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.”