80 FR 50559 - Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 161 (August 20, 2015)

Page Range		50559-50564
FR Document		2015-20554

The Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes the Food and Drug Administration (FDA or Agency) to award priority review vouchers (PRVs) to tropical disease product applicants when the applications meet certain criteria. The FD&C Act lists the diseases that are considered to be tropical diseases for purposes of obtaining PRVs, and also provides for Agency expansion of that list to include other diseases that satisfy the definition of ``tropical diseases'' as set forth in the FD&C Act. FDA has determined that Chagas disease and neurocysticercosis satisfy this definition, and therefore is adding them to the list of designated tropical diseases whose product applications may result in the award of PRVs. Sponsors submitting certain applications for the treatment of Chagas disease and neurocysticercosis may be eligible to receive a PRV if such applications are approved by FDA.

Federal Register, Volume 80 Issue 161 (Thursday, August 20, 2015)

[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Rules and Regulations]
[Pages 50559-50564]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-20554]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 317

[Docket No. FDA-2008-N-0567]
RIN 0910-AG37

Designating Additions to the Current List of Tropical Diseases in
the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Federal Food, Drug, and Cosmetic Act (the FD&C Act)
authorizes the Food and Drug Administration (FDA or Agency) to award
priority review vouchers (PRVs) to tropical disease product applicants
when the applications meet certain criteria. The FD&C Act lists the
diseases that are considered to be tropical diseases for purposes of
obtaining PRVs, and also provides for Agency expansion of that list to
include other diseases that satisfy the definition of ``tropical
diseases'' as set forth in the FD&C Act. FDA has determined that Chagas
disease and neurocysticercosis satisfy this definition, and therefore
is adding them to the list of designated tropical diseases whose
product applications may result in the award of PRVs. Sponsors
submitting certain applications for the treatment of Chagas disease and
neurocysticercosis may be eligible to receive a PRV if such
applications are approved by FDA.

DATES: This order is effective August 20, 2015.

ADDRESSES: Submit electronic comments on additional diseases suggested
for designation to www.regulations.gov. Submit written comments on
additional diseases suggested for designation to the Division of
Dockets Management (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: Kristiana Brugger, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6262, Silver Spring, MD 20993-0002, 301-
796-3601; 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. Criteria for Expansion of the List of Tropical Diseases
A. No Significant Market in Developed Nations
B. Disproportionately Affects Poor and Marginalized Populations
III. Diseases Being Designated
A. Chagas Disease
B. Neurocysticercosis
IV. Process for Requesting Additional Diseases To Be Added to the
List
V. Paperwork Reduction Act
VI. References

I. Background: Priority Review Voucher Program

Much of the global burden of disease falls on populations who lack
the resources to develop, encourage development of, or purchase disease
preventions or treatments. For this reason, many of the diseases
afflicting these populations do not receive the same level of
innovation investment as diseases afflicting wealthier or more
empowered populations.
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
(FDAAA), is designed to address the lack of treatment development
incentives for such tropical diseases. It uses a PRV incentive to
encourage the development of new drugs for prevention and treatment of
certain diseases that, in the aggregate, affect millions of people
throughout the world. Specifically, section 524 of the FD&C Act defines
the term ``tropical disease product application'' and sets forth
criteria which, if met, enable those who submit an application for a
tropical disease product to be eligible to receive a PRV upon approval
of that tropical disease product application. To be eligible for a PRV,
the tropical disease product application must meet all of the following
criteria:
The application must be a ``human drug application,'' as
defined in section 735(1) of the FD&C Act (21 U.S.C. 379g(1)).
The application must be for the ``prevention or treatment
of a tropical disease,'' as defined by statute.
The application must be deemed eligible for priority
review by the Secretary of HHS.
The application must be approved after the date of
enactment of FDAAA (i.e., September 27, 2007) for use in the
prevention, detection, or treatment of a tropical disease.
The application must be for ``a human drug, no active
ingredient (including any ester or salt of the active ingredient) of
which has been approved in any other application under section
505(b)(1) [21 U.S.C. 355(b)(1)] or section 351 of the [PHS Act].''
Section 524(a)(4) of the FD&C Act. In particular, the requirement
that an application must be eligible for priority review demonstrates
the PRV program's intent to reward tropical disease product
applications that have the potential to demonstrate significant
improvements in safety or effectiveness in the treatment or prevention
of tropical diseases (Ref. 1).
FDA will award a PRV to the application holder upon the approval of
a qualifying tropical disease product application that meets the
criteria previously listed. The voucher entitles the holder to a
priority review of a human drug application, submitted under section
505(b)(1) of the FD&C Act or section 351 of the PHS Act, of the voucher
holder's choosing. Once awarded to the application holder, the PRV may
be transferred to another entity, and the original holder may receive
consideration (including payment) for the transfer. To redeem the
voucher, a PRV holder must notify FDA of its intent to use the PRV at
least 90 days prior to the submission of the application for which the
PRV will be used. This notification constitutes a legally binding
agreement to pay the user fee that must be applied to applications
using a PRV.
Section 524(a)(3) of the FD&C Act lists the following diseases as
tropical diseases qualifying for a PRV:

Tuberculosis

[[Page 50560]]

Malaria
Blinding trachoma
Buruli ulcer
Cholera
Dengue/Dengue haemorrhagic fever
Dracunculiasis (guinea-worm disease)
Fascioliasis
Human African trypanosomiasis
Leishmaniasis
Leprosy
Lymphatic filariasis
Onchocerciasis
Schistosomiasis
Soil transmitted helminthiasis
Yaws
Filoviruses

In addition, section 524(a)(3)(R) of the FD&C Act authorizes the
Secretary to expand by order the list of tropical diseases to include
``[a]ny other infectious disease for which there is no significant
market in developed nations and that disproportionately affects poor
and marginalized populations[,]'' and that is the purpose of this
order.

