Draft Mandatory Qualification Criteria.pdf

Mandatory Qualification Criteria

Listed below are mandatory qualification criteria. Offerors must clearly demonstrate that the following requirements can be met by the time of contract award in order to receive further consideration for award. (note that the PHS Assurance must be met prior to award).

1. GLP Compliance

The Division of Translational Toxicology (DTT) requires that All work performed under this contract by the Contractor or any Subcontractor for any assignment that directly supports an DTT Toxicology study shall comply with Food and Drug Administration Good Laboratory Practices for Nonclinical Laboratory Studies (Good Laboratory Practice for Nonclinical Laboratory Studies) unless specifically authorized by the COR.

The offeror shall include information and documentation that demonstrates evidence of the testing laboratory’s current compliance with the provisions of 21 CFR 58.

2. Animal Welfare

The contract shall be conducted in compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals, the Animal Welfare Act Regulations, the current edition of the Guide for the Care and Use of Laboratory Animals (the Guide), all animal care policies described in the DTT Chemistry Specifications, and all local, state or federal regulations and policies.

The Offeror and any proposed subcontractors shall be accredited by the Association for Assessment & Accreditation of Laboratory Animal Care International (AAALAC).

Further information may be obtained from the following source:

Office of Laboratory Animal Welfare (OLAW) National Institutes of Health 6700B Rockledge Drive, Suite 2500, MSC 6910 Bethesda, MD 20892 (20817 zip code for delivery service or hand delivery) Phone: (301) 496-7163

3. PHS Assurance

The Contractor shall have an approved animal welfare assurance statement on file with the NIH Office of Laboratory Animal Welfare (OLAW) at the time of contract award. (Note: an offeror that does not have an OLAW-approved Animal Welfare Assurance may be selected but the Contracting Officer will have to initiate the process of obtaining an assurance from OLAW; contract funds may not be expended for animal work, until the assurance has been approved).

Further information may be obtained from the NIH Office of Laboratory Animal Welfare (see address under Item 2).

Copies of the PHS policy are available at: https://olaw.nih.gov/policies-laws/phs-policy.htm

4. Integrated Pest Management Program

Offerors shall have an active integrated pest management (IPM) program to prevent the introduction of pathogenic agents to animals housed in the isolator/barrier facilities.

https://www.fda.gov/files/about%20fda/published/Good-Laboratory-Practice-for-Nonclinical-Laboratory-Studies-Proposed-Rule-Regulatory-Impact-Analysis.pdf https://olaw.nih.gov/policies-laws/phs-policy.htm