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

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Agency Information Collection Activities: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
Document Number: 2020-12582
Type: Notice
Date: 2020-06-11
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.''
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-12565
Type: Notice
Date: 2020-06-10
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Generic Clearance for Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.''
Announcement of Intent To Award 35 Operating Division (OPDIV)-Initiated Supplements for Grantees Under the Direct Services for Survivors of Torture Program
Document Number: 2020-12564
Type: Notice
Date: 2020-06-10
Agency: Department of Health and Human Services, Administration for Children and Families
ACF, ORR, Division of Refugee Health announces the intent to award 35 OPDIV-Initiated Supplements in amounts ranging from $23,500 to $95,569 to grantees providing direct services funded through the Services for Survivors of Torture Program. See Table 1 below for more details on the supplement awards.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-12513
Type: Notice
Date: 2020-06-10
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of Learning Health Systems K12 Training Program.'' This proposed information collection was previously published in the Federal Register on March 12, 2020, and allowed 60 days for public comment. No comments were received from the public during this period. The purpose of this notice is to allow an additional 30 days for public comment.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-12461
Type: Notice
Date: 2020-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2020-12458
Type: Notice
Date: 2020-06-09
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-12457
Type: Notice
Date: 2020-06-09
Agency: Department of Health and Human Services, National Institutes of Health
Meeting of the Tick-Borne Disease Working Group
Document Number: 2020-12432
Type: Notice
Date: 2020-06-09
Agency: Department of Health and Human Services
As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the TBDWG will review the draft 2020 report to the HHS Secretary and Congress and review and approve graphics and images for the report. The 2020 report will address ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, and interventions for individuals with tick- borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tick-borne disease research.
Institutional Review Board Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency; Guidance for Institutional Review Boards and Clinical Investigators; Availability
Document Number: 2020-12429
Type: Notice
Date: 2020-06-09
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 ``Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency.'' To facilitate patient access to investigational drugs for treating COVID-19, FDA is issuing this guidance to provide recommendations regarding the key factors and procedures IRBs should consider when reviewing requests including when such reviews are conducted by a single-member of an IRBfor individual patient expanded access. Given the public health emergency presented by COVID-19, this guidance is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices.
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2020-12401
Type: Notice
Date: 2020-06-09
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-12369
Type: Notice
Date: 2020-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meetings
Document Number: 2020-12368
Type: Notice
Date: 2020-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-12367
Type: Notice
Date: 2020-06-09
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-12366
Type: Notice
Date: 2020-06-09
Agency: Department of Health and Human Services, National Institutes of Health
Child Support
Document Number: 2020-12188
Type: Rule
Date: 2020-06-09
Agency: Department of Health and Human Services, Administration for Children and Families
This rule is intended to eliminate regulations that are outdated or unnecessary and to make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement (FEM) final rule, published on December 20, 2016, including to amend the compliance date for review and adjustment of child support orders. The Office of Child Support Enforcement is also making conforming amendments to the regulations as a result of the Bipartisan Budget Act of 2018.
Second Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19
Document Number: 2020-12465
Type: Notice
Date: 2020-06-08
Agency: Department of Health and Human Services, Office of the Secretary
The Secretary issues this amendment pursuant to section 319F-3 of the Public Health Service Act to clarify that Covered Countermeasures under the Declaration include qualified pandemic and epidemic products that limit the harm COVID-19 might otherwise cause.
National Institute on Minority Health and Health Disparities; Notice of Closed Meeting
Document Number: 2020-12335
Type: Notice
Date: 2020-06-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2020-12334
Type: Notice
Date: 2020-06-08
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: 2020-12333
Type: Notice
Date: 2020-06-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-12332
Type: Notice
Date: 2020-06-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-12331
Type: Notice
Date: 2020-06-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-12330
Type: Notice
Date: 2020-06-08
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-12329
Type: Notice
Date: 2020-06-08
Agency: Department of Health and Human Services, National Institutes of Health
Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments
Document Number: 2020-12317
Type: Notice
Date: 2020-06-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is hosting a virtual public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2022. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2023 through 2027. These comments will be published and available on FDA's website.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Maternal Health Portfolio Evaluation Design, OMB No. 0906-xxxx-NEW
Document Number: 2020-12308
Type: Notice
Date: 2020-06-08
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 for Healthcare Research and Quality; Notice of Meeting
Document Number: 2020-12291
Type: Notice
Date: 2020-06-08
Agency: Department of Health and Human Services
The subcommittee listed below is part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at this meeting. This subcommittee meeting will be closed to the public.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-12287
Type: Notice
Date: 2020-06-08
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: 2020-12285
Type: Notice
Date: 2020-06-08
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.
Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR)
Document Number: 2020-12268
Type: Notice
Date: 2020-06-08
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 for the Board of Scientific Counselors, Center for Preparedness and Response, (BSC, CPR). This is a virtual meeting and is open to the public. The public is welcome to view the meeting via Zoom, limited only by the number of seats available, which is 500. Pre-registration is required by accessing the link at https:// cdc.zoomgov.com/webinar/register/WN_sAWlf9f4RO6UKTLI8_Jj9A.
