Department of Health and Human Services October 30, 2007 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry on Acute Bacterial Sinusitis: Developing Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Acute Bacterial Sinusitis: Developing Drugs for Treatment.'' The purpose of this guidance is to assist clinical trial sponsors and investigators in the development of antimicrobial drug products for the treatment of acute bacterial sinusitis (ABS). The agency's thinking in this area has evolved in recent years, and this draft guidance, when finalized, will inform sponsors of our current thinking in this area. In addition, it will fulfill a statutory requirement to publish such a guidance enacted in the Food and Drug Administration Amendments Act of 2007 (FDAAA).
Reimbursement of Travel and Subsistence Expenses Toward Living Organ Donation Proposed Eligibility Guidelines and Publication of Final Program Eligibility Guidelines
The Health Resources and Services Administration published a notice in the Federal Register of October 5, 2007 (FR Doc. E7-19747), on pages 57049-57052, regarding response to solicitation of comments and publication of final program eligibility guidelines.
Biomin GmbH; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Biomin GmbH, Industriestrasse 21, Herzogenburg, Austria 3130, has filed a petition proposing that the food additive regulations be amended to provide for the safe use of Eubacterium bacterial species in feed for detoxifying trichothecene mycotoxins in the digestive tracts of swine and poultry.
Privacy Act of 1974: New System of Records
In accordance with the requirements of the Privacy Act, the Health Resources and Services Administration (HRSA) is publishing a notice of a proposal to add a new system of records. The Campus Based Branch (CBB) of the Division of Health Careers Diversity and Development in the Bureau of Health Professions is currently utilizing a document management system (DMS) that dynamically manages its flow of documents produced and received. the DMS is an intra-office system in which documents contained within the system are only shared among CBB staff. The DMS contains names and other personally identifiable information of borrowers.
Office of the National Coordinator for Health Information Technology; American Health Information Community Chronic Care Workgroup Meeting
This notice anounces the 20th 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.)
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