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

Results 101 - 150 of 354
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2016-09221
Type: Notice
Date: 2016-04-21
Agency: Department of Health and Human Services, National Institutes of Health
Medicare Program; Temporary Exception for Certain Severe Wound Discharges From Certain Long-Term Care Hospitals Required by the Consolidated Appropriations Act, 2016; Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board
Document Number: 2016-09219
Type: Rule
Date: 2016-04-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period (IFC) implements section 231 of the Consolidated Appropriations Act of 2016 (CAA), which provides for a temporary exception for certain wound care discharges from the application of the site neutral payment rate under the Long- Term Care Hospital (LTCH) Prospective Payment System (PPS) for certain long-term care hospitals. This IFC also amends our current regulations to allow hospitals nationwide to reclassify based on their acquired rural status, effective with reclassifications beginning with fiscal year (FY) 2018. Hospitals with an existing Medicare Geographic Classification Review Board (MGCRB) reclassification would also have the opportunity to seek rural reclassification for IPPS payment and other purposes and keep their existing MGCRB reclassification. We would also apply the policy in this IFC when deciding timely appeals before the Administrator under our regulations for FY 2017 that were denied by the MGCRB due to existing regulations, which do not permit simultaneous rural reclassification for IPPS payment and other purposes and MGCRB reclassification. These regulatory changes implement the decisions in Geisinger Community Medical Center v. Secretary, United States Department of Health and Human Services, 794 F.3d 383 (3d Cir. 2015) and Lawrence + Memorial Hospital v. Burwell, No. 15-164, 2016 WL 423702 (2d Cir. Feb. 4, 2015) in a nationally consistent manner.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-09215
Type: Notice
Date: 2016-04-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2016-09197
Type: Notice
Date: 2016-04-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Data Collection Submitted for Public Comment and Recommendations: Collections Related to Synthetic Turf Fields With Crumb Rubber Infill; Extension of Public Comment Period
Document Number: 2016-09196
Type: Notice
Date: 2016-04-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
On February 18, 2016, the Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS) published a notice in the Federal Register [Volume 81, No. 32, page 8201-8202] requesting public comment on the proposed information collection entitled ``Collections Related to Synthetic Turf Fields with Crumb Rubber Infill''. Written and electronic comments were to be received on or before April 18, 2016. HHS/ATSDR has received requests asking for an extension of the comment period. In consideration of these requests, HHS/ATSDR is extending the comment period to May 2, 2016.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-09189
Type: Notice
Date: 2016-04-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-09188
Type: Notice
Date: 2016-04-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2016-09183
Type: Notice
Date: 2016-04-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Determination Concerning a Petition To Add a Class of Employees to the Special Exposure Cohort
Document Number: 2016-09131
Type: Notice
Date: 2016-04-21
Agency: Department of Health and Human Services
HHS gives notice of a determination concerning a petition to add a class of employees from the Kansas City Plant site, in Kansas City, Missouri, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA).
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-09209
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-09195
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2016-09190
Type: Notice
Date: 2016-04-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2016-09172
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Health Resources and Services Administration (HRSA) is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.
Request for Public Comment: 60 Day Information Collection: Indian Health Service Medical Staff Credentials and Privileges Files
Document Number: 2016-09170
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, Indian Health Service
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``Indian Health Service Medical Staff Credentials and Privileges Files,'' OMB Control Number 0917-0009, which expires August 31, 2016.
Final Revised Vaccine Information Materials for 9-valent HPV (Human Papillomavirus) Vaccine
Document Number: 2016-09167
Type: Notice
Date: 2016-04-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA)(42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On October 22, 2015, CDC published a notice in the Federal Register (80 FR 64002) seeking public comments on proposed updated vaccine information materials for 9-valent HPV (Human Papillomavirus) Gardasil[supreg]-9 vaccine. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials. Copies of the final vaccine information materials for 9-valent HPV Gardasil[supreg]-9 vaccine are available to download from https://www.cdc.gov/vaccines/hcp/vis/ or https:// www.regulations.gov (see Docket Number CDC-2015-0089).
