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

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Request for Public Comments on the Pain Management Best Practices Inter-Agency Task Force Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations
Document Number: 2018-28403
Type: Notice
Date: 2018-12-31
Agency: Department of Health and Human Services
The Comprehensive Addiction and Recovery Act of 2016 (CARA), requires that the public be given at least ninety (90) days to submit comments on any proposed updates and recommendations developed by the Pain Management Best Practices Inter-Agency Task Force (Task Force). The Task Force is requesting comments on the Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations (hereinafter referred to as Draft Report). Section 101 of the CARA authorized the creation of the Task Force to identify gaps or inconsistencies, and propose updates to best practices and recommendations for pain management, including chronic and acute pain. The Secretary of HHS convened the Task Force in cooperation with the Secretary of Veterans Affairs and Secretary of Defense. On September 26, 2018, the Task Force voted on the proposed updates and recommendations that would be provided to the public for comment, which are included in the Draft Report. Once the ninety (90) day comment period concludes, the Task Force will consider comments received and compile a Final Report with its proposed updates and recommendations.
Physician-Focused Payment Model Technical Advisory Committee; Meetings
Document Number: 2018-28402
Type: Notice
Date: 2018-12-31
Agency: Department of Health and Human Services
This notice announces the 2019 meetings of the Physician- Focused Payment Model Technical Advisory Committee (PTAC). These meetings will include deliberation and voting on proposals for physician-focused payment models (PFPMs) submitted by individuals and stakeholder entities. All meetings are open to the public.
Medicare Program; Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees
Document Number: 2018-28359
Type: Notice
Date: 2018-12-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice with comment period announces the increase of certain fees established under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The Public Health Service Act (PHSA) requires the Secretary to impose certificate fees to cover the general costs of administering the CLIA program, as well as additional fees, including Inspection fees for non-accredited laboratories. We are increasing these fees to cover the cost of administering the CLIA program as required by statute. We seek public comment regarding this increase, which we believe is necessary to meet the statutory requirements.
Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Pathways to Success and Extreme and Uncontrollable Circumstances Policies for Performance Year 2017
Document Number: 2018-27981
Type: Rule
Date: 2018-12-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. The policies included in this final rule provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses). These policies are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free-market principles. This final rule also provides new tools to support coordination of care across settings and strengthen beneficiary engagement; and ensure rigorous benchmarking. In this final rule, we also respond to public comments we received on the extreme and uncontrollable circumstances policies for the Shared Savings Program that were used to assess the quality and financial performance of ACOs that were subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, in performance year 2017, including the applicable quality data reporting period for performance year 2017.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-27337
Type: Notice
Date: 2018-12-31
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.
Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction
Document Number: 2018-28348
Type: Rule
Date: 2018-12-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the final rule with comment period that appeared in the November 21, 2018 Federal Register titled ``Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.''
Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS; Correction
Document Number: 2018-28347
Type: Rule
Date: 2018-12-28
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 14, 2018 titled ``Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS.''
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-28342
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-28341
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2018-28340
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2018-28339
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-28338
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-28337
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-28335
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine; Notice of Meeting
Document Number: 2018-28334
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-28333
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2018-28332
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health (NIMH); Notice of Meeting
Document Number: 2018-28331
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Meetings
Document Number: 2018-28330
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2018-28329
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2018-28328
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-28327
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, National Institutes of Health
Office of Urban Indian Health Programs; 4-in-1 Grant Programs
Document Number: 2018-28301
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, Indian Health Service
Meeting of the National Advisory Council on Nurse Education and Practice
Document Number: 2018-28292
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, Health Resources and Services Administration
National Advisory Council on Nurse Education and Practice (NACNEP) has scheduled a public meeting. Information about NACNEP and the agenda for this meeting can be found on the NACNEP website at https://www.hrsa.gov/advisory-committees/nursing/index.html.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-28280
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, 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 the Public Health Service (PHS) Act, as amended. While the Secretary of HHS 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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-28278
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Office on Trafficking in Persons; Notice of Meeting
Document Number: 2018-28264
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, Administration for Children and Families
Notice is hereby given, pursuant to the provisions of the Federal Advisory Committee Act (FACA) and the Preventing Sex Trafficking and Strengthening Families Act, that a meeting of the National Advisory Committee (NAC) on the Sex Trafficking of Children and Youth in the United States (Committee) will be held on January 9, 2019. The purpose of the meeting is for the Committee to finalize its outline of preliminary recommendations of best practices for States to follow in combating the sex trafficking of children and youth based on multidisciplinary research and promising, evidence-based models and programs.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for Quantitative Testing for the Development of Food and Drug Administration Communications
Document Number: 2018-28252
Type: Notice
Date: 2018-12-28
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 (PRA).
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Shortages Data Collection System
Document Number: 2018-28235
Type: Notice
Date: 2018-12-28
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 reinstatement of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Shortages Data Collection System for certain medical devices.
