[Federal Register Volume 85, Number 59 (Thursday, March 26, 2020)]
[Notices]
[Pages 17055-17056]
[FR Doc No: 2020-06320]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

    Docket Numbers: RP20-661-000.
    Applicants: Enable Gas Transmission, LLC.
    Description: Annual Revenue Crediting Filing of Enable Gas
Transmission, LLC under RP20-661.
    Filed Date: 3/17/20.
    Accession Number: 20200317-5207.
    Comments Due: 5 p.m. ET 3/30/20.

    Docket Numbers: RP18-940-007.
    Applicants: Empire Pipeline, Inc.

    Description: Compliance filing Metadata Corrective Tariff Record
Filing to be effective 1/1/2019.
    Filed Date: 3/18/20.
    Accession Number: 20200318-5111.
    Comments Due: 5 p.m. ET 3/30/20.

    Docket Numbers: RP20-663-000.
    Applicants: Natural Gas Pipeline Company of America.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Filing--Sempra
Gas & Power Marketing, LLC to be effective 4/1/2020.
    Filed Date: 3/19/20.
    Accession Number: 20200319-5047.
    Comments Due: 5 p.m. ET 3/31/20.

    Docket Numbers: RP20-664-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Compliance filing 2020 Annual Penalty Revenue
Crediting Report.
    Filed Date: 3/19/20.
    Accession Number: 20200319-5051.
    Comments Due: 5 p.m. ET 3/31/20.

    Docket Numbers: RP20-665-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Name Change Cleanup--Colonial
to Boston Gas to be effective 4/20/2020.
    Filed Date: 3/19/20.
    Accession Number: 20200319-5052.
    Comments Due: 5 p.m. ET 3/31/20.

    Docket Numbers: RP20-666-000.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Sec.  4(d) Rate Filing: Mar2020 Non-conforming Agrmt
Cleanup Filing, eff 4-23-2020 to be effective 4/23/2020.
    Filed Date: 3/19/20.
    Accession Number: 20200319-5120.
    Comments Due: 5 p.m. ET 3/31/20.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 20, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-06320 Filed 3-25-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 165 (Friday, August 24, 2018)]
[Notices]
[Pages 42904-42910]
[FR Doc No: 2018-18314]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 (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 tropical diseases for purposes of obtaining PRVs
and 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. The Agency has determined that chikungunya virus
disease, Lassa fever, rabies, and cryptococcal meningitis satisfy this
definition and is therefore adding them to the list of designated
tropical diseases whose product applications may result in the award of
PRVs. Sponsors submitting certain drug or biological product
applications for the prevention or treatment of chikungunya virus
disease, Lassa fever, rabies, and cryptococcal meningitis may be
eligible to receive a PRV if such applications are approved by FDA.

DATES: This order is effective August 24, 2018.

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 Office of Communication,
Outreach and Development (OCOD), Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002, 1-800-835-4709 or<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background: Priority Review Voucher Program
II. Diseases Being Designated
    A. Chikungunya Virus Disease
    B. Lassa Fever
    C. Rabies
    D. Cryptococcal Meningitis
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, 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. Further
information about the tropical disease PRV program can be found in
guidance for industry ``Tropical Disease Priority Review Vouchers'' (81
FR 69537, October 6, 2016, available at https://www.federalregister.gov/documents/2015/08/20/2015-20554/designating-additions-to-the-current-list-of-tropical-diseases-in-the-federal-food-drug-and-cosmetic). Additions to the statutory list of tropical
diseases published in the Federal Register can be accessed at https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm.
    On August 20, 2015, FDA published a final order (80 FR 50559)
(final order) designating Chagas disease and neurocysticercosis as
tropical diseases. That final order also sets forth FDA's
interpretation of the statutory criteria for tropical disease
designation and expands the list of tropical diseases under section
524(a)(3)(S) of the FD&C Act, which 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.
    In this document, FDA has applied its August 2015 criteria as set
forth in the final order to analyze whether Chikungunya virus disease,
Lassa fever, rabies, and cryptococcal meningitis meet the statutory
criteria for addition to the tropical disease list.

II. Diseases Being Designated

    FDA has considered all diseases submitted to the public docket
(FDA-2008-N-0567) between August 20, 2015, and June 20, 2018, as
potential additions to the list of tropical diseases under section 524
of the FD&C Act, pursuant to the docket review process explained on the
Agency's website (see https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm). Based on an
assessment using the criteria from its August 20, 2015, final order,
FDA has determined that the following additional diseases will be
designated as ``tropical diseases'' under section 524 of the FD&C Act:

