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. APPENDIX D Statutory Authorities The National Health Survey Act The National Center for Health Statistics

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52 APPENDIX D APPENDIX 11 NATIONAL HEALTH SURVEY ACT PUBLIC LAw 652 - 84TH CONGRESS CH AP T E R 510 - 2D S ESSION -S. 3076 AN ACT To provide for a continuing survey and special studies of sicicocss and disability in the United States, and for periodic reports of she results thereof, and for other purposes. Be it enacted by the Senate an' House of Representatives of the United States of America in Congress assembled That this Act may be cited as the "national Health Survey Act". Sec. 2. (a) The Congress hereby finds and declares (1) that the latest information on the number and relevant charac- teristics of persons in the country suffering from heart disease, cancer, diabetes, arthritis and rheumatism, and other diseases, injuries, and hand- icapping conditions is now seriously out of date; and (2) that periodic inventories providing reasonably current informa- tion on these matters are urgently needed for purposes such as (A) apprais- al of the true state of health of our population (including both adults and children), (B) adequate planning of any programs to improve their health, (C) research in the field of chronic diseases, and (~) measurement of the numbers of persons in the working ages so disabled as to be unable to per- form gainful work. (b) It is, therefore, the purpose of this Act to provide (1) for a continuing survey and special studies to secure on a non-compulsory basis accurate and current statistical information on the amount, distribution, and effects of illness and disability in the United States and the services received for or because of such conditions; and (2)for studying methods end survey techniques for securing such statistical information, with a view toward their continuing improvement. Sec. 3. Part A of title III of the Public Health Service Act (42 U. S. C. ch. 6A) is amended by adding after section 304 the following new section:

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STATUTORY AUTHORITIES 153 'NATIONAL HEALTH SURVEYS AND STUDIES Sec. 305. (a) The Surgeon General is authorized (1) to make, by sampling or other appropriate means, surveys and special studies of the population of the United States to determine the extent of illness and disability and related infor- mation such as: (A) the number, age, sex, ability to work or engage in other activities, and occupation or activities of persons afflicted with chronic or other disease or injury or handicapping condition; (B)the type of disease or injury or handicapping condition of each person so afflicted; (C) the length of time that each such person has been prevented from carrying on his occupation or activ- ities; (D) the amounts end types of cervices received for or because of such con- ditions; and (E) the economic and other impacts of such conditions; and (2) in connection therewith, to develop end test new or improved methods for obtaining current data on illness and disability and related information. "(b) The Surgeon General is authorized, at appropriate intervals, to make available, through publications and otherwise, to any interested governmental or other public or private agencies, organizations, or groups, or to Me public, the results of surveys or studies made pursuant to subsection (a). "(c) For each fiscal year beginning after June 30, 1956, there are authorized to be appropriated such sums as the Congress may determine for carrying out the provisions of this section. "(d) To assist in carrying out the provisions of this section the Surgeon General is authorized and directed to cooperate and consult with me Depart- ments of Commerce and Labor and any other interested Federal Departments or agencies and with State health departments. For such purpose he shall utilize insofar as possible the services or facilities of any agency of the Federal Gov- ernment and, without regard to section 3709 of the Revised Statutes, as amended, of any appropriate State or other public agency, and may, without re- gard to section 3709 ofthe Revised Statutes,as amended, utilize the services or facilities of any private agency, organization, group, or individual, in accord- ance with written agreements between the head of such agency, organization, or group, or such individual, and the Secretary of Heals, Education, and Welfare. Payment, if any, for such services or facilities shall be made in such amounts as may be provided in such agreement." Sec. 4. Section 301 of the Public Health Service Act (42 U. S. C. 241) is amended by striking out the word "and" atthe end of paragraph `0 redesignat- ing paragraph (g) as paragraph (h), and inserting immediately following para- graph (f) the following new paragraph: "(g) Make available, to health officials, scientists, and appropriate public and other nonprofit institutions and organizations, technical advice and assist- ance on the application of statistical methods to experiments, studies, and sur- veys in health and medical fields: and". Approved July 3, 1956.

