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

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

VerDate Sep<11>2014 15:15 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\20AUR1.SGM 20AUR1 rmajette on DSK7SPTVN1PROD with RULES 50560 Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations

• ‘‘tropical disease.’’ In the following with the drug development incentives • Blinding paragraphs, FDA sets forth its reflected in the statutory scheme. • interpretation of this provision and the Indeed, the U.N. itself has • criteria we propose to use in acknowledged that ‘‘[t]he [human • Dengue/Dengue haemorrhagic fever determining which diseases may be development index] was created to • (guinea-worm disease) designated by order of the Secretary as emphasize that people and their • Fascioliasis capabilities should be the ultimate • ‘‘tropical diseases’’ under section 524. Human criteria for assessing the development of • A. No Significant Market in Developed • a country, not economic growth alone’’ Leprosy Nations (Ref. 5). And although the IMF’s list of • • 1. ‘‘Developed Nations’’ ‘‘advanced economies’’ reflects purchasing power to some degree, the • In interpreting the term ‘‘developed World Bank calculus is more • Soil transmitted nations,’’ FDA acknowledges at the transparent and predictable than the • outset that the standards for IMF’s calculus, and the U.S. government • Filoviruses determining a nation’s level of routinely uses the World Bank lists development, as well as the threshold In addition, section 524(a)(3)(R) of the when determining a country’s eligibility for a ‘‘developed’’ country, are the FD&C Act authorizes the Secretary to for Generalized System of Preferences subject of debate. Some nations may expand by order the list of tropical benefits for trade in goods (Ref. 6). diseases to include ‘‘[a]ny other score well in some markers of infectious disease for which there is no development (e.g., gross domestic 2. ‘‘No Significant Market’’ significant market in developed nations product) and poorly in others (e.g., The list of tropical diseases in section and that disproportionately affects poor sanitation), leading to disagreements 524(a)(3) of the FD&C includes ‘‘[a]ny and marginalized populations[,]’’ and regarding which measures of other infectious disease for which there that is the purpose of this order. development should serve as dominant is no significant market in developed indicators. After also examining the nations. . .designated by order of the II. Criteria for Expansion of the List of International Monetary Fund (IMF)’s list Tropical Diseases Secretary.’’ As an initial matter, the of advanced economies (Ref. 2) and the Agency notes that ‘‘infectious diseases,’’ On December 12, 2008, FDA United Nations (U.N.)’s human as such do not have markets—but drugs convened a public hearing, at which the development index (Ref. 3), the Agency for the treatment or prevention of public provided suggestions regarding is proposing to use a country’s presence infectious diseases do. Because the the following topics: (1) Criteria that on the World Bank’s 1 list of ‘‘high statute offers vouchers for applications should be used to determine the income economies’’ (Ref. 4) as evidence for drugs for either the treatment or eligibility of an infectious disease for that the country should be considered a prevention of infectious diseases, it is designation as a tropical disease, (2) the ‘‘developed nation’’ for ‘‘tropical reasonable to assume that ‘‘no process that should be used to make disease’’ determination purposes. significant market’’ can refer to drugs for tropical disease designations, and (3) Similarly, FDA will use a country’s the treatment or prevention of infectious recommendations for specific diseases presence on the World Bank’s . Thus, FDA will analyze the that should be designated as tropical ‘‘low income economies’’ (id.) as market for drugs for both the treatment diseases. A number of participants in evidence that the country should not be and prevention of infectious diseases for the public meeting commented that, considered a ‘‘developed nation’’ for a particular infectious disease. given the lack of definitive data for purposes of ‘‘tropical disease’’ The threshold for what constitutes a some diseases, as well as the lack of determination. ‘‘significant market’’ for drugs for the consensus on how these criteria should FDA recognizes that there is a treatment or prevention of infectious be defined, FDA should use a flexible correlation between economic strength diseases is difficult to quantify. Because approach in determining whether (particularly purchasing power) and the of the challenges in providing a rigid specific diseases meet the criteria. market incentive for drug creation: definition of this term, FDA proposes FDA agrees with the use of a flexible People in high-income economies are that the following factors be considered approach to tropical disease designation more likely to be able to afford disease in determining whether a ‘‘significant and is proposing that a scientifically treatments and, thus, drug companies market’’ exists in developed countries. informed, qualitative assessment of have an incentive to create products that disease candidates is appropriate. FDA will be in demand in those countries. a. Occurrence of the Disease in also is establishing a public docket that The World Bank list of high-income Developed Nations will continuously remain open to economies is calculated based on gross As discussed previously, market receive future suggestions for tropical national income per capita, and, forces are important drivers of drug disease designations under section 524 importantly, it thus reflects wealth as a development. The purpose of section of the FD&C Act. The Agency proposes primary basis for categorization. FDA’s 524 of the FD&C Act is to provide an to review the contents of this public recognition of the role of wealth is why incentive (through a PRV) for docket periodically and to take action to we deemed the U.N. development index innovation where there otherwise designate additional diseases when less helpful: It measures development would be an insufficient financial or appropriate. across a broad array of categories (e.g., market incentive to invest in developing As stated previously, section mean years of schooling) that, while drugs for tropical diseases. The market 524(a)(3)(R) of the FD&C Act authorizes informative, are less directly correlated for many FDA-approved products the Secretary to designate by order includes situations in which individuals ‘‘[a]ny other infectious disease for 1 The ‘‘World Bank’’ is a term used to refer (often reimbursed by their insurers) which there is no significant market in collectively to the International Development purchase the products for use by a Association and the International Bank for developed nations and that Reconstruction and Development, which are two of specific patient. This reflects what we disproportionately affects poor and the five organizations that comprise the World Bank will refer to as the ‘‘direct’’ market, and marginalized populations’’ as a Group. the direct market for a drug in a

