IACUC Exhibitor Submission Form

NPS Institutional Animal Care and Use Committee (IACUC) General Submission, Exhibitor, Annual Review, and Amendment Forms

NPS IACUC Exhibition Form 2-1-2013

IACUC Exhibitor Submission Form (state and local)

OMB: 1024-0265

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OMB Control Number: 1024-0XXX

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United States Department of the Interior

NATIONAL PARK SERVICE

Biological Resource Management Division

Shape2 1201 Oakridge Drive, Suite 200

Fort Collins, CO 80525


INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE


Exhibitor Submission (ES) Form


Exhibition projects involving vertebrate animals in NPS units must be approved by the NPS Institutional Animal Care and Use Committee (NPS IACUC) prior to their commencement. Exhibitors are to submit the completed Exhibitor Submission Form (hereafter ES Form) to the NPS IACUC Office.


Please use Arial font at 12 point to complete the GS Form. Text should be inserted directly in tables and in spaces below questions. For boxes please use your computer mouse and (i) right click, (ii) click on Properties and (iii) change the Default value from not checked to checked .


Please submit the completed ES Form to the NPS IACUC Administrator by pressing “Submit” at the end of the form. If you do not receive an email confirming receipt of your form, please check to ensure we have received the document. You must sign the declaration page, (see appendix A for signature options). An IACUC filing number will be assigned to your completed ES Form. If you are unclear as to what is required to complete the GS Form, please contact (970-267-2145) or [email protected].


YOUR EXHIBITOR SUBMISSION FORM, AND THUS YOUR PROJECT, CANNOT BE APPROVED UNTIL COMPLETE.


The ES Form, and project outlined therein, is valid for the duration of the exhibition event only. Any changes to the project; e.g. in personnel and/or protocol, must be reported to the NPS IACUC immediately. The significance of such changes will be weighed by the NPS IACUC with three possible outcomes: 1.) Insignificant changes will be noted without amendment, 2.) Significant changes not serious enough to warrant de novo resubmission of the project will be noted by official amendment, or 3.) Significant changes deemed particularly serious will warrant a de novo resubmission of the project.







United States Department of the Interior

NATIONAL PARK SERVICE

Biological Resource Management Division

Shape3 1201 Oakridge Drive, Suite 200

Fort Collins, CO 80525


INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE


Check List and Instructions

Don’t forget to check this page before submitting your Assurance Form.


___ PIs should read the appropriate NPS IACUC Module prior to completing the ES form.


___ The ES form is a standalone document. The NPS IACUC will not review outside materials to answer questions left blank on the ES form. Supporting materials may be attached to the ES form, but they cannot substitute for material that must be answered on the ES form.


___ Specific recommendations and guidelines (e.g., Animal Welfare Act Regulations, Guidelines of the American Society of Mammalogists, Guidelines to the Use of Wild Birds in Research, and American Veterinary Medical Association Guidelines on Euthanasia) should be reviewed and referenced in the ES form.


___ Exhibitors must cite scientific literature to verify that all project methods employed are the most refined and best possible methods for their work.


___ The ES form must be signed prior to submission to the NPS IACUC. Please complete the form in Microsoft Word and complete the submission by pressing “Submit” at the end of the form. Signatures of Exhibitors and supervisors may be created via protocols found in the Resources section of the website.


___ If you are unsure of what is required to complete this form, please visit the NPS IACUC web page or contact the IACUC Administrator ([email protected]; 970-267-2145).





United States National Park Service

Institutional Animal Care and Use Committee


Assurance of Animal Care Form


NPS IACUC Use Only


IACUC Number: USDA Classification: C, D, or E

Date Received: Initial Review Date:

IACUC recommendations: Approved: Not Approved:

Date Revisions Received: Initital Approval Date:

IACUC Chair Signature: Date:




Project Title:



Name(s) of Funding Source(s):



Starting Date:



Completion Date:








  1. PERSONNEL


Principal Exhibitor (PE):


E-mail: Phone:


Mailing Address:


Due to the fact the PE may not be on site during the entire project, please designate an alternate, and provide a contact name and phone number in case of emergency, after hours, or if the PE cannot be contacted for time-sensitive decisions or concerns regarding the project. This person must be able to assume responsibility for decisions and/or actions necessary to ensure animal health and welfare in the event of unanticipated problems. If this alternate cannot be contacted, the NPS IACUC (possibly via the USDA APHIS AC) will assume responsibility and take actions deemed necessary to ensure appropriate animal care.


