Department of Health and Human Services May 3, 2005 – Federal Register Recent Federal Regulation Documents
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Risk Assessment of the Public Health Impact From Foodborne Listeria Monocytogenes in Smoked Finfish; and Evaluation of Food Code Provisions That Address Preventive Controls for Listeria Monocytogenes in Retail and Foodservice Establishments; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to July 5, 2005, the comment period for the notice that appeared in the Federal Register of March 4, 2005 (70 FR 10650). In the notice, FDA requested comments and scientific data and information to assist the agency in its plans to conduct a risk assessment for Listeria monocytogenes in smoked finfish and to evaluate the provisions of the 2001 Food Code that address preventive controls for L. monocytogenes in retail and foodservice establishments. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments and scientific data and information.
Funding Opportunity Title: Food Safety Task Force Conference Announcement Type: New Request for Applications Funding Opportunity Number: RFA-FDA-ORA-2005-3 Catalog of Federal Domestic Assistance (CFDA) Number(s):93-103
The Food and Drug Administration (FDA) is issuing a revised request for application (RFA) that will replace the announcements published June 25, 2004 (69 FR 35651) and February 4, 2005 (70 FR 6015). FDA, in collaboration with the Centers for Disease Control and Prevention (CDC), is announcing the availability of conference grant funding for meetings of State Food Safety and Food Security Task Forces. The original announcement of availability of funding for State Food Safety Task Force Meetings, published in the Federal Register on January 24, 2000 (65 FR 3720), is superseded by this announcement. This revised announcement provides new policies that apply to the State Food Safety and Food Security Task Force Meetings Conference Grant Program. The FDA views this program as an ongoing program announcement, contingent on the availability of funds.
Agency Information Collection Activities; Proposed Collection; Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring
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 regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.
Privacy Act of 1974: Revision to Existing System of Records
In accordance with the requirements of the Privacy Act, the Department of Health and Human Services (HHS) is publishing a notice of the revision of an existing system of records, 09-90-0200, Child Care Subsidy Program. The revised system will collect family income data from employees in the National Institutes of Health, as well as the Health Resources and Services Administration, the Food and Drug Administration (FDA), the Program Support Center (PSC), the Office of the Secretary (OS), the Administration on Aging (AoA), the Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry (CDC/ATSDR) and the Substance Abuse and Mental Health Services Administration (SAMHSA) who are already covered by this system, for the purpose of determining their eligibility for child care subsidies, and the amounts of the subsidies. It also will collect information from the employees' child care provider(s) for verification purposes, e.g., that the provider is licensed. Collection of data will be by subsidy application forms submitted by employees. HHS is also revising the name of the General Accounting Office (GAO) in Routine Use number 5 because the name of that office has changed to the Government Accountability Office.
Solicitation of Nomination for Appointment to the Advisory Committee on Blood Safety and Availability
The Department of Health and Human Services (DHHS), Office of Public Health and Science, is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Blood Safety and Availability (ACBSA). The ACBSA provides advice to the Secretary and the Assistant Secretary for Health on blood safety policy issues which encompass broad public health and societal implications that cannot be resolved through analysis of scientific data alone.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
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; Infant Formula Recall Regulations
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; Extralabel Drug Use in Animals
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 for 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 requirements when development of an analytical method for residue detection is required by FDA for a drug prescribed for extralabel use in animals.
Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarketing Adverse Drug Experience Reporting
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 postmarketing adverse drug experience reporting and recordkeeping requirements.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Third Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Registration and Listing
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device Registration and Listing'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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