42904 Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices OPQ staff participating in this submitting a proposal directly to Janet applications meet certain criteria. The program will benefit by gaining a better Wilson (see DATES and FOR FURTHER FD&C Act lists the diseases that are understanding of current industry INFORMATION CONTACT sections of this considered tropical diseases for practices, processes, and procedures. document for more information). To aid purposes of obtaining PRVs and Participating sites will have an in OPQ’s site selection and planning, provides for Agency expansion of that opportunity to showcase their your proposal should include the list to include other diseases that satisfy technologies and their actual information below: the definition of ‘‘tropical diseases’’ as manufacturing and testing facilities. • A contact person, set forth in the FD&C Act. The Agency • Although observation of all aspects of Site visit location(s), has determined that chikungunya virus • drug development and production Facility Establishment Identifier disease, Lassa fever, rabies, and would be beneficial to OPQ staff, OPQ and Data Universal Numbering System cryptococcal meningitis satisfy this has identified a number of areas of numbers, as applicable, • definition and is therefore adding them particular interest to its staff. The Maximum number of FDA staff that to the list of designated tropical diseases following list identifies some examples can be accommodated during a site visit whose product applications may result of these areas but is not intended to be (maximum of 20), in the award of PRVs. Sponsors exhaustive, mutually exclusive, or to • A proposed agenda outlining the submitting certain drug or biological limit industry response: learning objectives and associated product applications for the prevention • activities for the site visit, Drug products or treatment of chikungunya virus Æ Solutions, suspensions, emulsions, • Maximum number of site visits (no disease, Lassa fever, rabies, and and semisolids more than 2) that your site would be cryptococcal meningitis may be eligible Æ Modified- and immediate-release willing to host by the close of the formulations government fiscal year, September 30, to receive a PRV if such applications are Æ Drug-device combination products 2019, and approved by FDA. (e.g., inhalation products, transdermal • Proposed dates for each site visit DATES: This order is effective August 24, systems, implants intended for drug (i.e. month and week). 2018. delivery, and prefilled syringes) Please note that the requested • Active pharmaceutical ingredients proposed agenda will be reviewed to ADDRESSES: Submit electronic manufactured by determine the educational benefit to comments on additional diseases Æ Chemical synthesis OPQ in conducting the visit, and suggested for designation to https:// Æ Fermentation selected sites may be asked to refine the www.regulations.gov. Submit written Æ Biotechnology agenda to maximize the educational comments on additional diseases • Design, development, manufacturing benefit. After a site is selected, OPQ will suggested for designation to the Dockets and controls communicate with the contact person Management Staff (HFA–305), Food and Æ Engineering controls for aseptic for the site to determine the actual dates Drug Administration, 5630 Fishers processes for the visit. Lane, Rm. 1061, Rockville, MD 20852. Æ Novel delivery technologies Proposals submitted without this All comments should be identified with Æ Hot melt extrusion minimum information will not be the docket number found in brackets in Æ Soft-gel encapsulation Æ considered. Based on response rate and the heading of this document. Lyophilization type of responses, OPQ may or may not Æ Blow-Fill-Seal and isolators FOR FURTHER INFORMATION CONTACT: Æ consider alternative pathways to Spray-drying meeting our training goals. Katherine Schumann, Center for Drug Æ Process analytical technology, Evaluation and Research, Food and measurement systems, and real-time Dated: August 21, 2018. Drug Administration, 10903 New release testing Leslie Kux, Hampshire Ave., Bldg. 22, Rm. 6242, • Emerging technologies Associate Commissioner for Policy. Silver Spring, MD 20993–0002, 301– Æ Continuous manufacturing [FR Doc. 2018–18305 Filed 8–23–18; 8:45 am] 796–1300, Katherine.Schumann@ Æ 3-dimensional printing BILLING CODE 4164–01–P fda.hhs.gov; or Office of Æ Nanotechnology Communication, Outreach and III. Site Selection Development (OCOD), Center for DEPARTMENT OF HEALTH AND Biologics Evaluation and Research, Selection of potential facilities will be HUMAN SERVICES Food and Drug Administration, 10903 based on the priorities developed for New Hampshire Ave., Silver Spring, MD OPQ staff