Antiviral Drugs Advisory Committee; Notice of Meeting, 38086-38087 [E7-13560]

Download as PDF 38086 Federal Register / Vol. 72, No. 133 / Thursday, July 12, 2007 / Notices N.V.,all of Brussels, Belgium, Fortis Bank Nederland (Holding) N.V., Utrecht, Netherlands, and RFS Holdings B.V., Amsterdam, Netherlands, is revised to read as follows: A. Federal Reserve Bank of Boston (Richard Walker, Community Affairs Officer) P.O. Box 55882, Boston, Massachusetts 02106-2204: 1. Royal Bank of Scotland Group, plc, Edinburgh, Scotland, Banco Santander Central Hispano, S.A., Madrid, Spain, Santander Holanda B.V., Delft, Netherlands, Fortis N.V., Utrecht, Netherlands, Fortis S.A./N.V.,Fortis Brussels, S.A./N.V., Fortis Bank, all of Brussels, Belgium, Fortis Bank Nederland (Holding) N.V., Utrecht, Netherlands, and RFS Holdings B.V., Amsterdam, Netherlands; to control ABN AMRO Holding N.V. Amsterdam, Netherlands, and thereby indirectly acquire ABN AMRO North American Holding Company, LaSalle Bank Corporation, LaSalle Bank National Association, all of Chicago, Illinois, and LaSalle Bank Midwest National Association, Troy, Michigan. In connection with this proposal Fortis Bank Nederland (Holding) N.V., Santander Holand B.V. and RFS Holdings B.V. have applied to become bank holing companies. In addition, each of The Royal Bank of Scotland Group, plc, The Royal Bank of Scotland plc, RBSG International Holdings Limited, all of Edinburgh, Scotland, and Citizens Financial Group, Inc., Providence, Rhode Island, has applied to acquire control of ABN AMRO North American Holding Company, LaSalle Bank Corporation, LaSalle Bank National Association, and LaSalle Bank Midwest National Association in a transfer subsequent to the acquisition of control of ABN AMRO Holding N.V. Comments on this application must be received by July 25, 2007. Board of Governors of the Federal Reserve System, July 9, 2007. Robert deV. Frierson, Deputy Secretary of the Board. [FR Doc. E7–13530 Filed 7–11–07; 8:45 am] rwilkins on PROD1PC63 with NOTICES BILLING CODE 6210–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration Ethics Subcommittee, Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC) In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), CDC announces the following meeting for the aforementioned subcommittee. Times and dates: 1 p.m.–5:30 p.m., August 9, 2007. 8:30 a.m.–3:30 p.m., August 10, 2007. Place: CDC, 1825 Century Center, Conference Room 1 A/B, Atlanta, GA 30345. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 75 people. To accommodate public participation in the meeting, a conference telephone line will be available. The public is welcome to participate during the public comment periods by calling (866) 919–3560 and entering code 4168828. The public comment periods are tentatively scheduled from 4:45 p.m.–5 p.m. on August 9, 2007 and from 3 p.m.–3:15 p.m. on August 10, 2007. Purpose: The Ethics Subcommittee will provide counsel to the ACD, CDC regarding a broad range of public health ethics questions and issues arising from programs, scientists, and practitioners. Matters To Be Discussed: Agenda items will include: Ethical Guidance for Public Health Emergency Preparedness and Response, Ethical Issues relating to CDC Partnerships, Public Health Ethics and Genomics, Ethical Guidance for NonResearch Data Collections, and Updates on Ethical Issues relating to Pandemic Influenza Preparedness. Agenda items are subject to change as priorities dictate. For security reasons, members of the public interested in attending the meeting should contact the person below. The deadline for notification of attendance is August 2, 2007. Contact Person for More Information: Drue Barrett, Ph.D., Designated Federal Official, Ethics Subcommittee, CDC, 1600 Clifton Road, NE., M/S D–50, Atlanta, Georgia 30333. Telephone (404) 639–4690. E-mail: dbarrett@cdc.gov. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both CDC and the Agency for Toxic Substances and Disease Registry. Dated: July 5, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention (CDC). [FR Doc. E7–13523 Filed 7–11–07; 8:45 am] BILLING CODE 4163–18–P VerDate Aug<31>2005 16:42 Jul 11, 2007 Jkt 211001 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 Antiviral Drugs Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. Name of Committee: Antiviral Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA’s regulatory issues. Date and Time: The meeting will be held on September 5, 2007, from 8 a.m. to 4 p.m. and on September 6, 2007, from 9 a.m. to 1 p.m. Location: On September 5, 2007, the committee will meet at the Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., Silver Spring, MD. The hotel telephone number is 301–589–5200. On September 6, 2007, the committee will meet in closed session at FDA, White Oak Headquarters, rm. 2046, 10903 New Hampshire Ave., Silver Spring, MD. Contact Person: Cicely Reese, Center for Drug Evaluation and Research (HFD– 21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, FAX: 301– 827–6776, e-mail: Cicely.Reese@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512531. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. Agenda: On September 5, 2007, the committee will discuss new drug application (NDA) 22–145, raltegravir potassium, integrase inhibitor 400 milligram tablets, Merck & Co., Inc., for the treatment of Human Immunodeficiency Virus-1 (HIV–1) infection in combination with other E:\FR\FM\12JYN1.SGM 12JYN1 rwilkins on PROD1PC63 with NOTICES Federal Register / Vol. 72, No. 133 / Thursday, July 12, 2007 / Notices antiretroviral agents in treatmentexperienced patients with evidence of HIV–1 replication despite ongoing antiretroviral therapy. On September 6, 2007, the meeting will be closed to permit discussion and review of trade secret and/or confidential information. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ohrms/ dockets/ac/acmenu.htm, click on the year 2007 and scroll down to the appropriate advisory committee link. Procedure: On September 5, 2007, from 8 a.m. to 4 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before August 21, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 14, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 13, 2007. Closed Committee Deliberations: On September 6, 2007, from 9 a.m. to 1 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). The committee will be asked to provide feedback on a Phase 3 protocol in the development of a new indication. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical VerDate Aug<31>2005 16:42 Jul 11, 2007 Jkt 211001 disabilities or special needs. If you require special accommodations due to adisability, please contact Cicely Reese at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: July 5, 2007. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E7–13560 Filed 7–11–07; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. ACTION: Notice. AGENCY: SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/ 496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Compounds Binding to the N-Terminal Domains of STAT Proteins as Therapeutic Agents Description of Technology: Signal transducer and activator transcription (STAT) proteins, specifically STAT1, 2, 3, 4, 5a, 5b, and 6, are involved in the cellular and biological processes of cell proliferation, differentiation, apoptosis, host defense, and transformation. Constitutively active STAT proteins occur in many human tumor cells and cells transformed by oncoproteins. Inhibiting these STAT proteins has great therapeutic potential in the treatment of certain cancers. PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 38087 The current invention describes a family of short peptides that bind to the N-terminus domains of STAT proteins and their use as therapeutic agents. These compounds are the first inhibitors that can directly bind to N-domains of STATs and exhibit a direct inhibitory effect. STAT1, 3, and 5 inhibitors can serve as potent therapeutic agents for the treatment of a variety of tumors and STAT 4 inhibitors can be used to control autoimmune disorders. Applications and Modality: Other applications for this technology include using STAT1, STAT3 and STAT5 inhibitors for the treatment of various tumors; using STAT4 inhibitors to control autoimmune disorders; and using STAT inhibitors as research tools to study the function of STAT proteins. Market: There were approximately 600,000 deaths from cancer related diseases estimated in 2006. In 2006, the cancer drug market was estimated to be $25 billion. Development Status: The technology is currently in the pre-clinical stage of development. Inventors: Nadya I. Tarasova et al. (NCI). Relevant Publications: A manuscript directly related to the above technology will be available as soon as it is accepted for publication. Patent Status: U.S. Provisional Application No. 60/940,916 filed 30 May 2007 (HHS Reference No. E–164– 2007/0–US–01). Licensing Status: Available for exclusive and non-exclusive license. Licensing Contact: Adaku Nwachukwu, J.D.; 301/435–5560; madua@mail.nih.gov. Benztropinamine Analogs as Dopamine Transport Inhibitors Description of Technology: Dopamine is a neurotransmitter that is directly involved in motor activity, motivation and reward, and cognition. The dopamine transporter is expressed on the plasma membrane of dopamine neurons and is responsible for clearing dopamine released into the extracellular space, thereby regulating neurotransmission. The dopamine transporter plays a significant role in neuropsychiatric diseases, such as Parkinson’s disease, drug abuse (especially cocaine addiction), Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD), narcolepsy and a number of other CNS disorders. Therefore, the dopamine transporter is a target for research and potential therapeutics for the treatment of these indications. Benztropine and its analogs are an important class of dopamine transport E:\FR\FM\12JYN1.SGM 12JYN1