 Chikungunya virus disease
 Lassa fever
 Rabies
 Cryptococcal meningitis

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

A. Chikungunya Virus Disease

    Chikungunya virus (CHIKV) is an arbovirus transmitted by Aedes
mosquitoes in tropical climates in Africa, Asia, islands in the Indian
and Pacific Oceans, Europe, and, since 2013, the Americas (Ref. 1).
Although CHIKV mortality is relatively low (0.01 to 0.1 percent),
attack rates are very high (33 to 66 percent) and most infections are
symptomatic (Refs. 2 and 3). Many infected individuals experience
painful arthralgia, which can persist for months and even years (Ref.
4). Life-threatening manifestations of CHIKV, including organ failure,
meningoencephalitis, hemorrhagic symptoms, and myocardial disease, and
death occur in neonates, the elderly, and individuals with chronic
comorbidities (Ref. 3).
    There is no approved antiviral treatment for CHIKV in the United
States or anywhere else in the world (Refs. 5 and 6). Therapeutic
management largely aims to relieve pain and inflammation and limit the
loss of mobility and physical fitness through the use of analgesic and
non-steroidal anti-inflammatory drugs. There is no approved CHIKV
vaccine (Ref. 6).
1. No Significant Market in Developed Nations
    CHIKV disease occurs rarely in developed nations (Ref. 1).
Outbreaks of CHIKV primarily occur in poor tropical regions where
uncontrolled breeding of Aedes aegypti and Aedes albopictus mosquitoes
occurs in close proximity to humans due to inadequate sanitation and
poor living conditions (Ref. 7). For example, in 2015, more than
700,000 suspected or confirmed cases of CHIKV were reported in the
Americas; however, only 1,185 of those cases occurred in the United
States (excluding territories) and Canada, all of which were imported
(Refs. 8 and 9). The U.S. territories of Puerto Rico and the U.S.
Virgin Islands reported 202 cases, all of which were transmitted
locally (Ref. 8). There were no locally transmitted cases of CHIKV
reported in Europe, Japan, Australia, or New Zealand in 2015 (Ref. 10).
Even among U.S. military and military dependents, who are sometimes
deployed to outbreak areas, CHIKV infection is rare; there were only
121 CHIKV cases among U.S. Department of Defense healthcare
beneficiaries between January 2014 and February 2015 (Ref. 11).
    Based on the epidemiology of reported CHIKV cases, the market for
vaccines in developed nations such as the United States would largely
comprise travelers at risk of CHIKV infection and military populations.
These markets are unlikely to provide sufficient incentive to encourage
development of products to treat or prevent CHIKV infection. Although a
limited number of locally transmitted cases have recently been reported
in U.S. territories, the disease is not currently considered endemic in
those areas. Whether those populations could broaden the market for
products to treat or prevent CHIKV infection in the future is unknown.
CHIKV drug development is not significantly funded by U.S. Government
sources, and CHIKV is not among the Centers for Disease Control and
Prevention's (CDC) list of potential bioterrorism agents.
2. Disproportionately Affects Poor and Marginalized Populations
    Poor populations in tropical environments experience the primary
burden of CHIKV disease because they are disproportionally exposed to
its mosquito vectors (Ref. 7). Arboviral diseases disproportionally
affect low-income urban and rural populations through increased
mosquito exposure due to poor housing, lack of sanitation
infrastructure, and outdoor occupations such as animal husbandry (Refs.
7 and 12). Large-scale and systematic insecticide mosquito control
programs, once considered a public health priority throughout the world
due to yellow fever virus, were largely dismantled due to diminishing
resources and are therefore not available in most developing nations
(Ref. 13).
    Although CHIKV infection is rarely fatal, CHIKV sequelae have a
major impact on productivity and economics in developing nations (Ref.
7). CHIKV outbreaks are often explosively large, with high attack rates
and high rates of symptomatic disease (Refs. 1 and 3). An outbreak in
India in 2006 involved more than 1.3 million suspected cases and was
associated with more than 25,000 Disability Adjusted Life Years (DALYs)
lost (Ref. 14). A meta-analysis of 38 published studies confined to
cases occurring in 2005 estimated that CHIKV led to up to 1 million
years of healthy life lost and 1.5 million DALYs lost (Ref. 15).
    Neonates are particularly vulnerable to serious complications of
CHIKV infection. Among neonates born 1 day

before or within 5 days following the onset of their infected mothers'
symptoms, 50 percent are born with CHIKV infection (Ref. 3). Neonates
are also highly vulnerable to direct inoculation of CHIKV through
mosquito bites. Infected neonates present with fever, breastfeeding
difficulties, thrombocytopenia, lymphopenia, and moderate hepatic
cytolysis. One in four develops one or more serious complications, such
as encephalopathy with progressive cerebral edema, sepsis, coagulopathy
with hemorrhage, and cardiomyopathy (Ref. 3).
    The elderly and individuals with chronic comorbid conditions are
also susceptible to life-threatening CHIKV disease (Refs. 3 and 16). A
case series of 65 patients admitted to intensive care units with
confirmed CHIKV in Martinique and Guadeloupe found that most patients
were older than 50, and 83 percent of patients had preexisting
comorbidities such as hypertension, diabetes, heart failure, and
chronic kidney disease (Ref. 16). Upon admission, 57 percent required
mechanical ventilation, 46 percent had shock requiring vasoactive
drugs, 31 percent required renal replacement therapy, and 27 percent
died (Ref. 16).
    The World Health Organization (WHO) has designated Chikungunya as a
Neglected Tropical Disease (Ref. 17).
    Given the factors described above, FDA has determined that CHIKV
disease meets both statutory criteria of ``no significant market in
developed nations'' and ``disproportionately affects poor and
marginalized populations.'' Therefore, FDA is designating CHIKV disease
as a tropical disease under section 524 of the FD&C Act.

