Healthcare Infection Control Practices Advisory Committee (HICPAC), 36240-36241 [E9-17514]

Download as PDF 36240 Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices jlentini on DSKJ8SOYB1PROD with NOTICES Licensing Contact: Peter A. Soukas, J.D.; 301–435–4646; soukasp@mail.nih.gov. A Unique Infectious Hepatitis C Virus Clone, Strain HC–TN (genotype 1a) Description of Invention: It is anticipated that this infectious clone of hepatitis C virus (HCV) strain HC–TN (genotype 1a) will be useful for the development of vaccines and antiviral drugs that target HCV, genotype 1a. The HC–TN strain is unique because it has been shown to cause fulminant hepatitis. To date, only one other HCV strain, JFH1 (genotype 1b), has been isolated that is known to cause fulminant hepatitis. Additionally, little is known about the etiology of fulminant hepatitis C disease. Therefore, the HC–TN strain may be useful as a tool for studying the etiology of fulminant hepatitis. This invention includes the infectious clone, nucleotide sequences of the clone, and polypeptides encoded by the HC–TN clone. Methods are included for producing attenuated HCV, and for screening therapeutics against HCV and developing vaccines and diagnostics. Apparently, no companies or other laboratories have this HC–TN strain. The availability of the pHC–TN clone will be highly useful to pharmaceutical companies since no further research is required for its commercialization into, e.g., assays for testing antiviral compounds targeting HCV. Applications: • Production of attenuated viruses and polypeptides. • HCV vaccines, diagnostics, therapeutics and screening tool for antiHCV compounds. Advantages: There is no universally effective therapy against HCV infection. This invention enables development of vaccines, diagnostics and therapeutics that are specific for the HC–TN strain or HCV genotype 1a. Development Status: The technology is currently in the preclinical stage of development. Market: More than 80% of the HCV infections in North and South America, Europe, Russia, China, Japan and Australia are genotype 1. The instant technology may be transferred through biological materials licenses for territories in which no patent rights exist. Inventors: Jens Bukh, Robert H. Purcell, Suzanne U. Emerson, Akito Sakai, Patrizia Farci (NIAID). Publication: A Sakai et al. In vivo study of the HC–TN strain of hepatitis C virus recovered from a patient with fulminant hepatitis: RNA transcripts of a molecular clone (pHC–TN) are VerDate Nov<24>2008 16:04 Jul 21, 2009 Jkt 217001 infectious in chimpanzees but not in Huh7.5 cells. J Virol. 2007 July;81(13):7208–7219. Patent Status: U.S. Patent Application No. 12/061,504 filed 02 April 2008 (HHS Reference No. E–249–2007/0–US– 01); No foreign rights available. Licensing Status: Available for licensing. Licensing Contact: RC Tang, JD, LLM; 301–435–5031; tangrc@mail.nih.gov. Dated: July 13, 2009. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Transfer, National Institutes of Health. [FR Doc. E9–17319 Filed 7–21–09; 8:45 am] Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) Dated: July 14, 2009. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E9–17303 Filed 7–21–09; 8:45 am] BILLING CODE 4140–01–P BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention National Institutes of Health Healthcare Infection Control Practices Advisory Committee (HICPAC) National Institute of Environmental Health Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 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 Institute of Environmental Health Sciences Special Emphasis Panel. Formative Children’s Center Review 2. Date: July 24, 2009. Time: 2 p.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Washington Plaza Hotel, 10 Thomas Circle, NW., Washington, DC 20005. Contact Person: Linda K. Bass, PhD, Scientific Review Administrator, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute Environmental Health Sciences, P. O. Box 12233, MD EC–30, Research Triangle Park, NC 27709. (919) 541–1307. malone@niehs.nih.gov. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting for the aforementioned committee: Time and Date: 11 a.m.–12 p.m., July 23, 2009. Place: The teleconference call will originate at the CDC. Status: Open to the public. Teleconference access limited only by availability of telephone ports. To participate in the teleconference please dial 1 (800) 779–6036 and enter conference code 6417394. Purpose: The Committee is charged with providing advice and guidance to the Secretary, HHS; the Assistant Secretary for Health; the Director, CDC; and the Director, National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), regarding: (1) The practice of hospital infection control; (2) strategies for surveillance, prevention, and control of infections (e.g., nosocomial infections), antimicrobial resistance, and related events in settings where healthcare is provided; and (3) periodic updating of guidelines and other policy statements regarding prevention of healthcare-associated infections and healthcare-related conditions. Matters