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.

 

House Agriculture Committee Releases 2018 Farm Bill

Yesterday the House Agriculture Committee released their text of the 2018 Farm Bill. Why is this important to the research community? The Farm Bill effects virtually all actions taken by the U.S. Department of Agriculture (USDA), including the agency’s oversight of the Animal Welfare Act (AWA). This bill is a perennial target for use as a vehicle to enact further restrictions on animal research.

The Senate has yet to release its version of the bill. The question of whether a House version would be introduced was in doubt due to controversy over nutrition and food stamps issues.

Please visit the House Agriculture Committee’s web page on the Farm Bill to read the bill, fact sheets, and other resources.

NIH Director Testifies at FY19 Budget Hearing

Dr. Francis Collins, Director of the National Institutes of Health (NIH), appeared before the House Appropriations Subcommittee on Labor, Health and Human Services, and Education on Wednesday to discuss the FY 2019 budget.

Dr. Collins received nearly universal, bipartisan support for the work that NIH has done over the years. Many of the questions predominating the hearing revolved around the current opioid crisis and what work was being done to treat and prevent addiction. During one exchange with Rep. Mark Pocan (D-WI), Dr. Collins discussed how technology is rapidly changing the research arena, using a “kidney on a chip” as an example.

The consensus of the hearing was that, in strained financial times, the money spent on NIH was a worthwhile investment given the current opioid crisis and continued need for biomedical research. Dr. Collins noted that nearly 100% of the drugs approved by the Food and Drug Administration (FDA) between 2010 and 2016 benefited in some way by NIH’s involvement.

Please click here if you’d like the view the hearing.

Trump Picks HIV/AIDS Researcher as New CDC Director

President Donald Trump has named Robert Redfield as the new director of the Centers for Disease Control and Prevention (CDC). His appointment comes after former Director Brenda Fitzgerald resigned following a POLITICO investigation revealing she had traded tobacco, food, and drug stocks while leading the agency.

Redfield, a clinical scientist and former Army doctor, co-founded the Institute of Human Virology at the University of Maryland School of Medicine. He also previously served on President George W. Bush’s HIV/AIDS advisory panel and in various advisory roles at the National Institutes of Health (NIH).

The decision has been criticized because of Redfield’s earlier research and views, controversies that POLITICO highlights in coverage of his appointment. He has, however, received the support of Rep. Elijah Cummings (D-MD) who said in a statement, “Although I seldom agree with the Trump administration, I am in complete agreement that Dr. Bob Redfield is the best choice to lead the CDC."

President Signs Omnibus Bill

Earlier today, President Donald Trump signed the FY18 omnibus bill to keep the federal government open until September 30. President Trump had previously announced via Twitter earlier in the morning that he was considering vetoing the bill because of the border wall and Deferred Action for Childhood Arrivals (DACA) issues.

There were several animal provisions in the bill. The omnibus will include $30,810,000 (a $2 million increase from FY17) for enforcement of the Animal Welfare Act (AWA), including continuing inspections of U.S. Department of Agriculture (USDA) Agricultural Research Service (ARS) locations conducting research with farm animals.

The omnibus also addresses the USDA database issue by noting, “On February 3, 2017, USDA restricted the public's access to the search tool for the Animal Care Inspection System, saying it needed to conduct a comprehensive review of the information on its website. USDA is now posting heavily redacted inspection reports that make it difficult in certain cases for the public to understand the subject of the inspection, assess USDA's subsequent actions, and to evaluate the effectiveness of its enforcement. USDA's actions to date do not meet the requirements in H. Rpt. 115-232 that the online searchable database should allow analysis and comparison of data and include all inspection reports, annual reports, and other documents related to enforcement of animal welfare laws. USDA is directed to comply with these requirements and is reminded that as part of its oversight responsibilities, Congress has the right to make any inquiry it wishes into litigation in which USDA is involved. USDA is directed to respond to any such inquiries fully.”

Level funding of almost $21.5 million for the Environmental Protection Agency’s (EPA) Computational Toxicology program was also included in the bill to develop effective alternatives, as required by the 2016 reauthorization of TSCA, the Toxic Substances Control Act. Rejecting a $212 million cut proposed by the President, the bill also increases funding of the National Institute (NIH) National Center for the Advancement of Translational Sciences (NCATS) by over $36 million.

The omnibus didn’t stop there. Aside from encouraging the expedited transfer of NIH’s retired chimpanzees and expansion of the federal sanctuary system, it also contained a prohibition on funding for Class B licenses by the USDA, which has been included several times before. It also prohibits the Department of Veterans Affairs (VA) from using funding for “research using canines unless: the scientific objectives of the study can only be met by research with canines; the study has been directly approved by the Secretary; and the study is consistent with the revised Department of Veterans Affairs canine research policy document released on December 18, 2017.” Also, it requires the VA Secretary to submit to both the House and Senate Appropriations Committees a “detailed report outlining under what circumstances canine research may be needed if there are no other alternatives, how often it was used during that time period, and what protocols are in place to determine both the safety and efficacy of the research.”

To read the full 2,232 page FY18 omnibus, please click here.

Chairman of Senate Committee on Appropriations Announces Retirement

Senator Thad Cochran (R-MS) announced last week that he will retire from the U.S. Senate on April 1 for health reasons.

Elected in 1978, Cochran is chairman of the powerful Senate Committee on Appropriations. His retirement will lead to two Senate races in Mississippi this fall, as his colleague Sen. Roger Wicker (R-MS) is also up for reelection. Republican Gov. Phil Bryant will appoint a temporary replacement for Cochran until a special election in Nov.

As for his Chairmanship, the position will be filled by Senator Richard Shelby (R-AL) who told The New York Times “It would be a great honor, but I’m not there yet,”  adding, “I would be interested at the proper time.”

New NIH Working Group to Develop Guidelines for Chimpanzee Retirement

What to do with nearly 300 retired research chimpanzees has remained a question for quite some time. Currently in three medical research centers, the animals have been awaiting transfer to the only federal retirement sanctuary: Chimp Haven.

The National Institutes of Health (NIH) plans to organize a working group for developing recommendations for veterinarians to consider when or if to transfer chimpanzees. This comes after a number of deaths of former research chimps shortly after arriving at the sanctuary. The unavoidable stress of moving the animals, many of which are elderly and sick, has raised concerns leading many to question whether moving the animals at all is a wise endeavor.

“Retirement in place” at the medical research centers, in the animals’ existing social groupings, has been suggested as a preferable alternative. The NIH’s formation of a working group could signal a reevaluation of the subject of research chimpanzee retirement.

Nature covered this story early in the week, which can be read in its entirely here.

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