VerDate Sep<11>2014 15:15 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 E:\FR\FM\20AUR1.SGM 20AUR1 rmajette on DSK7SPTVN1PROD with RULES Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations 50561

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

VerDate Sep<11>2014 15:15 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00019 Fmt 4700 Sfmt 4700 E:\FR\FM\20AUR1.SGM 20AUR1 rmajette on DSK7SPTVN1PROD with RULES 50562 Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations

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

VerDate Sep<11>2014 15:15 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 E:\FR\FM\20AUR1.SGM 20AUR1 rmajette on DSK7SPTVN1PROD with RULES Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations 50563

diseases in section 524 of the FD&C Act and Biologics’’ (available at http:// Trypanosomiasis (also known as Chagas to be satisfied. This addition is effective www.fda.gov/downloads/drugs/ Disease): Detailed FAQs’’ (available at upon the publication of this order. guidancecompliance http://www.cdc.gov/parasites/chagas/ regulatoryinformation/guidances/ gen_info/detailed.html). IV. Process for Requesting Additional ucm358301.pdf), 2014. 17. Centers for Disease Control and Diseases To Be Added to the List 2. IMF, ‘‘World Economic Outlook: Recovery Prevention, ‘‘Parasites—American Strengthens, Remains Uneven,’’ Table B1 Trypanosomiasis (also known as Chagas The purpose of this order is to add (available at http://www.imf.org/ Disease): Epidemiology and Risk diseases to the list of tropical diseases external/pubs/ft/weo/2014/01/pdf/ that FDA has found to meet the criteria tblpartb.pdf). Factors,’’ (available at http:// in section 524(a)(3)(R) of the FD&C Act. 3. U.N. Development Programme, ‘‘Human www.cdc.gov/parasites/chagas/epi.html). By expanding the list with this order, Development Index (HDI)’’ (available at 18. Bern, C. and S.P. Montgomery, ‘‘An FDA does not mean to preclude the http://hdr.undp.org/en/content/human- Estimate of the Burden of Chagas Disease in the United States,’’ Clinical Infectious future addition of other diseases to this development-index-hdi). 4. The World Bank, ‘‘Country and Lending Diseases, 49:e52–54, 2009 (available at list. To facilitate the consideration of Groups’’ (available at http:// http://cid.oxfordjournals.org/content/49/ future additions to the list, FDA is data.worldbank.org/about/country-and- 5/e52.full). establishing a public docket (see lending-groups). 19. Centers for Disease Control and http://www.regulations.gov, Docket No. 5. U.N. Development Programme, Prevention, ‘‘Congenital Transmission of FDA–2008–N–0567) through which ‘‘Frequently Asked Questions—Human Chagas Disease—Virginia, 2010,’’ Development Index (HDI)’’ (available at interested persons may submit requests MMWR. Morbidity and Mortality Weekly for additional diseases to be added to http://hdr.undp.org/en/faq-page/human- development-index-hdi#t292n36). Report, 61(26):477–479, July 6, 2012 the list. Such requests should be 6. Congressional Research Service, (available at http://www.cdc.gov/mmwr/ _ accompanied by information to ‘‘Generalized System of Preferences: preview/mmwrhtml/mm6126a1.htm?s document that the disease meets the Background and Renewal Debate,’’ pp. 7, cid=mm6126a1_w). criteria set forth in section 524(a)(3)(R) 11 (available at http://fas.org/sgp/crs/ 20. Baird, R.A., S. Weibe, J.R. Zunt, et al., of the FD&C Act. FDA will periodically misc/RL33663.pdf). ‘‘Evidence-Based Guideline: Treatment review these requests, and, when 7. U.S. Department of Health and Human of Parenchymal Neurocysticercosis,’’ appropriate, expand the list. Services, ‘‘Public Health Emergency Neurology, 80:1424–1429, 2013 Medical Countermeasures Enterprise (available at http://www.neurology.org/ V. Paperwork Reduction Act (PHEMCE) Implementation Plan,’’ content/80/15/1424.full.pdf). December 2012 (available at http:// This final order establishes a public 21. White, A.C., Jr., ‘‘Neurcysticercosis: A www.phe.gov/Preparedness/mcm/ Major Cause of Neurological Disease docket through which interested