Notice of Decision Not To Designate Coccidioidomycosis as an Addition to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act, 42871-42876 [2020-15255]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42871-42876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15255]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0567]


Notice of Decision Not To Designate Coccidioidomycosis as an 
Addition to the Current List of Tropical Diseases in the Federal Food, 
Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency), in response 
to suggestions submitted to the public docket number FDA-2008-N-0567 
between October 1, 2018, and June 30, 2019, has analyzed whether 
coccidioidomycosis meets the statutory criteria for designation as a 
tropical disease for the purposes of obtaining a priority review 
voucher (PRV) under the Federal Food, Drug, and Cosmetic Act (FD&C 
Act), namely whether it primarily affects poor and marginalized 
populations, and whether there is ``no significant market'' for drugs 
that prevent or treat coccidioidomycosis infections in developed 
countries. The Agency has determined that coccidioidomycosis does not 
meet the statutory criteria for designation as a tropical disease 
eligible for PRV consideration because of the potential market for 
preventive products (such as vaccines), and therefore declines to 
designate it as an addition to the list of tropical disease PRV-
eligible diseases at this time.

DATES: July 15, 2020.

ADDRESSES: Submit electronic comments on additional diseases suggested 
for designation to https://www.regulations.gov. Submit written comments 
on additional diseases suggested for designation to the Dockets 
Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Katherine Schumann, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, 301-
796-1300, [email protected]; or Stephen Ripley, Center for 
Biologics Evaluation and Research, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 
240-402-7911.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Background: Priority Review Voucher Program
II. Decision Not To Designate Coccidioidomycosis
    A. Coccidioidomycosis
    B. FDA Determination
III. Process for Requesting Additional Diseases To Be Added to the 
List
IV. Paperwork Reduction Act
V. References

I. Background: Priority Review Voucher Program

    Section 524 of the FD&C Act (21 U.S.C. 360n), which was added by 
section 1102 of the Food and Drug Administration Amendments Act of 2007 
(Pub. L. 110-85), uses a PRV incentive to encourage the development of 
new drugs, including biological products, for prevention and treatment 
of certain diseases that, in the aggregate, affect millions of people 
throughout the world. Further information about the tropical disease 
PRV program can be found in the guidance for industry ``Tropical 
Disease Priority Review Vouchers,'' available at https://www.fda.gov/media/72569/download. Section 524(a)(3) of the FD&C Act includes a list 
of infectious diseases, applications for the prevention or treatment of 
which may be eligible to qualify for a PRV, and Congress has amended 
that list multiple times to add new diseases since section 524 was 
first enacted. Additions to the statutory list of PRV-eligible tropical 
diseases by an FDA final order published in the Federal Register can be 
accessed at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program.
    On August 20, 2015, FDA published a final order (80 FR 50559) 
(August 2015 final order) designating Chagas disease and 
neurocysticercosis as additions to the list of tropical diseases under 
section 524 of the FD&C Act. The August 2015 final order also set forth

[[Page 42872]]

FDA's interpretation of the statutory criteria for designating 
additions to the section 524 list of tropical diseases and expands the 
list of tropical diseases under section 524(a)(3)(R) of the FD&C Act. 
That section, later redesignated as section 524(a)(3)(S) of the FD&C 
Act, authorizes FDA to designate by order ``[a]ny other infectious 
disease for which there is no significant market in developed nations 
and that disproportionately affects poor and marginalized populations'' 
as a tropical disease for which approved drug applications may be 
eligible for a PRV.
    FDA has applied its criteria as set forth in the August 2015 final 
order to analyze whether the fungal infection coccidioidomycosis meets 
the statutory criteria for addition to this tropical disease list. As 
discussed below, the Agency has determined that coccidioidomycosis does 
not meet the statutory criteria for designation as a PRV-eligible 
``tropical disease'' under section 524 of the FD&C Act because of the 
potential market for preventive measures such as vaccines. Thus, FDA 
will not add it to the list of tropical diseases whose applications may 
be eligible for a priority review voucher at this time.

