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/.
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
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-28015
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2018-28014
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse Notice of Closed Meeting
Document Number: 2018-28013
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-28011
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-28010
Type: Notice
Date: 2018-12-27
Agency: Department of Health and Human Services, National Institutes of Health
Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid
Document Number: 2018-27966
Type: Rule
Date: 2018-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the food additive regulations for a required labeling statement for use of formic acid in complete feed for swine and poultry. This action is being taken to improve the accuracy and clarity of the regulations.
Ranjan Bhandari: Debarment Order
Document Number: 2018-27951
Type: Notice
Date: 2018-12-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Ranjan Bhandari, MD (Dr. Bhandari), for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Bhandari was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Bhandari was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Bhandari failed to request a hearing. Dr. Bhandari's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
Agency Information Collection Activities; Proposed Collection; Public Comment Request; Inventory of Adult Protective Services Practices and Service Innovations
Document Number: 2018-27902
Type: Notice
Date: 2018-12-26
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of certain information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 the information collection requirements relating to a new data collection (ICR New) effort titled ``Inventory of Adult Protective Services Practices and Service Innovations.''
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Independent Living Services (ILS) Program Performance Report (PPR) (0985-0043)
Document Number: 2018-27900
Type: Notice
Date: 2018-12-26
Agency: Department of Health and Human Services
The Administration for Community Living 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 Independent Living Services Program Performance Report (Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)).
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; Centers for Independent Living Program Performance Report (0985-NEW)
Document Number: 2018-27898
Type: Notice
Date: 2018-12-26
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) 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 section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to Centers for Independent Living Program Performance Report (New Data Collection (ICR New)).
Notice of Closed Meeting
Document Number: 2018-27896
Type: Notice
Date: 2018-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-27895
Type: Notice
Date: 2018-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-27894
Type: Notice
Date: 2018-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-27893
Type: Notice
Date: 2018-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Findings of Research Misconduct
Document Number: 2018-27874
Type: Notice
Date: 2018-12-26
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made against Uthra Rajamani, Ph.D. (Respondent), former project scientist in the Induced Pluripotent Stem Cell Core Facility, Cedars-Sinai Medical Center (CSMC). Dr. Rajamani engaged in research misconduct in research supported by National Center for Advancing Translational Science (NCATS), National Institutes of Health (NIH), grant UL1 TR000124. The administrative actions, including supervision for a period of one (1) year, were implemented beginning on November 27, 2018, and are detailed below.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-27855
Type: Notice
Date: 2018-12-26
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 on the Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) program. The WISEWOMAN program is designed to prevent, detect, and control, hypertension and other cardiovascular disease risk factors through healthy behavior support services, which are tailored for individual and group behavior change.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-27854
Type: Notice
Date: 2018-12-26
Agency: Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), 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 ``Exposure Characterization and Measurements during Activities Conducted on Synthetic Turf Fields with Tire Crumb Rubber Infill.'' The purpose of the proposed study is to evaluate and characterize human exposure potential to select chemicals during play on synthetic turf fields with tire crumb rubber infill.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-27853
Type: Notice
Date: 2018-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-27852
Type: Notice
Date: 2018-12-26
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Comment Request; Medicated Feed Mill License Application
Document Number: 2018-27812
Type: Notice
Date: 2018-12-26
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 the medicated feed mill licensing system.
Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses
Document Number: 2018-27809
Type: Rule
Date: 2018-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls). FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the preamendments class III ECT devices for all other uses that are not being reclassified to class II (product code GXC).
Modified Risk Tobacco Product Applications for IQOS System With Marlboro Heatsticks, IQOS System With Marlboro Smooth Menthol Heatsticks, and IQOS System With Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.; Closing of Comment Period
Document Number: 2018-27807
Type: Notice
Date: 2018-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a closing date for the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Philip Morris Products S.A. for its IQOS system products. FDA recently received amendments to these MRTPAs and has made them available for public comment.
Determination of Regulatory Review Period for Purposes of Patent Extension; ADLYXIN
Document Number: 2018-27805
Type: Notice
Date: 2018-12-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for ADLYXIN 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.
Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), January 16, 2019
Document Number: 2018-27804
Type: Notice
Date: 2018-12-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the next meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning CMS programs, initiatives, and priorities. This meeting is open to the public.
