Department of Health and Human Services December 7, 2017 – Federal Register Recent Federal Regulation Documents

Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-26399
Type: Notice
Date: 2017-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Draft-National Occupational Research Agenda for Traumatic Injury Prevention
Document Number: 2017-26359
Type: Notice
Date: 2017-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Traumatic Injury Prevention for public comment. To view the notice and related materials, visit https:// www.regulations.gov. and enter CDC-2017-0104 in the search field and click ``Search.''
Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability
Document Number: 2017-26357
Type: Notice
Date: 2017-12-07
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric Rare DiseasesA Collaborative Approach for Drug Development Using Gaucher Disease as a Model.'' This draft guidance focuses on drug development for pediatric patients with Gaucher disease. In particular, it proposes for consideration a novel approach to improve the efficiency of drug development in pediatric rare diseases using Gaucher disease as an example. The emergence of concomitant trials for multiple investigational drug products for the treatment of rare diseases can pose significant challenges to effective drug development, because there are limited numbers of patients for any given rare condition worldwide. This approach discusses the feasibility of the development of multiple drug products in a time-efficient manner while minimizing the number of patients necessary to be treated with placebo.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey
Document Number: 2017-26356
Type: Notice
Date: 2017-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, 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.
Submission for OMB Review; Comment Request
Document Number: 2017-26353
Type: Notice
Date: 2017-12-07
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2017-26325
Type: Notice
Date: 2017-12-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-26324
Type: Notice
Date: 2017-12-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-26323
Type: Notice
Date: 2017-12-07
Agency: Department of Health and Human Services, National Institutes of Health