Agencies

[Federal Register Volume 72, Number 133 (Thursday, July 12, 2007)]
[Notices]
[Pages 38086-38087]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-13560]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Antiviral Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Antiviral Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on September 5, 2007, from 
8 a.m. to 4 p.m. and on September 6, 2007, from 9 a.m. to 1 p.m.
    Location: On September 5, 2007, the committee will meet at the 
Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd., 
Silver Spring, MD. The hotel telephone number is 301-589-5200. On 
September 6, 2007, the committee will meet in closed session at FDA, 
White Oak Headquarters, rm. 2046, 10903 New Hampshire Ave., Silver 
Spring, MD.
    Contact Person: Cicely Reese, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-7001, FAX: 301-827-6776, e-mail: Cicely.Reese@fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512531. Please call the 
Information Line for up-to-date information on this meeting. A notice 
in the Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the agency's Web site and call the appropriate 
advisory committee hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On September 5, 2007, the committee will discuss new drug 
application (NDA) 22-145, raltegravir potassium, integrase inhibitor 
400 milligram tablets, Merck & Co., Inc., for the treatment of Human 
Immunodeficiency Virus-1 (HIV-1) infection in combination with other

[[Page 38087]]

antiretroviral agents in treatment-experienced patients with evidence 
of HIV-1 replication despite ongoing antiretroviral therapy. On 
September 6, 2007, the meeting will be closed to permit discussion and 
review of trade secret and/or confidential information.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at https://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2007 and scroll down to the appropriate advisory committee 
link.
    Procedure: On September 5, 2007, from 8 a.m. to 4 p.m., the meeting 
is open to the public. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Written submissions may be made to the contact person on 
or before August 21, 2007. Oral presentations from the public will be 
scheduled between approximately 1 p.m. and 2 p.m. Those desiring to 
make formal oral presentations should notify the contact person and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before August 14, 2007. Time allotted for 
each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by August 13, 2007.
    Closed Committee Deliberations: On September 6, 2007, from 9 a.m. 
to 1 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
The committee will be asked to provide feedback on a Phase 3 protocol 
in the development of a new indication.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to adisability, please contact Cicely Reese at least 
7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 5, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-13560 Filed 7-11-07; 8:45 am]
BILLING CODE 4160-01-S

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