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

Results 251 - 293 of 293
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-16835
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Privacy Act of 1974; Matching Program
Document Number: 2018-16821
Type: Notice
Date: 2018-08-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a re-established matching program between CMS and the Social Security Administration (SSA), ``Determining Enrollment or Eligibility for Insurance Affordability Programs Under the Patient Protection and Affordable Care Act (ACA).'' The matching program provides CMS with SSA data to use in determining individuals' eligibility to enroll in a qualified health plan through an exchange established under the ACA and for insurance affordability programs and certificates of exemption, and to make eligibility redeterminations and renewals, including appeal determinations.
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-16813
Type: Notice
Date: 2018-08-07
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.'' This guidance addresses the clinical endpoints acceptable to demonstrate effectiveness of drugs for medication-assisted treatment of opioid use disorder. FDA is also requesting comments on when the use of placebo or active controls is most appropriate in clinical trials for such drugs.
Future Format of the National Drug Code; Public Hearing; Request for Comments
Document Number: 2018-16807
Type: Proposed Rule
Date: 2018-08-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing a public hearing and an opportunity for public comment on the future format of the National Drug Code (NDC). FDA is seeking input from a variety of stakeholders through comments and responses to FDA questions included in this notice and associated web content to be published ahead of the hearing. The questions are intended to allow FDA to obtain stakeholders' perspectives on the impact of any future changes made to the length and format of the NDC.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-16797
Type: Notice
Date: 2018-08-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Institute of Mental Health; Notice of Meeting
Document Number: 2018-16794
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Workshop
Document Number: 2018-16793
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-16792
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2018-16791
Type: Notice
Date: 2018-08-07
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: 2018-16790
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-16789
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-16788
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-16787
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-16786
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Aging; Notice of Meeting
Document Number: 2018-16785
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-16784
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services
Decision To Evaluate a Petition To Designate a Class of Employees From the Superior Steel Company in Carnegie, Pennsylvania, To Be Included in the Special Exposure Cohort
Document Number: 2018-16761
Type: Notice
Date: 2018-08-06
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 Superior Steel Company in Carnegie, Pennsylvania, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products; Draft Guidance for Industry; Availability
Document Number: 2018-16726
Type: Notice
Date: 2018-08-06
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 ``Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.'' The document provides guidance regarding the nonclinical information FDA recommends to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and other chronic uses.
Findings of Research Misconduct
Document Number: 2018-16693
Type: Notice
Date: 2018-08-06
Agency: Department of Health and Human Services, Office of the Secretary
Notice is hereby given that on July 13, 2018, the U.S. Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on an Administrative Law Judge's findings of research misconduct against Christian Kreipke, Ph.D., former Research Associate Professor, Wayne State University. Dr. Kreipke engaged in research misconduct in research supported by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), grants R01 NS039860 and R01 NS064976-01A2. The administrative actions, including five (5) years of debarment, were implemented beginning on July 13, 2018, and are detailed below.
Medicare Program; FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements
Document Number: 2018-16539
Type: Rule
Date: 2018-08-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2019. The rule also makes conforming regulations text changes to recognize physician assistants as designated hospice attending physicians effective January 1, 2019. Finally, the rule includes changes to the Hospice Quality Reporting Program.
Medicare Program; FY 2019 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2018 (FY 2019)
Document Number: 2018-16518
Type: Rule
Date: 2018-08-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. These changes are effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2018 through September 30, 2019 (FY 2019). This final rule also updates the IPF labor-related share, the IPF wage index for FY 2019, and the International Classification of Diseases 10th Revision, Clinical Modification (ICD- 10-CM) codes for FY 2019. It also makes technical corrections to the IPF regulations, and updates quality measures and reporting requirements under the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program. In addition, it updates providers on the status of IPF PPS refinements.
Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019
Document Number: 2018-16517
Type: Rule
Date: 2018-08-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2019. As required by the Social Security Act (the Act), this final rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2019. This final rule also alleviates administrative burden for IRFs by removing the Functional Independence Measure (FIM\TM\) instrument and associated Function Modifiers from the IRF Patient Assessment Instrument (IRF-PAI) beginning in FY 2020 and revises certain IRF coverage requirements to reduce the amount of required paperwork in the IRF setting beginning in FY 2019. Additionally, this final rule incorporates certain data items located in the Quality Indicators section of the IRF-PAI into the IRF case-mix classification system using analysis of 2 years of data beginning in FY 2020. For the IRF Quality Reporting Program (QRP), this final rule adopts a new measure removal factor, removes two measures from the IRF QRP measure set, and codifies a number of program requirements in our regulations.
