Department of Health and Human Services April 16, 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Advisory Committee on Immunization Practices (ACIP)
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public. The meeting will be webcast live via the World Wide Web.
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 American Academy of Pediatrics (AAP) Neurodevelopmental Extension for Community Health Outcomes (ECHO)program on Children with Fetal Alcohol Spectrum Disorders (FASD). The purpose of this information collection is to monitor and evaluate the American Academy of Pediatrics (AAP) Neurodevelopmental Extension for Community Health Outcomes (ECHO) Program on Children with Fetal Alcohol Spectrum Disorders (FASD). The intent of the project is to improve practicing pediatrician capacity for identification and care of children with neurodevelopmental disorders, particularly prenatal exposure to alcohol, in the medical home.
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 SimpleReport Mobile Application. SimpleReport is a free web-based application that provides an easy way to manage the testing workflow, to record results for rapid point of care COVID tests, to report the results to the appropriate public health department on behalf of the testing site, and to comply with existing requirements.
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 Integrated Viral Hepatitis Surveillance and Prevention Funding for Health Departments. This new data collection is for viral hepatitis (VH) case reporting data collected from the National Notifiable Diseases Surveillance System (NNDSS) which provides the primary population-based data used to describe the epidemiology of VH in the United States and for annual reporting of surveillance, prevention, and epidemiology performance measures via an Annual Performance Report.
Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing the following public workshop entitled ``Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.'' The purpose of the workshop is to bring stakeholders together to discuss the scientific basis of morphine milligram equivalents (MMEs) with the goals of providing an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications.
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 the Chronic Disease Self- Management Questionnaire. The questionnaire used for this study will assess Chronic Disease Self-Management participant health behaviors and overall health before and after a six-week workshop.
Making Permanent Regulatory Flexibilities Provided During the COVID-19 Public Health Emergency by Exempting Certain Medical Devices From Premarket Notification Requirements; Withdrawal of Proposed Exemptions
The Department of Health and Human Services (HHS or ``The Department'') issued a Notice in the Federal Register of January 15, 2021, that, among other things, proposed to exempt 83 class II devices and 1 unclassified device from premarket notification. This Notice announces HHS's and the Food and Drug Administration's (FDA or ``the Agency'') withdrawal of the proposed exemptions for the 83 class II devices and 1 unclassified device. The comment period for the proposed class II and unclassified device exemptions closed on March 15, 2021. HHS and FDA are withdrawing the proposed exemptions after reviewing the Notice, its comments, inquiries to FDA, and other relevant information, and determining that the proposed exemptions and bases for them are flawed.
Medical Devices; Class I Surgeon's and Patient Examination Gloves
The Department of Health and Human Services (HHS or ``the Department'') issued a Notice in the Federal Register of January 15, 2021, that, among other things, identified seven types of reserved class I devices that the Department had determined no longer require premarket notification. The Department and the Food and Drug Administration (FDA or ``the Agency'') have reviewed the prior determination, including the record supporting it, and believe that the determination is flawed. This notice explains the basis for HHS and FDA's current view that the seven types of reserved class I devices identified in the January 15, 2021, Notice require a premarket notification, and explains why the reasoning supporting the prior determination was unsound. HHS and FDA are seeking comment on the matters discussed in this notice and will issue a future notice in the Federal Register containing a final determination regarding the class I medical gloves listed in the January 15, 2021, Notice.
Submission for OMB review; 30-Day Comment Request; Data and Specimen Hub (DASH) (Eunice Kennedy Shriver National Institute of Child Health and Human Development); Correction
The Department of Health and Human Services, National Institutes of Health published a Notice in the Federal Register on April 9, 2021. That Notice requires a correction in the SUPPLEMENTARY INFORMATION section.
Submission for OMB Review; OPRE Data Collection for Supporting Youth To Be Successful in Life (SYSIL) (New Collection)
The Administration for Children and Families (ACF) is requesting approval from the Office of Management and Budget (OMB) for a new data collection. The Supporting Youth to be Successful in Life study (SYSIL) will build evidence on how to end homelessness among youth and young adults with experience in the child welfare system by continuing work with an organization who conducted foundational work as part of the Youth At-Risk of Homelessness project (OMB Control Number: 0970-0445). SYSIL will provide important information to the field by designing and conducting a federally led evaluation of a comprehensive service model for youth at risk of homelessness.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
