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ARTICLE H.38. ANIMAL WELFARE



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ARTICLE H.38. ANIMAL WELFARE


All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy).  The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm
 

 In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set forth in the Vertebrate Animal Section (VAS) of the contractor's technical proposal, as modified in the Final Proposal Revision (FPR), dated            ,  which is incorporated by reference.



262

****(USE BELOW AS REQUIRED.

ADDITIONAL INFORMATION ABOUT THIS ITEM:

  1. First sentence:  Insert the appropriate I/C and contract number in each text box.

  2. Fifth sentence:   Insert the appropriate I/C in the text box.)****

ARTICLE H.39. INTRODUCTION OF RODENTS AND RODENT PRODUCTS


No rodent or rodent product shall be delivered into the NIH,       environment (NIH) directly, or through collaborative research or holding facilities under contract to       except by permit. Direct shipments to NIH from a Division of Veterinary Resources (DVR), Office of Research Services (ORS) approved source will be considered exempt. Non-exempt sources must be approved by permit issued through the DVR, ORS. The permit must be obtained by the Contractor prior to the shipment to NIH of the rodents and/or rodent products. The Contractor must be sure that this permit exists and is current before transferring rodents or rodent products into the NIH,       environment. Refusal or negligence to do so will be considered a material breach of contract and may be treated as any other such material breach. Applications for permits should be submitted by facsimile not less than 30 days prior (60 days in situations where quarantine is likely) to shipping date to: NIH Division of Veterinary Resources (DVR), Office of Research Services (ORS), Building 14G, Service Rd. South, Room 102, BETHESDA MD 20892-5210, (301)496-2527, FAX: (301) 402-0352.

263

****(FOR NIEHS USE ONLY, AS REQUIRED.)****

ARTICLE H.40. INTRODUCTION OF RODENTS AND RODENT PRODUCTS - NIEHS


No rodent or rodent product shall be delivered to NIEHS directly or through collaborative research or holding facilities under contract to NIEHS except by prior approval by the Comparative Medicine Branch, NIEHS.  The approval form, Application to Introduce Rodents and Rodent Products into NIEHS, is available by contacting the Comparative Medicine Branch, Quality Assurance Laboratory at 919-541-3239.  Approval must be obtained by the Contractor prior to shipment to NIEHS of the rodents and/or rodent products.  The Contractor must be sure that this approval exists and is current before transferring rodents or rodent products into the NIEHS.  Refusal or negligence to do so will be considered a material breach of contract and may be treated as any other such material breach.  Requests for approval should be submitted within 30 days of the shipping date to: NIEHS, Comparative Medicine Branch, Quality Assurance Laboratory, PO Box 12233, MD C1-06, Building 101, Room C128, Research Triangle Park, NC, 27709.  United States Department of Agriculture permits are required for the importation of monoclonal antibodies, hybridoma cell lines, cell cultures, and other biologic materials that have been in contact with material of animal origin.  USDA permit forms and information are available online ( http://www.aphis.usda.gov/permits/ ).  A copy of the completed permit form should be submitted to the Comparative Medicine Branch.

264

****(USE BELOW, WHEN THE CONTRACT WILL INCLUDE RESEARCH INVOLVING NON HUMAN PRIMATES.)****

ARTICLE H.41. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES


All Contractor personnel who work with nonhuman primates or enter rooms or areas containing nonhuman primates shall comply with the procedures set forth in NIH Policy Manual 3044-2, entitled, "Protection of NIH Personnel Who Work with Nonhuman Primates," located at the following URL:

http://oma.od1.nih.gov/manualchapters/intramural/3044-2/


265

****(USE BELOW ONLY IF OER, OLAW HAS GRANTED APPROVAL TO AWARD TO A CONTRACTOR NOT CURRENTLY COVERED BY AN APPROPRIATE ANIMAL WELFARE ASSURANCE AND VALID INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) APPROVAL. THE FOLLOWING MUST BE INCLUDED IN ANY CONTRACT RECEIVING THIS CONDITIONAL PREAWARD APPROVAL FROM OLAW.

ADDITIONAL INFORMATION TO COMPLETE THIS ARTICLE:

  • Select and/or remove the approval required from the choices in the brackets, as appropriate.)****

ARTICLE H.42. RESTRICTION FROM USE OF LIVE VERTEBRATE ANIMALS


UNDER GOVERNING POLICY, FEDERAL FUNDS ADMINISTERED BY THE PUBLIC HEALTH SERVICE (PHS) SHALL NOT BE EXPENDED FOR RESEARCH INVOLVING LIVE VERTEBRATE ANIMALS WITHOUT PRIOR APPROVAL BY THE OFFICE OF LABORATORY ANIMAL WELFARE (OLAW), OF [ AN ANIMAL WELFARE ASSURANCE THAT COMPLIES WITH THE PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS AND/OR A VALID INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC) APPROVAL ]. THIS RESTRICTION APPLIES TO ALL PERFORMANCE SITES (e.g. COLLABORATING INSTITUTIONS, SUBCONTRACTORS, SUBGRANTEES) WITHOUT OLAW-APPROVED ASSURANCES, WHETHER DOMESTIC OR FOREIGN.

266

****(USE BELOW, AS NECESSARY.)****

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