**SAMPLE ANIMAL WELFARE ASSURANCE**

**In accordance with the PHS Policy for**

**Humane Care and Use of Laboratory Animals**

This Animal Welfare Assurance (Assurance) sample document is provided to
assist institutions with the development of an Assurance in accordance
with the Public Health Service (PHS) Policy on Humane Care and Use of
Laboratory Animals (PHS Policy). Reviewing the entire document and
reading the PHS Policy **before** beginning to write will facilitate the
completion of your institution's Assurance. Additional guidance,
frequently asked questions (FAQs), and suggested references are
available on the Office of Laboratory Animal Welfare (OLAW) website
(<http://grants.nih.gov/grants/olaw/olaw.htm>).

This sample document should **not** be used by:

-   Foreign institutions.

-   Institutions that currently do not have their own animal care and
    use programs.

-   Institutions that are proposing animal activity to be conducted
    solely at a collaborating institution.

If one of these bullets describes your institution, please contact OLAW
by email at <olawdoa@mail.nih.gov> for guidance.

If you are unsure as to whether your institution is required to submit
an Assurance and OLAW has not contacted your institution, please consult
with OLAW. Do not submit an unsolicited Assurance. Assurances that have
not been requested by OLAW will not be processed.

This sample document supersedes all previous versions. It includes all
required elements of an Assurance. Words that are italicized and in
brackets \[*like this*\] indicate specific information the institution
must provide about its animal care and use program. Notes to help in
preparation of the document are in brackets \[NOTE: like this\] and
should be deleted from the completed Assurance. Please strive for clear
concise text in the document. Adherence to the sample document format
will facilitate the institution's preparation and OLAW's review of the
Assurance.

One or two page attachments are preferred and may be used to provide the
following:

-   Organizational structure of the animal care and use program.

-   Membership of the IACUC Roster.

-   Facility and Species Inventory.

-   Most recent semi-annual report of program and facilities. This is
    needed **only** for programs that are not Association for the
    Assessment and Accreditation of Laboratory Animal Care,
    International (AAALAC) accredited.

All other program elements are to be described in the text of the
Assurance. Please do not send additional attachments, more comprehensive
attachments, or include appendices, binders, or manuals. Due to OLAW's
use of electronic records, we will not accept these separate documents.

Submit completed Assurances to:

Office of Laboratory Animal Welfare/NIH

Division of Assurances

6705 Rockledge Drive

RKL1, Suite 360, MSC 7982

Bethesda, MD 20892-7982

(For express or hand-delivered mail use ZIP 20817)

All questions concerning this sample are to be directed to the staff of
the Division of Assurances at 301-496-7163, or email OLAW at:
<olawdoa@mail.nih.gov>

**\[*NAME OF INSTITUTION*\]**

\[*Insert Assurance number here if this is a renewal e.g., A3000-01.*

*For new Assurances, a number will be assigned at approval.*\]

**ANIMAL WELFARE ASSURANCE**

**in accordance with the PHS Policy for**

**Humane Care and Use of Laboratory Animals**

I, \[*Insert the name of Institutional Official*\] as named
Institutional Official for animal care and use at \[*Name of
Institution*\], hereinafter referred to as Institution, by means of this
document, provide assurance that this Institution will comply with the
Public Health Service Policy on Humane Care and Use of Laboratory
Animals, hereinafter referred to as PHS Policy.

**I. APPLICABILITY OF ASSURANCE**

This Assurance is applicable to all research, research training,
experimentation,

biological testing, and related activities, hereinafter referred to as
activities, involving live vertebrate animals supported by the Public
Health Service (PHS) and conducted at this Institution, or at another
institution as a consequence of the subgranting or

subcontracting of a PHS‑conducted or -supported activity by this
Institution.

