Department of Health and Human Services August 24, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 8 of 8
Agency Information Collection Activities; Proposed Collection; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002
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 publication of the criteria FDA intends to use to accredit third parties to conduct inspections of eligible manufacturers of class II or class III medical devices.
Findings of Misconduct in Science
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: Kui Zhu, Ph.D., Cleveland Clinic Research Foundation: Based on accumulated evidence including the Cleveland Clinic Research Foundation (CCF) investigation report (CCF Report) and additional analysis and information obtained by the Office of Research Integrity (ORI) during its oversight review of the CCF Report, the U.S. Public Health Service (PHS) found that Kui Zhu, Ph.D., former postdoctoral fellow, CCF, engaged in misconduct in science by intentionally and knowingly fabricating and falsifying data for figures in two publications and with research funded by National Cancer Institute (NCI), National Institutes of Health (NIH), grants R21 CA84038, R01 CA76204, and T32 CA09056. ORI has implemented the following administrative actions for a period of three (3) years, beginning June 7, 2006: (1) Dr. Zhu is debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government as defined in the debarment regulations at 45 CFR part 76; and (2) Dr. Zhu is prohibited from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Updated Vaccine Information Statements for Influenza Vaccines; Revised Instructions for Use of Vaccine Information Statements
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. Since January 1, 2006, use of trivalent influenza vaccine information materials has been required. This notice announces availability of updated influenza vaccine information materials for use in the upcoming 2006-07 influenza season.
Memorandum of Understanding Between the U.S. Food and Drug Administration, the National Cancer Institute, and the National Institute of Standards and Technology
The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the National Cancer Institute (NCI), the National Institute of Standards and Technology (NIST), and the Food and Drug Administration (FDA) (collectively ``the Parties'', or individually as a ``Party'') regarding the roles, responsibilities, and financial commitments of each Party relating to the collaboration through working groups and steering committees to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goal of facilitating the development of nanotechnologies that constitute novel research tools and safer, more effective cancer therapies by establishing a framework for effective risk identification, assessment and evaluation of emerging products based on nanotechnology. This collaboration among the Parties will be focused primarily on the Nanotechnology Characterization Laboratory and directly related activities.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
