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

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Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act & Improving Healthcare Choices To Empower
Document Number: 2017-13417
Type: Proposed Rule
Date: 2017-06-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Office of the Secretary
This document corrects an error that appeared in the request for information notice published in the Federal Register on June 12, 2017 entitled ``Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act & Improving Healthcare Choices to Empower.''
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-13414
Type: Notice
Date: 2017-06-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
National Advisory Council for Healthcare Research and Quality: Request for Nominations for Public Members
Document Number: 2017-13396
Type: Notice
Date: 2017-06-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Council advises the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to carry out its mission. AHRQ's mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. epartment of Health and Human Services and with other partners to make sure that the evidence is understood and used. Seven current members' terms will expire in November 2017
Supplemental Evidence and Data Request on Drug Therapy for Early Rheumatoid Arthritis in Adults-An Update
Document Number: 2017-13395
Type: Notice
Date: 2017-06-27
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 Drug Therapy for Early Rheumatoid Arthritis in AdultsAn Update, 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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Supplemental Evidence and Data Request on Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD): A Systematic Review Update
Document Number: 2017-13394
Type: Notice
Date: 2017-06-27
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 Psychological and Pharmacological Treatments for Adults with Posttraumatic Stress Disorder (PTSD): A Systematic Review Update, 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.
Meeting of the National Advisory Council for Healthcare Research and Quality
Document Number: 2017-13393
Type: Notice
Date: 2017-06-27
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2017-13363
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2017-13362
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Disease; Notice of Closed Meetings
Document Number: 2017-13361
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-13360
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute Amended; Notice of Meeting
Document Number: 2017-13359
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2017-13358
Type: Notice
Date: 2017-06-27
Agency: Department of Health and Human Services
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-State, Tribal, Local and Territorial (STLT) Subcommittee
Document Number: 2017-13339
Type: Notice
Date: 2017-06-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2017-13321
Type: Notice
Date: 2017-06-26
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.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2017-13320
Type: Notice
Date: 2017-06-26
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 efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. As part of a Broad Agency Announcement (BAA) issued for the competitive selection of research proposals, this notice invites comment on the proposed information collection project titled ``Applied Research to Address Emerging Public Health Priorities.''
National Vaccine Injury Compensation Program; List of Petitions Received
Document Number: 2017-13314
Type: Notice
Date: 2017-06-26
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.
Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas
Document Number: 2017-13313
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 1, 2017. The lists are available on HRSA's HPSAFind Web site.
Low-Income Levels Used for Various Health Professions and Nursing Programs Authorized in Titles III, VII, and VIII of the Public Health Service Act
Document Number: 2017-13312
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is updating income levels used to identify a ``low-income family'' for the purpose of determining eligibility for programs that provide health professions and nursing training to individuals from disadvantaged backgrounds. These various programs are authorized in Titles III, VII, and VIII of the Public Health Service Act. HHS periodically publishes in the Federal Register low-income levels to be used by institutions receiving federal grants and cooperative agreements to determine eligibility for programs providing training for (1) disadvantaged individuals, (2) individuals from disadvantaged backgrounds, or (3) individuals from low-income families.
Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
Document Number: 2017-13296
Type: Notice
Date: 2017-06-26
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 reporting requirements associated with extralabel drug use in animals.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-13288
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Administration for Children and Families
Submission for OMB Review; Comment Request
Document Number: 2017-13252
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals
Document Number: 2017-13248
Type: Notice
Date: 2017-06-26
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; Annual Reporting for Custom Device Exemption
Document Number: 2017-13245
Type: Notice
Date: 2017-06-26
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
Document Number: 2017-13240
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Document Number: 2017-13236
Type: Notice
Date: 2017-06-26
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 (the 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 Brineura (cerliponase alfa) manufactured by Biomarin Pharmaceuticals Inc., meets the criteria for a priority review voucher.
