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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, Viverrini 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- 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 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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FDA’s interpretation of the statutory soil disruption and wind. The species without immunosuppressive conditions, criteria for designating additions to the most commonly associated with disease advising that such patients receive section 524 list of tropical diseases and are C. immitis, which is endemic to supportive measures such as physical expands the list of tropical diseases parts of California, and C. posadasii, therapy and close monitoring. In under section 524(a)(3)(R) of the FD&C which is found in Arizona, Utah, Texas, individuals with severe disease or Act. That section, later redesignated as regions of Mexico, and Central and disseminated disease, these guidelines section 524(a)(3)(S) of the FD&C Act, South America (Ref. 1). Most reported advise antifungal therapy for a authorizes FDA to designate by order cases occur in individuals who live in minimum of 3 to 6 months with an ‘‘[a]ny other infectious disease for or have traveled to endemic areas. From azole (fluconazole or itraconazole), which there is no significant market in 1990 to 2011, the incidence of reported intravenous amphotericin B, or both. developed nations and that coccidioidomycosis in the United States Patients with immunocompromise or disproportionately affects poor and increased greater than 8-fold in areas of other underlying conditions may require marginalized populations’’ as a tropical endemicity (Ref. 2). therapy for 12 months or longer. In disease for which approved drug Manifestations of infection with individuals with meningitis due to applications may be eligible for a PRV. Coccidioides spp. can range from Coccidioides spp., these guidelines FDA has applied its criteria as set subclinical (estimated at one-half to recommend treatment for life (Ref. 13). forth in the August 2015 final order to two-thirds of infections), that might not There are two FDA-approved analyze whether the fungal infection be detected unless the person is treatments for coccidioidomycosis: coccidioidomycosis meets the statutory included in a skin test survey or Amphotericin B deoxycholate, available criteria for addition to this tropical serologic screening, to acute self-limited in brand or generic form, and disease list. As discussed below, the respiratory illness that may be difficult ketoconazole. In 2013, FDA warned that Agency has determined that to distinguish from other acute ketoconazole should not be used as a coccidioidomycosis does not meet the respiratory infections, to severe disease first-line therapy for any fungal statutory criteria for designation as a with chronic or life-threatening infection as it can cause severe liver PRV-eligible ‘‘tropical disease’’ under complications (Ref. 3). Acute respiratory injury, adrenal insufficiency, and section 524 of the FD&C Act because of coccidioidomycosis has a 1- to 3-week harmful drug interactions, and should the potential market for preventive incubation period and most commonly be prescribed only for endemic measures such as vaccines. Thus, FDA presents as a self-limited illness with mycoses, such as coccidioidomycosis, will not add it to the list of tropical fever, muscle pain, cough, , weight when alternative antifungal therapies diseases whose applications may be loss, and (Ref. 4). In areas where are not available or tolerated (Ref. 14). eligible for a priority review voucher at the illness is highly endemic, upwards With respect to preventative products, this time. of 30 percent of community-acquired no vaccines have yet been developed pneumonia cases may be caused by that protect persons from developing II. Decision Not To Designate Coccidioides spp. (Ref. 5). Five to ten infection or progressing from infection Coccidioidomycosis percent of affected patients develop to disease due to C. immitis, but FDA has considered all disease severe or chronic lung disease such as potential for development of such suggestions submitted to the public cavitary pneumonia, nodules, and vaccines has been a topic of interest in docket (FDA–2008–N–0567) between bronchiectasis, and in approximately some expert discussions as outlined in October 1, 2018, and June 30, 2019, as one percent of patients, infection the next section. potential additions to the list of tropical disseminates to the central nervous 1. Significant Market in Developed diseases under section 524 of the FD&C system, skin, joints, or bone. Individuals Nations Act, under the docket review process older than 65 years, smokers, and those explained on the Agency’s web page at with are at increased risk of In the August 2015 final order, FDA https://www.fda.gov/about-fda/center- pulmonary complications of interpreted the statutory criterion ‘‘no drug-evaluation-and-research-cder/ coccidioidomycosis, while those with significant market’’ to refer to the tropical-disease-priority-review- depressed cellular immune function market for drugs for the treatment or voucher-program. Based on an (Refs. 6 and 7), pregnant women (Ref. 8), prevention of infectious diseases. The assessment of currently available or persons of African or Asian descent August 2015 final order states, information, and using the criteria from have an elevated risk of disseminated ‘‘[b]ecause the statute offers vouchers its August 2015 final order, FDA has disease (Ref. 9). Coccidioidal meningitis for applications