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HHS/FDA RIN: 0910-AG37 Publication ID: Spring 2017 
Title: Additions to the List of Tropical Diseases in Section 524 of the Federal Food, Drug, and Cosmetic Act 
Abstract: FDA is required to award a priority review voucher to the sponsor of a tropical disease product application, as defined in section 524(a)(4). A priority review voucher entitles the sponsor of a tropical disease product application to a priority review of a single human drug application other than the tropical disease product application (see section 524(a)(2)). The term "tropical disease" is defined in section 524(a)(3) to mean any of the diseases listed in section 524(a)(3), and/or "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: Substantive, Nonsignificant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
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 U.S.C. 360n   
Legal Deadline:  None
Timetable:
Action Date FR Cite
Withdrawn  06/08/2017 
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