. 1168

  (Ordered to lie on the table.)
  Mr. BREAUX submitted an amendment intended to be proposed by him to 
the bill, S. 830, supra; as follows:

       At the appropriate place, add the following:
                          TITLE __--COMMISSION

     SEC. __1. ESTABLISHMENT OF COMMISSION.

       (a) In General.--There is established a Drug and Device 
     Review Advisory Commission (referred to in this title as the 
     ``Commission''), to conduct a study and prepare 
     recommendations concerning the determinations and 
     administrative processes of the Food and Drug Administration.
       (b) Membership.--
       (1) Composition.--The Commission shall be composed of 11 
     members, including--
       (A) 5 individuals appointed by the President;
       (B) 3 individuals appointed jointly by the President pro 
     tempore of the Senate and the majority and minority leaders 
     of the Senate; and
       (C) 3 individuals appointed jointly by the Speaker of the 
     House of Representatives and the majority and minority 
     leaders of the House of Representatives.
       (2) Qualifications.--
       (A) Drug and device manufacturers.--Two of the members 
     appointed under paragraph (1)(A), one of the members 
     appointed under paragraph (1)(B), and one of the members 
     appointed under paragraph (1)(C), shall be manufacturers of 
     drugs or devices (as such terms are defined in section 201 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)).
       (B) Medical professionals.--Two of the members appointed 
     under paragraph (1)(A), one of the members appointed under 
     paragraph (1)(B), and one of the members appointed under 
     paragraph (1)(C), shall be health personnel described in 
     section 792(a) of the Public Health Service Act (42 U.S.C. 
     295k(a)).
       (C) General public.--One of the members appointed under 
     paragraph (1)(A), one of the members appointed under 
     paragraph (1)(B), and one of the members appointed under 
     paragraph (1)(C), shall be members of the general public.
       (3) Appointment.--The members of the Commission shall be 
     appointed not later than 60 days after the date of enactment 
     of this Act.
       (c) Chairperson.--The Commission shall select a Chairperson 
     from among its members.
       (d) Term of Office.--
       (1) In general.--Except as otherwise provided in this 
     subsection, a member of the Commission shall be appointed for 
     a term of 5 years.
       (2) Initial members.--Of the members first appointed--
       (A) 2 shall be appointed for terms of 1 year;
       (B) 2 shall be appointed for terms of 2 years;
       (C) 2 shall be appointed for terms of 3 years;
       (D) 2 shall be appointed for terms of 4 years; and
       (E) 3 shall be appointed for terms of 5 years.
       (3) Schedule.--The appointing individuals described in 
     subsection (b)(1) shall jointly determine a schedule for the 
     appointment of members of the Commission that ensures that, 
     in any year--
       (A) no appointing individual appoints more than 1 member; 
     and
       (B) the appointing individuals appoint not more than 1 
     member from any class of persons described in subparagraph 
     (A), (B), or (C) of subsection (b)(2).
       (e) Vacancies.--Any vacancy occurring in the membership of 
     the Commission shall be filled in the same manner as the 
     original appointment for the position being vacated. The 
     vacancy shall not affect the power of the

[[Page S9344]]

     remaining members to execute the duties of the Commission.
       (f) Compensation and Expenses.--
       (1) Compensation.--Each member of the Commission who is not 
     an employee of the Federal Government shall receive 
     compensation at the daily equivalent of the rate specified 
     for level V of the Executive Schedule under section 5316 of 
     title 5, United States Code, for each day the member is 
     engaged in the performance of duties for the Commission, 
     including attendance at meetings and conferences of the 
     Commission, and travel to conduct the duties of the 
     Commission.
       (2) Travel expenses.--Each member of the Commission shall 
     receive travel expenses, including per diem in lieu of 
     subsistence, at rates authorized for employees of agencies 
     under subchapter I of chapter 57 of title 5, United States 
     Code, for each day the member is engaged in the performance 
     of duties away from the home or regular place of business of 
     the member.

