Department of Health and Human Services April 5, 2018 – Federal Register Recent Federal Regulation Documents

New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
Document Number: 2018-06961
Type: Rule
Date: 2018-04-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and a change of a sponsor's name and address.
Agency Information Collection Request. 60-Day Public Comment Request
Document Number: 2018-06959
Type: Notice
Date: 2018-04-05
Agency: Department of Health and Human Services
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Guidance for Industry; Availability
Document Number: 2018-06926
Type: Notice
Date: 2018-04-05
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 guidance for industry entitled ``Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.'' This guidance document finalizes the revised draft of the same name that published on October 30, 2015. This guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs) and abbreviated new drug applications (ANDAs), reviewed by the Center for Drug Evaluation and Research (CDER).
Notice of Meeting for the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC)
Document Number: 2018-06913
Type: Notice
Date: 2018-04-05
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
The Secretary of Health and Human Services (Secretary), in accordance with section 6031 of the 21st Century Cures Act, announces a meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting is open to the public and will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED), including data evaluation, and recommendations for action. Committee members will also discuss ISMICC member relationship to implementation workgroups, establishing the prevalence of SMI and SED, communication with non-federal organizations to engage non-federal support for ISMICC, and future meetings. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee.
National Library of Medicine; Amended; Notice of Meeting
Document Number: 2018-06898
Type: Notice
Date: 2018-04-05
Agency: Department of Health and Human Services, National Institutes of Health
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