National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting, 43604 [2012-18171]

Download as PDF 43604 Federal Register / Vol. 77, No. 143 / Wednesday, July 25, 2012 / Notices information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.273, Alcohol Research Programs; 93.701, ARRA Related Biomedical Research and Research Support Awards, National Institutes of Health, HHS) and Research Support Awards, National Institutes of Health, HHS) Dated: July 18, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2012–18172 Filed 7–24–12; 8:45 am] Dated: July 18, 2012. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2012–18171 Filed 7–24–12; 8:45 am] BILLING CODE 4140–01–P National Institutes of Health DEPARTMENT OF HEALTH AND HUMAN SERVICES Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council on Alcohol Abuse and Alcoholism. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. srobinson on DSK4SPTVN1PROD with NOTICES National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting National Institutes of Health Name of Committee: National Advisory Council on Alcohol Abuse and Alcoholism. Date: September 19–20, 2012. Closed: September 19, 2012, 5:00 p.m. to 7:30 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, 5635 Fishers Lane, T–508, Rockville, MD 20852. Open: September 20, 2012, 8:30 a.m. to 2:00 p.m. Agenda: Presentations and other business of the council. Place: National Institutes of Health, 5635 Fishers Lane, T–508, Rockville, MD 20852. Contact Person: Abraham P. Bautista, Ph.D., Executive Secretary, National Institute on Alcohol Abuse & Alcoholism National Institutes of Health, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, 301–443–9737, bautista@mail.nih.gov. Information is also available on the Institute’s/Center’s home page: https:// www.niaaa.nih.gov/Pages/default.aspx, where an agenda and any additional VerDate Mar<15>2010 17:49 Jul 24, 2012 Jkt 226001 National Institute of Allergy and Infectious Diseases (NIAID); Notice of Workshop 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, SUMMARY: PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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 development. 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: Æ No recent outbreaks in humans, or outbreaks occur only in remote locations with limited infrastructure and capabilities Æ Altered virulence or other properties of the natural agent Æ 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 percent • Incorporation and importance of biomarkers • Correlates of disease progression • Definition of supportive care and implementation given: Æ Adequate veterinary care Æ Intervention necessary for model development Æ Intervention to mimic human clinical care • Acceptability of euthanasia criteria and early study endpoints • Reproducibility of models E:\FR\FM\25JYN1.SGM 25JYN1

Agencies

[Federal Register Volume 77, Number 143 (Wednesday, July 25, 2012)]
[Notices]
[Page 43604]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18171]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Institute on Alcohol Abuse and Alcoholism; Notice of 
Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as 
amended (5 U.S.C. App.), notice is hereby given of a meeting of the 
National Advisory Council on Alcohol Abuse and Alcoholism.
    The meeting will be open to the public as indicated below, with 
attendance limited to space available. Individuals who plan to attend 
and need special assistance, such as sign language interpretation or 
other reasonable accommodations, should notify the Contact Person 
listed below in advance of the meeting.
    The meeting will be closed to the public in accordance with the 
provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 
U.S.C., as amended. The grant applications and the discussions could 
disclose confidential trade secrets or commercial property such as 
patentable material, and personal information concerning individuals 
associated with the grant applications, the disclosure of which would 
constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Advisory Council on Alcohol Abuse 
and Alcoholism.
    Date: September 19-20, 2012.
    Closed: September 19, 2012, 5:00 p.m. to 7:30 p.m.
    Agenda: To review and evaluate grant applications.
    Place: National Institutes of Health, 5635 Fishers Lane, T-508, 
Rockville, MD 20852.
    Open: September 20, 2012, 8:30 a.m. to 2:00 p.m.
    Agenda: Presentations and other business of the council.
    Place: National Institutes of Health, 5635 Fishers Lane, T-508, 
Rockville, MD 20852.
    Contact Person: Abraham P. Bautista, Ph.D., Executive Secretary, 
National Institute on Alcohol Abuse & Alcoholism National Institutes 
of Health, 5635 Fishers Lane, Room 2085, Rockville, MD 20852, 301-
443-9737, bautista@mail.nih.gov.
    Information is also available on the Institute's/Center's home 
page: https://www.niaaa.nih.gov/Pages/default.aspx, where an agenda 
and any additional information for the meeting will be posted when 
available.

(Catalogue of Federal Domestic Assistance Program Nos. 93.273, 
Alcohol Research Programs; 93.701, ARRA Related Biomedical Research 
and Research Support Awards, National Institutes of Health, HHS)

    Dated: July 18, 2012.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-18171 Filed 7-24-12; 8:45 am]
BILLING CODE 4140-01-P

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