Federal Regulations & Standards

Federal Regulations & Standards IACUC

Guidance & Best Practices for Performing Literature Searches

The U-M’s Institutional Animal Care & Use Committee (IACUC) requires that all Principal Investigators (PIs)/Study Teams provide detailed justification(s) for the use of any vertebrate animal or cephalopod in research or instruction. In addition to fulfilling its regulatory obligation(s), outlined in greater detail in the federal Animal Welfare Act & Animal Welfare Regulations (AWA/AWR), the ...
Computer with screenshot of USDA AWIC Literature Searching webpage and gold 3Rs logo

Drugs Federal Regulations & Standards Guidelines Policies ULAM

A Visual Guide to Finding Beyond Use Dates on Drug Packaging

Many pharmaceutical products used in animal-based research have a standard “Expiration Date” as well as a “Use-By-Date” (i.e., “Beyond Use Date”). These dates are generally included on the package insert or vial and can often be found under the headings “Storage,” “Storage Instructions,” or “Dosage and Administration.” Some products that are formulated by multiple manufacturers ...
Enrosite vial and packaging labeled with Beyond Use Date

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

Federal Regulations & Standards Policies Safety

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

May 2025 Update On May 5, 2025, a new Executive Order (EO) was issued calling for modifications to the 2024 United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (often referred to as the “USG DURC-PEPP Policy”). As the institution awaits additional guidance on how the provisions ...
document icon reading "new policy DRUC-PEPP"

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 ...
Icon of birds sitting on a branch with USDA logo

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