II. Criteria for Expansion of the List of Tropical Diseases

On December 12, 2008, FDA convened a public hearing, at which the
public provided suggestions regarding the following topics: (1)
Criteria that should be used to determine the eligibility of an
infectious disease for designation as a tropical disease, (2) the
process that should be used to make tropical disease designations, and
(3) recommendations for specific diseases that should be designated as
tropical diseases. A number of participants in the public meeting
commented that, given the lack of definitive data for some diseases, as
well as the lack of consensus on how these criteria should be defined,
FDA should use a flexible approach in determining whether specific
diseases meet the criteria.
FDA agrees with the use of a flexible approach to tropical disease
designation and is proposing that a scientifically informed,
qualitative assessment of disease candidates is appropriate. FDA also
is establishing a public docket that will continuously remain open to
receive future suggestions for tropical disease designations under
section 524 of the FD&C Act. The Agency proposes to review the contents
of this public docket periodically and to take action to designate
additional diseases when appropriate.
As stated previously, section 524(a)(3)(R) of the FD&C Act
authorizes the Secretary 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.'' In the following paragraphs, FDA sets forth
its interpretation of this provision and the criteria we propose to use
in determining which diseases may be designated by order of the
Secretary as ``tropical diseases'' under section 524.

A. No Significant Market in Developed Nations

1. ``Developed Nations''
In interpreting the term ``developed nations,'' FDA acknowledges at
the outset that the standards for determining a nation's level of
development, as well as the threshold for a ``developed'' country, are
the subject of debate. Some nations may score well in some markers of
development (e.g., gross domestic product) and poorly in others (e.g.,
sanitation), leading to disagreements regarding which measures of
development should serve as dominant indicators. After also examining
the International Monetary Fund (IMF)'s list of advanced economies
(Ref. 2) and the United Nations (U.N.)'s human development index (Ref.
3), the Agency is proposing to use a country's presence on the World
Bank's \1\ list of ``high income economies'' (Ref. 4) as evidence that
the country should be considered a ``developed nation'' for ``tropical
disease'' determination purposes. Similarly, FDA will use a country's
presence on the World Bank's list of ``low income economies'' (id.) as
evidence that the country should not be considered a ``developed
nation'' for purposes of ``tropical disease'' determination.
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\1\ The ``World Bank'' is a term used to refer collectively to
the International Development Association and the International Bank
for Reconstruction and Development, which are two of the five
organizations that comprise the World Bank Group.
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FDA recognizes that there is a correlation between economic
strength (particularly purchasing power) and the market incentive for
drug creation: People in high-income economies are more likely to be
able to afford disease treatments and, thus, drug companies have an
incentive to create products that will be in demand in those countries.
The World Bank list of high-income economies is calculated based on
gross national income per capita, and, importantly, it thus reflects
wealth as a primary basis for categorization. FDA's recognition of the
role of wealth is why we deemed the U.N. development index less
helpful: It measures development across a broad array of categories
(e.g., mean years of schooling) that, while informative, are less
directly correlated with the drug development incentives reflected in
the statutory scheme. Indeed, the U.N. itself has acknowledged that
``[t]he [human development index] was created to emphasize that people
and their capabilities should be the ultimate criteria for assessing
the development of a country, not economic growth alone'' (Ref. 5). And
although the IMF's list of ``advanced economies'' reflects purchasing
power to some degree, the World Bank calculus is more transparent and
predictable than the IMF's calculus, and the U.S. government routinely
uses the World Bank lists when determining a country's eligibility for
Generalized System of Preferences benefits for trade in goods (Ref. 6).
2. ``No Significant Market''
The list of tropical diseases in section 524(a)(3) of the FD&C
includes ``[a]ny other infectious disease for which there is no
significant market in developed nations. . .designated by order of the
Secretary.'' As an initial matter, the Agency notes that ``infectious
diseases,'' as such do not have markets--but drugs for the treatment or
prevention of infectious diseases do. Because 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.
The threshold for what constitutes a ``significant market'' for
drugs for the treatment or prevention of infectious diseases is
difficult to quantify. Because of the challenges in providing a rigid
definition of this term, FDA proposes that the following factors be
considered in determining whether a ``significant market'' exists in
developed countries.
a. Occurrence of the Disease in Developed Nations
As discussed previously, market forces are important drivers of
drug development. The purpose of section 524 of the FD&C Act is to
provide an incentive (through a PRV) for innovation where there
otherwise would be an insufficient financial or market incentive to
invest in developing drugs for tropical diseases. The market for many
FDA-approved products includes situations in which individuals (often
reimbursed by their insurers) purchase the products for use by a
specific patient. This reflects what we will refer to as the ``direct''
market, and the direct market for a drug in a

[[Page 50561]]

developed country can often be estimated by assessing the occurrence of
a particular disease in that country.\2\
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\2\ Exceptions may occur for diseases that have a low incidence
in developed countries through use of preventive drugs or biologics.
Thus, although the disease incidence is lower in developed countries
these are less likely to be the types of diseases for which section
524 of the FD&C Act is intended to spur innovation.
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If the prevalence of a disease in developed countries is less than
0.1 percent of the population of those countries, it is unlikely that
ordinary market forces will offer a sufficient incentive to drive the
development of new preventions or treatments. Thus, it is unlikely that
there will be a ``significant market'' for the disease's treatment in
those countries. Accordingly, FDA has decided to use a disease
prevalence rate of 0.1 percent of the population as a factor for aiding
in the determination of whether a ``significant market'' may exist for
a disease's treatment.
b. The Existence of a Sizeable Indirect Market for the Tropical Disease
Drug (e.g., Government, Including the Military) That Would Constitute a
Financial Incentive for Drug Development
As discussed previously, the market for many FDA-approved products
is the ``direct'' market, involving patients purchasing drugs for their
own use. However, some drugs may have a sizeable ``indirect'' market
composed of, for example, government entities or nongovernmental
organizations that wish to purchase and distribute a drug for the
treatment or prevention of an infectious disease, often for public
health reasons, to a particular group of people. Indeed, for some
diseases identified as high priorities for public health preparedness,
governmental entities have initiated programs to provide support for
product development and/or stockpiling (Ref. 7).\3\ In such cases, FDA
would consider that market as a factor in determining whether a
significant market for a drug for the treatment or prevention of an
infectious diseases disease exists in developed nations.
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\3\ For example, certain diseases have been prioritized for
medical countermeasure development and investment (see Ref. 7) or
are listed as priority pathogens by government entities such as the
National Institutes of Health (NIH)/National Institute of Allergy
and Infectious Diseases (NIAID), Center for Disease Control or
Prevention, and military programs (Refs. 8, 9, and 10). These and
other indications of potential priority designation that could
affect governmental resource allocation may be taken into account in
assessment of whether a market exists in developed countries.
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B. Disproportionately Affects Poor and Marginalized Populations