B. Lassa Fever

    Lassa fever (LF) is an acute viral infection caused by Lassa virus,
a single-stranded ribonucleic acid virus belonging to the arenavirus
family. LF is endemic in parts of West Africa (Benin, Ghana, Guinea,
Liberia, Mali, Sierra Leone, and Nigeria), but probably exists in other
West African countries where the animal vector for Lassa virus is
distributed. Most Lassa virus infections (~80 percent) are mild or
asymptomatic. In the remaining 20 percent of Lassa virus infections,
the disease may progress to more severe symptoms that include
respiratory distress, bleeding, shock, multiorgan system failure, and
death. Involvement of the central nervous system may also occur with
tremors, encephalitis, or hearing loss (Ref. 18).
    The overall mortality rate of all Lassa virus infections is
approximately 1 percent. However, the mortality rate in hospitalized
patients is about 15 to 20 percent (Ref. 19). The most common
complication of Lassa virus infection is sensorineural hearing loss.
About one-third of hospitalized patients develop hearing loss; in most
of these patients, hearing loss is permanent. Sensorineural hearing
loss may also occur in patients with mild or asymptomatic disease (Ref.
20).
    Currently, there are no FDA-approved drugs for prophylaxis or
treatment of LF. In the absence of vaccine that protects against LF,
disease prevention relies on good community hygiene to avert rodents
from entering homes.
1. No Significant Market in Developed Nations
    LF does not occur in developed countries, except for a few imported
cases. Characteristically, since 1969, only six cases of LF have been
documented in travelers returning to the United States (not including
convalescent patients) (Ref. 21). Thus, LF appears to meet the criteria
of not having a significant direct market in developed countries.
    FDA is also unaware of evidence of a significant indirect market
for LF products. Lassa virus, like other hemorrhagic viruses, has been
categorized as a Category A pathogen by CDC (Refs. 22 to 24). Category
A pathogens are considered a threat to public health and are viewed as
potential biological weapons threat agents. Therefore, if a drug
against a Category A pathogen is developed, it could have an indirect
market if stockpiled as a medical countermeasure for the U.S.
Government. At present, however, FDA is unaware of any significant
funding by the military, the Biomedical Advanced Research and
Development Authority, or any other U.S. Government sources for drug
development targeting treatment or prophylaxis against LF. Further,
Lassa virus is not listed as a high-priority threat in the 2017 Public
Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy
and Implementation Plan (Ref. 25).
2. Disproportionately Affects Poor and Marginalized Populations
    LF is exclusively endemic in some West African countries. LF cases
identified in areas where LF is not endemic have occurred rarely and
are usually imported by persons returning from West Africa. Every year,
Lassa virus is estimated to cause 100,000 to 300,000 infections in West
Africa, with approximately 5,000 deaths (Refs. 19 and 21). All
countries where LF is known to be endemic (Benin, Ghana, Guinea,
Liberia, Mali, Sierra Leone, and Nigeria) are classified by the World
Bank as either low income (gross national income per capita of $1,045
or less) or lower-middle income (gross national income per capita of
$1,046-$4,125). Further, the incidence of LF in endemic countries is
much higher among the poorest rural populations (Ref. 26). The
characteristics of the disease (high morbidity and mortality) indicate
a potentially significant DALY impact, although a comprehensive
literature search failed to identify any DALY data.
    LF causes serious disease and death in both sexes and in all age
groups, including children. The mortality rate is much higher for women
in their third trimester of pregnancy. Spontaneous abortion is also a
serious complication of Lassa virus infection, with a 95 percent
mortality in fetuses of pregnant women (Refs. 21 and 26).
    LF has not been designated by WHO as a neglected tropical disease.
However, a panel of scientists and public health experts convened by
WHO met in Geneva on December 8 and 9, 2015, to prioritize the top 5 to
10 emerging pathogens likely to cause severe outbreaks in the near
future and for which few or no medical countermeasures exist. LF was
one out of the nine diseases included in the initial list that need
research and development preparedness to help control future outbreaks
(Refs. 26 and 27).
    Given the factors described above, FDA has determined that LF meets
both statutory criteria of ``no significant market in developed
nations'' and ``disproportionately affects poor and marginalized
populations.'' Therefore, FDA is designating Lassa fever as a tropical
disease under section 524 of the FD&C Act.

C. Rabies

    Human rabies infection is caused by the rabies virus, which
typically enters the body through animal bite wounds or by direct
contact of the virus with the body's mucosal or respiratory surfaces.
Virtually all patients with human rabies infection ultimately progress
to coma followed by death, although rare recoveries have been reported
(Ref. 28).
    As rabies is almost always fatal, post-exposure prophylaxis is
recommended after suspected or proven exposure to rabies virus. Post-
exposure rabies prophylaxis (PEP) should include wound cleansing,
infiltration of rabies immunoglobulin into and around the wound, and
vaccination with cell culture rabies vaccines (Ref. 29). Pre-exposure
prophylaxis, consisting of