\"Institution\" includes the following branches and major components of
\[*Name of Institution*\]: \[*List every branch and major component
covered by the Assurance*.\]

"Institution" also includes the following: \[*List the names of any
other institution, or branch and components of any other institution,
covered by the Assurance.*\]

\[NOTE: Only those entities listed in this section will be entitled to
use the Assurance number for grant and contract submissions to PHS
agencies.\]

**II. INSTITUTIONAL COMMITMENT**

A. This Institution will comply with all applicable provisions of the
Animal Welfare Act and other Federal statutes and regulations relating
to animals.

B. This Institution is guided by the \"U.S. Government Principles for
the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training.\"

C. This Institution acknowledges and accepts responsibility for the care
and use of animals involved in activities covered by this Assurance. As
partial fulfillment of this responsibility, this Institution will ensure
that all individuals involved in the care and use of laboratory animals
understand their individual and collective responsibilities for
compliance with this Assurance, as well as all other applicable laws and
regulations pertaining to animal care and use.

D. This Institution has established and will maintain a program for
activities involving animals in accordance with the "Guide for the Care
and Use of Laboratory Animals" ("Guide").

**III. INSTITUTIONAL PROGRAM FOR ANIMAL CARE AND USE**

A. The lines of authority and responsibility for administering the
program and ensuring compliance with this Policy are as follows:
\[*Insert or attach a description or a diagram of the reporting channels
for the chief executive officer, the Institutional Official, the IACUC,
the veterinarian, and animal facility management or indicate diagram is
appended as an attachment. The description or diagram must demonstrate
direct reporting from the IACUC to the Institutional Official, and from
the veterinarian to the Institutional Official.*\]

B. The qualifications, authority, and percent of time contributed by the
veterinarian(s) who will participate in the program are as follows:

Name: \[*Enter veterinarian's name*\]

Qualifications:

-   Degrees: \[*Enter professional degrees and certifications*\]

-   Training and/or experience in laboratory animal medicine: \[*Briefly
    describe training and experience in laboratory animal medicine
    and/or the species being attended. Do not include the CV of the
    veterinarian affiliated with the Institution.*\]

Authority: Dr. \[*name*\] has \[*direct or delegated*\] program
authority and responsibility for the Institution's animal care and use
program.

Time Contributed to Program: \[*If full time, enter "full time employee"
and the percentage of time contributed to the animal care and use
program. If part time, enter the approximate number of hours per week or
month each veterinarian is present at the institution and the percentage
of those hours he or she contributes to the animal care and use
program.*\]

\[NOTE: If there is more than one veterinarian associated with the
program, please provide the information requested below for each. If
only one veterinarian is associated with the program, describe
provisions in place for a back-up veterinarian to ensure adequate
veterinary care of research animals should that veterinarian not be
available.\]

Name: \[*Enter veterinarian's name*\]

Qualifications:

-   Degrees: \[*Enter professional degrees and certifications*\]

-   Training and/or experience in laboratory animal medicine: \[*Briefly
    describe training and experience in laboratory animal medicine
    and/or the species being attended. Do not include the CV of the
    veterinarian affiliated with the Institution.*\]

Responsibilities: \[*Describe authority and responsibilities*\]

Time Contributed to Program: \[*If full time, enter "full time employee"
and the percentage of time contributed to the animal care and use
program. If part time, enter the approximate number of hours per week or
month each veterinarian is present at the institution and the percentage
of those hours he or she contributes to the animal care and use
program.*\]

C. The Institutional Animal Care and Use Committee (IACUC) at this
Institution is properly appointed in accordance with the PHS Policy
IV.A.3.a and is qualified through the experience and expertise of its
members to oversee the Institution\'s animal care and use program and
facilities. The IACUC consists of at least five members, and its
membership meets the composition requirements set forth in the PHS
Policy, Section IV.A.3.b. Attached is a list of the chairperson and
members of the IACUC and their names, degrees, profession, titles or
specialties, and institutional affiliations. \[*Insert or attach the
sample IACUC table (provided).*\] \[Note: Names of members, other than
the chairperson and veterinarian, may be represented by a number or
symbol in the attachment.\]