To Be Discussed: The agenda will include a follow up discussion of CDC’s Interim Guidance for Infection Control for Care of Patients with Confirmed or Suspected Novel Influenza A (H1N1) Virus Infection in a Healthcare Setting. Agenda items are subject to change as priorities dictate. This notice is being published less than 15 days prior to the meeting due to the public health emergency declared on April 26, 2009. There is a critical need for this committee to deliberate and discuss urgent matters related to the H1N1 virus, and be actively engaged in the national preparedness and response efforts as dictated by circumstances and events. E:\FR\FM\22JYN1.SGM 22JYN1 Federal Register / Vol. 74, No. 139 / Wednesday, July 22, 2009 / Notices Contact Person For More Information: Wendy Vance, HICPAC, Division of Healthcare Quality Promotion, NCPDCID, CDC, 1600 Clifton Road, NE., Mailstop D–10, Atlanta, Georgia 30333 Telephone (404) 639– 2891 or HICPAC@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 17, 2009. Elaine L. Baker, Director, Management Analysis and Services Office,Centers for Disease Control and Prevention (CDC). [FR Doc. E9–17514 Filed 7–21–09; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0302] Withdrawal of Approval of New Animal Drug Applications; Ketamine; S– Methoprene; Nitazoxanide AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA) listed in table 1 of this document. In a final rule published 36241 elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to remove portions reflecting approval of these NADAs and ANADA. DATES: Withdrawal of approval is effective August 3, 2009. FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary Medicine (HFV–212), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–276–9079, email: john.bartkowiak@fda.hhs.gov. The following sponsors have requested that FDA withdraw approval of the two NADAs and ANADA listed in table 1 of this document because the products are no longer manufactured or marketed: SUPPLEMENTARY INFORMATION: TABLE 1. Sponsor NADA/ANADA Number Product (Drug) 21 CFR Cite Affected (Sponsor Drug Labeler Code) Wellmark International, 1501 East Woodfield Rd., suite 200, West Schaumburg, IL 60173 NADA 141–162 Zodiac Fleatrol Flea Caps (S-methoprene) 520.1390 (011536) NADA 141–178 NAVIGATOR Paste (nitazoxanide) 520.1498 (065274) ANADA 200–279 KETAFLO Injection (ketamine HCl, USP) 522.1222a (000074) IDEXX Pharmaceuticals, Inc., 7009 Albert Pick Rd., Greensboro, NC 27409 Abbott Laboratories, North Chicago, IL 60064 Therefore, under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, and in accordance with § 514.116 Notice of withdrawal of approval of application (21 CFR 514.116), notice is given that approval of NADAs 141–162 and 141–178, and ANADA 200–279, and all supplements and amendments thereto, are hereby withdrawn, effective August 3, 2009. In a final rule published elsewhere in this issue of the Federal Register, FDA is amending the animal drug regulations to reflect the withdrawal of approval of these NADAs. Dated: July 14, 2009. Bernadette Dunham, Director, Center for Veterinary Medicine. [FR Doc. E9–17408 Filed 7–21–09; 8:45 am] jlentini on DSKJ8SOYB1PROD with NOTICES BILLING CODE 4160–01–S VerDate Nov<24>2008 16:04 Jul 21, 2009 Jkt 217001 DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency [Docket ID: FEMA–2009–0001] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Federal Emergency Management Agency, DHS. ACTION: Notice; 60-day notice and request for comments; revision of a currently approved information collection; OMB No. 1660–0095; No Form. SUMMARY: The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed revision of a currently approved information collection. In accordance with the Paperwork Reduction Act of 1995, this Notice seeks comments concerning the process for the appeal of decisions of flood insurance claims issued through the National Flood Insurance Program PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 (NFIP). The appeal process establishes a formal mechanism to allow policyholders to appeal the decisions of any insurance agent, adjuster, insurance company, or any FEMA employee or contractor, in cases or unsatisfactory decisions on claims, proof of loss, and loss estimates. DATES: Comments must be submitted on or before September 21, 2009. ADDRESSES: To avoid duplicate submissions to the docket, please use only one of the following means to submit comments: (1) Online. Submit comments at https://www.regulations.gov under docket ID FEMA–2009–0001. Follow the instructions for submitting comments. (2) Mail. Submit written comments to Office of Chief Counsel, Regulation and Policy Team, DHS/FEMA, 500 C Street, SW., Room 835, Washington, DC 20472– 3100. (3) Facsimile. Submit comments to (703) 483–2999. (4) E-mail. Submit comments to FEMA-POLICY@dhs.gov. Include docket ID FEMA–2009–0001 in the subject line. All submissions received must include the agency name and docket ID. Regardless of the method used for submitting comments or material, all submissions will be posted, without E:\FR\FM\22JYN1.SGM 22JYN1

