View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AG37 Publication ID: Fall 2011 
Title: Additions to the List of Tropical Diseases in Section 524 of the Federal Food, Drug, and Cosmetic Act 
Abstract: Section 524 of the Federal Food, Drug, and Cosmetic Act (21 USC 360n), "Priority Review to Encourage Treatments for Tropical Diseases," provides authority for the Food and Drug Administration to award to the sponsor of a tropical disease product application, defined in section 524(a)(4), a priority review voucher, entitling the sponsor to priority review of a single human drug application that is unrelated to the tropical disease product application. The term "tropical disease" means any of the diseases listed in section 524(a)(3), and "any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by regulation by the Secretary." The proposed rule will designate tropical diseases to be added to the list in accordance with section 524(a)(3)(Q). 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 360n   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2012    
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No 
Agency Contact:
Kristiana Brugger
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 6262, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2897
Fax:301 847-8437
Email: kristiana.brugger@fda.hhs.gov