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

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Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-10337
Type: Notice
Date: 2018-05-15
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 Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic User Fee Payment Request Forms
Document Number: 2018-10329
Type: Notice
Date: 2018-05-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on electronic user fee payment request forms.
Product Jurisdiction
Document Number: 2018-10321
Type: Proposed Rule
Date: 2018-05-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation. This proposed rule would update the regulations to clarify the scope of the regulations, streamline and clarify the appeals process, align the regulations with more recent legislative and regulatory measures, update advisory content, and otherwise clarify the regulations, including updates to reflect Agency practices and policies. These changes are intended to enhance regulatory clarity and efficiency.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-10320
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meetings
Document Number: 2018-10319
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2018-10318
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-10317
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-10316
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Center For Scientific Review; Notice of Closed Meetings
Document Number: 2018-10315
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-10314
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Findings of Research Misconduct
Document Number: 2018-10310
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made on the part of Gareth John, Ph.D., Professor, Department of Neurology, Icahn School of Medicine at Mount Sinai (ISMMS). Dr. John engaged in research misconduct in research supported by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grants R01 NS056074 and R01 NS062703. The administrative actions, including one (1) year of supervision, were implemented beginning on April 26, 2018, and are detailed below.
Patient-Focused Drug Development on Chronic Pain; Public Meeting; Request for Comments
Document Number: 2018-10284
Type: Notice
Date: 2018-05-15
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting and an opportunity for public comment on ``Patient-Focused Drug Development for Chronic Pain.'' The public meeting will provide patients (including adult and pediatric patients) with an opportunity to present to FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments. FDA is particularly interested in hearing from patients who experience chronic pain that is managed with analgesic medications such as opioids, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), antidepressants; other medications; and non-pharmacologic interventions or therapies.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-10281
Type: Notice
Date: 2018-05-15
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.
Prospective Grant of an Exclusive Patent License: Use of the CD47 Phosphorodiamidate Morpholino Oligomers for the Treatment, Prevention, and Diagnosis of Hematological Cancers
Document Number: 2018-10238
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Morphiex Biotherapeutics (``Morphiex'') located in Boston, MA.
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-10237
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-10236
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-10235
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2018-10234
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-10233
Type: Notice
Date: 2018-05-15
Agency: Department of Health and Human Services, National Institutes of Health
Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC)
Document Number: 2018-10224
Type: Notice
Date: 2018-05-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the space and ports available. The meeting room accommodates 70 participants and there will be 125 ports available. Due to the limited accommodations by phone ports and room size, we are encouraging the public to please register using the link provided: Register Here. There will be public comment periods from 11:10 a.m.-11:40 a.m., on June 19, 2018, and from 11:30 a.m.-11:45 a.m., on June 20, 2018. All public comments will be limited to two-minutes per speaker.
National Advisory Committee on Children and Disasters and National Preparedness and Response Science Board Public Meetings
Document Number: 2018-10212
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Advisory Committee on Children and Disasters (NACCD) and National Preparedness and Response Science Board (NPRSB) will hold public meetings on June 26-28, 2018.
Availability of Draft Interaction Profile for Mixtures of Insecticides: Pyrethroids, Organophosphorus Compounds, and Carbamates
Document Number: 2018-10204
Type: Notice
Date: 2018-05-14
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS) announces the availability of the Draft Interaction Profile for Mixtures of Insecticides: Pyrethroids, Organophosphorus Compounds, and Carbamates for review and comment. This interaction profile evaluates a mixture of chemicals often found in human blood, adipose tissue, and breast milk. The purpose of this interaction profile is to investigate the possible joint actions of these chemicals on endocrine, developmental, and neurobehavioral endpoints in humans. This interaction profile has undergone external peer-review and review by ATSDR's Interagency Workgroup on Mixtures. ATSDR remains committed to providing a public comment period for these documents as a means to best serve public health and the public.
Partial Withdrawal of Proposed Amendment to the Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use
Document Number: 2018-10194
Type: Proposed Rule
Date: 2018-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a partial withdrawal of a proposed rule published in the Federal Register of August 21, 2002 (2002 proposed rule). The proposed rule, if finalized, would have amended FDA's tentative final monograph (TFM) for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized as safe and effective (GRASE) analgesic/antipyretic active ingredient for OTC use. FDA is withdrawing this proposed rule due to changes in our understanding of ibuprofen since FDA issued the proposed rule. FDA is not withdrawing those portions of the 2002 proposed rule to amend its regulations to include consistent pregnancy and allergy warnings for OTC IAAA drug products containing nonsteroidal anti- inflammatory active ingredients.
Pediatric HIV Infection: Drug Development for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-10187
Type: Notice
Date: 2018-05-14
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 draft guidance for industry entitled ``Pediatric HIV Infection: Drug Development for Treatment.'' This guidance provides general recommendations on the development of drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients (birth to younger than 17 years of age).
Health Resources and Services Administration
Document Number: 2018-10182
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, 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.
Submission for OMB Review; Comment Request
Document Number: 2018-10178
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2018-10169
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, Administration for Children and Families
Occupational Robotics Research Prioritization
Document Number: 2018-10165
Type: Notice
Date: 2018-05-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention has recently established the Center for Occupational Robotics Research. NIOSH is requesting information to guide the prioritization of research to be undertaken by the Center. NIOSH is seeking input on priority gaps in knowledge on the safety and health of humans working with robotics technology, with an emphasis on worker safety and health research which is unlikely to be completed by other federal agencies, academia, and the private sector.
