The Federal Register

Fees for Sanitation Inspections of Cruise Ships

Mon, Nov 21 2005 11:00:00 GMT

This notice announces an increase in the fees for vessel sanitation inspections for the remainder of fiscal year 2006 (January 1, 2006, through September 30, 2006).

Medicare Program; Exclusion of Vendor Purchases Made Under the Competitive Acquisition Program (CAP) for Outpatient

Mon, Nov 21 2005 11:00:00 GMT

This interim final rule with comment period provides clarification and solicits comments on the relationship between drugs supplied under the Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals and the calculation of Average Sales Price (ASP). (For purposes of this interim final rule, the term ``drug'' refers to drugs and biologicals.) This interim final rule with comment period also will exclude units of drugs supplied under the CAP from ASP calculations for a period of up to 3 years, at which time the policy will be reevaluated. In addition, this rule revises the definition of unit to reflect the exclusion of units of CAP drugs administered to beneficiaries by participating CAP physicians.

RINs 0938-AN84 and 0938-AN58

Mon, Nov 21 2005 11:00:00 GMT

This rule addresses Medicare Part B payment policy, including the physician fee schedule that are applicable for calendar year (CY) 2006; and finalizes certain provisions of the interim final rule to implement the Competitive Acquisition Program (CAP) for Part B Drugs. It also revises Medicare Part B payment and related policies regarding: Physician work; practice expense (PE) and malpractice relative value units (RVUs); Medicare telehealth services; multiple diagnostic imaging procedures; covered outpatient drugs and biologicals; supplemental payments to Federally Qualified Health Centers (FQHCs); renal dialysis services; coverage for glaucoma screening services; National Coverage Decision (NCD) timeframes; and physician referrals for nuclear medicine services and supplies to health care entities with which they have financial relationships. In addition, the rule finalizes the interim RVUs for CY 2005 and issues interim RVUs for new and revised procedure codes for CY 2006. This rule also updat

New Animal Drugs; Florfenicol

Mon, Nov 21 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a new animal drug application (NADA) filed by ScheringPlough Animal Health Corp. The NADA provides for the use of florfenicol by veterinary feed directive in catfish feed for the control of mortality due to enteric septicemia of catfish.

Notice of Approval of Supplemental New Animal Drug Application; Ivermectin and Praziquantel Paste

Mon, Nov 21 2005 11:00:00 GMT

The Food and Drug Administration (FDA) is providing notice that it has approved a supplemental new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for oral use of an ivermectin and praziquantel paste as an overthecounter product for the treatment and control of various parasitic conditions of horses. This supplemental NADA reduces the minimum age for administration from 5 months to 2 months of age.

Public Meeting of the President's Council on Bioethics on December 8-9, 2005

Mon, Nov 21 2005 11:00:00 GMT

The President's Council on Bioethics (Edmund D. Pellegrino, MD, Chairman) will hold its twentysecond meeting, at which, among other things, it will discuss ethical issues relating to children. Subjects discussed at past Council meetings (though not on the agenda for the present one) include: Cloning, assisted reproduction, reproductive genetics, IVF, ICSI, PGD, sex selection, inheritable genetic modification, patentability of human organisms, neuroscience, aging
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retardation, lifespanextension, and organ procurement for
transplantation. Publications issued by the Council to date include: Human Cloning and Human Dignity: An Ethical Inquiry (July 2002); Beyond Therapy: Biotechnology and the Pursuit of Happiness (October 2003); Being Human: Readings from the President's Council on Bioethics (December 2003); Monitoring Stem Cell Research (January 2004), Reproduction and Responsibility: The Regulation of New Biotechnologies (March 2004), Alternative Sources of Human Pluripotent Stem Ce

National Eye Institute; Notice of Closed Meeting

Mon, Nov 21 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 Eye Institute Special Emphasis Panel, Gene Therapy Clinical Trial.

Date: November 21, 2005.

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

Agenda: To review and evaluate grant applications.

