Department of Health and Human Services November 13, 2008 – Federal Register Recent Federal Regulation Documents

Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Formal Meetings With Sponsors and Applicants for Prescription Drug User Fee Act Products
Document Number: E8-27008
Type: Notice
Date: 2008-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection contained in the guidance for industry on formal meetings with sponsors and applicants for Prescription Drug User Fee Act (PDUFA) products.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-27006
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: E8-27004
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: E8-27001
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Hearing: Reconsideration of Disapproval of Michigan State Plan Amendment (SPA) 07-21
Document Number: E8-26993
Type: Notice
Date: 2008-11-13
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Department of Health and Human Services (hhs)
This notice announces an administrative hearing to be held on January 6, 2009, at the CMS Chicago Regional Office, 233 N. Michigan Avenue, Suite 600, Chicago, Illinois 60601 to reconsider CMS' decision to disapprove Michigan SPA 07-21.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: E8-26988
Type: Notice
Date: 2008-11-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: E8-26965
Type: Notice
Date: 2008-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
Request for Notification From Industry Organizations Interested in Participating in the Selection Process for Nonvoting Industry Representative on Public Advisory Committees and Request for Nominations for Nonvoting Industry Representative on Public Advisory Committees
Document Number: E8-26963
Type: Notice
Date: 2008-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on its public advisory committees for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on CBER's public advisory committees. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for upcoming vacancies effective with this notice.
Grants Awarded: Program Titles and Funding Opportunity Announcements for Fiscal Year 2009
Document Number: E8-26889
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, Administration for Children and Families, Children and Families Administration
The Administration for Children and Families (ACF) hereby gives notice to the public that certain programs within the Agency will administratively impose a matching requirement on grants awarded under the following program titles and funding opportunity announcements for Fiscal Year 2009:
Notice of a Safety Symposium Sponsored by the NIH Recombinant DNA Advisory Committee (RAC) and the Intragovernmental Select Agent and Toxin Technical Advisory Committee (ISATTAC)
Document Number: E8-26886
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health, Office of the Director, Office of Biotechnology Activities, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: E8-26881
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health
Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans; Availability
Document Number: E8-26869
Type: Notice
Date: 2008-11-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans.'' The interim safety/risk assessment evaluated exposure to melamine and its analogues (cyanuric acid, ammelide and ammeline) in infant formula and other foods to identify, where possible, a level of exposure that would not raise public health concerns. FDA is seeking public comment on the interim safety/risk assessment.
National Library of Medicine; Notice of Meetings
Document Number: E8-26791
Type: Notice
Date: 2008-11-13
Agency: Department of Health and Human Services, National Institutes of Health