The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
Document Number: 2018-10148
Type: Rule
Date: 2018-05-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled ``The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration RegulationSmall Entity Compliance Guide.'' The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled ``The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules.''
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2018-10139
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2018-10138
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-10137
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Collection; 60-day Comment Request; Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's Contact Center (CC) Clients (National Cancer Institute)
Document Number: 2018-10136
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-10135
Type: Notice
Date: 2018-05-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and 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
Document Number: 2018-10130
Type: Notice
Date: 2018-05-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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 the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Solicitation of Nominations for Membership To Serve on the Council on Graduate Medical Education
Document Number: 2018-10129
Type: Notice
Date: 2018-05-14
Agency: Department of Health and Human Services
HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the Council on Graduate Medical Education (COGME). COGME provides advice and recommendations to the Secretary of HHS; the Senate Committee on Health, Education, Labor and Pensions; and the U.S. House of Representatives Committee on Energy and Commerce on matters concerning the supply and distribution of physicians in the United States, physician workforce trends, training issues, financing policies, and other matters of significance related to physician workforce and graduate medical education.
Meeting of the Advisory Committee on Minority Health
Document Number: 2018-10125
Type: Notice
Date: 2018-05-11
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting conducted as a telephone conference call. This call will be open to the public. Preregistration is required for both public participation and comment. Any individual who wishes to participate in the call should email OMH-ACMH@hhs.gov by June 18, 2018. Instructions regarding participating in the call and how to provide verbal public comments will be given at the time of preregistration. Information about the meeting is available from the designated contact and will be posted on the website for the Office of Minority Health (OMH), www.minorityhealth.hhs.gov. Information about ACMH activities can be found on the OMH website under the heading About OMH.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-July 25, 2018
Document Number: 2018-10120
Type: Notice
Date: 2018-05-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, July 25, 2018. This meeting will specifically focus on obtaining the MEDCAC's appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements (SAVRs), transcatheter aortic valve replacements (TAVRs) and percutaneous coronary interventions (PCIs), for hospitals to begin and maintain TAVR programs. This meeting is open to the public in accordance with the Federal Advisory Committee Act.
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT); Amended Notice of Meeting
Document Number: 2018-10111
Type: Notice
Date: 2018-05-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2018-10110
Type: Notice
Date: 2018-05-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll- free, dial-in number at 1-866-659-0537; the pass code is 9933701. The conference line has 150 ports for callers.
Determination That SODIUM IODIDE I 123 (Sodium Iodide I-123), Oral Solution, 2 Millicuries/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2018-10099
Type: Notice
Date: 2018-05-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that SODIUM IODIDE I 123 (sodium iodide I-123), oral solution, 2 millicuries (mCi)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for sodium iodide I 123, oral solution, 2 mCi/mL, if all other legal and regulatory requirements are met.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-10094
Type: Notice
Date: 2018-05-11
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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Healthcare Safety Network (NHSN). NHSN is a public health surveillance system that collects, analyzes, reports, and makes available data for monitoring, measuring, and responding to healthcare associated infections (HAIs), antimicrobial use and resistance, blood transfusion safety events, and the extent to which healthcare facilities adhere to infection prevention practices and antimicrobial stewardship.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-10090
Type: Notice
Date: 2018-05-11
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) has a comprehensive web-based Library of Patient-Centered Outcomes Research (PCOR) Resources to help make available the PCOR research, findings, tools, and other resources that have been developed as a result of investments by public, private, nonprofit, and academic organizations. This Library of PCOR Resources includes PCOR findings and evidence- based tools that have appeared in the published literature, as well as studies and projects that are in progress. The information in this web-based library is intended to assist researchers who may be conducting new studies, as well as clinicians, policymakers, consumers, and others who are seeking access to evidence- based health information. Each resource provided in the library provides a summary and access to information on PCOR studies and related syntheses and translations. Through this Request for Information (RFI), AHRQ is seeking feedback about the Library of PCOR Resources and the materials that can be accessed there to gauge how well the Library and those materials meet the needs of potential users in the general public.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019; Correction
Document Number: 2018-10089
Type: Rule
Date: 2018-05-11
Agency: Department of Health and Human Services
This document corrects technical errors that appeared in the final rule published in the Federal Register on April 17, 2018 entitled ``Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019.''
Medicare Program; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas
Document Number: 2018-10084
Type: Rule
Date: 2018-05-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period makes technical amendments to the regulation to reflect the extension of the transition period from June 30, 2016 to December 31, 2016 that was mandated by the 21st Century Cures Act for phasing in fee schedule adjustments for certain durable medical equipment (DME) and enteral nutrition paid in areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). In addition, this interim final rule with comment period amends the regulation to resume the transition period's blended fee schedule rates for items furnished in rural areas and non-contiguous areas (Alaska, Hawaii, and United States territories) not subject to the CBP from June 1, 2018 through December 31, 2018. This interim final rule with comment period also makes technical amendments to existing regulations for DMEPOS items and services to reflect the exclusion of infusion drugs used with DME from the DMEPOS CBP.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2018-10081
Type: Notice
Date: 2018-05-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2018-10080
Type: Notice
Date: 2018-05-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2018-10079
Type: Notice
Date: 2018-05-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meetings
Document Number: 2018-10078
Type: Notice
Date: 2018-05-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-10077
Type: Notice
Date: 2018-05-11
Agency: Department of Health and Human Services, National Institutes of Health