Department of Health and Human Services February 23, 2007 – Federal Register Recent Federal Regulation Documents
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Determination of Regulatory Review Period for Purposes of Patent Extension; AMITIZA
The Food and Drug Administration (FDA) has determined the regulatory review period for AMITIZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; S8 OVER-THE-WIRE SYSTEM
The Food and Drug Administration (FDA) has determined the regulatory review period for S8 OVER-THE-WIRE SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
Medicare Program; Listening Session on the Draft Plan for Medicare Hospital Value-Based Purchasing-April 12, 2007
This notice announces the second Listening Session being conducted as part of the development of a plan for Medicare hospital value-based purchasing, as authorized by section 5001(b) of the Deficit Reduction Act of 2005 (Pub. L. 109-171) (DRA). The purpose of the second Listening Session is to solicit comments on the Draft Plan that has been developed. Hospitals, hospital associations, and all interested parties are invited to attend and make comments in person. The perspectives expressed during this session and in writing will assist us in making revisions to the Draft Plan to create the final Medicare Hospital Value-Based Purchasing Plan to be completed by June 2007. The Draft Plan will be posted no later than March 22, 2007 on the CMS Web site, Hospital Center, under Spotlights at https:// www.cms.hhs.gov/center/hospital.asp.
Medicare and Medicaid Programs; Announcement of an Application From a Hospital Requesting Waiver for Organ Procurement Service Area
This notice announces a hospital's request for a waiver from entering into an agreement with its designated organ procurement organization (OPO), in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.
Withdrawal of Approval of 128 Suitability Petitions
The Food and Drug Administration (FDA) is withdrawing approval of 128 suitability petitions. This action is being taken in accordance with the Pediatric Research Equity Act of 2003 (PREA). Prior to PREA's enactment, FDA had approved these suitability petitions to permit abbreviated new drug applications (ANDAs) to be submitted for drugs that had a different active ingredient, dosage form, or route of administration than their reference listed drugs (RLDs). However, these approval decisions are being withdrawn because ANDAs were never submitted and PREA requires that all applications submitted on or after April 1, 1999, for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration contain an assessment of the safety and effectiveness of the drug for the claimed indications in relevant pediatric subpopulations unless the requirement is waived or deferred. This action is being taken without prejudice. Any of the suitability petitions may be resubmitted for action by the agency in accordance with current law.
Determination of Regulatory Review Period for Purposes of Patent Extension; BARACLUDE
The Food and Drug Administration (FDA) has determined the regulatory review period for BARACLUDE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; EXJADE
The Food and Drug Administration (FDA) has determined the regulatory review period for EXJADE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
Medicare Program; Announcement of New Members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups
This notice announces five new members selected to serve on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). 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. We will consider the Panel's advice as we prepare the annual updates of the hospital outpatient prospective payment system (OPPS).
Medicare Program; Notice of Supplemental Election Period for Provider Participation in the Calendar Year (CY) 2007 Competitive Acquisition Plan for Part B Drugs
This notice announces an additional physician election period for physicians who are not currently participating in the competitive acquisition program (CAP) for Medicare Part B drugs for calendar year (CY) 2007. The additional physician election period begins on May 1, 2007 and ends on June 15, 2007. Physicians who elect to join the CAP during this additional election period will enter into a physician election agreement effective August 1, 2007 through December 31, 2007.
Program; Public Meetings in Calendar Year 2007 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2007 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. Discussion will be directed toward responses to our specific preliminary recommendations and will include all items on the public meeting agenda.
Medicare, Medicaid, and CLIA Programs; Approval of the Joint Commission (Formerly the Joint Commission on Accreditation of Healthcare Organizations) as a CLIA Accreditation Organization
This notice announces CMS' grant of deeming authority to the Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations) under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the requirements of the Joint Commission accreditation process are equal to or more stringent than the CLIA condition level requirements, and that the Joint Commission has met the requirements of subpart E of 42 CFR part 493. Consequently, laboratories that are voluntarily accredited by the Joint Commission and continue to meet the Joint Commission requirements will be deemed to meet the CLIA condition level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by us or our designee.
Medicare, Medicaid, and CLIA Programs; Approval of COLA (Formerly the Commission on Office Laboratory Accreditation) as a CLIA Accreditation Organization
In this notice, we grant COLA (formerly the Commission on Office Laboratory Accreditation) deeming authority as an accrediting organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that the requirements of the COLA accreditation process are equal to or more stringent than the CLIA condition level requirements, and that COLA has met the requirements of subpart E of 42 CFR Part 493. Consequently, laboratories that are voluntarily accredited by COLA and continue to meet COLA requirements will be deemed to meet the CLIA condition-level requirements for laboratories and therefore are not subject to routine inspection by State survey agencies to determine their compliance with Federal requirements. They are, however, subject to Federal validation and complaint investigation surveys conducted by us or our designee.
Office of the National Coordinator for Health Information Technology; American Health Information Community Population Health and Clinical Care Connections Workgroup Meeting
This notice announces the 15th meeting of the American Health Information Community Population Care and Clinical Care Connections Workgroup [formerly BioSurveillance Workgroup] in accordance with the Federal Advisory Committee Act (Pub. L. no. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
This notice announces the 14th meeting of the American Health Information Community Chronic Care Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Electronic Health Records Workgroup Meeting
This notice announces the 14th meeting of the American Health Information Community Electronic Health Records Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Consumer Empowerment Workgroup Meeting
This notice announces the 15th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.)
Office of the National Coordinator for Health Information Technology; American Health Information Community Personalized Healthcare Workgroup Meeting
This notice announces the 3rd meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 93-463, 5 U.S.C., App.).
Office of the National Coordinator for Health Information Technology; American Health Information Community Quality Workgroup Meeting
This notice announces the 6th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Substances Approved for Use in the Preparation of Meat and Poultry Products; Announcement of Effective Date
The Food and Drug Administration (FDA) is announcing the effective date for the information collection requirements contained in a final rule published in the Federal Register of August 25, 2000 (65 FR 51758). The rule amended FDA's regulations on food additive and color additive petitions to permit an efficient joint review by both FDA and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), of petitions for approval to use a food ingredient or source of radiation in or on meat or poultry products. An information collection requirement cannot be instituted unless it is reviewed by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA), approved by OMB, and assigned an OMB control number. OMB's approval of the information collection requirements of the August 25, 2000, final rule was announced in the Federal Register of March 1, 2001 (66 FR 12938), and these requirements are currently approved under OMB control number 0910-0016. Accordingly, FDA is announcing that the information collection requirements of the August 25, 2000, final rule will go into effect on March 26, 2007.
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