D. The IACUC will:

1\. Review at least once every six months the Institution\'s program for
humane care and use of animals, using the "Guide" as a basis for
evaluation. The IACUC procedures for conducting semiannual program
reviews are as follows: \[*Describe the procedures the IACUC uses to
conduct the semiannual program reviews. For example, include who
performs the reviews, what items are included, and where, when, and how
those items are reviewed.*\]

2\. Inspect at least once every six months all of the Institution\'s
animal facilities, including satellite facilities, using the "Guide" as
a basis for evaluation. The IACUC procedures for conducting semiannual
facility inspections are as follows: \[*Describe the procedures the
IACUC uses to conduct the semiannual facility inspections.*\]

3\. Prepare reports of the IACUC evaluations as set forth in the PHS
Policy IV.B.3 and submit the reports to the Institutional Official. The
IACUC procedures for developing reports and submitting them to the
Institutional Official are as follows: \[*Describe the following: 1) the
procedures the IACUC uses to develop, approve, and submit the reports of
its evaluations (program reviews and facility inspections) to the
Institutional Official 2) how departures from the PHS Policy and the
"Guide" are identified, designated, and reported; and 3) the process
used to correct any deficiencies noted.*\]

4\. Review concerns involving the care and use of animals at the
Institution. The IACUC procedures for reviewing concerns are as follows:
\[*Describe the following: 1) the mechanisms in place to
facilitate/enable individuals to report concerns involving animal care
and use; 2) the procedures the IACUC uses to review such reported
concerns; and 3) the procedures the IACUC uses for reporting the
concerns and related IACUC findings and recommendations to the
Institutional Official.*\]

5\. Make written recommendations to the Institutional Official regarding
any aspect of the Institution\'s animal program, facilities, or
personnel training. The procedures for making recommendations to the
Institutional Official are as follows: \[*Describe how the IACUC
develops, approves, and submits written recommendations to the
Institutional Official regarding any aspect of the Institution's animal
care and use program, facilities, or personnel training*.\]

6\. In accord with the PHS Policy IV.C.1-3, the IACUC shall review and
approve, require modifications in (to secure approval), or withhold
approval of PHS-supported activities related to the care and use of
animals. The IACUC procedures for protocol review are as follows:
\[*Describe the procedures the IACUC uses to review, approve, require
modifications in (to secure approval), and withhold approval of
activities related to the care and use of animals. For example, include
descriptions of all IACUC procedures from initial receipt of the written
description of activity (protocol) through approval of the activity. The
descriptions should include, but not necessarily be limited to, the
following: receipt, pre-review or initial screening, notification of
members, distribution, meetings and attendance requirements, methods of
protocol review (full committee or designated member), conflicts of
interest, and voting. Also include descriptions of any alternate
processes or procedures for special or expedited reviews*.\]

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 as set forth in the PHS Policy IV.C.
The IACUC procedures for reviewing proposed significant changes in
ongoing research projects are as follows: \[*Describe how the IACUC
handles proposed significant changes in previously approved activities
involving the care and use of animals.*\] \[Note: Review and approval of
proposed significant changes must comply with the same requirements as
review and approval of new protocols as set forth in the PHS Policy
IV.C.\]

8\. Notify investigators and the Institution in writing of its decision
to approve or withhold approval of those activities related to the care
and use of animals, or of modifications required to secure IACUC
approval as set forth in the PHS Policy IV.C.4. The IACUC procedures to
notify investigators and the Institution of its decisions regarding
protocol review are as follows: \[*Describe how the IACUC notifies
investigators and the Institutional Official of its decisions regarding
protocol review*.\]

9\. Conduct continuing review of each previously approved, ongoing
activity covered by PHS Policy at appropriate intervals as determined by
the IACUC, including a complete review in accordance with the PHS Policy
IV.C.1-4 at least once every three years. The IACUC procedures for
conducting continuing reviews are as follows: \[*Describe the processes
the IACUC uses for monitoring of ongoing activities and continuing
review of previously approved protocols. Also include a description of
the procedures the IACUC uses to conduct a complete review of continuing
activities at least every three years.*\]

