NABR DOT Complaint Makes Headlines

As you may be aware, 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. The docket closed for comments on December 6th, with comments of support from 156 organizations, representing hundreds of thousands of research professionals. Additionally, hundreds of individuals in the research community commented, expressing their support for NABR's complaint. For everyone who made comments, we thank you.

And boy did your comments get attention! The Chicago Tribune ran a piece entitled, "Scientists say United, other airlines illegally refuse to fly lab monkeys, fearing animal rights protesters." The highlight of this piece was, "The association [NABR] says many other airlines also refuse to carry animals used in biomedical research even though the carriers will fly those same species if they're pets or destined for zoos and sanctuaries. That policy is hampering vital research needed to develop medicines and therapies."

Outsourcing-pharma also weighed in with an article titled, "‘Patients will lose’ if airlines refuse to transport lab animals: NABR files complaint." NABR President Matthew Bailey warned the zoo, agriculture, entertainment, and pet industries to pay close attention, "because if airlines are making decisions based on the word of PETA, which opposes animal use in most of those areas, they very well may be next."

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.” The Washington Times has also posted an analysis of the research animal transportation issue: https://www.washingtontimes.com/news/2018/oct/22/animal-rights-extremists-should-not-be-dictating-a/.

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. The docket will close for public comments on December 6. 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:

AAALAC International
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 Toxicology
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 for Pharmacology and Experimental Therapeutics
The American Society of Andrology
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
California Institute for Medical Research
Camarney S.L.U.
Cardiovascular Research Institute-UCSF Zebrafish Shared Facility
Carolina Center for Neurostimulation
Case Western Reserve University School of Medicine
Charles River
Coalition for the Life Sciences
College on Problems of Drug Dependence
Columbia Center for Translational Immunology
Columbia University Institute of Comparative Medicine
Comparative Biosciences, Inc.
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
Emory University
Envigo
European Animal Research Association
European College of Laboratory Animal Medicine
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
Indiana University
Interpharma
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 Animal Breeders Association of North America, Inc.
Laboratory of Pharmacology and Toxicology
La Jolla Institute for Immunology
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 (Spain)
New Jersey Association for Biomedical Research
New York University
New York University School of Medicine
Northwest Association for Biomedical Research
Northwestern University
Novartis Pharmaceuticals Corporation
Noveprim Ltd.
Oregon Health & Science University
Partners Healthcare
Pennsylvania Society for Biomedical Research
The Pet Industry Joint Advisory Council
Pfizer Inc.
The Poultry Science Association Inc.
PreLabs, LLC
Research4life
RxGen
Scripps Research
Shriners Hospital for Children-Canada/McGill University
Sinclair Bio-Resources
Sinclair Research
Sleep Research Society
Smithers Avanza Toxicology Services LLC
Society for Neuroscience
Society for Research on Biological Rhythms
Society of Toxicology
States United for Biomedical Research
Taconic Biosciences
Takeda Pharmaceuticals
Texas Society for Biomedical Research
Tulane University
The Society of University Surgeons
Understanding Animal Research
Universidad Peruana Cayetano Heredia
University of Alabama at Birmingham
University of Hawaii System
University of Houston Division of Research
University of Illinois
University of Illinois at Chicago
inte
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
The University of Texas Rio Grande Valley
University of Wisconsin-Madison School of Medicine
University of Wisconsin-Madison Stem Cell and Regenerative Medicine Center
VetEquip Inc.
Wake Forest University
Washington Animal Research Network
Washington University in St. Louis School of Medicine
Yale University
Zoological Association of America

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.