Advisory Committee on Interdisciplinary, Community-Based Linkages
Document Number: 2018-16671
Type: Notice
Date: 2018-08-03
Agency: Department of Health and Human Services
The Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL) has scheduled a public meeting. Information about ACICBL and the agenda for this meeting can be found on the ACICBL website at: https://www.hrsa.gov/advisory-committees/interdisciplinary- community-linkages/.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types
Document Number: 2018-16648
Type: Notice
Date: 2018-08-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority
Document Number: 2018-16618
Type: Notice
Date: 2018-08-03
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions
Document Number: 2018-16616
Type: Notice
Date: 2018-08-03
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 information collection provisions of our regulations regarding Food Additive Petitions and Investigational Food Additive Exemptions.
National Institute on Deafness and Other Communication Disorders; Notice of Meeting
Document Number: 2018-16592
Type: Notice
Date: 2018-08-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-16591
Type: Notice
Date: 2018-08-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-16590
Type: Notice
Date: 2018-08-03
Agency: Department of Health and Human Services, National Institutes of Health
Short-Term, Limited-Duration Insurance
Document Number: 2018-16568
Type: Rule
Date: 2018-08-03
Agency: Employee Benefits Security Administration, Department of Labor, Department of Health and Human Services, Internal Revenue Service, Department of Treasury, Department of the Treasury
This final rule amends the definition of short-term, limited- duration insurance for purposes of its exclusion from the definition of individual health insurance coverage. This action is being taken to lengthen the maximum duration of short-term, limited-duration insurance, which will provide more affordable consumer choices for health coverage.
Announce the Intent To Award an Administrative Supplement
Document Number: 2018-16561
Type: Notice
Date: 2018-08-02
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) announces the intent to award an administrative supplement to the current Help America Vote Act (HAVA) Training and Technical Assistance (T/TA) grantees held by the National Disability Rights Network (NDRN) and the National Federation of the Blind (NFB). The purpose of the HAVA programs are designed to establish and improve participation in the election process for individuals with a full range of disabilities. In each eligible state and territory, seven percent of HAVA funds are set aside for the Protection and Advocacy Systems (P&As) to ensure that individuals with disabilities have the opportunity to participate in every step of the voting process. After receiving training and technical assistance, P&As may inform others on the availability of accessible voting equipment and its use. The administrative supplement for FY 2018 will be in the amount of $122,721 bringing the total award for FY 2018 to $462,590. Program Name: Help America Vote Act Training and Technical Assistance. Recipients: National Disability Rights Network (NDRN) and National Federation of the Blind (NFB). Period of Performance: The supplement award will be issued for the second year of the two-year project period of September 1, 2018, through August 30, 2019. Total Award Amount: NDRN $326,274 in FY 2018 NFB $136,316 in FY2018. Award Type: Administrative Supplement. Statutory Authority: This program is authorized under Title II, Subtitle D, Part 5 of HAVA 42 U.S.C. 15461-62, Section 102 of the Developmental Disabilities Assistance and Bill of Rights Act of 2000 (DD Act) (42 U.S.C. 15002). Basis for Award: The additional funding will not be used to begin new projects. The funding will be used to increase NDRN's capacity building efforts to provide training and technical assistance to the Protection and Advocacy Systems in the electoral process and NFB will be able to attend voting related conferences, conduct voting outreach campaigns and translate materials into Spanish.