10\. Be authorized to suspend an activity involving animals as set forth
in the PHS Policy IV.C.6. The IACUC procedures for suspending an ongoing
activity are as follows: \[*Describe procedures used by the IACUC to
suspend an ongoing activity, as well as procedures used by the
Institutional Official to report an IACUC suspension to OLAW.*\]

E. The occupational health and safety program for personnel working in
laboratory animal facilities or have frequent contact with animals is as
follows: \[*Describe the Institution's occupational health and safety
(OH&S) program for personnel involved in the care and use of animals.
The description should be based on the relevant topics listed in the
"Guide" for the Care and Use of Laboratory Animals, such as:*

-   *Hazard identification and risk assessment.*

-   *Personnel training regarding zoonoses, chemical safety, physical
    hazards, allergies, handling of waste materials, precautions taken
    during pregnancy, illness or immune suppression.*

-   *Personal hygiene.*

-   *Facilities, procedures, and monitoring.*

-   *Animal experimentation involving hazards.*

-   *Personal protective equipment.*

-   *Medical evaluation and preventive medicine for personnel.*

*Some examples of other relevant topics might include, but not
necessarily be limited to, the following: personnel covered, measures to
alleviate identified risks, required vaccinations, occupational health
and safety training, handling of hazardous agents, and reporting and
treating injuries.*

*Where appropriate, describe special precautions for personnel working
with nonhuman primates (e.g,. tuberculosis screening, training and
procedures for bites and scratches, and education regarding
Cercopithecine herpesvirus 1 (Herpes B))*.\] \[NOTE: Please provide a
succinct description of the Institution's occupational health and safety
program in this section of the Assurance. Do not reference and/or send
attachments*.*\]

F. The total gross number of square feet in each animal facility
(including each satellite facility), the species of animals housed
therein and the average daily inventory of animals, by species, in each
facility is provided in the attached Facility and Species Inventory
table. \[*Please attach the Facilities and Species Inventory sample
table, provided.*\] \[Note: Institutions may identify animal areas in
any manner, e.g., initials, ID number, etc. in this attachment*.*\]

G. The training or instruction available to scientists, animal
technicians, and other personnel involved in animal care, treatment, or
use is as follows: \[*Provide a synopsis of training or instruction to
ensure that people caring for or using laboratory animals are trained
and qualified to do so. Describe training or instruction in the humane
practice of animal care and use, including training or instruction on
research or testing methods that minimize the number of animals required
to obtain valid results and limit animal pain and distress. Describe how
the IACUC members are provided orientation, background materials,
resources, and/or training.*\] \[NOTE: Do not reference and/or send
attachments.\]

**IV. INSTITUTIONAL PROGRAM EVALUATION AND ACCREDITATION**

All of this Institution\'s programs and facilities (including satellite
facilities) for activities involving animals have been evaluated by the
IACUC within the past six months and will be re-evaluated by the IACUC
at least once every six months thereafter, in accord with the PHS Policy
IV.B.1-2. Reports have been and will continue to be prepared in accord
with the PHS Policy IV.B.3. All IACUC semiannual reports will include a
description of the nature and extent of this Institution\'s adherence to
the "Guide." Any departures from the "Guide" will be identified
specifically and reasons for each departure will be stated. Reports will
distinguish significant deficiencies from minor deficiencies. Where
program or facility deficiencies are noted, reports will contain a
reasonable and specific plan and schedule for correcting each
deficiency. Semiannual reports of the IACUC's evaluations will be
submitted to the Institutional Official. Semiannual reports of IACUC
evaluations will be maintained by this Institution and made available to
the OLAW upon request.

\[NOTE: From the following two paragraphs, retain one paragraph that is
applicable and delete the one that is not applicable.\]

This Institution is Category One (1)---accredited by the Association for
Assessment and Accreditation of Laboratory Animal Care, International
(AAALAC). As noted above, reports of the IACUC's semiannual evaluations
(program reviews and facility inspections) will be made available upon
request.