Alternate PE Contact Name:


Email: Phone:























Attending Veterinarian:

The official Attending Veterinarian (AV) of record for all projects is the NPS IACUC AV John A. Bryan, II, DVM, MS. However, due to the vast territory of the NPS, it is impractical to have the official NPS IACUC AV serve as the on-location AV for all projects. In cases such as these, the AWAR (§ 2.33 b 3) provides the NPS IACUC AV with the authority to delegate/share this responsibility with another (other) licensed veterinarian(s) involved in the project. Any delegated veterinarian must hold a current, valid license to practice veterinary medicine in at least one state of the United States, and be in exemplary standing under said licensure. Delegated veterinarians must communicate as needed/requested with/by the NPS IACUC AV regarding veterinary care during the execution of the project. The NPS IACUC AV has the authority to, and may, conduct on-site, field evaluations/inspections of the project.


Yes No

Does this project intend the use of one or more delegated veterinarians in addition to the official NPS IACUC AV?

If yes, then please complete the following, and add additional names as needed:


Name of Delegated Veterinarian (as appears on licensure):


State of Current Licensure:



Email: Phone:



















Personnel Qualifications:


List all personnel involved with the animal components of this exhibition project and their qualifications. At minimum, include the principal exhibitor and co-exhibitor. List all personnel (technicians, graduate and undergraduate students, and volunteers) involved with this work. List their educational background and related qualifications for each task proposed. Repeat name blocks as needed if more than six persons need be identified.


Name: Degree(s):


Role(s) on Project:


Brief Outline of Relevant Experience:


Name: Degree(s):


Role(s) on Project:


Brief Outline of Relevant Experience:


Name: Degree(s):


Role(s) on Project:


Brief Outline of Relevant Experience:


Name: Degree(s):


Role(s) on Project:


Brief Outline of Relevant Experience:






Name: Degree(s):


Role(s) on Project:


Brief Outline of Relevant Experience:


Name: Degree(s):


Role(s) on Project:


Brief Outline of Relevant Experience:




























II. USE OF VERTEBRATE ANIMALS AND PROJECT DETAILS


animal species

(Scientific and Common Name)


Number to be Exhibited


General Location
















































Specific Project Areas: [Please describe the location of your project area]




Animal Housing: [You must describe –in great detail- the holding facilities that you intend to use, the time the animals will spend there, and your animal care protocol. A photograph, drawing, or illustration of the holding facility may help clarify your description.]


Permits: [Identify all permits necessary to conduct this project. Provide permit type(s), number(s), and expiration date(s). Please indicate if a permit application is pending a decision.] You must have a current, valid USDA APHIS exhibitor license to exhibit mammals, and/or state license/permit to exhibit any other species.


Permit Type

Permit Number

Expiration Date

















Purpose of Project:

A) How would you explain the objective(s) of your exhibition? Please explain how this benefits humans, animals, and/or how this project will provide a return of knowledge and understanding applicable to the species exhibited.


B) Justify the following:


Rationale for the use of animals: [Why must animals be exhibited rather than computer models, etc.?]


Appropriateness of species to be used: [Briefly describe the characteristics of the animal species selected that justifies its use in the proposed exhibition.]


Number of animals to be used: [How did you determine the number of animals?]














Animal Use Procedures: Please check either Yes or No, and add any needed information below the appropriate section. Expected information is explained in italics. Some protocols may require information not specifically listed here. Please ensure that all information needed to evaluate your project is provided. If you are planning activities not listed below, please describe all procedures under the section entitled Other.” For boxes please use your computer mouse and (i) right click, (ii) click on Properties and (iii) change the Default value from not checked to checked .


Yes No

Wildlife Capture [Describe equipment used, duration of trapping/restraint, monitoring protocol/schedule for traps, disposition of trapped animals. If anesthesia or immobilization is planned please refer to those sections of this form.]


Yes No

Animal Transportation [Describe how animals are transported. If an animal (live or dead) is to be transported, please describe measures taken to avoid potential disease transmission.]


Yes No

Physical Restraint [Describe method, duration, equipment used, dimensions of equipment if applicable, and observation schedule during confinement. Provide detailed justification and protocol if animals are to be physically restrained for longer than 1 hour at a time.

