May 3, 2018

NABR’s Comments to NIH on Regulatory Burden Available

The National Institutes for Health (NIH) released NOT-OD-18-152 on March 14, a Request for Information (RFI): Animal Care and Use in Research. The RFI’s stated objective is to assist the Office of Laboratory Animal Welfare (OLAW) with obtaining “information to improve the coordination of regulations and policies with respect to research with laboratory animals as required by the 21st Century Cures Act, Section 2034(d).” The background information of the notice states that “the NIH in collaboration with the United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) [will] complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions to reduce administrative burden on investigators. In carrying out this effort, the law requests NIH seek input to identify ways to ensure regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative.”

NABR will submit comments in response to the RFI, a draft of which can be located here. Responses must be submitted electronically at https://grants.nih.gov/grants/rfi/rfi.cfm?ID=71 by June 12, 2018.

In the April 5th issue of the NABR Update we provided our perspective of the RFI. The RFI indicates that in carrying out the review mandated in the language of the 21st Century Cures Act, the NIH, USDA, and FDA will be reviewing several reports and surveys. However, there is no indication they will actually be conducting a review of applicable regulations and policies, nor seeking the input of experts where appropriate in this process, as required by the Act. The RFI’s stated goal is to seek input on only the three process-related duties of the Director of the NIH, rather than the primary mandate. The primary mandate in the 21st Century Cures Act, Section 2034(d) is the review and revision of applicable regulations and policies in order to provide regulatory relief to investigators. Moreover, the Act does not require the NIH Director to seek the input of experts on the three processes as presented. The fact the RFI is seeking input on “proposed actions that the agencies have identified to improve coordination and harmonization of regulations and policies” does not appear to be consistent with the mandate in the Act. Additionally, the word count restriction for submissions prevents the research community from fully providing its desired comments regarding the USDA’s current RFI, Identifying Regulatory Reform Initiatives.

USDA to Consider Announced Inspections

NABR has learned that Bernadette Juarez, Deputy Administrator of Animal Care at the USDA’s Animal and Plant Health Inspection Service’s (APHIS), distributed a letter dated April 11 making some licensees and registrants with the Animal Welfare Act (AWA) aware that USDA is exploring the possibility of announced inspections to improve compliance rates. A pilot project with the stated goal of improving the use of USDA’s inspection resources is expected to be made public soon. The letter further states that research by USDA has found a combination of announced and unannounced inspections conducted by other regulatory bodies maximizes compliance. A final decision on the use of announced inspections has not yet been made. A copy of the letter can be read here.

VCU Researcher Reminds the Public Why Animal Research is Necessary

"We gotta get people out of the hospital. It's why we do research." That’s what Dr. Bill Dewey, Chair of the Virginia Commonwealth University (VCU) Pharmacology and Toxicology Department, said in a Richmond news article about animal research aimed at curbing the nation’s opioid addiction epidemic. Per the Centers for Disease Control (CDC), the opioid epidemic kills 115 people per day in the U.S., and WRIC in Richmond, VA reports there are five ongoing studies at VCU funded by the NIH. In the piece questioning VCU’s research, Dr. Dewey explained that the purpose of VCU’s research with primates is to find pain relief without addiction, a much-needed medical objective. When asked about the opposition of animal rights groups, he responded, "I disagree with that because I think it's like the story of giving a man a fish… Teaching him how to fish is better." To read and watch Dr. Dewey’s salient comments about the value of animal research studies, please click here.

Help FBR Today!

Can you help spread the important message of how animal research is leading to real world advancements in medicine? Then please consider writing a guest blog post for the Foundation for Biomedical Research’s (FBR) blog. As you may know, FBR is NABR’s sister organization and they are tasked with the challenging responsibility of public outreach highlighting the importance of animal models in today’s research for tomorrow’s cures. If you feel up to the task and would like to discuss your research, your direct impact to disease or illness, or how animal research has touched you or a loved one, for example, please email info@fbresearch.org for more information. If you don’t want to write but would still like to help, please consider a tax-deductible gift to FBR. Any amount helps and will go a long way in the effort to promote public understanding and support for humane and responsible animal research.