Department of Health and Human Services August 18, 2009 – Federal Register Recent Federal Regulation Documents

Findings of Research Misconduct
Document Number: E9-19795
Type: Notice
Date: 2009-08-18
Agency: Office of the Secretary, Department of Health and Human Services
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:
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Financial Disclosure by Clinical Investigators
Document Number: E9-19788
Type: Notice
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Financial Disclosure by Clinical Investigators'' 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; Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices
Document Number: E9-19787
Type: Notice
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Mental Models Study of Farmers' Understanding and Implementation of Good Agricultural Practices'' 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; Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
Document Number: E9-19784
Type: Notice
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Toll-Free Number for Consumer Reporting of Drug Product Side Effects in Direct-to-Consumer Television Advertisements for Prescription Drugs
Document Number: E9-19782
Type: Notice
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Development of Antiviral Products for Treatment of Smallpox and Related Poxvirus Infections; Public Workshop
Document Number: E9-19781
Type: Notice
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in clinical development of antiviral drug products for treatment of smallpox and related poxvirus infections. This public workshop is intended to provide information for and gain perspective from health care providers, academia, and industry on various aspects of antiviral product development for smallpox and related poxvirus infections, including the status of clinical understanding of smallpox from pre-eradication experience, current epidemiology of naturally occurring poxvirus infections, potential effect of antiviral treatment for smallpox and related poxvirus infections, and issues pertaining to animal models for smallpox and related poxvirus infections. The input from this public workshop will help in developing topics for further discussion.
Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010; Correction
Document Number: E9-19779
Type: Notice
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration is correcting a notice entitled that appeared in the Federal Register of August 3, 2009 (74 FR 38429). The document announced the Fiscal Year 2010 fee rates for the Animal Drug User Fee Act. The document was published with a typographical error. This document corrects that error.
Food and Drug Administration Transparency Task Force; Reopening of Comment Period
Document Number: E9-19778
Type: Notice
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening until November 6, 2009, the comment period for the notice of public meeting and request for comments that appeared in the Federal Register of June 3, 2009 (74 FR 26712). In the notice of public meeting and request for comments, FDA's Transparency Task Force requested comments on ways in which FDA can make useful and understandable information about FDA activities and decision making more readily available to the public. The agency is taking this action because the agency is planning a second public meeting this fall and is reopening the comment period to allow interested persons additional time to submit comments.
Board of Scientific Counselors, National Center for Public Health Informatics (BSC, NCPHI)
Document Number: E9-19754
Type: Notice
Date: 2009-08-18
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
New Animal Drugs for Use in Animal Feeds; Semduramicin; Virginiamycin
Document Number: E9-19738
Type: Rule
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Phibro Animal Health. The NADA provides for use of single-ingredient Type A medicated articles containing semduramyicin (as semduramicin sodium biomass) and virginiamycin to manufacture 2-way combination drug Type C medicated feeds for use in broiler chickens.
Delegations of Authority
Document Number: E9-19709
Type: Notice
Date: 2009-08-18
Agency: Office of the Secretary, Department of Health and Human Services
Notice of Interest Rate on Overdue Debts
Document Number: E9-19707
Type: Notice
Date: 2009-08-18
Agency: Office of the Secretary, Department of Health and Human Services
Office of the Commissioner Reorganization; Statement of Organizations, Functions, and Delegations of Authority
Document Number: E9-19680
Type: Notice
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has reorganized the Office of the Commissioner (OC). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the re-alignment of four Deputy- level offices within the Office of the Commissioner: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness).
National Institute of General Medical Sciences; Notice of Meeting
Document Number: E9-19663
Type: Notice
Date: 2009-08-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: E9-19624
Type: Notice
Date: 2009-08-18
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Irradiation in the Production, Processing, and Handling of Food
Document Number: 09-19785
Type: Notice
Date: 2009-08-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Irradiation in the Production, Processing, and Handling of Food'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
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