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Title of Law:Food and Drug Administration Modernization Act of 1997
Law #:Public Law 105-115
Passed by Congress:105th Congress (1st Session)

The following are excerpts, highlighted in red, from the final legislation and/or conference report which contain NRC studies. (Pound signs [##] between passages denote the deletion of unrelated text.)

S830 Jeffords (R-VT) 11/09/97
Enrolled (finally passed both houses)

Food and Drug Administration Modernization and Accountability Act of 1997
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(f) STUDIES AND REPORTS.--


(1) GENERAL ACCOUNTING OFFICE.--
(A) IN GENERAL.--The Comptroller General of the United States shall conduct a study to determine the impact of subchapter D of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this section, on the resources of the Department of Health and Human Services.
(B) REPORT.--Not later than January 1, 2002, the Comptroller General of the United States shall prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce of the House of Representatives a report of the results of the study.


(2) DEPARTMENT OF HEALTH AND HUMAN SERVICES.--
(A) IN GENERAL.--In order to assist Congress in determining whether the provisions of such subchapter should be extended beyond the termination date specified in subsection (e), the Secretary of Health and Human Services shall, in accordance with subparagraph (B), arrange for the conduct of a study of the scientific issues raised as a result of the enactment of such subchapter including issues relating to--
(i) the effectiveness of such subchapter with respect to the provision of useful scientific information to health care practitioners;
(ii) the quality of the information being disseminated pursuant to the provisions of such subchapter;
(iii) the quality and usefulness of the information provided, in accordance with such subchapter, by the Secretary or by the manufacturer at the request of the Secretary; and
(iv) the impact of such subchapter on research in the area of new uses, indications, or dosages, particularly the impact on pediatric indications and rare diseases.


(3) PROCEDURE FOR STUDY.--
(A) IN GENERAL.--The Secretary shall request the Institute of Medicine of the National Academy of Sciences to conduct the study required by paragraph (2), and to prepare and submit the report required by subparagraph (B), under an arrangement by which the actual expenses incurred by the Institute of Medicine in conducting the study and preparing the report will be paid by the Secretary. If the Institute of Medicine is unwilling to conduct the study under such an arrangement, the Comptroller General of the United States shall conduct such study.
(B) REPORT.--Not later than September 30, 2005, the Institute of Medicine or the Comptroller General of the United States, as appropriate, shall prepare and submit to the Committee on Labor and Human Resources of the Senate, the Committee on Commerce of the House of Representatives, and the Secretary a report of the results of the study required by paragraph (2). The Secretary, after the receipt of the report, shall make the report available to the public.

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SEC. 413. FOOD AND DRUG ADMINISTRATION STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD.

(a) LIST AND ANALYSIS.--The Secretary of Health and Human Services shall, acting through the Food and Drug Administration--
(1) compile a list of drugs and foods that contain intentionally introduced mercury compounds, and
(2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).
The Secretary shall compile the list required by paragraph (1) within 2 years after the date of enactment of the Food and Drug Administration Modernization Act of 1997 and shall provide the analysis required by paragraph (2) within 2 years after such date of enactment.


(b) STUDY.--The Secretary of Health and Human Services, acting through the Food and Drug Administration, shall conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study shall include data from other studies that have been made of such use.


(c) STUDY OF MERCURY SALES.--
(1) STUDY.--The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate--
(A) the scope of mercury use as a drug or dietary supplement; and
(B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or ingestion or inhalation of, mercury when so used. In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic Substances and Disease Registry, and, to the extent the Secretary believes necessary or appropriate, with any other Federal or private entity.
(2) REGULATIONS.--If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall be designed to protect the health of children and other sensitive populations from adverse effects resulting from exposure to, or ingestion or inhalation of, mercury. Such regulations, to the extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious ceremonies.