\*\*\* OR \*\*\*

This Institution is Category Two (2)---not accredited by the Association
for Assessment and Accreditation of Laboratory Animal Care,
International (AAALAC). As noted above, reports of the IACUC's
semiannual evaluations (program reviews and facility inspections) will
be made available upon request. The report of the most recent
evaluations (program review and facility inspection) is attached.
\[*Please attach the most recent semi-annual program review and facility
inspection report*.\]

**V. RECORDKEEPING REQUIREMENTS**

A. This Institution will maintain for at least three years:

1.  A copy of this Assurance and any modifications thereto, as approved
    by the PHS.

2.  Minutes of IACUC meetings, including records of attendance,
    activities of the committee, and committee deliberations.

3.  Records of applications, proposals, and proposed significant changes
    in the care and use of animals and whether IACUC approval was given
    or withheld.

4.  Records of semiannual IACUC reports and recommendations (including
    minority views) as forwarded to the Institutional Official,
    \[*Insert name or title of the Institutional Official signing the
    Assurance.*\].

5.  Records of accrediting body determinations.

B. This Institution will maintain records that relate directly to
applications, proposals, and proposed changes in ongoing activities
reviewed and approved by the IACUC for the duration of the activity and
for an additional three years after completion of the activity.

C. All records shall be accessible for inspection and copying by
authorized OLAW or other PHS representatives at reasonable times and in
a reasonable manner.

**VI. REPORTING REQUIREMENTS**

A. This Institution's reporting period is \[*insert "January 1 --
December 31", or another 12 month reporting period*\]. The IACUC,
through the Institutional Official, will submit an annual report to OLAW
on \[*insert "January 31" or the last day of the month following the end
of the reporting period*\] of each year. The report will include:

1.  Any change in the accreditation status of the Institution (e.g,. if
    the Institution obtains accreditation by AAALAC or AAALAC
    accreditation is revoked), any change in the description of the
    Institution\'s program for animal care and use as described in this
    Assurance, or any change in the IACUC membership. If there are no
    changes to report, this Institution will provide written
    notification that there are no changes.

2.  Notification of the dates that the IACUC conducted its semiannual
    evaluations of the Institution\'s program and facilities (including
    satellite facilities) and submitted the evaluations to the
    Institutional Official, \[*Insert name or title of the Institutional
    Official signing the Assurance*.\]

B. The IACUC, through the Institutional Official, will promptly provide
OLAW with a full explanation of the circumstances and actions taken with
respect to:

1.  Any serious or continuing noncompliance with the PHS Policy.

2.  Any serious deviations from the provisions of the "Guide."

3.  Any suspension of an activity by the IACUC.

C. Reports filed under sections VI.A. and VI.B. of this document shall
include any minority views filed by members of the IACUC.

**VII. INSTITUTIONAL ENDORSEMENT AND PHS APPROVAL**

A. Authorized Institutional Official

Name:

Title:

Name of Institution:

Address: \[*street address, city, state, zip code*\]

Phone:

Fax:

E-mail:

Signature:

Date:

B. PHS Approving Official

Name:

Title:

Address:

Phone:

Fax:

E-mail:

Signature:

Date:

C. Effective Date of Assurance:

D. Expiration Date of Assurance:

**MEMBERSHIP OF THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE**

DATE:

NAME OF INSTITUTION:

ASSURANCE NUMBER:

  -------------------------- --------------------------------------------
  Chairperson Name, Title,   Business Address, Phone, Fax, and Email of
  and Degree/Credentials     Chairperson

  Name\*:                    Address\*:

  Title\*:                   
  -------------------------- --------------------------------------------

  -------------------------- ----------- ------------ ---------------------
  Degree/credentials\*:      Phone\*:    Fax\*:       Email\*:

