[Federal Register Volume 80, Number 161 (Thursday, August 20, 2015)]
[Rules and Regulations]
[Pages 50559-50564]
[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,<PHONE_NUMBER>.

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

 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

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

``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

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).

    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 Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39881-39882]
[FR Doc No: 2017-17694]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2017-0767]

Merchant Mariner Medical Advisory Committee

AGENCY: U.S. Coast Guard, Department of Homeland Security.

ACTION: Notice of Federal Advisory Committee Meeting.

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SUMMARY: The Merchant Mariner Medical Advisory Committee and its
Working Groups will meet to discuss matters relating to medical
certification determinations for issuance of licenses, certificates of
registry, and merchant mariners' documents, medical standards and
guidelines for the physical qualifications of operators of commercial
vessels, medical examiner education, and medical research. The meetings
will be open to the public.

DATES: The Merchant Mariner Medical Advisory Committee and its Working
Groups are scheduled to meet on Tuesday, September 12, 2017, and
Wednesday, September 13, 2017, from 8 a.m. until 5:30 p.m. Please note
that these meetings may adjourn early if the Committee has completed
its business.

ADDRESSES: The meetings will be held at Seattle University, in the
Bannan Auditorium, 901 12th Avenue, Seattle, WA 98122-1090 (https://www.seattleu.edu/).
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the Alternate Designated Federal Officer as soon as possible using the
contact information provided in the FOR FURTHER INFORMATION CONTACT
section of this notice.
    Instructions: You are free to submit comments at any time,
including orally at the meetings, but if you want Committee members to
review your comment before the meetings, please submit your comments no
later than September 6, 2017. We are particularly interested in
comments on the issues in the ``Agenda'' section below. You must
include ``Department of Homeland Security'' and the docket number USCG-
2017-0767. Written comments may also be submitted using the Federal
eRulemaking Portal at http://www.regulations.gov. If you encounter
technical difficulties with comments submission, contact the individual
listed in the FOR FURTHER INFORMATION CONTACT section below. Comments
received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review the Privacy and Security Notice for the Federal Docket
Management System at https://www.regulations.gov/privacyNotice.
    Docket Search: For access to the docket to read documents or
comments related to this notice, go to http://www.regulations.gov, type
USCG-2017-0767 in the ``Search'' box, press Enter, and then click on
the item you wish to view.

FOR FURTHER INFORMATION CONTACT: Lieutenant Junior Grade James Fortin,
Alternate Designated Federal Officer of the Merchant Mariner Medical
Advisory Committee, 2703 Martin Luther King Jr. Ave. SE., Stop 7509,
Washington, DC 20593-7509, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER> or
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Notice of this meeting is pursuant with the
Federal Advisory Committee Act, Title 5 United States Code Appendix.
    The Merchant Mariner Medical Advisory Committee Meeting is
authorized by section 210 of the U.S. Coast Guard Authorization Act of
2010 (Pub. L. 111-281, codified at 46 United States Code 7115). The
Committee advises the Secretary on matters related to (a) medical
certification determinations for issuance of licenses, certificates of
registry, and merchant mariners' documents; (b) medical standards and
guidelines for the physical qualifications of operators of commercial
vessels; (c) medical examiner education; and (d) medical research.

Agenda

Day 1

    The agenda for the September 12, 2017, meeting is as follows:
    (1) Opening remarks from the Designated Federal Officer.
    (2) Opening remarks from U.S. Coast Guard leadership.
    (3) Roll call of Committee members and determination of a quorum.
    (4) Public comment period.
    (5) Working Groups will separately address the following task
statements which are available for viewing at https://homeport.uscg.mil/medmac.
    (a) Task statement 15-13, Mariner Occupational Health Risk Study
Analysis. This is a joint task statement with the Merchant Marine
Personnel Advisory Committee;
    (b) Task statement 16-24, requesting recommendations on appropriate
diets and wellness for mariners while aboard merchant vessels;

    (c) Task statement 17-25, requesting recommendations on functions
that would be useful to the mariner, ashore and afloat regarding their
medical certification;
    (d) Task statement 17-26, Input to Support Regulatory Reform of
Coast Guard Regulations--Executive Orders 13771 and 13783.
    (e) The Committee may receive new task statements from the U.S.
Coast Guard, review the information presented on each issue, deliberate
and formulate recommendations for the Department's consideration.
    (7) Adjournment of meeting.