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154 Excerpts from the Public Health Service Act General authority respecting research, evaluations, and demonstrations in health statistics, health services, and health care technology assessment APPENDIX D Sec. 304 [242b] (a) The Secretary may, through the Agency for Health Care Policy and Research or the National Center for Health Statistics or using National Research Service Awards or other appropriate authorities, undertake and support training programs to provide for an expanded and continuing supply of individuals qualified to perform the research, evaluation, and demonstration projects set forth in section 306 and in title IX. (b) To implement subsection (a), and section 306, the Secretary may, in addition to any other authority which under other provisions of this Act or any other law may be used by him to implement such subsection, do the following: (1) Utilize personnel and equipment, facilities, and other physical resources of the Department of Health and Human Services, permit appropriate (as determined by the Secretary) entities and individuals to utilize the physical resources of such Department, provide technical assistance and advice, make grants to public and nonprofit private entities and individuals, and, when appropriate, enter into contracts with public and private entities and individ- uals. (2) Admit and treat at hospitals and other facilities of the Service persons not otherwise eligible for admission and treatment at such facilities. (3) Secure, from time to time and for such periods as the Secretary deems advisable but in accordance with section 3109 of title 5, United States Code, the assistance and advice of consultants from the United States or abroad. The Secretary may for the purpose of carding out the functions set forth in sections 305, 306, and 309, obtain (in accordance with section 3109 of title 5 of the United States Code, but without regard to the limitation in such section on the number of days or the period of service) for each of the centers the services of not more than fifteen experts who have appropriate scientific or professional qualifications. , (4) Acquire, construct, improve, repair, operate, and maintain laboratory, research, and other necessary facilities and equipment, and such other real or personal property (including patents) as the Secretary deems necessary; and acquire, without regard to the Act of March 3, 1877 (40 U.S.C. 34), by lease or otherwise, through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia. (c)(l) The Secretary shall coordinate all health services research, evaluations, and demonstrations, all health statistical and epidemiological activities, and all research,

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STATUTORY AUTHORITIES 155 evaluations, and demonstrations respecting the assessment of health care technology undertaken and supported through units of the Department of Health feasible such coordination shall be carried out through the Agency for Health Care Policy and Research and the National Center for Health Statistics. (2) The Secretary shall coordinate the health services research, evaluations, and demonstrations, the health statistical and (where appropriate) epidemiological activities, and the research, evaluations, and demonstrations respecting the assess- ment of health care technology authorized by this Act through the Agency for Health Care Policy and Research and the National Center for Health Statistics. (d)~1) The Secretary, with the advice and assistance of the National Academy of Sciences (acting through the Institute of Medicine and other appropriate units), shall, in cooperation with the Administrator of the Environmental Protection Agency, the Secretary of Labor, the Consumer Product Safety Commission, the Council of Economic Advisers, the Council on Wage and Price Stability, the Council on Environmental Quality, and other entities of the Federal Government which the Secretary determines have the expertise in the subject of the study prescribed by this paragraph, conduct, with funds appropriated under section 308(i)~2), an ongoing study of the present and projected future health costs of pollution and other environmental conditions resulting from human activity (including human activity in any place in the indoor or outdoor environment, including places of employment and residence). In conducting the study, the Secretary shall, to the extent feasible (A) identify the pollution (and the pollutants responsible for the pollution) and other environmental conditions which are, or may reasonably be antici- pated to be, responsible for causing, contributing to, increasing susceptibility to, or aggravating human diseases and adverse effects on humans; (B) identify each such disease and adverse effect on humans and specifically determine whether cancer, birth defects, genetic damage, emphysema, asthma, bronchitis, and other respiratory diseases, heart disease, stroke, and mental illness and impairment are such a disease or effect; (C) identify (on a national, regional, or other geographical basis) the source or sources of such pollutants and conditions and estimate the portion of each pollutant and the extent of each condition which can be traced to a specific type of source; (D) ascertain (i) the extent to which the pollutants and conditions identified under subparagraph (A) are, or may reasonably be anticipated to be, respon- sible, individually or collectively, for causing, contributing to, increasing susceptibility to, or aggravating the diseases and effects identified under subparagraph (B), and (ii) the effect upon the incidence or severity of specific diseases and effects of individual or collective, as appropriate, incremental reductions in the pollutants and changes in such conditions; and (E) quantify (i) the present and projected future health costs of the diseases and effects identified under subparagraph (B), and (ii) the reduction in health costs which would result from each incremental reduction and change referred to in subparagraph (D)(ii). (2) The Secretary shall enter into appropriate arrangements with the Academy under which the Secretary shall be responsible for expenses incurred by the Academy in connection with the study prescribed by paragraph (1~. (3) The first report on the study prescribed by paragraph (1) shall be made to the Committee on Human Resources of the Senate and the Committee on Energy and Commerce of the House of Representatives by the Secretary not later than eighteen and Human Services. To the maximum extent