for drugs for either the determined that coccidioidomycosis cannot be reliably cured with current treatment or prevention of infectious does not currently fulfill the criteria for antifungal therapy and has a mortality diseases, it is reasonable to assume that addition to the list of diseases eligible rate of approximately 30 percent (Ref. ‘no significant market’ can refer to drugs for the tropical disease PRV program 10). Although the public health burden for the treatment or prevention of under section 524 of the FD&C Act and attributable to coccidioidomycosis in infectious diseases. Thus, FDA will is not designating it as an addition to the United States is primarily due to analyze the market for drugs for both the the list at this time. morbidity, an estimated 200 treatment and prevention of infectious coccidioidomycosis-associated deaths diseases for a particular infectious A. Coccidioidomycosis occur each year (Ref. 11). disease.’’ In other words, if there is a Coccidioidomycosis, also known as Treatment recommendations depend significant market for either the ‘‘Valley fever,’’ is a systemic fungal upon the severity, location, and treatment or prevention of the infectious infection caused by inhalation of dissemination of the disease as well as disease, the criterion that there be ‘‘no Coccidioides spp. spores. Major areas of the underlying immune status of the significant market’’ in developed endemicity include substantial parts of patient (Ref. 12). A 2016 publication of nations is not met. the southwestern United States. The professional society guidelines The relative importance of prevention fungus occurs in the environment, recommends against antifungal therapy markets may vary in part according to especially in certain soil types in hot, in patients with newly diagnosed, whether most cases of a particular dry climates, and inhalation may occur uncomplicated coccidioidal pneumonia, disease in developed countries are after environmental disturbance such as with mild or resolved symptoms, and attributable to exposure in those same

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countries (or would be in the absence of environment due to climate variation illness. Data to support a market a preventive product such as vaccine) or and soil disruption, greater exposure of estimate are limited, and discussions of to movement between countries of higher risk individuals, including the potential vaccine cost-effectiveness have persons exposed elsewhere, because immunocompromised, and increased used widely different assumptions preventive measures may be more numbers of susceptible individuals regarding annual target population size, widely important if exposure could be living in or traveling to endemic regions from 90,000 (based on targeting birth local and unavoidable than if the (Refs. 9 and 19). cohorts in highly endemic regions potential for exposure is restricted to a A recent Morbidity and Mortality within California and Arizona) (Ref. 21), small group of travelers. For example, in Weekly Report (MMWR) surveillance to ‘‘many millions’’ in a worldwide the August 24, 2018, final order adding summary noted fluctuating total estimate (Ref. 22). four diseases to the PRV-eligible list (83 numbers of reported U.S. cases in recent An annual target population size FR 42904), chikungunya and Lassa fever years (22,634 in 2011, 8,232 in 2014, estimate of 1,035,300 for a were noted as being principally 14,364 in 2017), all substantially higher coccidioidomycosis vaccine for use in imported diseases in their limited than numbers reported annually in the the United States was presented in an occurrence in developed countries (as United States from 1998 to 2000. The Institute of Medicine (IOM) committee also noted for Chagas disease and MMWR surveillance summary report on ‘‘Vaccines for the 21st neurocysticercosis in the August 2015 addressed potential factors contributing Century’’ commissioned by the National final order), rabies prophylaxis was to such fluctuations, including Institutes of Health (NIH), which analyzed and estimated at below 0.1 environmental, population, and utilized a quantitative model to provide percent per year in the United States, reporting changes; noted ‘‘Preliminary decision makers with a tool to aid in and cryptococcal meningitis was noted modeling estimates of the actual number prioritizing vaccine development (Ref. as not having prophylaxis of cases suggest that the number of 23). The committee determined an recommendations at present even in symptomatic cases nationwide could be estimate of annual target population for highly immunocompromised patients. 6 to 14 times higher than the number a coccidioidomycosis vaccine based Conversely, in the August 24, 2018, reported to public health authorities’’; upon targeting birth cohorts in five document (83 FR 42896), a significant and recommended ‘‘[h]ealth care States where infections are ‘‘most market for prevention was noted as the providers should consider a diagnosis of prominent’’ plus persons who migrate reason for not adding pneumocystis coccidioidomycosis in patients who live into that area. This methodology was pneumonia to the PRV-eligible list. or work in or have traveled to areas with used because persons who move into In the current analysis, FDA has known geographic risk for Coccidioides the endemic part of the United States found that a sizeable direct market may and be aware that those areas might be and were not previously vaccinated exist for products to prevent broader than previously recognized’’ could be at risk from environmental coccidioidomycosis (e.g., vaccines) in (Ref. 11). exposure in the endemic area after their developed nations, depending upon the In the August 2015 final order, FDA move. The committee report estimates specific attributes of the product and the used a disease prevalence rate of 0.1 that 90 percent of newborns and 10 recommended population. For this percent of the population in developed percent of persons moving into the reason, the statutory criterion that there countries for aiding in the targeted areas would receive the be ‘‘no significant market for prevention determination of whether a ‘‘significant vaccine. or treatment’’ of coccidioidomycosis is market’’ may exist for treatment of a Given the purpose of the IOM not met. (21 U.S.C. 360n(a)(3)(S)). disease. For purposes of determining a committee report, the methodology The United States is a high-income reasonable indicator for the number of used, and the experts and stakeholders economy according to the World Bank cases of coccidioidomycosis that might consulted in its development, FDA list of high-income countries and be considered for treatment in a given considers it a reasonable estimate of a therefore is considered a developed year annual incidence (new cases potential target population for a country for purposes of this order (Ref. appearing during a given year) was used licensed coccidioidomycosis vaccine. 15). The true incidence of by FDA. Based on the 2010 U.S. census We acknowledge that there are coccidioidomycosis in the United States population of 308.7 million, and using limitations to any hypothetical estimate is difficult to establish because reporting an estimate of 150,000 total cases per of a recommended population for a is not required in all States, case year, the calculated annual incidence licensed coccidioidomycosis vaccine, definitions may vary, and many cases rate in the United States would be and the true population would depend are misdiagnosed or lack confirmatory approximately 0.048 percent (Refs. 4 upon multiple factors that include, but testing (Refs. 11 and 16). However, up and 20). These estimates suggest the are not limited to: The incidence and/ to 150,000 new infections caused by annual number of persons potentially or prevalence of disease, the extent of Coccidioides spp. are estimated to occur considered for treatment for exposure risks that may not be readily annually in the United States (Ref. 3). coccidioidomycosis in the United States avoidable by means other than The incidence of reported is currently below 0.1 percent of the vaccination, and the indication, safety coccidioidomycosis in the United States population. However, these estimates profile, efficacy, and durability of the has increased in Arizona, California, should be considered with due regard to immune response associated with a Nevada, New Mexico, and Utah, from their inherent uncertainty and also in specific product. However, the IOM 5.3 per 100,000 population in 1998 to the context of potential development of analysis predicts a sizeable direct 42.6 per 100,000 in 2011 (Ref. 2). While products for prevention of infection or market for products to prevent the approximately 96 percent of infections prevention of disease due to disease, and no strong evidence has reported in 2017 in the United States Coccidioides spp. been found that the potential market has occurred in Arizona and California (Ref. Because of the ongoing environmental become smaller since the time of the 11), coccidioidomycosis is increasingly exposures and risk factors for severe committee report. being recognized outside these regions disease when infection occurs, the A few efforts have been initiated to (Refs. 17 and 18). Proposed reasons for market for prevention products such as help facilitate development of products the rise in cases and geographic vaccines could differ substantially from targeting coccidioidomycosis. At expansion include changes to the local that for treatment of clinically manifest present, FDA is aware of funding for

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coccidioidomycosis drug development the United States (Refs. 30 and 32). Coccidioidomycosis is not currently by U.S. government sources, including Coccidioidin skin test surveys in designated by WHO as a Neglected grants reported as being awarded by Mexico some decades ago were reported Tropical Disease and no data were FDA and the NIH (Refs. 25 and 26). as demonstrating positivity ranging from found on Disability-Adjusted Life Years FDA’s Office of Orphan Product 10 percent in Tijuana, to 40 percent in distinguishing the burden attributable to Development has accorded orphan Torreon, to as high as 93 percent in 12 coccidioidomycoses in developing product designation to several drugs communities in Coahuila (Ref. 30). In versus developed countries. However, intended to treat coccidioidomycosis Brazil, by one estimate, 7.12 of 1,000 patients with coccidioidomycosis often (Ref. 27). FDA added Coccidioides hospital admissions were due to experience prolonged symptoms, delays species to the ‘‘list of ‘‘qualifying coccidioidomycosis (Ref. 33). Treatment in diagnosis, and unnecessary pathogens’’ that have the potential to options are more limited in Latin antibacterial therapy (Ref. 43). Due to pose a serious threat to human health’’ America than in the United States, as greater barriers to medical care for under the Generating Antibiotic lipid formulations of amphotericin have diagnosis and treatment, poor and Incentives Now title of the Food and restricted availability due to the high marginalized patents in both developing Drug Administration Safety and cost (Ref. 34). and developed countries