Department of Health and Human Services July 3, 2013 – Federal Register Recent Federal Regulation Documents

World Trade Center Health Program Scientific/Technical Advisory Committee; Nominations of Candidates
Document Number: 2013-16015
Type: Notice
Date: 2013-07-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Eye Tracking Experimental Studies To Explore Consumer Use of Food Labeling Information and Consumer Response to Online Surveys
Document Number: 2013-16001
Type: Notice
Date: 2013-07-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Copy Testing of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaigns
Document Number: 2013-16000
Type: Notice
Date: 2013-07-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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 a notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on Copy Testing of FDA's General Market Youth Tobacco Prevention Campaigns.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-15896
Type: Notice
Date: 2013-07-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2013-15895
Type: Notice
Date: 2013-07-03
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and Medicaid Programs; Home Health Prospective Payment System Rate Update for CY 2014, Home Health Quality Reporting Requirements, and Cost Allocation of Home Health Survey Expenses
Document Number: 2013-15766
Type: Proposed Rule
Date: 2013-07-03
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would update the Home Health Prospective Payment System (HH PPS) rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, the low- utilization payment adjustment (LUPA) add-on, the nonroutine medical supplies (NRS) conversion factor, and outlier payments under the Medicare prospective payment system for home health agencies (HHAs), effective January 1, 2014. As required by the Affordable Care Act, this rule also proposes rebasing adjustments, with a 4-year phase-in, to the national, standardized 60-day episode payment rates; the national per- visit rates; and the NRS conversion factor. Finally, the proposed rule would also establish home health quality reporting requirements for CY 2014 payment and subsequent years and would clarify that a state Medicaid program must provide that, in certifying home health agencies, the state's designated survey agency must carry out certain other responsibilities that already apply to surveys of nursing facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICF-IID), including sharing in the cost of HHA surveys. For that portion of costs attributable to Medicare and Medicaid, we would assign 50 percent to Medicare and 50 percent to Medicaid, the standard method that CMS and states use in the allocation of expenses related to surveys of SNF/NF nursing homes.
Notice of Meeting
Document Number: 2013-15733
Type: Notice
Date: 2013-07-03
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The subcommittee listed below is part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at this meeting. This meeting will be closed to the public in accordance with 5 U.S.C. App. 2 section 10(d), 5 U.S.C. section 552b(c)(4), and 5 U.S.C. section 552b(c)(6). Name of Subcommittee: Health Care Research Training Virtual Review. Date: July 11, 2013 (Open from 9:00 a.m. to 9:30 a.m. on July 11 and closed for remainder of the meeting). Place: Agency for Healthcare Research and Quality, John Eisenberg Building, 540 Gaither Road, OEREP Conference Room, Rockville, MD 20850.
Patient Safety Organizations: Voluntary Relinquishment From Northern Metropolitan Patient Safety Institute
Document Number: 2013-15732
Type: Notice
Date: 2013-07-03
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Pubic Law 109-41, 42 U.S.C. 299b-21b-26, provides for the formation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found no longer to meet the requirements of the Patient Safety Act and Patient Safety Rule, or when a PSO chooses to voluntarily relinquish its status as a PSO for any reason. AHRQ has accepted a notification of voluntary relinquishment from the Northern Metropolitan Patient Safety Institute of its status as a PSO, and has delisted the PSO accordingly.
Organ Procurement and Transplantation Network
Document Number: 2013-15731
Type: Rule
Date: 2013-07-03
Agency: Department of Health and Human Services
HHS is issuing this final rule (herein referred to as ``this rule'') to add vascularized composite allografts (VCAs) as specified herein to the definition of organs covered by the rules governing the operation of the Organ Procurement and Transplantation Network (OPTN) (herein referred to as the OPTN final rule). When it enacted the National Organ Transplant Act in 1984, Congress included a definition of the term organ and authorized the Secretary to expand this definition by regulation. The Secretary has previously exercised this authority and expanded the statutory definition of organ. Prior to this rule, the OPTN final rule defined covered organs as ``a human kidney, liver, heart, lung, or pancreas, or intestine (including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract). Blood vessels recovered from an organ donor during the recovery of such organ(s) are considered part of an organ with which they are procured for purposes of this part if the vessels are intended for use in organ transplantation and labeled `For use in organ transplantation only.' '' This rule also includes a corresponding change to the definition of human organs covered by section 301 of the National Organ Transplant Act of 1984, as amended (NOTA).
Scientific Information Request on Vitamin D and Calcium
Document Number: 2013-15730
Type: Notice
Date: 2013-07-03
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on Vitamin D and Calcium. Scientific information is being solicited to inform the Vitamin D and Calcium: A Systematic Review of Health Outcomes project, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on vitamin D and calcium will improve the quality of this systematic review. AHRQ is conducting this systematic review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).
Scientific Information Request on Chronic Urinary Retention (CUR) Treatment
Document Number: 2013-15729
Type: Notice
Date: 2013-07-03
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public on medical devices to treat chronic urinary retention. Scientific information is being solicited to inform our review of chronic urinary retention (CUR) treatment, which is currently being conducted by the Evidence-based Practice Centers for the AHRQ Effective Health Care Program. Access to published and unpublished pertinent scientific information on medical devices to treat chronic urinary retention will improve the quality of this review. AHRQ is conducting this comparative effectiveness review pursuant to Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, and Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a).