Department of Health and Human Services July 31, 2012 – Federal Register Recent Federal Regulation Documents
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Notification of Single Source Cooperative Agreement Award for Project Hope
In FY2012, HHS/ASPR/OPP plans to provide a single source cooperative agreement award to Project Hope to strengthen emergency care delivery in the United States healthcare system through health information and promotion in support of the Homeland Security Presidential Directive-21 (2007) and the National Health Security Strategy (2009) and Implementation Plan (2012). In the past decade, numerous studies have described the delivery of emergency care in the United States as fragmented, overburdened, underfunded, and challenged in its efforts to provide an appropriate level of high quality and cost effective emergency care for Americans on a daily basis and in response to a public health emergency or disaster. These studies have recommended that the emergency care delivery system be redesigned and more broadly integrated into the U.S. healthcare system and healthcare sub-systems. As these changes will have implications for the broader healthcare community, particularly the primary care sub-system, it is essential that both expert and non- expert healthcare professionals, across the healthcare continuum, be informed and engaged in these key policy discussions. Project Hope will plan the publication of a Health Affairs thematic issue that will identify, explore and propose policy options for developing, strengthening and preparing a regionalized, accountable and coordinated system of emergency care that is broadly integrated into the United States healthcare system and capable of responding to a public health emergency or disaster. The project will serve to educate non-emergency medicine healthcare policy professionals and providers about the current state of emergency care delivery in the United States. It will also promote an interdisciplinary dialogue between emergency and other healthcare professionals and providers regarding policy options for the coordinated and integrated delivery of acute unscheduled care that might result from an acute onset of symptoms, exacerbation of a chronic disease, or a public health emergency or disaster. This project will focus on exploring, identifying and proposing policy options regarding workforce, finance, organization and medical care delivery that are essential to redesigning emergency care delivery and supporting its full integration into other healthcare sub- systems as well as the broader U.S. healthcare system. This work will be performed in the context of Homeland Security Presidential Directive-21 and Strategic Objective (4) of the National Health Security Strategy (2009) and Implementation Plan (2012) that seek to foster integrated, scalable healthcare delivery systems that can meet both daily demands and medical surge demands resulting from a public health emergency or disaster.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Medical Device User Fee Rates for Fiscal Year 2013
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2012 (Title 2 of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144, which was signed by the President on July 9, 2012) (MDUFA III), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for establishments subject to registration. The FY 2013 fee rates are provided in this document. These fees apply from October 1, 2012, through September 30, 2013. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This document provides information on how the fees for FY 2013 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Senior Medicare Patrol (SMP) Program Outcome Measurement
The Administration for Community Living (ACL) 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 requirements relating to Senior Medicare Patrol Program outcome measurement.
Draft Guidance for Industry and Food and Drug Administration Staff; Acceptance and Filing Review for Premarket Approval Applications; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Acceptance and Filing Review for Premarket Approval Applications (PMAs).'' The purpose of the acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete. This guidance document is intended to clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research. This draft guidance is not final nor is it in effect at this time.
Announcement of Requirements and Registration for “The Million Hearts Risk Check Challenge”
In communities across America, there are thousands of convenient and inexpensive ways to know your risk for heart-related conditionsoften, all it takes is making an appointment for a screening with your doctor or pharmacies. But, according to recent studies, up to 1 in 3 people at risk for cardiovascular disease (CVD) have not been screened and are therefore less likely to take preventative action. Through an initiative sponsored by Million Hearts and the Office of the National Coordinator for Health IT, we are reaching out to the millions of Americans who have significant risks for CVD and do not know it, and those that suspect it but have not yet overcome the inertia to act on their concern. By connecting these individuals to pharmacies for lipid and blood pressure screenings, we are intending to make it easy for them to turn their back-of-mind worries into personal knowledge and then help them hook into the delivery system if necessary. This new campaign and technology product will follow three steps: 1. Reach out to individuals across the country, taking special aim at those who may be at risk for CVD and don't know it. 2. Conduct a ``light'' health risk assessment that roughly estimates risk in an engaging interface and then ``hooks'' the user by showing that with the addition of LDL and BP readings, the accuracy of the risk assessment could be much more robust. This is done to drive folks to scale the next hurdle: The BP and blood test. 3. Direct individuals to nearby, convenient options for biometric screenings. National pharmacies and others will offer locations and special offers for this step. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Public L. 111- 358).
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