Regulations and Standards

AAALAC International Reviews Updated Guidelines
On 14 December 2010, AAALAC International reported it will begin to use three primary standards to evaluate animal care and use programs in the Fall of 2011: the ILAR Guide, the FASS Ag Guide, and the ETS 123.This is a change from simply recognizing the ILAR Guide as AAALAC’s sole primary standard. Until then, the 1996 version of the Guide will continue to be the main standard AAALAC will use to evaluate programs of animal care and use.

In its “Recap”, AAALAC reported it:

• Reviewed 121 changes, in the ILAR’s 8th edition of the Guide for the Care and Use of Laboratory Animals (the Guide,NRC), some of which are significant and may affect the accreditation process.
• Determined there was extensive harmonization between the Guide for the Care and Use of Agricultural Animals in Research and Teaching (FASS 2010) and the ILAR Guide, in spite of some key differences.
• Determined there is extensive harmonization between the principles of the ETS 123—the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purpose, and the ILAR Guide,with some differences identified in engineering standards. AAALAC plans to clarify these differences and its expectations for accredited institutions shortly.

Read AAALAC’s presentation at the 2010 National AALAS meeting: “Implementing the 2010 Guide” for more details.

• About AAALAC. 2010 recap. December 14, 2010. http://www.aaalac.org/about/guidetransition.cfm
• Directive 2010/63/EU of the European Parliament and of the Council on the protection of animals used for scientific purposes. 22 September, 2010. http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri= OJ:L:2010:276:0033:0079:EN:PDF
• Download a copy of AAALAC’s presentation at the 2010NationalAALAS: “Implementing the 2010 Guide” for more details from http://www.aaalac.org/about/AAALAC_International_Approach_to_Implementing_t he_2010_Guide.pdf

Hello National Advancing Translational Sciences Center— Goodbye NCRR
On 14 January 2011, Kathleen Sebelius, Secretary of Health and Human Services, informed Tom Harkin,Chairman of the Committee on Health, Labor, and Pensions of the United States Senate that, pursuant to section 401(d)(2) of the Public Health Service (PHS) Act, as amended, she has determined that, based on information the NIH Director provided her:

• It is necessary to establish the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).
• The new center will enhance the therapeutic development process and encompass multiple programs at NIH.
• No longer required, the National Center for Research Resources (NCRR) and its relevant functions and programs will be transferred to this new center in FY 2012.
• NCRR functions not involving translational sciences will be transferred to other existing Institutes and Centers at NIH, as appropriate.
• NIH will undertake a thorough scientific review of NCRR programs to make these assessments.

On 24 January 2011, in an effort to calm the ensuing media excitement about this announcement and the dreaded elimination of the popular and historically helpful NCRR, NIH Director Francis S. Collins and his NIH colleagues responded that, committed to continued support for basic, translational, and clinical research, the NIH believes:

• “The proposal for NCATS [is that it]will be assembled primarily from existing programs within the National Center for Research Resources (NCRR), the NIH Common Fund, and the National Human Genome Research Institute (NHGRI).”
• “NCATS is not intended to be a drug company. It is a facilitator of translational research across the NIH and complementary to translational research already being conducted and supported on a large scale in the individual NIH Institutes and Centers. NCATS will seek ways to leverage science to bring new ideas and materials to the attention of industry by demonstrating their value.”
• “The final budget for the proposed center is unknown at the present time. For the most part, the budget and staff for each relocated program will remain with that program. Thus, the overall budget for NCATS will be the sum of the imported programs— an amount much smaller than the several billion dollars currently being spent on translational research by existing Institutes and Centers.”
• “There are no plans to ‘cannibalize’ the budgets or programs of other NIH Institutes and Centers to form NCATS.”
• “The new Center will bring several existing efforts together in new ways to enhance the ability of all NIH Institutes and Centers to perform research that leads to the development of drugs, diagnostics, devices, vaccines, and strategies for prevention.”

On 16 January 2011,The NCRR Task Force, co-chaired by Dr. Larry Tabak and Alan Guttmacher posted a draft NCRR Straw Model of the proposed new NIH homes for current programs of NCRR.