II. Decision Not To Designate Coccidioidomycosis

    FDA has considered all disease suggestions submitted to the public 
docket (FDA-2008-N-0567) between October 1, 2018, and June 30, 2019, as 
potential additions to the list of tropical diseases under section 524 
of the FD&C Act, under the docket review process explained on the 
Agency's web page at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program. Based on an assessment of currently available information, and 
using the criteria from its August 2015 final order, FDA has determined 
that coccidioidomycosis does not currently fulfill the criteria for 
addition to the list of diseases eligible for the tropical disease PRV 
program under section 524 of the FD&C Act and is not designating it as 
an addition to the list at this time.

A. Coccidioidomycosis

    Coccidioidomycosis, also known as ``Valley fever,'' is a systemic 
fungal infection caused by inhalation of Coccidioides spp. spores. 
Major areas of endemicity include substantial parts of the southwestern 
United States. The fungus occurs in the environment, especially in 
certain soil types in hot, dry climates, and inhalation may occur after 
environmental disturbance such as soil disruption and wind. The species 
most commonly associated with disease are C. immitis, which is endemic 
to parts of California, and C. posadasii, which is found in Arizona, 
Utah, Texas, regions of Mexico, and Central and South America (Ref. 1). 
Most reported cases occur in individuals who live in or have traveled 
to endemic areas. From 1990 to 2011, the incidence of reported 
coccidioidomycosis in the United States increased greater than 8-fold 
in areas of endemicity (Ref. 2).
    Manifestations of infection with Coccidioides spp. can range from 
subclinical (estimated at one-half to two-thirds of infections), that 
might not be detected unless the person is included in a skin test 
survey or serologic screening, to acute self-limited respiratory 
illness that may be difficult to distinguish from other acute 
respiratory infections, to severe disease with chronic or life-
threatening complications (Ref. 3). Acute respiratory 
coccidioidomycosis has a 1- to 3-week incubation period and most 
commonly presents as a self-limited illness with fever, muscle pain, 
cough, rash, weight loss, and malaise (Ref. 4). In areas where the 
illness is highly endemic, upwards of 30 percent of community-acquired 
pneumonia cases may be caused by Coccidioides spp. (Ref. 5). Five to 
ten percent of affected patients develop severe or chronic lung disease 
such as cavitary pneumonia, nodules, and bronchiectasis, and in 
approximately one percent of patients, infection disseminates to the 
central nervous system, skin, joints, or bone. Individuals older than 
65 years, smokers, and those with diabetes are at increased risk of 
pulmonary complications of coccidioidomycosis, while those with 
depressed cellular immune function (Refs. 6 and 7), pregnant women 
(Ref. 8), or persons of African or Asian descent have an elevated risk 
of disseminated disease (Ref. 9). Coccidioidal meningitis cannot be 
reliably cured with current antifungal therapy and has a mortality rate 
of approximately 30 percent (Ref. 10). Although the public health 
burden attributable to coccidioidomycosis in the United States is 
primarily due to morbidity, an estimated 200 coccidioidomycosis-
associated deaths occur each year (Ref. 11).
    Treatment recommendations depend upon the severity, location, and 
dissemination of the disease as well as the underlying immune status of 
the patient (Ref. 12). A 2016 publication of professional society 
guidelines recommends against antifungal therapy in patients with newly 
diagnosed, uncomplicated coccidioidal pneumonia, with mild or resolved 
symptoms, and without immunosuppressive conditions, advising that such 
patients receive supportive measures such as physical therapy and close 
monitoring. In individuals with severe disease or disseminated disease, 
these guidelines advise antifungal therapy for a minimum of 3 to 6 
months with an azole (fluconazole or itraconazole), intravenous 
amphotericin B, or both. Patients with immunocompromise or other 
underlying conditions may require therapy for 12 months or longer. In 
individuals with meningitis due to Coccidioides spp., these guidelines 
recommend treatment for life (Ref. 13).
    There are two FDA-approved treatments for coccidioidomycosis: 
Amphotericin B deoxycholate, available in brand or generic form, and 
ketoconazole. In 2013, FDA warned that ketoconazole should not be used 
as a first-line therapy for any fungal infection as it can cause severe 
liver injury, adrenal insufficiency, and harmful drug interactions, and 
should be prescribed only for endemic mycoses, such as 
coccidioidomycosis, when alternative antifungal therapies are not 
available or tolerated (Ref. 14). With respect to preventative 
products, no vaccines have yet been developed that protect persons from 
developing infection or progressing from infection to disease due to C. 
immitis, but potential for development of such vaccines has been a 
topic of interest in some expert discussions as outlined in the next 
section.
1. Significant Market in Developed Nations
    In the August 2015 final order, FDA interpreted the statutory 
criterion ``no significant market'' to refer to the market for drugs 
for the treatment or prevention of infectious diseases. The August 2015 
final order states, ``[b]ecause the statute offers vouchers for 
applications for drugs for either the treatment or prevention of 
infectious diseases, it is reasonable to assume that `no significant 
market' can refer to drugs for the treatment or prevention of 
infectious diseases. Thus, FDA will analyze the market for drugs for 
both the treatment and prevention of infectious diseases for a 
particular infectious disease.'' In other words, if there is a 
significant market for either the treatment or prevention of the 
infectious disease, the criterion that there be ``no significant 
market'' in developed nations is not met.
    The relative importance of prevention markets may vary in part 
according to whether most cases of a particular disease in developed 
countries are attributable to exposure in those same