Medicare Program; Request for Renewal of Deeming Authority of the Utilization Review Accreditation Commission (URAC) for Health Maintenance Organizations and Preferred Provider Organizations
Document Number: 2018-27802
Type: Notice
Date: 2018-12-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice announces that CMS is considering granting approval of the Utilization Review Accreditation Commission's (URAC) renewal application for Medicare Advantage ``deeming authority'' of Health Maintenance Organizations and Preferred Provider Organizations. This new 6-year term of approval would begin on the date of publication of the final notice. This notice also announces a 30-day period for the public to submit comments on CMS' renewal of the application.
Organization, Functions, and Delegations of Authority; Part G; Indian Health Service
Document Number: 2018-27793
Type: Notice
Date: 2018-12-26
Agency: Department of Health and Human Services, Indian Health Service
National Institute of Neurological Disorders and Stroke, Interagency Pain Research Coordinating Committee Call for Committee Membership Nominations
Document Number: 2018-27737
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, National Institutes of Health
The Department of Health and Human Services (HHS) (Department) has created the Interagency Pain Research Coordinating Committee (IPRCC) and is seeking nominations for this committee.
Notice of Closed Meeting
Document Number: 2018-27722
Type: Notice
Date: 2018-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2018-27721
Type: Notice
Date: 2018-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
CDC/Mine Safety and Health Research Advisory Committee (MSHRAC); Notice of Charter Renewal
Document Number: 2018-27720
Type: Notice
Date: 2018-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice that under the Federal Advisory Committee Act of October 6, 1972, that the Mine Safety and Health Research Advisory Committee (MSHRAC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 30, 2020.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
Document Number: 2018-27719
Type: Notice
Date: 2018-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS). This meeting is open to the public.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS); Correction
Document Number: 2018-27718
Type: Notice
Date: 2018-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT); Notice of Charter Renewal
Document Number: 2018-27717
Type: Notice
Date: 2018-12-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 25, 2020.
Proposed Information Collection Activity; Comment Request
Document Number: 2018-27692
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2018-27687
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Document Number: 2018-27686
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, Administration for Children and Families
Determination of Regulatory Review Period for Purposes of Patent Extension; ABSORB GT1 BIORESORBABLE SCAFFOLD
Document Number: 2018-27678
Type: Notice
Date: 2018-12-21
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 ABSORB GT1 Bioresorbable Scaffold 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 medical device.
Prospective Grant of Exclusive Patent License: Production of Live Respiratory Syncytial Virus and Parainfluenza Virus Vaccines
Document Number: 2018-27674
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Medigen Vaccines Biologics Corp. (Medigen), having a place of business in Zhubei, Taiwan.
Prospective Grant of Exclusive Patent License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Zika and Dengue Vaccines
Document Number: 2018-27673
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Fundacao Butantan (Butantan), having a place of business in Sao Paulo, Brazil.
Prospective Grant of Co-Exclusive Patent License: Production of Monovalent Live Attenuated Zika Vaccines and Multivalent Live Attenuated Zika and Dengue Vaccines
Document Number: 2018-27672
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Co-Exclusive Commercialization Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Summary Information section of this notice to Medigen Vaccines Biologics Corp. (Medigen), having a place of business in Zhubei, Taiwan, and Panacea Biotec Ltd., having a place of business in New Delhi, India.
Prospective Grant of an Exclusive Patent License: “Multifunctional RNA Nanoparticles and Methods of Uses” and “RNA/DNA Hybrid Nanoparticles Modified With Single Stranded RNA Toeholds and Uses Thereof”
Document Number: 2018-27671
Type: Notice
Date: 2018-12-21
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 Patent Applications listed in the Supplementary Information section of this notice to Sixfold Biosciences Inc., (``Sixfold'') of Walnut, California.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Cigarette Warnings
Document Number: 2018-27658
Type: Notice
Date: 2018-12-21
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.
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data; Draft Guidance for Industry and Other Stakeholders; Availability
Document Number: 2018-27657
Type: Notice
Date: 2018-12-21
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 ``Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.'' This draft guidance is being developed under the 21st Century Cures Act (Cures Act), which directs FDA to issue guidance on how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency.
Agency Information Collection Activities; Proposed Collection; Comment Request; Substances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Document Number: 2018-27656
Type: Notice
Date: 2018-12-21
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 the recordkeeping requirements regarding animal proteins prohibited in ruminant feed.