Place: Sheraton Gateway Hotel Los Angeles Airport, 6101 W Century Blvd., Los Angeles, CA 90045.

Contact Person: Samuel Rawlings, PhD, Chief, Scientific Review Branch, D

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

Mon, Nov 21 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 Board of Scientific Counselors, NHLBI.

The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual grant applications conducted by the National Heart, Lung, and Blood Institute, including consideration of personnel
qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Board of Scientific Counselors, NHLBI. [[Page 70080]]

Date: December 14, 2005.

Time: 8:30 a.m. to 4:30 p.m.

Agenda: To review and evaluate the Laboratory of Cell Biology, the Laboratory of Molecular Cardiology, and the Laboratory of Developmental Biology.

Place: Hyatt Regency Bethesd

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

Mon, Nov 21 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 Heart, Lung, and Blood Institute Special Emphasis Panel; Review of ResourceRelated Research Project Applications (R24s).

Date: December 7, 2005.

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).

Cont

National Human Genome Research Institute; Notice of Closed Meeting

Mon, Nov 21 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: Center for Inherited Disease Research Access Committee, CIDR.

Date: January 5, 2006.

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

Agenda: To review and evaluate grant applications.

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

Contact Person: Jerry Roberts, PhD, Scientific Review Administrator, Scientific Review Branch, National Instit

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

Mon, Nov 21 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 Child Health and Human Development Special Emphasis Panel; Mitochondrial Disorder.

Date: December 9, 2005.

Time: 9 a.m. to 2 p.m.

Agenda: To review and evaluate grant applications.

Place: Hotel Washington, Pennsylvania Ave. at 15th Street, NW., Washington, DC 20004.

Contact Person: Norman Chang, PhD, Scientific Review A

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

Mon, Nov 21 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 Child Health and Human Development Special Emphasis Panel; Career Development Applications.

Date: December 7, 2005.

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

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852, (Telephone Conference Call).

Contact

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

Mon, Nov 21 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 Child Health and Human Development Special Emphasis Panel; Human Development Training.

Date: December 7, 2005.

Time: 10:30 a.m to 11:30 a.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6100 Executive Boulevard, Room 5B01, Rockville, MD 20852, (Telephone Conference Call).

Conta

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting

Mon, Nov 21 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 application, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel, MidCareer Investigator Award in PatientOriented Research.

Date: December 8, 2005.

Time: 8 a.m. to 10 a.m.

Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Boulevard, Bethesda, MD 2089

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings

Mon, Nov 21 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
[[Page 70082]]

is hereby given of the following meetings.

Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Cellular Signaling.

Date: December 6, 2005.

Time: 8:30 a.m. to 4:30 p.m.

Agenda: To review and evaluate grant applications.

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

Contact Person: Dan E. Matsumoto, Ph

National Institute on Aging; Notice of Closed Meeting

Mon, Nov 21 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 on Aging Special Emphasis Panel; CNS and Cerebrovascular Aging.

Date: December 12, 2005.

Time: 12 p.m. to 5 p.m.

Agenda: To review and evaluate grant applications.

Place: National Institute on Aging/NIH, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, (Telephone Conference Call).

Contact Person: A

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

Mon, Nov 21 2005 11:00:00 GMT

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

The meeting will be open to the public, 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: Recombinant DNA Advisory Committee; RAC.

Date: December 1314, 2005.

Time: 8 a.m to 6 p.m.

Agenda: The Committee will review and discuss selected human gene transfer protocols as well as related data management activities.

Place: Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814.

Contact Person: Laurie Lewallen, Advisory Committee Coordinator, Office of Biotechnology Activities, National Institutes of Health, 6705 Rockledge Drive, Room 750, Bethesda, MD 208927985, 301496 9838,

Center for Scientific Review; Notice of Closed Meetings

Mon, Nov 21 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; AIDSMolecular Biology.

Date: November 21, 2005.

Time: 1 p.m. to 4 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: Ranga V. Srinivas, PhD, Scientific Review