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156 APPENDIX D months after the date of the enactment of this subsection. Subsequent reports on the study shall be made by the Secretary every three years after the date the first report is submitted. Each report shall (A) identify deficiencies and limitations in the data on the matters considered in the study and recommend actions which may be taken to eliminate such deficiencies and limitations, (B) include such recommendations for legislation as the Secretary detainee appropriate, (C) include recommenda- tions for facilitating studies of the effects of hazardous substances on humans, and (D) include a description of any administrative action proposed to be taken by the Secretary, the Administrator of the Environmental Protection Agency, the Secretary of Labor, and the Consumer Product Safety Commission to reduce the costs which have been quantified under paragraph (l)(E)(i). In conducting the study, the Secretary shall seek assistance from public and private health financing entities in securing the data needed for the study. (4) For purposes of paragraph (1), the term "health costs of pollution and other environmental conditions" means the costs of human diseases and other adverse effects on humans which pollution and other environmental conditions are, or may reasonably be anticipated to be, responsible for causing, contributing to, increasing susceptibility to, or aggravating, including the costs of preventing such diseases and effects, the costs of the treatment, cure, convalescence, and rehabilitation of persons afflicted by such diseases, costs reasonably attributable to pain and suffering from such diseases and effects, loss of income and future earnings resulting from such diseases and effects, adverse effects on productivity (and thus increases in produc- tion costs and consumer prices) resulting from such diseases and effects, loss of tax revenues resulting from such decreases in earnings and productivity, costs to the welfare and unemployment compensation systems and the programs of health benefits under titles XVIII and XIX of the Social Security Act resulting from such diseases and effects, the overall increases in costs throughout the economy resulting from such diseases and effects, and other related direct and indirect costs. National Center for Health Statistics Sec. 306 [242k] (a) There is established in the Department of Health and Human Services the Nat'~-;;`al Center for Health Statistics (hereinafter in this section referred to as tip Renter") which shall be under the direction of a Director who shall be appointee by the Secretary. Ike Secretary, acting through the Center, shall conduct and support statistical and epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality of health services in the United States. (b) In carrying out subsection (a), the Secretary, acting through the Center (1) shall collect statistics on (A) the extent and nature of illness and disability of the population of the United States (or of any groupings of the people included in the population), including life expectancy, the incidence of various acute and chronic illnesses, and infant and maternal morbidity and mortality, (B) the impact of illness and disability of the population on the economy of the United States and on other aspects of the well-being of its population (or of such groupings), (C) environmental, social, and other health hazards, (D) determinants of health, (E) health resources, including physicians, dentists, nurses, and other health professionals by specialty and type of practice and the supply of

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STATUTORY AUTHORITIES 157 services by hospitals, extended care facilities, home health agencies, and other health institutions, (F) utilization of health care, including utilization of (i) ambulatory health services by specialties and types of practice of the health profes- sionals providing such services, and (ii) services of hospitals, extended care facilities, home health agencies, and other institutions, (G) health care costs and financing, including the trends in health care prices and cost, the sources of payments for health care services, and Federal, State, and local governmental expenditures for health care services, and (H) family formation, growth, and dissolution; (2) shall undertake and support (by grant or contract) research, demonstra- tions, and evaluations respecting new or improved methods for obtaining current data on the matters referred to in paragraph (1~; (3) may undertake and support (by grant or contract) epidemiological research, demonstrations, and evaluations on the matters referred to in paragraph (1~; and (4) may collect, furnish, tabulate, and analyze statistics, and prepare studies on matters referred to in paragraph (1) upon request of public and nonprofit private entities under arrangements under which the entities will pay the cost of the service provided. Amounts appropriated to the Secretary from payments made under arrangements made under paragraph (4) shall be available to the Secretary for obligation until expended. (c) The Center shall furnish such special statistical and epidemiological compila- tions and surveys as the Committee on Human Resources and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives may request. Such statistical and epidemiological compilations and surveys shall not be made subject to the payment of the actual or estimated cost of the preparation of such compilations and surveys. (d) To insure comparability and reliability of health statistics, the Secretary shall, through the Center, provide adequate technical assistance to assist State and local jurisdictions in the development of model laws dealing with issues of confidentiality and comparability of data. (e) For the purpose of producing comparable and uniform health information and statistics, there is established the Cooperative Health Statistics System. The Secretary, acting through the Center, shall (1) coordinate the activities of Federal agencies involved in the design and implementation of the System; (2) undertake and support (by grant or contract) research, development, demonstrations, and evaluations respecting the System; (3) make grants to and enter into contracts with State and local health agencies to assist them in meeting the costs of data collection and other activities carried out under the System; and (4) review the statistical activities of the Department of Health and Human Services to assure that they are consistent with the System. States participating in the System shall designate a State agency to administer or be responsible for the administration of the statistical activities within the State under the System. The Secretary, acting through the Center, shall prescribe guidelines to

