[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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,
``Testing for Coccidioidomycosis Among Patients With Community-
Acquired Pneumonia,'' Emerging Infectious Diseases, 14(7):1053-1059.
17. Marsden-Haug, N., M. Goldoft, C. Ralston, et al., 2013,
``Coccidioidomycosis Acquired in Washington State,'' Clinical
Infectious Diseases, epub ahead of print December 7, 2012, doi:
10.1093/cid/cis1028.
18. Engelthaler, D.M., C.C. Roe, C.M. Hepp, et al., 2016, ``Local
Population Structure and Patterns of Western Hemisphere Dispersal
for Coccidioides spp., the Fungal Cause of Valley Fever,'' mBio,
7(2):e00550-16.
19. Hector, R.F. and R. Laniado-Laborin, 2005,
``Coccidioidomycosis--A Fungal Disease of the Americas,'' PLoS Med,
2(1):e2.
20. * U.S. Census Bureau, 2011, ``Population Distribution and
Change: 2000 to 2010,'' 2010 Census Briefs, accessed January 10,
2020, https://www.census.gov/prod/cen2010/briefs/c2010br-01.pdf.
21. Barnato, A.E., G.D. Sanders, and D.K. Owens, 2001, ``Cost-
Effectiveness of a Potential Vaccine for Coccidioides Immitis,''
Emerging Infectious Diseases, 7(5):797-806.
22. Galgiani, J.N. 2008, ``Vaccines to Prevent Systemic Mycoses:
Holy Grails Meet Translational Realities,'' Journal Infectious
Diseases 197(7):938-940.
23. Stratton, K R., J.S. Durch, and R.S. Lawrence, 2000, ``Vaccines
for the 21st Century: A Toll for Decisionmaking,'' Washington, DC:
National Academies Press.
24. Galgiani, J N. 2019, ``Vaccines to Prevent Coccidioidomycosis:
60 Years and Counting,'' cited September 25, 2019, https://custom.cvent.com/5ED8172A3B414619A18F31932AAB4C72/files/39a4663417b84176bcbe678ab3c0259a.pdf.
25. University of Arizona, 2016, ``The Search for the Cure for
Valley Fever--Nikkomycin Z Development at the University of
Arizona,'' cited May 3, 2019, https://vfce.arizona.edu/sites/vfce/files/bio5_summary_nikz_development_plan_1.pdf.
26. * NIH, National Institutes of Allergy and Infectious Diseases,
2018, ``Two Clinical Trials Focus on Serious Fungal Disease Valley
Fever,'' cited May 2, 2019, https://www.niaid.nih.gov/news-events/two-clinical-trials-focus-serious-fungal-disease-valley-fever.
27. * FDA, 2002, ``Cumulative List of All Products That Have
Received Orphan Designation: Total Active Designations,'' effective
May 5, 2009, cited June 4, 2019, https://www.fda.gov/media/76409/download.
28. * CDC, U.S. Department of Health and Human Services (HHS),
January 19, 2017, ``Possession, Use, and Transfer of Select Agents
and Toxins; Biennial Review,'' final rule, Federal Register, 82 FR
6278.
29. * HHS, 2017, ``2017-2018 Public Health Emergency Medical
Countermeasures Enterprise (PHEMCE) Strategy and Implementation
Plan,'' accessed January 15, 2020, https://www.phe.gov/Preparedness/mcm/phemce/Documents/2017-phemce-sip.pdf.
30. Laniado-Laborin, R., 2007, ``Expanding
[[Page 42876]]
Understanding of Epidemiology of Coccidioidomycosis in the Western
Hemisphere,'' Annals of the New York Academy of Sciences, epub ahead
of print March 29, 2007, doi: 10.1196/annals.1406.004.
31. Wack, E.E., N.M. Ampel, R.H. Sunenshine, and J.N. Galgiani,
2015, ``The Return of Delayed-Type Hypersensitivity Skin Testing for
Coccidioidomycosis,'' Clinical Infectious Diseaes, epub ahead of
print May 15, 2015, doi: 10.1093/cid/civ388.
32. Laniado-Laborin, R., E.G. Arathoon, C. Canteros, et al.,
``Coccidioidomycosis in Latin America,'' Medical Mycology, 57(1
Suppl):S46-S55.
33. Giacomazzi, J., L. Baethgen, L.C. Carneiro, et al., in
association with the LIFE Program, 2016, ``The Burden of Serious
Human Fungal Infections in Brazil,'' Mycoses, epub ahead of print
December 22, 2015, doi: 10.1111/myc.12427.
34. Gonz[aacute]lez-Benavides, J., 1991, ``The Panorama of
Coccidioidomycosis in Nuevo Leon from 1978 to 1988,'' Gaceta Medica
de Mexico, 127(5):427-432.
35. Sondermeyer Cooksey, G., L.A. Lee, D. Gilliss, et al., 2013,
``Coccidioidomycosis-Associated Hospitalizations, California, USA,
2000-2011,'' Emerging Infectious Diseases, 10:1590-1597.
36. Sondermeyer Cooksey, G., L.A. Lee, D. Gilliss, and D.J. Vugia,
2016, ``Coccidioidomycosis-Associated Deaths in California, 2000-
2013,'' Public Health Reports, 131(4):531-535.
37. Ampel, N.M. 2005, ``Coccidioidomycosis in Persons Infected With
HIV Type 1,'' Clinical Infectious Diseases, epub ahead of print
September 12, 2005, doi: 10.1086/444502.
38. Benedict, K., O.Z. McCotter, S. Brady, et al., 2019,
``Surveillance for Coccidioidomycosis--United States, 2011-2017,''
MMWR Surveillance Summaries, 68(7):1-15.
39. Lee, L.A., G. Sondermeyer Cooksey, J.J. Kim, et al., 2019,
``Pediatric Coccidioidomycosis: Case Series From a California
Pediatric Infectious Diseases Clinic,'' Pediatric Infectious Disease
Journal, 38(2):115-121.
40. Sondermeyer Cooksey, G., L.A. Lee, D. Gilliss, et al.,
``Epidemiology of Pediatric Coccidioidomycosis in California, 2000-
2012,'' Pediatric Infectious Disease Journal, 35(2):166-171.
41. Wheeler, C., K.D. Lucas, and J.C. Mohle-Boetani, 2015, ``Rates
and Risk Factors for Coccidioidomycosis Among Prison Inmates,
California, USA, 2011,'' Emerging Infectious Diseases, 21(1):70-75.
42. U.S. District Court for the Northern District of California,
2013, Plata v. Brown, No. C01-1351 TEH, s.l.
43. Benedict, K., M. Ireland, M.P. Weinberg, et al., 2018,
``Enhanced Surveillance for Coccidioidomycosis, 14 U.S. States,''
Emerging Infectious Diseases, 242(8)1444-1452.
44. Garrett, A.L., Y.H. Chang, K. Ganley, and J.E. Blair, 2016,
``Uphill Both Ways: Fatigue and Quality of Life in Valley Fever,''
Medical Mycology, epub ahead of print November 26, 2015, doi:
10.1093/mmy/myv097.
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