Agencies

[Federal Register Volume 74, Number 139 (Wednesday, July 22, 2009)]
[Notices]
[Pages 36240-36241]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17514]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Healthcare Infection Control Practices Advisory Committee 
(HICPAC)

    In accordance with section 10(a)(2) of the Federal Advisory 
Committee Act (Pub. L. 92-463), the Centers for Disease Control and 
Prevention (CDC) announces the following meeting for the aforementioned 
committee:

    Time and Date: 11 a.m.-12 p.m., July 23, 2009.
    Place: The teleconference call will originate at the CDC.
    Status: Open to the public. Teleconference access limited only 
by availability of telephone ports. To participate in the 
teleconference please dial 1 (800) 779-6036 and enter conference 
code 6417394.
    Purpose: The Committee is charged with providing advice and 
guidance to the Secretary, HHS; the Assistant Secretary for Health; 
the Director, CDC; and the Director, National Center for 
Preparedness, Detection, and Control of Infectious Diseases 
(NCPDCID), regarding: (1) The practice of hospital infection 
control; (2) strategies for surveillance, prevention, and control of 
infections (e.g., nosocomial infections), antimicrobial resistance, 
and related events in settings where healthcare is provided; and (3) 
periodic updating of guidelines and other policy statements 
regarding prevention of healthcare-associated infections and 
healthcare-related conditions.
    Matters To Be Discussed: The agenda will include a follow up 
discussion of CDC's Interim Guidance for Infection Control for Care 
of Patients with Confirmed or Suspected Novel Influenza A (H1N1) 
Virus Infection in a Healthcare Setting.
    Agenda items are subject to change as priorities dictate. This 
notice is being published less than 15 days prior to the meeting due 
to the public health emergency declared on April 26, 2009. There is 
a critical need for this committee to deliberate and discuss urgent 
matters related to the H1N1 virus, and be actively engaged in the 
national preparedness and response efforts as dictated by 
circumstances and events.

[[Page 36241]]

    Contact Person For More Information: Wendy Vance, HICPAC, 
Division of Healthcare Quality Promotion, NCPDCID, CDC, 1600 Clifton 
Road, NE., Mailstop D-10, Atlanta, Georgia 30333 Telephone (404) 
639-2891 or HICPAC@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 17, 2009.
Elaine L. Baker,
Director, Management Analysis and Services Office,Centers for Disease 
Control and Prevention (CDC).
[FR Doc. E9-17514 Filed 7-21-09; 8:45 am]
BILLING CODE 4163-18-P

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