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158 APPENDIX D assure that statistical activities within States participating in the System produce uniform and timely data and assure appropriate access to such data. (f) To assist in carrying out this section, the Secretary, acting through the Center, shall cooperate and consult with the Departments of Commerce and Labor and any other interested Federal depot lments or agencies and with State and local health departments and agencies. For such purpose he shall utilize insofar as possible the services or facilities of any agency, of the Federal Government and, without regard to section 3709 of ~n~e Revised Statutes (41 U.S.C. 5), of any appropriate State or other public agency, and may, without regard to such section, utilize the services or facilities of any private agency, organization, group, or individual, in accordance with written agreements between the head of such agency, organization, or group and the Secretary or between such individual and the Secretary. Payment, if any, for such services or facilities shall be made in such amounts as may be provided in such agreement. (g) To secure uniformity in the registration and collection of mortality, morbidity, and other health data, the Secretary shall prepare and distribute suitable and necessary fonns for the collection and compilation of such data which shall be published as a part of the health reports published by the Secretary. (h)~1) There shall be an annual collection of data from the records of births, deaths, marriages, and divorces in registration areas. The data shall be obtained only from and restricted to such records of the States and municipalities which the Secretary, in his discretion, determines possess records affording satisfactory data in necessary detail and form. The Secretary shall encourage States and registration areas to obtain detailed data on ethnic and racial populations, including subpopu- lations of Hispanics, Asian Americans, and Pacific Islanders with significant representation in the State or registration area. Each State or registration area shall be paid by the Secretary the Federal share of its reasonable costs (as determined by the Secretary) for collecting and transcribing (at the request of the Secretary and by whatever method authorized by him) its records for such data. (2) There shall be an annual collection of data from a statistically valid sample concerning the general health, illness, and disability status of the civilian noninsti- tutionalized population. Specific topics to be addressed under this paragraph, on an annual or periodic basis, shall include the incidence of illness and accidental injuries, prevalence of chronic diseases and impairments, disability, physician visits, hospitalizations, and the relationship between demographic and socioeconomic characteristics and health characteristics. (i) The Center may provide to public and nonprofit private entities engaged in health planning activities technical assistance in the effective use in such activities of statistics collected or compiled by the Center. (I) In carrying out the requirements of section 304(c) and paragraph (1) of subsection (e) of this section, the Secretary shall coordinate health statistical and epidemiological activities of the Department of Health and Human Services by (1) establishing standardized means for the collection of health information and statistics under laws administered by the Secretary; (2) developing, in consultation with the National Committee on Vital and Health Statistics, and maintaining the minimum sets of data needed on a continuing basis to fulfill the collection requirements of subsection (b)~19; (3) after consultation with the National Committee on Vital and Health Statistics, establishing standards to assure the quality of health statistical and epidemiological data collection, processing, and analysis;