administration of a rabies vaccine course, is recommended for anyone
who is at continual, frequent, or increased risk for exposure to the
rabies virus (Ref. 30). Rabies vaccines licensed for human use in the
United States include human diploid cell vaccine (IMOVAX) and purified
chick embryo cell vaccine (RabAvert). WHO has recommended
discontinuation of nerve tissue vaccines, which are associated with
more severe adverse reactions and are less immunogenic than cell-
culture and embryonated egg-based rabies vaccines, since 1984; however,
these vaccines remain in use in some developing nations (Ref. 31). Two
rabies immunoglobulin products are licensed in the United States:
IMOGAM and HyperRab. There are no approved treatments for symptomatic
human rabies infection.
1. No Significant Market in Developed Nations
    In developed nations, wild animals (e.g., raccoons, bats, skunks,
foxes), rather than domesticated animals, account for the vast majority
of reported rabies cases. Successful rabies vaccination programs have
eliminated canine rabies in developed nations (including the United
States), except for cases contracted while living in or travelling to
rabies-endemic areas (Ref. 31). WHO categorizes Europe and North
America as low-risk areas for humans contracting rabies (Ref. 32).
Specific rabies prevalence information in the U.S. animal population
was not identified in review of CDC rabies surveillance data; however,
in 2014, a total of 6,033 animals were reported to be rabid in the
United States, over 90 percent occurring in wild animals (Ref. 33).
    Using pre-exposure or post-exposure prophylaxis can prevent human
rabies infection. Christian, et al. reported an estimated 6,000 to
7,000 vaccine doses used annually in the United States for pre-exposure
vaccination of critical personnel engaged in occupational activities
with a risk for rabies exposure, and a separate survey estimated 6,600
vaccine doses required each year to vaccinate approximately 2,200
veterinary students (Ref. 34).
    The United States does not have a national reporting system for use
of rabies PEP; therefore, the accurate usage information is unknown.
The CDC states an estimated 40,000 to 50,000 PEP treatments are
administered annually in the United States, yielding an incidence of
0.01 to 0.02 percent using 2015 U.S. Census Bureau population estimate
data (Refs. 35 and 36). Christian, et al. reported that between 2006
and 2008, the annual U.S. national average PEP use was estimated at
23,415 courses (range: 10,645-35,845), with an average annual rate of
PEP administration for 16 states and NYC of 8.46/100,000 persons
(range: 1.14-18.89/100,000 persons) (Ref. 34). The available data
regarding pre-exposure and post-exposure rabies prophylaxis in the
United States suggests that the population for whom rabies vaccines and
human rabies immunoglobulin products are used is below 0.1 percent of
the population, supporting the conclusion that there is no significant
market for preventing human rabies infection in developed nations.
    Between 2006 and 2011, there were 12 human rabies cases reported in
Europe, of which 6 were imported (Refs. 37 and 38). In the United
States and Puerto Rico, 37 persons have been diagnosed with human
rabies since 2003, including 11 cases (30 percent) with exposure
occurring outside of the United States and its territories and 5 cases
(14 percent) acquired from organ or tissue transplantation (Ref. 33).
Although a specific prevalence is not reported, the rarity of human
rabies infection in the United States is well below 0.1 percent of the
population. A direct market for products to treat symptomatic rabies
would therefore be small.
    The Joint Regulation on Immunizations and Chemoprophylaxis for the
Prevention of Infectious Diseases Army Regulation 40-562 provides
general guidance on rabies prevention recommendations for military
personnel (Army, Navy, Air Force, Marine Corps, Coast Guard) (Ref. 39).
Nevertheless, FDA is unaware of evidence suggesting any sizable
government or other indirect market for rabies virus products.
2. Disproportionately Affects Poor and Marginalized Populations
    Although rabies is present in all continents except Antarctica,
more than 95 percent of human deaths occur in Asia and Africa. WHO has
designated rabies virus as a Neglected Tropical Disease (Ref. 17). It
considers rabies a neglected disease of poor and vulnerable populations
and reports the majority of deaths (84 percent) occur in rural areas
(Ref. 31). In contrast to rabies epidemiology in developed nations,
domestic dogs account for 99 percent of human rabies cases globally.
Children in particular are at risk for human rabies infection: 40
percent of people bitten by suspected rabid animals are less than 15
years of age (Ref. 40).
    Human rabies infection is a preventable disease, and the
overwhelming majority of rabies deaths result from the lack of
recommended PEP administration following suspected rabies exposure
(Ref. 39). The annual number of human rabies deaths worldwide estimated
in 2010 ranged from 26,400 (95 percent confidence interval 15,200-
45,200) to 61,000 (95 percent CI 37,000-86,000) using different
statistical approaches (Ref. 31). Using these data, DALYs for human
rabies are estimated at 1.9 million (95 percent CI, 1.3-2.6 million)
(id.). In developing countries, licensed purified cell culture and
embryonated egg-based rabies vaccines and immunoglobulin for rabies PEP
are neither readily available (due to shortages) nor accessible
(distance to medical centers, affordability) (Refs. 39 and 40). The
average cost of rabies PEP is reported to be US $40 in Africa and US
$49 in Asia, which greatly exceeds the average daily income estimated
at US $1-$2 per person (Ref. 40).
    Given the factors described above, FDA has determined that rabies
meets both the statutory criteria of ``no significant market in
developed nations'' and ``disproportionately affects poor and
marginalized populations.'' Therefore, FDA is designating rabies as a
tropical disease under section 524 of the FD&C Act.

D. Cryptococcal Meningitis

    Cryptococcus species are encapsulated fungi found in the
environment throughout the world. The two most prominent species that
cause human disease are C. neoformans and C. gattii (Ref. 41). The
majority of cryptococcal meningitis (CM) is caused by C. neoformans
infection in immunocompromised individuals. The incidence of CM
increased substantially with the human immunodeficiency virus (HIV)/
acquired immune deficiency syndrome (AIDS) epidemic in the late 20th
century and remains high in developing countries that lack access to
effective antiretroviral therapy (Ref. 42).
    Cryptococcal infection typically occurs by inhalation of the fungi
into the lungs. In immunocompromised individuals, the resulting
pulmonary infection frequently spreads to the central nervous system,
causing meningitis (Ref. 43). The primary recommended treatment of CM
in developed countries includes a 2-week induction phase with
amphotericin B and oral flucytosine, followed by long-term maintenance
therapy with oral fluconazole (Ref. 44). In resource-limited nations,
oral fluconazole is often the only therapeutic option available. Poor
access to care and limited availability of standard antifungal therapy
for patients with CM result in

