remainder of a State's allotment under this subsection shall be available only for the provision under the State plan of services in communities of the State." (e) Subsection (e) of such section is amended by striking out "$62,500,000 for the fiscal year ending June 30, 1968," and inserting in lieu thereof "$70,000,000 for the fiscal year ending June 30, 1968, and such sums as may be necessary for the next four fiscal years".

(f) Effective July 1, 1967, subsection (c) of section 309 of such Act (42 U.S.C. 242g (c)), as amended by section 4 of the Comprehensive Health Planning and Public Health Services Admendments of 1966 (Public Law 89-749), is amended by striking out "each" after "$5,000,000" and by inserting after "the fiscal year ending June 30, 1968," the following: "and such sums as may be necessary for the next four fiscal years,”.

RESEARCH AND DEMONSTRATIONS RELATING TO HEALTH FACILITIES AND SERVICES SEC. 3. (a) Section 304 (42 U.S.C. 242b) of the Public Health Service Act is amended to read as follows:

"RESEARCH AND DEMONSTRATIONS RELATING TO HEALTH FACILITIES AND SERVICES "SEC. 304. (a) The Secretary is authorized

"(1) to make grants to States, political subdivisions, universities, hospitals, and other public or nonprofit private agencies, institutions, or organizations for projects for the conduct of research, experiments, or demonstrations (and related training), and

"(2) to make contracts with public or private agencies, institutions, or organizations for the conduct of research, experiments, or demonstrations (and related training), relating to the development, utilization, quality, organization, and financing of services, facilities, and resources of hospitals or other medical facilities (including, for purposes of this section, facilities for the mentally retarded, as defined in the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963), agencies, institutions, or organizations or to development of new methods or improvement of existing methods of organization, delivery, or financing of health services, including, among others

"(A) projects for the construction of units of hospitals or other medical facilities which involve experimental architectural designs or functional layout or use of new materials or new methods of construction, the efficiency of which can be tested and evaluated, or which involve the demonstration of such efficiency, particularly projects which also involve research, experiments, or demonstrations relating to delivery of health services, and

"(B) projects for development and testing of new equipment and systems, including automated equipment, and other new technology systems or concepts for the delivery of health services.

"(b) Except where the Secretary determines that unusual circumstances make a larger percentage necessary in order to effectuate the purposes of this section, a grant or contract under this section 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, experimental, or demonstration purposes. The provisions of clause (5) of the third sentence of section 605 (a) and such other conditions as the Secretary may determine shall apply with respect to grants or contracts under this section for projects for construction of a facility or for acquisition of equipment.

"(c) Payments of any grants or under any contracts under this section 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 this section,

"(d) There are authorized to be appropriated for payment of grants or under contracts under this section $20,000,000 for the fiscal year ending June 30, 1968, and such sums as may be necessary for succeeding fiscal years; except that, for any fiscal year ending after June 30, 1968, such portions of such sums as the Secretary may determine, but not exceeding 1 per centum thereof, shall be available to the Secretary for evaluation (directly or by grants or contracts) of the program authorized by this section."

(b) Effective with respect to appropriations for fiscal years ending after June 30, 1967

(1) section 624 of such Act is repealed; and

(2) the first sentence of section 314(e) of such Act is amended by inserting "or" at the end of clause (1), by striking out clause (3), by striking out ", or" at the end of clause (2), by inserting “(including related training)” after "providing services" in clause (1), and by amending clause (2) to read: "(2) developing and supporting for an initial period new programs of health services (including related training)"; and

(3) the second sentence of such section 314 (e) is amended by striking out "or (2)".

Any sums appropriated for the fiscal year ending June 30, 1968, for carrying out such sections 624 and 314(e) (3) which remain unobligated on the date of enactment of this Act shall be available for carrying out section 304 of the Public Health Service Act, and the total of such sums (and any portion of the appropriations for such year for such purpose obligated prior to such date of enactment in carrying out such sections) shall be deducted from the authorization for such year contained in such section 304.

COOPERATION WITH STATES IN EMERGENCIES

SEC. 4. Section 311 of the Public Health Service Act (42 U.S.C. 243) is amended by inserting at the end thereof the following new subsection:

"(c) The Secretary may enter into agreements providing for cooperative planning between Public Health Service medical facilities and community health facilities to cope with health problems resulting from disasters, and for participation by Public Health Service medical facilities in carrying out such planning. He may also, at the request of the appropriate State or local authority, extend temporary (not in excess of forty-five days) assistance to States or localities in meeting health emergencies of such a nature as to warrant Federal assistance. The Secretary may require such reimbursement of the United States for aid (other than planning) under the preceding sentences of this subsection as he may determine to be reasonable under the circumstances. Any reimbursement so paid shall be credited to the applicable appropriation of the Public Health Service for the year in which such reimbursement is received."

