Department of Health and Human Services May 1, 2008 – Federal Register Recent Federal Regulation Documents

Determination of Regulatory Review Period for Purposes of Patent Extension; ARTEFILL
Document Number: E8-9592
Type: Notice
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for ARTEFILL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; AZILECT
Document Number: E8-9591
Type: Notice
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined the regulatory review period for AZILECT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Food Labeling: Health Claims; Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease
Document Number: E8-9590
Type: Rule
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulation authorizing a health claim on the relationship between soluble fiber from certain foods and risk of coronary heart disease (CHD). The amendment exempts certain foods from the nutrient content requirement of ``low fat.'' The exemption will apply if the food exceeds the ``low fat'' requirement due to fat content derived from whole oat sources. The amendment expands the use of this health claim to some whole oat products that are currently ineligible for the health claim. FDA is taking this action in response to a petition submitted by the Quaker Oats Co.
Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of Meeting
Document Number: E8-9549
Type: Notice
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-9546
Type: Notice
Date: 2008-05-01
Agency: National Institute for Occupational Safety and Health, Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at Combustion Engineering, Windsor, Connecticut, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-9545
Type: Notice
Date: 2008-05-01
Agency: National Institute for Occupational Safety and Health, Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Lawrence Livermore National Laboratory, Livermore, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: E8-9544
Type: Notice
Date: 2008-05-01
Agency: National Institute for Occupational Safety and Health, Department of Health and Human Services
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Mound Plant, near Dayton, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On March 3, 2008, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E8-9537
Type: Notice
Date: 2008-05-01
Agency: Food and Drug Administration, Department of Health and Human Services
Government-Owned Inventions; Availability for Licensing
Document Number: E8-9535
Type: Notice
Date: 2008-05-01
Agency: Department of Health and Human Services, National Institutes of Health
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: Proposed Collection: Comment Request
Document Number: E8-9517
Type: Notice
Date: 2008-05-01
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: E8-9404
Type: Notice
Date: 2008-05-01
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: E8-9292
Type: Notice
Date: 2008-05-01
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
Medicare Program; Proposed Hospice Wage Index for Fiscal Year 2009
Document Number: 08-1198
Type: Proposed Rule
Date: 2008-05-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule proposes the hospice wage index for fiscal year 2009. This proposed rule also proposes to phase-out the Medicare hospice budget neutrality adjustment factor and clarify two wage index issues, pertaining to the definition of rural and urban areas and to multi-campus hospital facilities.