National Institute of Mental Health; Notice of Meeting
Pursuant to the NIH Reform Act of 2006 (42 U.S.C. 281(d)(4)), notice is hereby given that the National Institute of Mental Health (NIMH) will host a meeting to enable public discussion of the Institute's proposal to merge the Division of Adult Translational Research with the Division of Translational Research. The proposal seeks to capitalize on emerging scientific opportunities, while reducing barriers to scientific and interdisciplinary collaboration. This public meeting will take place on August 28, 2014. Information is available on the Institute's Web site, https://www.nimh.nih.gov/ index.shtml, where links to an agenda and any additional information for the meeting will be posted when available.
Generic Drug User Fee Amendments of 2012; Public Hearing on Policy Development; Request for Comments
The Food and Drug Administration (FDA) is announcing a public hearing to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA), and the GDUFA Commitment Letter that accompanies the legislation. The public hearing also will provide an opportunity for public input on future policy priorities. FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, regulated industry, consumers, patients, caregivers, health care professionals, and patient groups.
Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development grant program. The goal of FDA's Orphan Products Development (OPD) grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations: Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document was developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. The guidance is intended to provide clarification regarding the regulatory implications of the decisions that FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions.
The Department of Health and Human Services (HHS) is issuing a final rule to amend its Federal Acquisition Regulation (FAR) Supplementthe HHS Acquisition Regulation (HHSAR)to add two clauses, Patent RightsExceptional Circumstances and, Rights in Data Exceptional Circumstances, and their prescriptions.