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

Results 51 - 100 of 280
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2018-13636
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-13635
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2018-13634
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-13633
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2018-13632
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2018-13631
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2018-13630
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary & Integrative Health; Notice of Closed Meeting
Document Number: 2018-13629
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13628
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13627
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Agency Recordkeeping/Reporting Requirements Under Emergency Review by the Office of Management and Budget (OMB)
Document Number: 2018-13604
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, Administration for Children and Families
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2018-13593
Type: Notice
Date: 2018-06-26
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.
Proposed Standards for the Children's Hospitals Graduate Medical Education Payment Program's Quality Bonus System
Document Number: 2018-13592
Type: Notice
Date: 2018-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA published a notice in the Federal Register on October 11, 2017, soliciting feedback on the establishment of the Children's Hospitals Graduate Medical Education Payment (CHGME) Program's Quality Bonus System (QBS). In particular, HRSA requested feedback on the Fiscal Year (FY) 2019 and beyond multi-step implementation of the system, including demonstration of engagement in state or regional- level initiatives, documentation, and payment structure. This notice summarizes and responds to the comments received during the 60-day comment period.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Survey of Organ Donation Attitudes and Practices, OMB No. 0915-0290-Reinstatement With Change
Document Number: 2018-13590
Type: Notice
Date: 2018-06-26
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. The ICR is for reinstatement with change of a previously approved information collection, assigned OMB control number 0915-0290, which expired on March 31, 2015. 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: Public Comment Request Information Collection Request Title: Health Resources and Service Administration Uniform Data System, OMB No. 0915-0193-Revision
Document Number: 2018-13587
Type: Notice
Date: 2018-06-26
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.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-13544
Type: Notice
Date: 2018-06-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-13543
Type: Notice
Date: 2018-06-25
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Medicare Program; Request for Information Regarding the Physician Self-Referral Law
Document Number: 2018-13529
Type: Proposed Rule
Date: 2018-06-25
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This request for information seeks input from the public on how to address any undue regulatory impact and burden of the physician self-referral law.
Notice; Children's Bureau Proposed Research Priorities for Fiscal Years 2018-2020
Document Number: 2018-13526
Type: Notice
Date: 2018-06-25
Agency: Department of Health and Human Services, Administration for Children and Families
The Children's Bureau (CB) within the Administration on Children, Youth and Families (ACYF) announces the proposed priorities for research on the causes, prevention, assessment, identification, treatment, cultural and socio-economic distinctions, and the consequences of child abuse and neglect, and solicits comments regarding the prioritization.
Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer
Document Number: 2018-13486
Type: Notice
Date: 2018-06-25
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences, 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 Summary Information section of this notice to Apexx Oncology, Inc., located in New York, NY.
Medicare & Medicaid Programs, and Other Program Initiatives, and Priorities; Meeting of the Advisory Panel on Outreach and Education (APOE), June 20, 2018
Document Number: 2018-13503
Type: Notice
Date: 2018-06-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
On June 1, 2018, we published a Federal Register notice (83 FR 25461) announcing a new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel), which was scheduled for Wednesday, June 20, 2018. This notice announces the cancellation of the June 20, 2018 meeting.
Prospective Grant of an Exclusive Patent License: Methods of Modulating Erythropoiesis With Arginine Vasopressin Receptor 1B Molecules
Document Number: 2018-13443
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
The National Institute of Dental and Craniofacial Research, 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 ERYTHRYx Therapeutics, located in Los Angeles, California.
Medicare and Medicaid Programs; Application by The Compliance Team for Continued CMS Approval of Its Rural Health Clinic Accreditation Program
Document Number: 2018-13436
Type: Notice
Date: 2018-06-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve The Compliance Team (TCT) for continued recognition as a national accrediting organization for Rural Health Clinics (RHCs) that wish to participate in the Medicare or Medicaid programs.
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued Approval of its Ambulatory Surgical Center Accreditation Program
Document Number: 2018-13435
Type: Notice
Date: 2018-06-22
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.