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*********************************************************************************************
HRpt 105-399 CONFERENCE REPORT To accompany S. 830 FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997
Conference Committee
(11/09/97)

Special Typefaces Key:
[[ ]] Text to be omitted // \\ Italic text
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// (f) STUDIES AND REPORTS.--\\

// (1) GENERAL ACCOUNTING OFFICE.--\\
// (A) IN GENERAL.--The Comptroller General of the United States shall conduct a study to determine the impact of subchapter D of chapter V of the Federal Food, Drug, and Cosmetic Act, as added by this section, on the resources of the Department of Health and Human Services. \\
// (B) REPORT.--Not later than January 1, 2002, the Comptroller General of the United States shall prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce of the House of Representatives a report of the results of the study.\\

// (2) DEPARTMENT OF HEALTH AND HUMAN SERVICES.--\\
// (A) IN GENERAL.--In order to assist Congress in determining whether the provisions of such subchapter should be extended beyond the termination date specified in subsection (e), the Secretary of Health and Human Services shall, in accordance with subparagraph (B), arrange for the conduct of a study of the scientific issues raised as a result of the enactment of such subchapter including issues relating to--\\
// (i) the effectiveness of such subchapter with respect to the provision of\\ //useful scientific information to health care practitioners;\\
// (ii) the quality of the information being disseminated pursuant to the provisions of such subchapter; \\
// (iii) the quality and usefulness of the information provided, in accordance with such subchapter, by the Secretary or by the manufacturer at the request of the Secretary; and\\
// (iv) the impact of such subchapter on research in the area of new uses, indications, or dosages, particularly the impact on pediatric indications and rare diseases.\\

// (3) PROCEDURE FOR STUDY.--\\
// (A) IN GENERAL.--The Secretary shall request the Institute of Medicine of the National Academy of Sciences to conduct the study required by paragraph (2), and to prepare and submit the report required by subparagraph (B), under an arrangement by which the actual expenses incurred by the Institute of Medicine in conducting the study and preparing the report will be paid by the Secretary. If the Institute of Medicine is unwilling to conduct the study under such an arrangement, the Comptroller General of the United States shall conduct such study.\\
// (B) REPORT.--Not later than September 30, 2005, the Institute of Medicine or the Comptroller General of the United States, as appropriate, shall prepare and submit to the Committee on Labor and Human Resources of the Senate, the Committee on Commerce of the House of Representatives, and the Secretary a report of the results of the study required by paragraph (2). The Secretary, after the receipt of the report, shall make the report available to the public.\\

######

//SEC. 413. FOOD AND DRUG ADMINISTRATION STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD.\\

// (a) LIST AND ANALYSIS.--The Secretary of Health and Human Services shall, acting through the Food and Drug Administration--\\
// (1) compile a list of drugs and foods that contain intentionally introduced mercury compounds, and\\
// (2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).\\
//The Secretary shall compile the list required by paragraph (1) within 2 years after the date of enactment of the Food and Drug Administration Modernization Act of 1997 and shall provide the

analysis required by paragraph (2) within 2 years after such date of enactment.\\

// (b) STUDY.--The Secretary of Health and Human Services, acting through the Food and Drug Administration, shall conduct a study of the effect on humans of the use of mercury compounds in nasal sprays. Such study shall include data from other studies that have been made of such use.\\

// (c) STUDY OF MERCURY SALES.--\\
// (1) STUDY.--The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate--\\
// (A) the scope of mercury use as a drug or dietary supplement; and\\
// (B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or ingestion or inhalation of, mercury when so used.\\ //In conducting such study, the Secretary shall consult with the Administrator of the Environmental Protection Agency, the Chair of the Consumer Product Safety Commission, and the Administrator of the Agency for Toxic Substances and Disease Registry, \\ //and, to the extent the Secretary believes necessary or appropriate, with any other Federal or private entity.\\
// (2) REGULATIONS.--If, in the opinion of the Secretary, the use of elemental, organic, or inorganic mercury offered for sale as a drug or dietary supplement poses a threat to human health, the Secretary shall promulgate regulations restricting the sale of mercury intended for such use. At a minimum, such regulations shall be designed to protect the health of children and other sensitive populations from adverse effects resulting from exposure to, or ingestion or inhalation of, mercury. Such regulations, to the extent feasible, should not unnecessarily interfere with the availability of mercury for use in religious ceremonies.\\

######

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