The Federal Register

Availability of Final Toxicological Profiles

Fri, Nov 24 2006 11:00:00 GMT

This notice announces the availability of one new and five updated final toxicological profiles of priority hazardous substances comprising the eighteenth set prepared by ATSDR.

Request for Nominations of Candidates to Serve on the Advisory Committee on Immunization Practices, Centers for

Fri, Nov 24 2006 11:00:00 GMT

The Centers for Disease Control and Prevention (CDC) is soliciting nominations for possible membership on the Advisory Committee on Immunization Practices (ACIP). This committee provides advice and guidance to the Secretary, Department of Health and Human Services (HHS), and the Director, CDC, regarding the most appropriate application of antigens and related agents for effective communicable disease control in the civilian population. The committee reviews and reports regularly on immunization practices and recommends improvements in the national immunization efforts.

The committee also establishes, reviews, and as appropriate, revises the list of vaccines for administration to children eligible to receive vaccines through the Vaccines for Children (VFC) Program.

Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based upon expertise in the field of

Medicare Program; Hospital Outpatient Prospective Payment System and CY 2007 Payment Rates; CY 2007 Update to the

Fri, Nov 24 2006 11:00:00 GMT

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system, and to implement certain related provisions of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 and the Deficit Reduction Act (DRA) of 2005. In this final rule with comment period, we describe changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2007. In addition, this final rule with comment period implements future CY 2009 required reporting on quality measures for hospital outpatient services paid under the prospective payment system.

This final rule with comment period revises the current list of procedures that are covered when furnished in a Medicareapproved ambu

Agency Information Collection Activities: Proposed Collection; Comment Request

Fri, Nov 24 2006 11:00:00 GMT

Medicare Program; Request for Nominations to the Advisory Panel on Ambulatory Payment Classification Groups

Fri, Nov 24 2006 11:00:00 GMT

This notice invites nominations of members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). One vacancy presently exists on the Panel due to a Panel member's retirement in June 2006. There will be six more vacancies on the Panel between January 1 and September 30, 2007. Consequently, this solicitation is for seven new members.

The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary, DHHS, (the Secretary) and the Administrator, CMS, (the Administrator) concerning the clinical integrity of the APC groups and their associated weights. The advice provided by the Panel will be considered as we prepare our annual updates of the hospital Outpatient Prospective Payment System (OPPS) through rulemaking.

The Secretary rechartered the Panel in 2004 for a 2year period through November 21, 2006. The new Panel Charter will be effective through November 21, 2008.

Nominations: We will consider nominations if th

Medicare Program; Rechartering of the Advisory Panel on Ambulatory Payment Classification Groups

Fri, Nov 24 2006 11:00:00 GMT

This notice announces the rechartering of the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel) by the Secretary of DHHS (the Secretary) for a 2year period with the new Charter effective until November 21, 2008.

Medicare Program; Decisions Affecting Medicare Advantage Plans Deemed by Joint Commission for the Accreditation of

Fri, Nov 24 2006 11:00:00 GMT

This notice announces our decisions regarding deemed status of Joint Commission for the Accreditation of Health Care Organization accredited Medicare Advantage plans. These decisions follow business decisions made by Joint Commission for the Accreditation of Health Care Organization in late 2005 which affect its deeming operations beginning January 1, 2006 and continue until Joint Commission for the Accreditation of Health Care Organization's deeming authority expires on March 24, 2008.

Medicare Program; Listening Session on a Plan for Medicare Hospital Value-Based Purchasing--January 17, 2007

Fri, Nov 24 2006 11:00:00 GMT

This notice announces a listening session being conducted as part of the development of a plan for Medicare hospital valuebased purchasing, as authorized by the section 5001(b) of the Deficit Reduction Act (DRA) of 2005. The purpose of the listening session is to solicit comments on the range of design issues being considered for plan development. Hospitals, hospital associations, and all interested parties are invited to attend and make comments in person. It will also be possible to participate by teleconference, although due to time constraints, telephone participants will not be able to make verbal comments. Written comments are welcomed. The perspectives expressed during this session and in writing will assist us in drafting the plan. An issues paper outlining the design questions to be discussed and further information about the January listening session will be posted no later than January 3, 2007 on the CMS Web site, Hospital Center, under Spotlights at

Proposed Information Collection Activity; Comment Request

Fri, Nov 24 2006 11:00:00 GMT

Proposed Projects

Title: 45 CFR 1304 Head Start Program Performance Standards.

