396 • Alternatives to Animal Use in Research, Testing, and Education 
I. Quorum 
A majority of the members of the Institutional 
Animal Care and Use Committee. 
Implementation by Awardee 
Institutions 
A. Animal Welfare Assurance 
No activity involving animals will be supported 
by the PHS until the institution conducting the ac- 
tivity has provided a written Assurance acceptable 
to the PHS, setting forth compliance with this pol- 
icy for PHS-supported activities. Assurances shall 
be submitted to the Office for Protection from Re- 
search Risks (OPRR), Office of the Director, Na- 
tional Institutes of Health, 9000 Rockville Pike, 
Building 31, Room 4B09, Bethesda, Maryland 20205. 
The Assurance shall be typed on the institution’s 
letterhead and signed by an institutional official. 
OPRR will provide the applicant institution with 
necessary instructions and an example of an ac- 
ceptable Assurance. All Assurances submitted to 
the PHS in accordance with this policy will be 
evaluated by OPRR to determine the adequacy of 
the institution’s proposed program for the care and 
use of animals in PHS-supported activities. On the 
basis of this evaluation OPRR may approve or dis- 
approve the Assurance, or negotiate an approva- 
ble Assurance with the institution. Approval of an 
Assurance will be for a specified period of time (no 
longer than five years) after which time the insti- 
tution must submit a new Assurance to OPRR. 
OPRR may limit the period during which any par- 
ticular approved Assurance shall remain effective 
or otherwise condition, restrict, or withdraw ap- 
proval. Without an applicable PHS approved Assur- 
ance no PHS-supported activity involving animals 
at the institution will be permitted to continue. 
1. Institutional Program for Animal 
Care and Use 
The Assurance shall fully describe the insti- 
tution’s program for the care and use of animals 
in PHS-supported activities. The PHS requires in- 
stitutions to use the Guide for the Care and Use 
of Laboratory Animals (Guide) as a basis for de- 
veloping and implementing an institutional pro- 
gram for activities involving animals. The pro- 
gram description must include the following: 
a. a list of every branch and major component 
of the institution, as well as a list of every 
branch and major component of any other in- 
stitution which is to be included under the As- 
surance; 
b. the lines of authority and responsibility for ad- 
ministering the program and ensuring com- 
pliance with this policy; 
c. the qualifications, authority and responsibil- 
ity of the veterinarian(s) who will participate 
in the program; 
d. the membership list of the Institutional Ani- 
mal Care and Use Committee(s) 1 (IACUC) es- 
tablished in accordance with the require- 
ments set forth in IV. A. 3.; 
e. the procedures which the IACUC will follow 
to fulfill the requirements set forth in IV.B.; 
f . the health program for personnel who work 
in laboratory animal facilities or have frequent 
contact with animals; 
g. the gross square footage of each animal facil- 
ity (including satellite facilities), the species 
housed therein and the average daily inven- 
tory, by species, of animals in each facility; 
and 
h. any other pertinent information requested by 
OPRR. 
2. Institutional Status 
Each institution must assure that its program 
and facilities are in one of the following cate- 
gories: 
• Category 1— Accredited by the American Asso- 
ciation for the Accreditation of Laboratory 
Animal Care (AAALAC). All of the institution’s 
programs and facilities (including satellite fa- 
cilities) for activities involving animals have 
been evaluated and accredited by AAALAC, 
or other accrediting body recognized by PHS. 2 
• Category 2— Evaluated by the Institution. All 
of the institution’s programs and facilities (in- 
cluding satellite facilities) for activities involv- 
ing animals have been evaluated bv the IACUC 
and will be reevaluated by the IACUC at least 
once each year. The IACUC shall use the Guide 
for the Care and Use of Laboratory Animals 
as a basis for evaluating the institution’s pro- 
gram and facilities. A report of the IACUC 
evaluation shall be submitted to the institu- 
tional official and updated on an annual ba- 
sis. 3 The initial report shall be submitted to 
'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-supported activities is 
appropriate and humane in accordance with this policy However, each in- 
stitution may identify the committee by whatever name it chooses. Member- 
ship and responsibilities of the IACUC are set forth in IV. A. 3. and IV. B. 
2 As of the issuance date of this policy the only accrediting body recognized 
by PHS is the American Association for Accreditation of Laboratory Animal 
Care (AAALAC). 
3 The IACUC may, at its discretion, determine the best means of conduct- j 
ing an evaluation of the institution's programs and facilities. The IACUC may 
invite ad hoc consultants to conduct or assist in conducting the evaluation. 
However, the IACUC remains responsible for the evaluation and report. 