As with the term ``no significant market in developed nations,''
FDA has elected to analyze multiple factors--none of which, alone,
invariably will be outcome-determinative--in assessing whether a given
disease meets the requirement of ``disproportionately affects poor and
marginalized populations'' for classification as a ``tropical disease''
under section 524 of the FD&C Act. Those factors are the following:
1. The Proportion of Global Disability-Adjusted Life Years for the
Disease That Is Attributable to Developing Countries
A disability-adjusted life year (DALY) measurement is not a direct
measure of the prevalence of the disease; rather, it is a measure of
the impact of that disease on a given population. ``One DALY can be
thought of as one lost year of 'healthy' life'' (Ref. 11). An estimate
of disease-related morbidity (a term which, as used in this order,
refers to the state of being diseased (see Ref. 12)) and mortality in
affected countries thus can be made by assessing available information
about the DALY burden of a particular disease. ``DALYs for a disease or
health condition are calculated as the sum of the Years of Life Lost. .
.due to premature mortality in the population and the Years Lost due to
Disability. . .for people living with the health condition or its
consequences'' (Ref. 11). DALYs are an important measurement, enabling
FDA to weigh ``tropical disease'' eligibility for those diseases that,
although they may be present to some degree in developed countries
(e.g., because of travel or immigration), cause much more harm to the
public health of developing countries.
2. The Relative Burden of the Disease in the Most Impoverished
Populations Within the Countries in Which It Is Found
If a disease's prevalence is high in populations who cannot afford
treatment and low in populations that can, there likely will be little
market incentive for drug companies to create new treatments. In light
of section 524 of the FD&C Act's intent to create treatment development
incentives, as well as its clear goal of improving the health of
impoverished populations, FDA will consider the demographic
distribution of a disease in determining whether it should be
designated as a ``tropical disease'' for the purposes of section 524 of
the FD&C Act.
3. The Relative Burden of the Disease in Infants, Children, or Other
Marginalized Segments of the Population (e.g., Women, the Elderly)
Within the Countries in Which It Is Found
One of the clear goals of section 524 of the FD&C Act is improving
the health of marginalized populations, who generally suffer poorer
health outcomes than their non-marginalized neighbors, even within the
same country. To ``marginalize'' is to place (or keep) a person or
population in a powerless or unimportant position (see, e.g., Ref. 13).
Individuals or groups may be marginalized for any number of reasons,
including, for example, gender, age, or extreme poverty. Marginalized
populations generally lack a meaningful voice in societal
decisionmaking, including decisions relating to the acquisition,
distribution, and use of health resources. These populations,
therefore, are less likely to have their health needs met and less
likely to have the resources or political power needed to effect change
in those aspects of health policy that most affect them--including
incentivizing governments or private industry to offer disease
treatments. Understanding the relative prevalence of a disease in these
populations will help FDA determine whether treatment development for
that disease would be spurred by the provision of section 524 of the
FD&C Act's PRV incentive.
4. Designation by the World Health Organization as a Neglected Tropical
Disease
The World Health Organization (WHO), in its role as the directing
and coordinating authority on international health within the U.N.
system, has identified a list of diseases that it refers to as
``neglected tropical diseases'' (Ref. 14). According to the WHO, these
diseases ``are strongly associated with poverty'' and tend to affect
those with ``little political voice''; rarely receive the attention of
disease treatment innovators or the broader international community;
and often flourish in tropical climates (id.). The WHO's list includes
12 of the 17 enumerated diseases in section 524(a)(3) of the FD&C Act
(see Ref. 15). Because the WHO's list of ``neglected tropical
diseases'' includes many of the types of diseases for which section 524
was designed to incentivize treatment development, FDA believes it is
reasonable to consider WHO's ``neglected tropical disease''
designations in determining whether a disease should be designated as a

[[Page 50562]]

``tropical disease'' for purposes of section 524 of the FD&C Act.

III. Diseases Being Designated

FDA has considered a number of diseases recommended in response to
the Federal Register document announcing the December 12, 2008, public
meeting (see 73 FR 66050, November 6, 2008), by meeting participants or
others directing communications to FDA on the same topic. Based on an
assessment using the criteria proposed previously, FDA has determined
that the following diseases will be designated as ``tropical diseases''
under section 524 of the FD&C Act:
Chagas disease.
Neurocysticercosis.

FDA's rationale for adding these diseases to the list is discussed in
the analyses that follow.

