Department of Health and Human Services April 2005 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

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.

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).

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.

The Head Start Bureau is announcing the availability of funds and request for applications for professional development and training grants for institutions of higher education with experience and capability in educating and preparing professionals to work effectively with Hispanic young children and families, in partnership with Head Start, Migrant Head Start and Early Head Start programs. The Head StartHigher Education Hispanic Service Institution Partnership (HS-HEHSIPs) program is funded to improve the quality and long-term effectiveness of program services to Hispanic children and their families by developing academic and other training models and forming partnerships between institutions of higher education and Head Start, Migrant Head Start, and Early Head Start programs. Through this announcement, the Administration on Children, Youth and Families (ACYF) is making available up to $1,500,000 annually for each of five years to support Head StartHigher Education Hispanic Service Institution Partnerships (HS-HEHSIPs). These partnerships are designed to improve the quality and long-term effectiveness of Head Start, Migrant Head Start and Early Head Start grantees by developing academic and other training models to increase the number of Head Start teachers with degrees in early childhood education.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFAR.'' This draft guidance describes the circumstances under which certain applications for fixed dose combination (FDC) and copackaged versions of previously approved antiretroviral therapies for the treatment of human immunodeficiency virus (HIV) under the President's Emergency Plan for Acquired Immunodeficiency Syndrome Relief (PEPFAR) will not be assessed user fees. The draft guidance also describes circumstances under which some of the applications that will be assessed fees may be eligible for a public health or a barrier-to-innovation waiver.