PHS Policy section IV.A. PHS Policy on Humane Care and Use of Laboratory Animals (Policy) requires institutions to establish and maintain proper measures to ensure the appropriate care and use of live vertebrate animals involved in biomedical and behavioral research testing or training activities conducted or supported by the PHS. Each institution receiving PHS funding is required to file an Animal Welfare Assurance Statement to the Office of Laboratory Animal Welfare (OLAW) and the National Institute of Health (NIH) for approval. In order to approve proposed research projects or proposed significant changes in ongoing research projects, the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed research projects are in accordance with this Policy. Should institutions apply the PHS Policy to all animal activities regardless of the source of funding? Category 2 - Evaluated by the Institution. at least once every three years. 2131 et seq. If the IACUC suspends an activity involving animals, the Institutional Official in consultation with the IACUC shall review the reasons for suspension, take appropriate corrective action, and report that action with a full explanation to OLAW. All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated by the IACUC. The Assurance Statement indicates that the institution is committed to compliance with standards detailed in the Animal Welfare Act, the NIH Guide for the Care and Use of Laboratory Animals, and all other applicable laws and regulations. At least once every 12 months, the IACUC, through the Institutional Official, shall report in writing to OLAW: a. any change in the institution's program or facilities that would place the institution in a different category than specified in its Assurance (see IV.A.2.of this Policy); b. any change in the description of the institution's program for animal care and use as required by IV.A.1.a.-i. All institutions that accept PHS funding. The reports must distinguish significant deficiencies from minor deficiencies. OLAW may limit the period during which any particular approved Assurance shall remain effective or otherwise condition, restrict, or withdraw approval. In the U.S., the federal Animal Welfare Act (AWA) and the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) regulate the use of laboratory animals. Institutions That Do Not Have an Approved Assurance. The reports shall be maintained by the institution and made available to OLAW upon request. Unlike the USDA AWA regulations, PHS Policy applies to which animals? The IACUC shall conduct continuing review of each previously approved, ongoing activity covered by this Policy at appropriate intervals as determined by the IACUC, including a complete review in accordance with IV.C.1.-4. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. The IACUC may, at its discretion, determine the best means of conducting an evaluation of the institution's programs and facilities. Whenever U.S. Government agencies develop requirements for testing, research, or training procedures involving the use of vertebrate animals, the following principles shall be considered; and whenever these agencies actually perform or sponsor such procedures, the responsible Institutional Official shall ensure that these principles are adhered to: *For guidance throughout these Principles, the reader is referred to the Guide for the Care and Use of Laboratory Animals prepared by the Institute of Laboratory Animal Resources, National Academy of Sciences. This Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals and that they comply with the applicable regulations (9 CFR, Subchapter A) issued by USDA under the Animal Welfare Act. This reprint includes the Health Research Extension Act of 1985, Public Law 99-158, “Animals in Research” (November 20, 1985), which provides the statutory mandate for the PHS Policy. (5) A change in format, but not content, was made to PHS Policy IV.B.3. d. The living conditions of animals will be appropriate for their species and contribute to their health and comfort. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. "(1) The proper care of animals to be used in biomedical and behavioral research. Available at https://www.avma.org/KB/Policies/Documents/euthanasia.pdf. The Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy) applies to activities supported by any PHS agency. The use of laboratory animals is one of the most regulated uses of animals in the United States, and other countries as well. The PHS Policy is applicable to all PHS- supported activities involving animals, whether the activities are performed at a PHS agency, an awardee institution, or other institution (PHS Policy at I., II., III., and V.B. of this Policy; 7. review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities; and. 85-12059]. OLAW: Office of Laboratory Animal Welfare, Site Search | Site Index | Feedback | Staff Directory, For guidance on maintaining continuity of research and sponsored program activities during the COVID-19 crisis, please see ORSP’s, Research, Scholarship, Innovation, and Creativity, Office of Laboratory Animal Welfare (OLAW), Public Health Service Policy on Humane Care and Use of Laboratory Animals, OLAW: Office of Laboratory Animal Welfare, Chapter 4 - UM Institutional Animal Care and Use Committee ›. Intramural and extramural laboratories run by the Public Health Service (including NIH itself, the Food and Drug Administration, and the Centers for Disease Control and Prevention) (6) The verification shall be signed by an individual authorized by the institution, but need not be signed by the Institutional Official. These questions and answers provide guidance for institutions and IACUCs as they implement the PHS Policy. All Assurances submitted to the PHS in accordance with this Policy will be evaluated by OLAW to determine the adequacy of the institution's proposed program for the care and use of animals in PHS-conducted or supported activities. OLAW is responsible for the general administration and coordination of this Policy and will: PHS awarding units may not make an award for an activity involving animals unless the prospective awardee institution and all other participating institutions have approved Assurances on file with OLAW, and unless the awardee institution has provided verification of approval by the IACUC of those components of the application or proposal related to the care and use of animals. • Office of Laboratory Animal Welfare (OLAW) is responsible for administration of the PHS Policy It is the Policy of the Public Health Service (PHS) to require institutions to establish and maintain proper measures to ensure the appropriate care and use of all animals involved in research, research training, and biological testing activities (hereinafter referred to as "activities") conducted or supported by the PHS. Surgical or other painful procedures should not be performed on unanesthetized animals paralyzed by chemical agents. 4. I. APPLICABILITY OF ASSURANCE . 3. PHS Policy ____ an occupational health and safety program for PHS-assured institutions. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. As an agent of the institution, the IACUC shall with respect to PHS-conducted or supported activities: Applications and proposals (competing and noncompeting) for awards submitted to the PHS that involve the care and use of animals shall contain the following information: a. identification of the species and approximate number of animals to be used; b. rationale for involving animals, and for the appropriateness of the species and numbers used; c. a complete description of the proposed use of the animals; d. a description of procedures designed to assure that discomfort and injury to animals will be limited to that which is unavoidable in the conduct of scientifically valuable research, and that analgesic, anesthetic, and tranquilizing drugs will be used where indicated and appropriate to minimize discomfort and pain to animals; and. 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