Department of Health and Human Services September 4, 2012 – Federal Register Recent Federal Regulation Documents
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Determination That ALOXI (Palonosetron Hydrochloride) Capsules, 0.5 Milligram (Base), Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ALOXI (palonosetron hydrochloride (HCl)) Capsules, 0.5 milligram (mg) (base), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for palonosetron HCl capsules, 0.5 mg (base), if all other legal and regulatory requirements are met.
Nexira; Filing of Food Additive Petition; Amendment
The Food and Drug Administration (FDA) is amending the filing notice for a food additive petition filed by Nexira proposing that the food additive regulations be amended to provide for the expanded safe use of acacia gum (gum arabic) in foods.
Notice of FY 2012 Refugee Targeted Assistance Formula Awards to States and Wilson/Fish Alternative Project Grantees
The Office of Refugee Resettlement, Administration for Children and Families (ACF), announces the allocation of Refugee Targeted Assistance formula awards to States and Wilson/Fish Alternative Project grantees. The purpose of the Targeted Assistance program is to provide employment and other resettlement services to refugees, Amerasians, asylees, Cuban and Haitian entrants, victims of trafficking, and Iraqis and Afghans with Special Immigrant Visas. The grant allocations are awarded to States on behalf of counties that have had high levels of arrivals of the eligible populations. The awards supplement available refugee resettlement resources to ensure that refugees and other eligible populations become employed and self- sufficient as soon as possible. Awards are determined by the number of the eligible populations residing in each county during the two-year period from October 1, 2009, to September 30, 2011. Targeted Assistance allocations are available on the ORR Web page. The table of FY 2012 Allocations to Counties and Targeted Assistance Areas and the Table of FY 2012 Allocations to States may be found at: https://www.acf.hhs.gov/programs/orr/policy/fy2012_formula_ allocations_targeted_assistance.htm.
Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 2
This final rule specifies the Stage 2 criteria that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for Medicare and/or Medicaid electronic health record (EHR) incentive payments. In addition, it specifies payment adjustments under Medicare for covered professional services and hospital services provided by EPs, eligible hospitals, and CAHs failing to demonstrate meaningful use of certified EHR technology (CEHRT) and other program participation requirements. This final rule revises certain Stage 1 criteria, as finalized in the July 28, 2010 final rule, as well as criteria that apply regardless of Stage.
Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology
With this final rule, the Secretary of Health and Human Services adopts certification criteria that establish the technical capabilities and specify the related standards and implementation specifications that Certified Electronic Health Record (EHR) Technology will need to include to, at a minimum, support the achievement of meaningful use by eligible professionals, eligible hospitals, and critical access hospitals under the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal year and calendar year 2014. This final rule also makes changes to the permanent certification program for health information technology, including changing the program's name to the ONC HIT Certification Program.
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