Department of Health and Human Services July 2013 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 316
Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies
This rule proposes to update and make revisions to the End- Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2014. This rule also proposes to set forth requirements for the ESRD quality incentive program (QIP), including for payment year (PY) 2016 and beyond. In addition, this rule proposes to clarify the grandfathering provision related to the 3-year minimum lifetime requirement (MLR) for Durable Medical Equipment (DME). In addition, it provides clarification of the definition of routinely purchased DME. This rule also proposes the implementation of budget- neutral fee schedules for splints and casts, and intraocular lenses (IOLs) inserted in a physician's office. Finally, this rule would make a few technical amendments and corrections to existing regulations related to payment for DMEPOS items and services.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Pretest of the Ambulatory Surgery/Procedure Survey on Patient Safety Culture Questionnaire (Ambulatory Surgery SOPS).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
National Biodefense Science Board; Call for Nominees
The deadline for all application submissions to the National Biodefense Science Board (NBSB) is extended from July 7, 2013, to August 4, 2013 at 11:59 p.m. The Office of the Secretary is accepting application submissions from qualified individuals who wish to be considered for membership on the NBSB; six members have membership expiration dates of December 31, 2013, therefore, six new voting members will be selected for the Board. Nominees are being accepted in the following categories: Industry, Academia, Healthcare Consumer Organizations, and Organizations Representing Other Appropriate Stakeholders. Please visit the NBSB Web site at www.phe.gov/nbsb for all application submission information and instructions. All members of the public are encouraged to apply.
Declaration That Circumstances Exist Justifying Authorization of Emergency Use of All Oral Formulations of Doxycycline Accompanied by Emergency Use Information
The Secretary of Homeland Security determined on September 23, 2008, that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracispursuant to section 564(b)(1)(A) of the Federal Food, Drug, and Cosmetic (FD&C) Act.\1\ On the basis of that determination, and pursuant to section 564(b) of the FD&C Act, the Secretary of Health and Human Services (HHS) is declaring that circumstances exist justifying the authorization of emergency use of all oral formulations of doxycycline accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs under section 564(a) of the FD&C Act. This notice is being issued in accordance with section 564(b)(4) of the FD&C Act.
Lung Cancer Patient-Focused Drug Development; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the public docket on lung cancer patient-focused drug development. In the Federal Register of June 5, 2013 (78 FR 33581), FDA announced an opportunity for public comment on this topic and explained that the comment period would close on July 29, 2013. The Agency is taking this action to allow interested persons additional time to submit comments.
Determination That METADATE ER (Methylphenidate Hydrochloride) Extended-Release Tablet, 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that METADATE ER (methylphenidate hydrochloride (HCl)) extended-release tablet, 10 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methylphenidate HCl extended-release tablet, 10 mg, if all other legal and regulatory requirements are met.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
World Trade Center Health Program Scientific/Technical Advisory Committee; Nominations of Candidates
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
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
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.
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
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
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
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
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
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
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).
Coverage of Certain Preventive Services Under the Affordable Care Act
This document contains final regulations regarding coverage of certain preventive services under section 2713 of the Public Health Service Act (PHS Act), added by the Patient Protection and Affordable Care Act, as amended, and incorporated into the Employee Retirement Income Security Act of 1974 and the Internal Revenue Code. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women's preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). As authorized by the current regulations, and consistent with the HRSA guidelines, group health plans established or maintained by certain religious employers (and group health insurance coverage provided in connection with such plans) are exempt from the otherwise applicable requirement to cover certain contraceptive services. These final regulations simplify and clarify the religious employer exemption. These final regulations also establish accommodations with respect to the contraceptive coverage requirement for group health plans established or maintained by eligible organizations (and group health insurance coverage provided in connection with such plans), as well as student health insurance coverage arranged by eligible organizations that are institutions of higher education. These regulations also finalize related amendments to regulations concerning Affordable Insurance Exchanges.