Day 2

    The agenda for the September 13, 2017, meeting is as follows:
    (1) Committee work update.
    (2) Merchant Mariner Credentialing brief.
    (3) National Maritime Center brief.
    (4) Marine casualty data analysis presentation.
    (5) Continue work on task statements.
    (6) Public comment period.
    (7) By mid-afternoon, the Working Groups will report, and if
applicable, make recommendations for the full Committee to consider for
presentation to the U.S. Coast Guard. The Committee may deliberate and
vote on the Working Group's recommendations on this date. The public
will have an opportunity to speak after each Working Group's Report
before the full Committee takes any action on each report.
    (8) Closing remarks/plans for next meeting.
    (9) Adjournment of Meeting.
    A public comment period will be held on September 12, 2017, from
approximately 11:30 a.m.-12 p.m. and September 13, 2017, from
approximately 2:15 p.m.-2:45 p.m.
    A copy of all meeting documentation will be available at https://homeport.uscg.mil/medmac no later than September 4, 2017.
Alternatively, you may contact Lieutenant Junior Grade James Fortin as
noted in the FOR FURTHER INFORMATION section above.
    Public comments will be limited to 5 minutes per speaker. Please
note that the public comment periods will end following the last call
for comments. Contact Lieutenant Junior Grade James Fortin as indicated
in the FOR FURTHER INFORMATION CONTACT section of this document to
register as a speaker.
    Please note that the meeting may adjourn early if the work is
completed.

    Dated: August 15, 2017.
Jeffrey G. Lantz,
Director of Commercial Regulations and Standards.
[FR Doc. 2017-17694 Filed 8-21-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Rules and Regulations]
[Pages 61969-61971]
[FR Doc No: 2023-19201]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2022-0580; FRL-11047-02-R5]

Air Plan Approval; Ohio; Approval of the Muskingum River SO2
Attainment Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving, under
the Clean Air Act (CAA), a revision to the Ohio State Implementation
Plan (SIP) intended to provide for attainment of the 2010 primary,
health-based 1-hour sulfur dioxide (SO2) national ambient
air quality standard (NAAQS or standard) for the Muskingum River
SO2 nonattainment area. This SIP revision (hereinafter
referred to as Ohio's Muskingum River SO2 attainment plan or
plan), includes Ohio's attainment demonstration and other attainment
planning elements required under the CAA. EPA is finding that Ohio has
appropriately demonstrated that the plan provides for attainment of the
2010 1-hour primary SO2 NAAQS in the Muskingum River, Ohio
nonattainment area and that the plan meets the other applicable
requirements under the CAA. EPA is also incorporating by reference Ohio
Director's Final Findings and Orders (DFFOs), issued on May 23, 2023,
into the Ohio SIP. The DFFOs set forth additional requirements at Globe
Metallurgical (Globe) to verify appropriate source characterization for
modeling purposes.

