2nd Edition 2002 arena/olaw institutional Animal Care and Use Committee Guidebook


E.1. Table A. Federal Requirements: Recordkeeping



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E.1. Table A. Federal Requirements: Recordkeeping




Records


PHS Policy

AWRs

IACUC Minutes

  • Records of attendance, activities and deliberations

  • Records of attendance, activities and deliberations

Protocols

  • Records of proposed activities using animals

  • Record of proposed significant changes

  • Outcome of IACUC review

  • Records of proposed activities using animals

  • Record of proposed significant changes

  • Outcome of IACUC review

Basic Documents

  • Semiannual IACUC reports and recommendations

  • Assurance Document

  • Records of accrediting body determinations

  • Semiannual IACUC reports and recommendations

Animal

  • Refer to Guide regarding clinical records, pedigree information, standardized nomenclature, etc.

  • Records on acquired live dogs/cats or offspring including seven types of information

  • Records on dogs/cats transported/sold/euthanized including three types of information

  • “Random Source” Certificates (See 2.133 (f) and (g))

Other Requirements

  • All records must be kept for three years; records that relate to applications, proposals, and proposed significant changes must be maintained for the duration of the activity plus three years.

  • Accessible for inspection or copying by OLAW or other PHS officials

  • All records must be kept for three years; records that relate to applications, proposals, and proposed significant changes must be maintained for the duration of the activity plus three years.

  • Accessible to APHIS and Federal agency officials

  • USDA may extend the records retention requirements pending completion of an investigation.

Reference

Policy IV.E.

9 CFR Part 2, Subpart C 2.35


E.1. Table B. Federal Requirements: Assurance and Registration








PHS Institutional Assurance

USDA Research Facility Registration

When required

  • To receive PHS support for animal activities

  • Approved for up to five years

  • Animals covered by USDA Regulations held or used for regulated purposes

  • Updated every three years

Submit to

  • Office of Laboratory Animal Welfare (OLAW)

  • APHIS, AC Regional Director

Submitted by

  • IO

  • Signed by person with legal authority to bind organization

Forms

  • APHIS Form 7011

Contents

  • List all components of institution to be included, including sq. ft. of each facility, species housed and average daily inventory by species

  • Describe lines of authority and responsibility

  • List qualifications, responsibility, authority and percent of time contribution of each veterinarian

  • IACUC membership list and description of IACUC procedures

  • Describe occupational health program

  • Synopsis of training/instruction offered to personnel involved with animals.




After submission

  • Indicate AAALAC accreditation and include semiannual IACUC report if not accredited.

  • OLAW may negotiate changes before approval

  • Notify APHIS via AC Regional Director within ten (10) days of change of operation

Reference

PHS Policy IV.A.

9 CFR Part 2, Subpart C 2.30


E.1. Table C. Federal Requirements: Report of

Semiannual Evaluations








PHS Semiannual Report

USDA Semiannual Report

Timetable

an AAALAC report may fulfill

these requirements



  • Every six months;

an AAALAC report may

fulfill these requirements



Submit to

  • IO

  • IO

Submitted by

  • IACUC, as Committee action

  • IACUC; signed by a majority

of members

Form used

  • Not specified

  • Not specified

Contents

  • Describe adherence to Guide and PHS Policy and departures from Guide and PHS Policy

  • State reasons for departures; identify significant and minor deficiencies; include plan/ schedule to correct deficiencies; include minority views

  • Approved by IACUC

  • Maintained by institution

  • Available to OLAW upon request

  • Other: Identify facilities accredited by AAALAC

  • Describe adherence to AWRs and departures from AWRs;

  • State reasons for departures; identify significant and minor deficiencies; include plan/ schedule to correct deficiencies; include minority views

  • Reviewed and signed by majority of IACUC members

  • Maintained by Research Facility

Available to APHIS and funding agency upon request

  • Other: Report failure to adhere to plan/schedule through IO

to APHIS and funding agency

within 15 working days



Reference

PHS Policy IV.B.3. IV.E.1.d & IV.F.4.

9 CFR Part 2, Subpart C 2.31 (c) (3)

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