A. Chagas Disease

Chagas disease, also known as American trypanosomiasis, is a
vector-borne parasitic disease caused by the protozoan Trypanosoma
cruzi (Ref. 16). After the initial infection, a 2-month ``acute'' phase
occurs, during which there are some antiparasitic drugs that can be
used for treatment in some patients (id.). Treatment efficacy generally
decreases with length of infection, and if the disease is not cured
during the initial ``acute'' infection phase, the chronic infection
lingers over the next several years or decades, often causing organ and
tissue damage (id.). For example, some Chagas disease sufferers who
contract the disease during childhood die in early adulthood due to
heart arrhythmias or other effects of organ damage. Efforts to reduce
Chagas disease center around controlling the spread of the vector
insects (e.g., through insecticide and roof repair) and protecting
people from insect bites (e.g., through bed net use) (id.).
Chagas disease has a disproportionate effect on poor and
marginalized populations. Developing countries in Central and South
America suffer most of the global DALYs lost because of the disease
(id.). Estimates vary, but approximately 8 million people are believed
to be infected in Mexico, Central America, and South America (Ref. 17).
Within Chagas-endemic countries, the disease often affects rural and/or
poor populations who live in the mud huts that also are inhabited by
the vector insects (Ref. 16). WHO has designated Chagas as a neglected
tropical disease (Ref. 15).
There also is no significant market for Chagas disease treatment in
developed nations. Based on estimates derived by applying published
seroprevalence data to immigrant population estimates in the United
States, it is estimated that there are just over 300,000 persons
infected with T. cruzi in the United States (Refs. 17, 18, and 19). The
number of persons with chronic cases for whom definitive
recommendations for treatment would apply is likely less than 300,000.
Transmission and acute cases of Chagas disease would be considered
unlikely either in the United States or in other developed countries.
The most common insect vector that transmits the parasite, the
triatomine bug, is found mostly in Central and South America. The main
risk of Chagas transmission to uninfected persons in developed
countries is due to mother-to-child transmission, or blood transfusions
or organ donations where the donor has lived in or visited Chagas-
endemic countries--although there have been a few reports of vector-
borne Chagas infecting people in the United States (Refs. 16 and 17).
There are no approved vaccines or other preventative therapies for
the disease, either in the United States or elsewhere. The only drugs
used to treat Chagas are benznidazole and nifurtimox, which are not
approved in the United States for this use. In addition to the lack of
a commercial market in developed countries (presumably because of the
low prevalence of disease), there does not seem to be a sizeable
indirect (e.g., government) market for Chagas treatments either--
presumably because of the geographical limitations of the disease. As a
general matter, Chagas-endemic countries are developing countries in
Central and South America, and thus neither persons with Chagas disease
nor their governments are likely to be in a position to provide a
financial incentive for treatment development. Given the disease's
geographical limitations and its prevalence in non-touristed rural
areas, it is unlikely that the travelers' market would be a sufficient
incentive to encourage treatment development for Chagas.
Given the factors described in this document, FDA has determined
that Chagas disease meets both statutory criteria of ``no significant
market in developed nations'' and ``disproportionately affects poor and
marginalized populations.'' Therefore, FDA is designating Chagas
disease as a tropical disease under section 524 of the FD&C Act.

B. Neurocysticercosis

Cysticercosis is a disease caused by infection with Taenia solium,
a tapeworm of the phylum Platyhelminthes, and is contracted when a
person ingests the tapeworm eggs. After a person ingests the eggs, the
tapeworm enters the larval stage and begins to infect the host's
tissues. The most severe form of the disease, called
neurocysticercosis, occurs when larvae enter the central nervous system
and establish cysts that can cause epilepsy (see, e.g., Ref. 20).
Treatment guidelines from the American Academy of Neurology recommend
treatment with anti-helminthic drugs like albendazole, with
consideration for adjunctive corticosteroid therapy (Ref. 20).
Neurocysticercosis disproportionately affects poor and marginalized
populations. Indeed, patients who have infection with T. solium
generally have similar socioeconomic and demographic characteristics to
those patients with soil transmitted helminthiasis, a disease already
on the statutory list of ``tropical diseases'' in section 524 of the
FD&C Act. As of the late 1990s, approximately 50 million people
worldwide were estimated to harbor the tapeworm T. solium (Ref. 21),
most of them living in poverty in the world's poorest countries that
lack effective systems for meat inspection and adequate sanitation
(Refs. 22 and 23). Estimates of the number of people who have epilepsy
caused by neurocysticercosis ranges from 450,000 to 1,350,000 in
Central and South America and from 300,000 to 4,600,000 in sub-saharan
Africa (Ref. 23). Neurocysticercosis is believed to contribute to high
levels of human morbidity, notably epilepsy, though efforts are
underway to adequately characterize an estimate of DALY for
neurocysticercosis (Ref. 24). Notably, cysticercosis is included on
WHO's list of neglected tropical diseases (Ref. 15).
FDA also has determined that neurocysticercosis products have no
significant market in developed nations. Although the disease does
occur in the United States, estimates of annual incidence rates in the
general U.S. population are low, at approximately 0.2 cases per 100,000
population. Incidence rates are much higher among Hispanics living in
the United States, who most likely acquired the tapeworm in
cysticercosis-endemic areas of Central and South America (Ref. 25),
with estimates ranging between 3.1 and 5.8 cases per 100,000 Hispanic
population (Ref. 26). FDA also is unaware of evidence suggesting any
sizeable military, government, or other indirect market for
neurocysticercosis products.
In view of the disease characteristics discussed previously, FDA
considers the statutory criteria for addition of neurocysticercosis to
the list of tropical

[[Page 50563]]

diseases in section 524 of the FD&C Act to be satisfied. This addition
is effective upon the publication of this order.

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

The purpose of this order is to add diseases to the list of
tropical diseases that FDA has found to meet the criteria in section
524(a)(3)(R) of the FD&C Act. By expanding the list with this order,
FDA does not mean to preclude the future addition of other diseases to
this list. To facilitate the consideration of future additions to the
list, FDA is establishing a public docket (see http://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)(R) of the FD&C Act. FDA will periodically review these
requests, and, when appropriate, expand the list.

V. Paperwork Reduction Act

This final order establishes a 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)(R) of the FD&C Act. This 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.
3501-3520). 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 agency's
full consideration of the comment.''

VI. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m. Monday through Friday, and
are available electronically at http://www.regulations.gov.

