The Federal Register

Privacy Act System of Records

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4), the IHS has amended and is publishing the proposed alteration of a system of records, System No. 09170001, ``Medical, Health and Billing Records.'' The amended and altered system of records makes only administrative edits and revisions as necessary.

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Dec 30 2005 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6394766 or send an email to
omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3956974. Written comments should be received within 30 days of this notice. Proposed Project

Helping to End Lead Poisoning (HELP): A Questionnaire Study of Medicaid Providers' SelfReported Attitudes, Practices, Beliefs, and Barriers to Childhood Blood Lead TestingNewNational Center for Environmental Health, Centers for Disease Control and Prevention (CDC). Background and Brief Description

According to the United States Department of Health and Human Services (DHHS), lead poisoning is one of

Agency Forms Undergoing Paperwork Reduction Act Review

Fri, Dec 30 2005 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 6394766 or send an email to
omb@cdc.gov. Send written comments to CDC Desk Officer, Office of Management and Budget, Washington, DC or by fax to (202) 3956974. Written comments should be received within 30 days of this notice. Proposed Project

NCEH/ATSDR Exposure Investigations (EIs)NewNational Center for Environmental Health (NCEH) and the Agency for Toxic Substances and Disease Registry (ATSDR), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

This is a brief summary of a joint clearance between the NCEH and ATSDR, (hereafter ATSDR will represent both ATSDR and NCEH). ATSDR is mandated pursuant to the 1

Public Notice

Fri, Dec 30 2005 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC), National Center for Infectious Disease (NCID), Division of Bacterial and Mycotic Diseases (DBMD) and the National Immunization Program, Epidemiology and Surveillance Division through its component Branches have lead technical responsibility for research, development and evaluation of diagnostic tools for pertussis and application of these to epidemiologic studies of pertussis. CDC uses epidemiologic, laboratory, clinical, and biostatistical sciences to control and prevent vaccine preventable infectious diseases. CDC also conducts applied research in a variety of settings, and translates the findings of this research into public health practice.

CDC is seeking to evaluate commercial products, or products in development, for in vitro serological diagnosis of pertussis. Specifically these should include tests to detect antipertussis toxin antibodies in infected and vaccinated individuals. The tests should be based on standardized reagents c

National Center for Environmental Health/Agency for Toxic Substances and Disease Registry

Fri, Dec 30 2005 11:00:00 GMT

The Program Peer Review Subcommittee of the Board of Scientific Counselors (BSC), Centers for Disease Control and Prevention (CDC), National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR): Teleconference.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), The Centers for Disease Control and Prevention, NCEH/ATSDR announces the following subcommittee meeting:

Name: Program Peer Review Subcommittee (PPRS).

Times and Dates: 12:30 p.m.2 p.m., January 23, 2006.

Place: The teleconference will originate at the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry in Atlanta, Georgia. Please see SUPPLEMENTARY INFORMATION for details on accessing the teleconference.

Status: Open to the public, teleconference access limited only by availability of telephone ports.

Purpose: Under the charge of the BSC, NCEH/ATSDR the PPRS will provide the BSC, NCEH/ATSDR with a

National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC)

Fri, Dec 30 2005 11:00:00 GMT

Name: The Draft Document: NIOSH Current Intelligence

Bulletin: Evaluation of Health Hazard and Recommendations for Occupational Exposure to Titanium Dioxide.

Meeting Date and Time: February 27, 2006, 9 a.m.4 p.m.

Place: Robert A. Taft Laboratories, Taft Auditorium, NIOSH, CDC, 4676 Columbia Parkway, Cincinnati, Ohio 45226.

Purpose: To explain and discuss the scientific basis for the draft document, ``NIOSH Current Intelligence Bulletin: Evaluation of Health Hazard and Recommendations for Occupational Exposure to Titanium Dioxide,'' current research on titanium dioxide, and information on occupational exposure to titanium dioxide. Special emphasis will be placed on discussion of the following:
(1) What animal and human data best describe the health concerns from exposure to titanium dioxide; (2) What strategies are being used to control occupational exposure to titanium dioxide (e.g., engineering controls, work practices, personal protective equipment); (3) In which workplac

National Institute for Occupational Safety and Health Advisory Board on Radiation and Worker Health

Fri, Dec 30 2005 11:00:00 GMT

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92463), the Centers for Disease Control and Prevention (CDC) announces the following committee meeting:

Name: Working Group of the Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH).

