3040-2 Animal Care and Use in the Intramural Program

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| PROPOSAL \# [.]{.underline}                                           |
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| APPROVAL DATE [.]{.underline}                                         |
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| EXPIRATION DATE [.]{.underline}                                       |
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PLEASE TYPE:

A.  **ADMINISTRATIVE DATA:**

> Institute or Center      
>
> Principal Investigator      
>
> Building/Room       Telephone       Fax      
>
> Division, Laboratory, or Branch      
>
> Project Title      

Initial Submission Renewal or Modification of Proposal Number      

List the names of all individuals authorized to conduct procedures
involving animals under this proposal and identify key personnel (i.e.,
Co-investigator(s))

>      

B.  **ANIMAL REQUIREMENTS:**

Species       Age/Weight/Size       Sex      

Stock or Strain      

Source(s)       Holding Location(s)      

Animal Procedure Location(s)      

**Number of Animals to Be Used:**

  ---------------- ---------------- ---------------- ------- --------------
  **     **        **     **        **     **                **     **

  Year 1           Year 2           Year 3           **=**   TOTAL
  ---------------- ---------------- ---------------- ------- --------------

C.  **TRANSPORTATION:\
    **Transportation of animals must conform to all NIH and Facility
    guidelines/policies. If animals will be transported between
    facilities, describe the methods and containment to be utilized. If
    animals will be transported within the Clinical Center, also include
    the route and elevator(s) to be utilized.

>      

D.  **STUDY OBJECTIVES:\
    **Briefly explain in non-technical terms the aim of the study and
    why the study is important.

>      

E.  **RATIONALE FOR ANIMAL USE:\
    **1) Explain your rationale for animal use. 2) Justify the
    appropriateness of the species selected. 3) Justify the number of
    animals to be used. (Use additional sheets if necessary.)

>      

F.  **DESCRIPTION OF EXPERIMENTAL DESIGN AND ANIMAL PROCEDURES:\
    **Briefly explain the experimental design and specify all animal
    procedures. This description should allow the ACUC to understand the
    experimental course of an animal from its entry into the experiment
    to the endpoint of the study. Specifically address the following:\
    *(Use additional sheets if necessary.)*

> • **Injections** **or Inoculations** (substances, e.g., infectious
> agents, adjuvants, etc.; dose, sites, volume, route, and schedules)
>
> **• Blood Withdrawals** (volume, frequency, withdrawal sites, and
> methodology)
>
> • **Non-Survival Surgical Procedures** (Provide details of survival
> surgical procedures in Section G.)
>
> • **Radiation** (dosage and schedule)
>
> • **Methods of Restraint** (e.g., restraint chairs, collars, vests,
> harnesses, slings, etc.)
>
> **• Animal Identification Methods** (e.g., ear tags, tattoos, collar,
> cage card, etc.)
>
> • **Other Procedures** (e.g., survival studies, tail biopsies, etc.)
>
> • **Resultant Effects**, if any, the animals are expected to
> experience (e.g., pain or distress, ascites production, etc.)
>
> • **Experimental Endpoint Criteria** (i.e., tumor size, percentage
> body weight gain or loss, inability to eat or drink, behavioral
> abnormalities, clinical symptomatology, or signs of toxicity) must be
> specified when the administration of tumor cells, biologics,
> infectious agents, radiation or toxic chemicals are expected to cause
> significant symptomatology or are potentially lethal. List the
> criteria to be used to determine when euthanasia is to be performed.
> Death as an endpoint must always be scientifically justified.
>
>      

G.  **SURVIVAL SURGERY ---** If proposed, complete the following:

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1.  Identify and describe the surgical procedure(s) to be performed.
    Include the aseptic methods to be utilized. *(Use a**dditional
    sheets if necessary.):*

>      

2.  Who will perform surgery and what are their qualifications and/or
    experience?

>      

3.  Where will surgery be performed (Building and Room)?

>      

4.  Describe post-operative care required and identify the responsible
    individual:

>      

5.  Has major survival surgery been performed on any animal prior to
    being placed on this study? \
    Yes No

> If yes, please explain:      

6.  Will more than one major survival surgery be performed on an animal
    while on this study?\
    Yes No

> If yes, please justify:      

**H. PAIN OR DISTRESS CATEGORY ---** The ACUC is responsible for
applying U.S. Government Principle IV. Contained in Appendix 3: \"Proper
use of animals, including the avoidance or minimization of discomfort,
distress, and pain when consistent with sound scientific practices, is
imperative. 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.\" Check the appropriate
category(ies) and indicate the approximate number of animals in each.
Sum(s) should equal total from Section B.

IF ANIMALS ARE INDICATED IN COLUMN E, A SCIENTIFIC JUSTIFICATION IS
REQUIRED TO EXPLAIN WHY THE USE OF ANESTHETICS, ANALGESICS, SEDATIVES OR
TRANQUILIZERS DURING AND/OR FOLLOWING PAINFUL OR DISTRESSFUL PROCEDURES
IS CONTRAINDICATED. PLEASE COMPLETE THE EXPLANATION FOR COLUMN E
LISTINGS FORM AT THE END OF THIS DOCUMENT. THIS FORM WILL ACCOMPANY THE
NIH ANNUAL REPORT TO THE USDA. NOTE: THIS COLUMN E FORM, AND ANY
ATTACHMENTS, e.g., THE ASP, ARE SUBJECT TO THE FREEDOM OF INFORMATION
ACT.