phemce/Documents/2012-PHEMCE- Worldwide,’’ Clinical Infectious Disease, persons may submit requests for Implementation-Plan.pdf). additional diseases to be added to the 8. National Institute of Allergy and Infectious 24:101–115, 1997 (available at http:// list of tropical diseases that FDA has Diseases, NIAID Emerging Infectious cid.oxfordjournals.org/content/24/2/ 101.long). found to meet the criteria in section Diseases/Pathogens (available at http:// www.niaid.nih.gov/topics/ 22. Institute of Medicine, ‘‘The Causes and 524(a)(3)(R) of the FD&C Act. This Impacts of Neglected Tropical and request for information is exempt from biodefenserelated/biodefense/pages/ cata.aspx). Zoonotic Diseases: Opportunities for Office of Management and Budget 9. Centers for Disease Control and Integrated Intervention Strategies,’’ review under 5 CFR 1320.3(h)(4) of the Prevention, Bioterrorism Agents/ Washington, DC: The National Paperwork Reduction Act of 1995 (44 Diseases (available at http:// Academies Press (available at http:// U.S.C. 3501–3520). Specifically, ‘‘[f]acts www.bt.cdc.gov/agent/agentlist- www.ncbi.nlm.nih.gov/books/ or opinions submitted in response to category.asp). NBK62507/pdf/TOC.pdf). general solicitations of comments from 10. Joint Program Executive Office for 23. Mewara, A., K. Goyal, and R. Sehgal, the public, published in the Federal Chemical and Biological Defense, Joint ‘‘Neurocysticercosis: A Disease of Vaccine Acquisition Program (JVAP) Register or other publications, Neglect,’’ Tropical Parasitology, (available at http:// 3(2):106–113, 2013 (available at http:// regardless of the form or format thereof’’ www.jpeocbd.osd.mil/packs/ are exempt, ‘‘provided that no person is Default.aspx?pg=1208). www.ncbi.nlm.nih.gov/pmc/articles/ required to supply specific information 11. WHO, ‘‘Metrics: Disability Adjusted Life PMC3889086/?report=printable). pertaining to the commenter, other than Year (DALY)’’ (available at http:// 24. Bhattarai, R., H. Carabin, and C. Budke, that necessary for self-identification, as www.who.int/healthinfo/global_burden_ ‘‘The Burden of Cysticercosis,’’ Novel a condition of the agency’s full disease/metrics_daly/en/). Aspects on Cysticercosis and consideration of the comment.’’ 12. Medline Plus/Merriam-Webster Medical Neurocysticercosis, H.F. Sibat, ed. Dictionary Online, ‘‘Morbidity’’ (available at http:// VI. References (available at http://www.merriam- www.intechopen.com/books/novel- The following references have been webster.com/medlineplus/morbidity). aspects-on-cysticercosis-and- 13. Merriam-Webster Dictionary Online, placed on display in the Division of neurocysticercosis/the-burden-of- ‘‘Marginalize’’ (available at http:// cysticercosis). Dockets Management (see ADDRESSES) www.merriam-webster.com/dictionary/ 25. Wallin, M.T. and J.F. Kurtzke, and may be seen by interested persons marginalize). ‘‘Neurocysticercosis in the United States: between 9 a.m. and 4 p.m. Monday 14. WHO, ‘‘First WHO Report on Neglected Review of an Important Emerging Tropical Diseases: Working to Overcome through Friday, and are available Infection,’’ Neurology, 63:1559–1564, the Global Impact of Neglected Tropical electronically at http:// 2004 (available at http:// www.regulations.gov. Diseases’’ (available at http:// whqlibdoc.who.int/publications/2010/ www.neurology.org/content/63/9/ (FDA has verified the Web site addresses, 9789241564090_eng.pdf). 1559.long). but FDA is not responsible for any 15. WHO, ‘‘Neglected Tropical Diseases: 26. O’Neal, S., J. Noh, P. Wilkins, et al, subsequent changes to the Web sites after this Diseases Covered by NTD Department’’ ‘‘Taenia solium Tapeworm Infection, document publishes in the Federal Register.) (available at http://www.who.int/ Oregon, 2006–2009,’’ Emerging 1. U.S. Food and Drug Administration, neglected_diseases/diseases/en/). Infectious Disease, 17(6):1030–1036, ‘‘Guidance for Industry: Expedited 16. Centers for Disease Control and 2011 (available at http://wwwnc.cdc.gov/ Programs For Serious Conditions—Drugs Prevention, ‘‘Parasites—American eid/article/17/6/10-1397_article).

