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PUBLIC LAW 90-174-DEC. 5, 1967 COOPERATION W I T H STATES I N

58 Stat. 6 9 3; 80 Stat. 1190.

Reimbursement of U.S.

[81 STAT.

EMERGENCIES

SEC. 4. Section 311 of the Public Health Service Act (42 TJ.S.G. 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. H e 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 I ] M P R 0 V E M E N T

Clinical Laboratories Improvement Act of 1967. 58 Stat. 702.

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: "LICEN'STNG—BIOLOGICAL P R O D U C T S A N D C L I N I C A L LABORAT O R I E S ", and by adding after section 352 (42 U.S.C. 263) the following new section: "LICENSING OF

"Laboratory, * " c l i n i c a l laboratory."

"Interstate commerce."

Exemption.

Standards.

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 providing 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 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. " (b)(1) No person may solicit or accept in interstate commerce, directly or indirectly, any specimen for laboratory examination or other laboratory procedures, unless there is in effect a license for such laboratory issued by the Secretary under this section applicable to such procedures. "(2) The Secretary shall by regulation exempt from the provisions of this section laboratories whose operations are so small or infrequent as not to constitute a significant threat to the public health. "(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 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. Such standards shall be designed to assure consistent performance by the laboratories

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