Federal Regulations & Standards Archives

Apr 23 2025

Drugs Federal Regulations & Standards Guidelines Policies ULAM

Additional Guidance & Resources for Managing Products with Beyond Use Dates

Navigating the many nuanced requirements for the proper management, storage, and maintenance of drugs, agents, and other substances used in animal-based research can be challenging and confusing, especially when these supplies are dated. Many pharmaceutical products have both a standard “Expiration Date” and a “Use-By-Date” (i.e., “Beyond Use Date”), which are often described in the ...

Image of vials being picked up by person with gloved hand

Mar 28 2025

Federal Regulations & Standards Policies Safety

Plan Ahead: New Federal Policy on Research with Pathogens and Biological Toxins

On May 6, 2025, the new United States Government Policy for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (USG DURC-PEPP Policy) will go into effect. The policy, which was first introduced in May 2024, requires life sciences research to be assessed at the point of grant proposal submission to ensure that ...

Feb 20 2024

Federal Regulations & Standards IACUC

Birds Now Covered by the AWA / AWR: What Researchers Can Expect

On August 21, 2023, the United States Department of Agriculture (USDA) amended the Animal Welfare Act and Animal Welfare Regulations (AWA / AWR) to include the oversight of birds. Consequently, some researchers performing animal research or teaching activities involving birds may be required to adhere to additional regulatory requirements. Determining What is Now Covered by ...

Jan 11 2024

eRAM Federal Regulations & Standards

ACUO Develops New Process for Collecting USDA Annual Report Data

In an effort to streamline reporting and minimize administrative burden on Study Teams, the Animal Care & Use Office (ACUO) has developed a new process to collect data for the U-M’s annual report to the United States Department of Agriculture (USDA). Laboratories whose work involves at least one USDA-regulated species (e.g., all live or dead ...

Jul 24 2023

Facilities Federal Regulations & Standards Husbandry

Reminders for Laboratories Using USDA-Regulated Species

The Animal Care & Use (ACU) Program is committed to providing the U-M research community with the tools and resources necessary for safeguarding animal welfare and assuring programmatic compliance. To that end, we have several important reminders for laboratories using USDA-regulated species (e.g., all live or dead warm-blooded animals except rats of the genus Rattus ...

Jan 27 2022

eRAM Federal Regulations & Standards IACUC

Annual Reviews Eliminated for USDA Studies

February 9, 2022 Update: Individuals with protocols involving a USDA-regulated species that are funded by the United States Department of Defense (DoD) should contact the Quality Assurance (QA) Team in the Animal Care & Use Office for additional guidance on how the federal Animal Care & Use Review Office (ACURO), the administrative oversight body for ...

Screenshot of APHIS Announcement Regarding Elimination of Annual Reviews for Most USDA Studies

May 29 2020

Federal Regulations & Standards

DoD Moves to Single Animal Use Appendix Template for All Protocol Submissions

The United States Department of Defense (DoD) recently announced changes to the formatting of appendices documents submitted for DoD funding via the Animal Care and Use Review Office (ACURO). Specifically, the Office has moved to a single version of the ACURO Animal Use Appendix (note: clicking on this link will download a PDF version of ...

Mar 25 2019

Federal Regulations & Standards IACUC

What Happens to Semi-Annual Inspection Findings

With Institutional Animal Care & Use Committee (IACUC) semi-annual facility inspections concluding and individuals following up on any eRAM Action Items, you may be wondering what happens to all of the information the Animal Care & Use Office (ACUO) collects. The semi-annual inspection process is used by the IACUC to ensure that U-M continues to ...