Agency Information Collection Request; 30-Day Public Comment Request
Document Number: 2018-28227
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Determination of Regulatory Review Period for Purposes of Patent Extension; PARSABIV
Document Number: 2018-28221
Type: Notice
Date: 2018-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PARSABIV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601
Document Number: 2018-28220
Type: Notice
Date: 2018-12-28
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 Form FDA 3601, entitled ``Medical Device User Fee Cover Sheet,'' which must be submitted along with certain medical device product applications, supplements, and fee payment of those applications.
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV; Draft Guidance for Industry; Availability
Document Number: 2018-28219
Type: Notice
Date: 2018-12-28
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 (GFI) #259 entitled ``Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV'' (VICH GL58). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH draft guidance document is an annex to the VICH parent stability guidance, GFI #73/ VICH GL3(R), ``Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision),'' and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration or application submitted within the regions in climatic zones III and IV.
Determination of Regulatory Review Period for Purposes of Patent Extension; XERMELO
Document Number: 2018-28218
Type: Notice
Date: 2018-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XERMELO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; RUBRACA
Document Number: 2018-28217
Type: Notice
Date: 2018-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RUBRACA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; RYDAPT
Document Number: 2018-28216
Type: Notice
Date: 2018-12-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RYDAPT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Product-Specific Guidance for Linaclotide; Draft Guidance for Industry; Availability
Document Number: 2018-28213
Type: Notice
Date: 2018-12-28
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 draft guidance for industry on generic linaclotide oral capsules, entitled ``Draft Guidance on Linaclotide.'' The draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for linaclotide oral capsules.
Findings of Research Misconduct
Document Number: 2018-28139
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made on the part of Venkata Sudheer Kumar Ramadugu, Ph.D. (Respondent), former postdoctoral scientist in the Department of Chemistry, University of Michigan (UM). Dr. Ramadugu engaged in research misconduct in research supported by National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grant R01 GM084018 and National Institute on Aging (NIA), NIH, grant R01 AG048934. The administrative actions, including debarment for a period of five (5) years, were implemented beginning on December 4, 2018, and are detailed below.
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-28136
Type: Notice
Date: 2018-12-28
Agency: Department of Health and Human Services, 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 the Public Health Service (PHS) Act, as amended. While the Secretary of HHS 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.
Medicare and Medicaid Programs; Risk Adjustment Data Validation
Document Number: 2018-28070
Type: Proposed Rule
Date: 2018-12-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document only extends the comment period for the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' that was published in the November 1, 2018 Federal Register. The comment period for the RADV provision of this proposed rule, which would end on December 31, 2018, is extended by 120 days until April 30, 2019. The comment period for all other provisions of the November 1, 2018 proposed rule ends on December 31, 2018.
Advisory Council on Alzheimer's Research, Care, and Services; Meeting
Document Number: 2018-28058
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services
This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer's Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. During the January meeting, the Research Subcommittee will be taking charge of the theme. The topics covered will include: Non- pharmacological interventions, pragmatic trials, and maximizing the quality of life for people living with dementia. The meeting will also include updates on work from the previous meetings and federal workgroup updates.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Environmental Information Documentation (EID), OMB No. 0915-0324-Revision
Document Number: 2018-28029
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the requirement for opportunity for public comment on proposed data collection projects 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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-28022
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-28021
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-28020
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-28019
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; National and Tribal Evaluation of the 2nd Generation of the Health Profession Opportunity Grants (OMB #0970-0462)
Document Number: 2018-28018
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is proposing data collection activities as part of the Health Profession Opportunity Grants (HPOG) to Serve TANF Recipients and Other Low Income Individuals. ACF has developed a multi-pronged research and evaluation approach for the HPOG Program to better understand and assess the activities conducted and their results. Two rounds of HPOG grants have been awardedthe first in 2010 (HPOG 1.0) and the second in 2015 (HPOG 2.0). There are federal evaluations associated with each round of grants. HPOG grants provide funding to government agencies, community- based organizations, post-secondary educational institutions, and tribal-affiliated organizations to provide education and training services to Temporary Assistance for Needy Families (TANF) recipients and other low-income individuals, including tribal members. Under HPOG 2.0, ACF provided grants to five tribal-affiliated organizations and 27 non-tribal entities. OMB previously approved data collection under OMB Control Number 0970-0462 for the HPOG 2.0 National and Tribal Evaluation. The first submission, approved in August 2015, included baseline data collection instruments and the grant performance management system. A second submission, approved in June 2017, included additional data collection for the National Evaluation impact study, the National Evaluation descriptive study, and the Tribal Evaluation. A third submission for National Evaluation impact study data collection was approved in June 2018. The proposed data collection activities described in this Federal Register Notice will provide data for the impact, descriptive, and cost benefit studies of the 27 non-tribal grantees participating in the National Evaluation of HPOG 2.0.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-28017
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-28016
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health