Authorizing Legislation

TITLE III—GENERAL POWERS AND DUTIES OF PUBLIC

HEALTH SERVICE

PART A—RESEARCH AND INVESTIGATION

IN GENERAL

SEC. 301. o241. (a) The Secretary shall conduct in the Service,

and encourage, cooperate with, and render assistance to other appropriate

public authorities, scientific institutions, and scientists in

the conduct of, and promote the coordination of, research, investigations,

experiments, demonstrations, and studies relating to the

causes, diagnosis, treatment, control, and prevention of physical

and mental diseases and impairments of man, including water purification,

sewage treatment, and pollution of lakes and streams. In

carrying out the foregoing the Secretary is authorized to—

(1) collect and make available through publications and

other appropriate means, information as to, and the practical

application of, such research and other activities;

(2) make available research facilities of the Service to appropriate

public authorities, and to health officials and scientists

engaged in special study;

(3) make grants-in-aid to universities, hospitals, laboratories,

and other public or private institutions, and to individuals

for such research projects as are recommended by the advisory

council to the entity of the Department supporting such

projects and make, upon recommendation of the advisory council

to the appropriate entity of the Department, grants-in-aid

to public or nonprofit universities, hospitals, laboratories, and

other institutions for the general support of their research;

(4) secure from time to time and for such periods as he

deems advisable, the assistance and advice of experts, scholars,

and consultants from the United States or abroad;

(5) for purposes of study, admit and treat at institutions,

hospitals, and stations of the Service, persons not otherwise eligible

for such treatment;

(6) make available, to health officials, scientists, and appropriate

public and other nonprofit institutions and organizations,

technical advice and assistance on the application of statistical

methods to experiments, studies, and surveys in health

and medical fields;

(7) enter into contracts, including contracts for research in

accordance with and subject to the provisions of law applicable

to contracts entered into by the military departments under

title 10, United States Code, sections 2353 and 2354, except

that determination, approval, and certification required thereby

shall be by the Secretary of Health, Education, and Welfare;

and

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(8) adopt, upon recommendations of the advisory councils

to the appropriate entities of the Department or, with respect

to mental health, the National Advisory Mental Health Council,

such additional means as the Secretary considers necessary

or appropriate to carry out the purposes of this section.

The Secretary may make available to individuals and entities, for

biomedical and behavioral research, substances and living organisms.

Such substances and organisms shall be made available

under such terms and conditions (including payment for them) as

the Secretary determines appropriate.

(b)(1) The Secretary shall conduct and may support through

grants and contracts studies and testing of substances for carcinogenicity,

teratogenicity, mutagenicity, and other harmful biological

effects. In carrying out this paragraph, the Secretary shall consult

with entities of the Federal Government, outside of the Department

of Health, Education, and Welfare, engaged in comparable activities.

The Secretary, upon request of such an entity and under appropriate

arrangements for the payment of expenses, may conduct

for such entity studies and testing of substances for carcinogenicity,

teratogenicity, mutagenicity, and other harmful biological effects.

(2)(A) The Secretary shall establish a comprehensive program

of research into the biological effects of low-level ionizing radiation

under which program the Secretary shall conduct such research

and may support such research by others through grants and contracts.

(B) The Secretary shall conduct a comprehensive review of

Federal programs of research on the biological effects of ionizing

radiation.

(3) The Secretary shall conduct and may support through

grants and contracts research and studies on human nutrition,

with particular emphasis on the role of nutrition in the prevention

and treatment of disease and on the maintenance and promotion

of health, and programs for the dissemination of information respecting

human nutrition to health professionals and the public. In

carrying out activities under this paragraph, the Secretary shall

provide for the coordination of such of these activities as are performed

by the different divisions within the Department of Health,

Education, and Welfare and shall consult with entities of the Federal

Government, outside of the Department of Health, Education,

and Welfare, engaged in comparable activities. The Secretary, upon

request of such an entity and under appropriate arrangements for

the payment of expenses, may conduct and support such activities

for such entity.

(4) The Secretary shall publish a biennial report which

contains—

(A) a list of all substances (i) which either are known to

be carcinogens or may reasonably be anticipated to be carcinogens

and (ii) to which a significant number of persons residing

in the United States are exposed;

(B) information concerning the nature of such exposure

and the estimated number of persons exposed to such substances;

(C) a statement identifying (i) each substance contained in

the list under subparagraph (A) for which no effluent, ambient,

71 PUBLIC HEALTH SERVICE ACT Sec. 306

1 Former section 305 was repealed by section 6103(d)(1)(A) of Public Law 101–239 (103 Stat.

2205). Title IX now applies to the matter with which former section 305 was concerned.

(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)(1) The Secretary shall coordinate all health services research,

evaluations, and demonstrations, all health statistical and

epidemiological activities, and all research, evaluations, and demonstrations

respecting the assessment of health care technology undertaken

and supported through units of the Department of Health

and Human Services. To the maximum extent 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 assessment of health care

technology authorized by this Act through the Agency for Health

Care Policy and Research and the National Center for Health Statistics.

NATIONAL CENTER FOR HEALTH STATISTICS

SEC. 306. 1 o242k. (a) There is established in the Department

of Health and Human Services the National Center for Health Statistics

(hereinafter in this section referred to as the ‘‘Center’’) which

shall be under the direction of a Director who shall be appointed

by the Secretary. The 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 services by hospitals, exSec.