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STATUTORY AUTHORITIES 159 (4) in the case of proposed health data collections of the Department which are required to be reviewed by the Director of the Office of Management and Budget under section 3509 of title 44, United States Code, reviewing such proposed collections to determine whether they conform with the minimum sets of data and the standards promulgated pursuant to paragraphs (2) and (3), and if any such proposed collection is found not to be in conformance, by taking such action as may be necessary to assure that it will conform to such sets of data and standards, and (5) periodically reviewing ongoing health data collections of the Department, subject to review under such section 3509, to detains if the collections are being conducted in accordance with the minimum sets of data and the standards promulgated pursuant to paragraphs (2) and (3) and, if any such collection is found not to be in conformance, by taking such action as may be necessary to assure that the collection will conform to such sets of data and standards not later than the nineteenth day after the date of the completion of the review of the collection. (k)~1) There is established in the Office of the Secretary a committee to be known as the National Committee on Vital and Health Statistics (hereinafter in this subsection, referred to as the "Committee") which shall consist of 16 members. (2~(A) The members of the Committee shall be appointed by the Secretary from among persons who have distinguished themselves in the fields of health statistics, health planning, epidemiology, and the provision of health services. Except as provided in subparagraph (B), members of the Committee shall be appointed for terms of 4 years. (B)(i) In the case of membership terms on the Committee under this subsection (as in effect prior to January 1, 1988) that expire in calendar year 1988, the appoint- ments to three such terms in such calendar year shall be for a period of 4 years and the appointments to two such terms in such calendar year shall be for a period of 3 years, as designated by the Secretary. (ii) In the case of membership terms on the Committee under this subsection (as In effect prior to January 1, 1988) that expire in calendar year 1989, one such tea shall be extended for an additional consecutive 1-year period, as designated by the Secretary. (iii) In the case of membership terms on the Committee under this subsection (as in effect prior to January 1, 1988) that expire in calendar year 1990, two of such terms shall each be extended for an additional consecutive 1-year period, as designated by the SecretaIy. (3) Members of the Committee shall be compensated in accordance with section 208(c). (4) It shall be the function of the Committee to assist and advise the Secretary (A) to delineate statistical problems bearing on health and health services which are of national or international interest; (B) to stimulate studies of such problems by other organizations and agencies whenever possible or to make investigations of such problems through subcom- mittees; (C) to detel~ine, approve, and revise the terms, definitions, classifications, and guidelines for assessing health status and health services, their distribution and costs, for use (i) within the Department of Health and Human Services, (ii) by all programs administered or funded by the Secretary, including the Federal- State-local cooperative health statistics system referred to in subsection (e), and (iii) to the extent possible as determined by the head of the agency involved, by

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160 APPENDIX D the Veterans' Administration, the Department of Defense, and other Federal agencies concerned with health and health services; (D) with respect to the design of and approval of health statistical and health information systems concerned with the collection, processing, and tabulation of health statistics within the Department of Health and Human Services, with respect to the Cooperative Health Statistics System established under subsec- tion (e), and with respect to the standardized means for the collection of health information and statistics to be established by the Secretary under subsection ~; (E) to review and comment on findings and proposals developed by other organizations and agencies and to make recommendations for their adoption or implementation by local, State, national, or international agencies; (F) to cooperate with national committees of other countries and with the World Health Organization and other national agencies in the studies of problems of mutual interest; and (G) to issue an annual report on the state of the Nation's health, its health services, their costs and distributions, and to make proposals for improvement of the Nation's health statistics and health information systems. (5) In carrying out health statistical activities under this part, the Secretary shall consult with, and seek the advice of, the Committee and other appropriate professional advisory groups. (1~1) The Secretary, acting through the Center, shall develop a plan for the collection and coordination of statistical and epidemiological data on the effects of the environment on health. Such plan shall include a review of the data now available on health effects, deficiencies in such data, and methods by which existing data deficiencies can be corrected. The Secretary shall submit such plan to the Congress not later than January 1, 1980. (2~(A) The Secretary, acting through the Center and in cooperation with the Office of Federal Statistical Policy and Standards, shall establish, not later than two years after the date of the enactment of this subsection, guidelines for the collection, compilation, analysis, publication, and distribution of statistics and information necessary for determining the effects of conditions of employment and indoor and outdoor environmental conditions on the public health. Guidelines established under this subparagraph shall not (i) authorize or require the disclosure of any matter described in section 552(b)~6) of title 5, United States Code, and (ii) authorize or require the disclosure of any statistics or other information which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b)~4) of such section. The guideii.nes shall be reviewed and, if appropriate, revised at least every three years after the date they are initially established. Guidelines shall take effect on the date of the promulgation of the regulation establishing or revising the guidelines or such later date as may be specified in the guidelines. (B) The guidelines shall be designed (i) to improve coordination of environmental and health studies, statistics, and information, and to prevent overlap and unnecessary duplication with respect to such studies, statistics, and inflation; (ii) to assure that such studies, statistics, and information will be available to executive departments responsible for the administration of laws relating to the protection of the public health and safety or the environment; (iii) to encourage the more effective use of executive departments of such studies, statistics, and inflation;