Audio Conference Call Time and Date: 10 a.m.4 p.m., EST, Monday, January 9, 2006.

Place: Audio conference call via FTS conferencing. The USA toll free dialin number is 18883906586, pass code 41964.

Status: Open to the public, but without a public comment period.

Background: The ABRWH was established under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) of 2000 to advise the President, delegated to the Secretary, Department of Health and Human Services (HHS), on a variety of policy and technical functions required to implement and effectively manage the new compensation program. Key functions of the Board include providi

Agency Information Collection Activities: Submission for OMB Review; Comment Request

Fri, Dec 30 2005 11:00:00 GMT

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Devices;

Fri, Dec 30 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Devices; Humanitarian Use Devices'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Mammography Quality

Fri, Dec 30 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Cosmetic Product

Fri, Dec 30 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Cosmetic Product Voluntary Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Regulations Under

Fri, Dec 30 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Regulations Under the Federal Import Milk Act'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

Fri, Dec 30 2005 11:00:00 GMT

Government-Owned Inventions; Availability for Licensing

Fri, Dec 30 2005 11:00:00 GMT

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 federallyfunded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Government-Owned Inventions; Availability for Licensing

Fri, Dec 30 2005 11:00:00 GMT

National Cancer Institute; Notice of Closed Meeting

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following 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 Cancer Institute Special Emphasis Panel; Molecular Oncology 2.

Date: February 2122, 2006.

Time: 4 p.m. to 6 p.m.

Agenda: To review and evaluate grant applications.

Place: Marriott Bethesda North Hotel and Conference Ctr., 5700 Marinelli Road, North Bethesda, MD 20852.

Contact Person: Shamala K. Srinivas, PhD, Scientific Review Admini

National Center for Complementary & Alternative Medicine; Notice of Closed Meeting

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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 Center for Complementary and Alternative Medicine Special Emphasis Panel; Clinical Science.

Date: February 1314, 2006.

Time: 8 a.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817.

Contact Person: Jeanette M Hosseini, Scientific Review Adminis

National Eye Institute; Notice of Meeting

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Eye Council.

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 sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the
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discussions could disclose confidential trade secrets of commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion

National Institute of Environmental Health Sciences; Notice of Closed Meeting

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Research Program Projects (P01s).

Date: January 24, 2006.

Time: 1 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: NIEHS/National Institutes of Health, Building 4401, East Campus, 79 T.W. Alexander Drive, Research Triangle Park, NC 27709. (Telepho

National Institute of General Medical Sciences; Notice of Meeting

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory General Medical Sciences Council.

Name of Committee: Nat

National Institute of Mental Health; Notice of Closed Meetings

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings 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 Mental Health Initial Review Group, Services Research Review Committee.

Date: February 1415, 2006.

Time: 8:30 a.m. to 5:30 p.m.

Agenda: To review and evaluate grant applications.

Place: Melrose Hotel, 2430 Pennsylvania Ave., NW., Washington, DC 20037.

Contact Person: Marina Broitman, PhD, Scientific Review Administrat

National Institute on Aging; Notice of Meeting

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of the National Advisory Council on Aging.

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/or contract proposals 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of persona

National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the National Advisory Council on Alcohol Abuse and Alcoholism.

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/or contract proposals 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 and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion

National Institute on Drug Abuse; Notice of Closed Meetings

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

The meetings 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 contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institute on Drug Abuse Special Emphasis Panel; Dissemination of an EvidenceBased Drug Prevention Program for High School Health Providers.

Date: January 11, 2006.

Time: 9:30 a.m. to 4 p.m.

Agenda: To review and evaluate contract proposals.

Place: National Institutes of Health, 6101 Executive Boulevard, Rockville, MD 20852, (Telephone

National Library of Medicine; Notice of Meeting

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting.

