The Federal Register

Public Health Assessments and Health Consultations Completed

Thu, Dec 14 2006 11:00:00 GMT

This notice announces those sites for which ATSDR has completed public health assessments and health consultations during the period from July 2006 through September 2006. This list includes sites that are on or proposed for inclusion on the National Priorities List (NPL) and includes sites for which assessments or consultations were prepared in response to requests from the public.

Proposed Data Collections Submitted for Public Comment and Recommendations

Thu, Dec 14 2006 11:00:00 GMT

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 4046395960 and send comments to Seleda Perryman, CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MSD74, Atlanta, GA 30333 or send an email to omb@cdc.gov.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected

Agency Forms Undergoing Paperwork Reduction Act Review

Thu, Dec 14 2006 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) 6395960 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

Congenital Syphilis (CS) Case Investigation and Report Form (CDC73.126)OMB No. 09200128ExtensionNational Center for HIV/ AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Coordinating Center for Infectious Diseases (CCID), Centers for Disease Control and Prevention (CDC).

Background and Brief Description

CDC proposes to continue data collection for congenital syphilis case investigations under

Proposed Data Collections Submitted for Public Comment and Recommendations

Thu, Dec 14 2006 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 4046394604 or send a 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. [[Page 75256]]

Background and Brief Description

Descriptive Epidemiology of Missed or Delayed Diagnoses for Conditions Detected by Newborn Screening(OMB No. 09200641)
RevisionNational Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC). Every state in the United States and Washington, DC, has a public health program to test newborn babies for congenital metabolic and other disorders throu

Mine Safety and Health Research Advisory Committee: Notice of Charter Renewal

Thu, Dec 14 2006 11:00:00 GMT

This gives notice under the Federal Advisory Committee Act (Public Law 92463) of October 6, 1972, that the Mine Safety and Health Research Advisory Committee, Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2year period through November 30, 2008.

For information, contact Jeffrey Kohler, Ph.D., Executive Secretary, Mine Safety and Health Research Advisory Committee, Centers for Disease Control and Prevention, Department of Health and Human Services, 626 Cochrans Mill Road, Mailstop P05, Pittsburgh, Pennsylvania 15236, telephone 412/3865301 or fax 404/3865300.

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 the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry.

Dated: December 8, 2006.
Alvin Hall,
Director, Manag

Decision To Evaluate a Petition To Designate a Class of Employees at Dow Chemical Company, Madison, IL, To Be

Thu, Dec 14 2006 11:00:00 GMT

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR Sec. 83.12(e) of a decision to evaluate a petition to designate a class of employees at Dow Chemical Company, Madison, Illinois, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows:

Facility: Dow Chemical Company.

Location: Madison, Illinois.

Job Titles and/or Job Duties: All Atomic Weapons Employer employees who were monitored, or should have been monitored, for exposure to ionizing radiation while working for a number of work days aggregating at least 250 work days, either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees in the Special Exposure Cohort.

Period of Employment: January 1, 1957 through December

Charging for Investigational Drugs

Thu, Dec 14 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend its investigational new drug application (IND) regulation concerning charging patients for investigational new drugs. FDA is proposing to revise the current charging regulation to clarify the circumstances in which charging for an investigational drug in a clinical trial is appropriate, to set forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in the agency's proposed rule on expanded access for treatment use of investigational drugs published elsewhere in this issue of the Federal Register, and to clarify what costs can be recovered for an investigational drug. The proposed rule is intended to permit charging for a broader range of investigational and expanded access uses than is explicitly permitted in current regulations.

Expanded Access to Investigational Drugs for Treatment Use

Thu, Dec 14 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is proposing to amend its regulations on access to investigational new drugs for the treatment of patients. The proposed rule would clarify existing regulations and add new types of expanded access for treatment use. Under the proposal, expanded access to investigational drugs for treatment use would be available to individual patients, including in emergencies; intermediatesize patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The proposed rule is intended to improve access to investigational drugs for patients with serious or immediately life threatening diseases or conditions, who lack other therapeutic options and who may benefit from such therapies.

Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2007

Thu, Dec 14 2006 11:00:00 GMT

This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for administrative law judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustments to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2007. The 2007 AIC threshold amounts are $110 for ALJ hearings and $1,130 for judicial review.

Request for Information (RFI): Guidance for Prioritization of Pre-pandemic and Pandemic Influenza Vaccine

Thu, Dec 14 2006 11:00:00 GMT

Influenza viruses have threatened the health of animal and human populations for centuries. A pandemic occurs when a novel strain of influenza virus emerges that has the ability to infect and be passed between humans. Because humans lack immunity to the new virus, a worldwide epidemic, or pandemic, can ensue. Three human influenza pandemics occurred in the 20th century. In the U.S., each pandemic led to illness in approximately 30 percent of the population and death in between 2 in 100 and 2 in 1,000 of those infected. It is projected that a modern pandemic, absent effective control measures, could result in the deaths of 200,000 to 2 million people in the United States alone. Extensive information on Federal government strategic and
implementation plans for pandemic flu is available at http://www.pandemicflu.gov .

A critical part of the United States Government (USG)

Government-Owned Inventions; Availability for Licensing

Thu, Dec 14 2006 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 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.

National Cancer Institute; Notice of Closed Meetings

Thu, Dec 14 2006 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 Cancer Institute Special Emphasis Panel, Molecular Biology Special Emphasis Panel.

Date: January 2931, 2007.

Time: 6 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: Marriott Conference Center, 5701 Marinelli Road, Bethesda, MD 20852.