306 PUBLIC HEALTH SERVICE ACT 72

tended 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 professionals 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,

demonstrations, 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

compilations and surveys as the Committee on Labor

and 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

73 PUBLIC HEALTH SERVICE ACT Sec. 306

1 So in law. Probably should be capitalized.

(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 assure that

statistical activities within States participating in the system 1

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

departments 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 the 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 forms for the collection

and compilation of such data.

(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 subpopulations 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 noninstitutionalized 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.

Sec. 306 PUBLIC HEALTH SERVICE ACT 74

(i) The Center may provide to public and nonprofit private entities

technical assistance in the effective use in such activities of

statistics collected or compiled by the Center.

(j) 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)(1);

(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;

(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

determine 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 18 members.

(2) The members of the Committee shall be appointed from

among persons who have distinguished themselves in the fields of

health statistics, electronic interchange of health care information,

privacy and security of electronic information, population-based

public health, purchasing or financing health care services, integrated

computerized health information systems, health services

research, consumer interests in health information, health data

standards, epidemiology, and the provision of health services.

Members of the Committee shall be appointed for terms of 4 years.

(3) Of the members of the Committee—

(A) 1 shall be appointed, not later than 60 days after the

date of the enactment of the Health Insurance Portability and

75 PUBLIC HEALTH SERVICE ACT Sec. 306

Accountability Act of 1996, by the Speaker of the House of

Representatives after consultation with the Minority Leader of

the House of Representatives;

(B) 1 shall be appointed, not later than 60 days after the

date of the enactment of the Health Insurance Portability and

Accountability Act of 1996, by the President pro tempore of the

Senate after consultation with the Minority Leader of the Senate;

and

(C) 16 shall be appointed by the Secretary.

(4) Members of the Committee shall be compensated in accordance

with section 208(c).

(5) The Committee—

(A) shall assist and advise the Secretary—

(i) to delineate statistical problems bearing on health

and health services which are of national or international

interest;

(ii) to stimulate studies of such problems by other organizations

and agencies whenever possible or to make investigations

of such problems through subcommittees;

(iii) to determine, 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 the Department of Veterans Affairs,

the Department of Defense, and other Federal agencies

concerned with health and health services;

(iv) 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 subsection (e), and

with respect to the standardized means for the collection

of health information and statistics to be established by

the Secretary under subsection (j)(1);

(v) 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;

(vi) 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;

(vii) 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;

and

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(viii) in complying with the requirements imposed on

the Secretary under part C of title XI of the Social Security

Act;

(B) shall study the issues related to the adoption of uniform

data standards for patient medical record information

and the electronic exchange of such information;

(C) shall report to the Secretary not later than 4 years

after the date of the enactment of the Health Insurance Portability

and Accountability Act of 1996 recommendations and

legislative proposals for such standards and electronic exchange;

and

(D) shall be responsible generally for advising the Secretary

and the Congress on the status of the implementation

of part C of title XI of the Social Security Act.

(6) 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.

(7) Not later than 1 year after the date of the enactment of the

Health Insurance Portability and Accountability Act of 1996, and

annually thereafter, the Committee shall submit to the Congress,

and make public, a report regarding the implementation of part C

of title XI of the Social Security Act. Such report shall address the

following subjects, to the extent that the Committee determines appropriate:

(A) The extent to which persons required to comply with

part C of title XI of the Social Security Act are cooperating in

implementing the standards adopted under such part.

(B) The extent to which such entities are meeting the security

standards adopted under such part and the types of penalties

assessed for noncompliance with such standards.

(C) Whether the Federal and State Governments are receiving

information of sufficient quality to meet their responsibilities

under such part.

(D) Any problems that exist with respect to implementation

of such part.

(E) The extent to which timetables under such part are

being met.

(l) 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 carried out

under this subsection shall be in addition to any activities carried

out under subsection (m).

(m)(1) 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 sup77

PUBLIC HEALTH SERVICE ACT Sec. 307

ported 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.

(4)(A) Subject to subparagraph (B), the Secretary, acting

through the Center, shall collect data on Hispanics and major Hispanic

subpopulation groups and American Indians, and for developing

special area population studies on major Asian American and

Pacific Islander populations.

(B) The provisions of subparagraph (A) shall be effective with

respect to a fiscal year only to the extent that funds are appropriated

pursuant to paragraph (3) of subsection (n), and only if the

amounts appropriated for such fiscal year pursuant to each of paragraphs

(1) and (2) of subsection (n) equal or exceed the amounts

so appropriated for fiscal year 1997.

(n)(1) For health statistical and epidemiological activities undertaken

or supported under subsections (a) through (l), there are

authorized to be appropriated such sums as may be necessary for

each of the fiscal years 1991 through 2003.

(2) For activities authorized in paragraphs (1) through (3) of

subsection (m), there are authorized to be appropriated such sums

as may be necessary for each of the fiscal years 1999 through 2003.

Of such amounts, the Secretary shall use not more than 10 percent

for administration and for activities described in subsection (m)(2).

(3) For activities authorized in subsection (m)(4), there are authorized

to be appropriated $1,000,000 for fiscal year 1998, and

such sums as may be necessary for each of the fiscal years 1999

through 2002.