DATES: This final rule is effective on October 10, 2023.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2022-0580. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
through www.regulations.gov or at the Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays and facility
closures due to COVID-19. We recommend that you telephone Gina
Harrison, Environmental Scientist, at<PHONE_NUMBER> before visiting
the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Gina Harrison, Attainment Planning and
Maintenance Section, Air Programs Branch (AR-18J), U.S. Environmental
Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago,
Illinois 60604,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

I. Background

    On January 18, 2022 (87 FR 2555), EPA partially approved and
partially disapproved Ohio's SO2 plan for the Muskingum
River area submitted on April 3, 2015, and October 13, 2015, and
supplemented on June 23, 2020. EPA's January 18, 2022, final rule
provided an explanation of the applicable provisions in the CAA and the
measures and limitations identified in Ohio's attainment plan to
satisfy these provisions.
    The partial disapproval started sanctions clocks for this area
under CAA section 179(a)-(b), including a requirement for 2-for-1
offsets for any major new sources or major modifications 18 months
after the effective date of this action, and highway funding sanctions
6 months thereafter, as well as initiated an obligation for EPA to
promulgate a Federal Implementation Plan (FIP) within 24 months, under
CAA section 110(c).
    Ohio supplemented the attainment demonstration on June 24, 2022,
substituting new measures in lieu of a land acquisition and modifying
the air quality modeling to include the use of site-specific
meteorological data. Ohio submitted additional supplemental information
on July 28, 2022, and May 23, 2023, including revised DFFOs for Globe,
issued on May 23, 2023, that supersede the June 23, 2020 DFFOs.

II. Proposed Rule

    On June 22, 2023 (88 FR 40726), EPA proposed to approve Ohio's SIP
attainment plan submission for the Muskingum River SO2
nonattainment area, which the state submitted to EPA on April 3, 2015,
October 13, 2015, and June 23, 2020, and supplemented on June 24, 2022,
July 28, 2022, and May 23, 2023. The SO2 attainment plan
included Ohio's attainment

demonstration for this area. The attainment plan also addressed
requirements for emission inventories, reasonably available control
measures (RACM) and reasonably available control technology (RACT),
reasonable further progress (RFP), and contingency measures. Ohio has
previously addressed requirements regarding nonattainment area new
source review. Because Ohio's submission provides an appropriate
testing requirement to confirm the modeling, EPA has determined that
Ohio's SO2 attainment plan for the Muskingum River
SO2 nonattainment area meets the applicable requirements of
CAA sections 110, 172, 191, and 192.
    A key element of Ohio's attainment plan is Ohio's revised DFFOs,
issued to Globe on May 23, 2023. Among other requirements, Ohio's DFFOs
retain SO2 emission limits for Globe set forth in the 2020
DFFOs as a matrix of limits based on 26 separate operating scenarios at
the two baghouses, where each of the 26 scenarios was modeled to
demonstrate attainment and maintenance of the SO2 standard.
As part of the proposed approval of Ohio's attainment plan for this
area, EPA proposed to approve Ohio's May 23, 2023, DFFOs for the Globe
facility into the SIP. These DFFOs supersede the previous 2020 DFFOs,
retain the SO2 limits and other requirements set forth in
the 2020 DFFOs, and require additional testing, monitoring, and
confirmation of certain flow parameters for verification of source
modeling characterization. For the reasons discussed in the proposed
rule, EPA finds that these requirements are sufficient for the required
attainment plan demonstration.

III. Public Comments

    The public comment period for EPA's proposed rule ended on July 24,
2023. EPA received no comments on the proposal.

IV. Final Action

    EPA is approving Ohio's SIP attainment plan submission for the
Muskingum River SO2 nonattainment area, which the state
previously submitted to EPA on April 3, 2015, October 13, 2015, and
June 23, 2020, and supplemented on June 24, 2022, July 28, 2022, and
May 23, 2023. This SO2 attainment plan included Ohio's
attainment demonstration for this area. The attainment plan also
addressed requirements for emission inventories, RACT/RACM, RFP, and
contingency measures. By this action, EPA is codifying its approval of
both Ohio's May 23, 2023, DFFOs issued to Globe and Ohio's attainment
plan for the Muskingum River SO2 nonattainment area.
    This approval terminates the highway funding sanction and FIP
clocks started under CAA section 179 resulting from EPA's partial
disapproval of the prior SIP. It also removes the permitting offset
sanction that has been in place since August 17, 2023.

V. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of the Ohio
Regulations described in section II of this preamble and set forth in
the amendments to 40 CFR part 52 below. EPA has made, and will continue
to make, these documents generally available through
www.regulations.gov, and at the EPA Region 5 Office (please contact the
person identified in the FOR FURTHER INFORMATION CONTACT section of
this preamble for more information). Therefore, these materials have
been approved by EPA for inclusion in the SIP, have been incorporated
by reference by EPA into that plan, are fully federally enforceable
under sections 110 and 113 of the CAA as of the effective date of the
final rulemaking of EPA's approval, and will be incorporated by
reference in the next update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, and 14094 (88 FR 21879, April 11, 2023);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997) because it approves a state program;
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001); and
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA.
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    Executive Order 12898 (Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations, 59 FR 7629,
February 16, 1994) directs Federal agencies to identify and address
``disproportionately high and adverse human health or environmental
effects'' of their actions on minority populations and low-income
populations to the greatest extent practicable and permitted by law.
EPA defines environmental justice (EJ) as ``the fair treatment and
meaningful involvement of all people regardless of race, color,
national origin, or income with respect to the development,
implementation, and enforcement of environmental laws, regulations, and
policies.'' EPA further defines the term fair treatment to mean that
``no group of people should bear a disproportionate burden of
environmental harms and risks, including those resulting from the
negative environmental consequences of industrial, governmental, and
commercial operations or programs and policies.''
    Ohio EPA did not evaluate environmental justice considerations as
part of its SIP submittal; the CAA and applicable implementing
regulations neither prohibit nor require such an evaluation. EPA did
not perform an EJ analysis and did not consider EJ in this

action. Consideration of EJ is not required as part of this action, and
there is no information in the record inconsistent with the stated goal
of E.O. 12898 of achieving environmental justice for people of color,
low-income populations, and Indigenous peoples.
    This action is subject to the Congressional Review Act, and EPA
will submit a rule report to each House of the Congress and to the
Comptroller General of the United States. This action is not a ``major
rule'' as defined by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 7, 2023. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Reporting and recordkeeping
requirements, Sulfur oxides.

    Dated: August 31, 2023.
Debra Shore,
Regional Administrator, Region 5.

    For the reasons stated in the preamble, title 40 CFR part 52 is
amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
2. In Sec.  52.1870:
0
a. Amend the table in paragraph (d) by adding an entry for ``Globe
Metallurgical, Inc.'' before the entry for ``Hilton Davis''.
0
b. Amend the table in paragraph (e) under the heading ``Summary of
Criteria Pollutant Attainment Plans'' by revising the entry entitled
``SO2 (2010)'' for ``Muskingum River''.
    The addition and revision read as follows:

Sec.  52.1870  Identification of plan.

* * * * *
    (d) * * *

                                  EPA Approved Ohio Source-Specific Provisions
----------------------------------------------------------------------------------------------------------------
                                                           Ohio effective
          Name of source                    Number              date         EPA approval date       Comments
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Globe Metallurgical Inc...........  DFFOs................       5/23/2023  9/8/2023, [Insert      ..............
                                                                            Federal Register
                                                                            Citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

    (e) * * *

                        EPA Approved--Ohio Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                                          Applicable
               Title                 geographical or non-    State date         EPA approval         Comments
                                       attainment area
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                 Summary of Criteria Pollutant Attainment Plans
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
SO2 (2010)........................  Muskingum River......       5/24/2023  9/8/2023, [Insert      ..............
                                                                            Federal Register
                                                                            Citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

0
3. Section 52.1873 is amended by removing and reserving paragraph (b).

