Department of Health and Human Services October 2016 – Federal Register Recent Federal Regulation Documents

Results 251 - 300 of 301
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-24125
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-24124
Type: Notice
Date: 2016-10-06
Agency: Department of Health and Human Services, National Institutes of Health
Abbreviated New Drug Applications and 505(b)(2) Applications
Document Number: 2016-22690
Type: Rule
Date: 2016-10-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.
Request for Nominations for Voting Members for the Patient Engagement Advisory Committee
Document Number: 2016-24100
Type: Notice
Date: 2016-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) is requesting additional nominations for members to serve on the Center for Devices and Radiological Health's (CDRH) Patient Engagement Advisory Committee (the PEAC or Committee). The Committee provides relevant skills and perspectives in order to improve communication of benefits, risks and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, particularly encourages nominations of appropriately qualified candidates from these groups.
Pharmacy Compounding Advisory Committee; Notice of Meeting
Document Number: 2016-24085
Type: Notice
Date: 2016-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmacy Compounding Advisory Committee (PCAC). The general function of the committee is to provide advice on scientific, technical, and medical issues concerning drug compounding, as well as any other product for which FDA has regulatory responsibility, and to make appropriate recommendations to the Agency. The meeting will be open to the public.
Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2016-24050
Type: Notice
Date: 2016-10-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals; Correction
Document Number: 2016-24042
Type: Rule
Date: 2016-10-05
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the final rule that appeared in the August 22, 2016 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals.''
Prospective Grant of Exclusive Patent License: Development of Anti-CD70 Chimeric Antigen Receptors for the Treatment of CD70 Expressing Cancers
Document Number: 2016-24030
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to Kite Pharma, Inc. (``Kite'') located in Santa Monica, CA to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2016-24028
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2016-24027
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-24026
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-24025
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, And Blood Institute; Notice of Closed Meeting
Document Number: 2016-24024
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-24023
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-24022
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2016-24012
Type: Notice
Date: 2016-10-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Information Collection Activity; Comment Request
Document Number: 2016-23951
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2016-23950
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, Administration for Children and Families
Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Extension of Comment Period
Document Number: 2016-23931
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is extending the comment period for the revised draft guidance for industry entitled ``Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,'' that appeared in the Federal Register of August 12, 2016. We are taking this action in response to requests to extend the comment period to allow interested persons additional time to submit comments.
Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Union
Document Number: 2016-23930
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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 reporting requirements in implementing the lists of United States (U.S.) firms/processors exporting shell eggs, game meat and game meat products, gelatin, and collagen to the European Union (the EU).
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2016-23925
Type: Notice
Date: 2016-10-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed study project entitled ``Survey of Sexually Transmitted Disease (STD) Provider Practices in the United States''. The primary goal of this study is to better understand policies and practices for STD care delivery among medical providers who typically see patients for STDs. Another goal is to assess awareness and use of CDC's STD treatment guidelines.
Center for Devices and Radiological Health Veteran Amputee Devices; Public Workshop; Request for Comments
Document Number: 2016-23924
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Center for Devices and Radiological Health Veteran Amputee Devices.'' The purpose of this workshop is to engage all stakeholders involved in the research, development, and marketing of prosthetic limb medical devices used by veteran amputees. A specific goal is to engage veteran amputees who use prosthetic limb medical devices and hear their views on these devices so that these perspectives may be considered in the total product life cycle of prosthetic limb devices.
Announcement of a Single-Source Supplement Grant to the National Child Welfare Capacity Building Center for Tribes
Document Number: 2016-23909
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Administration for Children Youth and Families (ACYF), Children's Bureau announces the award of a single-source supplement grant in the amount of $547,000 to the National Child Welfare Capacity Building Center for Tribes (CBCT), operated by the University of Denver (Colorado Seminary). The primary goal of this grant is to provide capacity-building services to title IV-E and IV-B American Indian and Alaska Native Nations (AI/AN), and to promote intergovernmental collaboration between tribes and state child welfare agencies in system improvement work.
Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
Document Number: 2016-23901
Type: Rule
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for method, metallic reduction, glucose (urinary, nonquantitative) devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as ''copper reduction tablet test''). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
Document Number: 2016-23899
Type: Rule
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for ``method, metallic reduction, glucose (urinary, nonquantitative)'' devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as ``copper reduction tablet test''). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2016-23898
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway
Document Number: 2016-23897
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2016-23895
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Workshop on Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for Comments
Document Number: 2016-23894
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Library of Medicine (NLM) of the National Institutes of Health (NIH), the Office of the National Coordinator for Health Information Technology (ONC), and the Centers for Medicare and Medicaid Services (CMS) are announcing the following public workshop entitled ``CDC/FDA/NLM/ONC/CMS Workshop on Promoting Semantic Interoperability of Laboratory Data.'' The purpose of this public workshop is to receive and discuss input from stakeholders regarding proposed approaches to facilitate the adoption and implementation of interoperability standards in a manner that enables consistent, accurate, and harmonized descriptions of in vitro diagnostic tests and results.
Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications
Document Number: 2016-23893
Type: Notice
Date: 2016-10-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
National Institute of Mental Health; Amended Notice of Meeting
Document Number: 2016-23885
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meeting
Document Number: 2016-23883
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23882
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-23881
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-23880
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2016-23879
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2016-23878
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2016-23877
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-23876
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2016-23875
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23874
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23873
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, National Institutes of Health
Privacy Act of 1974; CMS Computer Match No. 2016-15; HHS Computer Match No. 1609
Document Number: 2016-23866
Type: Notice
Date: 2016-10-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a Computer Matching Program that CMS plans to conduct with the Peace Corps (PC).
Proposed Information Collection Activity; Comment Request
Document Number: 2016-23865
Type: Notice
Date: 2016-10-04
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities
Document Number: 2016-23503
Type: Rule
Date: 2016-10-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule will revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These revisions are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2016-23796
Type: Notice
Date: 2016-10-03
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at http:// www.samhsa.gov/workplace.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-23736
Type: Notice
Date: 2016-10-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2016-23735
Type: Notice
Date: 2016-10-03
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2016-23734
Type: Notice
Date: 2016-10-03
Agency: Department of Health and Human Services, National Institutes of Health