experience a Innovation Act, noting ‘‘[i]t is estimated In the United States, several racial significant burden of disease. Resolution that up to 60 percent of people living in and ethnic minority groups have been of symptoms may take months, thus the endemic areas of southwestern reported to have increased risk of severe resulting in significant impairment of United States have been exposed to the disease; genetic, socioeconomic, activities of daily living and loss of fungus’’ (June 5, 2014, 79 FR 32464). C. occupational, and geographic factors productivity (Ref. 44). immitis and C. posadasii were have been suggested as potentially The above information demonstrates previously on the HHS list of Select contributory factors. Analyses of it is reasonable to conclude that Agents and Toxins but were removed in hospitalizations from 2000 to 2011 and coccidioidomycosis disproportionately 2012 based on availability of treatment deaths from 2000 to 2013 in California affects poor and marginalized and a lowered assessment of impact on have reported higher rates in African- populations. human health (Ref. 28). Further, Americans, Hispanics, and older Coccidioides species are not listed as a persons compared to the general B. FDA Determination population (Refs. 35 and 36). Among high priority threat in the 2017–2018 Given the factors described above, immunocompromised or Public Health Emergency Medical FDA has determined that Countermeasures Enterprise Strategy immunosuppressed populations, coccidioidomycoses meets the statutory and Implementation Plan (Ref. 29). persons with HIV infection were criteria of ‘‘disproportionately affects In summary, based on the analyses reported to be strikingly vulnerable outlined above focusing on the during the early years of the HIV poor and marginalized populations,’’ estimated vaccination rates of infants pandemic. While effective antiretroviral but it does not meet the criteria of ‘‘no born in endemic areas and persons who therapy has decreased the disease significant market in developed may be exposed by moving into those burden in individuals with HIV, nations’’ due to the potentially areas, FDA has found a significant affected patients lacking access to significant direct market for products to potential direct market for products for treatment, or with poorly-controlled prevent the disease. Therefore, FDA prevention of coccidioidomycosis. disease, are at higher risk for severe or declines to designate disseminated disease (Ref. 37). coccidioidomycosis as an addition to 2. Coccidioides spp. Disproportionately While adults over the age of 60 have the tropical disease list under section Affects Poor and Marginalized the highest incidence of 524 of the FD&C Act. Populations coccidioidomycosis (Ref. 38), children III. Process for Requesting Additional Illnesses caused by Coccidioides spp. under the age of 17 and their caretakers Diseases To Be Added to the List cause significant morbidity with a bear a substantial burden of the disease disproportionate impact on poor and in endemic regions, experiencing delays FDA’s current determination marginalized populations. In addition to in diagnosis, prolonged symptoms, regarding coccidioidomycoses does not the well-known endemic regions of the hospitalizations, and missed school and prevent interested persons from United States, cases and outbreaks of work (Ref. 39). In California, for requesting its consideration in the coccidioidomycosis have been reported example, during a period when reported future. To facilitate the consideration of in Mexico, Guatemala, Honduras, cases and hospitalizations in the general future additions to the list, FDA Nicaragua, Colombia, Venezuela, population increased 4.5-fold and 2.7- established a public docket (see https:// Argentina, Brazil, Paraguay, and Bolivia fold, respectively, cases and www.regulations.gov, Docket No. FDA– (Ref. 30). With the exception of the hospitalizations in children increased 2008–N–0567) through which interested United States and Argentina, none of almost 6-fold (Ref. 40). persons may submit requests for these countries is on the World Bank list Prison inmates in endemic regions are additional diseases to be added to the of high-income economies, which in the at particularly high risk of symptomatic list. Such requests should be August 2015 final order FDA disease. One study in California found accompanied by information to determined would be used as evidence that the risk of primary disease was document that the disease meets the that the country should be considered a highest in prisoners over the age of 40 criteria set forth in section 524(a)(3)(S) ‘‘developed nation’’ for tropical disease and in non-white ethnic groups (Ref. of the FD&C Act. FDA will periodically determination (Ref. 15). While 41). A significant increase in review these requests, and, when coccidioidal skin test antigens do not coccidioidomycosis that was observed appropriate, expand the list. For further distinguish subclinical infection from in two California prisons led to a court information, see FDA’s Tropical Disease symptomatic disease, and recent data ruling excluding inmates from Priority Review Voucher Program web from skin test surveys are sparse (Ref. incarceration at those locations if they page at https://www.fda.gov/about-fda/ 31), available information indicates that were in risk groups identified by the center-drug-evaluation-and-research- coccidioidomycosis may be as prevalent American Thoracic Society for high risk cder/tropical-disease-priority-review- in parts of Latin America as in parts of of severe coccidioidomycosis (Ref. 42). voucher-program.

