[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Pages 43604-43605]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18168]



National Institutes of Health

National Institute of Allergy and Infectious Diseases (NIAID); 
Notice of Workshop

SUMMARY: The National Institute of Allergy and Infectious Diseases 
(NIAID), a component of the National Institutes of Health; the Food and 
Drug Administration (FDA); the Transformational Medical Technologies 
(TMT); and Biomedical Advanced Research and Development Authority 
(BARDA) are holding an Animal Model Development Workshop to explore the 
scientific and regulatory challenges of developing medical 
countermeasures (MCM) under the ``Animal Rule'' (21 CFR 314.600 for 
drugs; 21 CFR 601.90 for biological products). The goals of this 
workshop are to highlight the significant progress made in animal model 
development for MCMs, review recent case studies of products under 
development using animal models, and capture lessons learned to inform 
future animal model development efforts. In addition, the workshop will 
provide a forum to discuss current challenges and identify potential 
solutions or mitigation strategies.

DATES: The workshop will be held on September 17-18, 2012, at 8 a.m. 
EST. Participants must register by September 10, 2012.

ADDRESSES: The workshop will be held at the NIH Natcher Conference 
Center, Building 45, 45 Center Drive, Bethesda, Maryland 20892.

SUPPLEMENTARY INFORMATION: During the past decade, much progress has 
been made in the development of candidate medical products to prevent, 
treat, or diagnose the health effects of exposure to chemical, 
biological, radiological, and nuclear (CBRN) agents. With the 
convergence of scientific progress in medical countermeasures (MCMs) 
development, improvements in containment laboratory infrastructure, 
technological advances, and additional regulatory guidance, the stage 
is set for tangible progress in our ability to advance MCMs for CBRN 
agents. The effects of these efforts were evident in several recent FDA 
Advisory Committee meetings: anthrax vaccines (2010), smallpox 
therapeutics (2011), and plague antimicrobials (2012). Especially 
promising is the recent emphasis on cooperation among government 
agencies to leverage resources (scientific, human, and fiscal) in an 
effort to advance the development of animal models.
    A solid regulatory and policy framework for fostering development 
of well-characterized animal models now exists. The Animal Rule laid 
the foundation for current efforts. FDA's draft guidance on Animal 
Models--Essential Elements to Address Efficacy Under the Animal Rule 
(January 2009) built upon that foundation and is currently undergoing 
substantial revision. More recently, the draft guidance on 
Qualification Process for Drug Development Tools (October 2010) 
outlined a concrete process for qualifying animal models. However, 
multiple scientific and regulatory challenges remain in animal model 
    This workshop is designed to explore the unique challenges being 
faced with the development of animal models for the evaluation of 
medical countermeasures for CBRN agents, including, but not limited to, 
the following crosscutting issues:
     Missing or limited data on the pathophysiological 
mechanisms of disease development in humans, especially with:
    [cir] No recent outbreaks in humans, or outbreaks occur only in 
remote locations with limited infrastructure and capabilities
    [cir] Altered virulence or other properties of the natural agent
    [cir] A difference between the normal route of exposure and the 
route likely to be used in a bioterrorism event
     Use of mortality as an endpoint, particularly when case 
fatality of naturally occurring disease in humans is less than 100 
     Incorporation and importance of biomarkers
     Correlates of disease progression
     Definition of supportive care and implementation given:
    [cir] Adequate veterinary care
    [cir] Intervention necessary for model development
    [cir] Intervention to mimic human clinical care
     Acceptability of euthanasia criteria and early study 
     Reproducibility of models

[[Page 43605]]

    If you are interested in attending, please register at the 
following link: https://respond.niaid.nih.gov/conferences/AMDW/Pages/default.aspx by September 10, 2012. There is no registration fee for 
the workshop. Early registration is recommended because seating is 
limited. If you need special accommodations due to a disability, please 
contact Dr. Judy Hewitt (see FOR FURTHER INFORMATION CONTACT) at least 
7 days in advance of the workshop.

FOR FURTHER INFORMATION CONTACT: Dr. Judy Hewitt, Office of Biodefense 
Research Affairs, Division of Microbiology and Infectious Diseases, 
NIAID, at telephone 301-402-4197 or telefax 301-480-1263 or email 
AMworkshopSep2012@mail.nih.gov (Subject line: Animal Model Workshop).

    Dated: July 18, 2012.
Lawrence A. Tabak,
Deputy Director, NIH.
[FR Doc. 2012-18168 Filed 7-24-12; 8:45 am]