(FDA has verified the Web site addresses, but FDA is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)

1. U.S. Food and Drug Administration, ``Guidance for Industry:
Expedited Programs For Serious Conditions--Drugs and Biologics''
(available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf),
2014.
2. IMF, ``World Economic Outlook: Recovery Strengthens, Remains
Uneven,'' Table B1 (available at http://www.imf.org/external/pubs/ft/weo/2014/01/pdf/tblpartb.pdf).
3. U.N. Development Programme, ``Human Development Index (HDI)''
(available at http://hdr.undp.org/en/content/human-development-index-hdi).
4. The World Bank, ``Country and Lending Groups'' (available at
http://data.worldbank.org/about/country-and-lending-groups).
5. U.N. Development Programme, ``Frequently Asked Questions--Human
Development Index (HDI)'' (available at http://hdr.undp.org/en/faq-page/human-development-index-hdi#t292n36).
6. Congressional Research Service, ``Generalized System of
Preferences: Background and Renewal Debate,'' pp. 7, 11 (available
at http://fas.org/sgp/crs/misc/RL33663.pdf).
7. U.S. Department of Health and Human Services, ``Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation
Plan,'' December 2012 (available at http://www.phe.gov/Preparedness/mcm/phemce/Documents/2012-PHEMCE-Implementation-Plan.pdf).
8. National Institute of Allergy and Infectious Diseases, NIAID
Emerging Infectious Diseases/Pathogens (available at http://www.niaid.nih.gov/topics/biodefenserelated/biodefense/pages/cata.aspx).
9. Centers for Disease Control and Prevention, Bioterrorism Agents/
Diseases (available at http://www.bt.cdc.gov/agent/agentlist-category.asp).
10. Joint Program Executive Office for Chemical and Biological
Defense, Joint Vaccine Acquisition Program (JVAP) (available at
http://www.jpeocbd.osd.mil/packs/Default.aspx?pg=1208).
11. WHO, ``Metrics: Disability Adjusted Life Year (DALY)''
(available at http://www.who.int/healthinfo/global_burden_disease/metrics_daly/en/).
12. Medline Plus/Merriam-Webster Medical Dictionary Online,
``Morbidity'' (available at http://www.merriam-webster.com/medlineplus/morbidity).
13. Merriam-Webster Dictionary Online, ``Marginalize'' (available at
http://www.merriam-webster.com/dictionary/marginalize).
14. WHO, ``First WHO Report on Neglected Tropical Diseases: Working
to Overcome the Global Impact of Neglected Tropical Diseases''
(available at http://whqlibdoc.who.int/publications/2010/9789241564090_eng.pdf).
15. WHO, ``Neglected Tropical Diseases: Diseases Covered by NTD
Department'' (available at http://www.who.int/neglected_diseases/diseases/en/).
16. Centers for Disease Control and Prevention, ``Parasites--
American Trypanosomiasis (also known as Chagas Disease): Detailed
FAQs'' (available at http://www.cdc.gov/parasites/chagas/gen_info/detailed.html).
17. Centers for Disease Control and Prevention, ``Parasites--
American Trypanosomiasis (also known as Chagas Disease):
Epidemiology and Risk Factors,'' (available at http://www.cdc.gov/parasites/chagas/epi.html).
18. Bern, C. and S.P. Montgomery, ``An Estimate of the Burden of
Chagas Disease in the United States,'' Clinical Infectious Diseases,
49:e52-54, 2009 (available at http://cid.oxfordjournals.org/content/49/5/e52.full).
19. Centers for Disease Control and Prevention, ``Congenital
Transmission of Chagas Disease--Virginia, 2010,'' MMWR. Morbidity
and Mortality Weekly Report, 61(26):477-479, July 6, 2012 (available
at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6126a1.htm?s_cid=mm6126a1_w).
20. Baird, R.A., S. Weibe, J.R. Zunt, et al., ``Evidence-Based
Guideline: Treatment of Parenchymal Neurocysticercosis,'' Neurology,
80:1424-1429, 2013 (available at http://www.neurology.org/content/80/15/1424.full.pdf).
21. White, A.C., Jr., ``Neurcysticercosis: A Major Cause of
Neurological Disease Worldwide,'' Clinical Infectious Disease,
24:101-115, 1997 (available at http://cid.oxfordjournals.org/content/24/2/101.long).
22. Institute of Medicine, ``The Causes and Impacts of Neglected
Tropical and Zoonotic Diseases: Opportunities for Integrated
Intervention Strategies,'' Washington, DC: The National Academies
Press (available at http://www.ncbi.nlm.nih.gov/books/NBK62507/pdf/TOC.pdf).
23. Mewara, A., K. Goyal, and R. Sehgal, ``Neurocysticercosis: A
Disease of Neglect,'' Tropical Parasitology, 3(2):106-113, 2013
(available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3889086/?report=printable).
24. Bhattarai, R., H. Carabin, and C. Budke, ``The Burden of
Cysticercosis,'' Novel Aspects on Cysticercosis and
Neurocysticercosis, H.F. Sibat, ed. (available at http://www.intechopen.com/books/novel-aspects-on-cysticercosis-and-neurocysticercosis/the-burden-of-cysticercosis).
25. Wallin, M.T. and J.F. Kurtzke, ``Neurocysticercosis in the
United States: Review of an Important Emerging Infection,''
Neurology, 63:1559-1564, 2004 (available at http://www.neurology.org/content/63/9/1559.long).
26. O'Neal, S., J. Noh, P. Wilkins, et al, ``Taenia solium Tapeworm
Infection, Oregon, 2006-2009,'' Emerging Infectious Disease,
17(6):1030-1036, 2011 (available at http://wwwnc.cdc.gov/eid/article/17/6/10-1397_article).