OMB No. 09700148.

Description: Head Start Program Performance Standards require Head Start and Early Head Start Programs and Delegate Agencies to maintain program records. The Administration for Children and Families, Office of Head Start, is proposing to renew, without changes, the authority to require certain record keeping in all programs as provided for in 45 CFR 1304 Head Start Program Performance Standards. These standards prescribe the services that Head Start and Early Head Start programs provide to enrolled children and their families.

Respondents: Head Start and Early Head Start grantees and delegate agencies.
Annual Burden Estimates Number of responses Average burden hours Number of respondents per respondent per response Total burden hours Instrument

Food Defense Workshop; Public Workshop

Fri, Nov 24 2006 11:00:00 GMT

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southwest Regional Office (SWRO), in cosponsorship with the Risk Management Small Business Development Center (RMSBDC), is announcing a public workshop entitled ``Food Defense Workshop.'' This public workshop is intended to provide information about food defense, the regulations authorized by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), and other related subjects to FDAregulated food facilities (farms, manufacturers, processors, distributors, retailers, and restaurants).

Date and Time: This public workshop will be held on March 29, 2007, from 8 a.m. to 5 p.m.

Location: The public workshop will be held at the Hoblitzelle Auditorium at the Bill Priest Campus of El Centro College, 1402 Corinth St., Dallas, TX 75215.

Contact: David Arvelo, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, Suite 900, Dallas, TX 7520

Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee; Notice of Meeting

Fri, Nov 24 2006 11:00:00 GMT

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on scientific disputes between the Center for Devices and Radiological Health and sponsors, applicants, and manufacturers.

Date and Time: The meeting will be held on December 15, 2006, from 9 a.m. to 5 p.m.

Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.

Contact Person: Nancy CollazoBraier, Office of the Center Director (HFZ1), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 2402763959, nancy.braier@fda.hhs.gov, or FDA Advisory Committee Information Line, 18007418138 (3014430572 in the Washington, DC area

Guidance for Industry, Food and Drug Administration Staff, Eye Care Professionals, and Consumers; Decorative,

Fri, Nov 24 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers: Decorative, Non Corrective Contact Lenses.'' This guidance document explains recently enacted legislation under which all contact lenses are deemed devices within the meaning of the Federal Food, Drug, and Cosmetic Act (the act). All contact lenses, including decorative, noncorrective contact lenses, require premarket approval or clearance by FDA and may be dispensed only upon a lawful prescription order by an eye care professional. Although this guidance document is being immediately implemented, the agency welcomes comments at any time in accordance with the agency's good guidance practices (GGPs).

Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum Level

Fri, Nov 24 2006 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled ``Guidance for Industry: Lead in Candy Likely to Be Consumed Frequently by Small Children; Recommended Maximum level and Enforcement Policy,'' and a supporting document entitled ``Supporting Document for Maximum Recommended Level for Lead in Candy Likely to Be Consumed Frequently By Small Children.'' The guidance provides a maximum recommended lead level in candy likely to be consumed frequently by small children. FDA considers the recommended maximum level to be protective of human health and to be achievable with the use of good manufacturing practices in the production of candy and candy ingredients. The guidance states FDA's commitment to take enforcement action against candy containing lead at levels that may pose a health risk. These two documents are intended to assist candy manufacturers in achieving reduced lead levels in their products consistent with the agency's policy of

Office of the National Coordinator for Health Information Technology; American Health Information Community

Fri, Nov 24 2006 11:00:00 GMT

This notice announces the twelfth meeting of the American Health Information Community Biosurveillance Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92463, 5 U.SD.C., App.).