VerDate Sep<11>2014 15:15 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 E:\FR\FM\20AUR1.SGM 20AUR1 rmajette on DSK7SPTVN1PROD with RULES 50564 Federal Register / Vol. 80, No. 161 / Thursday, August 20, 2015 / Rules and Regulations

Dated: August 14, 2015. a voucher holder to use the voucher dating violence, sexual assault, and Leslie Kux, assistance outside the jurisdiction of the stalking have access to the resources Associate Commissioner for Policy. PHA that initially issues the family its necessary to relocate to a safe, stable [FR Doc. 2015–20554 Filed 8–19–15; 8:45 am] voucher. While portability offers an home away from an abuser. Further, BILLING CODE 4164–01–P important mechanism to increase moves to areas with relatively low housing choice, this feature has not concentrations of neighborhood poverty been maximized by PHAs and have shown to relay important benefits DEPARTMENT OF HOUSING AND participating families because the to housing choice voucher families, in URBAN DEVELOPMENT current process for allowing a family to particular mental and physical health move from one jurisdiction to another is for adults and long-term educational 24 CFR Part 982 time consuming and burdensome. HUD and earning gains for young children. recognizes that for the HCV program’s HUD recognizes that some policies may [Docket No. FR–5453–F–02] goals to support mobility and housing increase burden for some PHAs; RIN 2577–AC86 choice to be realized, the regulations however, the added clarity to the governing the portability process must portability process afforded by this final Housing Choice Voucher Program: be clarified so that the burden on rule is expected to improve the Streamlining the Portability Process families and the PHA is reduced. This portability process and reduce the final rule completes the rulemaking burden on families and PHAs. AGENCY: Office of the Assistant process, which commenced in 2012, to The streamlining changes do not add Secretary for Public and Indian revise the existing portability any substantial cost to the HCV Housing, HUD. regulations to streamline the portability program. ACTION: Final rule. process and facilitate the ability of II. Background—the March 28, 2012, SUMMARY: This final rule amends HUD’s participating families to move to the Proposed Rule jurisdiction of their choice. regulations governing portability in the On March 28, 2012, at 77 FR 18731, Housing Choice Voucher (HCV) B. Summary of the Major Provisions of HUD published a rule in the Federal program. Portability is a feature of the the Regulatory Action Register that proposed to amend HUD’s HCV program that allows an eligible The key regulatory changes by this regulations governing portability in the family with a housing choice voucher to final rule include: HCV program. The HCV program is the use that voucher to lease a unit • Removing the mandatory Federal Government’s largest program anywhere in the United States where absorption requirement discussed in the for assisting very low-income families, there is a public housing agency (PHA) proposed rule and clarifying the the elderly, and persons with operating an HCV program. The purpose notification requirement for mandatory disabilities to afford decent, safe, and of HUD’s changes to the portability voucher suspension; sanitary housing in the private market. regulations is to enable PHAs to better • Requiring an initial PHA to notify The HCV program is authorized by serve families and expand housing the local HUD office within 