Department of Health and Human Services February 2018 – Federal Register Recent Federal Regulation Documents

Medicare Program; Public Meetings in Calendar Year 2018 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations
Document Number: 2018-04105
Type: Notice
Date: 2018-02-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2018 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-04061
Type: Notice
Date: 2018-02-28
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 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including 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.
Dietary Guidelines for Americans: Request for Comments on Topics and Questions
Document Number: 2018-04058
Type: Notice
Date: 2018-02-28
Agency: Department of Agriculture, Department of Health and Human Services
The Departments of Agriculture (USDA) and Health and Human Services (HHS) solicit written comments on the topics and questions to be examined in the review of scientific evidence supporting the development of the 2020-2025 Dietary Guidelines for Americans.
National Committee on Vital and Health Statistics: Meeting
Document Number: 2018-04057
Type: Notice
Date: 2018-02-28
Agency: Department of Health and Human Services
Solicitation for Nominations for Members of the U.S. Preventive Services Task Force (USPSTF)
Document Number: 2018-04052
Type: Notice
Date: 2018-02-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF).
Request for Information Regarding Patient-Reported Outcome Measures
Document Number: 2018-04050
Type: Notice
Date: 2018-02-28
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
AHRQ is seeking information submissions from the public. Information is being solicited to inform our work on patient-reported outcomes (PROs). Access to information regarding physical function PRO measure use will assist the selection of measures for AHRQ's efforts to develop and implement user-friendly technical tools to collect and integrate PRO data in electronic health records or other health information technology products.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-04039
Type: Notice
Date: 2018-02-28
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-04019
Type: Notice
Date: 2018-02-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended; Notice of Meeting
Document Number: 2018-04018
Type: Notice
Date: 2018-02-28
Agency: Department of Health and Human Services
National Cancer Institute Amended; Notice of Meeting
Document Number: 2018-04017
Type: Notice
Date: 2018-02-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2018-04016
Type: Notice
Date: 2018-02-28
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2018-04015
Type: Notice
Date: 2018-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-04014
Type: Notice
Date: 2018-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-04013
Type: Notice
Date: 2018-02-28
Agency: Department of Health and Human Services, National Institutes of Health
Submission for OMB Review; Comment Request
Document Number: 2018-03976
Type: Notice
Date: 2018-02-27
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-03972
Type: Notice
Date: 2018-02-27
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 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including 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: 2018-03966
Type: Notice
Date: 2018-02-27
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: Proposed Collection; Comment Request; Correction
Document Number: 2018-03964
Type: Notice
Date: 2018-02-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality published a document in the Federal Register of February 16, 2018 concerning the current use of the AHRQ Quality Indicators (AHRQ QIs) for quality improvement efforts. This document contained an incorrect deadline date.
Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation; Public Workshop; Request for Comments
Document Number: 2018-03961
Type: Notice
Date: 2018-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled ``Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation.'' The purpose of the public workshop is to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity FDA should consider when approving a product with a tissue agnostic indication.
Supplemental Evidence and Data Request on Home Mechanical Ventilators
Document Number: 2018-03927
Type: Notice
Date: 2018-02-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Home Mechanical Ventilators, which is currently being conducted by the AHRQ's Evidence- based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2018-03926
Type: Notice
Date: 2018-02-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
Wyeth Pharmaceuticals Inc. et al.; Withdrawal of Approval of 121 New Drug Applications and 161 Abbreviated New Drug Applications; Correction
Document Number: 2018-03925
Type: Notice
Date: 2018-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of June 21, 2017 (82 FR 28322). The document announced the withdrawal of approval of 121 new drug applications (NDAs) and 161 abbreviated new drug applications from multiple applicants, withdrawn as of July 21, 2017. The document indicated that FDA was withdrawing approval of NDA 204508, Clinolipid 20% (olive oil and soybean oil) USP, 16%/4%, after receiving a request from the NDA holder, Baxter Healthcare Corp. (Baxter), 32650 N Wilson Rd., Round Lake, IL 60073. Before the approval of NDA 204508 was withdrawn, Baxter informed FDA that it did not want the approval of this NDA withdrawn. Because Baxter timely requested that approval of this NDA not be withdrawn, the approval of NDA 204508 is still in effect.
Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems
Document Number: 2018-03924
Type: Rule
Date: 2018-02-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying Lynch syndrome test systems into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Lynch syndrome test systems' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2018-03897
Type: Notice
Date: 2018-02-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-03873
Type: Notice
Date: 2018-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Closed Meetings
Document Number: 2018-03872
Type: Notice
Date: 2018-02-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2018-03871
Type: Notice
Date: 2018-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-03870
Type: Notice
Date: 2018-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-03869
Type: Notice
Date: 2018-02-27
Agency: Department of Health and Human Services, National Institutes of Health
Women's Preventive Services Guidelines
Document Number: 2018-03840
Type: Notice
Date: 2018-02-27
Agency: Department of Health and Human Services, Health Resources and Service Administration
Applicable as of December 29, 2017, HRSA updated the HRSA- supported Women's Preventive Services Guidelines for purposes of health insurance coverage for preventive services that address health needs specific to women based on clinical recommendations from the Women's Preventive Services Initiative. This 2017 update adds two additional servicesScreening for Diabetes Mellitus after Pregnancy and Screening for Urinary Incontinenceto the nine preventive services included in the 2016 update to the HRSA-supported Women's Preventive Services Guidelines. The nine services included in the 2016 update are as follows: Breast Cancer Screening for Average Risk Women, Breastfeeding Services and Supplies, Screening for Cervical Cancer, Contraception, Screening for Gestational Diabetes Mellitus, Screening for Human Immunodeficiency Virus Infection, Screening for Interpersonal and Domestic Violence, Counseling for Sexually Transmitted Infections, and Well-Woman Preventive Visits. This notice serves as an announcement of the decision to update the guidelines as listed below. Please see https://www.hrsa.gov/womens-guidelines/index.html for additional information.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-03855
Type: Notice
Date: 2018-02-26
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 changes to the currently approved information collection project: ``Medical Expenditure Panel Survey (MEPS) Household Component and the MEPS Medical Provider Component.'' This proposed information collection was previously published in the Federal Register on December 22, 2017 and allowed 60 days for public comment. AHRQ received no substantive comments. 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: 2018-03854
Type: Notice
Date: 2018-02-26
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 ``Patient Safety Organization Certification for Initial Listing and Related Forms, Patient Safety Confidentiality Complaint Form, and Common Formats.''
Request for Nominations
Document Number: 2018-03853
Type: Notice
Date: 2018-02-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of four qualified candidates to be considered for appointment as members of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (Committee). The Committee consists of 18 public members, including two co-chairs. The Committee membership maintains a balance of diverse experiences and expertise. Those requesting consideration require expertise in areas such as: Public health; epidemiology; laboratory practice; immunology; infectious diseases; behavioral health and science including, but not limited to opioid use and related expertise; health education; healthcare delivery; state health programs; clinical care; preventive health; medical education; health services and clinical research; and healthcare financing. In addition, people living with HIV and affected populations as well as individuals employed by state and local health and education agencies, HIV/viral hepatitis/STD community-based organizations, and the ethics or religious community are encouraged to submit nomination packages for consideration. Current federal employees will not be considered.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-03849
Type: Notice
Date: 2018-02-26
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; Substances Prohibited From Use in Animal Food or Feed
Document Number: 2018-03848
Type: Notice
Date: 2018-02-26
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Recall Regulations
Document Number: 2018-03847
Type: Notice
Date: 2018-02-26
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.
Advisory Commission on Childhood Vaccines
Document Number: 2018-03812
Type: Notice
Date: 2018-02-26
Agency: Department of Health and Human Services, Health Resources and Service Administration
In accordance with the Federal Advisory Committee Act, notice is hereby given that a meeting is scheduled for the Advisory Commission on Childhood Vaccines (ACCV). This meeting will be open to the public. Information about the ACCV and the agenda for this meeting can be obtained by accessing the following website: http://www.hrsa.gov/ advisorycommittees/childhoodvaccines/index.html.
