Department of Health and Human Services March 28, 2019 – Federal Register Recent Federal Regulation Documents

Advisory Committee; Cellular, Tissue and Gene Therapies Advisory Committee, Renewal
Document Number: 2019-05985
Type: Notice
Date: 2019-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee (Committee) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until October 28, 2020.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2019-05978
Type: Notice
Date: 2019-03-28
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.
Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability
Document Number: 2019-05977
Type: Notice
Date: 2019-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling.'' This guidance is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. This guidance finalizes the draft guidance issued on February 28, 2013.
Veterinary Feed Directive Regulation Questions and Answers; Small Entity Compliance Guide; Draft Guidance for Industry; Availability
Document Number: 2019-05976
Type: Notice
Date: 2019-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft revised guidance for industry (GFI) #120 entitled ``Veterinary Feed Directive Regulation Questions and Answers.'' This draft revised guidance document, when finalized, will aid industry in complying with the requirements of the veterinary feed directive (VFD) regulation.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 2019-05975
Type: Notice
Date: 2019-03-28
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.
National Firefighter Registry; Request for Information
Document Number: 2019-05971
Type: Notice
Date: 2019-03-28
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain information regarding the development and maintenance of a voluntary registry of U.S. firefighters. The purpose of the Registry will be to collect health and occupational information for the purpose of determining cancer incidence. CDC is seeking input on approaches to maximizing firefighter participation in the Registry and coordination of data collection.
National Institute of Mental Health Amended; Notice of Meeting
Document Number: 2019-05965
Type: Notice
Date: 2019-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-05964
Type: Notice
Date: 2019-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2019-05963
Type: Notice
Date: 2019-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-05962
Type: Notice
Date: 2019-03-28
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings
Document Number: 2019-05961
Type: Notice
Date: 2019-03-28
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review Amended; Notice of Meeting
Document Number: 2019-05960
Type: Notice
Date: 2019-03-28
Agency: Department of Health and Human Services, National Institutes of Health
United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; Public Meeting; Request for Comments
Document Number: 2019-05955
Type: Notice
Date: 2019-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Amsterdam, Netherlands, scheduled for June 2 through 6, 2019. The topics to be addressed at the public meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Amsterdam.
Uralkali PSJ; Filing of Food Additive Petition
Document Number: 2019-05954
Type: Proposed Rule
Date: 2019-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have filed a petition, submitted by Uralkali PSJ, proposing that the food additive regulations be amended to provide for the safe use of yellow prussiate of soda as an anticaking agent for potassium chloride in animal food.
Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds; Guidance for Industry; Availability
Document Number: 2019-05953
Type: Rule
Date: 2019-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled ``Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds.'' This document states the intent of FDA to exercise enforcement discretion regarding the requirements of the ``Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption'' regulation (Produce Safety Regulation) as they apply to entities growing, harvesting, packing, and holding hops, wine grapes, pulse crops, and almonds.
Annual Public Meeting; Reagan-Udall Foundation for the Food and Drug Administration
Document Number: 2019-05944
Type: Notice
Date: 2019-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Reagan-Udall Foundation (the Foundation) for the Food and Drug Administration (FDA), which was created by Title VI of the Food and Drug Administration Amendments Act of 2007, is announcing its annual public meeting. The Foundation will discuss its activities and how they support FDA.
Center for Substance Abuse Prevention; Notice of Meeting
Document Number: 2019-05926
Type: Notice
Date: 2019-03-28
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Mammography Quality Standards Act
Document Number: 2019-05803
Type: Proposed Rule
Date: 2019-03-28
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is proposing to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are proposing updates to modernize the regulations by incorporating current science and mammography best practices. These updates would improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.
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