News

The U.S. Food and Drug Administration (FDA) is holding a public hearing on Wednesday, September 12, 2018 on its Predictive Toxicology Roadmap. The Agency is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate them into regulatory review, as applicable.

The public hearing will be held at the FDA White Oak Campus in Silver Spring, Maryland, and will also be webcast. Those wishing to attend in person or view the webcast must register by Wednesday, August 29, 2018.

The June 30 Federal Register notice announcing the public hearing and providing instructions on submitting comments is available at https://www.federalregister.gov/d/2018-14052. More information about the FDA Predictive Toxicology Roadmap is available at https://www.fda.gov/ScienceResearch/AboutScienceResearchatFDA/ucm601090.htm. Information about the FDA White Oak Campus for those planning to attend in person is available at https://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm.

In a May 10 Federal Register notice, the U.S. Food and Drug Administration (FDA) announced availability of final guidance on the benefits and limitations of the use of microsampling techniques in toxicokinetics studies. Benefits of these techniques include reducing the numbers of animals needed for these studies.

The Federal Register notice is available at https://www.gpo.gov/fdsys/pkg/FR-2018-05-10/pdf/2018-09930.pdf. All FDA guidance documents are available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm

Register now  for the 5th Annual Symposium on Social Housing of Laboratory Animals being held June 4-5, 2018, in Beltsville, MD. Don’t miss out on the opportunity to learn about and discuss the social housing, environmental enrichment, and behavior of laboratory animals.

Findings show that although much 3Rs knowledge exists, its sharing can be improved through better coordination, communication and outreach, and by more emphasis on targeted education and training initiatives.

Pre-proposal deadline: April 30, 2018 - maximum grant amount has been changed to $40,000.

CAAT’s research grants program (http://caat.jhsph.edu/programs/grants) is a centerpiece of our work, providing initial funding for scientists to develop alternatives to the use of animals in biomedical research and product safety testing. To date, the center has funded some 300 grants (including renewals) for a total of more than $6 million.

The Johns Hopkins Center for Alternatives to Animal Testing (CAAT) is soliciting projects that focus on the implementation of the NAS Report: Toxicity Testing in the 21st Century: A Vision and a Strategy in the following areas:

• Proposals Relating to Toxicology: Maximum grant amount is $40,000. The objective should be to significantly reduce or replace laboratory animals. Projects should be developed to provide mechanistic understanding of in vitro responses to toxicants in human cells.  Consideration should be given to the translation of this new method to evaluate/predict health outcomes.
   
• Proposal Relating to Refinement:  See Science-Based Animal Welfare Awards – funded separately.

Although relatively small individually, these grants offer critical seed money that allows researchers to demonstrate the value of a particular area of study so they can gain support from the NIH and other sources.

We have a stringent, peer-reviewed process for selecting the recipients of these grants. This process consists of sending each application to at least four experts in the field from academic, industrial, and government institutions. These reviewers evaluate the applications with regard to scientific merit, budget appropriateness, suitability to CAAT's mission, and expertise of the investigators. They also assign a priority score based on the scoring system used by the NIH.

At the CAAT annual advisory board meeting, these applications are reviewed by board members. Board members constitute the voting contingent for the grant applications and assign priority scores in a secret ballot format based upon a synopsis of the outside reviews and the board reviewers. The applications are then ranked in order of priority score and those that receive fundable scores are awarded funds based upon availability of money for the fiscal year.

We continue to monitor the long-term progress of the Research Grant Program by requiring our grant recipients to submit copies of publications resulting from the work supported by CAAT grant funds. We maintain a list of publications and an archive of journal reprints.