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IV. Paperwork Reduction Act the Treatment of Coccidioidomycosis,’’ et al., 2013, ‘‘Coccidioidomycosis Clinical Infectious Diseases, 63(6):717– Acquired in Washington State,’’ Clinical This notice reiterates the ‘‘open’’ 722. Infectious Diseases, epub ahead of print status of the previously established 5. Valdivia, L., D. Nix, M. Wright, et al., 2006, December 7, 2012, doi: 10.1093/cid/ public docket through which interested ‘‘Coccidioidomycosis as a Common cis1028. persons may submit requests for Cause of Community-Acquired 18. Engelthaler, D.M., C.C. Roe, C.M. Hepp, additional diseases to be added to the Pneumonia,’’ Emerging Infectious et al., 2016, ‘‘Local Population Structure list of tropical diseases that FDA has Diseases, 12(6):958–962. and Patterns of Western Hemisphere found to meet the criteria in section 6. Bergstrom, L., D.E. Yocum, N.M. Ampel, Dispersal for Coccidioides spp., the 524(a)(3)(S) of the FD&C Act. Such a et al., 2004, ‘‘Increased Risk of Fungal Cause of Valley Fever,’’ mBio, Coccidioidomycosis in Patients Treated 7(2):e00550–16. request for information is exempt from with Tumor Necrosis Factor Alpha 19. Hector, R.F. and R. Laniado-Laborin, Office of Management and Budget Antagonists,’’ Arthritis & Rheumatology, 2005, ‘‘Coccidioidomycosis—A Fungal review under 5 CFR 1320.3(h)(4) of the 50(6):1959–1966. Disease of the Americas,’’ PLoS Med, Paperwork Reduction Act of 1995 (44 7. Miller, M.B., R. Hendren, and P.H. 2(1):e2. U.S.C. 3501–3521). Specifically, ‘‘[f]acts Gilligan, 2004, ‘‘Posttransplantation 20. * U.S. Census Bureau, 2011, ‘‘Population or opinions submitted in response to Disseminated Coccidioidomycosis Distribution and Change: 2000 to 2010,’’ general solicitations of comments from Acquired From Donor Lungs,’’ Journal of 2010 Census Briefs, accessed January 10, the public, published in the Federal Clinical Microbiology, 42(5):2347–2349. 2020, https://www.census.gov/prod/ 8. Bercovitch, R.S., A. Catanzaro, B.S. cen2010/briefs/c2010br-01.pdf. Register or other publications, Schwartz, et al., 2011, 21. Barnato, A.E., G.D. Sanders, and D.K. regardless of the form or format thereof’’ ‘‘Coccidioidomycosis During Pregnancy: Owens, 2001, ‘‘Cost-Effectiveness of a are exempt, ‘‘provided that no person is A Review and Recommendations for Potential Vaccine for Coccidioides required to supply specific information Management,’’ Clinical Infectious Immitis,’’ Emerging Infectious Diseases, pertaining to the commenter, other than Diseases, 53(4)363–368. 7(5):797–806. that necessary for self-identification, as 9. *CDC, 2009, ‘‘Increase in 22. Galgiani, J.N. 2008, ‘‘Vaccines to Prevent a condition of the full consideration of Coccidioidomycosis—California, 2000– Systemic Mycoses: Holy Grails Meet the comment.’’ 2007,’’ MMWR Morb Mortal Wkly Rep, Translational Realities,’’ Journal 58(5):105–109. Infectious Diseases 197(7):938–940. V. References 10. Johnson, R.H. and H.E. Einstein, 2006, 23. Stratton, K R., J.S. Durch, and R.S. The following references marked with ‘‘Coccidioidal Meningitis,’’ Clinical Lawrence, 2000, ‘‘Vaccines for the 21st Infectious Diseases, epub ahead of print Century: A Toll for Decisionmaking,’’ an asterisk (*) have been placed on November 29, 2005, doi: 10.1086/ Washington, DC: National Academies display at the Dockets Management Staff 497596. Press. (see ADDRESSES). They may be seen by 11. *CDC, 2019, ‘‘Valley Fever 24. Galgiani, J N. 2019, ‘‘Vaccines to Prevent interested persons between 9 a.m. and 4 (Coccidioidomycosis) Statistics,’’ cited Coccidioidomycosis: 60 Years and p.m., Monday through Friday, and are May 3, 2019, https://www.cdc.gov/ Counting,’’ cited