Privacy Act of 1974; CMS Computer Match No. 2013-11; HHS Computer Match No. 1302
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS intends to conduct with State-based Administering Entities (AEs). Under this CMP CMS will disclose certain information to the State-based AEs within the Health Insurance Exchanges Program. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed matching program, CMS invites comments on all portions of this notice. See ``Effective Dates'' section below for comment period.
World Trade Center Health Program; Addition of Prostate Cancer to the List of WTC-Related Health Conditions
On May 2, 2013, the Administrator of the World Trade Center (WTC) Health Program received a petition (Petition 002) requesting the addition of prostate cancer to the List of WTC-Related Health Conditions (List) covered in the WTC Health Program. The Administrator has determined to publish a proposed rule adding malignant neoplasm of the prostate (prostate cancer) to the List in the WTC Health Program regulations.
Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' dated July 2013. The draft guidance document provides sponsors of Investigational New Drug Applications (INDs) for cellular therapy (CT) and gene therapy (GT) products (referred to collectively as CGT products) with recommendations to assist in designing early-phase clinical trials of CGT products.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Establishing and Maintaining a List of U.S. Dairy Product Manufacturers/Processors With Interest in Exporting to Chile'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Interstate Shellfish Dealer's Certificate
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Interstate Shellfish Dealer's Certificate'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling; Notification Procedures for Statements on Dietary Supplements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Food Labeling; Notification Procedures for Statements on Dietary Supplements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Recordkeeping Requirements for Microbiological Testing and Corrective Measures for Bottled Water'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Designated New Animal Drugs for Minor Use and Minor Species
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 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 paperwork associated with designation under the Minor Use and Minor Species (MUMS) Act.
Announcement of Agency Decision: Recommendations on the Use of Chimpanzees in NIH-Supported Research
This notice announces the responses to public comments and decisions of the National Institutes of Health (NIH) regarding the use of chimpanzees in research. In February 2012, the NIH charged a working group of the Council of Councils, a federal advisory committee, to provide advice on implementing recommendations made by the Institute of Medicine (IOM) Committee on the Use of Chimpanzees in Biomedical and Behavioral Research in its 2011 report, Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity. On January 22, 2013, the NIH Council of Councils (Council) accepted recommendations presented by the Working Group on the Use of Chimpanzees in NIH-Supported Research and provided these recommendations to the NIH. The NIH subsequently issued a request for comments to obtain broad public input on the 28 Council recommendations that the NIH is considering as it determines how to implement the IOM Committee's recommendations. This notice summarizes the comments received in response to the request for comments and announces the agency's decisions with respect to the Council recommendations. The NIH plans to prepare subsequent procedural guidance and technical assistance, as appropriate, to implement some of these decisions. Investigators should continue to follow existing guidance (see NOT-OD-12-025 at https://grants.nih.gov/grants/guide/ notice-files/NOT-OD-12-025.html) regarding the submission of applications, proposals, or protocols for research involving chimpanzees until the NIH announces the procedural guidance.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
The Food and Drug Administration (FDA) 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.
Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs; Correction
The Food and Drug Administration (FDA) is correcting a proposed order that appeared in the Federal Register of June 12, 2013 (78 FR 35173). The document proposed to reclassify stair-climbing wheelchairs. The document was published with typographical errors in the DATES section of the document. This document corrects those errors.
Draft Guidance for Industry on Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases.'' The purpose of the draft guidance is to assist sponsors in the development of new antibacterial drugs to treat serious bacterial diseases, particularly in areas of unmet need, and new antibacterial drugs that are pathogen-focused (i.e., drugs that have a narrow spectrum of activity or are only active against a single genus or species of bacteria).
Medicare Program; Notification of Closure of Teaching Hospitals and Opportunity To Apply for Available Slots; Correction
This document corrects a typographical error that appeared in the notice published in the Federal Register on May 31, 2013 entitled ``Notification of Closure of Teaching Hospitals and Opportunity to Apply for Available Slots.''
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