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STATUTORY AUTHORITIES 161 (iv) to improve the statistical validity and reliability of such studies, statistics, and information; and (v) to assure greater responsiveness by the Department of Health and Human Services and other executive departments in meeting informational and analytical needs for determining the effects of employment and indoor and outdoor environmental conditions on public health (C) In establishing and revising guidelines under subparagraph (A), the Secretary shall take into consideration the plan developed pursuant to para- graph aid. (D)(i) Each executive department shall comply with the substantive and procedural requirements of the guidelines. (ii) The President shall by Executive order require each executive depart- ment to comply with requests, made in accordance with the guidelines, by the Secretary, the Administrator of the Environmental Protection Agency, the Consumer Product Safety Commission, or the Secretary of Labor for statistics and inflation. (iii) The President may by Executive order exempt any executive depart- ment from compliance with a requirement of the guidelines respecting specific statistics or other information if the President determines that the exemption is necessary in the interest of national security. (E) In carrying out his duties under this paragraph, the Secretary, acting through the Center, shall, insofar as practicable, provide for coordination of his activities with those of other Federal agencies and interagency task forces relating to the collection, analysis, publication, or distribution of statistics and information necessary for determining the effects of conditions of employment and indoor and outdoor environmental conditions on the public health. (F) For purposes of this paragraph, the term "guidelines" means the guidelines, either as initially established or as revised, in effect under this paragraph. (3) The Secretary, acting through the Center, shall conduct a study of the issues respecting, and the recommendations for, establishing a Federal system to assist, in a manner designed to avoid invasion of personal privacy, Federal, State, and other entities in locating individuals who have been or may have been exposed to hazardous substances to determine the effect on their health of such exposure and to assist them in obtaining appropriate medical care and treatment. In conducting such study, the Secretary may consult with any public and private entity which it determines has expertise on any matter to be considered in the study. Not later than one year after the date of the enactment of this subsection, the Secretary shall complete the study and report to the Congress the results of the study and any recommendations for legislation or administrative action. (4) In carrying out paragraphs (1), (2), and (3), the Secretary shall consult with and take into consideration any recommendations of the Task Force on Environmental Cancer and Heart and Lung Disease, the Administrator of the Environmental Protection Agency, the Secretary of Labor, the Consumer Product Safety Commis- sion, the Council on Environmental Quality, the National Committee on Vital and Health Statistics, and the National Academy of Sciences (including the Institute of Medicine and any other unit of the Academy). (m) In carrying out this section, the Secretary, acting through the Center, shall collect and analyze adequate health data that is specific to particular ethnic and racial populations, including data collected under national health surveys. Activities

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162 APPENDIX D carried out under this subsection shall be in addition to any activities carried out under subsection (n). (n)(l)The Secretary, acting through the Center, may make grants to public and nonprofit private entities for (A) the conduct of special surveys or studies on the health of ethnic and racial populations or subpopulations; (B) analysis of data on ethnic and racial populations and subpopulations; and (C) research on improving methods for developing statistics on ethnic and racial populations and subpopulations. (2) The Secretary, acting through the Center, may provide technical assistance, standards, and methodologies to grantees supported by this subsection in order to maximize the data quality and comparability with other studies. (3) Provisions of section 308 (d) do not apply to surveys or studies conducted by grantees under this subsection unless the Secretary, in accordance with regulations the Secretary may issue, determines that such provisions are necessary for the conduct of the survey or study and receives adequate assurance that the grantee will enforce such provisions. (o)~1) For health statistical and epidemiological activities undertaken or supported under subsections (a) through (m), there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 1991 through 1993. (2) For activities authorized in subsection (n), there are authorized to be appropriated $S,000,000 for fiscal year 1991, $7,500,000 for fiscal year 1992, and $10,000,000 for fiscal year 1993. Of such amounts, the Secretary shall use not more than 10 percent for administration and for activities described in subsection (n)~2~. International cooperation Sec. 307 [2421] (a) For the purpose of advancing the status of the health sciences in the United States (and thereby the health of the American people), the Secretary may participate with other countries in cooperative endeavors in biomedical research, health care technology, and the health services research and statistical activities authorized by section 306 and by title IX. (b) In connection with the cooperative endeavors authorized by subsection (a), the Secretary may (1) make such use of resources offered by participating foreign countries as he may find necessary and appropriate; (2) establish and maintain fellowships in the United States and in participat- ing foreign countries; (3) make grants to public institutions or agencies and to nonprofit private institutions or agencies in the United States and in participating foreign countries for the purpose of establishing and maintaining the fellowships authorized by paragraph (2~; (4) make grants or loans of equipment and materials, for use by public or nonprofit private institutions or agencies, or by individuals, in participating foreign countries; (5) participate and otherwise cooperate in any international meetings, conferences, or other activities concerned with biomedical research, health services research, health statistics, or health care technology; (6) facilitate the interchange between the United States and participating foreign countries, and among participating foreign countries, of research scientists and experts who are engaged in experiments or programs of biomed- ical research, health services research, health statistical activities, or health care

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STATUTORY AUTHORITIES 163 technology activities, and in carrying out such purpose may pay per diem compensation, subsistence, and travel for such scientists and experts when away from their places of residence at rates not to exceed those provided in section 5703(b) of title 5, United States Code, for persons in the Government service employed intermittently; and (7) procure, in accordance with section 3109 of title 5, United States Code, the temporary or intermittent services of experts or consultants. The Secretary may not, in the exercise of his authority under this section, provide financial assistance for the construction of any facility in any foreign country. General provisions respecting effectiveness, efficiency, and quality of health services Sec. 308 [242m] (apt) Not later than March 15 of each year, the Secretary shall submit to the President and Congress the following reports: (A) A report on (i) the administration of sections 304, 306, and 307 and title IX during the preceding fiscal year; and (ii) the current state and progress of health services research, health statistics, and health care technology. (B) A report on health care costs and financing. Such report shall include a description and analysis of the statistics collected under section 306(b)~1~(G). (C) A report on health resources. Such report shall include a description and analysis, by geographical area, of the statistics collected under section 306(b)~1~(E). (D) A report on the utilization of health resources. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under section 306(b)~1~(F). (E) A report on the health of the Nation's people. Such report shall include a description and analysis, by age, sex, income, and geographic area, of the statistics collected under section 306(b)~1~(A). (2) The reports required by subparagraphs (B) through (E) of paragraph (2) shall be prepared through the Agency for Health Care Policy and Research and the National Center for Health Statistics. (3) The Office of Management and Budget may review any report required by paragraph (1) of this subsection before its submission to Congress, but the Office may not revise any such report or delay its submission beyond the date prescribed for its submission, and may submit to Congress its comments respecting any such report. (b)(1) No grant or contract may be made under section 304, 306, or 307, unless an application therefor has been submitted to the Secretary in such form and manner, and containing such information, as the Secretary may by regulation prescribe and unless a peer review group referred to in paragraph (2) has recommended the application for approval. (IDA) Each application submitted for a grant or contract under section 306 in an amount exceeding $50,000 of direct costs and for a health services research, evaluation, or demonstration project, or for a grant under section 306(n), shall be submitted to a peer review group for an evaluation of the technical and scientific merits of the proposals made in each such application. The Director of the National