[FR Doc. 2023-19201 Filed 9-7-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 229 (Wednesday, November 30, 2022)]
[Notices]
[Page 73561]
[FR Doc No: 2022-26057]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2855]

Mylan Institutional, Inc.; Withdrawal of Approval of a New Drug
Application for SULFAMYLON[supreg] (Mafenide Acetate, USP) Powder for
5% Topical Solution

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of new drug application (NDA) 019832 for SULFAMYLON[supreg] (Mafenide
Acetate, USP) Powder for 5% Topical Solution, held by Mylan
Institutional, Inc., a Viatris company (Mylan). Mylan has voluntarily
requested withdrawal of this application and has waived its opportunity
for a hearing.

DATES: Applicable November 30, 2022.

FOR FURTHER INFORMATION CONTACT: Kristiana Brugger, Office of
Regulatory Policy, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On June 5, 1998, the Food and Drug
Administration (FDA) approved NDA 019832 for SULFAMYLON[supreg]
(Mafenide Acetate, USP) Powder for 5% Topical Solution, under the
Agency's accelerated approval regulations (see generally 21 CFR subpart
H). It was approved for ``for use as an adjunctive topical
antimicrobial agent to control bacterial infection when used under
moist dressings over meshed autografts on excised burn wounds.''
    NDA 019832's accelerated approval was ``subject to the requirement
that the applicant study the drug further, to verify and describe its
clinical benefit, where there is uncertainty as to the relation of the
surrogate endpoint to clinical benefit, or of the observed clinical
benefit to ultimate outcome'' (21 CFR 314.510). To date, however, Mylan
has not completed the required confirmatory study. Mylan acknowledged
in its December 10, 2021, letter requesting withdrawal of approval that
a successful confirmatory study was necessary to fulfill the
accelerated approval requirements, but stated that conducting such a
study is not feasible. Mylan thus requested that NDA 019832 be
withdrawn under 21 CFR 314.150(d), and waived its right to a hearing.
    Thus, for the reasons discussed above, under 21 CFR 314.150(d),
approval of NDA 019832 for SULFAMYLON[supreg] (Mafenide Acetate, USP)
Powder for 5% Topical Solution, and all amendments and supplements
thereto, is withdrawn. Distribution of SULFAMYLON[supreg] (Mafenide
Acetate, USP) Powder for 5% Topical Solution in interstate commerce
without an approved application is illegal and subject to regulatory
action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C.
355(a) and 331(d)).

    Dated: November 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26057 Filed 11-29-22; 8:45 am]
BILLING CODE P


[Federal Register Volume 84, Number 61 (Friday, March 29, 2019)]
[Notices]
[Pages 11971-11972]
[FR Doc No: 2019-06025]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2014-0076; FRL-9989-91-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for the Surface Coating of Large
Household and Commercial Appliances (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), NESHAP for the Surface Coating of
Large Household and Commercial Appliances (EPA ICR Number 1954.07, OMB
Control Number 2060-0457), to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR, which is currently approved
through March 31, 2019. Public comments were previously requested, via
the Federal Register, on May 30, 2018 during a 60-day comment period.
This notice allows for an additional 30 days for public comments. A
fuller description of the ICR is given below, including its estimated
burden and cost to the public. An agency may neither conduct nor
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before April 29,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2014-0076, to: (1) EPA online using www.regulations.gov (our
preferred method), or by email to [email protected], or by mail to:
EPA Docket Center, Environmental Protection Agency, Mail Code 28221T,
1200 Pennsylvania Ave. NW, Washington, DC 20460; and (2) OMB via email
to [email protected]. Address comments to OMB Desk Officer
for EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that EPA will be collecting, are available in
the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit: http://www.epa.gov/dockets.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for the Surface Coating of Large Household and
Commercial Appliances (40 CFR part 63, subpart NNNN) apply to both
existing and new facilities that perform surface coating of large
household and commercial appliances and related parts where the total
Hazardous Air Pollutants (HAPs) emitted are greater than or equal to 10
tons per year of any one HAP, or where the total HAPs emitted are
greater than or equal to 25 tons per year of any combination of HAPs.
New facilities include those that commenced construction or
reconstruction after the date of proposal. In general, all NESHAP
standards require initial notifications, performance tests, and
periodic reports by the owners/operators of the affected facilities.
They are also required to maintain records of the occurrence and
duration of any startup, shutdown, or