     SEC. __2. STUDY AND REPORT.

       (a) Study.--The Commission shall annually conduct a study 
     of the determinations and administrative processes of the 
     Food and Drug Administration.
       (b) Report.--Not later than 15 months after the date of the 
     enactment of this Act, and annually thereafter, the 
     Commission shall prepare and submit to the President and the 
     appropriate committees of Congress a written report 
     containing--
       (1) the findings and conclusions of the Commission 
     resulting from the study conducted under subsection (a); and
       (2) recommendations, based on the findings and conclusions 
     described in paragraph (1), for improvements in the 
     efficiency and administrative processes of the Food and Drug 
     Administration.

     SEC. __3. POWERS OF THE COMMISSION.

       (a) In General.--The Commission is authorized to--
       (1) hold such hearings and sit and act at such times;
       (2) take such testimony;
       (3) have such printing and binding done;
       (4) enter into such contracts and other arrangements;
       (5) make such expenditures; and
       (6) take such other actions;
     as the Commission may determine to be necessary to carry out 
     the duties of the Commission.
       (b) Obtaining Information from Federal Agencies.--The 
     Commission may secure directly from any Federal agency such 
     information as the Commission may require to carry out its 
     duties.
       (c) Use of Mail.--The Commission may use the United States 
     mails in the same manner and under the same conditions as 
     Federal agencies.

     SEC. __4. STAFF AND CONSULTANTS.

       (a) Staff.--
       (1) Appointment and compensation.--The Commission may 
     appoint and determine the compensation of such staff as the 
     Commission determines to be necessary to carry out the duties 
     of the Commission.
       (2) Limitations.--The rate of compensation for each staff 
     member shall not exceed the daily equivalent of the rate 
     specified for level V of the Executive Schedule under section 
     5316 of title 5, United States Code for each day the staff 
     member is engaged in the performance of duties for the 
     Commission. The Commission may otherwise appoint and 
     determine the compensation of staff without regard to the 
     provisions of title 5, United States Code, that govern 
     appointments in the competitive service, and the provisions 
     of chapter 51 and subchapter III of chapter 53 of title 5, 
     United States Code, that relate to classification and General 
     Schedule pay rates.
       (b) Experts and Consultants.--The Chairperson of the 
     Commission may obtain such temporary and intermittent 
     services of experts and consultants and compensate the 
     experts and consultants in accordance with section 3109(b) of 
     title 5, United States Code, as the Commission determines to 
     be necessary to carry out the duties of the Commission.
       (c) Detail of Federal Employees.--On the request of the 
     Chairperson of the Commission, the head of any Federal agency 
     shall detail, without reimbursement, any of the personnel of 
     the agency to the Commission to assist the Commission in 
     carrying out its duties. Any detail shall not interrupt or 
     otherwise affect the civil service status or privileges of 
     the Federal employee.
       (d) Technical Assistance.--On the request of the 
     Chairperson of the Commission, the head of a Federal agency 
     shall provide such technical assistance to the Commission as 
     the Commission determines to be necessary to carry out its 
     duties.

     SEC. __5. AUTHORIZATION OF APPROPRIATIONS.

       There are authorized to be appropriated to the Commission 
     such sums as may be necessary to carry out the provisions of 
     this title. The sums shall remain available until expended, 
     without fiscal year limitation.

     SEC. __6. TERMINATION.