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
Document Number: 2018-27655
Type: Notice
Date: 2018-12-21
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 information collection for administrative detention and banned medical devices.
Labeling of Red Blood Cell Units With Historical Antigen Typing Results; Guidance for Industry; Availability
Document Number: 2018-27654
Type: Notice
Date: 2018-12-21
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 final guidance entitled ``Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Guidance for Industry.'' The guidance document provides establishments that collect blood and blood components for transfusion with recommendations for labeling Red Blood Cell (RBC) units with non-ABO/Rh(D) antigen typing results obtained from previous donations (historical antigen typing results). The guidance provides recommendations to transfusion services for managing RBC units labeled with historical antigen typing results. The guidance also provides licensed blood establishments that choose to implement labeling of RBC units with historical antigen typing results instructions regarding how to report the manufacturing and labeling changes under the biologics regulations. The guidance does not apply to test results for ABO and Rh(D) antigens. The guidance announced in this notice finalizes the draft guidance of the same title dated January 2017.
Submission for OMB Review; Comment Request
Document Number: 2018-27639
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, Administration for Children and Families
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2018-27637
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-27634
Type: Notice
Date: 2018-12-21
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Medicare and Medicaid Programs: Approval of the Accreditation Association for Ambulatory Health Care, Inc. (AAAHC) Application for Continued Approval of Its Ambulatory Surgical Center Accreditation Program
Document Number: 2018-27592
Type: Notice
Date: 2018-12-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Accreditation Association for Ambulatory Health Care, Inc. for continued recognition as a national accrediting organization for ambulatory surgical centers that wish to participate in the Medicare or Medicaid programs.
Food Labeling; Revision of the Nutrition and Supplement Facts Labels; Technical Amendments
Document Number: 2018-27431
Type: Rule
Date: 2018-12-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the regulations pertaining to the Nutrition Facts and Supplement Facts labels. The amendments correct errors that were made in labeling examples, restore incorrect deletions, correct the edition of a reference cited in the rule, and correct cross-references to other regulations. This action is ministerial or editorial in nature.
Proposed Information Collection Activity; ACF's Generic Clearance for Grant Reviewer Recruitment Forms (OMB #0970-0477)
Document Number: 2018-27551
Type: Notice
Date: 2018-12-20
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation (OPRE) is proposing an extension of a currently approved generic clearance (OMB no. 0970-0477) for Grant Reviewer Recruitment (GRR) forms. The GRR forms will be used to select reviewers who will participate in the grant review process for the purpose of selecting successful applications.
Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations; Extension of Comment Period
Document Number: 2018-27519
Type: Proposed Rule
Date: 2018-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the proposed rule that appeared in the Federal Register of November 15, 2018. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
Solicitation of Nominations for Organizational Representatives to the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2018-27518
Type: Notice
Date: 2018-12-20
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations from organizations to send a representative to be a liaison to the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). Selections will be based on a review of the organization's subject area of expertise, mission, relevancy, and benefit provided relative to the Committee's purpose. The organizational representatives are non-voting liaisons. The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS. HRSA is seeking nominations of qualified organizations to fill up to three positions. Authority: Section 1111 of the Public Health Service (PHS) Act, as amended by the Newborn Screening Saves Lives Reauthorization Act of 2014 (42 U.S.C. 300b-10). The Committee is governed by the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App.), and 41 CFR part 102-3, which set forth standards for the formation and use of advisory committees.
Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information
Document Number: 2018-27506
Type: Proposed Rule
Date: 2018-12-20
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This request for information (RFI) seeks public comment regarding the appropriateness of the practices of some Medicare- approved Accrediting Organizations (AOs) to provide fee-based consultative services for Medicare-participating providers and suppliers as part of their business model. We wish to determine whether AO practices of consulting with the same facilities which they accredit under their CMS approval could create actual or perceived conflicts of interest between the accreditation and consultative entities. We intend to consider information received in response to this RFI to assist in future rulemaking.
Uniform Compliance Date for Food Labeling Regulations
Document Number: 2018-27429
Type: Rule
Date: 2018-12-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is establishing January 1, 2022, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2019, and on or before December 31, 2020. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2018-27470
Type: Notice
Date: 2018-12-19
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.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2018-27469
Type: Notice
Date: 2018-12-19
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.
