Department of Health and Human Services March 2006 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 332
Prospective Grant of Exclusive License: Dengue Virus Vaccine
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Centers for Disease Control and Prevention (CDC), Technology Transfer Office, Department of Health and Human Services (DHHS), is contemplating the grant of a worldwide, limited field of use, exclusive license to practice the inventions embodied in the patent application referred to below to Inviragen, LLC, having a place of business in Fort Collins, Colorado. The patent rights in these inventions have been assigned to the government of the United States of America.
National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners: Reporting on Adverse and Negative Actions
This proposed rule would revise existing regulations under sections 401-432 of the Health Care Quality Improvement Act of 1986, governing the National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners, to incorporate statutory requirements under section 1921 of the Social Security Act, as amended by section 5(b) of the Medicare and Medicaid Patient and Program Protection Act of 1987, and as amended by the Omnibus Budget Reconciliation Act of 1990. The Medicare and Medicaid Patient and Program Protection Act of 1987, along with certain additional provisions in the Omnibus Budget Reconciliation Act of 1990, was designed to protect program beneficiaries from unfit health care practitioners, and otherwise improve the anti-fraud provisions of the Medicare and State health care programs. Section 1921, the statutory authority upon which this regulatory action is based, requires each State to adopt a system of reporting to the Secretary of Health and Human Services (the Secretary) certain adverse licensure actions taken against health care practitioners and health care entities licensed or otherwise authorized by a State (or a political subdivision thereof) to provide health care services. It also requires each State to report any negative actions or findings that a State licensing authority, peer review organization, or private accreditation entity has concluded against a health care practitioner or health care entity.
Determination of Regulatory Review Period for Purposes of Patent Extension; MYCAMINE
The Food and Drug Administration (FDA) has determined the regulatory review period for MYCAMINE 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.
Memorandum of Understanding Between the United States Food and Drug Administration, the National Cancer Institute, and the Centers for Medicare and Medicaid Services
The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the Food and Drug Administration (FDA), the National Cancer Institute (NCI), and the Centers for Medicare and Medicaid Services (CMS) to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goal of improving the clinical utility of biomarker technologies as diagnostic and assessment tools that facilitate the development of safer and more effective cancer therapies. This collaboration among FDA, NCI, and CMS shall be known as the Oncology Biomarker Qualification Initiative.
Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science; Cancellation
The Food and Drug Administration (FDA) is canceling the meeting of the Manufacturing Subcommittee of the Advisory Committee for Pharmaceutical Science scheduled for April 18 and 19, 2006. This meeting was announced in the Federal Register of February 16, 2006 (71 FR 8307).
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Emergency Clearance: Public Information Collection; Requirements Submitted to the Office of Management and Budget (OMB); Correction
This document corrects an incorrect date that appeared in the notice [Document Identifier: CMS-10185] titled ``Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)'' that was published in the Federal Register on March 3, 2006 (71 FR 10976).
Decision To Evaluate a Petition To Designate a Class of Employees at the Nevada Test Site, Mercury, Nevada, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Nevada Test Site, Mercury, Nevada, 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: Nevada Test Site. Location: Mercury, Nevada. Job Titles and/or Job Duties: Workers potentially exposed to above- ground weapons testing. Period of Employment: 1951 to 1963.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emergency Shortages Data Collection System (Formerly the Emergency Medical Device Shortage Program Survey)
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; Submission for Office of Management and Budget Review; Comment Request; Notice of Participation
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: Proposed Collection; Comment Request; Prescription Drug Marketing Act of 1987
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting and recordkeeping requirements contained in the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA).
National Vaccine Injury Compensation Program; List of Petitions Received
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (``the Program''), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
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