       Section 15 of the Federal Advisory Committee Act (5 U.S.C. 
     App.) shall not apply to the Commission.
                                 ______
                                 

                     REED AMENDMENTS NOS. 1169-1170

  (Ordered to lie on the table.)
  Mr. REED submitted two amendments intended to be proposed by him to 
the bill, S. 830, supra; as follows:

                           Amendment No. 1169

       Strike section 404.
                                  ____


                           Amendment No. 1170

       On page 30, strike lines 1 through 16, and insert the 
     following:
       (b) Premarket Notifications.--Section 513(i)(1) (21 U.S.C. 
     360c(i)(1)) is amended by adding at the end the following:
       ``(C) Whenever the Secretary requests information to 
     demonstrate that the devices with differing technological 
     characteristics are substantially equivalent, the Secretary 
     shall only request information that is necessary to make a 
     substantial equivalence determination. In making such a 
     request, the Secretary shall consider the least burdensome 
     means of demonstrating substantial equivalence and shall 
     request information accordingly.
       ``(D) The determination of the Secretary under this 
     subsection and section 513(f)(1) with respect to the intended 
     use of a device shall be based on the intended use included 
     in the proposed labeling of the device submitted in a report 
     under section 510(k), except that nothing in this 
     subparagraph may be construed to limit what the Secretary may 
     consider in determining whether a device is substantially 
     equivalent to a predicate device under subparagraph 
     (A)(ii).''.
                                 ______
                                 

                       HARKIN AMENDMENT NO. 1171

  (Ordered to lie on the table.)
  Mr. HARKIN submitted an amendment intended to be proposed by him to 
the bill, S. 830, supra; as follows:

                           Amendment No. 1171

       At the end of title VIII, add the following:

     SEC.   . ELECTRONIC PASTEURIZATION.

       (a) Definition.--In this section, the term ``electronic 
     pasteurization'' means exposure of a food to en electron 
     beam, or to an x-ray produced from an energy source generated 
     by electricity.
       (b) Regulation.--
       (1) In general.--Notwithstanding any other provision of 
     this Act, not later than 90 days after the date of enactment 
     of this Act, the Secretary of Health and Human Services shall 
     issue a final rule amending the regulation issued under the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) 
     relating to labeling requirements applicable to the use of 
     ionizing radiation for the treatment of food.
       (2) Provision.--The amended regulation shall provide that a 
     food that has been treated by electronic pasteurization and 
     has not been irradiated by a radioactive isotope source--
       (A) shall not be considered to violate the labeling 
     requirements solely because the labeling and other 
     identifying materials associated with the food fail to 
     identify the food as having been treated with radiation or 
     treated by irradiation; and
       (B) shall be considered to comply with the labeling 
     requirements if the labeling and other identifying materials 
     identify the food as electronically pasteurized or having 
     been treated with electronic pasteurization.
                                 ______
                                 

                        COATS AMENDMENT NO. 1172

  (Ordered to lie on the table.)
  Mr. COATS submitted an amendment intended to be proposed by him to 
the bill, S. 830, supra; as follows:

       At the appropriate place, insert the following:
       Sec.    . Examinations and Procedures.--
       Paragraph 353(d)(3) of the Public Health Service Act (42 
     U.S.C. 263a(d)(3)) is amended--
       (1) by striking ``, including those which'' and by 
     inserting in its place ``. The following three types of 
     examinations and procedures shall each be deemed to meet the 
     standards in the preceding sentence'';
       (2) in subparagraph (A), by inserting at the end thereof 
     ``even if FDA places limits on the sale of the devices 
     associated with such examinations or procedures (e.g., 
     prescription status), or''; and
       (3) in subparagraph (B), by inserting ``by the user'' 
     before ``negligible''.
                                 ______
                                 

                   JEFFORDS AMENDMENTS NOS. 1173-1175

  (Ordered to lie on the table.)
  Mr. JEFFORDS submitted three amendments intended to be proposed by 
him to the bill, S. 830, supra; as follows:

                           Amendment No. 1173

       Strike section 619 and insert the following:

     SEC. 619. POSITRON EMISSION TOMOGRAPHY.