Board of Scientific Counselors, National Institute for Occupational Safety and Health, National Firefighter Registry Subcommittee Meeting
Document Number: 2020-12267
Type: Notice
Date: 2020-06-08
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 National Institute for Occupational Safety and Health (BSC, NIOSH) for National Firefighter Registry Subcommittee. This meeting is open to the public via webcast and by teleconference. If you wish to attend by webcast or teleconference, please register at the NIOSH website (https:// www.cdc.gov/niosh/bsc/nfrs/registration.html) or call (513-841-4203) at least five business days in advance of the meeting.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-12266
Type: Notice
Date: 2020-06-08
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Identifying and Testing Strategies for Management of Opioid Use and Misuse in Older Adults in Primary Care Practices.''
National Institute of Mental Health; Amended Notice of Meeting
Document Number: 2020-12258
Type: Notice
Date: 2020-06-08
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-12259
Type: Notice
Date: 2020-06-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases Notice of Closed Meeting
Document Number: 2020-12257
Type: Notice
Date: 2020-06-05
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2020-12256
Type: Notice
Date: 2020-06-05
Agency: Department of Health and Human Services, National Institutes of Health
National Library of Medicine Notice of Meetings Amended Notice of Meeting
Document Number: 2020-12254
Type: Notice
Date: 2020-06-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-12253
Type: Notice
Date: 2020-06-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-12252
Type: Notice
Date: 2020-06-05
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-12249
Type: Notice
Date: 2020-06-05
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-12244
Type: Notice
Date: 2020-06-05
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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Colorectal Cancer Control Program (CRCCP) Monitoring Activities. CDC is requesting a revision to OMB No. 0920-1074 to include a redesigned survey, a redesigned clinic-level data collection instrument, and a new quarterly awardee-level program update survey.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-12243
Type: Notice
Date: 2020-06-05
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 effort 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. This notice invites comment on the National Vital Statistics Report Forms. This collection is used by State and/or county vital registration offices to report to the Federal government (a) provisional counts of births, deaths, and infant deaths, at the end of each month and (b) annual counts of marriages and divorces/ annulments in support of the National Vital Statistics System.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-12242
Type: Notice
Date: 2020-06-05
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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Mycoplasma genitalium Treatment Failure Registry.'' The purpose of the collection is to determine which second-line antibiotics are in use for M. genitalium treatment failure and monitor antibiotic resistance patterns for treatment failure cases throughout the United States.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-12241
Type: Notice
Date: 2020-06-05
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 effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled COVID-19 Pandemic Response, Laboratory Data Reporting. The collection will be used to gather comprehensive laboratory testing data to ensure a rapid and thorough federal response to the COVID-19 pandemic.
Request for Information-Long-Term Monitoring of Health Care System Resilience
Document Number: 2020-12238
Type: Notice
Date: 2020-06-05
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health (OASH) in the Department of Health and Human Services seeks to gain a more comprehensive understanding of how organizations, networks, non-federal government agencies, and other relevant stakeholders in the United States have operationally defined ``resilience'' in their respective components of the health system; including their use of data, analytic approaches and proven indicators. OASH also seeks to identify opportunities to strengthen the U.S. healthcare system, as a whole, through public-private partnerships in data sharing and comprehensive analytics. OASH welcomes any public feedback related to how these questions should be addressed and/or potential solutions. The set of questions is available in the SUPPLEMENTARY INFORMATION section below.
Proposed Information Collection Activity; Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Review and Technical Assistance Process (New Collection)
Document Number: 2020-12125
Type: Notice
Date: 2020-06-05
Agency: Department of Health and Human Services, Administration for Children and Families
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to establish a generic clearance to collect information to assess regulatory requirements of title IV-E agencies' Comprehensive Child Welfare Information System (CCWIS) and ensure that the CCWIS is utilized for purposes consistent with the efficient, economical, and effective administration of the title IV-B and IV-E plans. The information collected is intended to be used for review and technical assistance processes.
Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
Document Number: 2020-12117
Type: Notice
Date: 2020-06-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the issuance and reissuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the coronavirus disease 2019 (COVID-19) public health emergency. FDA has issued, and in some cases reissued, the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by Secretary of Health and Human Services (HHS) that there is a public health emergency that has significant potential to affect national security or the health and security of U.S. citizens living abroad, which involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance and reissuance, are listed in this document and are available on FDA's website at the links indicated in this document.
Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption From the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry; Availability
Document Number: 2020-12109
Type: Rule
Date: 2020-06-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled ``Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices. The guidance communicates the Agency's intention to exercise enforcement discretion, in the manner described in the guidance, regarding sales to qualified end-users when determining eligibility for the qualified exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, due to disruptions to supply chains, for the duration of the COVID-19 public health emergency.
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2020-12100
Type: Notice
Date: 2020-06-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.