[[Page 50564]]

Dated: August 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20554 Filed 8-19-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations 50559

captioned proceeding. Revisions to ADDRESSES: Submit electronic disease product application’’ and sets
Auxiliary Installations, Replacement comments on additional diseases forth criteria which, if met, enable those
Facilities, and Siting and Maintenance suggested for designation to who submit an application for a tropical
Regulations, 152 FERC ¶ 61,049 (2015). www.regulations.gov. Submit written disease product to be eligible to receive
This errata notice makes a correction to comments on additional diseases a PRV upon approval of that tropical
the Final Rule as issued. suggested for designation to the Division disease product application. To be
In FR Doc. 2015–17919 appearing on of Dockets Management (HFA–305), eligible for a PRV, the tropical disease
page 43949 in the Federal Register of Food and Drug Administration, 5630 product application must meet all of the
Friday, July 24, 2015, the following Fishers Lane, Rm. 1061, Rockville, MD following criteria:
correction is made: 20852. All comments should be • The application must be a ‘‘human
1. On page 43949, in the second identified with the docket number drug application,’’ as defined in section
column, § 157.216(b)(2)(i)(A) of the found in brackets in the heading of this 735(1) of the FD&C Act (21 U.S.C.
regulatory text is revised to read as document. 379g(1)).
follows: FOR FURTHER INFORMATION CONTACT: • The application must be for the
‘‘(A) Will not exceed the cost limit in Kristiana Brugger, Center for Drug ‘‘prevention or treatment of a tropical
§ 157.208(d) for activities under the Evaluation and Research, Food and disease,’’ as defined by statute.
prior notice provisions;’’ Drug Administration, 10903 New • The application must be deemed
Dated: August 14, 2015. Hampshire Ave., Bldg. 51, rm. 6262, eligible for priority review by the
Kimberly D. Bose, Silver Spring, MD 20993–0002, 301– Secretary of HHS.
Secretary. 796–3601; or Stephen Ripley, Center for • The application must be approved
[FR Doc. 2015–20538 Filed 8–19–15; 8:45 am] Biologics Evaluation and Research, after the date of enactment of FDAAA
BILLING CODE 6717–01–P Food and Drug Administration, 10903 (i.e., September 27, 2007) for use in the
New Hampshire Ave., Bldg. 71, rm. prevention, detection, or treatment of a
7301, Silver Spring, MD 20993–0002, tropical disease.
DEPARTMENT OF HEALTH AND 240–402–7911. • The application must be for ‘‘a
HUMAN SERVICES SUPPLEMENTARY INFORMATION: human drug, no active ingredient
(including any ester or salt of the active
Table of Contents ingredient) of which has been approved
Food and Drug Administration
I. Background: Priority Review Voucher in any other application under section
21 CFR Part 317 Program 505(b)(1) [21 U.S.C. 355(b)(1)] or section
II. Criteria for Expansion of the List of 351 of the [PHS Act].’’
[Docket No. FDA–2008–N–0567] Tropical Diseases Section 524(a)(4) of the FD&C Act. In
A. No Significant Market in Developed particular, the requirement that an
RIN 0910–AG37
Nations
B. Disproportionately Affects Poor and application must be eligible for priority
Designating Additions to the Current Marginalized Populations review demonstrates the PRV program’s
List of Tropical Diseases in the Federal III. Diseases Being Designated intent to reward tropical disease
Food, Drug, and Cosmetic Act A. Chagas Disease product applications that have the
B. Neurocysticercosis potential to demonstrate significant
AGENCY: Food and Drug Administration,
IV. Process for Requesting Additional improvements in safety or effectiveness
HHS. Diseases To Be Added to the List in the treatment or prevention of
ACTION: Final order. V. Paperwork Reduction Act
tropical diseases (Ref. 1).
VI. References
SUMMARY: The Federal Food, Drug, and FDA will award a PRV to the
Cosmetic Act (the FD&C Act) authorizes I. Background: Priority Review application holder upon the approval of
the Food and Drug Administration (FDA Voucher Program a qualifying tropical disease product
or Agency) to award priority review Much of the global burden of disease application that meets the criteria
vouchers (PRVs) to tropical disease falls on populations who lack the previously listed. The voucher entitles
product applicants when the resources to develop, encourage the holder to a priority review of a
applications meet certain criteria. The development of, or purchase disease human drug application, submitted
FD&C Act lists the diseases that are preventions or treatments. For this under section 505(b)(1) of the FD&C Act
considered to be tropical diseases for reason, many of the diseases afflicting or section 351 of the PHS Act, of the
purposes of obtaining PRVs, and also these populations do not receive the voucher holder’s choosing. Once
provides for Agency expansion of that same level of innovation investment as awarded to the application holder, the
list to include other diseases that satisfy diseases afflicting wealthier or more PRV may be transferred to another
the definition of ‘‘tropical diseases’’ as empowered populations. entity, and the original holder may
set forth in the FD&C Act. FDA has Section 524 of the FD&C Act (21 receive consideration (including
determined that Chagas disease and U.S.C. 360n), which was added by payment) for the transfer. To redeem the
neurocysticercosis satisfy this section 1102 of the Food and Drug voucher, a PRV holder must notify FDA
definition, and therefore is adding them Administration Amendments Act of of its intent to use the PRV at least 90
to the list of designated tropical diseases 2007 (FDAAA), is designed to address days prior to the submission of the
whose product applications may result the lack of treatment development application for which the PRV will be
in the award of PRVs. Sponsors incentives for such tropical diseases. It used. This notification constitutes a
submitting certain applications for the uses a PRV incentive to encourage the legally binding agreement to pay the
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treatment of Chagas disease and development of new drugs for user fee that must be applied to
neurocysticercosis may be eligible to prevention and treatment of certain applications using a PRV.
receive a PRV if such applications are diseases that, in the aggregate, affect Section 524(a)(3) of the FD&C Act lists
approved by FDA. millions of people throughout the the following diseases as tropical
DATES: This order is effective August 20, world. Specifically, section 524 of the diseases qualifying for a PRV:
2015. FD&C Act defines the term ‘‘tropical • Tuberculosis