       (a) Regulation of Compounded Positron Emission Tomography 
     Drugs Under the Federal Food, Drug, and Cosmetic Act.--
       (1) Definition.--Section 201 (21 U.S.C. 321) is amended by 
     adding at the end the following:
       ``(ii) The term `compounded positron emission tomography 
     drug'--
       ``(1) means a drug that--
       ``(A) exhibits spontaneous disintegration of unstable 
     nuclei by the emission of positrons and is used for the 
     purpose of providing dual photon positron emission 
     tomographic diagnostic images; and
       ``(B) has been compounded by or on the order of a 
     practitioner who is licensed by a State to compound or order 
     compounding for a drug described in subparagraph (A), and is 
     compounded in accordance with that State's

[[Page S9345]]

     law, for a patient or for research, teaching, or quality 
     control; and
       ``(2) includes any nonradioactive reagent, reagent kit, 
     ingredient, nuclide generator, accelerator, target material, 
     electronic synthesizer, or other apparatus or computer 
     program to be used in the preparation of such a drug.''.
       (b) Adulteration.--
       (1) In general.--Section 501(a)(2) (21 U.S.C. 351(a)(2)) is 
     amended by striking ``; or (3)'' and inserting the following: 
     ``; or (C) if it is a compounded positron emission tomography 
     drug and the methods used in, or the facilities and controls 
     used for, its compounding, processing, packing, or holding do 
     not conform to or are not operated or administered in 
     conformity with the positron emission tomography compounding 
     standards and the official monographs of the United States 
     Pharmacopeia to assure that such drug meets the requirements 
     of this Act as to safety and has the identity and strength, 
     and meets the quality and purity characteristics, that it 
     purports or is represented to possess; or (3)''.
       (2) Sunset.--Sections 201(ii) and 501(a)(2)(C) (21 U.S.C. 
     321(ii) and 351(a)(2)(C)) shall not apply 4 years after the 
     date of enactment of this Act or 2 years after the date or 
     which the Secretary of Health and Human Services establishes 
     the requirements described in subsection (c)(1)(B), whichever 
     is later.
       (c) Requirements for Review of Approval Procedures and 
     Current Good Manufacturing Practices for Positron Emission 
     Tomography.--
       (1) Procedures and requirements.--
       (A) In general.--In order to take account of the special 
     characteristics of positron emission tomography drugs and the 
     special techniques and processes required to produce these 
     drugs, not later than 2 years after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall 
     establish--
       (i) appropriate procedures for the approval of positron 
     emission tomography drugs pursuant to section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
       (ii) appropriate current good manufacturing practice 
     requirements for such drugs.
       (B) Considerations and consultation.--In establishing the 
     procedures and requirements required by subparagraph (A), the 
     Secretary of Health and Human Services shall take due account 
     of any relevant differences between not-for-profit 
     institutions that compound the drugs for their patients and 
     commercial manufacturers of the drugs. Prior to establishing 
     the procedures and requirements, the Secretary of Health and 
     Human Services shall consult with patient advocacy groups, 
     professional associations, manufacturers, and physicians and 
     scientists licensed to make or use positron emission 
     tomography drugs.
       (2) Submission of new drug applications and abbreviated new 
     drug applications.--
       (A) In general.--The Secretary of Health and Human Services 
     shall not require the submission of new drug applications or 
     abbreviated new drug applications under subsection (b) or (j) 
     of section 505 (21 U.S.C. 355), for compounded positron 
     emission tomography drugs that are not adulterated drugs 
     described in section 501(a)(2)(C) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) (as amended by 
     subsection (b)), for a period of 4 years after the date of 
     enactment of this Act, or for 2 years after the date or which 
     the Secretary establishes procedures and requirements under 
     paragraph (1), whichever is later.
       (B) Construction.--Nothing in this Act shall prohibit the 
     voluntary submission of such applications or the review of 
     such applications by the Secretary of Health and Human 
     Services. Nothing in this Act shall constitute an exemption 
     for a positron emission tomography drug from the requirements 
     of regulations issued under section 505(i) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) for such 
     drugs.
       (d) Revocation of Certain Inconsistent Documents.--Within 
     30 days after the date of enactment of this Act, the 
     Secretary of Health and Human Services shall publish in the 
     Federal Register a notice terminating the application of the 
     following notices and rule:
       (1) A notice entitled ``Regulation of Positron Emission 
     Tomography Radiopharmaceutical Drug Products; Guidance; 
     Public Workshop'', published in the Federal Register on 
     February 27, 1995, 60 Fed. Reg. 10594.
       (2) A notice entitled ``Draft Guideline on the Manufacture 
     of Positron Emission Tomography Radiopharmaceutical Drug 
     Products; Availability'', published in the Federal Register 
     on February 27, 1995, 60 Fed. Reg. 10593.
       (3) A final rule entitled ``Current Good Manufacturing 
     Practice for Finished Pharmaceuticals; Positron Emission 
     Tomography'', published in the Federal Register on April 22, 
     1997, 62 Fed. Reg. 19493 (codified at part 211 of title 21, 
     Code of Federal Regulations).
       (e) Definition.--In this section:
       (1) Compounded positron emission tomography drug.--The term 
     ``compounded positron emission tomography drug'' means a 
     positron emission tomography drug that has been compounded by 
     or on the order of a practitioner who is licensed by a State 
     to compound or order compounding for such a drug, and is 
     compounded in accordance with that State's law, for a patient 
     or for research, teaching, or quality control.
       (2) Drug.--The term ``drug'' has the meaning given the term 
     in section 201 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 321 et seq.).
       (3) Positron emission tomography drug.--The term ``positron 
     emission tomography drug'' means a drug that--
       (A) exhibits spontaneous disintegration of unstable nuclei 
     by the emission of positrons and is used for the purpose of 
     providing dual photon positron emission tomographic 
     diagnostic images; and
       (B) includes any nonradioactive reagent, reagent kit, 
     ingredient, nuclide generator, accelerator, target material, 
     electronic synthesizer, or other apparatus or computer 
     program to be used in the preparation of such a drug.
                                  ____