September 25, 2019, available electronically at https:// fungal/diseases/coccidioidomycosis/ https://custom.cvent.com/ www.regulations.gov. References statistics.html. 5ED8172A3B414619A18F319 without asterisks are not on public 12. Galgiani, J.N. 2019, ‘‘Valley Fever 32AAB4C72/files/ display at https://www.regulations.gov (Coccidioidomycosis): Tutorial for 39a4663417b84176bcbe Primary Care Professionals,’’ cited 678ab3c0259a.pdf. because they have copyright restriction. January 15, 2019, https:// 25. University of Arizona, 2016, ‘‘The Search Some may be available at the website vfce.arizona.edu/sites/default/files/9- for the Cure for Valley Fever— address, if listed. References without valley_fever_tutorial.pdf. Nikkomycin Z Development at the asterisks are available for viewing only 13. Galgiani, J.N., N.M. Ampel, J.E. Blair, et University of Arizona,’’ cited May 3, at the Dockets Management Staff. FDA al., 2016, ‘‘2016 Infectious Diseases 2019, https://vfce.arizona.edu/sites/vfce/ has verified the website addresses but is Society of America (IDSA) Clinical files/bio5_summary_nikz_development_ not responsible for any subsequent Practice Guideline for the Treatment of plan_1.pdf. changes to the websites after this Coccidioidomycosis,’’ Clinical Infectious 26. * NIH, National Institutes of and document publishes in the Federal Diseases, epub ahead of print July 27, Infectious Diseases, 2018, ‘‘Two Clinical 2016, doi: 10.1093/cid/ciw360. Trials Focus on Serious Fungal Disease Register. 14. *FDA, 2017, ‘‘FDA Drug Safety Valley Fever,’’ cited May 2, 2019, https:// 1. Saubolle, M.A., P.P. McKellar, and D. Communication: FDA Limits Usage of www.niaid.nih.gov/news-events/two- Sussland, 2007, ‘‘Epidemiologic, Nizoral (Ketoconazole) Oral Tablets Due clinical-trials-focus-serious-fungal- Clinical, and Diagnostic Aspects of to Potentially Fatal Liver Injury and Risk disease-valley-fever. Coccidioidomycosis,’’ Journal of Clinical of Drug Interactions and Adrenal Gland 27. * FDA, 2002, ‘‘Cumulative List of All Microbiology, epub ahead of print Problems,’’ cited May 10, 2019, https:// Products That Have Received Orphan November 15, 2006, doi: 10.1128/ www.fda.gov/drugs/drug-safety-and- Designation: Total Active Designations,’’ JCM.02230–06. availability/fda-drug-safety- effective May 5, 2009, cited June 4, 2019, 2. *U.S. Centers for Disease Control and communication-fda-limits-usage-nizoral- https://www.fda.gov/media/76409/ Prevention (CDC), 2013, ‘‘Increase in ketoconazole-oral-tablets-due- download. Reported Coccidioidomycosis—United potentially. 28. * CDC, U.S. Department of Health and States, 1998–2011,’’ Morbitity and 15. The World Bank, 2018, World Bank Human Services (HHS), January 19, Mortality Weekly Report (MMWR), Country and Lending Groups, cited April 2017, ‘‘Possession, Use, and Transfer of 62(12):217–221. 29, 2019, https:// Select Agents and Toxins; Biennial 3. Galgiani, J.N., N.M. Ampel, J.E. Blair, et al., datahelpdesk.worldbank.org/ Review,’’ final rule, Federal Register, 82 and the Infectious Diseases Society of knowledgebase/articles/906519-world- FR 6278. America, 2005, ‘‘Coccidioidomycosis,’’ bank-country-and-lending-groups. 29. * HHS, 2017, ‘‘2017–2018 Public Health Clinical Infectious Diseases, epub ahead 16. Chang, D.C., S. Anderson, K. Emergency Medical Countermeasures of print September 20, 2005, doi: Wannemuehler, et al., 2008, ‘‘Testing for Enterprise (PHEMCE) Strategy and 10.1086/496991. Coccidioidomycosis Among Patients Implementation Plan,’’ accessed January 4. Galgiani, J.N., N.M. Ampel, J.E. Blair, et al., With Community-Acquired Pneumonia,’’ 15, 2020, https://www.phe.gov/ 2016, ‘‘Executive Summary: 2016 Emerging Infectious Diseases, Preparedness/mcm/phemce/Documents/ Infectious Diseases Society of America 14(7):1053–1059. 2017-phemce-sip.pdf. (IDSA) Clinical Practice Guideline for 17. Marsden-Haug, N., M. Goldoft, C. Ralston, 30. Laniado-Laborin, R., 2007, ‘‘Expanding