significantly higher mortality and treatment failure rates in
developing countries (Ref. 45). Park, et al. (2009) estimated that,
excluding HIV/AIDS, CM is the fourth leading cause of death in sub-
Saharan Africa, causing more deaths than tuberculosis (Ref. 46).
1. No Significant Market in Developed Nations
    Immunocompromised patients are typically the most vulnerable
population to develop serious manifestations from infection with
Cryptococcus, and the prevalence of CM is closely linked to the
prevalence of untreated and poorly managed HIV/AIDS. There has been a
reduction in the incidence of CM in the United States and other
developed nations due to the availability of antiretroviral therapy and
lower rates of individuals with advanced HIV/AIDS (Ref. 42). Per the
CDC, national estimates of the incidence of cryptococcosis are
difficult to establish because it is only reportable in a few states
(id.). In 2000, a population-based surveillance study in two U.S.
metropolitan areas estimated that the annual incidence of
cryptococcosis among persons with AIDS was between 2 and 7 cases per
1,000, and the overall incidence was 0.4 to 1.3 cases per 100,000 (Ref.
47). As of 2009, Pyrgos, et al. estimated that approximately 3,400
annual hospitalizations were associated with CM in the United States
(Ref. 48). Given that the overwhelming majority of patients diagnosed
with CM in the United States will initiate therapy in the hospital, FDA
considers 3,400 annually a rough estimate of the number of cases of CM
in the United States. Based on the CDC treatment guidelines for CM, FDA
estimates that most CM patients will receive at least 1 year of
therapy. Therefore, even if the proportion of CM patients on therapy at
any given time is 50 times the annual incidence of CM, the prevalence
of CM in the United States remains below 0.1 percent of the population.
    Clinical practice guidelines for the management of cryptococcal
disease do not routinely recommend primary antifungal prophylaxis for
cryptococcosis in HIV-infected patients in the United States and
Europe. This recommendation is based on the relative infrequency of
cryptococcal disease, lack of survival benefits, potential for drug-
drug interactions, creation of direct antifungal drug resistance,
medication compliance, and costs. Routine primary prophylaxis for
cryptococcosis is also not currently recommended in transplant
recipients (Ref. 44).
    The emergence of C. gattii in the Pacific Northwest in 2004,
primarily among immunocompetent individuals, raised concerns about a
new serious infectious disease risk for people residing in or traveling
to the Pacific Northwest states. However, there have been only 60 cases
reported to CDC between 2004 and 2010 (Ref. 49). U.S. cases continue to
be reported at a relatively low rate, 20-23 cases per year each in 2012
and 2013 (Ref. 50). The emergence of C. gattii in the United States has
not resulted in a large number of cases that could potentially warrant
a significant market for treatment or prevention.
    Therefore, in the United States and other developed countries,
there does not appear to be a significant market for developing new
drugs or vaccines for the treatment or prevention of CM. Additionally,
given the low incidence of CM and the low risk of infection to
immunocompetent individuals, it is unlikely that antifungal therapies
specifically directed against CM will become a national stockpiling
priority in the foreseeable future.
2. Disproportionately Affects Poor and Marginalized Populations
    CM is not currently designated by WHO as a Neglected Tropical
Disease (Ref. 17). Additionally, no DALY data were found to distinguish
the disease burden of CM in developing versus developed countries.
However, the incidence of CM is high in developing countries due to
limited access to antiretroviral therapy to treat HIV infection (Ref.
42). Annually, there are approximately 1 million cases of CM worldwide
in patients with HIV/AIDS and 625,000 deaths (Ref. 46). Approximately
75 percent of these infections are in sub-Saharan Africa (id.). The
case fatality rate for CM patients living in sub-Saharan Africa is 35
to 65 percent, compared to a 10- to 20-percent case fatality rate in
most developed nations (Ref. 51).
    The HIV epidemic imposes a particular burden on women and children,
specifically in sub-Saharan Africa where women account for
approximately 57 percent of all people living with HIV (Ref. 52). In
2012, there were an estimated 260,000 newly infected children in low-
and middle-income countries (id.). Children with HIV are more likely to
face gaps in access to HIV treatment. For example, in 2012,
approximately 34 percent of children had access to HIV treatment versus
approximately 64 percent for adults (id.). As CM is most prevalent in
persons infected with HIV and HIV disproportionately impacts women and
children, it is reasonable to conclude that CM also disproportionately
affects these populations.
    Given the factors described above, FDA has determined that CM meets
both statutory criteria of ``no significant market in developed
nations'' and ``disproportionately affects poor and marginalized
populations.'' Therefore, FDA is designating cryptococcal meningitis as
a tropical disease under section 524 of the FD&C Act.

III. 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)(S) of the FD&C Act. By expanding the list with this order,
FDA does not mean to preclude the addition of other diseases to this
list in the future. Interested persons may submit requests for
additional diseases to be added to the list to the public docket
established by FDA for this purpose (see https://www.regulations.gov,
Docket No. FDA-2008-N-0567). 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 https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm534162.htm.

IV. Paperwork Reduction Act

    This final order 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. 3501-3520).
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.''

V. References

    The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for

viewing by interested persons between 9 a.m. and 4 p.m. Monday through
Friday; they are also available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.

