Department of Health and Human Services September 20, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services is modifying a system of records maintained by the National Institutes of Health (NIH), 09-25-0225 ``NIH Electronic Research Administration (eRA) Records, HHS/NIH/OD/OER,'' to include a new routine use allowing NIH to disclose information to applicant organizations for the purpose of communicating with the applicants about matters related to agency award programs.
Proposed Information Collection Activity; Coparenting and Healthy Relationship and Marriage Education for Dads (New Collection)
The Administration for Children and Families (ACF), Office of Planning, Research, and Evaluation (OPRE) proposes to collect information as part of the Coparenting and Healthy Relationship and Marriage Education for Dads (CHaRMED) study. The purpose of the CHaRMED study is to better understand the services that fatherhood programs provide in the areas of Healthy Marriage and Relationship Education (HMRE) and coparenting to learn what strategies hold promise for promoting active engagement in these services.
The Food and Drug Administration Solicits Input on Potential Role for Abuse-Deterrent Formulations of Central Nervous System Stimulants; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket to receive comments from interested parties, including patients, patient advocates, healthcare providers, academics, researchers, the pharmaceutical industry, and other government entities, on considerations related to the development and evaluation of abuse-deterrent formulations (ADFs) of central nervous system stimulants and whether such products could play a role in addressing public health concerns related to prescription stimulant misuse and abuse. This notice provides an overview of available postmarket data on the use, misuse, and abuse of prescription stimulants and associated morbidity and mortality, along with similar data on prescription opioids to provide context; background information on the development and evaluation of ADF products; and specific questions on which FDA seeks input. The Appendix lists the sources used in developing this overview.
Safety and Performance Based Pathway Device-Specific Guidance; Draft Guidances for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of several device-specific draft guidance documents for the Safety and Performance Based Pathwayspecifically, ``Spinal Plating SystemsPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff''; ``Cutaneous Electrode for Recording PurposesPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff''; ``Conventional Foley CathetersPerformance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff''; and ``Orthopedic Non-Spinal Metallic Bone Screws and Washers Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff.'' The device-specific draft guidances identified in this notice were developed in accordance with the finalized guidance entitled ``Safety and Performance Based Pathway.'' These draft guidances are not final nor are they in effect at this time.
Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Adverse Event Program for Medical Devices (Medical Program Safety Network (MedSun)).
Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Feed Regulatory Program Standards
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on FDA's Animal Feed Regulatory Program Standards (AFRPS).
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