Decisions Related to the Development of a Clearinghouse of Evidence-Based Practices in Accordance With the Family First Prevention Services Act of 2018
Document Number: 2018-13420
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families, HHS, solicits comments by July 22, 2018 on initial criteria and potential candidate programs and services for review in a Clearinghouse of evidence-based practices in accordance with the Family First Prevention Services Act of 2018. The Clearinghouse will identify promising, supported, and well-supported practices for mental health and substance abuse prevention and treatment programs, in-home parent skill-based programs, and kinship navigator programs appropriate for children who are candidates for foster care pregnant or parenting foster youth, and the parents or kin caregivers of those children and youth.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2018-13419
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-13418
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2018-13417
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-13416
Type: Notice
Date: 2018-06-22
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.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-13415
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2018-13414
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2018-13413
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Medical Devices; Immunology and Microbiology Devices; Classification of the Next Generation Sequencing Based Tumor Profiling Test
Document Number: 2018-13406
Type: Rule
Date: 2018-06-22
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the next generation sequencing based tumor profiling test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the next generation sequencing based tumor profiling test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2018-13405
Type: Notice
Date: 2018-06-22
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 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.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13391
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2018-13389
Type: Notice
Date: 2018-06-22
Agency: Department of Health and Human Services, National Institutes of Health
Availability of Draft Toxicological Profile: Perfluoroalkyls
Document Number: 2018-13385
Type: Notice
Date: 2018-06-21
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 the Draft Toxicological Profile for Perfluoroalkyls 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, reports, and studies about the health effects of these substances. Although ATSDR considers key studies for this substance during the profile development process, this document solicits any relevant, additional studies. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion into the profile. ATSDR remains committed to providing a comment period for this document as a means to best serve public health.
Draft-National Occupational Research Agenda for Healthcare and Social Assistance
Document Number: 2018-13308
Type: Notice
Date: 2018-06-21
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Healthcare and Social Assistance (HCSA) for public comment. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2018-0050 in the search field and click ``Search.''
Major Depressive Disorder: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-13297
Type: Notice
Date: 2018-06-21
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 ``Major Depressive Disorder: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of major depressive disorder (MDD). Specifically, this draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. This draft guidance is intended to serve as a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public. This draft guidance revises the guidance for industry entitled ``Guidelines for the Clinical Evaluation of Antidepressant Drugs'' issued in September 1977.
Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-13296
Type: Notice
Date: 2018-06-21
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 Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products; Draft Guidance for Industry; Availability
Document Number: 2018-13295
Type: Notice
Date: 2018-06-21
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 ``Prescription Drug Act User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.'' This revised draft guidance provides recommendations to applicants planning to request a waiver or reduction in user fees. This draft guidance is a revision of the guidance for industry entitled ``User Fee Waivers, Reductions, and Refunds for Drug and Biological Products,'' issued in September 2011.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act
Document Number: 2018-13294
Type: Notice
Date: 2018-06-21
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 adverse event reporting for outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications
Document Number: 2018-13293
Type: Notice
Date: 2018-06-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of five 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.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-13265
Type: Notice
Date: 2018-06-20
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: 2018-13264
Type: Notice
Date: 2018-06-20
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-13263
Type: Notice
Date: 2018-06-20
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2018-13262
Type: Notice
Date: 2018-06-20
Agency: Department of Health and Human Services, National Institutes of Health
Mitigation Strategies To Protect Food Against Intentional Adulteration; Draft Guidance for Industry; Availability
Document Number: 2018-13222
Type: Notice
Date: 2018-06-20
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.'' This draft guidance document, when finalized, will help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act (FD&C Act) comply with the requirements of our regulation entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.''
Fees for Sanitation Inspection of Cruise Ships
Document Number: 2018-13216
Type: Notice
Date: 2018-06-20
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS) announces fees for vessel sanitation inspections for Fiscal Year (FY) 2019. These inspections are conducted by HHS/CDC's Vessel Sanitation Program (VSP). VSP helps the cruise line industry fulfill its responsibility for developing and implementing comprehensive sanitation programs to minimize the risk for acute gastroenteritis. Every vessel that has a foreign itinerary and carries 13 or more passengers is subject to twice-yearly unannounced inspections and, when necessary, reinspection.
National Committee on Vital and Health Statistics: Meeting
Document Number: 2018-13179
Type: Notice
Date: 2018-06-20
Agency: Department of Health and Human Services
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