Q11 Development and Manufacture of Drug Substances-Questions and Answers (Chemical Entities and Biotechnological/Biological Entities); International Council for Harmonisation; Guidance for Industry; Availability
Document Number: 2018-03809
Type: Notice
Date: 2018-02-26
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 ``Q11 Development and Manufacture of Drug SubstancesQuestions and Answers (Chemical Entities and Biotechnological/Biological Entities).'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance consists of questions and answers that were developed to clarify the principles for selecting starting materials described in the ICH guidance ``Q11 Development and Manufacture of Drug Substances'', published November 20, 2012. The guidance is intended to provide additional clarification and to promote convergence on the considerations for the selection and justification of starting materials. The questions and answers focus on chemical entity drug substances, and provide recommendations on the information that should be provided in marketing authorization applications and/or master files to justify the starting materials.
Psychopharmacologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-03808
Type: Notice
Date: 2018-02-26
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 Psychopharmacologic 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.
Center for Drug Evaluation and Research and You: Keys to Effective Engagement; Public Workshop
Document Number: 2018-03805
Type: Notice
Date: 2018-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is announcing the following public workshop entitled ``CDER and You: Keys to Effective Engagement.'' The purpose of the public workshop is to build upon previous efforts to help advocates understand how they can engage with FDA to enhance drug development and safety. This marks the third annual CDER public workshop for patient advocacy groups.
Promoting the Use of Complex Innovative Designs in Clinical Trials; Public Meeting; Request for Comments
Document Number: 2018-03804
Type: Notice
Date: 2018-02-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Promoting the Use of Complex Innovative Designs in Clinical Trials.'' The topic to be discussed is the use of complex innovative designs (CID) in clinical trials of drugs and biological products to inform regulatory decision making. This meeting will inform development of a guidance document as required by the 21st Century Cures Act (Cures Act) and is being conducted to meet the performance goal of convening a public workshop on CID included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA). This meeting will also inform the development of a CID pilot program. FDA is seeking comments on the use of CID to inform regulatory decision making and is also seeking input on the CID pilot program.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-03803
Type: Notice
Date: 2018-02-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2018-03780
Type: Notice
Date: 2018-02-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health; Notice of Closed Meeting
Document Number: 2018-03779
Type: Notice
Date: 2018-02-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health; Notice of Meeting
Document Number: 2018-03778
Type: Notice
Date: 2018-02-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health; Notice of Meeting
Document Number: 2018-03777
Type: Notice
Date: 2018-02-26
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Secretary's Advisory Committee on Human Research Protections
Document Number: 2018-03768
Type: Notice
Date: 2018-02-23
Agency: Department of Health and Human Services
Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP website at: http://www.dhhs.gov/ ohrp/sachrp-committee/meetings/index.html.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Annual Long-Term Care Ombudsman Report Known as the National Ombudsman Reporting System (NORS) and Instructions (OMB No: 0985-0005)
Document Number: 2018-03767
Type: Notice
Date: 2018-02-23
Agency: Aging Administration, Department of Health and Human Services
The Administration for Community Living/Administration on Aging (ACL/AoA) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the Long-Term Care Ombudsman Program (Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)).
Findings of Research Misconduct
Document Number: 2018-03766
Type: Notice
Date: 2018-02-23
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made on the part of Colleen T. Skau, Ph.D., former postdoctoral fellow in the Cell Biology and Physiology Center, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH). Dr. Skau engaged in research misconduct in research supported by NHLBI, NIH. The administrative actions, including three (3) years of supervision, were implemented beginning on January 25, 2018, and are detailed below.
Patient Safety Organizations: Expired Listing for Quality Solutions
Document Number: 2018-03744
Type: Notice
Date: 2018-02-23
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. The listing for Quality Solutions has expired and AHRQ has delisted the PSO accordingly.