Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate below, or any other aspect of the ICR.
Guidance for Industry: Safety Labeling Changes-Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Safety Labeling ChangesImplementation of Section 505(o)(4) of the FD&C Act.'' The Food and Drug Administration Amendments Act of 2007 (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizing FDA to require certain drug and biological product application holders to make safety-related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the FD&C Act or the Public Health Service Act (the PHS Act). This final guidance provides information on the implementation of section 505(o)(4) of the FD&C Act, including a description of the types of safety labeling changes that ordinarily might be required under this section; how FDA plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes; and enforcement of the requirements for safety labeling changes.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance on Reagents for Detection of Specific Novel Influenza A Viruses'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
The National Institute of Dental and Craniofacial Research (NIDCR) Strategic Plan Request for Comments
NIDCR is developing a new strategic plan to guide the Institute's research efforts and priorities over the next six years (2014-2019). The purpose of this time-sensitive Request for Information (RFI) is to seek input from a broad range of stakeholders about prospective activities, areas of research emphasis, future research approaches, needs, and opportunities.