***Number of Animals Used Each Year:***

  --------------------------------------------- -------- --------- --------
                                                **Year   **Year    **Year
                                                1**      2**       3**

  ***USDA Column C***\                                                  
  Minimal, Transient, or No Pain or Distress                       

  ***USDA Column D\                                                     
  ***Pain or Distress Relieved By Appropriate                      
  Measures                                                         

  ***USDA Column E***\                                                  
  Unrelieved Pain or Distress                                      
  --------------------------------------------- -------- --------- --------

*Describe your consideration of alternatives to procedures listed for
Column D and E that may cause more than momentary or slight pain or
distress to the animals, and your determination that alternatives were
not available. \[*Note: *Principal investigators must certify in
paragraph N. 5. that no valid alternative was identified to any
described procedures which may cause more than momentary pain or
distress, whether it is relieved or not.\] Delineate the methods and
sources used in the search below. Database references must include
databases searched, the date of the search**, period covered, and
keywords, used:*

>      

I.  **ANESTHESIA, ANALGESIA, TRANQUILIZATION ---** For animals indicated
    in Section H, Column D, specify the anesthetics, analgesics,
    sedatives or tranquilizers that are to be used. Include the name of
    the agent(s), the dosage, route and schedule of administration.

>      

J.  **METHOD OF EUTHANASIA OR DISPOSITION OF ANIMALS AT END OF STUDY\
    **Indicate the proposed method, and if a chemical agent is used,
    specify the dosage and route of administration. If the method(s) of
    euthanasia include those not recommended by the AVMA Panel Report on
    Euthanasia, e.g., decapitation or cervical dislocation without
    anesthesia, provide scientific justification why such methods must
    be used. Indicate the method of carcass disposal if not as MPW.

>      

**K. HAZARDOUS AGENTS\
**Use of hazardous agents requires the approval of an IC safety
specialist. Registration Documents for the use of recombinant DNA or
potential human pathogens may be attached at the discretion of the ACUC.

  ------------------------------ ----- ---- ------------------------------
                                 YES   NO   **List Agents & Registration
                                            Document \# (if applicable)**

  Radionuclides                                  

  Biological Agents                              

  Hazardous Chemicals or Drugs                   

  Recombinant DNA                                
  ------------------------------ ----- ---- ------------------------------

Study conducted at Animal Biosafety Level:      

*Describe the practices and procedures required for the safe handling
and disposal of contaminated animals and material associated with this
study. Also describe methods for removal of radioactive waste and, if
applicable, t**he monitoring of radioactivity.*

>      

Additional safety considerations:

>      

**L. BIOLOGICAL MATERIAL/ANIMAL PRODUCTS FOR USE IN ANIMALS** (e.g.,
cell lines, antiserum, etc.):

1\. Specify Material      

2\. Source       Material Sterile or Attenuated Yes No

3\. If derived from rodents, has the material been MAP/RAP/HAP tested?\
Yes (Attach copy of results) No

4.  I certify that the MAP/RAP/HAP tested materials to be used have not
    been passed through rodent species outside of the animal facility in
    question and/or the material is derived from the original MAP tested
    sample. To the best of my knowledge the material remains
    uncontaminated with rodent pathogens.

[     ]{.underline} Initials of Principal Investigator.

M.  **SPECIAL CONCERNS OR REQUIREMENTS OF THE STUDY ---** List any
    special housing, equipment, animal care (i.e., special caging,
    water, feed, or waste disposal, etc.).

>      

**N. PRINCIPAL INVESTIGATOR CERTIFICATIONS:**

1.  I certify that I have attended an approved NIH investigator training
    course.

Year of Course Attendance       Location      

> 2\. I certify that I have determined that the research proposed herein
> is not unnecessarily duplicative of previously reported research.
>
> 3\. I certify that all individuals working on this proposal who have
> significant animal contact are participating in the NIH Animal
> Exposure Surveillance Program.
>
> 4\. I certify that the individuals listed in Section A are authorized
> to conduct procedures involving animals under this proposal have
> attended the course \"Using Animals in Intramural Research: Guidelines
> for Animal Users\" and received training in the biology, handling, and
> care of this species; aseptic surgical methods and techniques (if
> necessary); the concept, availability, and use of research or testing
> methods that limit the use of animals or minimize distress; the proper
> use of anesthetics, analgesics, and tranquilizers (if necessary);
> procedures for reporting animal welfare concerns.
>
> *5. FOR ALL COLUMN D AND COLUMN E PROPOSALS (see section H):* I
> certify that I have reviewed the pertinent scientific literature and
> the sources and/or databases as noted in paragraph H. and have found
> no valid alternative to any procedures described herein which may
> cause more than momentary pain or distress, whether it is relieved or
> not.
>
> 6\. I will obtain approval from the ACUC before initiating any
> significant changes in this study.

Principal Investigator: Signature Date [.]{.underline}

**O. CONCURRENCES: PROPOSAL NUMBER (LEAVE BLANK)**

*Laboratory/Branch Chief certification of review and approval on the
basis of scientific merit. Scientific Director\'s signature required for
proposals submitted by a Laboratory or Branch Chief.*

Name Signature Date [.]{.underline}

*Safety Representative certification of review and concurrence.
(Required of all studies utilizing hazardous agents.)*

Name Signature Date [.]{.underline}

*Facility Manager certification of resource capability in the indicated
facility to support the proposed study.*

Facility Name Signature Date [.]{.underline}

Facility Name Signature Date [.]{.underline}

Facility Name Signature Date [.]{.underline}

Facility Name Signature Date [.]{.underline}

COMMENTS:\
     

*Facility Veterinarian certification of review.*

Name Signature Date [.]{.underline}

*Attending Veterinarian certification of review.*

Name Signature Date [.]{.underline}

**P. FINAL APPROVAL:**

Certification of review and approval by the       Animal Care and Use
Committee Chairperson.

Chairperson Signature Date [.]{.underline}