Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act

by the Food and Drug Administration on 04/19/2021.

The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking...

National Vaccine Injury Compensation Program; List of Petitions Received

by the Health Resources and Services Administration on 04/19/2021.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United...

Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System, OMB No. 0906-0017, Revision

by the Health Resources and Services Administration on 04/19/2021.

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...

Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: National Survey of Organ Donation Attitudes and Practices, OMB No. 0915-0290-Extension

by the Health Resources and Services Administration on 04/19/2021.

In compliance with 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.

Meeting of the COVID-19 Health Equity Task Force

by the Health and Human Services Department on 04/19/2021.

As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on April 30, 2021. The purpose of this meeting is to consider interim recommendations specific to mental and behavioral health across...

Center for Scientific Review; Notice of Closed Meetings

by the National Institutes of Health on 04/19/2021.

Advisory Committee for Women's Services (ACWS); Notice of Meeting

by the Substance Abuse and Mental Health Services Administration on 04/19/2021.

Proposed Data Collection Submitted for Public Comment and Recommendations

by the Centers for Disease Control and Prevention on 04/16/2021.

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...

Proposed Data Collection Submitted for Public Comment and Recommendations

by the Centers for Disease Control and Prevention on 04/16/2021.

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...

Advisory Committee on Immunization Practices (ACIP)

by the Centers for Disease Control and Prevention on 04/16/2021.

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

by the Centers for Disease Control and Prevention on 04/16/2021.

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...

Proposed Data Collection Submitted for Public Comment and Recommendations

by the Centers for Disease Control and Prevention on 04/16/2021.

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...

Submission for OMB Review; OPRE Data Collection for Supporting Youth To Be Successful in Life (SYSIL) (New Collection)

by the Children and Families Administration on 04/16/2021.

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...

Medical Devices; Class I Surgeon's and Patient Examination Gloves

by the Food and Drug Administration on 04/16/2021.

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...

Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions; Public Workshop; Request for Comments

by the Food and Drug Administration on 04/16/2021.

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...

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

by the Food and Drug Administration on 04/16/2021.

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'')...

National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting

by the National Institutes of Health on 04/16/2021.

National Institute of Allergy and Infectious Diseases; Notice of Meetings

by the National Institutes of Health on 04/16/2021.

National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings

by the National Institutes of Health on 04/16/2021.

Center for Scientific Review; Notice of Closed Meetings

by the National Institutes of Health on 04/16/2021.