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

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Patient Protection and Affordable Care Act; Adoption of the Methodology for the HHS-Operated Permanent Risk Adjustment Program for the 2018 Benefit Year Proposed Rule
Document Number: 2018-17142
Type: Proposed Rule
Date: 2018-08-10
Agency: Department of Health and Human Services
This rule proposes to adopt the risk adjustment methodology that HHS previously established for the 2018 benefit year. In February 2018, a district court vacated the use of statewide average premium in the HHS-operated risk adjustment methodology for the 2014 through 2018 benefit years. HHS is proposing to adopt the HHS-operated risk adjustment methodology for the 2018 benefit year as established in the final rules published in the March 23, 2012 Federal Register and the December 22, 2016 Federal Register.
Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation; Public Workshop; Request for Comments
Document Number: 2018-17130
Type: Notice
Date: 2018-08-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the following 1-day public workshop entitled ``Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.'' The purpose of the public workshop is to provide a forum to discuss the current state and future directions of the collection of human data on the potential skin toxicity with the use of medications applied topically. The workshop will review current approaches to the collection of human data during the clinical development of topical drug products. The workshop will also address the impact of human skin toxicity studies on drug labeling and consider alternative approaches to providing information about skin toxicity.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-17127
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-17126
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Submission for OMB Review; Comment Request
Document Number: 2018-17121
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, Administration for Children and Families
Chronic Pain: The Science of Complementary and Integrative Health Approaches
Document Number: 2018-17118
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, National Institutes of Health
This symposium on September 11, 2018, sponsored by the National Center for Complementary and Integrative Health, will bring leading researchers to discuss the science and potential uses of complementary and integrative health approaches in treating chronic pain.
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2018-17107
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting
Document Number: 2018-17105
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services
National Cancer Institute Amended; Notice of Meeting
Document Number: 2018-17104
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-17103
Type: Notice
Date: 2018-08-10
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Disclosures in Professional and Consumer Prescription Drug Promotion
Document Number: 2018-17045
Type: Notice
Date: 2018-08-09
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; Submission for Office of Management and Budget Review; Comment Request; Generic Clearance for the Collection of Quantitative Data on Tobacco Products and Communications
Document Number: 2018-17044
Type: Notice
Date: 2018-08-09
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.
Notice of Closed Meeting
Document Number: 2018-17043
Type: Notice
Date: 2018-08-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH)
Document Number: 2018-17042
Type: Notice
Date: 2018-08-09
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 33 people. The meeting is also open to the public via webcast. If you wish to attend in person or by webcast, please see the NIOSH website to register (http://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (888) 397-9578, Participant Pass Code 63257516. Adobe Connect webcast will be available at https:// odniosh.adobeconnect.com/nioshbsc/ for participants wanting to connect remotely. This meeting is open to the public, limited only by the space available. The public is welcome to participate during the public comment period, 12:30 p.m. to 12:45 p.m., EDT, September 27, 2018. Please note that the public comment period ends at the time indicated above. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following website: http://www.cdc.gov/niosh/bsc/contact.html.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-17036
Type: Notice
Date: 2018-08-09
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.
Determination That PROLIXIN (Fluphenazine Hydrochloride) Tablets, 1 Milligram, 2.5 Milligrams, 5 Milligrams, and 10 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2018-17026
Type: Notice
Date: 2018-08-09
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that PROLIXIN (fluphenazine hydrochloride) tablets, 1 milligram (mg), 2.5 mg, 5 mg, and 10 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for fluphenazine hydrochloride tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, if all other legal and regulatory requirements are met.
Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances; Guidance for Industry; Availability
Document Number: 2018-17025
Type: Notice
Date: 2018-08-09
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 ``Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances.'' This guidance has been developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), or abbreviated new drug applications (ANDAs), as appropriate, for orally administered immediate-release (IR) drug products that contain highly soluble drug substances. The guidance is intended to describe when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived From Genetically Engineered Plants
Document Number: 2018-17024
Type: Notice
Date: 2018-08-09
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 associated with the guidance to assist manufacturers who wish to voluntarily label their foods (human and animal) as being made with or without bioengineering, or the use of bioengineered ingredients, to ensure that labeling is truthful and not misleading.
Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications
Document Number: 2018-16985
Type: Notice
Date: 2018-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Elemental Impurities in Drug Products; Guidance for Industry; Availability
Document Number: 2018-16984
Type: Notice
Date: 2018-08-08
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 ``Elemental Impurities in Drug Products.'' This guidance finalizes the draft guidance issued July 1, 2016, which provides recommendations regarding the control of elemental impurities of human drug products marketed in the United States consistent with the implementation of International Council for Harmonisation (ICH) guidance for industry entitled ``Q3D Elemental Impurities'' (ICH Q3D). This guidance will also assist manufacturers of compendial drug products in responding to the issuance of the United States Pharmacopeia (USP) requirement for the control of elemental impurities.
