Department of Health and Human Services June 4, 2019 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection; Comment Request
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.
Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.'' The draft guidance, when finalized, will provide recommendations on the factors that covered farms should consider if they are selecting an alternate curriculum training to meet the requirements of the ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' (Produce Safety Rule) and for educators when developing or evaluating alternate curricula.
Solicitation for Written Comments on an Updated Health Literacy Definition for Healthy People 2030
The Department of Health and Human Services (HHS) provides notice of a request for comments about the proposed update to the definition of health literacy. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for Healthy People 2030 used the following working definition: ``Health literacy occurs when a society provides accurate health information and services that people can easily find, understand, and use to inform their decisions and actions.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Sanitary Transportation of Human and Animal Food
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
The Food and Drug Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that MAYZENT (siponimod) approved March 26, 2019, meets the redemption criteria.
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products
The Food and Drug Administration (FDA) is withdrawing the approval of five abbreviated new drug applications (ANDAs) for products containing pemoline. The holders of the applications requested withdrawal of the applications and have waived their opportunity for a hearing.
Notice of Subcommittee Meetings for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
The Secretary of Health and Human Services (Secretary) announces subcommittee meetings of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meetings are open to the public and can be accessed via telephone only. Agenda with call-in information will be posted on the SAMHSA website prior to the meetings at: https://www.samhsa.gov/about- us/advisory-councils/meetings. The meetings will include information on the following focus areas: Data, Access, Treatment and Recovery, Justice, and Finance. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee (subcommittee meetings).
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