Please File Letters of Support for NABR DOT Complaint

As previously reported in our update, NABR has filed an official complaint with the U.S. Department of Transportation (DOT) regarding the refusal of major airlines to carry animals for the purpose of research. Opponents to animal research have now activated their grassroots networks and are flooding the docket with individual comments. Please help us show the DOT how critical this issue is to the future of biomedical research.

The importation of non-human primates (NHPs) for research into the U.S. has become problematic. Further, the transport of several other research species around the world has also become increasingly challenging. As a result, the research community is beginning to see increased costs and uncertainty about the future of research projects. However, without access to the appropriate models for medical research, the public stands to lose the most, as treatments for emerging public health crises may be delayed, discontinued, or moved to other countries. This issue was also featured on September 21 in The Scientist, in that article NABR President Matthew Bailey stated, “Unfortunately, opponents to animal research have engaged in tactics of harassment, protests, and public smear campaigns in an effort to end the transportation of vital research animals involved in health studies worldwide.”

NABR strongly encourages research institutions to submit letters of support for NABR’s complaint on the DOT docket which argues that airlines’ refusal to ship research animals violates common carrier rules regarding discrimination of cargo. If you have not done so, please submit a letter either as an individual or institution. Instructions on how to access the docket can be downloaded here: http://www.nabr.org/wp-content/uploads/2018/09/Instructions-for-Access-DOT-docket.docx. NABR has also made a template letter available for download.

Please take a moment to file a personal comment of support or draft a letter on behalf of your organization.

The following organizations have currently filed comments in support of the complaint:

• AbbVie Inc.
• Academy of Laboratory Animal Veterinary Technicians and Nurses
• Agenda Resource Management
• American Association for Laboratory Animal Science
• American Association of Immunologists
• American Brain Coalition
• American College of Laboratory Animal Medicine
• American College of Neuropsychopharmacology
• American College of Veterinary Pathologists
• American Federation of Aviculture, Inc.
• American Neurological Association
• American Physiological Society
• American Psychological Association
• Americans for Medical Progress
• American Society of Andrology
• American Society for Pharmacology and Experimental Therapeutics
• American Society of Animal Science
• American Society of Clinical Psychopharmacology
• American Society of Laboratory Animal Practitioners
• American Society of Primatologists
• American Veterinary Medical Association
• Arizona State University School of Life Sciences
• Associated Medical Schools of New York
• Association for Research in Vision and Ophthalmology
• Association of American Medical Colleges
• Association of American Universities
• Association of American Veterinary Medical Colleges
• Association of Primate Veterinarians
• Association of Public and Land Grant Universities
• Animal Health Institute
• Axion Research Foundation
• Basel Declaration Society
• Baylor College of Medicine
• BFC Israel
• Bioculture (Mauritius) Ltd.
• Bridge the Gap
• Brown University
• California Biomedical Research Association
• Camarney S.L.U.
• Cardiovascular Research Institute-UCSF Zebrafish Shared Facility
• Carolina Center for Neurostimulation
• Case Western Reserve University School of Medicine
• Coalition for the Life Sciences
• College on Problems of Drug Dependence
• Columbia Center for Translational Immunology
• Columbia University Institute of Comparative Medicine
• Cornell University
• Council on Governmental Relations
• Drexel University
• Duke University Laboratory Animal Resources
• Duquesne University
• The Preston Robert Tisch Brain Tumor Center at Duke University
• Ellegaard Gottingen Minipigs
• Envigo
• European Animal Research Association
• European Federation of Pharmaceutical Industries and Associations
• Federation of American Societies for Experimental Biology
• Federation of European Laboratory Animal Science Associations
• Federation of European Neuroscience Societies
• GIRCOR
• Harvard University, Faculty of Arts and Sciences Office of Animal Resources
• Helsinki Institute of Life Science
• Howard Hughes Medical Institute Janelia Research Campus
• Icahn School of Medicine at Mount Sinai
• Illinois State Veterinary Medical Association
• Institutional Officials Consortium
• International Mammalian Genome Society
• International Society for Stem Cell Research
• The Jackson Laboratory
• JMC Welfare International Ltd.
• Johns Hopkins University -signed by Professor and Vice Provost for Research
• International Society for Transgenic Technologies
• Laboratory of Pharmacology and Toxicology
• Louisiana State University
• The Mannheimer Foundation, Inc.
• Massachusetts Society for Medical Research
• The Max Planck Institute for Neuroscience
• McLaughlin Research Institute for Biomedical Sciences
• McLean Hospital
• MD Anderson Cancer Center
• Medical College of Wisconsin
• Merck KGaA
• The Michael J Fox Foundation for Parkinson’s Research
• Michigan State University
• Musella Foundation
• National Animal Interest Alliance
• National Association for the Advancement of Animal Science
• National Association of Veteran’s Research and Education Foundations
• National Primate Research Centers
• The Neuropsychopharmacology Translational Research Unit of the Albacete General Hospital
• New Jersey Association for Biomedical Research
• New York University
• New York University School of Medicine
• Northwest Association for Biomedical Research
• Northwestern University
• Noveprim Ltd.
• Oregon Health & Science University
• Partners Healthcare
• Pennsylvania Society for Biomedical Research
• The Pet Industry Joint Advisory Council
• Pfizer Inc.
• PreLabs, LLC
• Research4life
• RxGen
• Scripps Research
• Shriners Hospital for Children-Canada/McGill University
• Sinclair Research
• Sleep Research Society
• Smithers Avanza Toxicology Services LLC
• Society for Neuroscience
• Society of Toxicology
• States United for Biomedical Research
• Texas Society for Biomedical Research
• The Society of University Surgeons
• Understanding Animal Research
• Universidad Peruana Cayetano Heredia
• University of Alabama at Birmingham
• University of Houston Division of Research
• University of Illinois
• University of Iowa
• University of Maryland School of Medicine
• University of Michigan
• University of Minnesota Research Animal Resources
• University of New Mexico Health Sciences Center
• The University of Oklahoma
• University of Pennsylvania
• University of Pennsylvania Animal Welfare
• University of Pittsburgh School of Medicine
• University of Wisconsin-Madison Stem Cell and Regenerative Medicine Center
• VetEquip Inc.
• Wake Forest University
• Washington Animal Research Network
• Washington University, St. Louis School of Medicine
• Yale University

