Department of Health and Human Services February 18, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 24 of 24
Medicare and Medicaid Programs; Requirements for Long-Term Care (LTC) Facilities; Notice of Facility Closure
This interim final rule amends the requirements that a long- term care (LTC) facility must meet in order to qualify to participate as a skilled nursing facility (SNF) in the Medicare program, or a nursing facility (NF) in the Medicaid program. These requirements implement section 6113 of the Affordable Care Act to ensure that, among other things, in the case of a LTC facility closure, individuals serving as administrators of a SNF or NF provide written notification of the impending closure and a plan for the relocation of residents at least 60 days prior to the impending closure or, if the Secretary terminates the facility's participation in Medicare or Medicaid, not later than the date the Secretary determines appropriate.
Medicare Program; Home Health Prospective Payment System Rate Update for Calendar Year 2011; Changes in Certification Requirements for Home Health Agencies and Hospices; Correction
In the November 17, 2010 issue of the Federal Register, we published a final rule that set forth an update to the Home Health Prospective Payment System (HH PPS) rates, including: The national standardized 60-day episode rates, the national per-visit rates, the nonroutine medical supply (NRS) conversion factors, and the low utilization payment amount (LUPA) add-on payment amounts, under the Medicare prospective payment system for HHAs. This correcting amendment corrects a technical error identified in the November 17, 2010 final rule.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Health Resources and Services Administration published an Agency Information Collection document in the Federal Register of January 31, 2011 (FR Doc. 2011-1997), on page 5389, regarding the Data System for Organ Procurement and Transplantation Network (42 CFR Part 121, OMB No. 0915-0184): Extension. The Burden Table is incorrect.
Poison Control Program
HRSA will transfer funds and duties from Kaleida Health and University of Rochester to the Research Foundation of SUNY d.b.a. the Upstate New York Poison Control Center. HRSA will also transfer funds and duties from Winthrop University to the New York City Health & Hospitals Corporation d.b.a. the New York City Poison Control Center. These transfers are necessary in order to maintain poison control services and education efforts throughout the State of New York.
Unapproved Animal Drugs; Extension of Comment Period
The Food and Drug Administration (FDA) is extending to April 19, 2011, the comment period for the notice that appeared in the Federal Register of December 20, 2010 (75 FR 79383). In the notice FDA requested comments on strategies to address the prevalence of animal drug products marketed in the United States without approval or other legal marketing status. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.'' The draft guidance is intended to assist the pharmaceutical industry and other investigators engaged in new drug development in evaluating how variations in the human genome could affect the clinical pharmacology properties and clinical responses of drugs.
Health Claim; Phytosterols and Risk of Coronary Heart Disease
The Food and Drug Administration (FDA) is extending the period of time that it intends to exercise enforcement discretion, concerning the use of the health claim for phytosterols and risk of coronary heart disease (CHD), in a manner that is consistent with FDA's February 14, 2003, letter of enforcement discretion to Cargill Health and Food Technologies. In the proposed rule for this health claim that published on December 8, 2010 (75 FR 76526), the Agency provided a period of 75 days from the date of publication of the proposed rule during which FDA intended to exercise its enforcement discretion for the use of such claim consistent with the 2003 letter. FDA is extending this period during which the Agency intends to exercise enforcement discretion to February 21, 2012.
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