Yes No

Cleaning Procedures [Please describe the cleaning procedures and frequency of cleaning of any equipment that will be used to capture, transport, contain, etc. animals]


Yes No

Personal Protective Equipment (PPE) [Please describe any and all PPE that will be used by personnel including, gloves, respirators, goggles or faceshields, etc.]

Yes No

Monitoring of Physiological Vital Signs [Describe physiological parameters (e.g., temperature, pulse rate, respiration rate, capillary refill time) to be monitored. Provide protocol for addressing physiological parameters outside of normal ranges (e.g., how do you plan to treat hypothermia?]






Yes No

Marking or Tagging [Describe leg band type (e.g., USGS, colored, alphanumeric code), neck collar (manufacturer & model), transmitter (e.g., VHF, satellite, GPS), passive integrated transponder (PIT) tags, or other devices or methods (e.g., dying feathers or fur) to used. Document why the device or method is not expected to interfere with the behavior, health, or social status of an individual. Provide the mass of attachment device, range of body mass of the study species, device mass as a proportion of body mass, and the recommended device mass as a percent of body mass.]

Yes No

Behavior and observation (without significant restraint) [Describe procedure.]

Yes No

Special Diets [Will food items other than routine husbandry diets be used? If yes, describe diet, duration of use, anticipated nutritional effect, and weight monitoring of animal(s).]


Yes No

Food and Water [Describe duration and frequency per species]

Yes No

Use of Controlled and/or Prescription Substances Irrespective of source, describe arrangements for use, ordering, record keeping, storage, and precautions taken to avoid unauthorized access.


Yes No

Other [Describe any other procedure to be administered not previously addressed.]








If stress to the animal(s) being exhibited is a potential aspect of the event, describe the following:


Methods used to estimate pain/stress:



Measures to alleviate pain/stress:




III. TYPE, FREQUENCY, AND TREATMENT OF INJURIES


Describe the most likely forms of injuries to exhibition animals, how frequent an injury (ies) is (are) expected to occur, and planned procedures to treat injuries. Even if you do not intend or expect to injure an animal, you must describe potential injuries and expected methods of treatment(s).




IV. EUTHANASIA AND DISPOSITION


All methods of euthanasia must follow the American Veterinary Medical Association Panel on Euthanasia Guidelines on Euthanasia (June 2007, 36pp). Any deviations must be scientifically justified. Even if you do not intend to euthanize animals, a method of euthanasia must be listed in cases of emergency.


Describe the method of euthanasia planned. If by chemical agent you must identify the compound and specify the dose (mg/kg) and route of administration. Physical methods (gunshot, captive bolt, cervical dislocation, or decapitation) may be used only after other methods have been excluded and when scientifically justified; e.g. as environmentally advantageous field methods.


Describe the method used to ensure the animal will not revive and method of disposal of remains. Please verify that a university, museum, or other research/educational institution has agreed to accept the remains.




VII. DECLARATION

The information on this Exhibitor Submission Form is an accurate description of my animal care and use protocol(s). All people using animals have been properly trained to use appropriate methods and have read and agree to comply with this protocol. All individuals working under this Assurance will comply with the procedures and methods outlined in The Animal Welfare Act, its Regulations, and the Interagency Research Animal Committee. All work proposed herein is designed in the attempt to avoid discomfort, stress, and pain to the animals.



Principal Exhibitor



_______________________________________________________




Date



___________________________________























UNITED STATES NATIONAL PARK SERVICE

INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE


Assurance of Animal Care Form


Attachment A: Categories of Invasiveness in Animal Experiments


Each year the U.S. Department of Agriculture, Animal and Plant Health Inspection Service requires an annual report from the NPS IACUC in which animal projects are categorized as to degree of invasiveness. Please assist the NPS IACUC in this determination by assigning the animal procedures in your project to one of the categories below. The U.S. Government Principles Regarding the Care and Use of Animals state, “Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.”


1. Experiments which cause little or no discomfort or stress.** (Nil)

Examples: individual or small numbers of animals being confined and maintained in natural habitat that affords an appropriate quantity and quality of food, cover, and water; injection of materials in amounts that will not cause adverse reactions by the following routes: intravenous, subcutaneous, intramuscular, intraperitoneal, or oral, but not intrathoracic or intracardiac (Category 2); acute non-survival studies in which the animals are completely anesthetized and do not regain consciousness; approved methods of euthanasia following rapid unconsciousness such as anesthetic overdose or decapitation; short periods of food and/or water-deprivation equivalent to periods of abstinence in nature.

