[Congressional Record Volume 143, Number 123 (Tuesday, September 16, 1997)]
[Senate]
[Pages S9428-S9429]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


                          AMENDMENTS SUBMITTED

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

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                       KENNEDY AMENDMENT NO. 1190

  (Ordered to lie on the table.)
  Mr. KENNEDY submitted an amendment intended to be proposed by him 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:

       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 from such 
     device.''.
                                 ______
                                 

                    HATCH AMENDMENTS NOS. 1191-1192

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

                           Amendment No. 1191

       At the end of the matter proposed to be inserted, insert 
     the following:

     SEC. __. SAFETY REPORT DISCLAIMERS.

       Chapter IX (21 U.S.C. 391 et seq.), as amended by section 
     804, is further amended by adding at the end the following:

     ``SEC. 908. SAFETY REPORT DISCLAIMERS.

       ``With respect to any entity that submits or is required to 
     submit a safety report or other information in connection 
     with the safety of a product (including a product which is a 
     food, drug, new drug, device, dietary supplement, or 
     cosmetic) under this Act (and any release by the Secretary of 
     that report or information), such report or information shall 
     not be construed to necessarily reflect a conclusion by the 
     entity or the Secretary that the report or information 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience, or otherwise caused or 
     contributed to a death, serious injury, serious illness, or 
     malfunction. Such an entity need not admit, and may deny, 
     that the report or information submitted by the entity 
     constitutes an admission that the product involved caused or 
     contributed to an adverse experience or caused or contributed 
     to a death, serious injury, serious illness, or 
     malfunction.''.
                                  ____


                           Amendment No. 1192

       At the end of the matter proposed to be inserted, insert 
     the following:
       (d) Mission Statement.--Section 903(b), as amended by 
     section 101(2), is further amended by striking paragraphs (1) 
     and (2) and inserting the following:
       ``(1) In general.--The Secretary, acting through the 
     Commissioner, in consultation with experts in science, 
     medicine, and public health, and in cooperation with 
     consumers, users, manufacturers, importers packers, 
     distributors, and retailers of regulated products, shall 
     protect the public health by taking actions that help ensure 
     that--
       ``(A) foods are safe, wholesome, sanitary, and properly 
     labeled;
       ``(B) human and veterinary drugs, including biologics, are 
     safe and effective;
       ``(C) there is reasonable assurance of safety and 
     effectiveness of devices intended for human use;
       ``(D) cosmetics are safe; and
       ``(E) public health and safety are protected from 
     electronic product radiation.
       ``(2) Special rules.--The Secretary, acting through the 
     Commissioner, shall promptly and efficiently review clinical 
     research and take appropriate action on the marketing of 
     regulated products in a manner that does not unduly impede 
     innovation or product availability. The Secretary, acting 
     through the Commissioner, shall participate with other 
     countries to reduce the burden of regulation, to harmonize 
     regulatory requirements, and to achieve appropriate 
     reciprocal arrangements with other countries.''.
                                 ______
                                 

                 HARKIN (AND OTHERS) AMENDMENT NO. 1193

  (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 an amendment 
intended to be proposed to the bill, S. 830, supra; as follows:

       At the end of the amendment, 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 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

[[Page S9429]]

     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 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.

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