The portions of the meeting devoted to the review and evaluation of journals for potential indexing by the National Library of Medicine will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B), Title 5 U.S.C., as amended. Premature disclosure of the titles of the journals as potential titles to be indexed by the National Library of Medicine, the discussions, and the presence of individuals associated with these publications could significantly frustrate the review and evaluation of individual j

Center for Scientific Review; Notice of Closed Meetings

Fri, Dec 30 2005 11:00:00 GMT

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meetings.

Name of Committee: Center for Scientific Review Special Emphasis Panel; Cardiovascular Development.

Date: January 3, 2006.

Time: 2:30 p.m. to 3:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call).

Contact Person: Larry Pinkus, PhD., Scientific Re

Assistant Secretary for Planning & Evaluation Medicaid Program; Meeting of the Medicaid Commission--January 24-26,

Fri, Dec 30 2005 11:00:00 GMT

This notice announces a public meeting of the Medicaid Commission. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Medicaid Commission will advise the Secretary on ways to modernize the Medicaid program so that it can provide highquality health care to its beneficiaries in a financially sustainable way.

Prospective Grant of Exclusive License: Treatment of Cardiovascular Conditions With Nitrite Therapy

Fri, Dec 30 2005 11:00:00 GMT

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of an exclusive license to practice the invention embodied in PCT patent applications PCT/US2004/21985 and PCT/US2004/22232, filed July 9, 2004, both entitled ``Use of Nitrite Salts for the Treatment of Cardiovascular Conditions'' [HHS Reference Number: E2542003/23PCT 01], to Hope Medical Enterprises, Inc., dba Hope
Pharmaceuticals^TM, an Arizona SCorporation having a principle place of business in Scottsdale, Arizona. The field of use may be limited to the use of nitrite salts for the treatment of cerebral vasospasm following subarachnoid hemorrhage and/or cardiovascular conditions. The United States of America is an assignee of the patent rights in these inventions.

Prospective Grant of Exclusive License: Software for Predicting Molecular Properties and Pathogen Detection

Fri, Dec 30 2005 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in E 1692000/0 ``Drift Compensation Method for Fingerprint Spectra,'' U.S. Patent Application No. 09/975,530 filed October 10, 2001; E2972001/0 ``Methods For Predicting Properties of Molecules,'' U.S. Patent Application No. 10/383,602 filed March 7, 2003; and E0172003/0 ``Improved Pattern Recognition Of Whole Cell Mass Spectra Via Separation Of Specific Charge States,'' U.S. Patent Application No. 10/ 863,745 filed June 7, 2004; to Litmus, LLC an Arkansas corporation having its headquarters in Little Rock, Arkansas. The United States of America is the assignee of the patent rights of the above inventions.

The contemplated exclusive license may be granted in the field of providing software solutions for pathogen detection and for pred

Prospective Grant of Exclusive License: Implants for Sustained Ocular Therapeutic Agent Delivery

Fri, Dec 30 2005 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in E 2411999/0, ``Ocular Therapeutic Agent Delivery Devices And Methods For Making And Using Such Devices;'' U.S. Patent 6,713,081 issued March 30, 2004 and expires March 15, 2021; U.S. Patent Application 10/471,468 filed September 12, 2004; and European Patent Application 02723446.7 filed March 14, 2002; to Lux Biosciences, a Delaware corporation having a principle place of business in Jersey City, New Jersey. The United States of America is the assignee of the patent rights of the above inventions.

The contemplated exclusive license may be granted in the field of ocular cyclosporine A delivery for the treatment of graftversushost diseaseassociated dry eye and Sj[ouml]gren's Syndrome.

Prospective Grant of Exclusive License: Fusion Proteins Comprising Circularly Permuted Ligands

Fri, Dec 30 2005 11:00:00 GMT

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in United States Patent No. 4,892,827, issued on January 9, 1990, entitled ``Recombinant Pseudomonas Exotoxin: Construction Of An Active Immunotoxin With Low Side Effects'' [E3851986/0US01]; U.S. Patent No. 5,635,599, issued on June 3, 1997, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E0471994/0US01]; PCT Patent Application No. PCT/US95/04468, filed April 6, 1995, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E0471994/ 0PCT02]; Switzerland Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E 0471994/0CH03]; Spain Patent No. 0754192, issued on January 29, 2003, entitled ``Fusion Proteins Comprising Circularly Permuted Ligands'' [E04