  -------------------------- ----------- ------------ ---------------------

+--------------------+---------------+---------------+----------------+
| Name of            | Degre         | Position      | PHS Policy     |
| Member/Code\*\*    | e/Credentials | Title         |                |
|                    |               |               | Requ           |
|                    |               |               | irements\*\*\* |
+--------------------+---------------+---------------+----------------+
|                    |               |               |                |
+--------------------+---------------+---------------+----------------+
|                    |               |               |                |
+--------------------+---------------+---------------+----------------+
|                    |               |               |                |
+--------------------+---------------+---------------+----------------+
|                    |               |               |                |
+--------------------+---------------+---------------+----------------+
|                    |               |               |                |
+--------------------+---------------+---------------+----------------+
|                    |               |               |                |
+--------------------+---------------+---------------+----------------+
|                    |               |               |                |
+--------------------+---------------+---------------+----------------+
|                    |               |               |                |
+--------------------+---------------+---------------+----------------+
|                    |               |               |                |
+--------------------+---------------+---------------+----------------+

+-----------------------------------------------------------------------+
| \*This information is mandatory.                                      |
|                                                                       |
| \*\*Names of members, other than the chairperson and veterinarian,    |
| may be represented by a number or symbol in this submission to OLAW.  |
| Sufficient information to determine that all appointees are           |
| appropriately qualified must be provided and the identity of each     |
| member must be readily ascertainable by the Institution and available |
| to authorized OLAW or other PHS representatives upon request.         |
|                                                                       |
| \*\*\*PHS Policy Requirements - identify which IACUC members meet the |
| four criteria below:                                                  |
|                                                                       |
| -   Veterinarian (V) - a veterinarian with direct or delegated        |
|     program responsibility.                                           |
|                                                                       |
| -   Scientist (S) - a practicing scientist experienced in research    |
|     involving animals.                                                |
|                                                                       |
| -   Nonscientist (NS) - a member whose primary concerns are in        |
|     non-scientific areas (e.g. ethicist, lawyer, member of the        |
|     clergy).                                                          |
|                                                                       |
| -   Nonaffiliated (NA) - a member who is not affiliated with the      |
|     Institution in any way other than as a member of the IACUC, and   |
|     who is not a member of the immediate family of a person who is    |
|     affiliated. This member is expected to represent the interests of |
|     the general community in the proper care and use of animals and   |
|     should not be a laboratory animal user. A consulting attending    |
|     veterinarian may not be considered nonaffiliated.                 |
|                                                                       |
| Notes:                                                                |
|                                                                       |
| 1.  All members must be appointed by the CEO (or individual with      |
|     specific written delegation to appoint members) and must be       |
|     voting members. Ad hoc or nonvoting members may be listed and     |
|     identified as such, but are not considered members for the        |
|     purpose of the PHS Policy, and do not contribute to a quorum.     |
|                                                                       |
| 2.  If Alternate members are listed, identify for whom (by name or    |
|     code number, not specialty) they will serve as Alternates.        |
|                                                                       |
| **OTHER KEY CONTACTS (OPTIONAL)**                                     |
|                                                                       |
| If there are other individuals within the Institution who may be      |
| contacted regarding this Assurance, please provide information below. |
|                                                                       |
| Name:                                                                 |
|                                                                       |
| Title:                                                                |
|                                                                       |
| Phone & Fax:                                                          |
|                                                                       |
| E-mail:                                                               |
|                                                                       |
| Name:                                                                 |
|                                                                       |
| Title:                                                                |
|                                                                       |
| Phone & Fax:                                                          |
|                                                                       |
| E-mail:                                                               |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+
|                                                                       |
+-----------------------------------------------------------------------+

**FACILITY AND SPECIES INVENTORY**

DATE:

NAME OF INSTITUTION:

ASSURANCE NUMBER:

+------------------+------------------+------------------+------------+
| ###              | ### Gross Squar  | ### Sp           | ### A      |
|  Laboratory, Uni | e Feet (includin | ecies Housed in  | pprox. Ave |
| t, or Building\* | g service areas) | Unit (use comple | rage Daily |
|                  |                  | te common names) |  Inventory |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+
|                  |                  |                  |            |
+------------------+------------------+------------------+------------+

\*Institutions may identify animal areas in any manner, e.g., initials,
ID number, etc. However, the name and location must be provided to OLAW
upon request.