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164 APPENDIX Center for Health Statistics shall establish such peer review groups as may be necessary to provide for such an evaluation of each such application. (B) A peer review group to which an application is submitted pursuant to subparagraph (A) shall report its finding and recommendations respecting the application to the Secretary, acting through the Director of the locational Center for Health Statistics, in such form and manner as the Secretary shall by regulation prescribe. The Secretary may not approve an application described in such subparagraph unless a peer review group has recommended the application for approval. (C) The Secretary, acting through the Director of the National Center for Health Statistics, shall make appointments to the peer review groups required in subparagraph (A) from among persons who are not officers or employees of the United States and who possess appropriate technical and scientific qualifications, except that peer review groups regarding grants under section 306(n) may include appropriately qualified such officers and employees. (c) The aggregate number of grants and contracts made or entered into under sections 304 and 305 for any fiscal year respecting a particular means of delivery of health services or another particular aspect of health services may not exceed twenty; and the aggregate amount of funds obligated under grants and contracts under such sections for any fiscal year respecting a particular means of delivery of health services or another particular aspect of health services may not exceed $5,000,000. (d) No information, if an establishment or person supplying the information or described in it is identifiable, obtained in the course of activities undertaken or supported under section 304, 306, or 307 may be used for any purpose other than the purpose for which it was supplied unless such establishment or person has consented (as determined under regulations of the Secretary) to its use for such other purpose and in the case of information obtained in the course of health statistical or epidemiological activities under section 304 or 306, such information may not be published or released in other form if the particular establishment or person supplying the information or described in it is identifiable unless such establishment or person has consented (as determined under regulations of the Secretary) to its publication or release in other form. (e)~1) Payments of any grant or under any contract under section 304, 306, or 307 may be made in advance or by way of reimbursement, and in such installments and on such conditions, as the Secretary deems necessary to carry out the purposes of such section. (2) The amounts otherwise payable to any person under a grant or contract made under section 304, 306, or 307 shall be reduced by (A) amounts equal to the fair market value of any equipment or supplies furnished to such person by the Secretary for the purpose of carrying out the project with respect to which such grant or contract is made, and (B) amounts equal to the pay, allowances, traveling expenses, and related personnel expenses attributable to the performance of services by an officer or employee of the Government in connection with such project, if such officer or employee was assigned or detailed by the Secretary to perform such services, but only if such person requested the Secretary to furnish such equipment or supplies, or such services, as the case may be.

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STATUTORY AUTHORITIES 165 (f) Contracts may be entered into under section 304 or 306 without regard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 529; 41 U.S.C. 5~. (g)~1) The Secretary shall (A) publish, make available, and disseminate, promptly in understandable form and on as broad a basis as practicable, the results of health services research, demonstrations, and evaluations undertaken and supported under sections 304 and 305; (B) make available to the public data developed in such research, demon- strations, and evaluations; and (C) provide indexing, abstracting, translating, publishing, and other services leading to a more effective and timely dissemination of information on health services research, demonstrations, and evaluations in health care delivery to public and private entities and individuals engaged in the improvement of health care delivery and the general public; and undertake programs to develop new or improved methods for making such information available. (2) The Secretary shall (A) take such action as may be necessary to assure that statistics developed under sections 304 and 306 are of high quality, timely, comprehensive as well as specific, standardized, and adequately analyzed and indexed, and (B) publish, make available, and disseminate such statistics on as wide a basis as is practicable. (h)~1) Except where the Secretary determines that unusual circumstances make a larger percentage necessary in order to effectuate the purposes of section 306, a grant or contract under any of such sections with respect to any project for construction of a facility or for acquisition of equipment may not provide for payment of more than 50 per centum of so much of the cost of the facility or equipment as the Secretary determines is reasonably attributable to research, evaluation, or demonstration purposes. (2) Laborers and mechanics employed by contractors and subcontractors in the construction of such a facility shall be paid wages at rates not less than those prevailing on similar work in the locality, as determined by the Secretary of Labor in accordance with the Act of March 3, 1931 (40 U.S.C. 267a267a-5, known as the Davis-Bacon Act); and the Secretary of Labor shall have with respect to any labor standards specified in this paragraph the authority and functions set forth in Reorganization Plan Numbered 14 of 1950 (5 U.S.C. Appendix) and section 2 of the Act of June 13, 1934 (40 U.S.C. 276c). (3) Such grants and contracts shall be subject to such additional requirements as the Secretary may by regulation prescribe.

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166 Related authorities outside the Public Health Service Act: Public Law Number Date 95-626 11/10/78 101-239 12/19/89 101~45 10/22/90 10~-582 11/15/90 APPENDIX D Title Health Services and Centers Amendments of 1978 Section 404 mandated the publication of a "Prevention Profile" on every three years, presenting data on health promotion and disease prevention. Omnibus Budget Reconciliation Act of 1989 Section 6507 required the development of a national system to link data from birth, infant death, and Medicaid records. National Nutrition Monitoring and Related Research Act of 1990 Mandated a coordinated, 10-year program to improve the data for monitoring nutrition status, and to improve the comparability of nutrition monitoring data collected by DHHS and USDA; established a National Nutrition Monitoring Advisory Council; and established new procedures for review and clearance of dietary guidance. Year 2000 Health Objectives Planning Act of 1990 Provides for grants to States for the development of plans to implement the Year 2000 Health Objectives within each State, including the assessment of health within the State; and mandates the development of uniform health status indicators for use by Federal, State, and local health agencies, along with model methods of collecting and reporting data.