[[Page 42873]]

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

[[Page 42874]]

coccidioidomycosis drug development by U.S. government sources, 
including grants reported as being awarded by FDA and the NIH (Refs. 25 
and 26). FDA's Office of Orphan Product Development has accorded orphan 
product designation to several drugs intended to treat 
coccidioidomycosis (Ref. 27). FDA added Coccidioides species to the 
``list of ``qualifying pathogens'' that have the potential to pose a 
serious threat to human health'' under the Generating Antibiotic 
Incentives Now title of the Food and Drug Administration Safety and 
Innovation Act, noting ``[i]t is estimated that up to 60 percent of 
people living in the endemic areas of southwestern United States have 
been exposed to the fungus'' (June 5, 2014, 79 FR 32464). C. immitis 
and C. posadasii were previously on the HHS list of Select Agents and 
Toxins but were removed in 2012 based on availability of treatment and 
a lowered assessment of impact on human health (Ref. 28). Further, 
Coccidioides species are not listed as a high priority threat in the 
2017-2018 Public Health Emergency Medical Countermeasures Enterprise 
Strategy and Implementation Plan (Ref. 29).
    In summary, based on the analyses outlined above focusing on the 
estimated vaccination rates of infants born in endemic areas and 
persons who may be exposed by moving into those areas, FDA has found a 
significant potential direct market for products for prevention of 
coccidioidomycosis.

