Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses
The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization, which is a preamendments class III device, into class II (special controls) based on new information. FDA is also proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECP devices for other intended uses specified in this proposed order. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the devices to meet the statute's approval requirements for other intended uses specified in this proposed order. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.
Human Immunodeficiency Virus Patient-Focused Drug Development and Human Immunodeficiency Virus Cure Research: Public Meeting
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on human immunodeficiency virus (HIV) Patient-Focused Drug Development and HIV Cure Research. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). FDA is interested in obtaining patient input on the impact of HIV on daily life, available therapies to treat the condition, and patients' views on issues related to HIV cure research, such as perceived benefits and acceptable risks for participating in HIV cure research and clear communication of benefits and risks through informed consent.
Request for Nominations for Voting Members on Public Advisory Panels or Committees
The Food and Drug Administration (FDA) is requesting nominations for voting members on the Food Advisory Committee with expertise in microbiology, nutrition, food science, food technology, pediatric development, or nanotechnology in food. Nominations will be accepted for current vacancies and those that will or may occur through June 30, 2013. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees, and therefore encourages nominations of appropriately qualified candidates from these groups.
Notice of Meeting
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), announcement is made of an Agency for Healthcare Research and Quality (AHRQ) Special Emphasis Panel (SEP) meeting on ``Estimating the Costs of Supporting Primary Care Practice Transformation (R03)''.
Notice of Meetings
The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. These meetings will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. section 552b(c)(4), and 5 U.S.C. section 552b(c)(6).