1. Petersen, L.R. and A.M. Powers, ``Chikungunya: Epidemiology,''
F1000Research, 5(F1000 Faculty Rev):82, 2016.
2. Sergon, K., A.A. Yahaya, J. Brown, et al., ``Seroprevalence of
Chikungunya Virus Infection on Grande Comore Island, Union of the
Comoros, 2005,'' American Journal of Tropical Medicine and Hygiene,
76:1189-1193, 2007.
3. Simon, F., E. Javelle, A. Cabie, et al., ``French Guidelines for
the Management of Chikungunya (Acute and Persistent Presentations)
November 2014,'' Medecine Et Maladies Infectieuses, 45:243-263,
2015.
4. Borgherini, G., P. Poubeau, A. Jossaume, et al., ``Persistent
Arthralgia Associated With Chikungunya Virus: A Study of 88 Adult
Patients on Reunion Island,'' Clinical Infectious Diseases, 47:469-
475, 2008.
5. Abdelnabi, R., J. Neyts, and L. Delang, ``Towards Antivirals
Against Chikungunya Virus,'' Antiviral Research, 121:59-68, 2015.
6. McSweegan, E., S.C. Weaver, M. Lecuit, et al., ``The Global Virus
Network: Challenging Chikungunya,'' Antiviral Research, 120:147-152,
2015.
7. LaBeaud, A.D., ``Why Arboviruses Can Be Neglected Tropical
Diseases,'' PLOS Neglected Tropical Disease, 2:e247, 2008.
8. CDC, ``Chikungunya: 2015 Final Data for the United States;''
available at https://www.cdc.gov/chikungunya/geo/united-states-2015.html.
9. Pan American Health Organization, Regional Office for the
Americans of the World Health Organization, ``Chikungunya;''
available at https://www.paho.org/hq/index.php?option=com_topics&view=article&id=343&Itemid=40931.
10. CDC, ``Chikungunya Virus Geographic Distribution;'' available at
https://www.cdc.gov/chikungunya/geo/index.html.
11. Writer, J.V. and L. Hurt, ``Chikungunya Infection in DoD
Healthcare Beneficiaries Following the 2013 Introduction of the
Virus into the Western Hemisphere, 1 January 2014 to 28 February
2015,'' Medical Surveillance Monthly Report, 22:2-6, 2015.
12. Labeaud, A.D., F. Bashir, and C.H. King, ``Measuring the Burden
of Arboviral Diseases: The Spectrum of Morbidity and Mortality from
Four Prevalent Infections,'' Population Health Metrics, 9:1, 2011.
13. Marimoutou, C., E. Vivier, M. Oliver, et al., ``Morbidity and
Impaired Quality of Life 30 Months After Chikungunya Infection:
Comparative Cohort of Infected and Uninfected French Military
Policemen in Reunion Island,'' Medicine (Baltimore), 91:212-219,
2012.
14. Krishnamoorthy, K., K.T. Harichandrakumar, A. Krishna Kumari, et
al., ``Burden of Chikungunya in India: Estimates of Disability
Adjusted Life Years (DALY) Lost in 2006 Epidemic,'' Journal of
Vector Borne Diseases, 46:26-35, 2009.
15. Labeaud, A.D., F. Bashir, C.H. King, ``Measuring the Burden of
Arboviral Diseases: The Spectrum of Morbidity and Mortality from
Four Prevalent Infections,'' Population Health Metrics, 9:1, 2011.
16. Crosby, L., C. Perreau, B. Madeux, et al., ``Severe
Manifestations of Chikungunya Virus in Critically Ill Patients
During the 2013-2014 Caribbean Outbreak,'' International Journal of
Infectious Diseases, 48:78-80, 2016.
17. WHO Neglected Tropical Diseases Program, ``Neglected Tropical
Diseases;'' available at http://www.who.int/neglected_diseases/diseases/en/(accessed August 19, 2016).
18. Seregin, A., N. Yun, and S. Paessler, ``Lymphocytic
Choriomenengitis, Lassa Fever, and South American Hemorrhagic Fevers
(Arenaviruses),'' in: Mandell, G.L., J.E. Bennett, and R. Dolin,
eds. Mandell, Douglas, and Bennett's Principles and Practice of
Infectious Diseases, 8th ed. PA: Churchill Livingstone Elsevier;
2031-2037, 2014.
19. CDC, ``Imported Lassa Fever--New Jersey, 2004,'' Morbidity and
Mortality Weekly Report, 53:894-897, 2004, available at https://www.ncbi.nlm.nih.gov/pubmed/15457145.
20. Cummins, D., J.B. McCormick, D. Bennett, et al., ``Acute
Sensorineural Deafness in Lassa Fever,'' Journal of the American
Medical Association, 264:2093-2096, 1990.
21. CDC, ``Lassa Fever Confirmed in Death of U.S. Traveler Returning
from Liberia,'' May 25, 2015; available at https://www.cdc.gov/media/releases/2015/p0525-lassa.html.
22. Rotz, L.D., A.S. Khan, S.R. Lillibridge, et al., ``Public Health
Assessment of Potential Biological Terrorism Agents,'' Emerging
Infectious Disease, 8:225-230, 2002.
23. Borio, L., T. Inglesby, C.J. Peters, et al., ``Hemorrhagic Fever
Viruses as Biological Weapons: Medical and Public Health
Management,'' Journal of the American Medical Association, 287:2391-
2397, 2002.
24. Ryan, C.P., ``Zoonoses Likely To Be Used in Bioterrorism,''
Public Health Reports, 123:276-281; available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2289981/.
25. Department of Health and Human Services, ``2017-2018 Public
Health Emergency Medical Countermeasures Enterprise (PHEMCE)
Strategy and Implementation Plan,'' 2017; available at https://www.phe.gov/Preparedness/mcm/phemce/Pages/strategy.aspx.
26. WHO, ``Essential Medicines and Health Products: WHO Publishes
List of Top Emerging Diseases Likely To Cause Major Epidemics,''
December 10, 2015; available at http://www.who.int/medicines/ebola-treatment/WHO-list-of-top-emerging-diseases/en/.
27. WHO, ``2017 Annual Review of Diseases Prioritized Under the
Research and Development Blueprint,'' February 11, 2018; available
at http://www.who.int/blueprint/what/research-development/2017-Prioritization-Long-Report.pdf.
28. Bassin, S.L., C.D. Rupprecht, and T.P. Bleck, ``Rhabdoviruses,''
in: Mandell, G.L., J.E. Bennett, R. Dolin, eds., Principles and
Practice of Infectious Diseases, 7th ed., Philadelphia, PA:
Churchill Livingstone; 2249-2258, 2010.
29. Rupprecht, C.E., D. Briggs, C.M. Brown, et al., ``Use of a
Reduced (4-Dose) Vaccine Schedule for Postexposure Prophylaxis to
Prevent Human Rabies: Recommendations of the Advisory Committee on
Immunization Practices,'' Centers for Disease Control and Prevention
(CDC), Morbidity and Mortality Weekly Report, Recomm Rep. 59(RR-
2):1-9, March 19, 2010. Erratum in: Morbidity and Mortality Weekly
Report, Recomm Rep. 59(16):493, April 30, 2010.
30. WHO, ``WHO Guide for Rabies Pre and Post Exposure Prophylaxis in
Humans (updated 2014);'' available at http://www.who.int/rabies/PEP_Prophylaxis_guideline_15_12_2014.pdf (accessed September 7,
2016).
31. WHO, ``WHO Expert Consultation on Rabies, 2nd Report, WHO
Technical Report Series 982 Geneva,'' WHO Press, 2013.
32. WHO, ``Distribution of Risk Levels for Humans Contacting Rabies,
Worldwide, 2013;'' available at http://www.who.int/rabies/Global_distribution_risk_humans_contracting_rabies_2013.png
(accessed August 19, 2016).
33. Monroe, B.P., P. Yager, J. Blanton, et al., ``Rabies
Surveillance in the United States During 2014,'' Journal of the
American Veterinary Medical Association. 248(7):777-788, April 1,
2016.
34. Christian, K.A., J.D. Blanton, M. Auslander, et al.,
``Epidemiology of Rabies Post-Exposure Prophylaxis--United States of
America, 2006-2008,'' Vaccine, 27(51):7156-7161, November 27, 2009.
35. U.S. Census Bureau, Population Division, ``Annual Estimates of
the Resident Population: April 1, 2010 to July 1, 2015,'' available
at https://factfinder.census.gov/faces/nav/jsf/pages/index.xhtml.
36. WHO, ``Rabies Fact Sheet,'' March 2016; available at http://www.who.int/mediacentre/factsheets/fs099/en/ (accessed August 18,
2016).
37. See https://ecdc.europa.eu/en/rabies/facts (accessed January 9,
2017).
38. The European Centre for Disease Prevention and Control, ``Expert
Consultation on Rabies Post-Exposure Prophylaxis,'' January 15,
2009; available at https://ecdc.europa.eu/en/publications/
Publications/0906_MER_