                           Amendment No. 1174

       On page 30, strike lines 17 through 20, and insert the 
     following:
       (c) Rule of Construction.--Nothing in the amendments made 
     by subsections (a) and (b) shall be construed to alter any 
     authority of the Secretary of Health and Human Services to 
     regulate any tobacco product, or any additive or ingredient 
     of a tobacco product.
                                  ____


                           Amendment No. 1175

       Strike section 602 and insert the following:

     SEC. 602. ENVIRONMENTAL IMPACT REVIEW.

       Chapter VII (21 U.S.C. 371 et seq.), as amended by section 
     402, is further amended by adding at the end the following:

     ``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.

       ``Notwithstanding any other provision of law, an 
     environmental impact statement prepared in accordance with 
     the regulations published in part 25 of title 21, Code of 
     Federal Regulations (as in effect on August 31, 1997) in 
     connection with an action carried out under (or a 
     recommendation or report relating to) this Act, shall be 
     considered to meet the requirements for a detailed statement 
     under section 102(2)(C) of the National Environmental Policy 
     Act of 1969 (42 U.S.C. 4332(2)(c)).''.
                                 ______
                                 

                     REED AMENDMENTS NOS. 1176-1177

  (Ordered to lie on the table.)
  Mr. REED submitted two amendments intended to be proposed by him to 
the bill, S. 830, supra; as follows:

                           Amendment No. 1176

       On page 30, line 16, after the first period, insert the 
     following: ``Nothing in the preceding sentence shall be 
     construed to prohibit the Secretary from determining that a 
     new device is not substantially equivalent to a predicate 
     device because changes in the technological characteristics 
     of the new device demonstrate that the device is intended for 
     a different use than the use stated in the labeling of the 
     device.''.
                                  ____


                           Amendment No. 1177

       On page 30, line 16, insert before the first period the 
     following: ``if the proposed labeling is neither false nor 
     misleading''.

                          ____________________