CLINICAL LABORATORIES IMPROVEMENT

SEC. 5. (a) Part F of title III of the Public Health Service Act (42 U.S.C. 262-3) is amended by changing the title to read: "LICENSING-BIOLOGICAL PRODUCTS AND CLINICAL LABORATORIES", and by adding after section 352 (42 U.S.C. 263) the following new section:

"LICENSING OF LABORATORIES

"SEC. 353. (a) As used in this section

"(1) the term 'laboratory' or 'clinical laboratory' means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body, for the purpose of obtaining information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, man;

"(2) the term 'interstate commerce' means trade, traffic, commerce, transportation, transmission, or communication between any State, territory, or possession of the United States, the Commonwealth of Puerto Rico, or the District of Columbia and any place outside thereof; or within the District of Columbia, the Commonwealth of Puerto Rico, or any territory or possession of the United States.

"(b) No person may solicit or accept in interstate commerce, directly or indirectly, any specimen for laboratory examination, nor introduce or deliver for introduction into interstate commerce, directly or indirectly, any specimen with respect to which a laboratory has performed, or alleges to have performed, one or more laboratory procedures, or introduce, or deliver for introduction into interstate commerce, directly or indirectly, the results of or any report on any such procedures, unless there is in effect a license for such laboratory issued by the Secretary under this section applicable to such procedures.

"(c) A license issued by the Secretary under this section may be applicable to all laboratory procedures or only to specified laboratory procedures or categories of laboratory procedures.

“(d) (1) A license shall not be issued in the case of any clinical laboratory unless (A) the application therefor contains or is accompanied by such information and assurances as the Secretary finds necessary, and (B) the applicant agrees and the Secretary determines that such laboratory will be operated in accordance with standards found necessary by the Secretary to carry out the purposes of this section.

"(2) A license issued under this section shall be valid for a period of three years, or such shorter period as the Secretary may establish for any clinical laboratory or any class or classes thereof; and may be renewed in such manner as the Secretary may prescribe.

"(3) The Secretary may, if he deems it appropriate, require payment of fees for the issuance and renewal of licenses, but the amount of such fees shall not exceed such sum (which in no event may be more than the sum determined by him to be necessary on the average to provide, maintain, and equip an adequate service for the purpose) as the Secretary may by regulation prescribe from time to time.

"(e) A laboratory license may be revoked, suspended, or limited if the Secretary finds, after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that such owner or operator or any employee of the laboratory

"(1) has been guilty of misrepresentation in obtaining the license; "(2) has engaged or attempted to engage or represented himself as entitled to perform any laboratory procedure or category of procedures not authorized in the license;

"(3) has failed to comply with the standards with respect to laboratories and laboratory personnel prescribed by the Secretary pursuant to this section;

"(4) has failed to comply with reasonable requests of the Secretary for any information or materials, or work on materials, he deems necessary to determine the laboratory's continued eligibility for its license hereunder or continued compliance with the Secretary's standards hereunder;

"(5) has refused a request of the Secretary or any Federal officer or employee duly designated by him for permission to inspect the laboratory and its operations and pertinent records at any reasonable time; or

"(6) has violated or aided and abetted in the violation of any provisions of this section or of any rule or regulation promulgated thereunder. "(f) The license of any laboratory under this section may be temporarily suspended without a hearing for a period of not to exceed 60 days if the Secretary determines that the public safety or welfare would otherwise be in imminent danger.

"(g) (1) Any party aggrieved by any final action taken under this section may at any time within sixty days after the date of such action file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for judicial review of such action. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record on which the action of the Secretary is based, as provided in section 2112 of title 28, United States Code.

"(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may deem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendations, if any, for the modification or setting aside of his original action, with the return of such additional evidence.

"(3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the atcion, or to set it aside in whole or in part, temporarily or permanently. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.

"(4) The judgment of the court affirming or setting aside, in whole or in part, any such action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28, United States Code.

"(h) Any person who violates any provision of this section or any rule or regulation promulgated thereunder shall be guilty of a misdemeanor and shall on conviction thereof be subject to imprisonment for not more than one year, or a fine of not more than $1,000, or both such imprisonment and fine.

"(i) The provisions of this section shall not apply to any clinical laboratory operated by a licensed physician, osteopath, or podiatrist who performs laboratory tests or procedures, personally or through his employees, solely as an adjunct to the treatment of his own patients.

"(j) In carrying out this functions under this section, the Secretary is authorized, pursuant to agreement, to utilize the services or facilities of any Federal or State or local public agency or nonprofit private agency or organization, and may pay therefor in advance or by way of reimbursement, and in such installments, as he may determine.

"(k) Nothing in this section shall be construed as affecting the power of any State to enact and enforce laws relating to the matters covered by this section to the extent that such laws are not inconsistent with the provisions of this section or with the rules and regulations issued under this section."

(b) The amendment made by subsection (a) shall become effective on the first day of the thirteenth month after the month in which it is enacted, except that the Secretary of Health, Education, and Welfare may postpone such effective date for such additional period as he finds necessary, but not beyond the the first day of the 19th month after such month in which the amendment is enacted.

(c) This section may be cited as the "Clinical Laboratories Improvement Act of 1967".