Expert_Consultation_on_Rabies_Post-exposure_Prophylaxis.pdf
(accessed January 9, 2017).
39. See https://armypubs.army.mil/ProductMaps/PubForm/AR_Details.aspx?ID=0902c85180010355 (accessed May 5, 2017).
40. CDC, ``Cost of Rabies Prevention,'' updated August 3, 2015;
available at https://www.cdc.gov/rabies/location/usa/cost.html
(accessed February 9, 2017).
41. Gullo, F.P., S.A. Rossi, J.C. Sardi, et al., ``Cryptococcosis:
Epidemiology, Fungal Resistance, and New Alternatives for
Treatment,'' European Journal of Clinical Microbiology and
Infectious Diseases, 32:1377-1391, 2013.
42. CDC, ``C. neoformans Infection Statistics;'' available at
https://www.cdc.gov/fungal/diseases/cryptococcosis-neoformans/statistics.html (accessed August 8, 2016).
43. Makadzange, A.T. and G. McHugh, ``New Approaches to the
Diagnosis and Treatment of Cryptococcal Meningitis,'' Seminars in
Neurology, 34(1):47-60, 2014.
44. Perfect, J.R., W.E. Dismukes, F. Dromer, et al., ``Clinical
Practice Guidelines for the Management of Cryptococcal Disease: 2010
Update by the Infectious Disease Society of America,'' Clinical
Infectious Diseases, 50:291-322, 2010.
45. Rothe, C., D.J. Sloan, P. Goodson, et al., ``A Prospective
Longitudinal Study of the Clinical Outcomes from Cryptococcal
Meningitis Following Treatment Induction with 800 mg Oral
Fluconazole in Blantyre, Malawi,'' PLOS One, 8(6):e67311, 2013.
46. Park, B.J., K.A. Wannemuehler, B.J. Marston, et al.,
``Estimation of the Current Global Burden of Cryptococcal Meningitis
Among Persons Living with HIV/AIDS,'' AIDS, 23:525-530, 2009.
47. Mirza, S.A., M. Phelan, D. Rimland, et al., ``The Changing
Epidemiology of Cryptococcosis: An Update from Population-Based
Active Surveillance in 2 Large Metropolitan Areas, 1992-2000,''
Clinical Infectious Diseases, 36(6):789-794, 2003.
48. Pyrgos, V., A.E. Seitz, C.A. Steiner, et al., ``Epidemiology of
Cryptococcal Meningitis in the US: 1997-2009,'' PLOS One,
8(2):e56269, 2013.
49. CDC, ``Emergence of Cryptococcus gattii--Pacific Northwest,
2004-2010,'' Morbidity and Mortality Weekly Report, 59(28):865-868,
2010 available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5928a1.htm?s_cid=mm5928a1_w.
50. Espinel-Ingroff, A. and S.E. Kidd, ``Current Trends in the
Prevalence of Cryptococcus Gattii in the United States and Canada,''
Infection and Drug Resistance, 8:89-97, May 11, 2015.
51. WHO, ``Rapid Advice: Diagnosis, Prevention and Management of
Cryptococcal Disease in HIV-Infected Adults, Adolescents and
Children,'' December 2011; available at http://www.who.int/hiv/pub/cryptococcal_disease2011/ (accessed August 8, 2016).
52. Joint United Nations Programme on HIV/AIDS (UNAIDS), ``Global
Report: UNAIDS Report on the Global AIDS Epidemic 2013;'' available
at http://files.unaids.org/en/media/unaids/contentassets/documents/epidemiology/2013/gr2013/UNAIDS_Global_Report_2013_en.pdf (accessed
August 8, 2016).

