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
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.
Notice of Hearing: Reconsideration of Disapproval of Michigan State Plan Amendment (SPA) 07-21
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.
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
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
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:
Interim Safety and Risk Assessment of Melamine and Its Analogues in Food for Humans; Availability
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.