Contact Person: Michael B Small, PhD, Scientific Review Administrator, Res

National Heart, Lung, and Blood Institute; Notice of Closed Meetings

Thu, Dec 14 2006 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
[[Page 75261]]
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 Heart, Lung, and Blood Institute Special Emphasis Panel, Genetics Research Project.

Date: February 20, 2007.

Time: 3 p.m. to 5 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: Mark Rolts

National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting

Thu, Dec 14 2006 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 Institute of Biomedical Imaging and Bioengineering Special Emphasis Panel, ZEB1 OSR C M2 P LDMOS.

Date: February 15, 2007.

Time: 12 p.m. to 3 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Suite 200 Large conference room, Bethesda, MD 20892 (Te

National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting

Thu, Dec 14 2006 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 for Biomedical Imaging and

Bioengineering.

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.

Name

National Institute of Child Health and Human Development; Notice of Closed Meeting

Thu, Dec 14 2006 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 Child Health and Human Development Special Emphasis Panel, Prenatal Virally Induced Brain Disorder in Mouse.

Date: December 14, 2006.

Time: 1 p.m. to 2:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852 (Telephone Conferen

National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting

Thu, Dec 14 2006 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: Training Grant and Career Development Review Committee.

Date: January 2526, 2007.

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

Agenda: To review and evaluate grant applications.

Place: The Carlyle Suite Hotel, 1731 New Hampshire Avenue, NW., Washington, DC 20009.

Contact Person: Raul A. Saavedra, PhD, Scientific Review Administrator, Scientific Review Branch, Div

National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

Thu, Dec 14 2006 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 Neurological Disorders and Stroke Special Emphasis Panel, Epilepsy Clinical Trial.

Date: December 15, 2006.

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

Agenda: To review and evaluate grant applications.

Place: The Watergate Hotel, 2650 Virginia Avenue, Washington, DC 20037.

Contact Person: Shantadurga Rajaram, PhD, Scientific Review Admin

National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Thu, Dec 14 2006 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 on Alcohol Abuse and Alcoholism Initial Review Group, Health Services and Behavioral Research Review Subcommittee.

Date: March 2829, 2007.

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

Agenda: To review and evaluate grant applications.

Place: Doubletree Hotel & Executive Meeting Center, 8120 Wisconsin Ave., Bethesda, MD 20814.

Contact Person:

National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Thu, Dec 14 2006 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 Institutes on Alcohol Abuse and Alcoholism Initial
[[Page 75262]]
Review Group, Biomedical Research Review Subcommittee.

Date: February 2627, 2007.

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

Agenda: To review and evaluate grant applications.

Place: Hyatt Regency Bethesda, 7400 Wisconsin Avenue, Bethesda, MD 20814.

Contact Person: Katrina L. Foster, PhD,

National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting

Thu, Dec 14 2006 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 [[Page 75263]]
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 on Alcohol Abuse and Alcoholism Initial Review Group, Clinical and Treatment
Subcommittee.

Date: March 12, 2007.

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

Agenda: To review and evaluate grant applications.

Place: Double Tree Rockville, 1750 Rockville Pike, Rockville, MD 20852.

Contact Person: Katrina L. Foster, PhD., Scienti

National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings

Thu, Dec 14 2006 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 meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 52b(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 on Deafness and Other Communication Disorders Special Emphasis Panel, Cochlear
Implantation.

Date: January 16, 2007.

Time: 1:30 p.m. to 2:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852 (Telephone Conference Call).

Contact Person: Sh

National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting

Thu, Dec 14 2006 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,
[[Page 75265]]
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 on Deafness and Other Communication Disorders Special Emphasis Panel, Baloh P50 Review.

Date: January 18, 2007.

Time: 2:30 p.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6120 Executive Blvd., Rockville, MD 20852. (Telephone Conference Call).

Contact Per

National Institute on Drug Abuse; Notice of Closed Meetings

Thu, Dec 14 2006 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, State and Local Epidemiology Planning and
Information Development.

Date: January 2425, 2007.

Time: 9 a.m. to 5 p.m.

Agenda: To review and evaluate contract proposals.

Place: Courtyard by Marriott Rockville, 2500 Research Boulevard, Rockville, MD 20850.

Contact Person: Lyle Furr, Cont

National Institute on Drug Abuse; Notice of Meeting

Thu, Dec 14 2006 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 Drug Abuse.

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.

Name of Committee: National Advis

Center for Scientific Review; Notice of Closed Meetings

Thu, Dec 14 2006 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, Optimizing Stem Cell Grafts.

Date: December 12, 2006.

Time: 2 p.m. to 4:30 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: Lawrence Baizer, PhD, Scientific R

Center for Scientific Review; Amended Notice of Meeting

Thu, Dec 14 2006 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Center for Scientific Special Emphasis Panel, November 28, 2006, 11 a.m., to November 28, 2006, 4 p.m. National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 which was published in the Federal Register on November 17, 2006, 71 FR 6695866959.

The meeting will be held December 19, 2006. The meeting time and location remain the same. The meeting is closed to the public.

Dated: December 8, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 069704 Filed 121306; 8:45 am]
BILLING CODE 414001M

Center for Scientific Review; Notice of Closed Meetings

Thu, Dec 14 2006 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, Computational Biophysics.

Date: February 1, 2007.

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

Agenda: To review and evaluate grant applications.

Place: The Watergate, 2650 Virginia Avenue, NW., Washington, DC 20037.

Contact Person: James W. Mack, PhD., Scientific Review Administrator, Center for Scientific R