[Docket No. FDA-2011-N-0776] HEADAgency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
Document Number: 2018-16983
Type: Notice
Date: 2018-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) 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.
Merck Sharp & Dohme Corporation, et al.; Withdrawal of Approval of Four New Drug Applications
Document Number: 2018-16982
Type: Notice
Date: 2018-08-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of four new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
NIH Clinical Center Research Hospital Board; Notice of Charter Renewal
Document Number: 2018-16979
Type: Notice
Date: 2018-08-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Meeting
Document Number: 2018-16978
Type: Notice
Date: 2018-08-08
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: 2018-16977
Type: Notice
Date: 2018-08-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Minority Health and Health Disparities; Notice of Meeting
Document Number: 2018-16976
Type: Notice
Date: 2018-08-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice of Meeting
Document Number: 2018-16975
Type: Notice
Date: 2018-08-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-16974
Type: Notice
Date: 2018-08-08
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the President's Council on Sports, Fitness, and Nutrition; Correction
Document Number: 2018-16970
Type: Notice
Date: 2018-08-08
Agency: Department of Health and Human Services
The Department of Health and Human Services published a document in the Federal Register of July 27, 2018, concerning the upcoming annual meeting of the President's Council on Sports, Fitness, and Nutrition (PCSFN). The document contained an incorrect location and time.
Meeting of the President's Council on Sports, Fitness, and Nutrition; Correction
Document Number: 2018-16969
Type: Notice
Date: 2018-08-08
Agency: Department of Health and Human Services
The Department of Health and Human Services published a document in the Federal Register of July 27, 2018, concerning the upcoming annual meeting of the President's Council on Sports, Fitness, and Nutrition (PCSFN). The document contained an incorrect location and time.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-16947
Type: Notice
Date: 2018-08-08
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Final Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting Program
Document Number: 2018-16570
Type: Rule
Date: 2018-08-08
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019. This final rule also replaces the existing case-mix classification methodology, the Resource Utilization Groups, Version IV (RUG-IV) model, with a revised case-mix methodology called the Patient-Driven Payment Model (PDPM) beginning on October 1, 2019. The rule finalizes revisions to the regulation text that describes a beneficiary's SNF ``resident'' status under the consolidated billing provision and the required content of the SNF level of care certification. The rule also finalizes updates to the SNF Quality Reporting Program (QRP) and the Skilled Nursing Facility Value-Based Purchasing (VBP) Program.
Medicare and Medicaid Programs: National Dialysis Accreditation Commission (NDAC) for Approval of its End Stage Renal Disease (ESRD) Facility Accreditation Program
Document Number: 2018-16871
Type: Notice
Date: 2018-08-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the National Dialysis Accreditation Commission (NDAC) for recognition as a national accrediting organization (AO) for End Stage Renal Disease (ESRD) Facilities that wish to participate in the Medicare or Medicaid programs.
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-April Through June 2018
Document Number: 2018-16860
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services
This quarterly notice announces the reorganization and revision of the OMHA Case Processing Manual (OCPM) and lists the OCPM manual instructions that were published from April through June 2018. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
Declaration Under the Public Readiness and Emergency Preparedness Act for Zika Virus Vaccines
Document Number: 2018-16856
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary is amending a Declaration pursuant to the Public Health Service Act to provide liability immunity protection for activities related to Zika virus vaccines consistent with the terms of the Declaration.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-16841
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.
Scientific Advisory Committee on Alternative Toxicological Methods; Announcement of Meeting; Request for Comments
Document Number: 2018-16840
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM, a federally chartered, external advisory group composed of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organization, will review and provide advice on programmatic activities. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activites of NICEATM. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at https:/ /ntp.niehs.nih.gov/go/32822.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-16839
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-16838
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.
Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2016-2017; Availability of Report
Document Number: 2018-16837
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2016-2017. This report, prepared in accordance with requirements of the ICCVAM Authorization Act of 2000, describes activities and accomplishments from January 2016 through December 2017.
Prospective Grant of Exclusive Patent License: Treatment of Type I Diabetes and its Comorbidities
Document Number: 2018-16836
Type: Notice
Date: 2018-08-07
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent License to Inversago Pharma, Inc., located in Montreal, Quebec, Canada, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
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