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

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Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-02249
Type: Notice
Date: 2019-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-02248
Type: Notice
Date: 2019-02-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2019-02247
Type: Notice
Date: 2019-02-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Meeting
Document Number: 2019-02246
Type: Notice
Date: 2019-02-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Meetings
Document Number: 2019-02245
Type: Notice
Date: 2019-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2019-02244
Type: Notice
Date: 2019-02-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2019-02243
Type: Notice
Date: 2019-02-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Nursing Research; Notice of Closed Meeting
Document Number: 2019-02242
Type: Notice
Date: 2019-02-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2019-02240
Type: Notice
Date: 2019-02-14
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-02235
Type: Notice
Date: 2019-02-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-02231
Type: Notice
Date: 2019-02-14
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Notice of Availability of Draft Environmental Impact Statement, Public Meeting, and Request for Comments; Acquisition of Site for Development of a Replacement Underground Safety Research Program Facility for the Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health (CDC/NIOSH) in Mace, West Virginia
Document Number: 2019-01910
Type: Notice
Date: 2019-02-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS), in cooperation with the General Services Administration (GSA), announces the availability of a Draft Environmental Impact Statement (EIS) for the proposed acquisition of a site in Mace, West Virginia, and the development of this site into a replacement for the National Institute for Occupational Safety and Health (NIOSH) Underground Safety Research Program facility (Proposed Action). The proposed acquisition and development would replace the former Lake Lynn Experimental Mine in Fayette County, Pennsylvania, and would support research programs focused on miner health and safety issues. The site being considered for acquisition and development includes 461.35 acres located off U.S. Route 219 in Randolph and Pocahontas Counties near Mace, West Virginia (Site). The Draft EIS and this notice are published pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA) as implemented by the Council on Environmental Quality (CEQ) Regulations (40 CFR parts 1500-1508). In parallel with the NEPA process, CDC is also conducting consultation under Section 106 of the National Historic Preservation Act to evaluate the potential effects, if any, of the Proposed Action on historic properties. A Notice of Intent for this Draft EIS was published in the Federal Register on June 14, 2018 (83 FR 27781).
Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2019-02208
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has scheduled a public meeting. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable- disorders/index.html.
Meeting of the National Advisory Committee on Rural Health and Human Services
Document Number: 2019-02207
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, Health Resources and Services Administration
The Secretary's National Advisory Committee on Rural Health and Human Services (NACRHHS) has scheduled a public meeting. Information about NACRHHS and the agenda for this meeting can be found on the NACRHHS website at https://www.hrsa.gov/advisory-committees/ rural-health/index.html.
Notice of Closed Meeting
Document Number: 2019-02172
Type: Notice
Date: 2019-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Notice of Closed Meeting
Document Number: 2019-02165
Type: Notice
Date: 2019-02-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of a New Drug Application for OMONTYS (peginesatide) Injection
Document Number: 2019-02146
Type: Notice
Date: 2019-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 202799 for OMONTYS (peginesatide) Injection, held by Takeda Pharmaceuticals U.S.A., Inc. (Takeda USA). Takeda Development Center America, Inc., on behalf of Takeda USA, requested withdrawal of approval of this application under relevant FDA regulations and, in so doing, has waived its opportunity for a hearing.
Determination That LOTRIMIN (Clotrimazole) Topical Solution, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2019-02139
Type: Notice
Date: 2019-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that LOTRIMIN (clotrimazole) topical solution, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection of Ebola virus; Availability
Document Number: 2019-02134
Type: Notice
Date: 2019-02-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for an in vitro diagnostic device for detection of Ebola virus (species Zaire ebolavirus and hereafter referred to as Ebola virus) in response to the Ebola virus outbreak in the Democratic Republic of the Congo. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as requested by Chembio Diagnostic Systems, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized in vitro diagnostic device. The Authorization follows the September 22, 2006, determination by then-Secretary of the Department of Homeland Security (DHS), Michael Chertoff, that the Ebola virus presents a material threat against the U.S. population sufficient to affect national security. On the basis of such determination, the Secretary of Health and Human Services (HHS) declared on August 5, 2014, that circumstances exist justifying the authorization of emergency use of in vitro diagnostic devices for detection of Ebola virus, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2019-02129
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Amended Notice of Meeting
Document Number: 2019-02128
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2019-02127
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2019-02126
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meeting
Document Number: 2019-02125
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-02124
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Closed Meeting
Document Number: 2019-02123
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-02122
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2019-02121
Type: Notice
Date: 2019-02-13
Agency: Department of Health and Human Services, National Institutes of Health
Determination of Regulatory Review Period for Purposes of Patent Extension; XADAGO
Document Number: 2019-02044
Type: Notice
Date: 2019-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XADAGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ZEJULA
Document Number: 2019-02036
Type: Notice
Date: 2019-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ZEJULA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Control of Communicable Diseases: Foreign; Requirements Relating to Collection, Storage, and Transmission of Airline and Vessel Passenger, Crew, and Flight and Voyage Information for Public Health Purposes
Document Number: 2019-02035
Type: Notice
Date: 2019-02-12
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on a report as required by agency rules that relate to the transmission of passenger, crew, and flight/voyage information for public health purposes. The report can be found at https://www.cdc.gov/quarantine/final-rule-communicable-diseas es.html. Interested members of the public may submit comment regarding this report.
Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications
Document Number: 2019-02032
Type: Notice
Date: 2019-02-12
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Submission for OMB Review; 30-Day Comment Request; International Research Fellowship Award Program of the (National Institute on Drug Abuse)
Document Number: 2019-02028
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995, the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Request for Information for a Review of the NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding Document
Document Number: 2019-02027
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Through this Request for Information (RFI), the Office of AIDS Research (OAR) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), Office of the Director (OD), National Institutes of Health (NIH) invites feedback from interested stakeholders on a review of the NIH HIV/AIDS Research Priorities and Guidelines for Determining AIDS Funding (NOT-OD-15-137) now entering year four of implementation. The original Notice was released on August 12, 2015 to inform the scientific community of the overarching HIV/AIDS research priorities and the guidelines used by NIH to determine HIV/ AIDS funding beginning in fiscal year 2016 for the next three to five years.
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2019-02011
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2019-02004
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Biomedical Imaging and Bioengineering; Notice of Closed Meeting
Document Number: 2019-02001
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-01993
Type: Notice
Date: 2019-02-12
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2019-01992
Type: Notice
Date: 2019-02-12
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Assessment of Combination Product Review Practices
Document Number: 2019-01979
Type: Notice
Date: 2019-02-12
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; Food Contact Substance Notification Program
Document Number: 2019-01977
Type: Notice
Date: 2019-02-12
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.
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2019-01974
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meetings
Document Number: 2019-01973
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2019-01972
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2019-01971
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Deafness and Other Communication Disorders; Notice of Closed Meeting
Document Number: 2019-01970
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-01969
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-01968
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-01967
Type: Notice
Date: 2019-02-12
Agency: Department of Health and Human Services, National Institutes of Health