Chapter 9 Institutions (constitution 1996)

[Henrietta Naughton]

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-

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.

"(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."

The development of knowledge necessary for the improvement of the health and well-being of humans as well as other animals requires in vivo experimentation with a wide variety of animal species. 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.

The Assurance shall fully describe the institution's program for the care and use of animals in PHS-conducted or supported activities. The PHS requires institutions to use the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for developing and implementing an institutional program for activities involving animals.2 The program description must include the following:

Category 1 - Accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). All of the institution's programs and facilities (including satellite facilities) for activities involving animals have been evaluated and accredited by AAALAC, or another accrediting body recognized by the PHS.4 All of the institution's programs and facilities (including satellite facilities) for activities involving animals have also been evaluated by the IACUC and will be reevaluated by the IACUC at least once every six months, in accordance with IV.B.1. and 2. of this Policy, and reports prepared in accordance with IV.B.3.of this Policy.

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

Noncompeting applications and contract proposals for other than full and open competitions need not repeat the information required by IV.D.1.a.-e. if the information was complete in the last competing application or proposal and there are no significant changes to that information. However, the application or proposal must contain a statement to that effect. If there are significant changes in the information, then the application or proposal must specifically identify them and state the reasons for the changes.

Applications or proposals (competing and noncompeting) covered by this Policy from institutions that have an approved Assurance on file with OLAW shall include verification of approval (including the date of the most recent approval) by the IACUC of those components related to the care and use of animals. For competing applications or proposals only, such verification may be filed at any time prior to award unless specifically required earlier by the funding component. If verification of IACUC approval is submitted subsequent to the submission of the application or proposal, the verification shall state the modifications, if any, required by the IACUC. The verification shall be signed by an individual authorized by the institution, but need not be signed by the Institutional Official.

For applications and proposals covered by this Policy from institutions that do not have an approved Assurance on file with OLAW, the signature of the official signing for the applicant organization shall constitute a declaration that the institution will submit an Assurance when requested by OLAW. Upon such request, the institution shall prepare the Assurance as instructed by OLAW and in accordance with IV.A. of this Policy. The authorized IACUC shall review those components of the application or proposal as required by IV.C. of this Policy. Upon IACUC approval of those components of the application or proposal, the institution shall submit the Assurance to OLAW.

Each awardee institution is subject to review at any time by PHS staff and advisors, which may include a site visit, to assess the adequacy or accuracy of the institution's compliance or expressed compliance with this Policy.

Institutions may request a waiver of a provision or provisions of this Policy by submitting a request to OLAW. No waiver will be granted unless sufficient justification is provided and the waiver is approved in writing by OLAW.

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 the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement of this Policy.

The name Institutional Animal Care and Use Committee (IACUC) as used in this Policy is intended as a generic term for a committee whose function is to ensure that the care and use of animals in PHS-conducted or supported activities are appropriate and humane in accordance with this Policy. However, each institution may identify the committee by whatever name it chooses.

The Health Research Extension Act of 1985 requires the IACUC to be appointed by the Chief Executive Officer (CEO) of the entity for which the committee is established. OLAW considers the CEO to be the highest operating official of the organization (such as the President of a University). If the CEO delegates authority to appoint the IACUC then the delegation must be specific and in writing. The CEO may or may not be the Institutional Official as defined by this Policy (see definition at III.G.).

Institutions may, at their discretion, represent the names of members other than the chairperson and veterinarian with program authority (see IV.A.3.) by using numbers or other symbols in submissions to OLAW. Sufficient information for OLAW to determine that all appointees are appropriately qualified must be provided. The identity of each member must be readily ascertainable by the institution and available to authorized OLAW or other PHS representatives upon request.

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 regulations (9 CFR, Subchapter A) issued by USDA under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement of this Policy.

The IACUC may, at its discretion, determine the best means of conducting an evaluation of the institution's programs and facilities. The IACUC may invite ad hoc consultants to assist in conducting the evaluation. However, the IACUC remains responsible for the evaluation and report.

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. The Guide may differ from USDA regulations in some respects. Compliance with applicable USDA regulations is an absolute requirement of this Policy.

Sec. 17a-90. (Formerly Sec. 17-32). Supervision over welfare of children. Portion of cost payable by parent, collection. (a) The Commissioner of Children and Families shall have general supervision over the welfare of children who require the care and protection of the state.

(b) The Commissioner of Children and Families shall furnish protective services or provide and pay, wholly or in part, for the care and protection of children other than those committed by the Superior Court whom the commissioner finds in need of such care and protection from the state, and such payments shall be made in accordance with the provisions of subsection (l) of section 46b-129, provided the Commissioner of Administrative Services shall be responsible for billing and collecting such sums as are determined to be owing and due from the parent of the noncommitted child in accordance with section 4a-12 and subsection (b) of section 17b-223.

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