training, the facility’s current Food and Drug Administration 20993–0002, 1–800–835–4709 or 240– compliance status with FDA, and in [Docket No. FDA–2008–N–0567] 402–8010, [email protected]. consultation with the appropriate FDA district office. All travel expenses Designating Additions to the Current SUPPLEMENTARY INFORMATION: associated with this program will be the List of Tropical Diseases in the Federal Table of Contents responsibility of OPQ; therefore, Food, Drug, and Cosmetic Act selection will be based on the I. Background: Priority Review Voucher availability of funds and resources for AGENCY: Food and Drug Administration, Program the fiscal year. OPQ will not provide HHS. II. Diseases Being Designated financial compensation to the ACTION: Final order. A. Chikungunya Virus Disease pharmaceutical site as part of this B. Lassa Fever program. SUMMARY: The Federal Food, Drug, and C. Rabies Cosmetic Act (FD&C Act) authorizes the D. Cryptococcal Meningitis IV. Proposals for Participation Food and Drug Administration (FDA or III. Process for Requesting Additional Companies interested in offering a site Agency) to award priority review Diseases To Be Added to the List visit or learning more about this site vouchers (PRVs) to tropical disease IV. Paperwork Reduction Act visit program should respond by product applicants when the V. References VerDate Sep<11>2014 19:17 Aug 23, 2018 Jkt 244001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 daltland on DSKBBV9HB2PROD with NOTICES Federal Register / Vol. 83, No. 165 / Friday, August 24, 2018 / Notices 42905 I. Background: Priority Review designated as ‘‘tropical diseases’’ under CHIKV cases among U.S. Department of Voucher Program section 524 of the FD&C Act: Defense healthcare beneficiaries • between January 2014 and February Section 524 of the FD&C Act (21 Chikungunya virus disease • Lassa fever 2015 (Ref. 11). U.S.C. 360n), which was added by • Based on the epidemiology of section 1102 of the Food and Drug Rabies • Cryptococcal meningitis reported CHIKV cases, the market for Administration Amendments Act of vaccines in developed nations such as FDA’s rationale for adding these 2007, uses a PRV incentive to encourage the United States would largely the development of new drugs for diseases to the list is discussed in the comprise travelers at risk of CHIKV prevention and treatment of certain analyses that follow. infection and military populations. diseases that, in the aggregate, affect A. Chikungunya Virus Disease These markets are unlikely to provide millions of people throughout the sufficient incentive to encourage Chikungunya virus (CHIKV) is an world. Further information about the development of products to treat or arbovirus transmitted by Aedes tropical disease PRV program can be prevent CHIKV infection. Although a mosquitoes in tropical climates in found in guidance for industry limited number of locally transmitted Africa, Asia, islands in the Indian and ‘‘Tropical Disease Priority Review cases have recently been reported in Pacific Oceans, Europe, and, since 2013, Vouchers’’ (81 FR 69537, October 6, U.S. territories, the disease is not the Americas (Ref. 1). Although CHIKV 2016, available at https:// currently considered endemic in those www.federalregister.gov/documents/ mortality is relatively low (0.01 to 0.1 areas. Whether those populations could 2015/08/20/2015-20554/designating- percent), attack rates are very high (33 broaden the market for products to treat additions-to-the-current-list-of-tropical- to 66 percent) and most infections are or prevent CHIKV infection in the future diseases-in-the-federal-food-drug-and- symptomatic (Refs. 2 and 3). Many is unknown. CHIKV drug development cosmetic). Additions to the statutory list infected individuals experience painful is not significantly funded by U.S. of tropical diseases published in the arthralgia, which can persist for months Government sources, and CHIKV is not Federal Register can be accessed at and even years (Ref. 4). Life-threatening among the Centers for Disease Control https://www.fda.gov/AboutFDA/ manifestations of CHIKV, including and Prevention’s (CDC) list of potential CentersOffices/OfficeofMedicalProducts organ failure, meningoencephalitis, bioterrorism agents. andTobacco/CDER/ucm534162.htm. hemorrhagic symptoms, and myocardial disease, and death occur in neonates, 2. Disproportionately Affects Poor and On August 20, 2015, FDA published the elderly, and individuals with Marginalized Populations a final order (80 FR 50559) (final order) chronic comorbidities (Ref. 3). designating Chagas disease and Poor populations in tropical There is no approved antiviral environments experience the primary neurocysticercosis as tropical diseases. treatment for CHIKV in the United