NMU's Compliance Database - Northern Michigan University

9 C.F.R. § 2.36: Annual report.

(a) The reporting facility shall be that segment of the research facility, or that department, agency, or instrumentality of the United States that uses or intends to use live animals in research, tests, experiments, or for teaching. Each reporting facility shall submit an annual report to the Deputy Administrator on or before December 1st of each calendar year. The report shall cover the previous Federal fiscal year. The Annual Report of Research Facility (APHIS Form 7023), Continuation Sheet for Annual Report of Research Facility (APHIS Form 7023A), and Annual Report of Research Facility Column E Explanation (APHIS Form 7023B) are forms which may be used to submit the information required by paragraph (b) of this section.

(b) The annual report shall:

(1) Assure that professionally acceptable standards governing the care, treatment, and use of animals, including appropriate use of anesthetic, analgesic, and tranquilizing drugs, prior to, during, and following actual research, teaching, testing, surgery, or experimentation were followed by the research facility;

(2) Assure that each principal investigator has considered alternatives to painful procedures;

(3) Assure that the facility is adhering to the standards and regulations under the Act, and that it has required that exceptions to the standards and regulations be specified and explained by the principal investigator and approved by the IACUC. A summary of all such exceptions must be attached to the facility's annual report. In addition to identifying the IACUC-approved exceptions, this summary must include a brief explanation of the exceptions, as well as the species and number of animals affected;

(4) State the location of all facilities where animals were housed or used in actual research, testing, teaching, or experimentation, or held for these purposes;

(5) State the common names and the numbers of animals upon which teaching, research, experiments, or tests were conducted involving no pain, distress, or use of pain-relieving drugs. Routine procedures (e.g., injections, tattooing, blood sampling) should be reported with this group;

(6) State the common names and the numbers of animals upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used;

(7) State the common names and the numbers of animals upon which teaching, experiments, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs would have adversely affected the procedures, results, or interpretation of the teaching, research, experiments, surgery, or tests. An explanation of the procedures producing pain or distress in these animals and the reasons such drugs were not used shall be attached to the annual report;

(8) State the common names and the numbers of animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery but not yet used for such purposes.

Governs the treatment of animals used for research: dogs, cats, monkeys, guinea pigs, hamsters, and other warm-blooded animals.

The USDA also performs inspections, either by: 1) pre-licensing inspections, to make sure the applicant can meet the federal standards prior to being licensed/registered; 2) routine, unannounced compliance inspections of all entities to make sure they are adhering to the federal standards and regulations; and 3) focused inspections based upon public complaints or allegations of unlicensed activities.

The USDA has a 3 year registration cycle.

The university must also provide an Assurance of Compliance with PHS Policy, which can last for a period up to five years.