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Understanding of Epidemiology of Fever,’’ Medical Mycology, epub ahead of third party may not wish to be posted, Coccidioidomycosis in the Western print November 26, 2015, doi: 10.1093/ such as medical information, your or Hemisphere,’’ Annals of the New York mmy/myv097. anyone else’s Social Security number, or Academy of Sciences, epub ahead of Dated: July 8, 2020. confidential business information, such print March 29, 2007, doi: 10.1196/ annals.1406.004. Lowell J. Schiller, as a manufacturing process. Please note 31. Wack, E.E., N.M. Ampel, R.H. Principal Associate Commissioner for Policy. that if you include your name, contact Sunenshine, and J.N. Galgiani, 2015, [FR Doc. 2020–15255 Filed 7–14–20; 8:45 am] information, or other information that ‘‘The Return of Delayed-Type identifies you in the body of your BILLING CODE 4164–01–P Hypersensitivity Skin Testing for comments, that information will be Coccidioidomycosis,’’ Clinical Infectious posted on https://www.regulations.gov. Diseaes, epub ahead of print May 15, • If you want to submit a comment 2015, doi: 10.1093/cid/civ388. DEPARTMENT OF HEALTH AND HUMAN SERVICES with confidential information that you 32. Laniado-Laborin, R., E.G. Arathoon, C. do not wish to be made available to the Canteros, et al., ‘‘Coccidioidomycosis in public, submit the comment as a Latin America,’’ Medical Mycology, 57(1 Food and Drug Administration Suppl):S46–S55. written/paper submission and in the [Docket No. FDA–1997–D–0444] 33. Giacomazzi, J., L. Baethgen, L.C. Carneiro, manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). et al., in association with the LIFE Special Considerations, Incentives, Program, 2016, ‘‘The Burden of Serious Written/Paper Submissions Human Fungal Infections in Brazil,’’ and Programs To Support the Mycoses, epub ahead of print December Approval of New Animal Drugs for Submit written/paper submissions as 22, 2015, doi: 10.1111/myc.12427. Minor Uses and for Minor Species; follows: 34. Gonza´lez-Benavides, J., 1991, ‘‘The Draft Guidance for Industry; • Mail/Hand Delivery/Courier (for Panorama of Coccidioidomycosis in Availability written/paper submissions): Dockets Nuevo Leon from 1978 to 1988,’’ Gaceta Management Staff (HFA–305), Food and AGENCY: Food and Drug Administration, Medica de Mexico, 127(5):427–432. Drug Administration, 5630 Fishers 35. Sondermeyer Cooksey, G., L.A. Lee, D. HHS. Lane, Rm. 1061, Rockville, MD 20852. Gilliss, et al., 2013, ACTION: Notice of availability. • For written/paper comments ‘‘Coccidioidomycosis-Associated submitted to the Dockets Management Hospitalizations, California, USA, 2000– SUMMARY: The Food and Drug Staff, FDA will post your comment, as 2011,’’ Emerging Infectious Diseases, Administration (FDA or Agency) is well as any attachments, except for 10:1590–1597. announcing the availability of draft 36. Sondermeyer Cooksey, G., L.A. Lee, D. information submitted, marked, and guidance for industry (GFI) #61 entitled Gilliss, and D.J. Vugia, 2016, identified as confidential, if submitted ‘‘Special Considerations, Incentives, and ‘‘Coccidioidomycosis-Associated Deaths as detailed in ‘‘Instructions.’’ in California, 2000–2013,’’ Public Health Programs to Support the Approval of Instructions: All submissions received Reports, 131(4):531–535. New Animal Drugs for Minor Uses and must include the Docket No. FDA– 37. Ampel, N.M. 2005, ‘‘Coccidioidomycosis for Minor Species.’’ This draft guidance 1997–D–0444 for ‘‘Special in Persons Infected With HIV Type 1,’’ is intended to assist those interested in Considerations, Incentives, and Clinical Infectious Diseases, epub ahead pursuing FDA approval of new animal of print September 12, 2005, doi: Programs to Support the Approval of drugs intended for minor uses in major New Animal Drugs for Minor Uses and 10.1086/444502. species or for use in minor species 38. Benedict, K., O.Z. McCotter, S. Brady, et for Minor Species.’’ Received comments al., 2019, ‘‘Surveillance for (MUMS drugs). It outlines the basic will be placed in the docket and, except Coccidioidomycosis—United States, statutory and regulatory requirements for those submitted as ‘‘Confidential 2011–2017,’’ MMWR Surveillance and special considerations for these Submissions,’’ publicly viewable at Summaries, 68(7):1–15. approvals, and describes the incentives https://www.regulations.gov or at the 39. Lee, L.A., G. Sondermeyer Cooksey, J.J. available to encourage the development Dockets Management Staff between 9 Kim, et al., 2019, ‘‘Pediatric of MUMS drugs. Coccidioidomycosis: Case Series From a a.m. and 4 p.m., Monday through DATES: Submit either electronic or Friday, 240–402–7500. California Pediatric Infectious Diseases • Clinic,’’ Pediatric Infectious Disease written comments on the draft guidance Confidential Submissions—To Journal, 38(2):115–121. by November 12, 2020 to ensure that the submit a comment with confidential 40. Sondermeyer Cooksey, G., L.A. Lee, D. Agency considers your comment on this information that you do not wish to be Gilliss, et al., ‘‘Epidemiology of Pediatric draft guidance before it begins work on made publicly available, submit your Coccidioidomycosis in California, 2000– the final version of the guidance. comments only as a written/paper 2012,’’ Pediatric Infectious Disease ADDRESSES: You may submit comments submission. You should submit two Journal, 35(2):166–171. on any guidance at any time as follows: copies total. One copy will include the 41. Wheeler, C., K.D. Lucas, and J.C. Mohle- information you claim to be confidential Boetani, 2015, ‘‘Rates and Risk Factors Electronic Submissions for Coccidioidomycosis Among Prison with a heading or cover note that states Inmates, California, USA, 2011,’’ Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS Emerging Infectious Diseases, 21(1):70– following way: CONFIDENTIAL INFORMATION.’’ The 75. • Federal eRulemaking Portal: Agency will review this copy, including 42. U.S. District Court for the Northern https://www.regulations.gov. Follow the the claimed confidential information, in District of California, 2013, Plata v. instructions for submitting comments. its consideration of comments. The Brown, No. C01–1351 TEH, s.l. Comments submitted electronically, second copy, which will have the 43. Benedict, K., M. Ireland, M.P. Weinberg, including attachments, to https:// claimed confidential information et al., 2018, ‘‘Enhanced Surveillance for www.regulations.gov will be posted to redacted/blacked out, will be available Coccidioidomycosis, 14 U.S. States,’’ Emerging Infectious Diseases, the docket unchanged. Because your for public viewing and posted on 242(8)1444–1452. comment will be made public, you are https://www.regulations.gov. Submit 44. Garrett, A.L., Y.H. Chang, K. Ganley, and solely responsible for ensuring that your both copies to the Dockets Management J.E. Blair, 2016, ‘‘Uphill Both Ways: comment does not include any Staff. If you do not wish your name and and Quality of Life in Valley confidential information that you or a contact information to be made publicly

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