Regulatory Brief

 Docket 2010-29748 Recommendations from the NIH Translational Medicine and Therapeutics Working Group


Formal title: Docket Number [2010-29748] U.S. Department of Health and Human Services, National Institutes of Health; Notice of Meeting of the Scientific Management Review Board

AVMA responds to notice of a meeting of the Scientific Management Review Board.

Brief Description:

In accordance with the National Institutes of Health (NIH) Reform Act of 2006, organizational authorities to the U.S. Department of Health and Human Services (HHS) and NIH officials establish or abolish national research institutes; reorganize the offices within the Office of the Director, NIH; and reorganize divisions, centers, or other administrative units within an NIH national research institute or national center. The Scientific Management Review Board (SMRB), advisory council within the NIH, held a meeting on December 7, 2010 to consider recommendations from the Translational Medicine and Therapeutics (TMAT) working group regarding the use of certain organizational authorities to potentially develop a new translational medicine institute. The recently authorized Cures Acceleration Network (CAN) and the established Clinical and Translational Science Awards (CTSA) program and consortium (an integral component of the NIH's National Center for Research Resources [NCRR]) are key components of the new institute/center (IC) proposed by the TMAT working group.

AVMA Response:

The AVMA suggests that the SMRB should maintain the integrity of each of the NCRR's divisions and programs, including not only the CTSA consortium, but also multiple other important programs that are administered through NCRR's four divisions—Comparative Medicine, Clinical Research Resources, Biomedical Technology, and Research Infrastructure.

The programs administered through the NCRR's Division of Comparative Medicine (DCM) are of particular importance to the AVMA's more than 81,000 members. AVMA notes that veterinary scientists understand: 1) the health and welfare needs of all species of laboratory animals and are able to ensure those needs are met; 2) the usefulness and limitations of animal models; and 3) the regulatory requirements to bring a new human drug to market. All of these are key components of translational medicine and therapeutic development research. As such, the AVMA strongly supports and affirms the recognition by the NIH of the role of veterinarians as scientists, educators, trainers, and collaborating partners in scientific research that takes a comparative, one-medicine approach to improvements in human and public health, as stated in the NCRR 2009-2013 strategic plan (www.ncrr.nih.gov/strategic_plan/). Current DCM programs are as essential a component of a strong translational medicine and therapeutic development research institute as are the CAN and CTSA programs.

Background Documents:

The AVMA responded with written comments on December 6, 2010.

View Federal Register document

In addition, Dr. Mark Lutschaunig, Director of the AVMA Governmental Relations Division, attended the December 7, 2010 meeting and provided oral comments on behalf of the Association.