Administrative Simplification: Rescinding the Adoption of the Standard Unique Health Plan Identifier and Other Entity Identifier
Document Number: 2018-27435
Type: Proposed Rule
Date: 2018-12-19
Agency: Department of Health and Human Services, Office of the Secretary
This proposed rule would rescind the adopted standard unique health plan identifier (HPID) and the implementation specifications and requirements for its use and the other entity identifier (OEID) and implementation specifications for its use. The decision to propose to rescind the adopted standards was made following a careful assessment of industry input, as well as HHS's intention to explore options for a more effective standard unique health plan identifier in the future.
Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-27433
Type: Notice
Date: 2018-12-19
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 final guidance entitled ``Breakthrough Devices Program; Guidance for Industry and Food and Drug Administration Staff.'' This guidance document describes policies that FDA intends to use to implement the new Breakthrough Devices Program, established by the 21st Century Cures Act (Cures Act). The Breakthrough Devices Program supersedes and combines elements from FDA's Expedited Access Pathway (EAP), which was intended to facilitate the development and expedite review of certain devices that demonstrate the potential to address unmet medical needs, as well as the Priority Review Program, which implemented statutory criteria for granting priority review to premarket approval applications (PMAs) and applied those criteria to other types of premarket submissions for medical devices. This guidance is intended to clarify certain principles and features of the new program, the designation criteria for Breakthrough Devices, the designation request review process, the process for withdrawing from the program, as well as the recommended information device manufacturers should provide in their designation request for entrance into the program.
Submission for OMB Review; Comment Request
Document Number: 2018-27398
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, Administration for Children and Families
National Library of Medicine; Notice of Meetings
Document Number: 2018-27387
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Meetings
Document Number: 2018-27384
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences Notice of Closed Meeting
Document Number: 2018-27383
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meetings
Document Number: 2018-27382
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-27381
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Notice of Meeting
Document Number: 2018-27380
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2018-27379
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Meeting
Document Number: 2018-27378
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2018-27377
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental and Craniofacial Research; Notice of Closed Meeting
Document Number: 2018-27376
Type: Notice
Date: 2018-12-19
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: 2018-27375
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2018-27374
Type: Notice
Date: 2018-12-19
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2018-27366
Type: Notice
Date: 2018-12-18
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.
Notice To Announce Webinar To Request Public Input on Upcoming Surgeon General's Report on Oral Health
Document Number: 2018-27363
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH), National Institute of Dental and Craniofacial Research (NIDCR), is announcing a webinar to provide background information pertaining to the commissioning of a new report on oral health by the Surgeon General and to obtain public input on the report.
Supplemental Evidence and Data Request on Diagnostic and Treatment of Clinical Alzheimer's-Type Dementia (CATD)
Document Number: 2018-27361
Type: Notice
Date: 2018-12-18
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 Diagnostic and Treatment of Clinical Alzheimer's-type Dementia (CATD), 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.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-27359
Type: Notice
Date: 2018-12-18
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: ``Online Application Order Form for Products from the Healthcare Cost and Utilization Project (HCUP).''
Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies; New Date for Public Hearing; Request for Comments
Document Number: 2018-27352
Type: Proposed Rule
Date: 2018-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a new date for the public hearing to discuss its efforts to eliminate youth electronic cigarette (e-cigarette) use as well as other tobacco product use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies. FDA is also extending the comment period.
Intent To Consider the Appropriate Classification of Hyaluronic Acid Intra-articular Products Intended for the Treatment of Pain in Osteoarthritis of the Knee Based on Scientific Evidence
Document Number: 2018-27351
Type: Notice
Date: 2018-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing our intent to consider the appropriate classification of hyaluronic acid (HA) intra-articular products intended for the treatment of pain in osteoarthritis (OA) of the knee. Although HA products intended for this use have been regulated as devices (Procode MOZ; acid, hyaluronic, intra-articular), the current published scientific literature supports that HA achieves its primary intended purpose of treatment of pain in OA of the knee through chemical action within the body. Because HA for this use may not meet the definition of a device, sponsors of HA products who intend to submit a premarket approval application (PMA) or a supplement to a PMA for a change in indications for use, formulation, or route of administration are encouraged to obtain an informal or formal classification and jurisdiction determination through a Pre- Request for Designation (Pre-RFD) or Request for Designation (RFD), respectively, from FDA prior to submission. If a sponsor believes their product meets the device definition, they may provide relevant evidence in the Pre-RFD or RFD.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Maternal, Infant, and Early Childhood Home Visiting Program Quarterly Data Collection, OMB No. 0906-0016-Revision
Document Number: 2018-27348
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. A 60-day Federal Register Notice was published in the Federal Register on February 21, 2018. There were 24 public comments. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-27335
Type: Notice
Date: 2018-12-18
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: Proposed Collection: Public Comment Request Information Collection Request Title: HRSA AIDS Education and Training Centers Evaluation Activities, OMB No. 0915-0281-Revision
Document Number: 2018-27328
Type: Notice
Date: 2018-12-18
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.