VOLUNTEER SERVICES

SEC. 6. Title II of the Public Health Service Act is amended by adding after section 222 (42 U.S.C. 217a) the following new section:

"VOLUNTEER SERVICES

"SEC. 223. Subject to regulations, volunteer and uncompensated services may be accepted by the Secretary, or by any other officer or employee of the Department of Health, Education, and Welfare designated by him, for use in the operation of any health care facility or in the provision of health care."

COOPERATION AS TO MEDICAL CARE FACILITIES AND RESOURCES

SEC. 7. Part C of title III of the Public Health Service Act is amended by adding after section 327 (42 U.S.C. 254) the following new section:

"SHARING OF MEDICAL CARE FACILITIES AND RESOURCES

"SEC. 328. (a) For purposes of this section

"(1) the term 'specialized health resources' means health care resources (whether equipment, space, or personnel) which, because of cost, limited availability, or unusual nature, are either unique in the health care community or are subject to maximum utilization only through mutual use; "(2) the term 'hospital', unless otherwise specified, includes (in addition to other hospitals) any Federal hospital.

"(b) For the purpose of maintaining or improving the quality of care in Public Health Service facilities and to provide a professional environment therein which will help to attract and retain highly qualified and talented health personnel, to encourage mutually beneficial relationships between Public Health Service facilities and hospitals and other health facilities in the health care community, and to promote the full utilization of hospitals and other health facilities and resources, the Secretary may

"(1) enter into agreements or arrangements with schools of medicine, and with other health schools, agencies, or institutions, for such interchange or cooperative use of facilities and services on a reciprocal or reimbursable basis, as will be of benefit to the training or research programs of the participating agencies; and

"(2) enter into agreements or arrangements with hospitals and other health care facilities for the mutual use or the exchange of use of specialized health resources, and providing for reciprocal reimbursement.

Any reimbursement pursuant to any such agreement or arrangement shall be based on charges covering the reasonable cost of such utilization, including normal depreciation and amortization costs of equipment. Any proceeds to the Government under this subsection shall be credited to the applicable appropriation of the Public Health Service for the year in which such proceeds are received."

PROGRAM EVALUATION

SEC. 8. (a) Paragraph (1) of section 314 (d) of the Public Health Service Act is amended by inserting before the period at the end thereof the following: “, except that, for any fiscal year ending after June 30, 1968, such portion of such sums as the Secretary may determine, but not exceeding 1 per centum thereof, shall be available to the Secretary for evaluation (directly or by grants or contracts) of the programs authorized by this subsection and the amount available for allotments hereunder shall be reduced accordingly".

(b) Section 314(e) of such Act is amended by inserting at the end thereof the following new sentence: "For any fiscal year ending after June 30, 1968, such portion of the appropriations for grants under this subsection as the Secretary may determine, but not exceeding one per centum thereof, shall be available to the Secretary for evaluation (directly or by grants or contracts) of the program authorized by this subsection."

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(c) Section 309 (c) of such Act is amended by inserting (1)" after "except that" and by inserting before the period at the end thereof the following: ", and (2) for any fiscal year ending after June 30, 1968, such portions of the funds made available under this subsection as the Secretary may determine, but not exceeding 1 per centum thereof, shall be available to the Secretary for evaluation (directly or by grants or contracts) of the program authorized by this subsection".

RESEARCH CONTRACT AUTHORITY

SEC. 9. Paragraph (h) of section 301 of the Public Health Service Act (42 U.S.C. 241) is amended by striking out "during the fiscal year ending June 30, 1966, and each of the two succeeding fiscal years".

MEDICAL CARE FOR FEDERAL EMPLOYEES AT REMOTE STATIONS OF THE SERVICE

SEC. 10. (a) Section 324 of the Public Health Service Act (42 U.S.C. 251) is amended by inserting "(a)" immediately after "SEC. 324." and by redesignating clauses (a) through (d) of such section, and references thereto, as clauses (1) through (4).

(b) Section 324 of such Act is further amended by adding at the end thereof the following new subsection:

"(b) At remote medical facilities of the Public Health Service where other medical care and treatment are not available, the Secretary is authorized to provide medical, surgical, and dental treatment and hospitalization for Federal employees (as defined in section 8901(1) of title 5 of the United States Code) and their dependents. Such employees and their dependents who are not entitled to this care and treatment under any other provision of law shall be charged for it at rates established by the Secretary to reflect the reasonable cost of providing the care and treatment. Any payments pursuant to the preceding sentence shall be credited to the applicable appropriation to the Public Health Service for the year in which such payments are received."

(c) Subsection (a) of section 322 of such Act is amended by striking out paragraph (7) and by renumbering paragraph (8) as paragraph (7).

MINOR OR TECHNICAL AMENDMENTS

SEC. 11. (a) Section 806 (c) (1) of the Public Health Service Act (42 U.S.C. 296e(c) (1)) is amended by inserting after "from a loan fund established pursuant to section 822" the following: "or from sums paid by the Secretary from the revolving fund created by section 827 (d)".

(b) The second sentence of section 312 of such Act (42 U.S.C. 244) is amended by inserting "and officials of other State or local public or private agencies, institutions, or organizations" after “such health authorities".