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Federal Register/Vol. 85, No. 136/Wednesday, July 15, 2020 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices 42883 interest to the IRS product DEPARTMENT OF HEALTH AND SUPPLEMENTARY INFORMATION: manufacturers who submitted timely HUMAN SERVICES Table of Contents exceptions, to determine whether the companies remained interested in Food and Drug Administration I. Background: Priority Review Voucher pursuing their appeals of the ALJ’s Program [Docket No. FDA–2008–N–0567] II. Diseases Being Designated Initial Decision. FDA informed the A. Opisthorchiasis companies that, if they did not respond Designating Additions to the Current B. Paragonimiasis and affirm their desire to pursue their List of Tropical Diseases in the Federal III. Process for Requesting Additional appeals by January 8, 2018, the Office of Food, Drug, and Cosmetic Act Diseases To Be Added to the List the Commissioner would conclude that IV. Paperwork Reduction Act AGENCY: Food and Drug Administration, V. References the companies no longer wish to pursue HHS. the appeal of the ALJ’s Initial Decision ACTION: Final order. I. Background: Priority Review and will proceed as if the appeals have Voucher Program been withdrawn. The Office of the SUMMARY: The Federal Food, Drug, and Section 524 of the FD&C Act (21 Commissioner did not receive a Cosmetic Act (FD&C Act) authorizes the U.S.C. 360n), which was added by response from any of the companies by Food and Drug Administration (FDA or section 1102 of the Food and Drug the given date; therefore, the Agency) to award priority review Administration Amendments Act of Commissioner now deems the vouchers (PRVs) to tropical disease 2007 (Pub. L. 110–85), uses a PRV exceptions withdrawn. product applicants when the incentive to encourage the development applications meet certain criteria. The of new drugs, including biological II. Conclusion and Order FD&C Act lists the diseases that are products, for prevention and treatment considered tropical diseases for Given that the exceptions have been of certain diseases that, in the aggregate, purposes of obtaining PRVs and affect millions of people throughout the deemed withdrawn, this proceeding is provides for Agency expansion of that world. To be eligible to receive a now in the same procedural posture as list to include other diseases that satisfy tropical disease PRV, a drug must be for if no exceptions had ever been filed. the definition of ‘‘tropical diseases’’ prevention or treatment of a ‘‘tropical When parties do not file exceptions to eligible for PRVs as set forth in the disease’’ as listed under section the ALJ’s Initial Decision, and the FD&C Act. The Agency has determined 524(a)(3) of the FD&C Act. This list can Commissioner does not file a notice of that two foodborne trematode be expanded by the Agency under review, the ALJ’s Initial Decision infections, opisthorchiasis and section 524(a)(3)(S) of the FD&C Act, becomes the final decision of the paragonimiasis, satisfy this definition, which authorizes FDA to designate by Commissioner (see 21 CFR 12.120(e)). and is therefore adding them to the list order ‘‘[a]ny other infectious disease for FDA will publish a notice in the Federal of designated tropical diseases whose which there is no significant market in Register when an initial decision product applications may result in the developed nations and that becomes the final decision of the award of PRVs. Sponsors submitting disproportionately affects poor and Commissioner without appeal to or certain drug or biological product marginalized populations’’ as an applications for the prevention or review by the Commissioner (see 21 addition to the list of tropical diseases, treatment of opisthorchiasis or CFR 12.120(f)). approved drug applications for which paragonimiasis infections may be may be eligible to receive a PRV. Pursuant to the findings in the ALJ’s eligible to receive a PRV if such Further information about the tropical Initial Decision, under section 505(e) of applications are approved by FDA. disease PRV program can be found in the FD&C Act (21 U.S.C. 355(e)), there DATES: This order is issued on July 15, the October 6, 2016 (81 FR 69537), is a lack of substantial evidence that 2020. guidance for industry ‘‘Tropical Disease Vasodilan will have the effect it ADDRESSES: Submit electronic Priority Review Vouchers,’’ available at purports or is represented to have under comments on additional diseases https://www.fda.gov/media/72569/ the conditions of use prescribed, suggested for designation to https:// download. recommended, or suggested in its www.regulations.gov. Submit written On August 20, 2015, FDA published labeling for: (1) SDAT or multiple comments on additional diseases a final order (80 FR 50559) (August 2015 infarct dementia and (2) peripheral suggested for designation to the Dockets final order) designating Chagas disease vascular disease. Distribution of Management Staff (HFA–305), Food and and neurocysticercosis