Department of Health and Human Services August 2014 – Federal Register Recent Federal Regulation Documents

Results 251 - 300 of 325
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary National Retail Food Regulatory Program Standards
Document Number: 2014-18600
Type: Notice
Date: 2014-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary National Retail Food Regulatory Program Standards'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2014-18597
Type: Notice
Date: 2014-08-07
Agency: Department of Health and Human Services, National Institutes of Health
Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Document Number: 2014-18616
Type: Notice
Date: 2014-08-06
Agency: Food and Drug Administration, Department of Health and Human Services
Draft Guidance for Industry on Upper Facial Lines: Developing Botulinum Toxin Drug Products; Availability
Document Number: 2014-18564
Type: Notice
Date: 2014-08-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Upper Facial Lines: Developing Botulinum Toxin Drug Products.'' The purpose of this draft guidance is to assist sponsors with their clinical trial designs using botulinum toxin drug products intended for the treatment of upper facial lines. This draft guidance clarifies FDA's thinking on endpoint development and clinical trial design considerations for botulinum toxin drug products that present unique safety concerns.
Agency Information Collection Activities: Proposed Collection: Public Comment Request
Document Number: 2014-18551
Type: Notice
Date: 2014-08-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Area Health Education Centers (AHEC) Program: Request for Single-Case Deviation
Document Number: 2014-18549
Type: Notice
Date: 2014-08-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA)'s Bureau of Health Workforce is issuing a single-case deviation from competition requirements for the Virginia Health Workforce Development Authority (VHWDA) Area Health Education Center (AHEC) Point of Service Maintenance and Enhancement (POSME) Award (Grant U77HP26289) to extend the duration of the grant, through August 31, 2017.
In Vitro Companion Diagnostic Devices; Guidance for Industry and FDA Staff; Availability
Document Number: 2014-18538
Type: Notice
Date: 2014-08-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``In Vitro Companion Diagnostic Devices.'' This guidance is intended to assist sponsors who are planning to develop a therapeutic product for which the use of an in vitro companion diagnostic device is essential for the therapeutic product's safe and effective use as well as sponsors planning to develop an in vitro companion diagnostic device that is intended to be used with a corresponding therapeutic product.
Office of Direct Service and Contracting Tribes; National Indian Health Outreach and Education II
Document Number: 2014-18531
Type: Notice
Date: 2014-08-06
Agency: Department of Health and Human Services, Indian Health Service
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2015
Document Number: 2014-18447
Type: Rule
Date: 2014-08-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2015 as required by the statute. This final rule finalizes a policy to collect data on the amount and mode (that is, Individual, Concurrent, Group, and Co-Treatment) of therapy provided in the IRF setting according to therapy discipline, revises the list of diagnosis and impairment group codes that presumptively meet the ``60 percent rule'' compliance criteria, provides a way for IRFs to indicate on the Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF- PAI) form whether the prior treatment and severity requirements have been met for arthritis cases to presumptively meet the ``60 percent rule'' compliance criteria, and revises and updates quality measures and reporting requirements under the IRF quality reporting program (QRP). This rule also delays the effective date for the revisions to the list of diagnosis codes that are used to determine presumptive compliance under the ``60 percent rule'' that were finalized in FY 2014 IRF PPS final rule and adopts the revisions to the list of diagnosis codes that are used to determine presumptive compliance under the ``60 percent rule'' that are finalized in this rule. This final rule also addresses the implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), for the IRF prospective payment system (PPS), which will be effective when ICD-10- CM becomes the required medical data code set for use on Medicare claims and IRF-PAI submissions.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Fiscal Year Beginning October 1, 2014 (FY 2015)
Document Number: 2014-18329
Type: Rule
Date: 2014-08-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs). These changes will be applicable to IPF discharges occurring during the fiscal year (FY) beginning October 1, 2014 through September 30, 2015. This final rule will also address implementation of ICD-10-CM and ICD-10-PCS codes; finalize a new methodology for updating the cost of living adjustment (COLA), and finalize new quality measures and reporting requirements under the IPF quality reporting program.
Design Considerations for Devices Intended for Home Use; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-18470
Type: Notice
Date: 2014-08-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Design Considerations for Devices Intended for Home Use.'' This document is intended to assist manufacturers in designing and developing home use medical devices that comply with applicable standards of safety and effectiveness and other regulatory requirements. Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This document identifies several factors that manufacturers should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.
Proposed Information Collection Activity; Comment Request
Document Number: 2014-18468
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Comment Request; Senior Legal Helplines Operating Within Model Approaches to Statewide Legal Assistance Systems Demonstrations
Document Number: 2014-18463
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) 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 proposed information collection requirements relating to Senior Legal Helplines (SLHs) operating within Model Approaches to Statewide Legal Assistance Systems Demonstrations.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-18420
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meeting
Document Number: 2014-18419
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2014-18418
Type: Notice
Date: 2014-08-05
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2015
Document Number: 2014-18335
Type: Rule
Date: 2014-08-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2015. In addition, it adopts the most recent Office of Management and Budget (OMB) statistical area delineations to identify a facility's urban or rural status for the purpose of determining which set of rate tables will apply to the facility, and to determine the SNF PPS wage index including a 1-year transition with a blended wage index for all providers for FY 2015. This final rule also contains a revision to policies related to the Change of Therapy (COT) Other Medicare Required Assessment (OMRA). This final rule includes a discussion of a provision related to the Affordable Care Act involving Civil Money Penalties. Finally, this final rule discusses the SNF therapy payment research currently underway within CMS, observed trends related to therapy utilization among SNF providers, and the agency's commitment to accelerating health information exchange in SNFs.