2. Coccidioides spp. Disproportionately Affects Poor and Marginalized 
Populations

    Illnesses caused by Coccidioides spp. cause significant morbidity 
with a disproportionate impact on poor and marginalized populations. In 
addition to the well-known endemic regions of the United States, cases 
and outbreaks of coccidioidomycosis have been reported in Mexico, 
Guatemala, Honduras, Nicaragua, Colombia, Venezuela, Argentina, Brazil, 
Paraguay, and Bolivia (Ref. 30). With the exception of the United 
States and Argentina, none of these countries is on the World Bank list 
of high-income economies, which in the August 2015 final order FDA 
determined would be used as evidence that the country should be 
considered a ``developed nation'' for tropical disease determination 
(Ref. 15). While coccidioidal skin test antigens do not distinguish 
subclinical infection from symptomatic disease, and recent data from 
skin test surveys are sparse (Ref. 31), available information indicates 
that coccidioidomycosis may be as prevalent in parts of Latin America 
as in parts of the United States (Refs. 30 and 32). Coccidioidin skin 
test surveys in Mexico some decades ago were reported as demonstrating 
positivity ranging from 10 percent in Tijuana, to 40 percent in 
Torreon, to as high as 93 percent in 12 communities in Coahuila (Ref. 
30). In Brazil, by one estimate, 7.12 of 1,000 hospital admissions were 
due to coccidioidomycosis (Ref. 33). Treatment options are more limited 
in Latin America than in the United States, as lipid formulations of 
amphotericin have restricted availability due to the high cost (Ref. 
34).
    In the United States, several racial and ethnic minority groups 
have been reported to have increased risk of severe disease; genetic, 
socioeconomic, occupational, and geographic factors have been suggested 
as potentially contributory factors. Analyses of hospitalizations from 
2000 to 2011 and deaths from 2000 to 2013 in California have reported 
higher rates in African-Americans, Hispanics, and older persons 
compared to the general population (Refs. 35 and 36). Among 
immunocompromised or immunosuppressed populations, persons with HIV 
infection were reported to be strikingly vulnerable during the early 
years of the HIV pandemic. While effective antiretroviral therapy has 
decreased the disease burden in individuals with HIV, affected patients 
lacking access to treatment, or with poorly-controlled disease, are at 
higher risk for severe or disseminated disease (Ref. 37).
    While adults over the age of 60 have the highest incidence of 
coccidioidomycosis (Ref. 38), children under the age of 17 and their 
caretakers bear a substantial burden of the disease in endemic regions, 
experiencing delays in diagnosis, prolonged symptoms, hospitalizations, 
and missed school and work (Ref. 39). In California, for example, 
during a period when reported cases and hospitalizations in the general 
population increased 4.5-fold and 2.7-fold, respectively, cases and 
hospitalizations in children increased almost 6-fold (Ref. 40).
    Prison inmates in endemic regions are at particularly high risk of 
symptomatic disease. One study in California found that the risk of 
primary disease was highest in prisoners over the age of 40 and in non-
white ethnic groups (Ref. 41). A significant increase in 
coccidioidomycosis that was observed in two California prisons led to a 
court ruling excluding inmates from incarceration at those locations if 
they were in risk groups identified by the American Thoracic Society 
for high risk of severe coccidioidomycosis (Ref. 42).
    Coccidioidomycosis is not currently designated by WHO as a 
Neglected Tropical Disease and no data were found on Disability-
Adjusted Life Years distinguishing the burden attributable to 
coccidioidomycoses in developing versus developed countries. However, 
patients with coccidioidomycosis often experience prolonged symptoms, 
delays in diagnosis, and unnecessary antibacterial therapy (Ref. 43). 
Due to greater barriers to medical care for diagnosis and treatment, 
poor and marginalized patents in both developing and developed 
countries experience a significant burden of disease. Resolution of 
symptoms may take months, thus resulting in significant impairment of 
activities of daily living and loss of productivity (Ref. 44).
    The above information demonstrates it is reasonable to conclude 
that coccidioidomycosis disproportionately affects poor and 
marginalized populations.

B. FDA Determination

    Given the factors described above, FDA has determined that 
coccidioidomycoses meets the statutory criteria of ``disproportionately 
affects poor and marginalized populations,'' but it does not meet the 
criteria of ``no significant market in developed nations'' due to the 
potentially significant direct market for products to prevent the 
disease. Therefore, FDA declines to designate coccidioidomycosis as an 
addition to the tropical disease list under section 524 of the FD&C 
Act.

III. Process for Requesting Additional Diseases To Be Added to the List

    FDA's current determination regarding coccidioidomycoses does not 
prevent interested persons from requesting its consideration in the 
future. To facilitate the consideration of future additions to the 
list, FDA established a public docket (see https://www.regulations.gov, 
Docket No. FDA-2008-N-0567) through which interested persons may submit 
requests for additional diseases to be added to the list. Such requests 
should be accompanied by information to document that the disease meets 
the criteria set forth in section 524(a)(3)(S) of the FD&C Act. FDA 
will periodically review these requests, and, when appropriate, expand 
the list. For further information, see FDA's Tropical Disease Priority 
Review Voucher Program web page at https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program.

[[Page 42875]]

IV. Paperwork Reduction Act

    This notice reiterates the ``open'' status of the previously 
established public docket through which interested persons may submit 
requests for additional diseases to be added to the list of tropical 
diseases that FDA has found to meet the criteria in section 
524(a)(3)(S) of the FD&C Act. Such a request for information is exempt 
from Office of Management and Budget review under 5 CFR 1320.3(h)(4) of 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). 
Specifically, ``[f]acts or opinions submitted in response to general 
solicitations of comments from the public, published in the Federal 
Register or other publications, regardless of the form or format 
thereof'' are exempt, ``provided that no person is required to supply 
specific information pertaining to the commenter, other than that 
necessary for self-identification, as a condition of the full 
consideration of the comment.''

V. References

    The following references marked with an asterisk (*) have been 
placed on display at the Dockets Management Staff (see ADDRESSES). They 
may be seen by interested persons between 9 a.m. and 4 p.m., Monday 
through Friday, and are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses but is 
not responsible for any subsequent changes to the websites after this 
document publishes in the Federal Register.

