App. C— Public Health Service Policy on Humane Care and Use of Laboratory Animals by Awardee Institutions • 399 
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able in the conduct of scientifically valuable 
research, and that analgesic, anesthetic, and 
tranquilizing drugs will be used where indi- 
cated and appropriate to minimize discomfort 
and pain to animals; and 
e. a description of any euthanasia method to be 
used. 
2. Institutions That Have an Approved Assurance 
Applications or proposals covered by this pol- 
icy from institutions which have an approved As- 
surance on file with OPRR shall include verifi- 
cation of approval by the IACUC of those sections 
related to the care and use of animals. With the 
authorization of PHS, such verification may be 
filed at a time not to exceed 60 days after sub- 
mission of applications or proposals. 6 
If verification of IACUC approval is submitted 
subsequent to the submission of the application 
or proposal, the verification shall state the 
modifications, if any, required by the IACUC. 
The verification shall be signed by an individual 
authorized by the institution, but need not be 
signed by the institutional official who signed the 
Assurance. 
3. Institutions That Do Not Have an Approved As- 
surance 
Applications and proposals involving animals 
from institutions that do not have an approved 
Assurance on file with OPRR shall contain a dec- 
laration that the institution will establish an IA- 
CUC and submit an Assurance upon request by 
OPRR. After OPRR has requested the Assurance, 
the institution shall establish an IACUC as re- 
quired by IV .A. 3. and the IACUC shall review 
those sections of the application or proposal as 
required by IV.C. The institution shall then sub- 
mit to OPRR the Assurance and verification of 
IACUC approval. The verification shall state the 
modifications, if any, required by the IACUC. 
The verification shall be signed by an individual 
authorized by the institution, but need not be 
signed by the institutional official who signed the 
Assurance. 
E. Recordkeeping 
1. The awardee institution shall maintain: 
a. an Assurance approved by the PHS; 
b. minutes of IACUC meetings, including records 
of attendance, activities of the committee, and 
committee deliberations; 
“Until further notice, PHS hereby authorizes all institutions with approved 
Assurances to file verification of IACUC approval either along with the ap- 
plication or proposal or within 60 days of submission of the application or 
proposal. From time to time PHS will reevaluate this blanket authorization. 
Any decision to withdraw this authorization will take place only after ample 
opportunity is provided for comment by the public. 
c. records of applications, proposals and pro- 
posed significant changes in the care and use 
of animals and whether IACUC approval was 
given or withheld; 
d. records of any IACUC reports and recommen- 
dations as forwarded to the institutional offi- 
cial; and 
e. records of accrediting body determinations. 
2. All records shall be maintained for at least three 
years; records that relate directly to applications, 
proposals, and proposed significant changes in 
ongoing activities reviewed and approved by the 
IACUC shall be maintained for the duration of 
the activity and for an additional three years af- 
ter the completion of the activity. All records 
shall be accessible for inspection and copying by 
authorized OPRR or other PHS representatives 
at reasonable times and in a reasonable manner. 
F. Reporting Requirements 
1. On or before each anniversary of approval of its 
Assurance, the institution shall report in writ- 
ing to OPRR: 
a. any change in the institution's program or fa- 
cilities which would place the institution in a 
different category than specified in its Assur- 
ance (see IV .A. 2.); 
b. any change in the description of the institu- 
tion’s program for animal care and use as re- 
quired by IV.A.l.a.-h.; 
c. any changes in IACUC membership; and 
d. if the institution’s program and facilities are 
in Category 2 (see IV.A.2.), verification that the 
IACUC has conducted an annual evaluation of 
the institution’s program and facilities and sub- 
mitted the evaluation to the institutional 
official. 
2. Institutions that have no changes to report as 
specified in IV.F.l.a.-c. shall submit a letter to 
OPRR stating that there are no changes. 
3. Institutions shall provide OPRR promptly with 
a full explanation of the circumstances and ac- 
tions taken with respect to: 
a. any serious or continuing noncompliance with 
this policy; 
b. any serious deviation from the provisions of 
the Guide; or 
c. any suspension of an activity by the IACUC. 
Implementation by PHS 
A. Responsibilities of OPRR 
OPRR is responsible for the general administra- 
tion and coordination of this policy and will: 
1. request and negotiate, approve or disapprove, 