malfunction in the operation of an affected facility, or any period
during which the monitoring system is inoperative. These notifications,
reports, and records are essential in determining compliance, and are
required of all affected facilities subject to NESHAP. This information
is being collected to assure compliance with 40 CFR part 63, subpart
NNNN.
    Form Numbers: None.
    Respondents/affected entities: Facilities that perform surface
coating of large household and commercial appliances and related parts.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart NNNN).
    Estimated number of respondents: 10 (total).
    Frequency of response: Initially, occasionally, and semiannually.
    Total estimated burden: 3,870 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $429,000 (per year), which includes $5,400 in
annualized capital/startup and/or operation & maintenance costs.
    Changes in the Estimates: There is an adjustment decrease in the
total estimated burden as currently identified in the OMB Inventory of
Approved Burdens. This increase is not due to any program changes. The
change in the burden and cost estimates occurred due to a decrease in
the total number of facilities subject to the NESHAP. The estimate is
based on EPA's recent reevaluation of the source category inventory
associated with the recently-proposed amendments to 40 CFR part 63,
subpart NNNN (83 FR 46262, September 12, 2018). Per EPA's reevaluation,
the number of respondents in the source category has decreased from the
estimates in the 2002 final rule because the final rule included
assumptions regarding several facilities that were not major sources of
HAP. Additionally, there have been changes within the large appliance
surface coating industry that result in fewer facilities being subject
to the NESHAP. For example, many facilities that used liquid coatings
have switched to powder coatings, or have switched to plastic parts and
stainless steel instead of painted steel parts, or are using precoated
metal coils instead of coating finished parts. As a result, there is a
much smaller number of major sources. In addition to the burden
decrease from the decreased number of respondents, there is also a
burden decrease in the operating and maintenance costs due to the
determination that only one affected source uses an emission control
device to comply with the NESHAP. These changes result in an overall
decrease in the labor hours O&M costs, and number of responses.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-06025 Filed 3-28-19; 8:45 am]
BILLING CODE 6560-50-P


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learn more =
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A>=20

=20

First=20
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American=20
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American Community Survey - an ongoing survey that =
provides=20
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learn more  |  =
get data</=
A>=20

Puerto Rico Community Survey - the equivalent of the =
American=20
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learn=20
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         |  en=20
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learn=20
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A>=20

Economic Census - profiles the U.S. economy every 5=20
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A>=20

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La Encuesta sobre la Comunidad de Puerto =
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2007-2009=20
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more from=20
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2007-2009=20
      Puerto Rico Community Survey (PRCS) 3-Year Estimates are now =
available=20
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2010 Apportionment Data Release, =
See=20
      the first 2010 =

      Census results.

2005-2009 American Community Survey=20
      5-Year Estimates are now=20
      available for cities, all counties and other areas with =
smaller=20
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from the=20
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      Sets page.

2005-2009=20
      Puerto Rico Community Survey (PRCS) 5-Year Estimates in =
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      available for Puerto Rico cities, all municipios and other =
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Estimates=20
      for Puerto Rico areas 65,000 population or greater are available =
from the=20
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      Sets page.

2008 County Business Patterns =
Quick=20
      Reports and Thematic Maps data are now available from the D=
ata=20
      Sets page.

Economy-Wide Key Statistics are =
available now=20
      from the Data=20
      Sets page. Economic data on nation, states, counties, places =
and=20
      metropolitan areas will be released soon.

2009 Population Estimates are=20
      expanded to include the demographic characteristics of age, race, =
sex and=20
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2008 Nonemployer Statistics data =
are=20
      now available from the Data=20
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