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Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations 50561

developed country can often be B. Disproportionately Affects Poor and 3. The Relative Burden of the Disease in
estimated by assessing the occurrence of Marginalized Populations Infants, Children, or Other Marginalized
a particular disease in that country.2 Segments of the Population (e.g.,
As with the term ‘‘no significant Women, the Elderly) Within the
If the prevalence of a disease in market in developed nations,’’ FDA has
developed countries is less than 0.1 Countries in Which It Is Found
elected to analyze multiple factors—
percent of the population of those none of which, alone, invariably will be One of the clear goals of section 524
countries, it is unlikely that ordinary outcome-determinative—in assessing of the FD&C Act is improving the health
market forces will offer a sufficient whether a given disease meets the of marginalized populations, who
incentive to drive the development of requirement of ‘‘disproportionately generally suffer poorer health outcomes
new preventions or treatments. Thus, it affects poor and marginalized than their non-marginalized neighbors,
is unlikely that there will be a populations’’ for classification as a even within the same country. To
‘‘significant market’’ for the disease’s ‘‘tropical disease’’ under section 524 of ‘‘marginalize’’ is to place (or keep) a
treatment in those countries. the FD&C Act. Those factors are the person or population in a powerless or
Accordingly, FDA has decided to use a following: unimportant position (see, e.g., Ref. 13).
disease prevalence rate of 0.1 percent of Individuals or groups may be
the population as a factor for aiding in 1. The Proportion of Global Disability-
Adjusted Life Years for the Disease That marginalized for any number of reasons,
the determination of whether a including, for example, gender, age, or
Is Attributable to Developing Countries
‘‘significant market’’ may exist for a extreme poverty. Marginalized
disease’s treatment. A disability-adjusted life year (DALY) populations generally lack a meaningful
b. The Existence of a Sizeable Indirect measurement is not a direct measure of voice in societal decisionmaking,
Market for the Tropical Disease Drug the prevalence of the disease; rather, it including decisions relating to the
is a measure of the impact of that acquisition, distribution, and use of
(e.g., Government, Including the
disease on a given population. ‘‘One health resources. These populations,
Military) That Would Constitute a
DALY can be thought of as one lost year therefore, are less likely to have their
Financial Incentive for Drug
of ’healthy’ life’’ (Ref. 11). An estimate health needs met and less likely to have
Development
of disease-related morbidity (a term the resources or political power needed
As discussed previously, the market which, as used in this order, refers to to effect change in those aspects of
for many FDA-approved products is the the state of being diseased (see Ref. 12)) health policy that most affect them—
‘‘direct’’ market, involving patients and mortality in affected countries thus including incentivizing governments or
purchasing drugs for their own use. can be made by assessing available private industry to offer disease
However, some drugs may have a information about the DALY burden of treatments. Understanding the relative
sizeable ‘‘indirect’’ market composed of, a particular disease. ‘‘DALYs for a prevalence of a disease in these
for example, government entities or disease or health condition are populations will help FDA determine
nongovernmental organizations that calculated as the sum of the Years of whether treatment development for that
wish to purchase and distribute a drug Life Lost. . .due to premature mortality disease would be spurred by the
for the treatment or prevention of an in the population and the Years Lost provision of section 524 of the FD&C
infectious disease, often for public due to Disability. . .for people living Act’s PRV incentive.
health reasons, to a particular group of with the health condition or its
4. Designation by the World Health
people. Indeed, for some diseases consequences’’ (Ref. 11). DALYs are an
Organization as a Neglected Tropical
identified as high priorities for public important measurement, enabling FDA
Disease
to weigh ‘‘tropical disease’’ eligibility
health preparedness, governmental
for those diseases that, although they The World Health Organization
entities have initiated programs to
may be present to some degree in (WHO), in its role as the directing and
provide support for product
developed countries (e.g., because of coordinating authority on international
development and/or stockpiling (Ref.
travel or immigration), cause much health within the U.N. system, has
7).3 In such cases, FDA would consider
more harm to the public health of identified a list of diseases that it refers
that market as a factor in determining developing countries.
whether a significant market for a drug to as ‘‘neglected tropical diseases’’ (Ref.
for the treatment or prevention of an 2. The Relative Burden of the Disease in 14). According to the WHO, these
infectious diseases disease exists in the Most Impoverished Populations diseases ‘‘are strongly associated with
developed nations. Within the Countries in Which It Is poverty’’ and tend to affect those with
Found ‘‘little political voice’’; rarely receive the
2 Exceptions may occur for diseases that have a
attention of disease treatment
low incidence in developed countries through use If a disease’s prevalence is high in innovators or the broader international
of preventive drugs or biologics. Thus, although the populations who cannot afford community; and often flourish in
disease incidence is lower in developed countries treatment and low in populations that tropical climates (id.). The WHO’s list
these are less likely to be the types of diseases for can, there likely will be little market includes 12 of the 17 enumerated
which section 524 of the FD&C Act is intended to
spur innovation. incentive for drug companies to create diseases in section 524(a)(3) of the
3 For example, certain diseases have been new treatments. In light of section 524 FD&C Act (see Ref. 15). Because the
prioritized for medical countermeasure of the FD&C Act’s intent to create WHO’s list of ‘‘neglected tropical
development and investment (see Ref. 7) or are treatment development incentives, as diseases’’ includes many of the types of
listed as priority pathogens by government entities
well as its clear goal of improving the diseases for which section 524 was
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such as the National Institutes of Health (NIH)/
National Institute of Allergy and Infectious Diseases health of impoverished populations, designed to incentivize treatment
(NIAID), Center for Disease Control or Prevention, FDA will consider the demographic development, FDA believes it is
and military programs (Refs. 8, 9, and 10). These distribution of a disease in determining reasonable to consider WHO’s
and other indications of potential priority
designation that could affect governmental resource
whether it should be designated as a ‘‘neglected tropical disease’’
allocation may be taken into account in assessment ‘‘tropical disease’’ for the purposes of designations in determining whether a
of whether a market exists in developed countries. section 524 of the FD&C Act. disease should be designated as a

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50562 Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations

