Submission of a Proposed Draft Guidance for Industry on Developing Drugs for Treatment of Duchenne Muscular Dystrophy; Establishment of a Public Docket
The Food and Drug Administration (FDA) is establishing a public docket to discuss issues related to developing drugs for Duchenne muscular dystrophy (DMD). During a public-private policy forum for DMD on December 12, 2013, FDA agreed that Parent Project Muscular Dystrophy (PPMD) and other interested parties in the DMD community could submit for FDA consideration a proposal for a draft guidance for industry on developing drugs for DMD. That proposed draft guidance was submitted to FDA on June 25, 2014. FDA values the guidance provided by the DMD community and is posting the document to seek additional guidance and public comment.
Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program for 2014 and Other Changes to the EHR Incentive Program; and Health Information Technology: Revisions to the Certified EHR Technology Definition and EHR Certification Changes Related to Standards
This final rule changes the meaningful use stage timeline and the definition of certified electronic health record technology (CEHRT) to allow options in the use of CEHRT for the EHR reporting period in 2014. It also sets the requirements for reporting on meaningful use objectives and measures as well as clinical quality measure (CQM) reporting in 2014 for providers who use one of the CEHRT options finalized in this rule for their EHR reporting period in 2014. In addition, it finalizes revisions to the Medicare and Medicaid EHR Incentive Programs to adopt an alternate measure for the Stage 2 meaningful use objective for hospitals to provide structured electronic laboratory results to ambulatory providers; to correct the regulation text for the measures associated with the objective for hospitals to provide patients the ability to view online, download, and transmit information about a hospital admission; and to set a case number threshold exemption for CQM reporting applicable for eligible hospitals and critical access hospitals (CAHs) beginning with FY 2013. Finally, this rule finalizes the provisionally adopted replacement of the Data Element Catalog (DEC) and the Quality Reporting Document Architecture (QRDA) Category III standards with updated versions of these standards.
Ryan White HIV/AIDS Program, AIDS Education and Training Centers, The University of Washington, Northwest AIDS Education and Training Center
HRSA will be issuing a non-competitive award under the AETC Program, to current grantee, the University of Washington NWAETC, for approximately $250,239 during the budget period July 1, 2014, to June 30, 2015. This will allow the University of Washington NWAETC to develop a unique and flexible HIV distance learning curriculum that can be used in a variety of health care settings by a variety of health care providers. This on-line curriculum will enhance our ability to reach and so increase the numbers of health care providers skilled in delivering HIV/AIDS care and treatment at a time when there is a greater demand for these professionalsespecially primary care physicians.
Ryan White HIV/AIDS Program, Special Projects of National Significance (SPNS), the Albert Einstein College of Medicine, Enhancing Access to and Retention in Quality HIV Care for Women of Color Initiative
HRSA will be issuing a non-competitive award under the SPNS Program to current grantee, the Albert Einstein College of Medicine (Grant 5 H97HA15152-05-00), for approximately $55,000 during the budget period September 1, 2014, to August 31, 2015. This will allow the Albert Einstein College of Medicine to cover the costs associated with the publication of a special supplemental issue of the journal AIDS Patient Care and STD's, which will feature eight articles on findings from the Special Projects of National Significance (SPNS) Program Enhancing Access to and Retention in Quality HIV Care for Women of Color Initiative. A program expansion supplement will allow SPNS wider dissemination of the most current best practices and lessons learned for the care of women of color living with HIV. The journal AIDS Patient Care and STD's has a combined 18,200 print and online subscribers, and the publisher will also extend online distribution to readers of the Journal of Women's Health (approximately 32,000 additional subscribers) and to attendees of the Congress on Women's Health (approximately 800 physicians and nurses).