Health Research Extension Act of 1985

The Health Research Extension Act of 1985 (HREA) provides the legislative mandate for the PHS Policy. It was signed into law by the 99th U.S. Congress with the purpose to “amend the Public Health Service Act to revise and extend the authorities under that Act relating to the National Institutes of Health and National Research Institutes, and for other purposes.” (Pub. L. 99-158) Among other things, it instructs the Secretary of the U.S. Department of Health and Human Services (through the NIH Director) to establish a plan for the care and use of animals in biomedical and behavioral research relating to the NIH. This requirement is met in the 1986 edition of the PHS Policy and subsequent revisions. Scroll down to the blue title banner to view an excerpt of the HREA. This excerpt can also be found in the PHS Policy, and the complete legal text is available online from the U.S. Government Printing Office. The Public Health Service Act (PHSA), as amended, contains language added by the HREA in 42 U.S. Code Subchapter III.   HREA full text PHSA amendment full text

 

Excerpt From the Health Research Extension Act of 1985

Public Law 99-158

November 20, 1985, "Animals in Research"

Sec. 495.

(a) The Secretary, acting through the Director of NIH, shall establish guidelines for the following: 

• "(1) The proper care of animals to be used in biomedical and behavioral research.
  
  "(2) The proper treatment of animals while being used in such research. Guidelines under this paragraph shall require-
   
  • "(A) the appropriate use of tranquilizers, analgesics, anesthetics, paralytics, and euthanasia for animals in such research; and
    
    "(B) appropriate pre-surgical and post-surgical veterinary medical and nursing care for animals in such research.

Such guidelines shall not be construed to prescribe methods of research. 

• "(3) The organization and operation of animal care committees in accordance with subsection (b).

• "(b) (1) Guidelines of the Secretary under subsection (a)(3) shall require animal care committees at each entity which conducts biomedical and behavioral research with funds provided under this Act (including the National Institutes of Health and the national research institutes) to assure compliance with the guidelines established under subsection (a).

• "(2) Each animal care committee shall be appointed by the chief executive officer of the entity for which the committee is established, shall be composed of not fewer than three members, and shall include at least one individual who has no association with such entity and at least one doctor of veterinary medicine.
  
  "(3) Each animal care committee of a research entity shall-
   
  • "(A) review the care and treatment of animals in all animal study areas and facilities of the research entity at least semiannually to evaluate compliance with applicable guidelines established under subsection (a) for appropriate animal care and treatment;
    
    "(B) keep appropriate records of reviews conducted under sub-paragraph (A); and
    
    "(C) for each review conducted under subparagraph (A), file with the Director of NIH at least annually (i) a certification that the review has been conducted, and (ii) reports of any violations of guidelines established under subsection (a) or assurances required under paragraph (1) which were observed in such review and which have continued after notice by the committee to the research entity involved of the violations.

Reports filed under subparagraph (C) shall include any minority views filed by members of the committee.

"(c) The Director of NIH shall require each applicant for a grant, contract, or cooperative agreement involving research on animals which is administered by the National Institutes of Health or any national research institute to include in its application or contract proposal, submitted after the expiration of the twelve-month period beginning on the date of enactment of this section-  

• "(1) assurances satisfactory to the Director of NIH that-
   
  • "(A) the applicant meets the requirements of the guidelines established under paragraphs (1) and (2) of subsection (a) and has an animal care committee which meets the requirements of subsection (b); and
    
    "(B) scientists, animal technicians, and other personnel involved with animal care, treatment, and use by the applicant have available to them instruction or training in the humane practice of animal maintenance and experimentation, and the concept, availability, and use of research or testing methods that limit the use of animals or limit animal distress; and
  
  
  "(2) a statement of the reasons for the use of animals in the research to be conducted with funds provided under such grant or contract.

Notwithstanding subsection (a)(2) of section 553 of title 5, United States Code, regulations under this subsection shall be promulgated in accordance with the notice and comment requirements of such section.

"(d) If the Director of NIH determines that-
 

• "(1) the conditions of animal care, treatment, or use in an entity which is receiving a grant, contract, or cooperative agreement involving research on animals under this title do not meet applicable guidelines established under subsection (a);
  
  "(2) the entity has been notified by the Director of NIH of such determination and has been given a reasonable opportunity to take corrective action; and
  
  "(3) no action has been taken by the entity to correct such conditions;

the Director of NIH shall suspend or revoke such grant or contract under such conditions as the Director determines appropriate.

"(e) No guideline or regulation promulgated under subsection (a) or (c) may require a research entity to disclose publicly trade secrets or commercial or financial information which is privileged or confidential."