‘‘tropical disease’’ for purposes of applying published seroprevalence data Platyhelminthes, and is contracted
section 524 of the FD&C Act. to immigrant population estimates in when a person ingests the tapeworm
the United States, it is estimated that eggs. After a person ingests the eggs, the
III. Diseases Being Designated
there are just over 300,000 persons tapeworm enters the larval stage and
FDA has considered a number of infected with T. cruzi in the United begins to infect the host’s tissues. The
diseases recommended in response to States (Refs. 17, 18, and 19). The most severe form of the disease, called
the Federal Register document number of persons with chronic cases neurocysticercosis, occurs when larvae
announcing the December 12, 2008, for whom definitive recommendations enter the central nervous system and
public meeting (see 73 FR 66050, for treatment would apply is likely less establish cysts that can cause epilepsy
November 6, 2008), by meeting than 300,000. Transmission and acute (see, e.g., Ref. 20). Treatment guidelines
participants or others directing cases of Chagas disease would be from the American Academy of
communications to FDA on the same considered unlikely either in the United Neurology recommend treatment with
topic. Based on an assessment using the States or in other developed countries. anti-helminthic drugs like albendazole,
criteria proposed previously, FDA has The most common insect vector that with consideration for adjunctive
determined that the following diseases transmits the parasite, the triatomine corticosteroid therapy (Ref. 20).
will be designated as ‘‘tropical diseases’’ bug, is found mostly in Central and Neurocysticercosis disproportionately
under section 524 of the FD&C Act: South America. The main risk of Chagas affects poor and marginalized
• Chagas disease. transmission to uninfected persons in populations. Indeed, patients who have
• Neurocysticercosis. developed countries is due to mother-to- infection with T. solium generally have
FDA’s rationale for adding these child transmission, or blood similar socioeconomic and demographic
diseases to the list is discussed in the transfusions or organ donations where characteristics to those patients with
analyses that follow. the donor has lived in or visited Chagas- soil transmitted helminthiasis, a disease
A. Chagas Disease endemic countries—although there have already on the statutory list of ‘‘tropical
been a few reports of vector-borne diseases’’ in section 524 of the FD&C
Chagas disease, also known as Chagas infecting people in the United Act. As of the late 1990s, approximately
American trypanosomiasis, is a vector- States (Refs. 16 and 17). 50 million people worldwide were
borne parasitic disease caused by the There are no approved vaccines or estimated to harbor the tapeworm T.
protozoan Trypanosoma cruzi (Ref. 16). other preventative therapies for the solium (Ref. 21), most of them living in
After the initial infection, a 2-month disease, either in the United States or poverty in the world’s poorest countries
‘‘acute’’ phase occurs, during which elsewhere. The only drugs used to treat that lack effective systems for meat
there are some antiparasitic drugs that Chagas are benznidazole and inspection and adequate sanitation
can be used for treatment in some nifurtimox, which are not approved in (Refs. 22 and 23). Estimates of the
patients (id.). Treatment efficacy the United States for this use. In number of people who have epilepsy
generally decreases with length of addition to the lack of a commercial caused by neurocysticercosis ranges
infection, and if the disease is not cured market in developed countries from 450,000 to 1,350,000 in Central
during the initial ‘‘acute’’ infection (presumably because of the low and South America and from 300,000 to
phase, the chronic infection lingers over prevalence of disease), there does not 4,600,000 in sub-saharan Africa (Ref.
the next several years or decades, often seem to be a sizeable indirect (e.g., 23). Neurocysticercosis is believed to
causing organ and tissue damage (id.). government) market for Chagas contribute to high levels of human
For example, some Chagas disease treatments either—presumably because morbidity, notably epilepsy, though
sufferers who contract the disease of the geographical limitations of the efforts are underway to adequately
during childhood die in early adulthood disease. As a general matter, Chagas- characterize an estimate of DALY for
due to heart arrhythmias or other effects endemic countries are developing neurocysticercosis (Ref. 24). Notably,
of organ damage. Efforts to reduce countries in Central and South America, cysticercosis is included on WHO’s list
Chagas disease center around and thus neither persons with Chagas of neglected tropical diseases (Ref. 15).
controlling the spread of the vector disease nor their governments are likely FDA also has determined that
insects (e.g., through insecticide and to be in a position to provide a financial neurocysticercosis products have no
roof repair) and protecting people from incentive for treatment development. significant market in developed nations.
insect bites (e.g., through bed net use) Given the disease’s geographical Although the disease does occur in the
(id.). limitations and its prevalence in non- United States, estimates of annual
Chagas disease has a disproportionate touristed rural areas, it is unlikely that incidence rates in the general U.S.
effect on poor and marginalized the travelers’ market would be a population are low, at approximately
populations. Developing countries in sufficient incentive to encourage 0.2 cases per 100,000 population.
Central and South America suffer most treatment development for Chagas. Incidence rates are much higher among
of the global DALYs lost because of the Given the factors described in this Hispanics living in the United States,
disease (id.). Estimates vary, but document, FDA has determined that who most likely acquired the tapeworm
approximately 8 million people are Chagas disease meets both statutory in cysticercosis-endemic areas of
believed to be infected in Mexico, criteria of ‘‘no significant market in Central and South America (Ref. 25),
Central America, and South America developed nations’’ and with estimates ranging between 3.1 and
(Ref. 17). Within Chagas-endemic ‘‘disproportionately affects poor and 5.8 cases per 100,000 Hispanic
countries, the disease often affects rural marginalized populations.’’ Therefore, population (Ref. 26). FDA also is
and/or poor populations who live in the FDA is designating Chagas disease as a unaware of evidence suggesting any
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mud huts that also are inhabited by the tropical disease under section 524 of the sizeable military, government, or other
vector insects (Ref. 16). WHO has FD&C Act. indirect market for neurocysticercosis
designated Chagas as a neglected products.
tropical disease (Ref. 15). B. Neurocysticercosis In view of the disease characteristics
There also is no significant market for Cysticercosis is a disease caused by discussed previously, FDA considers
Chagas disease treatment in developed infection with Taenia solium, a the statutory criteria for addition of
nations. Based on estimates derived by tapeworm of the phylum neurocysticercosis to the list of tropical

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Document Created: 2015-12-15 11:09:02
Document Modified: 2015-12-15 11:09:02

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final order.
Dates		This order is effective August 20, 2015.
Contact		Kristiana Brugger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6262, Silver Spring, MD 20993-0002, 301- 796-3601; 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.
FR Citation		80 FR 50559
RIN Number		0910-AG37

80 FR 50559 - Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Act

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 161 (August 20, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration