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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. companies that, if they did not respond Designating Additions to the Current B. 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 I. Background: Priority Review and will proceed as if the appeals have Voucher Program been withdrawn.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 L. 110–85), uses a PRV exceptions withdrawn.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certain diseases that, in the aggregate, purposes of obtaining PRVs and affect millions of people throughout the deemed withdrawn, this proceeding is provides for Agency expansion of that world.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

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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 , 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 , and (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 (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 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 , 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, , • Opisthorchiasis exist for a disease’s treatment. In these approved in 1982 and indicated for the • Paragonimiasis three high-income countries where O. treatment of infections due to all species viverrini and O. felineus have been The four primary foodborne of and infections due to the reported, the prevalence rates are trematode infections identified by the liver flukes and O. significantly lower than that which FDA World Health Organization (WHO) viverrini (Ref. 6). would consider could offer a sufficient include these two infections, as well as market incentive to drive the fascioliasis, which was included in the 1. No Significant Market in Developed Nations development of new drug products to original statutory list of tropical diseases prevent or treat opisthorchiasis. under section 524(a)(3) of the FD&C Act, No significant market exists for the Therefore, in developed nations where and , which FDA has treatment or prevention of opisthorchiasis occurs, the prevalence determined does not at this time meet opisthorchiasis in developed nations. rates of infection are not large enough to the requirements to be designated as an As stated above, opisthorchiasis occurs create a significant market for treatment. addition to the list of tropical diseases, as a result of O. viverrini and O. felineus There is currently no estimate of the approved drug applications for which (Ref. 7). O. viverrini have been reported number of individuals infected with may be eligible for a PRV under section in Thailand, Laos, Cambodia, and opisthorchiasis in the United States. 524 of the FD&C Act (see FDA’s ‘‘Notice Vietnam. O. felineus have been reported The available information concerning of Decision Not to Designate in Italy, Germany, Belarus, Russia, opisthorchiasis in the United States Clonorchiasis as an Addition to the Kazakhstan, and Ukraine (Ref. 7). Since suggests that the prevalence of Current List of Tropical Diseases in the O. viverrini and O. felineus have a opisthorchiasis is much lower than 0.1 Federal Food, Drug, and Cosmetic Act,’’ limited geographic range, infections in percent of the population. Of the published elsewhere in this issue of the other countries only occur from infections that do occur in the United Federal Register). movement of infected persons. O. States, foodborne trematode infections Foodborne trematode infections are viverrini and O. felineus flukes have a occur predominantly in immigrants and caused by parasitic trematodes, life span of 25 to 30 years, meaning that travelers to and from endemic regions commonly known as flukes. Trematode opisthorchiasis may persist long after a (Refs. 10 and 11). For example, in a infections are naturally transmissible patient is initially infected, however, as retrospective study in one U.S. travel from vertebrate animals to people and described below, these numbers are low medicine clinic over 6 years, only 17 back. People become infected through in developed countries. cases of spp. and the consumption of raw or undercooked Thailand, Laos, Cambodia, Vietnam, Clonorchis spp. were identified through food (e.g., fish, crustaceans, and Belarus, Russia, Kazakhstan, and the review of medical records (Ref. 12). vegetables), which harbor the minute Ukraine are not on the World Bank list All patients with identified cases were larval stages of the parasites. of high-income economies, which, as migrants from Laos, Cambodia, FDA’s rationale for adding these described in FDA’s August 2015 final Thailand, Vietnam, the former Soviet diseases to the list is discussed in the order, will be used as evidence that the Union, and Ecuador (Ref. 12). analyses that follow. country should be considered a There is evidence that U.S. military ‘‘developed nation’’ for determination of personnel were exposed to Opisthorchis A. Opisthorchiasis additions to the PRV-eligible tropical spp. and Clonorchis spp. during their Opisthorchiasis is caused by the diseases list under section 524 of the service in the Vietnam War (Ref. 13). In trematodes or O. FD&C Act (Ref. 8). Germany, Greece, one study, there was evidence that felineus, acquired by the consumption and Italy, however, are on the World veterans were likely previously infected, of raw or undercooked fish (Ref. 1). The Bank list of high-income economies, but patients in the study did not have natural final hosts of these O. viverrini and therefore are considered to be evidence of ongoing infection, given

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negative stool exams and negative life years (DALYs), which is calculated movement of infected persons. From the imaging studies, and therefore would by adding the number of years of life countries and regions listed above, not have ongoing infections requiring lost to mortality and the number of South Korea, Taiwan, Uruguay, Chile, treatment at present (Ref. 13). years lived with disability due to and Panama all are on the World Bank’s As illustrated above, opisthorchiasis morbidity due to the illness, of 188,346 list of high-income economies (Ref. 8). occurs rarely in developed nations. The (Refs. 19 and 20). In developed nations where market for drugs for opisthorchiasis in Given the above information, FDA spp. are found, the developed nations such as the United concludes that opisthorchiasis prevalence of paragonimiasis is low, States would largely be comprised of disproportionately affects poor and according to the published data immigrants and travelers to and from marginalized populations. obtained by the Agency. For example, in endemic regions and military Japan, there were 443 patients who were 3. FDA Determination populations serving in endemic regions. referred to one academic institution and These markets are unlikely to provide Given the factors described above, diagnosed as having paragonimiasis sufficient incentive to encourage FDA has determined that from 2001 to 2012 (Ref. 22). The development of products to treat or opisthorchiasis meets both the statutory majority of native Japanese patients prevent opisthorchiasis. At present, criteria of ‘‘no significant market in with paragonimiasis were residents of FDA is unaware of any significant developed nations’’ and one island; while one quarter of the funding for opisthorchiasis drug ‘‘disproportionately affects poor and cases occurred in immigrants mostly development by the U.S government marginalized populations.’’ Therefore, from China, Thailand, and Korea (Ref. sources, and opisthorchiasis is not FDA is designating opisthorchiasis as an 22). In South Korea, the prevalence of among the Centers for Disease Control addition to the tropical diseases list paragonimiasis has precipitously and Prevention’s (CDC) list of potential under section 524 of the FD&C Act. dropped as the country has developed; bioterrorism agents. B. Paragonimiasis in the 1960s, at least 2 million people were estimated to be infected with 2. Opisthorchiasis Disproportionately Paragonimiasis is caused by paragonimiasis based on intradermal Affects Poor and Marginalized Paragonimus spp., which are testing; by the 1990s, the prevalence Populations trematodes acquired through the was reduced to 1 percent of the previous Opisthorchiasis disproportionately consumption of raw or undercooked estimate (Ref. 23). In a relatively recent affects poor and marginalized crustaceans (crabs and crayfish) (Ref. 1). review of medical records at another populations around the world. Within The natural final hosts of Paragonimus large referral medical center in Seoul, countries where O. viverrini or O. spp. are cats, dogs, and other crustacean South Korea, only 36 patients were felineus are reported, opisthorchiasis eating carnivores (Ref. 1). Paragonimus diagnosed with pulmonary predominantly occurs in populations spp. are reported in China, the paragonimiasis over a 10-year period living in impoverished settings. For Philippines, Japan, Vietnam, the (1994 to 2004). FDA was unable to find example, in rural northeast Thailand, Republic of Korea (South Korea), published information about the where the per capita gross domestic Taiwan, Thailand, Central and South prevalence of paragonimiasis in humans product (GDP) is less than $4,000, America, Africa, and there have been in Uruguay, Chile, Argentina, or Panama reported opisthorchiasis prevalence rare reports of these flukes being found (there are rare reports in the midwestern typically exceeds 30 percent of the in the midwestern United States (Ref. United States). One study reported 16 population (Ref. 14). In contrast, in 21). The final location in humans of cases of paragonimiasis acquired in urban Bangkok, where the per capita adult Paragonimus spp. is in tissue Missouri from 2008 to 2014, which were GDP is around $15,000, opisthorchiasis (Ref. 1). The symptoms caused by associated with consumption of raw prevalence is reported to be less than 5 paragonimiasis are chronic with crayfish (Ref. 24). percent of the population (Refs. 14 and blood-stained , , The market for drugs for 15). Likewise, in Laos, in the poorer dyspnea, and (Ref. 1). paragonimiasis in most developed rural southern provinces ( rates Paragonimus spp. can migrate to other nations would largely be comprised of of 30 to 50 percent), reported parts of the body, e.g., to the brain, immigrants and travelers from endemic opisthorchiasis prevalence is the highest where they can cause severe cerebral regions. These low prevalence rates in at 20 to 30 percent, whereas in the manifestations (Ref. 1). There are no developed countries are unlikely to relatively wealthier urban Vientiane FDA-approved treatments for provide sufficient incentive to region of Laos (poverty rate less than 20 paragonimiasis. encourage development of products to percent), opisthorchiasis prevalence is treat or prevent paragonimiasis in 1. No Significant Market in Developed reportedly less than 5 percent (Refs. 15 developed countries. and 16). In Cambodia, a similar trend is Nations noted, where the highest reported FDA is unaware of any significant 2. Paragonimiasis Disproportionately prevalence of opisthorchiasis (24 market for the treatment or prevention Affects Poor and Marginalized percent) can be found in the rural of paragonimiasis in the United States Populations Kampong Cham and Take´o provinces, or other developed nations. As stated Paragonimiasis disproportionately where poverty rates exceed 50 percent above, paragonimiasis is caused by affects poor and marginalized (Refs. 15 and 17). Paragonimus spp. flukes that have been populations around the world. The true Opisthorchiasis is also included in reported in China, the Philippines, burden of paragonimiasis is unclear the WHO List of Neglected Tropical Japan, Vietnam, South Korea, Taiwan, given the population it impacts; under- Diseases (Ref. 18). The WHO Foodborne Thailand, Central and South America, reporting is likely, particularly in Disease Burden Reference Africa, and there have been rare reports African regions (Refs. 25 and 26). While Group identified opisthorchiasis as an of these flukes being found in the epidemiologic data for paragonimiasis important cause of disability, with an midwestern United States. The limited are scant, of foodborne estimated annual incidence of over range of Paragonimus spp. means trematodes within countries is typically 16,315 infections and 1,498 deaths, infections outside of these endemic restricted to limited areas and reflects resulting in a global disability-adjusted countries only occur from the behavioral and ecological patterns

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which are related to socioeconomic information, visit the Agency’s web Monographs on the Identification of status. This includes people’s food page at https://www.fda.gov/AboutFDA/ Carcinogenic Hazards to Humans, Agents habits, methods of food production and CentersOffices/OfficeofMedical Classified by the IARC Monographs,’’ preparation, and the distribution of ProductsandTobacco/CDER/ Vols. 1–124, accessed October 23, 2019, https://monographs.iarc.fr/agents- intermediate hosts. For example, food ucm534162.htm. classified-by-the-iarc/. can be contaminated through IV. Paperwork Reduction Act 5. * WHO, IARC, 2012, ‘‘IARC Monographs unhygienic preparation and storage. on the Evaluation of Carcinogenic Risks Furthermore, the consumption of raw This final order reiterates the ‘‘open’’ in Humans, Opisthorchis Viverrini and fish and crustaceans is a main risk factor status of the previously established Clonorchis Sinensis,’’ Vol. 100B, 341– for contracting these parasites. The life public docket through which interested 370, accessed October 23, 2019, https:// cycle of the parasites is closely linked persons may submit requests for monographs.iarc.fr/wp-content/uploads/ with water and . In additional diseases to be added to the 2018/06/mono100B-13.pdf. populations without access to toilets, or list of tropical diseases that FDA has 6. U.S. National Library of Medicine, 2015, found to meet the criteria in section ‘‘Label: Biltricide-Praziquantel Tablet, without sewage system infrastructure, Film Coated,’’ DailyMed. unprocessed human and animal fecal 524(a)(3)(S) of the FD&C Act. Such a 7. * CDC, 2018, ‘‘Parasites—Opisthorchis waste may be found near water or used request for information is exempt from Infection: Resources for Health as manure or fish feed. This can Office of Management and Budget Professionals,’’ accessed October 24, contaminate drinking water and aquatic review under 5 CFR 1320.3(h)(4) of the 2019, https://www.cdc.gov/parasites/ vegetables, leading to a continuous Paperwork Reduction Act of 1995 (44 opisthorchis/health_professionals/ cycle of infections. U.S.C. 3501–3521). Specifically, facts or index.html. Paragonimiasis is included in the opinions submitted in response to 8. The World Bank, 2018, ‘‘World Bank WHO List of Neglected Tropical general solicitations of comments from Country and Lending Groups,’’ accessed Diseases (Ref. 18). The WHO Foodborne December 12, 2018, https:// the public, published in the Federal datahelpdesk.worldbank.org/ Disease Burden Epidemiology Reference Register or other publications, knowledgebase/articles/906519-world- Group identified paragonimiasis as an regardless of the form or format thereof bank-country-and-lending-groups. important cause of disability, with an are exempt, provided that no person is 9. Pozio, E., O. Armignacco, F. Ferri, and M. estimated annual incidence rate of required to supply specific information Gomez, 2013, ‘‘, an 139,238 infections and 250 deaths, pertaining to the commenter, other than Emerging Infection in Italy and its resulting in global disability-adjusted that necessary for self-identification, as Implication for the European Union,’’ life years of 1,048,937 (Ref. 27). Given a condition of the Agency’s full Acta Tropica, epub ahead of print the above information, FDA has consideration of the comment. January 18, 2013, doi: 10.1016/ concluded that paragonimiasis j.actatropica.2013.01.005. disproportionately affects poor and V. References 10. Furst, T., U. Duthaler, B. Sripa, et al., 2012, ‘‘Trematode Infections: Liver and marginalized populations. The following references marked with Lung Flukes,’’ Infectious Disease Clinics an asterisk (*) are on display at the 3. FDA Determination of North America, 26(2):399–419. Dockets Management Staff (see 11. Qian, M–B., Y–D. Chen, S. Liang, et al., Given the factors described above, ADDRESSES) and are available for 2012, ‘‘The Global Epidemiology of FDA has determined that viewing by interested persons between Clonorchiasis and Its Relation with paragonimiasis meets both the statutory 9 a.m. and 4 p.m., Monday through Cholangiocarcinoma,’’ Infectious criteria of ‘‘no significant market in Friday; they also are available Diseases of Poverty, epub ahead of print developed nations,’’ and electronically at https:// October 25, 2012, doi: 10.1186/2049– ‘‘disproportionately affects poor and www.regulations.gov. References 9957–1–4. 12. Stauffer, W.M., J.S. Sellman, and P.F. marginalized populations.’’ Therefore, without asterisks are not on public FDA is designating paragonimiasis as an Walker, 2004, ‘‘Billiary Liver Flukes display at https://www.regulations.gov (Opisthorchiasis and Clonorchiasis) in addition to the tropical diseases list because they have copyright restriction. Immigrants in the United States: Often under section 524 of the FD&C Act. Some may be available at the website Subtle and Diagnosed Years After III. Process for Requesting Additional address, if listed. References without Arrival,’’ Journal of Travel Medicine, Diseases To Be Added to the List asterisks are available for viewing only 11(3):157–159. at the Dockets Management Staff. FDA 13. Psevdos, G., F.M. Ford, and S.T. Hong, The purpose of this order is to add has verified the website addresses, as of 2018, ‘‘Screening U.S. Vietnam Veterans diseases to the list of tropical diseases the date this document publishes in the for Exposure 5 Decades After that FDA has found to meet the criteria the End of the War,’’ Infectious Diseases Federal Register, but websites are in Clinical Practice, epub ahead of print in section 524(a)(3)(S) of the FD&C Act. subject to change over time. By expanding the list with this order, January 16, 2018, doi: 0.1097/ FDA does not mean to preclude the 1. * WHO, 2018, ‘‘Fact Sheet on Foodborne IPC.0000000000000611. 14. * Office of the National Economic and addition of other diseases to this list in ,’’ accessed October 23, 2019, https://www.who.int/news-room/ Social Development Board of Thailand, the future. Interested persons may fact-sheets/detail/foodborne- 2015, ‘‘Gross Regional and Provincial submit requests for additional diseases trematodiases. Product, 2016 Edition,’’ accessed to be added to the list to the public 2. * CDC, 2018, ‘‘Parasites—Opisthorchis October 25, 2019, https:// docket established by FDA for this Infection, Epidemiology & Risk Factors,’’ www.nesdc.go.th/nesdb_en/ewt_w3c/ purpose (see https:// accessed February 20, 2018, https:// ewt_dl_link.php?filename=national_ www.regulations.gov, Docket No. FDA– www.cdc.gov/parasites/opisthorchis/ account&nid=4317. 2008–N–0567). Such requests should be epi.html. 15. Sithithaworn, P., P. Yongvanit, K. accompanied by information to 3. * WHO, 2018, ‘‘Fact Sheet on Foodborne Duenngai, et al., 2014, ‘‘Roles of Liver Trematodiases,’’ accessed February 8, Fluke Infection As Risk Factor for document that the disease meets the 2018, https://www.who.int/news-room/ Cholangiocarcinoma,’’ Journal of criteria set forth in section 524(a)(3)(S) fact-sheets/detail/foodborne- Hepato-Biliary-Pancreatic Science, epub of the FD&C Act. FDA will periodically trematodiases. ahead of print January 10, 2014, doi: review these requests, and, when 4. * WHO, International Agency for Research 10.1002/jhbp.62. appropriate, expand the list. For further on Cancer (IARC), 2019, ‘‘IARC 16. Epprecht, M., N. Minot, R. Dewina, et al.,

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and the International Food Policy DEPARTMENT OF HEALTH AND written/paper submission and in the Research Institute, 2008, ‘‘The HUMAN SERVICES manner detailed (see ‘‘Written/Paper Geography of Poverty and Inequality in Submissions’’ and ‘‘Instructions’’). the Lao PDR,’’ Swiss National Centre of Food and Drug Administration Competence in Research North-South, Written/Paper Submissions [Docket No. FDA–2020–D–1401] Geographica Bernensia. Submit written/paper submissions as 17. Asian Development Bank, 2014, Adaptive and Other Innovative Designs follows: ‘‘Cambodia Country Poverty Analysis, for Effectiveness Studies of New • Mail/Hand Delivery/Courier (for Mandaluyong City, Philippines,’’ Asian Animal Drugs; Draft Guidance for written/paper submissions): Dockets Development Bank. Industry; Availability Management Staff (HFA–305), Food and 18. * WHO, 2018, ‘‘Neglected Tropical Drug Administration, 5630 Fishers Diseases,’’ accessed October 24, 2019, AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. _ https://www.who.int/neglected diseases/ HHS. • For written/paper comments diseases/en/. ACTION: Notice of availability. submitted to the Dockets Management 19. * WHO, Foodborne Disease Burden Staff, FDA will post your comment, as Epidemiology Reference Group, 2015, SUMMARY: The Food and Drug well as any attachments, except for ‘‘WHO Estimates of the Global Burden of Administration (FDA or Agency) is information submitted, marked and Foodborne Diseases 2007–2015,’’ announcing the availability of a draft identified, as confidential, if submitted accessed October 24, 2019, https:// guidance for industry (GFI) #268 as detailed in ‘‘Instructions.’’ www.who.int/foodsafety/publications/ entitled ‘‘Adaptive and Other Innovative Instructions: All submissions received foodborne_disease/fergreport/en/. Designs for Effectiveness Studies of New 20. Yeh, T.C., P.R. Lin, E.R. Chen, and M.F. must include the Docket No. FDA– Animal Drugs.’’ The draft guidance, if 2020–D–1401 for ‘‘Adaptive and Other Shaio, 2001, ‘‘Current Status of Human finalized, will describe FDA’s current Parasitic Infections in Taiwan,’’ Journal Innovative Designs for Effectiveness thinking with respect to assisting Studies of New Animal Drugs.’’ of Microbiology, Immunology and sponsors in incorporating complex Infection, 34(3):155–160. Received comments will be placed in adaptive and other novel investigation the docket and, except for those 21. * CDC, 2013, ‘‘Parasites—Paragonimias: designs into proposed clinical Epidemiology & Risk Factors,’’ accessed submitted as ‘‘Confidential investigation protocols and applications Submissions,’’ publicly viewable at October 24, 2019, https://www.cdc.gov/ for new animal drugs under the Federal parasites/paragonimus/epi.html. https://www.regulations.gov or at the Food, Drug, and Cosmetic Act (FD&C Dockets Management Staff between 9 22. Nagayasu, E., A. Yoshida, A. Hombu, et Act). al., 2015, ‘‘Paragonimiasis in Japan: A a.m. and 4 p.m., Monday through Twelve-Year Retrospective Case Review, DATES: Submit either electronic or Friday, 240–402–7500. 2001–2012,’’ Internal Medicine, epub written comments on the draft guidance • Confidential Submissions—To ahead of print January 15, 2015, doi: by October 13, 2020 to ensure that the submit a comment with confidential 10.2169/internalmedicine.54.1733. Agency considers your comment on this information that you do not wish to be 23. Cho, S.Y., Y. Kong, and S.Y. Kang, 1997, draft guidance before it begins work on made publicly available, submit your ‘‘Epidemiology of Paragonimiasis in the final version of the guidance. comments only as a written/paper Korea,’’ Southeast Asian Journal of ADDRESSES: You may submit comments submission. You should submit two Tropical Medicine and Public Health, on any guidance at any time as follows: copies total. One copy will include the 28(Suppl 1):S32–36. information you claim to be confidential 24. Fischer, P.U. and G.J. Weil, 2015, ‘‘North Electronic Submissions with a heading or cover note that states American Paragonimiasis: Epidemiology Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS and Diagnostic Strategies,’’ Expert following way: CONFIDENTIAL INFORMATION.’’ The Review of Anti-Infect Therapy, epub • Federal eRulemaking Portal: Agency will review this copy, including ahead of print April 3, 2015, doi: https://www.regulations.gov. Follow the the claimed confidential information, in 10.1586/14787210.2015.1031745. instructions for submitting comments. its consideration of comments. The 25. * WHO, Foodborne Disease Burden Comments submitted electronically, second copy, which will have the Epidemiology Reference Group, 2015, including attachments, to https:// claimed confidential information ‘‘WHO Estimates of the Global Burden of www.regulations.gov will be posted to redacted/blacked out, will be available Foodborne Disease, 2007–2015,’’ the docket unchanged. Because your for public viewing and posted on accessed October 24, 2019, https:// comment will be made public, you are https://www.regulations.gov. Submit www.who.int/foodsafety/publications/ solely responsible for ensuring that your both copies to the Dockets Management _ foodborne disease/fergreport/en/. comment does not include any Staff. If you do not wish your name and 26. * CDC, 2018, ‘‘Parasites—Clonorchis: confidential information that you or a contact information to be made publicly Resources for Health Professionals,’’ third party may not wish to be posted, available, you can provide this accessed October 24, 2019, https:// such as medical information, your or information on the cover sheet and not www.cdc.gov/parasites/clonorchis/ _ anyone else’s Social Security number, or in the body of your comments and you health professionals/index.html. confidential business information, such must identify this information as 27. Nakamura-Uchiyama, F., K. Hiromatsu, as a manufacturing process. Please note ‘‘confidential.’’ Any information marked K. Ishiwata, et al., 2003, ‘‘The Current that if you include your name, contact as ‘‘confidential’’ will not be disclosed Status of Parasitic Diseases in Japan,’’ information, or other information that except in accordance with 21 CFR 10.20 Internal Medicine, 42(3):222–236. identifies you in the body of your and other applicable disclosure law. For Dated: July 8, 2020. comments, that information will be more information about FDA’s posting Lowell J. Schiller, posted on https://www.regulations.gov. of comments to public dockets, see 80 • Principal Associate Commissioner for Policy. If you want to submit a comment FR 56469, September 18, 2015, or access with confidential information that you the information at: https:// [FR Doc. 2020–15252 Filed 7–14–20; 8:45 am] do not wish to be made available to the www.govinfo.gov/content/pkg/FR-2015- BILLING CODE 4164–01–P public, submit the comment as a 09-18/pdf/2015-23389.pdf.

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