National Institute of Environmental Health Sciences (NIEHS); Workshop: Children's Environmental Health: Past, Present

Fri, Nov 24 2006 11:00:00 GMT

On January 22-23, 2007, the NIEHS is hosting a workshop titled ``Children's Environmental Health Research: Past, Present, and Future.'' The goal of this workshop is to develop new strategies for research, exposure and effects monitoring, intervention and prevention in children's environmental health. Specific objectives are to maximize the effectiveness of scientific researchbasic science, exposure monitoring/biomonitoring, epidemiology, toxicology, clinical medicine and multidisciplinary studiesand to enhance the translation of research to the bedside, to the community and to public policy. This meeting is open to the public with attendance limited only by the space available. Time will be set aside for public discussion. Additional information about the workshop and online registration are available from the NIEHS Web site at http://www.apps.niehs.ni

Findings of Research Misconduct

Fri, Nov 24 2006 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

James C. Lin, Ph.D., University of Illinois at Chicago: Based on the findings from an inquiry by the University of Illinois at Chicago (UIC) and on additional analysis conducted by ORI during its oversight review, the U.S. Public Health Service (PHS) found that James C. Lin, Ph.D., Professor, Department of Electrical and Computer Engineering, Physiology, and Biophysics, UIC, engaged in research misconduct concerning National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grant application 1 R01 NS4723801, ``BloodBrain Barrier Interactions of CellularPhone Radi.''

Specifically, PHS found that Dr. Lin committed research misconduct relative to the legend and related text for Figure 2 (data from a colleague on other experiments) for his NIH application 1 R01 NS47238 01, by falsely claiming the fi

Findings of Misconduct in Science

Fri, Nov 24 2006 11:00:00 GMT

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

Clifford R. Robinson, Ph.D., University of Delaware: Based on the reports of investigations conducted by 3Dimensional Pharmaceuticals, Inc. (3DP) and the University of Delaware (UD) and additional analysis conducted by ORI during its oversight review, the U.S. Public Health Service (PHS) found that Clifford R. Robinson, Ph.D., Assistant Professor, Department of Chemistry and Biochemistry, UD, engaged in misconduct in science involving research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants 1 R43 GM5895001 and 2 R44 GM5895002, ``Four helix bundle analog of a Gprotein coupled receptor (C. Robinson, Principal Investigator [P.I.]). The following grant applications also were involved in Dr. Robinson's misconduct in science:

1 R43 GM6270801, ``Improved method for protein refoldin

National Cancer Institute; Notice of Closed Meetings

Fri, Nov 24 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, NCI Transition Career Development Award.

Date: December 12, 2006.

Time: 11 a.m. to 12 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6130 Executive Blvd., Rockville, MD 20852, (Telephone Conference Call).

Contact Person: Robert Bird, PhD., Scien

National Center for Research Resources; Notice of Meeting

Fri, Nov 24 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 Research Resources 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 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

National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings

Fri, Nov 24 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: National Institute of Allergy and Infectious Diseases Special Emphasis Panel, Revised Unsolicited Complement Program Project Review.

Date: December 12, 2006.

Time: 1 p.m. to 3:30 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Rockledge 6700, 6700B Rockledge Drive, Room 3118, Bethesda, MD 20817, (T

National Institute on Aging; Notice of Closed Meeting

Fri, Nov 24 2006 11:00:00 GMT

Notice is hereby given of a change in the meeting of the National Institute on Aging Special Emphasis Panel, December 4, 2006, 7 p.m. to December 5, 2006 6 p.m. Holiday Inn Chevy Chase, 5520 Wisconsin Avenue, Chevy Chase, MD 20815 which was published in the Federal Register on November 3, 2006, Vol. 71/64730.

The meeting will now be held at the Hilton San Diego Airport Hotel, San Diego, California from December 45, 2006. The meeting is closed to the public.

Dated: November 16, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 069386 Filed 112206; 8:45 am]
BILLING CODE 414001M

Office of the Director, National Institutes of Health; Amended Notice of Meeting

Fri, Nov 24 2006 11:00:00 GMT

Notice is hereby given of a change in the meeting of the Recombinant DNA Advisory Committee, December 5, 2006, 8 a.m. to December 6, 2006, 6 p.m., National Institutes of Health, Building 31, 31 Center Drive, Bethesda, MD 20892 which was published in the Federal Register on November 13, 2006, 71 FR 218, page 66180.

The meeting of the Recombinant DNA Advisory Committee will begin on December 5 at 12 noon and will end December 6, 2006 at 6 p.m. instead of 8 a.m. to 6 p.m. The meeting is open to the public.

Dated: November 16, 2006.
Anna Snouffer,
Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 069387 Filed 112206; 8:45 am]
BILLING CODE 414001M

Center for Scientific Review; Notice of Closed Meetings

Fri, Nov 24 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 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 constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Skeletal Muscle and Exercise Physiology.

Date: November 28, 2006.

Time: 1 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: John P. Holden, P