National Institute of Allergy and Infectious Diseases Notice of Closed Meetings
Document Number: 2018-27282
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research Notice of Closed Meeting
Document Number: 2018-27277
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
Document Number: 2018-27238
Type: Rule
Date: 2018-12-18
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy and readability of the regulations.
Child Support Technical Corrections Notice of Proposed Rulemaking
Document Number: 2018-27224
Type: Proposed Rule
Date: 2018-12-18
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Child Support Enforcement proposes to eliminate regulations rendered outdated or unnecessary and make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement (FEM) final rule, published on December 20, 2016, including proposing to amend the compliance date for review and adjustment of child support orders. We are also proposing conforming amendments to the regulations as a result of Bipartisan Budget Act of 2018, Public Law 115-123.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-27182
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-27178
Type: Notice
Date: 2018-12-18
Agency: Department of Health and Human Services, National Institutes of Health
Manufacturing Site Change Supplements: Content and Submission; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-27237
Type: Notice
Date: 2018-12-17
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 final guidance entitled ``Manufacturing Site Change Supplements: Content and Submissions; Guidance for Industry and Food and Drug Administration Staff.'' This guidance describes the decision-making steps that FDA recommends to determine whether a premarket approval application (PMA) supplement should be submitted when a manufacturer intends to change the manufacturing site (including a change to the processing, packaging, or sterilization site) of its legally marketed PMA-approved device. This guidance also discusses the general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement.
Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-27236
Type: Notice
Date: 2018-12-17
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 draft guidance entitled ``Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment.'' This draft guidance provides clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray systems and their major components. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of ``electronic products,'' as defined in FDA regulations. This draft guidance, when finalized, will supersede FDA's guidance entitled ``Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment.'' This draft guidance is not final nor is it in effect at this time.
Submission for OMB Review; Annual Survey of Refugees (OMB #0907-0033)
Document Number: 2018-27235
Type: Notice
Date: 2018-12-17
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) seeks to continue data collection for the Annual Survey of Refugees with minor updates to improve survey administration procedures. The Annual Survey of Refugees is a yearly sample survey of refugees entering the U.S. in the previous five fiscal years. No changes to the survey instrument or estimated response burden are proposed.
Listing of Color Additives Subject to Certification; D&C Yellow No. 8; Confirmation of Effective Date
Document Number: 2018-27234
Type: Rule
Date: 2018-12-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of October 26, 2018, for the final rule that appeared in the Federal Register of September 25, 2018, and that amended the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-27223
Type: Notice
Date: 2018-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-27222
Type: Notice
Date: 2018-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-27221
Type: Notice
Date: 2018-12-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare and Medicaid Programs, and Other Program Initiatives, and Priorities; Request for Nominations to the Advisory Panel on Outreach and Education (APOE)
Document Number: 2018-27198
Type: Notice
Date: 2018-12-17
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice requests nominations for individuals to serve on the Advisory Panel on Outreach and Education (APOE).
Proposed Information Collection Activity; Comment Request
Document Number: 2018-27185
Type: Notice
Date: 2018-12-17
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-27180
Type: Notice
Date: 2018-12-17
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-27179
Type: Notice
Date: 2018-12-17
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry
Document Number: 2018-27165
Type: Notice
Date: 2018-12-17
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) has scheduled a public meeting. Information about ACTPCMD and the agenda for this meeting can be found on the ACTPCMD website at: https://www.hrsa.gov/advisory-committees/ primarycare-dentist/.
Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures
Document Number: 2018-27015
Type: Rule
Date: 2018-12-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.