Center for Substance Abuse Treatment; Notice of Meeting
Document Number: 2017-13221
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-13220
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2017-13219
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-13218
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2017-13217
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meetings
Document Number: 2017-13216
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Complementary and Integrative Health Notice of Closed Meeting
Document Number: 2017-13215
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2017-13214
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-13213
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-13212
Type: Notice
Date: 2017-06-26
Agency: Department of Health and Human Services, National Institutes of Health
Medicare and Medicaid Programs: Approval of an Application From the Center for Improvement in Healthcare Quality for Continued CMS Approval of Its Hospital Accreditation Program
Document Number: 2017-13207
Type: Notice
Date: 2017-06-26
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the Center for Improvement in Healthcare Quality (CIHQ) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs.
Arthritis Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2017-13203
Type: Notice
Date: 2017-06-26
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 Arthritis 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. FDA is establishing a docket for public comment on this document.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-13198
Type: Notice
Date: 2017-06-26
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.
Submission of Proposed Recommendations for Industry on Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing; Establishment of a Public Docket
Document Number: 2017-13195
Type: Notice
Date: 2017-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
In connection with promoting the use of innovative technologies, the Food and Drug Administration (FDA or Agency) is establishing a public docket to invite discussion of issues related to the adoption of continuous manufacturing by the pharmaceutical industry.
Patient-Focused Drug Development for Alopecia Areata; Public Meeting; Request for Comments
Document Number: 2017-13194
Type: Notice
Date: 2017-06-23
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 and an opportunity for public comment on ``Patient-Focused Drug Development for Alopecia Areata.'' Patient- Focused Drug Development is part of FDA's performance commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patients' perspectives on the impact of alopecia areata, including on daily life. FDA is also seeking patients' views on treatment approaches and decision factors taken into account when selecting a treatment.
Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee
Document Number: 2017-13182
Type: Notice
Date: 2017-06-23
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health. In accordance with the 21st Century Cures Act, this notice provides an annual opportunity for patients, representatives of patients, and sponsors of medical device submissions to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Federal Tort Claims Act (FTCA) Program Deeming Applications for Free Clinics, OMB No. 0915-0293-Extension
Document Number: 2017-13178
Type: Notice
Date: 2017-06-23
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, the Health Resources and Services Administration (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 Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Federal Tort Claims Act (FTCA) Program Deeming Applications for Health Centers, OMB No. 0906-XXXX-New
Document Number: 2017-13176
Type: Notice
Date: 2017-06-23
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 Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Federal Tort Claims Act (FTCA) Program Deeming Applications for Health Center Volunteer Health Professionals
Document Number: 2017-13172
Type: Notice
Date: 2017-06-23
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, 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.
Draft Report on Carcinogens Monograph on Haloacetic Acids Found as Water Disinfection By-Products; Availability of Document; Request for Comments; Notice of Peer-Review Meeting
Document Number: 2017-13159
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
The National Toxicology Program (NTP) announces a meeting to peer review the Draft Report on Carcinogens (RoC) Monograph on Haloacetic Acids Found as Water Disinfection By-Products. The monograph was prepared by the Office of the Report on Carcinogens (ORoC), Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS). The peer review meeting is open to the public. Registration is requested for both public attendance and oral comment and required to access the webcast. Information about the meeting and registration is available at https:// ntp.niehs.nih.gov/go/38853.
Announcement of the Award of 43 Single-Source Low-Cost Extension Supplement Grants Within the Office of Refugee Resettlement's Unaccompanied Alien Children's (UAC) Program
Document Number: 2017-13081
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR, announces the award of 43 single-source low-cost extension supplement grants for a total of $34,847,803 under the Unaccompanied Alien Children's (UAC) Program.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2017-13080
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meetings
Document Number: 2017-13079
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2017-13078
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2017-13077
Type: Notice
Date: 2017-06-23
Agency: Department of Health and Human Services, National Institutes of Health