Department of Health and Human Services April 20, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 39 of 39
National Health Education Enhancement Program
The purpose of the program is to strengthen the nation's capacity to carry out public health activities in the area of asthma education. More specifically, the objective is to provide appropriate resources for health education of patients and others impacted by asthma.
Levothyroxine Sodium Therapeutic Equivalence; Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting on the therapeutic equivalence of levothyroxine sodium drug products. This will be a workshop involving FDA staff and representatives of three medical societies: The American Thyroid Association (ATA), the Endocrine Society, and the American Association of Clinical Endocrinologists (AACE). The purpose of the public meeting is to discuss FDA's regulatory standards and methodological approaches for determining therapeutic equivalence between levothyroxine sodium drug products. The agency is seeking comments and input from interested constituencies, including patient advocacy and education groups, and pharmaceutical sponsors.
Agency Information Collection Activities; Proposed Collection; Comment Request; Survey of Need for Online Medical Device Information
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a survey of customers who should be served by FDA's Center for Devices and Radiological Health (CDRH) Web site, in order to determine the kind and quality of services they want.
Prospective Grant of Exclusive License: Human Anesthetic Formulation Based Upon Cyclodextrin Carriers
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in U.S. Patent No. 6,407,079, entitled ``Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation,'' to Jurox Pty Ltd., having a place of business in Rutherford, Australia. The field of use may be limited to the development of injectable anesthetic formulations containing Alfaxalone-hydroxypropyl-beta cyclodextrin complex for use in humans. The United States of America has an interest in the patent rights of this invention.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
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; New Animal Drugs For Investigational Use
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 (the PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Health Claims on Food Packages
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.
Draft “Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection;” Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,'' dated April 2005. The draft guidance document provides revisions to the previously published recommendations for assessing donor suitability and product safety when donors are diagnosed with or suspected of West Nile Virus (WNV) infections based on symptoms and laboratory tests. This draft guidance proposes revised deferral periods for such donors, and updates information on product retrieval and quarantine. When finalized, this guidance will supersede ``Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,'' dated May 2003.
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