Department of Health and Human Services 2020 – Federal Register Recent Federal Regulation Documents

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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.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Substance Use Disorder Treatment and Recovery Loan Repayment Program, OMB No. 0906-xxxx-New
Document Number: 2020-12040
Type: Notice
Date: 2020-06-04
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: Submission for OMB Review; Comment Request
Document Number: 2020-12031
Type: Notice
Date: 2020-06-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2020-12005
Type: Notice
Date: 2020-06-04
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: Submission for OMB Review; Comment Request
Document Number: 2020-12002
Type: Notice
Date: 2020-06-04
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.
Privacy Act of 1974; Matching Program
Document Number: 2020-11996
Type: Notice
Date: 2020-06-04
Agency: Department of Health and Human Services, Administration for Children and Families
In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Administration for Children and Families (ACF), Office of Planning, Research and Evaluation (OPRE), is providing notice of a re-established matching program between the Department of Veterans Affairs (VA) and State Public Assistance Agencies (SPAAs) participating in the Public Assistance Reporting Information System (PARIS) Program. The matching program provides the SPAAs with VA compensation and pension data on a periodic basis to use in determining public assistance applicants' and recipients' eligibility for certain public assistance benefits. HHS/ACF/OPRE facilitates the matching program, and the Department of Defense (DoD), Defense Manpower Data Center (DMDC) conducts the matches of SPAA and VA data and provides associated support.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2020-11992
Type: Notice
Date: 2020-06-03
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 for OMB Review; Refugee Support Services (RSS) and RSS Set Aside Sub-Agency List (New Collection)
Document Number: 2020-11985
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, Administration for Children and Families
The Administration for Children and Families (ACF) seeks approval for a new information collection requesting Refugee Support Services (RSS) grantees and RSS Set Aside grantees to provide the agency name, city, state, phone number, and funding amount for each contracted sub-grantee.
National Heart, Lung, and Blood Institute; Notice of Closed Meetings
Document Number: 2020-11982
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Secretary; Notice of Meeting
Document Number: 2020-11980
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-11913
Type: Notice
Date: 2020-06-03
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: 2020-11911
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11910
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions and Delegations of Authority
Document Number: 2020-11769
Type: Notice
Date: 2020-06-03
Agency: Department of Health and Human Services, Health Resources and Services Administration
Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019
Document Number: 2020-11898
Type: Notice
Date: 2020-06-02
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the process for publishing FDA Emergency Use Authorizations (EUAs) for medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA believes that this process will allow the Agency to rapidly publish EUAs that have been issued for medical devices under the Federal Food, Drug, and Cosmetic Act.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2020-11883
Type: Notice
Date: 2020-06-02
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 Pediatric Oncology Subcommittee of the Oncologic 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.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2020-11880
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11879
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2020-11878
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11876
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Dental & Craniofacial Research; Notice of Closed Meeting
Document Number: 2020-11875
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Request. 30-Day Public Comment Request
Document Number: 2020-11862
Type: Notice
Date: 2020-06-02
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.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Information Collection Request Title: Ryan White HIV/AIDS Program Part F Dental Services Report, OMB No. 0915-0151-Extension
Document Number: 2020-11834
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with of 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. 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. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11815
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11814
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2020-11813
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2020-11812
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2020-11811
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Meeting
Document Number: 2020-11810
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2020-11809
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2020-11808
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Drug Abuse; Notice of Closed Meeting
Document Number: 2020-11804
Type: Notice
Date: 2020-06-02
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2020-11803
Type: Notice
Date: 2020-06-02
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. This notice invites comment on the ``Behavioral Risk Factor Surveillance System (BRFSS) Asthma Call-back Survey (ACBS)'' (OMB Control No. 0920-1204, expiration date 11/30/2020). The ACBS is an in-depth asthma survey conducted on a subset of BRFSS respondents with an asthma diagnosis. The goal of this survey is to strengthen the existing body of asthma data and to address critical questions surrounding the health and experiences of persons with asthma.