  1. Experiments which cause minor stress or pain of short duration. (Low)

Examples: cannulation or catheterization of blood vessels or body cavities under anesthesia; minor surgical procedures under anesthesia, such as biopsies or laparoscopy; short periods of restraint beyond that required for simple observation or examination, but consistent with minimal stress; short periods of food and/or water deprivation which exceed period of abstinence in nature; behavioral experiments on conscious animals that involve short-term, stressful restrain; short term exposure to noxious but non-lethal levels of drugs or chemicals. Such procedures should not cause significant changes in the animal’s appearance, in physiological parameters such as respiratory or cardiac rate, or fecal or urinary output, or in social responses.

  1. Experiments which cause moderate to severe stress or discomfort. (Moderate) Examples: major surgical procedures conducted under general anesthesia, with subsequent recovery; prolonged (several hours or more) periods of physical restraint; induction of behavioral stresses such as maternal deprivation, aggression, predator-prey interactions; procedures which cause severe, persistent or irreversible disruption of sensorimotor organization; the use of adjuvants which cause clinically evident swelling or abscesses. Other examples include induction of anatomical and physiological abnormalities that will result in pain or distress; the exposure of an animal to noxious stimuli from which escape is impossible; exposure to drugs or chemicals at levels that impair physiological systems. Note: procedures used in Category 3 studies should not cause prolonged or severe clinical distress as may be exhibited by a wide range of clinical signs, such as marked abnormalities in behavioral patterns or attitudes, the absence of grooming, dehydration, abnormal vocalization, prolonged anorexia, circulatory collapse, extreme lethargy or disinclination to move, and clinical signs of severe or advanced local or systemic infection, etc..


4 Procedures which cause severe pain near, at, or above the pain tolerance threshold of unanesthetized conscious animals. (High)

Examples: exposure to noxious stimuli or agents whose effects are unknown; exposure to drugs or chemicals at levels that (may) markedly impair physiological systems and which cause death, severe pain, or extreme distress: completely new biomedical experiments which have a high degree of invasiveness; behavioral studies about which the effects of the degree of distress are not known; use of muscle relaxants or paralytic drugs without anesthetics; burn or trauma infliction on unanesthetized animals, a euthanasia method not approved by the American Veterinary Medical Association; any procedures (e.g., the injection of noxious agents or the induction of severe stress or shock) that will result in pain which approaches the pain tolerance threshold and cannot be relieved by analgesia (e.g., when toxicity testing and experimentally-induced infectious disease studies have death as the endpoint).











I have read and understand the above Categories of Invasiveness in Animal Experiments:

















The U.S.D.A. Annual Report requires the NPS IACUC to report the number of animals used by or under control in each of the following categories:


(A) Number of animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes.


(B) Number of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain-relieving drugs.


(C) Number of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.


(D) Number of animals upon which teaching experiments, research, surgery or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests (An explanation of the procedures producing pain or distress in these animals and the reasons such drugs were not used must be attached to this report.


One of these categories will be assigned and approved by the NPS IACUC and recorded on the approval letter sent to the principal investigator of each project.






I have read and understand the above USDA APHIS AC Categories:






Paperwork Reduction Act Statement: The National Park Service is authorized by the Animal Welfare Act Regulations (7 U.S.C. 2131-2159;§2.31, d, 1) to collect this information for the purposes of reviewing activities related to the care and use of animals and to approve all research, teaching, and exhibition activities involving vertebrate animals on NPS managed lands and territories. Your response to this request is mandatory in order to conduct research involving vertebrate animals on NPS managed lands and territories. The time to complete this form is estimated to be 3 hours per response. A Federal agency may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB Control Number. You may send comments concerning the burden estimates or any aspect of this information collection to: John A. Bryan, II, DVM, NPS IACUC Chair and Attending Veterinarian, National Park Service, 1201 Oakridge Drive, Suite 200, Fort Collins, CO 80525.



**** The text of these categories has been freely adapted from a document originally published by the Canadian Council on Animal Care (CCAC).

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