Click here to view the docket which includes all relevant documents: https://www.regulations.gov/docketBrowser?rpp=25&so=DESC&sb=commentDueDate&po=0&D=DOT-OST-2018-0124 

Senate Commerce Committee Unanimously Advances OSTP Nominee

The Senate Committee on Commerce, Science, and Transportation advanced the nomination of Dr. Kelvin Droegemeier for Director of the White House Office of Science and Technology Policy (OTSP) on Wednesday during their executive session. The committee voted unanimously to advance Droegemeier, who is expected to face a full Senate vote later this month.

Droegemeier was Vice President for Research at the University of Oklahoma-Norman from 2009 until August of 2018. He also served on the National Science Board under both Presidents George W. Bush and Barack Obama. Droegemeier is currently Secretary of Science and Technology for the state of Oklahoma.

During his August 23 confirmation hearing, Droegemeier indicated his strong support for the U.S. research community by stating, “We need to make sure we are the strongest research center in the world.”

Rally for Medical Research This Week, September 12 and 13

The American Association for Cancer Research (AACR) is hosting their annual Rally for Medical Research in Washington, DC on September 12 and 13 to call on Congress to make funding for the National Institutes of Health (NIH) a national priority. The event is also an opportunity for individuals and organizations to showcase why they support medical research and how it positively impacts lives every day. You can read more about the event at the Rally for Medical Research’s Facebook page or web site.

Can’t make it to Washington next week but still want to help? Please print an “I Rally For...” sign, fill it out, and post in on social media like Facebook, Twitter, and Instagram with the hashtags #IRallyFor and #RallyMedRes. If using Twitter, remember to tag NABR (@NABRorg) and our sister organization the Foundation for Biomedical Research (FBR)(@researchsaves), as well.

Mark your Calendars for NABR’s October Webinar

NABR will be hosting our next webinar, “Advocating for Sound Public Policy: The Challenges and Opportunities for Participating in the Process” on Tuesday, October 9. In this webinar, we will discuss what constitutes sound public policy, how NABR engages in that process, and —most importantly— what NABR members can do to assist.

For example, in the past year, the research community has been afforded opportunities to respond to Requests for Information (RFI) on reducing regulatory burden from the USDA, the NIH, and the FDA. These RFIs have provided the research community an excellent opportunity to advocate for the development and implementation of improved regulations, policies, and guidelines.

On July 25, the Health subcommittee of the House Energy & Commerce (E&C) committee held a hearing titled "21st Century Cures Implementation: Updates from FDA and NIH." During that hearing NIH Director Dr. Francis Collins responded to questions concerning the regulatory relief mandate in the 21st Century Cures Act. In this webinar we will discuss how NABR formulates responses to those RFIs and we will review how the research community can participate in these processes, draft their own responses, and engage in the policy process to have a significant impact on the environment in which we all work.

