Department of Health and Human Services January 17, 2013 – Federal Register Recent Federal Regulation Documents

Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2013-00925
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Los Alamos National Laboratory (LANL), in Los Alamos, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, 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: 2013-00924
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from Oak Ridge National Laboratory (X-10), in Oak Ridge, Tennessee, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, 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: 2013-00923
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Nuclear Metals, Inc. facility in West Concord, Massachusetts, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, 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: 2013-00920
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Mound Plant, in Miamisburg, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On December 7, 2012, 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:
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-00885
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00884
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2013-00883
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2013-00882
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2013-00881
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2013-00880
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meetings
Document Number: 2013-00879
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of a Co-Exclusive License: Adenovirus-Based Controls and Calibrators for Molecular Diagnostics of Infectious Disease Agents
Document Number: 2013-00878
Type: Notice
Date: 2013-01-17
Agency: Department of Health and Human Services, National Institutes of Health
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 (HHS), is contemplating the grant of a worldwide co-exclusive license, to practice the inventions embodied in US patent 6,013,638 (HHS Reference E-129-1991/0- US-03), issued January 11, 2000 and entitled ``Adenovirus Comprising Deletions on the E1A, E1B And E3 Regions for Transfer of Genes to the Lung'', and US patent 6,136,594 (HHS Reference E-129-1991/1- US-03), issued October 24, 2000, and entitled ``Replication Deficient Recombinant Adenovirus Vector'' to Life Technologies Corporation (LTC) of Carlsbad, California. The United States of America is an assignee of the rights of the above inventions. The field of use may be limited to the ``use of adenovirus-based recombinant constructs as controls and calibrators for molecular diagnostics for infectious disease agents.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2013-00860
Type: Notice
Date: 2013-01-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2013-00858
Type: Notice
Date: 2013-01-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Generic Drug User Fee-Active Pharmaceutical Ingredient and Finished Dosage Form Facility Fee Rates for Fiscal Year 2013
Document Number: 2013-00851
Type: Notice
Date: 2013-01-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA), enacted the Food and Drug Administration Safety and Innovation Act, as further amended by the FDA User Fee Corrections Act of 2012, authorizes FDA to assess and collect user fees for certain applications and supplements associated with human generic drug products, on applications in the backlog as of October 1, 2012, on finished dosage form (FDF) and active pharmaceutical ingredient (API) facilities, and on Type II API drug master files (DMF) to be made available for reference. GDUFA directs FDA to establish each year the generic drug user fee rates for the upcoming year. In the first year of GDUFA (FY 2013), some rates will be published in separate Federal Register notices because of the timing specified in the statute. Each year thereafter the GDUFA fee rates will be published 60 days before the start of the fiscal year. This document establishes the FY 2013 rate for API and FDF facility fees. These fees are due on March 4, 2013.