10 business section 8(o) of the United States opportunities by improving portability days of a determination to deny a Housing Act of 1937 (42 U.S.C. 1473f(o)) processes. portability move based on insufficient (1937 Act), and the HCV program DATES: Effective: September 21, 2015. funding; regulations are found in 24 CFR part • FOR FURTHER INFORMATION CONTACT: Providing that the voucher issued 982. Becky Primeaux, Director, Housing by the receiving PHA to the family may Housing choice vouchers are Voucher and Management Operations not expire before 30 calendar days has administered locally by PHAs. PHAs Division, Office of Housing Choice passed from the expiration date of the receive Federal funds from HUD to initial PHA’s voucher; administer the HCV program. Under the Vouchers, Office of Public and Indian • Housing, Department of Housing and Requiring briefings for all HCV program, housing assistance is Urban Development, 451 7th Street SW., participating on how portability works provided on behalf of the participating Room 4216, Washington, DC 20410– and the benefits of living in low-poverty family who is responsible for finding a census tracts; and suitable housing unit of their choice 8000, telephone number 202–708–0477 • (this is not a toll-free number). Allowing a family to choose the where the owner agrees to rent under Individuals with speech or hearing receiving PHA to administer their the program. The participant is free to impairments may access this number voucher should they choose to use choose any rental housing, including through TTY by calling the Federal portability. single family homes, townhouses, and Relay Service at 800–877–8339 (this is Please see Section III of this preamble, apartments, that meets the requirements a toll-free number). entitled ‘‘Changes at the Final Rule of the program and is not limited to Stage’’ for a more detailed discussion of units located in subsidized housing SUPPLEMENTARY INFORMATION: all the changes proposed by this rule. projects. Under certain circumstances, if I. Executive Summary authorized by the PHA, a family may C. Costs and Benefits use its voucher to purchase a modest A. Purpose of the Regulatory Action The changes made by this final rule home. The purpose of this final rule is to are designed to minimize burden for A housing subsidy is paid to the improve the portability process of the PHAs and participating HCV families landlord directly by the PHA on behalf HCV program. Under the HCV program, and thereby increase the ability of of the participating family. The family the participating family is free to choose participating families to live in areas of then pays the difference between the any housing that meets the requirements their choice or relocate to a new area for actual rent charged by the landlord and of the program. As a means to enable employment opportunities or to gain the amount subsidized by the program. housing choice and mobility to access to preferred schools for their The PHA determines the amount that encourage social and economic children. In addition, the improved the family will contribute toward rent, integration, the HCV program offers portability process contributes to which is generally 30 percent of its voucher portability; that is, the ability of helping victims of domestic violence, adjusted annual income. A key feature

VerDate Sep<11>2014 15:15 Aug 19, 2015 Jkt 235001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\FR\FM\20AUR1.SGM 20AUR1 rmajette on DSK7SPTVN1PROD with RULES