Humane Care and Development of Substitutes for Animals in Research Act

(Reported to House from the Committee on Science and Technology with amendments, H. Rept. 97-777 (Part I))

Humane Care and Development of Substitutes for Animals in Research Act - Title I: Development of Improved Research and Testing Methods - Authorizes the Secretary of Health and Human Services to make awards to sponsor research and development of scientific testing methods which eliminate the use of live animals, reduce the number of live animals required, or limit animal pain and distress. Requires that applications and proposals for such awards be assessed through peer review procedures.

Requires the Secretary to designate an Advisory Panel to: (1) give advice on his or her responsibilities under this Act; (2) make recommendations on specific opportunities or problems regarding research support of nonanimal testing; and (3) set up a system for insuring that applications or proposals meeting the requirements of this title receive full consideration for funding by the Department of Health and Human Services (Department) or for funding under this title.

Makes funds for making awards under this title available through the allocation of research resources within the Department.

Provides that the Secretary, consulting with the Environmental Protection Agency and other regulatory and scientific research agencies, shall direct the National Institutes of Health, the Food and Drug Administration, and the National Toxicology Program to: (1) promote new nonanimal testing methods; (2) evaluate existing nonanimal methods; (3) develop new methodologies for the toxicology data systems; and (4) enhance and integrate data systems or more efficient use of test data involving animals.

Requires the Secretary to report to the Speaker of the House of Representatives and the President of the Senate on progress under this Act, within two years after enactment of this Act and biennially thereafter.

Title II: Federal Award Requirements - Requires that a research entity be accredited by a recognized accrediting agency in order to be eligible to receive a Federal award for testing involving a large number of animals.

Requires the Secretary to designate accrediting agencies, which: (1) are able to ascertain the qualifications of research entities to conduct testing involving animals; (2) have an accreditation system; (3) have a system for routine inspection of laboratory animal facilities at accredited research entities; (4) have established a set of standards for acceptable animal care, treatment, and use in experimental procedures; and (5) have established a mechanism for liaison with the institutional animal studies committees in accredited research entities and for the involvement of such committees in monitoring compliance with the accreditation standards.

Requires research entities to comply with accreditation standards ten years after the date of enactment of this Act. Authorizes provisional accreditation in the interim period.

Provides for the establishment of a Federal accreditation mechanism, if there are no private agencies to carry out such functions.

Provides that in order to be eligible for a Federal award for testing involving large numbers of animals, a research entity must provide to the responsible Federal agency a statement of assurances that: (1) the research entity has established an institutional animal studies committee; (2) the committee will meet regularly, make periodic inspections of all animal study areas and facilities of the research entity, review research methods and practices, and file with the responsible Federal agency certification that such inspections and reviews have occurred and reports on deficient animal care or treatment conditions; (3) the committee will maintain complete records of its activities; (4) committee members will be encouraged to notify the Animal and Plant Health Inspection Service of the Department of Agriculture, the responsible Federal agency, and the applicable accrediting agency of any unacceptable animal care conditions with respect to the research entity; and (5) the committee will establish courses, for personnel involved with animal care and use, on humane animal maintenance and experimentation and on research or testing methods that minimize animal use and animal distress.

Requires that Federal support be withheld where animal care conditions are unacceptable despite notification to the research entity.

Requires research entities to inform their employees of the provisions under this title and to instruct employees to report violations to the animal studies committee.

Authorizes the Secretary to waive accreditation requirements under certain circumstances.

Directs the Secretary to facilitate agency compliance with this title through the establishment of an information clearinghouse on animal research methods and models.

Title III: Special Procedures - Prohibits Federal agency approval of a research proposal involving animal use, unless such proposal justifies any anticipated animal distress in terms of research benefits and provides for the consulting services of a veterinarian, the proper use of tranquilizers, analgesics, anesthetics, and paralytics, appropriate pre- and postsurgical care, and the limited use of animals in major operations.

Makes regulations promulgated under this Act ineffective if disapproved by either House of Congress within 60 days after proposal.

Title IV: Exemption - Exempts from the requirements of this Act: (1) activities intended to improve animal health, breeding, or management or wild animal conservation; and (2) specific experiments or research programs for which such requirements would present national security risks or risks to the safety of manned space flight.

Title V - Terminates all authority conferred by this Act ten years after enactment.