1. Saubolle, M.A., P.P. McKellar, and D. Sussland, 2007, 
``Epidemiologic, Clinical, and Diagnostic Aspects of 
Coccidioidomycosis,'' Journal of Clinical Microbiology, epub ahead 
of print November 15, 2006, doi: 10.1128/JCM.02230-06.
2. *U.S. Centers for Disease Control and Prevention (CDC), 2013, 
``Increase in Reported Coccidioidomycosis--United States, 1998-
2011,'' Morbitity and Mortality Weekly Report (MMWR), 62(12):217-
221.
3. Galgiani, J.N., N.M. Ampel, J.E. Blair, et al., and the 
Infectious Diseases Society of America, 2005, 
``Coccidioidomycosis,'' Clinical Infectious Diseases, epub ahead of 
print September 20, 2005, doi: 10.1086/496991.
4. Galgiani, J.N., N.M. Ampel, J.E. Blair, et al., 2016, ``Executive 
Summary: 2016 Infectious Diseases Society of America (IDSA) Clinical 
Practice Guideline for the Treatment of Coccidioidomycosis,'' 
Clinical Infectious Diseases, 63(6):717-722.
5. Valdivia, L., D. Nix, M. Wright, et al., 2006, 
``Coccidioidomycosis as a Common Cause of Community-Acquired 
Pneumonia,'' Emerging Infectious Diseases, 12(6):958-962.
6. Bergstrom, L., D.E. Yocum, N.M. Ampel, et al., 2004, ``Increased 
Risk of Coccidioidomycosis in Patients Treated with Tumor Necrosis 
Factor Alpha Antagonists,'' Arthritis & Rheumatology, 50(6):1959-
1966.
7. Miller, M.B., R. Hendren, and P.H. Gilligan, 2004, 
``Posttransplantation Disseminated Coccidioidomycosis Acquired From 
Donor Lungs,'' Journal of Clinical Microbiology, 42(5):2347-2349.
8. Bercovitch, R.S., A. Catanzaro, B.S. Schwartz, et al., 2011, 
``Coccidioidomycosis During Pregnancy: A Review and Recommendations 
for Management,'' Clinical Infectious Diseases, 53(4)363-368.
9. *CDC, 2009, ``Increase in Coccidioidomycosis--California, 2000-
2007,'' MMWR Morb Mortal Wkly Rep, 58(5):105-109.
10. Johnson, R.H. and H.E. Einstein, 2006, ``Coccidioidal 
Meningitis,'' Clinical Infectious Diseases, epub ahead of print 
November 29, 2005, doi: 10.1086/497596.
11. *CDC, 2019, ``Valley Fever (Coccidioidomycosis) Statistics,'' 
cited May 3, 2019, https://www.cdc.gov/fungal/diseases/coccidioidomycosis/statistics.html.
12. Galgiani, J.N. 2019, ``Valley Fever (Coccidioidomycosis): 
Tutorial for Primary Care Professionals,'' cited January 15, 2019, 
https://vfce.arizona.edu/sites/default/files/9-valley_fever_tutorial.pdf.
13. Galgiani, J.N., N.M. Ampel, J.E. Blair, et al., 2016, ``2016 
Infectious Diseases Society of America (IDSA) Clinical Practice 
Guideline for the Treatment of Coccidioidomycosis,'' Clinical 
Infectious Diseases, epub ahead of print July 27, 2016, doi: 
10.1093/cid/ciw360.
14. *FDA, 2017, ``FDA Drug Safety Communication: FDA Limits Usage of 
Nizoral (Ketoconazole) Oral Tablets Due to Potentially Fatal Liver 
Injury and Risk of Drug Interactions and Adrenal Gland Problems,'' 
cited May 10, 2019, https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-limits-usage-nizoral-ketoconazole-oral-tablets-due-potentially.
15. The World Bank, 2018, World Bank Country and Lending Groups, 
cited April 29, 2019, https://datahelpdesk.worldbank.org/knowledgebase/articles/906519-world-bank-country-and-lending-groups.
16. Chang, D.C., S. Anderson, K. Wannemuehler, et al., 2008, 
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    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15255 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P