Final Revised Vaccine Information Materials for Meningococcal ACWY Vaccines
Document Number: 2016-09166
Type: Notice
Date: 2016-04-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Under the National Childhood Vaccine Injury Act (NCVIA) (42 U.S.C. 300aa-26), CDC must develop vaccine information materials that all health care providers are required to give to patients/parents prior to administration of specific vaccines. On October 14, 2015, CDC published a notice in the Federal Register (80 FR 61819) seeking public comments on proposed updated vaccine information materials for Meningococcal ACWY and Serogroup B Meningococcal vaccines. Following review of comments submitted and consultation as required under the law, CDC has finalized the materials for Meningococcal ACWY vaccines. Copies of the final vaccine information materials for Meningococcal ACWY vaccines are available to download from https://www.cdc.gov/ vaccines/hcp/vis/ or https://www.regulations.gov (see Docket Number CDC-2015-0059). CDC will publish the final vaccine information materials for Serogroup B Meningococcal vaccines when they are completed.
Meeting of the Community Preventive Services Task Force
Document Number: 2016-09164
Type: Notice
Date: 2016-04-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) announces the next meeting of the Community Preventive Services Task Force (Task Force). The Task Force is an independent, nonpartisan, nonfederal, and unpaid panel. Its members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health, and are appointed by the CDC Director. The Task Force was convened in 1996 by the Department of Health and Human Services (HHS) to identify community preventive programs, services, and policies that increase healthy longevity, save lives and dollars and improve Americans' quality of life. CDC is mandated to provide ongoing administrative, research, and technical support for the operations of the Task Force. During its meetings, the Task Force considers the findings of systematic reviews on existing research and issues recommendations. Task Force recommendations are not mandates for compliance or spending. Instead, they provide information about evidence-based options that decision makers and stakeholders can consider when determining what best meets the specific needs, preferences, available resources, and constraints of their jurisdictions and constituents. The Task Force's recommendations, along with the systematic reviews of the scientific evidence on which they are based, are compiled in the Guide to Community Preventive Services (Community Guide).
Animal Generic Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Generic Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2016-09152
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Generic Drug User Fee Act (AGDUFA). The statutory authority for AGDUFA expires September 30, 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic experts in developing recommendations for the next AGDUFA program, and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these regular discussions by establishing consistent stakeholder representation.
Animal Drug User Fee Act; Stakeholder Consultation Meetings on the Animal Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate
Document Number: 2016-09151
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on reauthorization of the Animal Drug User Fee Act (ADUFA). The statutory authority for ADUFA expires September 30, 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholdersincluding patient and consumer advocacy groups, veterinary professionals, and scientific and academic expertsin developing recommendations for the next ADUFA program, and hold discussions with these stakeholders at least once every 4 months during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these regular discussions by establishing consistent stakeholder representation.
Animal Generic Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2016-09150
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Generic Drug User Fee Act (AGDUFA). FDA invites public comment on the AGDUFA program and suggestions regarding the features FDA should propose for the next AGDUFA program.
Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
Document Number: 2016-09149
Type: Notice
Date: 2016-04-20
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 information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.
Animal Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2016-09148
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting on the Animal Drug User Fee Act (ADUFA). FDA invites public comment on the ADUFA program and suggestions regarding the features FDA should propose for the next ADUFA program.
Preparation for International Cooperation on Cosmetics Regulation
Document Number: 2016-09143
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
Distributor Labeling for New Animal Drugs; Guidance for Industry; Availability
Document Number: 2016-09141
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of guidance for industry #231 entitled ``Distributor Labeling for New Animal Drugs.'' This guidance discusses FDA's current thinking with respect to the factors it considers in determining whether to take regulatory action against distributor labeling for a new animal drug that differs from the labeling approved as part of a new animal drug application or abbreviated new animal drug application in ways other than those permitted by regulation.
Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-09140
Type: Notice
Date: 2016-04-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices.'' This guidance provides industry and Agency staff with recommendations regarding the technical performance assessment data for the evaluation of a digital whole slide imaging (WSI) system. The guidance provides suggestions on how to best characterize the technical aspects that are relevant to WSI performance for their intended use and determine any possible limitations that might affect their safety and effectiveness.
Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information; Draft Guidance for Industry; Availability
Document Number: 2016-09137
Type: Notice
Date: 2016-04-20
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 ``Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.'' This document is a revised version of a draft guidance that published in February 2003 entitled ``Comparability Protocols: Chemistry, Manufacturing, and Controls Information.'' A related draft guidance entitled ``Comparability ProtocolsProtein Drug Products and Biological ProductsChemistry, Manufacturing, and Controls Information,'' that published in September 2003, was withdrawn on May 6, 2015. The revised draft guidance provides recommendations to human drug and biologics manufacturers on implementing a chemistry, manufacturing, and controls (CMC) postapproval change(s) through the use of a comparability protocol (CP). By using a CP, manufacturers who fall within the scope of this guidance will not have to submit commercial- scale CMC information on postchange products to FDA before making the proposed change. This draft guidance is intended to establish a framework to promote manufacturing of quality drug products.
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
Document Number: 2016-09130
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). This meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/priorities/prevention/advisorygrp/advi sory- group-meetings.html.
Office of the National Coordinator for Health Information Technology; Delegation of Authorities
Document Number: 2016-09128
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, Office of the Secretary
Proposed Information Collection Activity; Comment Request
Document Number: 2016-09123
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2016-09055
Type: Notice
Date: 2016-04-20
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2016-09020
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; Reopening of Comment Period
Document Number: 2016-09017
Type: Proposed Rule
Date: 2016-04-19
Agency: Department of Health and Human Services
This document reopens the comment period for the June 17, 2015, proposed rule entitled ``340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.'' The comment period for the proposed rule, which ended on August 17, 2015, is reopened for 30 days.
National Institute of Diabetes and Digestive and Kidney Diseases Notice of Closed Meeting
Document Number: 2016-08996
Type: Notice
Date: 2016-04-19
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: 2016-08995
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2016-08994
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2016-08993
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2016-08992
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2016-08991
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of Exclusive License: The Development of MRI-1569, MRI-2213 and MRI-2214 as a Therapeutic To Treat Obesity, Diabetes, Fatty Liver Disease and Liver Fibrosis
Document Number: 2016-08986
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the following inventions embodied in the following patent applications, entitled ``CB1 receptor mediating compounds'':
Prospective Grant of Exclusive License: Development of the CB1/iNOS Series of Compounds as a Therapeutic To Treat System Sclerosis, Scleroderma, and Other Skin Fibrotic Diseases in Humans
Document Number: 2016-08985
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR part 404.7, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the following inventions embodied in the following patent applications, entitled ``CB1 receptor mediating compounds'':
Submission for OMB Review; Comment Request
Document Number: 2016-08979
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-08975
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
Document Number: 2016-08974
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, Office of the Secretary
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for revision of the approved information collection assigned OMB control number 0990-0424, which expires on January 31, 2019. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; State Health Insurance Assistance Program (SHIP) Client Contact Form, Public and Media Activity Report Form, and Resource Report Form
Document Number: 2016-08958
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
National Cancer Institute; Notice of Open Meeting
Document Number: 2016-08949
Type: Notice
Date: 2016-04-19
Agency: Department of Health and Human Services, National Institutes of Health
Tobacco Farm Site Tours Program
Document Number: 2016-08900
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Tobacco Farm Site Tours Program. This program is intended to give CTP staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers in order to gain a better understanding of tobacco farming and the processes involved in curing and preparing tobacco intended for sale to tobacco product manufacturers. This program is not an FDA regulatory inspection, and tobacco farms are not regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer. The purpose of this notice is to invite parties interested in participating in the Tobacco Farm Site Tours Program to submit requests to CTP.
Radiation Biodosimetry Medical Countermeasure Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2016-08899
Type: Notice
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Radiation Biodosimetry Medical Countermeasure Devices.'' FDA has developed this guidance to provide industry and Agency staff with recommendations for the types of information that should be submitted to support marketing authorization for radiation biodosimetry medical countermeasure devices.
Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
Document Number: 2016-08898
Type: Rule
Date: 2016-04-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.
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