Health and Human Services Department, Food and Drug Administration
The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered tropical diseases for purposes of obtaining PRVs and provides for Agency expansion of that list to include other diseases that satisfy the definition of "tropical diseases" as set forth in the FD&C Act. The Agency has determined that brucellosis satisfies this definition and is therefore adding it to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain drug or biological product applications for the prevention or treatment of brucellosis may be eligible to receive a PRV if such applications are approved by FDA.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2008-N-0567] AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; final order. SUMMARY: The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered tropical diseases for purposes of obtaining PRVs and provides for Agency expansion of that list to include other diseases that satisfy the definition of “tropical diseases” as set forth in the FD&C Act. The Agency has determined that brucellosis satisfies this definition and is therefore adding it to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain drug or biological product applications for the prevention or treatment of brucellosis may be eligible to receive a PRV if such applications are approved by FDA. DATES: This order is issued on July 15, 2020. ADDRESSES: Submit electronic comments on additional diseases suggested for designation to https://www.regulations.gov . Submit written comments on additional diseases suggested for designation to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the d…
Other Federal Register documents from the same docket.
Notice of Decision Not To Designate Hepatitis Delta Virus Diseases as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Notice of Decision Not To Designate Coccidioidomycosis as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Notice of Decision Not To Designate Clonorchiasis as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act
Citation: 85 FR 42860