Click here to reserve your spot!

President Trump’s Nominee for Science Advisor Committed to Science Over Politics

Nature reported on August 23 that President Donald Trump’s nominee for the White House Office of Science and Technology Policy (OSTP), Meteorologist Dr. Kelvin Droegemeier, said that science should be conducted without political influence or interference.

Droegemeier was Vice President for Research at the University of Oklahoma-Norman from 2009 until August of 2018. He also served on the National Science Board under both Presidents George W. Bush and Barack Obama. Droegemeier is the current Secretary of Science and Technology for Oklahoma.

During his August 23 Senate Commerce, Science, and Transportation Committee nomination hearing, Droegemeier stated, “Science never provides immutable evidence about anything. I think science is the loser when we tend to vilify and marginalize other voices. We need to have everyone at the table.” The quote was from a segment where Droegemeier was questioned about climate change, though his attitudes towards science trumping politics is important and interesting to note especially since it is regarding an equally controversial research topic.

Droegemeier also emphasized the need to be competitive in research regarding China, telling the Committee, “We need to make sure we are the strongest research center in the world.” This is an interesting point since The Scientist reported on August 21 that primate research is dropping in the west while China is positioning itself to be a global leader in that sphere.

The Committee is set to vote on August 29 on whether to advance Droegemeier’s nomination to the full Senate.

Research!America Offers Novel Civil Engagement Initiative

Research!America has rolled out a novel bipartisan civic engagement initiative that is providing $1,000-$3,000 grants to student science policy groups. The goal is to better engage the next generation of scientists in the public policy process and impressing upon policymakers the importance of science in the 2018 midterm elections. The grants can be used for “lab tours, roundtable discussions, and policy briefings with candidates; host community science events and Pub Nights; support social media engagement including Twitter chats; conduct media outreach; and organize webinars highlighting the benefits of federally funded research.”

This initiative is born from the necessity to get researchers, particularly young researchers, involved in the public policy process to protect and promote their work. Lawmakers take input from the scientific community seriously, however researchers are often reluctant to engage in the policy process and share their work. Research!America’s civic engagement initiative is a creative way to incentivize communication with legislators that the research community needs.

Congress Questions NIH Director on Animal Research Regulatory Burden

On July 25, the Health subcommittee of the House Energy & Commerce (E&C) committee held a hearing titled "21st Century Cures Implementation: Updates from FDA and NIH." A recording of the hearing can be viewed on the House E&C YouTube site. The intent of this hearing was to get an update from the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) on their implementation of the 21st Century Cures Act.

Of interest to the animal research community is Section 2034(d) of the 21st Century Cures Act, enacted on December 13, 2016, which reads, “Not later than 2 years after the date of enactment of this Act, the Director of National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs, shall complete a review of applicable regulations and policies for the care and use of laboratory animals and make revisions, as appropriate, to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals. In carrying out this effort, the Director of the National Institutes of Health shall seek the input of experts, as appropriate.”

On March 14 the NIH put out a Request for Information (RFI) regarding animal care and use in research in an effort to comply with Section 2034(d) of the 21st Century Cures Act. However, in his written testimony submitted prior to the hearing, NIH Director Francis Collins included a section on reducing administrative burden and increasing efficiency, but did not mention animal research.

Two members of Congress on the Health subcommittee asked pointed questions of the Director on this issue. The first question came just after the 40:00 mark from Chairman Michael Burgess (R-TX), who asked, “We tried to identify ways to get regulations and policies that were inconsistent, and to give you some flexibility to move past some of these that are over-lapping and unnecessarily duplicative to relieve some of the administrative burden. I think the Act asked you to review that, so can you perhaps share with us where you are in the review and how NIH has identified some opportunities to relieve the burden on investigators?”

While Dr. Collins’ answer initially focused on how the NIH deals with grants, near the end of his answer he mentioned animal care and use by stating, “We’re looking right now at animal care and use and the oversight that is necessary, of course, to be sure that we’re dealing with animals in an ethical way. Some of those of those particular oversight mechanisms are now being reviewed. We put out an RFI and got 19,000 comments back from people who have opinions about how we might streamline these processes. Those are a few examples.”

Later, just after the 2:21:00 mark, Rep. “Buddy” Carter (R-GA) pushed Dr. Collins for a more direct answer by asking, “I wanted to ask about one of the initiatives of 21st Century cures, and that was to really review the regulations and policies with respect to research with laboratory animals. As I understand it you are working with USDA now and the FDA to try to complete a review of that. I wanted to ask you if you could tell us the current status of that review and when do you anticipate the completion of that review?

Dr. Collins replied, “We did put out an RFI back in March to ask for comments in this area in terms of whether the oversight that we currently apply to animal experimentation is sufficient or whether it has areas that are overly bureaucratic, which has been a concern. Obviously, we are deeply concerned about maintaining our ethical responsibilities in terms of how we take care of animals that are subjected to various experimental approaches, from which we learn a great deal that has led to many medical advances. We got 19,000 responses to that request and they are currently being sorted at the moment. We would expect to have, based upon those, a draft set of recommendations about animal care and use sometime probably in September. We will then need to have responses to that. So, we would hope to have a final version of this by December, or early in 2019.”

Rep. Carter pressed further asking, “Any opportunities that you’ve identified thus far that may help you?

Again, Dr. Collins highlighted grant issues by stating, “…I think there are concerns that some of the requirements that we put on grant applicants, in terms of animal care and use, could be delayed until the award is actually made as opposed to asking them to have all those things in place when they submit an application. That can add a lot of time and effort, and obviously our concern is that if we’re actually going to make the award we want to be sure that the animal care is being done in the best possible way. That is one area. Obviously, there are differences of opinion here and we’re seeing those in 19,000 responses and at some point, we have to try to come down on what we think is a fair and balanced approach.”

NIH Issues RFI on Assessing the Safety of Relocating At-Risk Chimpanzees

The National Institutes of Health (NIH) issued a Request for Information (RFI) on June 11 in the Federal Register titled, “Input on Report from Council of Councils on Assessing the Safety of Relocating At-Risk Chimpanzees.” This RFI stems from the 2015 decision by NIH Director Francis Collins that all NIH-owned chimpanzees should be retired and relocated to the chimpanzee sanctuary, Chimp Haven, in Keithville, LA. However, many of the NIH-owned chimpanzees are of an advanced age and relocation has caused unnecessary stress on several of them. Additionally, there have been an alarming number of deaths of retired chimpanzees after relocation to Chimp Haven during the past several years.

The NIH posted the notice in the Federal Register to inform the research community, and other interested parties, that it has received a report from the Council of Councils Working Group on Assessing the Safety of Relocating At-Risk Chimpanzees. The NIH will consider the recommendations in the report and is inviting the public to comment in response the RFI. This RFI is open for public comment for a period of 60 days and comments must be submitted by August 10, 2018. Comments must be submitted electronically here: https://grants.nih.gov/grants/rfi/rfi.cfm?ID=72.

USDA-APHIS Will Not Recognize Third-Party Inspections and Certifications

On May 25, the U.S. Department of Agriculture's (USDA) Animal and Plant Health Inspection Service (APHIS) released a statement which reads, “it will not establish new criteria for recognizing third-party inspection and certification programs when determining the Agency’s own inspection frequency under the Animal Welfare Act (AWA).”

APHIS had announced a series of public listening sessions starting in December of 2017 to hear feedback from the regulated community and others. APHIS also posted a Federal Register notice in January 2018 asking for written comments through March 21. In the end, APHIS received over 35,000 written comments, many of which were submitted by animal rights groups. APHIS asserts the vast majority of comments they received expressed concern with AWA compliance being in jeopardy if third-party inspections were utilized.

APHIS continues to support its risk-based inspection system when determining the frequency of their AWA inspections. You can view the listening session comments here and the Federal Register comments here.

Farm Bill Amendment for Regulatory Relief Filed in U.S. House

Rep. David Rouzer (R-NC) has filed an amendment to H.R. 2, the 2018 Farm Bill, to address the need to provide regulatory relief for the nation’s animal researchers. The proposed change, as drafted by Rep. Rouzer, replaces the yearly mandate for U.S. Department of Agriculture (USDA) inspections at animal research facilities with “every three years.” As a draft amendment, it must clear the House Rules Committee. The Senate, which has yet to hammer out their own version of the Farm Bill, has not indicated whether a similar provision will be included. It is important to clarify that this amendment in no way ends USDA's inspections.

NABR strongly supports this move towards regulatory relief for the biomedical research community and improved flexibility for the USDA to focus efforts on bad actors. The National Science Board (NSB) has reported that researchers spend as much as 42% of their time responding to regulatory and administrative burdens. Numerous reports, including the October 2010 report by the Federation of American Societies for Experimental Biology (FASEB), the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), and the National Association for Biomedical Research (NABR) have made recommendations for reducing regulatory burdens in biomedical research. Additionally, the 21st Century Cures Act signed into law, signed into law on December 13, 2016, mandates that federal agencies work to reduce regulatory burden on the animal research community.