Department of Health and Human Services June 16, 2016 – Federal Register Recent Federal Regulation Documents
Results 1 - 17 of 17
Announcement of the Award of Two Single-Source Program Expansion Supplement Grants Under the Unaccompanied Children's (UC) Program
The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), announces the award of two single-source program expansion supplement grants for a total of $16,476,723 under the Unaccompanied Children's (UC) Program.
Tribal Management Grant Program; Extension of Due Dates
This document extends due dates in the Fiscal Year 2016 Tribal Management Grant Program funding announcement that was published in the Federal Register (81 FR 20396) on April 7, 2016. Several key dates have been extended.
Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service; Correction
The Indian Health Service published a document in the Federal Register on June 3, 2016, for the Notice of Tribal Consultation and Urban Confer Sessions on the State of the Great Plains Area Indian Health Service. The notice contained the incorrect U.S. Code regarding consultation.
Prior Notice of Imported Food Questions and Answers (Edition 3); Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Prior Notice of Imported Food Questions and Answers (Edition 3): Guidance for Industry.'' The guidance provides updated information pertaining to prior notice of imported food under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food Safety Modernization Act (FSMA) on January 4, 2011. The guidance is intended to help the food industry and others comply with prior notice requirements.
Pediatric Clinical Investigator Training; Public Workshop
The Food and Drug Administration's (FDA) Office of Pediatric Therapeutics, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development are announcing a 2-day public workshop entitled ``Pediatric Clinical Investigator Training.'' The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. Although we have learned a lot about conducting pediatric trials over the past two decades, there are still challenges that need to be addressed. The training course is intended to provide investigators with: (1) A clear understanding of some of the challenges of studying products in the pediatric population, including: Pediatric study design, neonates, biomarkers, endpoints, orphan drugs and rare disease trial design, formulations; (2) an overview of extrapolation as it relates to the pediatric population; and (3) an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Factors To Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.'' This draft guidance, when finalized, is intended to provide clarity for FDA staff and industry regarding the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and patient safety. Although product availability and other medical device compliance and enforcement decisions are generally fact-specific, FDA believes that consideration of the factors listed in the draft guidance, when relevant, will improve the consistency and transparency of those decisions and that a shared understanding of benefit and risk will better align industry's and FDA's focus on actions that maximize benefit to patients, improve medical device quality, and reduce risk to patients. This draft guidance is not final nor is it in effect at this time.
Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process”; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Use of International Standard ISO 10993-1, `Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process.' '' FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and de novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993- 1, ``Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk management process'' to support applications to FDA. This guidance supersedes Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled ``Use of International Standard ISO-10993, `Biological Evaluation of Medical DevicesPart 1: Evaluation and Testing.' ''
Medicare and Medicaid Programs; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care
This proposed rule would update the requirements that hospitals and critical access hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These proposals are intended to conform the requirements to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.
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