Availability of Set 29 Draft Toxicological Profiles
Document Number: 2018-16557
Type: Notice
Date: 2018-08-02
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
The Agency for Toxic Substances and Disease Registry (ATSDR), within the Department of Health and Human Services (HHS) announces the availability of Set 29 Draft Toxicological Profiles for review and comment. All toxicological profiles issued as ``Drafts for Public Comment'' represent ATSDR's best efforts to provide important toxicological information on priority hazardous substances. ATSDR is seeking public comments and additional information or reports on studies about the health effects of Tribufos, Bromodichloromethane, Bromomethane, and 2-Hexanone for review and potential inclusion in the profiles. Although ATSDR considers key studies for these substances during the profile development process, this document solicits any relevant, additional information. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR also seeks comments on the organization and format of the Toxicological Profile for Bromodichloromethane. In an effort to improve the usability of the profiles, ATSDR recently made content and organizational changes based on user feedback, as well as data identifying the most used profile content. Changes include: Removing redundant content; adding summary figures and tables to Chapters 1, 2, 5, and 6 that did not exist in previous Toxicological Profiles; and reformatting the Levels of Significant Exposure (LSE) tables in Chapter 2. ATSDR has only applied the changes to the Draft Toxicological Profile for Bromodichloromethane, but intends to use the new format for future profiles. Specifically, ATSDR would like to know: (1) Does the chapter organization make it easier for you to find the information you need? For example, are you satisfied with the organization of the health effects chapter by organ system rather than exposure route? (2) Are the new tables and figures clear and useful? Do they make the Toxicological Profile easier to read? (3) If you have previously used any Toxicological Profile(s) for your work, which parts or content are the most useful to you, and what do you use it for? (4) Does the profile contain all of the information you need? If no, please elaborate on what additional information would be helpful. (5) Is there information you would like to see in the profile that is not currently included? If yes, please elaborate on the additional information you would like to see in the profile. ATSDR remains committed to providing a public comment period for these documents as a means to provide the best service to the public regarding public health.
Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
Document Number: 2018-16547
Type: Rule
Date: 2018-08-02
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non- emergency ground ambulance suppliers and home health agencies and branch locations in Medicaid and the Children's Health Insurance Program in those states.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco Among the Lesbian Gay Bisexual Transgender Community
Document Number: 2018-16538
Type: Notice
Date: 2018-08-02
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 FDA's Research and Evaluation Survey for the Public Education Campaign on Tobacco (RESPECT) among the Lesbian Gay Bisexual Transgender (LGBT).
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola Virus
Document Number: 2018-16537
Type: Notice
Date: 2018-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUA) (the Authorization) issued to Zalgen Labs, LLC for the ReEBOV Antigen Rapid Test. FDA revoked this Authorization on May 18, 2018, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by Zalgen Labs, LLC by letter dated March 1, 2018. The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.
Advancing the Development of Pediatric Therapeutics 5: Advancing Pediatric Pharmacovigilance; Public Workshop
Document Number: 2018-16524
Type: Notice
Date: 2018-08-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Division of Pediatric and Maternal Health, Office of Surveillance and Epidemiology, and Office of Pediatric Therapeutics, Food and Drug Administration (FDA or the Agency) are announcing a public workshop entitled ``Advancing the Development of Pediatric Therapeutics 5: Advancing Pediatric Pharmacovigilance.'' The purpose of this 1-day workshop is to provide a forum to gather information on the latest developments in pediatric pharmacovigilance from the perspective of various stakeholders and to expand the conversation to include the utility and challenges of emerging pharmacovigilance tools, including specific challenges associated with pediatric data tools.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-16506
Type: Notice
Date: 2018-08-02
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Secretary; Notice of Meeting
Document Number: 2018-16505
Type: Notice
Date: 2018-08-02
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2018-16492
Type: Notice
Date: 2018-08-02
Agency: Department of Health and Human Services
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2018-16440
Type: Notice
Date: 2018-08-01
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace.
Outsourcing Facility Fee Rates for Fiscal Year 2019
Document Number: 2018-16416
Type: Notice
Date: 2018-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2019 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2019 rates for the small business establishment fee ($5,461), the non-small business establishment fee ($18,375), and the re-inspection fee ($16,382) for outsourcing facilities; provides information on how the fees for FY 2019 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2018, and will remain in effect through September 30, 2019.
Prescription Drug User Fee Rates for Fiscal Year 2019
Document Number: 2018-16387
Type: Notice
Date: 2018-08-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products, and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2019.
Notice for Proposed Model Family Foster Home Licensing Standards
Document Number: 2018-16380
Type: Notice
Date: 2018-08-01
Agency: Department of Health and Human Services, Administration for Children and Families
The Family First Prevention Services Act (FFPSA) directs the U.S. Department of Health and Human Services (HHS) to identify ``reputable model licensing standards with respect to the licensing of foster family homes. In response to this directive, the Children's Bureau (CB) solicits comments on the proposed National Model Family Foster Home Licensing Standards.
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