Request for Information on Modifying HIPAA Rules To Improve Coordinated Care
Document Number: 2018-27162
Type: Proposed Rule
Date: 2018-12-14
Agency: Department of Health and Human Services
The Office for Civil Rights (OCR) is issuing this Request for Information (RFI) to assist OCR in identifying provisions of the Health Insurance Portability and Accountability Act privacy and security regulations that may impede the transformation to value-based health care or that limit or discourage coordinated care among individuals and covered entities (including hospitals, physicians, and other providers, payors, and insurers), without meaningfully contributing to the protection of the privacy or security of individuals' protected health information. This RFI requests information on whether and how the rules could be revised to promote these goals, while preserving and protecting the privacy and security of such information and individuals' rights with respect to it.
Proposed Collection; 60-Day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NIAID)
Document Number: 2018-27145
Type: Notice
Date: 2018-12-14
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 Institute of Allergy and Infectious Diseases (NIAID) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Decision To Evaluate a Petition To Designate a Class of Employees From the Y-12 Plant in Oak Ridge, Tennessee, To Be Included in the Special Exposure Cohort
Document Number: 2018-27136
Type: Notice
Date: 2018-12-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Y-12 Plant in Oak Ridge, Tennessee, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
Document Number: 2018-27135
Type: Notice
Date: 2018-12-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Sandia National Laboratories in Albuquerque, New Mexico, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Proposed Collection; 60-Day Comment Request; International Research Fellowship Award Program of the (National Institute on Drug Abuse)
Document Number: 2018-27107
Type: Notice
Date: 2018-12-14
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 Institute on Drug Abuse (NIDA), 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: 2018-27104
Type: Notice
Date: 2018-12-14
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: Proposed Collection; Comment Request
Document Number: 2018-27101
Type: Notice
Date: 2018-12-14
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 (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.
Withdrawal of Proposed Rule on Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products
Document Number: 2018-27098
Type: Proposed Rule
Date: 2018-12-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the withdrawal of the proposed rule on ``Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products'' that published in the Federal Register of November 13, 2013. FDA is taking this action in light of concerns expressed by commenters and considerations regarding Agency resources. FDA is continuing to consider ways to improve the communication of important, newly acquired drug safety information to healthcare providers and the public and to facilitate efforts to keep drug product labeling up to date throughout the product lifecycle.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2018-27043
Type: Notice
Date: 2018-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that GAMIFANT (emapalumab-lzsg) Injection, manufactured by Novimmune S.A., meets the criteria for a priority review voucher.
Submission for OMB Review; Comment Request
Document Number: 2018-27041
Type: Notice
Date: 2018-12-13
Agency: Department of Health and Human Services, Administration for Children and Families
Determination That IC-GREEN (Indocyanine Green for Injection), 10 Milligrams/Vial, 40 Milligrams/Vial, and 50 Milligrams/Vial Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2018-26975
Type: Notice
Date: 2018-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that IC-GREEN (indocyanine green for injection), 10 milligrams (mg)/vial, 40 mg/vial, and 50 mg/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for indocyanine green for injection, 10 mg/vial, 40 mg/vial, and 50 mg/vial if all other legal and regulatory requirements are met.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-26960
Type: Notice
Date: 2018-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2018-26959
Type: Notice
Date: 2018-12-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2018-26958
Type: Notice
Date: 2018-12-13
Agency: Department of Health and Human Services, National Institutes of Health
Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for Industry; Availability
Document Number: 2018-26957
Type: Notice
Date: 2018-12-13
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 final guidance for industry entitled ``Data Integrity and Compliance With Drug CGMP: Questions and Answers.'' The purpose of the guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. (Unless otherwise noted, the term CGMP refers to CGMPs for drugs, including biologics.) The guidance has been developed in response to an increase in findings of data integrity lapses in recent inspections. FDA expects that all data be reliable and accurate. CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies and business models.
Impossible Foods, Inc.; Filing of Color Additive Petition
Document Number: 2018-26949
Type: Proposed Rule
Date: 2018-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Impossible Foods, Inc., proposing that the color additive regulations be amended to provide for the safe use of soy leghemoglobin as a color additive in plant-based, non-animal derived ground beef analogue products.
Allied Pharma, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications
Document Number: 2018-26947
Type: Notice
Date: 2018-12-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Biomarker Qualification: Evidentiary Framework; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-26900
Type: Notice
Date: 2018-12-12
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 and FDA staff entitled ``Biomarker Qualification: Evidentiary Framework.'' This draft guidance provides recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act (Cures Act), enacted on December 13, 2016, that added a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Qualification of a biomarker is a determination that within the stated context of use, the biomarker can be relied on to have a specific interpretation and application in drug development and regulatory review.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26876
Type: Notice
Date: 2018-12-12
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 Million Hearts[supreg] Hypertension Control Challenge, a program designed to identify clinical practices and health systems that have been successful in achieving high rates of hypertension control and to develop models for dissemination of successful strategies to control hypertension.
Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities
Document Number: 2018-26857
Type: Notice
Date: 2018-12-12
Agency: Department of Health and Human Services
The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee's 2019 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format.
The “Deemed to be a License” Provision of the BPCI Act: Questions and Answers; Draft Guidance for Industry; Availability; Request for Comments on Preliminary List of Affected Applications
Document Number: 2018-26855
Type: Notice
Date: 2018-12-12
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 ``The `Deemed to be a License' Provision of the BPCI Act: Questions and Answers.'' This draft guidance is intended to provide answers to common questions about FDA's interpretation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. This guidance also describes FDA's compliance policy for the labeling of biological products that will be the subject of deemed biologics license applications (BLAs). This guidance is intended to facilitate planning for the March 23, 2020, transition date and provide further clarity regarding the Agency's interpretation of this statutory provision. FDA also invites comment on the preliminary list of approved new drug applications (NDAs) for biological products under the FD&C Act that will be deemed to be BLAs on the transition date.
Interpretation of the “Deemed To Be a License” Provision of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability
Document Number: 2018-26854
Type: Notice
Date: 2018-12-12
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 final guidance for industry entitled ``Interpretation of the `Deemed To Be a License' Provision of the Biologics Price Competition and Innovation Act of 2009.'' This guidance describes FDA's interpretation of the statutory provision under which an application for a biological product approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020, will be deemed to be a license for the biological product under the Public Health Service Act (PHS Act) on March 23, 2020. Specifically, this guidance describes FDA's interpretation of the ``deemed to be a license'' provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are approved under the FD&C Act as of March 23, 2020. This guidance also provides recommendations to sponsors of proposed protein products intended for submission in an application that may not receive final approval under the FD&C Act on or before March 23, 2020, to facilitate alignment of product development plans with FDA's interpretation of the transition provision of the BPCI Act.
Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability
Document Number: 2018-26853
Type: Notice
Date: 2018-12-12
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 final guidance for industry entitled ``Questions and Answers on Biosimilar Development and the BPCI Act.'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled ``Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009'' issued April 28, 2015.
New and Revised Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Revision 2); Draft Guidance for Industry; Availability
Document Number: 2018-26852
Type: Notice
Date: 2018-12-12
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 ``New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).'' The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA's interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document revises the draft guidance document entitled ``Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,'' issued May 13, 2015, to provide new and revised Q&As.
Definition of the Term “Biological Product”
Document Number: 2018-26840
Type: Proposed Rule
Date: 2018-12-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is proposing to amend its regulation that defines ``biological product'' to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms ``protein'' and ``chemically synthesized polypeptide.'' Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-26790
Type: Notice
Date: 2018-12-11
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.
Su-Chiao Kuo: Debarment Order
Document Number: 2018-26778
Type: Notice
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. Su-Chiao Kuo for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Kuo was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Kuo was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Kuo failed to request a hearing. Dr. Kuo's failure to request a hearing constitutes a waiver of her right to a hearing concerning this action.
Submission for OMB Review; 30-Day Comment Request National Cancer Institute (NCI) Future Fellows Resume Databank
Document Number: 2018-26765
Type: Notice
Date: 2018-12-11
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
National Institute of Mental Health; Notice of Closed Meeting
Document Number: 2018-26764
Type: Notice
Date: 2018-12-11
Agency: Department of Health and Human Services, National Institutes of Health
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-26760
Type: Notice
Date: 2018-12-11
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.
Nominations to the Advisory Committee on Blood and Tissue Safety and Availability
Document Number: 2018-26756
Type: Notice
Date: 2018-12-11
Agency: Department of Health and Human Services
The Office of Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). ACBTSA is a Federal advisory committee within the Department of Health and Human Services. Management support for the activities of this Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration of appointment as members of the ACBTSA. Members of the Committee, including the Chair, are appointed by the Secretary. Members are invited to serve on the Committee for up to four-year terms.
Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
Document Number: 2018-26745
Type: Notice
Date: 2018-12-11
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces availability of the Draft NTP Monograph on the Systematic Review of Evidence of Long-Term Neurological Effects Following Acute Exposure to the Organophosphorus Nerve Agent Sarin for public comment prior to peer review. In partnership with the National Institutes of Health (NIH) Countermeasures Against Chemical Threats (CounterACT) Program, the Office of Health Assessment and Translation (OHAT), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS), conducted a systematic review to evaluate the evidence of long-term neurological damage in humans after acute, sub-lethal exposure to sarin. The date for the peer review is not yet set; however, it is anticipated to occur in early 2019. The peer-review meeting will be held by webcast only and open to the public; registration will be required for attendance by webcast and to present oral comments. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/36051.
The Food and Drug Administration's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock; Public Meeting; Request for Comments
Document Number: 2018-26725
Type: Notice
Date: 2018-12-11
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 entitled ``FDA's Proposed Current Good Manufacturing Practice Policies for Outsourcing Facilities: Considerations Regarding Access to Office Stock.'' Stakeholders, including healthcare providers (HCPs) and medical specialty groups, have expressed concerns regarding the availability of certain compounded drug products from outsourcing facilities that they would like to have on-hand as in-office supplies of non-patient-specific compounded drugs (``office stock''). The purpose of the public meeting is to provide HCPs, outsourcing facilities, entities considering becoming outsourcing facilities, and other interested parties with an opportunity to present to FDA their perspectives concerning access to office stock from outsourcing facilities in light of FDA's enforcement policies as proposed in the revised draft guidance on current good manufacturing practice (CGMP) for human drug compounding outsourcing facilities.
Current Good Manufacturing Practice-Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Draft Guidance for Industry; Availability
Document Number: 2018-26724
Type: Notice
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled ``Current Good Manufacturing PracticeGuidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.'' This revised draft guidance describes FDA's policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility's operations.
David J. Fishman: Debarment Order
Document Number: 2018-26722
Type: Notice
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Dr. David J. Fishman for a period of 3 years from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Fishman was convicted of a misdemeanor under the FD&C Act for causing the introduction or delivery for introduction into interstate commerce of prescription drugs that were misbranded. In addition, FDA has determined that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs. Dr. Fishman was given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Fishman failed to request a hearing. Dr. Fishman's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.
The Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2018-26721
Type: Notice
Date: 2018-12-11
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 Tobacco Products Scientific Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
Document Number: 2018-26712
Type: Rule
Date: 2018-12-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule adds two entries to this list of drug products.
Advancing Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Smoke, and Identify and Eliminate Tobacco-Related Disparities; Request for Information
Document Number: 2018-26708
Type: Notice
Date: 2018-12-11
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) leads comprehensive efforts to prevent the initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; help current smokers quit; and identify and eliminate tobacco-related disparities. In late 2017, CDC solicited input from the public in the Federal Register Notice 82 FR 50428 regarding nationwide priorities for cessation. CDC is currently reviewing and compiling public comments to inform future activities that could efficiently and cost effectively help people quit using tobacco by employing evidence-based treatment options. CDC will share the outcome of this request for information with the public on a date to be determined. Now, CDC is seeking information to inform future activities to advance tobacco control practices that prevent initiation of tobacco use among youth and young adults; eliminate exposure to secondhand smoke; and identify and eliminate tobacco-related disparities.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-26676
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2018-26675
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
Document Number: 2018-26674
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Meetings
Document Number: 2018-26673
Type: Notice
Date: 2018-12-10
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: 2018-26672
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2018-26671
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Amended Notice of Meeting
Document Number: 2018-26670
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2018-26659
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26637
Type: Notice
Date: 2018-12-10
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 Application for Training (OMB Control No. 0920-0017). The Training and Continuing Education Online (TCEO) system is used in the management of the accreditation process for non-federal educators who develop public health and healthcare educational activities and for non-federal health professionals who seek continuing education necessary to maintain professional licensures and certifications. This request for revision is to add new questions to the TCEO New Participant Registration, a new TCEO Post-Course Evaluation, and a new TCEO Follow-up Evaluation. Both new evaluation tools will improve the quality of educational activities. Each TCEO tool ensures compliance with accreditation requirements.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26636
Type: Notice
Date: 2018-12-10
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 Understanding How Discounting Affects Decision Making and Adoption of Prevention Through Design Solutions. The goal of this information collection is to understand the social and organizational factors that may increase or decrease the adoption of practices that keep workers safe.
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