Draft Guidance for Industry on Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the Public Health Service Act; Availability
Document Number: 2014-18169
Type: Notice
Date: 2014-08-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.'' This draft guidance is intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.
Payments for Services
Document Number: 2014-18426
Type: Rule
Date: 2014-08-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Submission for OMB Review; 30-Day Comment Request; NCI Cancer Genetics Services Directory Web-Based Application and Update Mailer
Document Number: 2014-18352
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on May 8, 2014 Vol. 79, page 26438 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Cancer Institute (NCI), National Institutes of Health, may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Submission for OMB Review; 30-Day Comment Request; The National Diabetes Education Program (NDEP) Comprehensive Evaluation Plan
Document Number: 2014-18351
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on March 19 2014, pages 15351 and 15351[FR DOC : 2014-06064], and allowed 60 days for public comment. There was 1 public comment received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments To OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer.
Administrative Simplification: Change to the Compliance Date for the International Classification of Diseases, 10th Revision (ICD-10-CM and ICD-10-PCS) Medical Data Code Sets
Document Number: 2014-18347
Type: Rule
Date: 2014-08-04
Agency: Department of Health and Human Services, Office of the Secretary
This final rule implements section 212 of the Protecting Access to Medicare Act of 2014 by changing the compliance date for the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) for diagnosis coding, including the Official ICD-10-CM Guidelines for Coding and Reporting, and the International Classification of Diseases, 10th Revision, Procedure Coding System (ICD-10-PCS) for inpatient hospital procedure coding, including the Official ICD-10-PCS Guidelines for Coding and Reporting, from October 1, 2014 to October 1, 2015. It also requires the continued use of the International Classification of Diseases, 9th Revision, Clinical Modification, Volumes 1 and 2 (diagnoses), and 3 (procedures) (ICD-9- CM), including the Official ICD-9-CM Guidelines for Coding and Reporting, through September 30, 2015.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-18343
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2014-18342
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Specifications for Medical Examinations of Coal Miners
Document Number: 2014-18336
Type: Rule
Date: 2014-08-04
Agency: Department of Health and Human Services
With this action, the Department of Health and Human Services (HHS), in accordance with a final rule recently published by the Department of Labor's Mine Safety and Health Administration (MSHA), is amending its regulations to establish standards for the approval of facilities that conduct spirometry examinations and to require that all coal mine operators submit a plan for the provision of spirometry and X-ray examinations to all surface and underground coal miners.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2014-18325
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Recall Regulations
Document Number: 2014-18322
Type: Notice
Date: 2014-08-04
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 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 FDA recalls for human drugs, biological products, devices, animal drugs, food, cosmetics, and tobacco.
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-18304
Type: Notice
Date: 2014-08-04
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Food and Drug Administration Commissioner's Fellowship Program
Document Number: 2014-18302
Type: Notice
Date: 2014-08-04
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 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 the application for participation in the FDA Commissioner's Fellowship Program (CFP).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-18299
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services
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: ``Evaluation of the Implementation of TeamSTEPPS in Primary Care Settings (ITS-PC).'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on May 21st, 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2014-18297
Type: Notice
Date: 2014-08-04
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Updating and Expanding the AHRQ QI Toolkit for Hospitals.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104- 13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on May 12th 2014 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Agency Information Collection Activities; Proposed Collection; Comment Request
Document Number: 2014-18296
Type: Notice
Date: 2014-08-04
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
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: ``Continuing Education for Comparative Effectiveness Research Survey.'' In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ invites the public to comment on this proposed information collection.
Tribal Management Grant Program; Correction
Document Number: 2014-18281
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, Indian Health Service
The Indian Health Service published a document in the Federal Register on July 3, 2014, for the FY 2014 Tribal Management Grant Program Announcement. Key information pertaining to Funding Restrictions was omitted.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2014-18244
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Fogarty International; Center Notice of Meeting
Document Number: 2014-18243
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Meeting
Document Number: 2014-18242
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2014-18241
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2012-2013; Availability of Report
Document Number: 2014-18239
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces the availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2012-2013. This report describes ICCVAM and ICCVAM agency activities during the period from January 2012 through December 2013 and was prepared in accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l-3).
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2014-18238
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting
Document Number: 2014-18237
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2014-18236
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2014-18233
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2014-18232
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meeting
Document Number: 2014-18231
Type: Notice
Date: 2014-08-04
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974; Computer Matching Agreement
Document Number: 2014-18245
Type: Notice
Date: 2014-08-01
Agency: Department of Health and Human Services, Administration for Children and Families
In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Supplemental Nutrition Assistance Program (SNAP).
Intent To Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-18198
Type: Notice
Date: 2014-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements.'' This draft guidance describes FDA's intent to exempt certain Class II medical devices and certain Class I medical devices, subject to the reserved criteria, from premarket notification requirements. FDA believes devices identified in this guidance document are sufficiently well understood and do not present risks that require premarket notification review to assure their safety and effectiveness. This draft guidance is not final nor is it in effect at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
Document Number: 2014-18197
Type: Notice
Date: 2014-08-01
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 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 information collection associated with the medical device labeling regulations.
Agency Information Collection Activities; Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications
Document Number: 2014-18195
Type: Notice
Date: 2014-08-01
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 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 Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications.
Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2015
Document Number: 2014-18178
Type: Notice
Date: 2014-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for fiscal year (FY) 2015 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Generic Drug User Fee Amendments of 2013 (AGDUFA II), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2015.
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extended Temporary Moratoria on Enrollment of Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
Document Number: 2014-18174
Type: Rule
Date: 2014-08-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the extension of temporary moratoria on the enrollment of new ambulance suppliers and home health agencies (HHAs) in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse.