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the SUPPLEMENTARY INFORMATION section to CVM to demonstrate substantial DEPARTMENT OF HEALTH AND for electronic access to the draft evidence of effectiveness for new animal HUMAN SERVICES guidance document. drug applications or a reasonable FOR FURTHER INFORMATION CONTACT: expectation of effectiveness for Food and Drug Administration Susan Storey, Center for Veterinary applications for conditional approval of [Docket No. FDA–2008–N–0567] Medicine (HFV–131), Food and Drug a new animal drug. It also describes Administration, 7500 Standish Pl., how sponsors may obtain feedback from Notice of Decision Not To Designate Rockville, MD 20855, 240–402–0578, CVM regarding the incorporation of data as an Addition to the [email protected]. from foreign countries into Current List of Tropical Diseases in the SUPPLEMENTARY INFORMATION: investigations and study protocols Federal Food, Drug, and Cosmetic Act I. Background before the submission of an application. AGENCY: Food and Drug Administration, FDA is committed to supporting data FDA is announcing the availability of HHS. that may be recognized globally in order draft GFI #265 entitled ‘‘Use of Data ACTION: Notice. to enhance animal drug development, from Foreign Investigational Studies to facilitate the use of foreign data, and SUMMARY: The Food and Drug Support Effectiveness of New Animal Administration (FDA or Agency), in Drugs.’’ Section 305 of the Animal Drug minimize the need to conduct duplicative studies. response to suggestions submitted to the and Animal Generic Drug User Fee public docket FDA–2008–N–0567, Amendments of 2018 (Pub. L. 115–234), This level 1 draft guidance is being between June 20, 2018, and November among other things, directed FDA to issued consistent with FDA’s good 21, 2018, has analyzed whether the hold a public meeting for interested guidance practices regulation (21 CFR foodborne trematode infection parties to discuss innovative animal 10.115). The draft guidance, if finalized, clonorchiasis meets the statutory criteria drug investigation designs and to issue will represent the current thinking of for designation as a ‘‘tropical disease’’ guidance addressing the incorporation FDA regarding the use of data from for the purposes of obtaining a priority of the use of such elements of foreign investigational studies to review voucher (PRV) under the Federal investigations as complex adaptive and support the effectiveness of new animal Food, Drug, and Cosmetic Act (FD&C other novel investigation designs, data drugs. It does not establish any rights for Act), namely whether it primarily from foreign countries, real-world any person and is not binding on FDA affects poor and marginalized evidence (including ongoing or the public. You can use an alternative populations and whether there is ‘‘no surveillance activities, observational approach if it satisfies the requirements significant market’’ for drugs that studies, and registry data), biomarkers, of the applicable statutes and prevent or treat clonorchiasis in and surrogate endpoints into clinical regulations. developed countries. The Agency has investigation protocols and applications determined at this time that to support the effectiveness of new II. Paperwork Reduction Act of 1995 clonorchiasis does not meet the animal drugs. statutory criteria for addition to the In the Federal Register of July 9, 2019 FDA tentatively concludes that this tropical diseases list under the FD&C (84 FR 32749), FDA’s Center for draft guidance contains no collection of Act. Although clonorchiasis Veterinary Medicine (CVM) published a information. Therefore, clearance by the disproportionately affects poor and notice of a public meeting entitled Office of Management and Budget marginalized populations, it is an ‘‘Incorporating Alternative Approaches (OMB) under the Paperwork Reduction infectious disease for which there is a in Clinical Investigations for New Act of 1995 (PRA) (44 U.S.C. 3501– significant market in developed nations; Animal Drugs’’ giving interested 3521) is not required. therefore, FDA declines to add it to the persons until August 17, 2019, to However, this draft guidance refers to list of tropical diseases. comment on the topics discussed at the previously approved FDA collections of DATES: July 15, 2020. public meeting and the questions information found in FDA regulations ADDRESSES: Submit electronic published in the meeting notice (84 FR comments on additional diseases 1 for new animal drug applications 32749 at 32750–32751). On August 13, suggested for designation to https:// 2019, we published a notice announcing submitted under sections 512(b) (21 U.S.C. 360b(b)) and 571 (21 U.S.C. www.regulations.gov. Submit written the extension of the comment period to comments on additional diseases September 16, 2019 (84 FR 40071). CVM 360ccc) of the FD&C Act. These collections of information are subject to suggested for designation to the Dockets received numerous comments on the Management Staff (HFA–305), Food and review by the OMB under the PRAct. topics discussed at the public meeting Drug Administration, 5630 Fishers The collections of information in 21 and the questions published in the Lane, Rm. 1061, Rockville, MD 20852. meeting notice and those comments CFR part 514 have been approved under All comments should be identified with were considered as the draft GFI #265 OMB control number 0910–0032. the docket number found in brackets in entitled ‘‘Use of Data from Foreign III. Electronic Access the heading of this document. Investigational Studies to Support FOR FURTHER INFORMATION CONTACT: Effectiveness of New Animal Drugs’’ Persons with access to the internet Katherine Schumann, Center for Drug was developed. may obtain the draft guidance at either Evaluation and Research, Food and This draft guidance describes https://www.fda.gov/animal-veterinary/ Drug Administration, 10903 New principles for designing, conducting, guidance-regulations/guidance-industry Hampshire Ave., Bldg. 22, Rm. 6242, and reporting the results for or https://www.regulations.gov. Silver Spring, MD 20993–0002, 301– investigations or studies, including data Dated: July 9, 2020. 796–1300, Katherine.Schumann@ from foreign countries, in submissions fda.hhs.gov; or Stephen Ripley, Center Lowell J. Schiller, for Biologics Evaluation and Research, 1 https://www.fda.gov/animal-veterinary/ Principal Associate Commissioner for Policy. workshops-conferences-meetings/public-meeting- Food and Drug Administration, 10903 [FR Doc. 2020–15242 Filed 7–14–20; 8:45 am] incorporating-alternative-approaches-clinical- New Hampshire Ave., Rm. 7301, Silver investigations-new-animal-drugs. BILLING CODE 4164–01–P Spring, MD 20993–0002, 240–402–7911.

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SUPPLEMENTARY INFORMATION: section 524 of the FD&C Act; thus, FDA 1. Significant Market in Developed will not add it to the list of tropical Nations Table of Contents diseases whose applications may be FDA was unable to make the I. Background: Priority Review Voucher eligible for a priority review voucher. determination that no significant market Program II. Decision Not To Designate Clonorchiasis II. Decision Not To Designate exists for the treatment or prevention of A. Clonorchiasis Clonorchiasis clonorchiasis in developed nations, as B. FDA Determination the most recent data shows significant III. Process for Requesting Additional FDA has considered all disease prevalence of clonorchiasis in a Diseases To Be Added to the List suggestions submitted to the public developed nation. As stated above, IV. Paperwork Reduction Act docket (FDA–2008–N–0567) between clonorchiasis occurs as a result of V. References June 20, 2018, and November 21, 2018, infection by C. sinensis, which has been I. Background: Priority Review as potential additions to the list of reported in North Korea, South Korea, Voucher Program tropical diseases under section 524 of China, Taiwan, Vietnam, Japan, and the Section 524 of the FD&C Act (21 the FD&C Act, under the docket review Russian Far East. The limited range of U.S.C. 360n), which was added by process explained on the Agency’s web C. sinensis means that individuals are section 1102 of the Food and Drug page at https://www.fda.gov/AboutFDA/ infected only in those countries noted, Administration Amendments Act of CentersOffices/OfficeofMedical and infections in other countries only 2007 (Pub. L. 110–85), uses a PRV ProductsandTobacco/CDER/ occur from the movement of infected incentive to encourage the development ucm534162.htm. Based on an persons. North Korea, China, Vietnam, of new drugs, including biological assessment of currently available and the Russian Federation (Russia) are products, for prevention and treatment information, and using the criteria from not on the World Bank’s list of high- of certain diseases that, in the aggregate, its August 2015 final order, FDA has income countries (Ref. 6). However, affect millions of people throughout the determined that clonorchiasis will not South Korea, Japan, and Taiwan are world. Further information about the be designated as a ‘‘tropical disease’’ for high-income economies, based on World Bank’s list of high-income tropical disease PRV program can be purposes of the tropical disease PRV countries, and therefore are considered found in the October 6, 2016 (81 FR program under section 524 of the FD&C developed countries for purposes of this 69537) guidance for industry ‘‘Tropical Act. Disease Priority Review Vouchers,’’ order (Ref. 6). available at https://www.fda.gov/media/ A. Clonorchiasis In the developed countries where C. 72569/download. Additions to the sinensis is found, clonorchiasis rates are Clonorchiasis is caused by Clonorchis statutory list of tropical diseases by an typically low. C. sinensis was endemic FDA final order published in the sinensis, trematodes (parasitic in Japan throughout the 1950s; however, Federal Register can be accessed at ), also known as flukes, which improved hygiene associated with https://www.fda.gov/about-fda/center- are acquired by humans through the modernization and industrialization has drug-evaluation-and-research-cder/ consumption of raw or undercooked reduced its incidence in humans in the tropical-disease-priority-review- (Ref. 1). The natural final hosts of country to a negligible level (Ref. 7). voucher-program. C. sinensis are dogs and other fish- Likewise, in Taiwan, C. sinensis has On August 20, 2015, FDA published eating carnivores (Ref. 2). C. sinensis are been nearly eliminated from all but a a final order (80 FR 50559) (August 2015 reported in the Democratic People’s small number of poor rural areas (Refs. final order) designating Chagas disease Republic of Korea (North Korea), the 8 and 9). However, as of 2008, South and neurocysticercosis as additions to Republic of Korea (South Korea), China, Korea had an estimated 1.4 million the list of tropical diseases under Taiwan, Vietnam, Japan, and the people infected with C. sinensis. Based section 524 of the FD&C Act. The Russian Far East (Ref. 1). on data from 1981, the egg-positive August 2015 final order also set forth The final location of adult C. sinensis proportion of people living near 7 major FDA’s interpretation of the statutory is the smaller bile ducts of the liver (Ref. rivers was 22 percent among 13,373 examined, varying from 0.6 percent to criteria for designating additions to the 2). The symptoms of clonorchiasis are 45.5 percent (Ref. 10). The persistence section 524 list of tropical diseases and related to inflammation and fibrosis of of C. sinensis infection is thought to be expands the list of tropical diseases the tissues adjacent to bile ducts. While primarily due to difficulties in changing under section 524(a)(3)(R) of the FD&C the majority of infected individuals are the traditional habit of eating raw Act. That section, later redesignated as asymptomatic, patients may develop freshwater fish (Refs. 10 and 11). The section 524(a)(3)(S) of the FD&C Act, cholangitis, intrahepatic calculi, or 2017 South Korean population was authorizes FDA to designate by order cholangiohepatitis (Ref. 2). Chronic ‘‘[a]ny other infectious disease for 51.42 million, and using the most recent infection is also associated with the which there is no significant market in estimate of 1.4 million people infected development of cholangiocarcinoma, a developed nations and that with C. sinensis, the estimated severe and fatal form of bile duct cancer, disproportionately affects poor and prevalence of C. sinensis infection in and C. sinensis is recognized by the marginalized populations’’ as a tropical South Korea is over 2 percent of the International Agency for Research on disease for which approved drug population (Ref. 12). This prevalence is Cancer (IARC) as Group 1, which means applications may be eligible for a PRV. higher than 0.1 percent of the FDA has applied its criteria as set that the agent is classified as population of South Korea. The 0.1 forth in the August 2015 final order to carcinogenic to humans (Refs. 3 and 4). percent of the population was discussed analyze whether clonorchiasis meets the There is one FDA approved treatment in FDA’s order of 2015 as a factor for statutory criteria for addition to the for clonorchiasis, , aiding in the determination of whether tropical diseases list. As discussed approved in 1982 and indicated for the a significant market may exist for a below, the Agency has determined that treatment of infections due to all species disease’s treatment. FDA worked to find clonorchiasis does not meet the of schistosoma and infections due to the a more recent prevalence rate for statutory criteria for designation as a liver flukes C. sinensis and clonorchiasis infections in South Korea PRV-eligible ‘‘tropical disease’’ under viverrini (Ref. 5). but was unsuccessful. If more recent

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prevalence information is publicly through unhygienic preparation and Priority Review Voucher Program web accessible, please provide this storage. Furthermore, the consumption page at https://www.fda.gov/about-fda/ information to the Dockets Management of raw fish and crustaceans is a main center-drug-evaluation-and-research- Staff for Docket No. FDA–2008–N–0567 risk factor for contracting these cder/tropical-disease-priority-review- (see ADDRESSES) and the Agency will parasites. The parasite’s life cycle is voucher-program. reevaluate our findings. closely linked with water and IV. Paperwork Reduction Act There is currently no estimate of the sanitation. In populations without number of individuals with access to toilets, or without sewage This notice reiterates the ‘‘open’’ clonorchiasis in the United States. Of system infrastructure, unprocessed status of the previously established the infections that do occur in the human and animal fecal waste may be public docket through which interested United States, foodborne trematode found near water or used as manure or persons may submit requests for infections occur predominantly in fish feed. This can contaminate drinking additional diseases to be added to the immigrants and travelers from endemic water and aquatic vegetables, leading to list of tropical diseases that FDA has regions (Refs. 13 and 14). For example, a continuous cycle of infections. found to meet the criteria in section in a retrospective study in one U.S. Clonorchiasis is included in the 524(a)(3)(S) of the FD&C Act. Such a travel medicine clinic over 6 years, only World Health Organization (WHO) List request for information is exempt from 17 cases of Opisthorchis spp. and of Neglected Tropical Diseases (Ref. 17). Office of Management and Budget Clonorchis spp. were identified through The WHO Foodborne Disease Burden review under 5 CFR 1320.3(h)(4) of the the review of ova and parasite records Epidemiology Reference Group Paperwork Reduction Act of 1995 (44 (Ref. 15). All patients with identified identified clonorchiasis as an important U.S.C. 3501–3521). Specifically, ‘‘[f]acts cases were migrants from Laos, cause of disability, with an estimated or opinions submitted in response to Cambodia, Thailand, Vietnam, the annual incidence of over 31,620 general solicitations of comments from former Soviet Union, and Ecuador (Ref. infections and 5,770 deaths, resulting in the public, published in the Federal 15). global disability adjusted life years, Register or other publications, There is evidence that U.S. military which is calculated by adding the regardless of the form or format thereof’’ personnel were exposed to Opisthorchis number of years of life lost to mortality are exempt, ‘‘provided that no person is spp. and Clonorchis spp. during their and the number of years lived with required to supply specific information service in the Vietnam War (Ref. 16). In disability due to morbidity due to the pertaining to the commenter, other than one study, there was evidence that illness, of 522,863 (Ref. 18). Given the that necessary for self-identification, as veterans were likely previously infected, above information, it is reasonable to a condition of the full consideration of but patients in the study did not have conclude that clonorchiasis the comment.’’ evidence of ongoing infection given disproportionately affects poor and negative stool exams and negative marginalized populations. V. References imaging studies, and therefore would The following references marked with B. FDA Determination not have ongoing infections requiring an asterisk (*) are on display at the treatment now (Ref. 16). In sum, although clonorchiasis Dockets Management Staff (see As illustrated above, clonorchiasis disproportionately affects poor and ADDRESSES) and are available for occurs rarely in most developed nations. marginalized populations, it is an viewing by interested persons between However, in South Korea, the infectious disease that fails to meet the 9 a.m. and 4 p.m., Monday through prevalence was 1.4 million people statutory criterion for ‘‘no significant Friday; they also are available infected as of 2008, which may offer an market in developed nations.’’ FDA has electronically at https:// incentive to drive development of new determined that, at this time, the www.regulations.gov. References drug products to treat or prevent available information does not support without asterisks are not on public clonorchiasis. a determination that clonorchiasis meets display at https://www.regulations.gov the statutory criteria in section 524 of 2. Clonorchiasis Disproportionately because they have copyright restriction. the FD&C Act for addition to the list of Some may be available at the website Affects Poor and Marginalized tropical diseases. Populations address, if listed. References without asterisks are available for viewing only Clonorchiasis disproportionately III. Process for Requesting Additional Diseases To Be Added to the List at the Dockets Management Staff. FDA affects poor and marginalized has verified the website addresses, as of populations around the world. As areas FDA’s current determination the date this document publishes in the where clonorchiasis occurs develop regarding clonorchiasis does not Federal Register, but websites are economically, the epidemiology of preclude interested persons from subject to change over time. clonorchiasis changes, and fewer cases requesting its consideration in the of clonorchiasis occur. This is future. To facilitate the consideration of 1. *U.S. Centers for Disease Control and future additions to the list, FDA Prevention, 2018, ‘‘Parasites— supported by data in Japan and Taiwan Clonorchis: Epidemiology & Risk where incidences of clonorchiasis have established a public docket (see https:// Factors,’’ accessed October 24, 2019, fallen rapidly with improved hygiene as www.regulations.gov, Docket No. FDA– https://www.cdc.gov/parasites/ the countries have developed (Refs. 7 2008–N–0567) through which interested clonorchis/epi.html. and 8). persons may submit requests for 2. *WHO, 2018, ‘‘Fact Sheet on Foodborne Transmission of foodborne trematodes additional diseases to be added to the ,’’ accessed October 23, within countries is typically restricted list. Such requests should be 2019, https://www.who.int/news-room/ to limited areas and reflects behavioral accompanied by information to fact-sheets/detail/foodborne- and ecological patterns that are related document that the disease meets the trematodiases. 3. *WHO, IARC, 2019, ‘‘IARC Monographs on to socioeconomic status. This includes criteria set forth in section 524(a)(3)(S) the Identification of Carcinogenic people’s food habits, methods of food of the FD&C Act. FDA will periodically Hazards to Humans, Agents Classified by production and preparation, and the review these requests, and, when the IARC Monographs,’’ Vols. 1–125, distribution of intermediate hosts. For appropriate, expand the list. For further accessed October 23, 2019, https:// example, food can be contaminated information, see FDA’s Tropical Disease monographs.iarc.fr/agents-classified-by-

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the-iarc/. diseases/en/. the docket number found in brackets in 4. *WHO, IARC, 2012, ‘‘IARC Monographs on 18. *WHO, Foodborne Disease Burden the heading of this document. the Evaluation of Carcinogenic Risks in Epidemiology Reference Group, 2015, FOR FURTHER INFORMATION CONTACT: Humans, and ‘‘WHO Estimates of the Global Burden of ,’’ Vol. 100B, 341– Foodborne Diseases 2007–2015,’’ Katherine Schumann, Center for Drug 370, accessed October 23, 2019, https:// accessed October 24, 2019, https:// Evaluation and Research, Food and monographs.iarc.fr/wp-content/uploads/ www.who.int/foodsafety/publications/ Drug Administration, 10903 New 2018/06/mono100B-13.pdf. foodborne_disease/fergreport/en/. Hampshire Ave., Bldg. 22, Rm. 6242, 5. U.S. National Library of Medicine, 2015, Dated: July 8, 2020. Silver Spring, MD 20993–0002, 301– ‘‘Label: Biltricide-Praziquantel Tablet, Lowell J. Schiller, 796–1300, Katherine.Schumann@ Film Coated,’’ DailyMed. fda.hhs.gov; or Stephen Ripley, Center 6. The World Bank, ‘‘World Bank Country Principal Associate Commissioner for Policy. and Lending Groups,’’ accessed for Biologics Evaluation and Research, [FR Doc. 2020–15253 Filed 7–14–20; 8:45 am] Food and Drug Administration, 10903 December 12, 2018, https:// BILLING CODE 4164–01–P datahelpdesk.worldbank.org/ New Hampshire Ave., Bldg. 71, Rm. knowledgebase/articles/906519-world- 7301, Silver Spring, MD 20993–0002, bank-country-and-lending-groups. DEPARTMENT OF HEALTH AND 240–402–7911. 7. Nakamura-Uchiyama, F., K. Hiromatsu, K. SUPPLEMENTARY INFORMATION: Ishiwata, et al., 2003, ‘‘The Current HUMAN SERVICES Status of Parasitic Diseases in Japan,’’ Table of Contents Internal Medicine, 42(3):222–236. Food and Drug Administration I. Background: Priority Review Voucher 8. Lo, T.C., J.H. Chang, H.H. Lee, et al., 2013, [Docket No. FDA–2008–N–0567] ‘‘Risk Factors for and Prevalence of Program II. Decision Not To Designate Clonorchiasis in Miaoli County, Notice of Decision Not To Designate Taiwan,’’ Southeast Asian Journal of Coccidioidomycosis Coccidioidomycosis as an Addition to A. Coccidioidomycosis Tropical Medicine and Public Health, the Current List of Tropical Diseases in 44(6):950–958. B. FDA Determination 9. Yeh, T.C., P.R. Lin, E.R. Chen, et al., 2001, the Federal Food, Drug, and Cosmetic III. Process for Requesting Additional ‘‘Current Status of Human Parasitic Act Diseases To Be Added to the List Infections in Taiwan,’’ Journal of IV. Paperwork Reduction Act AGENCY: Food and Drug Administration, Microbiology, Immunology, and V. References HHS. Infection, 34(3):155–160. I. Background: Priority Review ACTION: Notice. 10. Seo, B.S., S.H. Lee, S.Y. Cho, et al., 1981, Voucher Program ‘‘An Epidemiologic Study on Clonorchiasis and Metagonimiasis in SUMMARY: The Food and Drug Section 524 of the FD&C Act (21 Riverside Areas in Korea,’’ Administration (FDA or Agency), in U.S.C. 360n), which was added by Kisaengchunghak Chapchi, 19(2):137– response to suggestions submitted to the section 1102 of the Food and Drug 150. public docket number FDA–2008–N– Administration Amendments Act of 11. Shin, E.H., S.M. Guk, H.J. Kim, et al., 0567 between October 1, 2018, and June 2007 (Pub. L. 110–85), uses a PRV 2008, ‘‘Trends in Parasitic Diseases in 30, 2019, has analyzed whether incentive to encourage the development the Republic of Korea,’’ Trends in coccidioidomycosis meets the statutory Parasitology, epub ahead of print of new drugs, including biological criteria for designation as a tropical products, for prevention and treatment February 5, 2008, doi: 10.1016/ disease for the purposes of obtaining a j.pt.2007.12.003. of certain diseases that, in the aggregate, 12. Statistics Korea, 2018, ‘‘2017 Population priority review voucher (PRV) under the affect millions of people throughout the and Housing Census,’’ accessed October Federal Food, Drug, and Cosmetic Act world. Further information about the 24, 2019, http://kostat.go.kr/portal/eng/ (FD&C Act), namely whether it tropical disease PRV program can be pressReleases/8/7/index.board. primarily affects poor and marginalized found in the guidance for industry 13. Furst, T., U. Duthaler, B. Sripa, et al., populations, and whether there is ‘‘no ‘‘Tropical Disease Priority Review 2012, ‘‘Trematode Infections: Liver and significant market’’ for drugs that Vouchers,’’ available at https:// Lung Flukes,’’ Infectious Disease Clinics prevent or treat coccidioidomycosis of North America, 26(2):399–419. www.fda.gov/media/72569/download. infections in developed countries. The Section 524(a)(3) of the FD&C Act 14. Qian, M.-B., Y.-D. Chen, S. Liang, et al., Agency has determined that 2012, ‘‘The Global Epidemiology of includes a list of infectious diseases, Clonorchiasis and its Relation with coccidioidomycosis does not meet the applications for the prevention or Cholangiocarcinoma,’’ Infectious statutory criteria for designation as a treatment of which may be eligible to Diseases of Poverty, epub ahead of print tropical disease eligible for PRV qualify for a PRV, and Congress has October 25, 2012, doi: 10.1186/2049– consideration because of the potential amended that list multiple times to add 9957–1–4. market for preventive products (such as new diseases since section 524 was first 15. Stauffer, W.M., J.S. Sellman, and P.F. vaccines), and therefore declines to enacted. Additions to the statutory list Walker, 2004, ‘‘Biliary Liver Flukes designate it as an addition to the list of ( and Clonorchiasis) in of PRV-eligible tropical diseases by an tropical disease PRV-eligible diseases at FDA final order published in the Immigrants in the United States: Often this time. Subtle and Diagnosed Years After Federal Register can be accessed at Arrival,’’ Journal of Travel Medicine, DATES: July 15, 2020. https://www.fda.gov/about-fda/center- 11(3):157–159. ADDRESSES: Submit electronic drug-evaluation-and-research-cder/ 16. Psevdos, G., F.M. Ford, and S.T. Hong, comments on additional diseases tropical-disease-priority-review- 2018, ‘‘Screening US Vietnam Veterans suggested for designation to https:// voucher-program. for Exposure 5 Decades After www.regulations.gov. Submit written On August 20, 2015, FDA published the End of the War,’’ Infectious Diseases comments on additional diseases a final order (80 FR 50559) (August 2015 in Clinical Practice, epub ahead of print January 16, 2018, doi: 0.1097/ suggested for designation to the Dockets final order) designating Chagas disease IPC.0000000000000611. Management Staff (HFA–305), Food and and neurocysticercosis as additions to 17. *WHO, 2018, ‘‘Neglected Tropical Drug Administration, 5630 Fishers the list of tropical diseases under Diseases,’’ accessed October 24, 2019, Lane, Rm. 1061, Rockville, MD 20852. section 524 of the FD&C Act. The https://www.who.int/neglected_diseases/ All comments should be identified with August 2015 final order also set forth

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