Department of Health and Human Services May 17, 2017 – Federal Register Recent Federal Regulation Documents

National Committee on Vital and Health Statistics: Meeting
Document Number: 2017-09982
Type: Notice
Date: 2017-05-17
Agency: Department of Health and Human Services
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Document Number: 2017-09961
Type: Notice
Date: 2017-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's Web site. The guidances identified in this notice were developed using the process described in that guidance.
Determination That CALCIJEX (Calcitriol) Injectable, 1 Microgram/Milliliter and 2 Micrograms/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2017-09960
Type: Notice
Date: 2017-05-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that the drug product listed in this document was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-09912
Type: Notice
Date: 2017-05-17
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Document Number: 2017-09911
Type: Notice
Date: 2017-05-17
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2017-09910
Type: Notice
Date: 2017-05-17
Agency: Department of Health and Human Services, National Institutes of Health