as additions to products subject to the Initial Decision Drug Administration, 5630 Fishers the list of tropical diseases under in interstate commerce without an Lane, Rm. 1061, Rockville, MD 20852. section 524 of the FD&C Act. The approved application is prohibited and All comments should be identified with August 2015 final order also sets forth subject to regulatory action (see, e.g., the docket number found in brackets in FDA’s interpretation of the statutory sections 505(a) and 301(d) of the FD&C the heading of this document. criteria for tropical disease designation Act (21 U.S.C. 355(a) and 331(d)). FOR FURTHER INFORMATION CONTACT: and expands the list of tropical diseases Katherine Schumann, Center for Drug under section 524(a)(3)(R) of the FD&C The full text of the ALJ’s Initial Evaluation and Research, Food and Act (redesignated as section 524(a)(3)(S) Decision may be seen at Dockets Drug Administration, 10903 New of the FD&C Act). Additions by order to Management Staff (see ADDRESSES). Hampshire Ave., Bldg. 22, Rm. 6242, the statutory list of PRV-eligible tropical Dated: July 9, 2020. Silver Spring, MD 20993–0002, 301– diseases published in the Federal Lowell J. Schiller, 796–1300, Katherine.Schumann@ Register can be accessed at https:// fda.hhs.gov; or Stephen Ripley, Center www.fda.gov/AboutFDA/CentersOffices/ Principal Associate Commissioner for Policy. for Biologics Evaluation and Research, OfficeofMedicalProductsandTobacco/ [FR Doc. 2020–15248 Filed 7–14–20; 8:45 am] Food and Drug Administration, 10903 CDER/ucm534162.htm. BILLING CODE 4164–01–P New Hampshire Ave., Bldg. 71, Rm. In this document, FDA has applied its 7301, Silver Spring, MD 20993–0002, August 2015 final order criteria to 240–402–7911. analyze whether the foodborne VerDate Sep<11>2014 17:59 Jul 14, 2020 Jkt 250001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\15JYN1.SGM 15JYN1 khammond on DSKJM1Z7X2PROD with NOTICES 42884 Federal Register / Vol. 85, No. 136 / Wednesday, July 15, 2020 / Notices trematode infections opisthorchiasis or O. felineus flukes are cats and other developed nations for the purposes of and paragonimiasis meet the statutory fish-eating carnivores (Ref. 1). O. this order (Ref. 8). criteria for addition to the tropical viverrini flukes are reported in In developed countries where O. diseases list under section 524 of the Thailand, Laos, Cambodia, and Vietnam viverrini and O. felineus are found, the FD&C Act. while O. felineus flukes are reported in prevalence of opisthorchiasis is very Italy, Germany, Belarus, Russia, low. There have only been II. Diseases Being Designated Kazakhstan, and Ukraine (Ref. 2). approximately five cases of human FDA has considered all diseases The final location of adult O. viverrini infections of O. felineus reported in submitted to the public docket (FDA– and O. felineus is the smaller bile ducts Germany since the 1980s, and two in 2008–N–0567) between June 20, 2018, of the liver (Ref. 3). The symptoms Greece in the late 1990s and early 2000s and November 21, 2018, as potential caused by opisthorchiasis are related to (though one of those infections may additions to the list of tropical diseases inflammation and fibrosis of the tissues have originated elsewhere) (Ref. 9). Italy under section 524 of the FD&C Act, adjacent to bile ducts. While the has seen an increase in reported human pursuant to the docket review process majority of infected individuals are infections due to the increased explained on the Agency’s web page at asymptomatic, patients may develop consumption of marinated fillets of raw https://www.fda.gov/AboutFDA/Centers cholangitis, intrahepatic calculi, or tench (Tinca tinca), infected with O. Offices/OfficeofMedicalProductsand cholangiohepatitis. Chronic infection is felineus (Ref. 9). However, even with Tobacco/CDER/ucm534162.htm. Based also associated with the development of this rise in infection rates, the total on an assessment using the criteria from cholangiocarcinoma, a severe and fatal number of reported opisthorchiasis its August 2015 final order, FDA has form of bile duct cancer, and O. viverrini cases in Italy was only 211 from 2003 determined that the following are recognized by the International to 2011 (Ref. 9). As described in the additional diseases will be designated as Agency for Research on Cancer as Group August 2015 final order, FDA uses a additions to the list of tropical diseases 1, which means that the agent is disease prevalence rate of 0.1 percent of for purposes of the tropical disease PRV classified as carcinogenic to humans the population of developed countries program under section 524 of the FD&C (Refs. 4 and 5). for aiding in the determination of Act: There is one FDA-approved treatment whether a ‘‘significant market’’ may for opisthorchiasis, praziquantel, • Opisthorchiasis exist for a disease’s treatment. In these approved in 1982 and indicated for the • Paragonimiasis three high-income countries where O.
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