Department of Health and Human Services June 5, 2020 – Federal Register Recent Federal Regulation Documents
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Proposed Data Collection Submitted for Public Comment and Recommendations
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
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
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
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
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)
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
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
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.
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