    Dated: August 21, 2018.
Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2018-18314 Filed 8-23-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 28, 2006 (Volume 71, Number 249)]
[Notices]
[Page 78186]
[DOCID:fr28de06-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting
Comments, Motions To Intervene, and Protests

December 20, 2006.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No: 12750-000.
    c. Date Filed: November 2, 2006.
    d. Applicant: Oregon Wave Energy Partners, LLC.
    e. Name of Project: Newport OPT Wave Park Project.
    f. Location: The proposed tidal project would be located in the
Pacific Ocean about 3 to 6 miles off shore in Lincoln County, Oregon.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contacts: Charles F. Dunleavy, Oregon Wave Energy
Partners, LLC, 1590 Reed Road, Pennington, NJ 08534, phone: (609)-730-
0400.
    i. FERC Contact: Mr. Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing motions to intervene, protests and comments:
60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-12750-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Competing Application: Project No. 12727-000, Date Filed: August
17, 2006, Date Issued: October 11, 2006, Due Date: December 11, 2006.
    l. Description of Project: The proposed project would consist of:
(1) 200 to 400 Power Buoys having a total installed capacity of 100
megawatts, (2) a proposed 13.8 kilovolt transmission line, and (3)
appurtenant facilities. The project is estimated to have an annual
generation of 306.6 gigawatt-hours per-unit per-year, which would be
sold to a local utility.
    m. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street NE., Room 2A,
Washington DC 20426, or by calling<PHONE_NUMBER>. This filing may also
be viewed on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item
h. above.
    n. Individuals desiring to be included on the Commission(s mailing
list should so indicate by writing to the Secretary of the Commission.
    o. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    p. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    q. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. An additional copy must be sent to Director,
Division of Hydropower Administration and Compliance, Federal Energy
Regulatory Commission, at the above-mentioned address. A copy of any
notice of intent, competing application or motion to intervene must
also be served upon each representative of the Applicant specified in
the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under the ``e-Filing''
link. The Commission strongly encourages electronic filings.
    r. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-22230 Filed 12-27-06; 8:45 am]

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[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Proposed Rules]
[Pages 44511-44513]
[FR Doc No: 2012-18461]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0798; Directorate Identifier 2012-CE-023-AD]
RIN 2120-AA64

Airworthiness Directives; Alpha Aviation Concept Limited
Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of Proposed Rulemaking (NPRM).

-----------------------------------------------------------------------

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Alpha Aviation Concept Limited Model R2160 Airplanes. This proposed AD
results from mandatory continuing airworthiness information (MCAI)
originated by an aviation authority of another country to identify and
correct an unsafe condition on an aviation product. The MCAI describes
the unsafe condition as possible installation of non-conforming air
filter elements that are not fitted with metallic mesh and could
internally collapse resulting in

disruption of the powerplant operation. We are issuing this proposed AD
to require actions to address the unsafe condition on these products.

DATES: We must receive comments on this proposed AD by September 13,
2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Alpha Aviation, 59 Hautapu Road, RD 1, Cambridge 3493, New Zealand;
telephone: +64 7 827 0528; fax: +64 7 929 2878; Internet:
www.alphaaviation.co.nz. You may review copies of the referenced
service information at the FAA, Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0798;
Directorate Identifier 2012-CE-023-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Civil Aviation Authority (CAA), which is the aviation authority
for New Zealand, has issued DCA/R2000/41, dated June 8, 2012 (referred
to after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    This emergency AD with the effective date 11 June 2012 is
prompted by a report from EASA of finding a non conforming air
filter fitted to an overseas aircraft during maintenance.
Investigation revealed that air filters with P/N <IP_ADDRESS>
supplied by CEAPR between June 2009 and April 2012 may not have the
metallic mesh inside the filter. This AD mandates an inspection of
air filters with P/N <IP_ADDRESS> to determine if a metallic mesh is
fitted.

Relevant Service Information

    Alpha Aviation has issued Service Bulletin AA-SB-71-006, dated May
2012. The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 10 products of U.S.
registry. We also estimate that it would take about .5 work-hour per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $425, or 42.50 per product.
    In addition, we estimate that any necessary follow-on actions would
take about .5 work-hour and require parts costing $100 for a cost of
$142.50 per product. We have no way of determining the number of
products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Alpha Aviation Concept Limited: Docket No. FAA-2012-0798;
Directorate Identifier 2012-CE-023-AD.

(a) Comments Due Date

    We must receive comments by September 13, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Alpha Aviation Concept Limited Model R2160
airplanes, all serial numbers, certificated in any category.

(d) Subject

    Air Transport Association of America (ATA) Code 71, Power Plant.

(e) Reason

    This AD was prompted by reports of possible installation of non-
conforming air filter elements that are not fitted with metallic
mesh and could internally collapse resulting in disruption of the
powerplant operation. We are issuing this proposed AD to inspect the
air filter element and replace if applicable.

 (f) Actions and Compliance

    Unless already done, do the following actions following Alpha
Aviation Service Bulletin AA-SB-71-006, dated May 2012:
    (1) Within the next 30 days time-in-service (TIS) after the
effective date of this AD, inspect the air filter part number (P/N)
<IP_ADDRESS> to determine if it has been fitted with a perforated
metal liner.
    (2) If, after the inspection required in paragraph (f)(1) of
this AD, the air filter part number (P/N) <IP_ADDRESS> is found to
include the perforated metal liner, no further action is required.
    (3) If, after the inspection required in paragraph (f)(1) of
this AD, the air filter is found to not contain the perforated metal
liner, before further flight, replace the air filter with a new air
filter P/N <IP_ADDRESS> that does contain the perforated metal
liner.
    (4) After the effective date of this AD, do not install any air
filter P/N <IP_ADDRESS> that does not have the perforated metal
liner depicted in Alpha Aviation Service Bulletin AA-SB-71-006,
dated May 2012.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Before using any approved AMOC on
any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI DCA/R2000/41 issued by the Civil Aviation
Authority (CAA), which is the aviation authority for New Zealand,
dated June 8, 2012; and Alpha Aviation Service Bulletin AA-SB-71-
006, dated May 2012, for related information. For service
information related to this AD, contact Alpha Aviation, 59 Hautapu
Road, RD 1, Cambridge 3493, New Zealand; telephone: +64 7 827 0528;
fax: +64 7 929 2878; Internet: www.alphaaviation.co.nz. You may
review copies of the referenced service information at the FAA,
Small Airplane Directorate, 901 Locust, Kansas City, Missouri 64106.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on July 24, 2012.
James Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-18461 Filed 7-27-12; 8:45 am]
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