Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Proposed Rules 15087

Dated: March 9, 2020. notice of proposed rulemaking, go to toxins based on the following criteria Howard H. Wright, http://www.regulations.gov. Comments outlined under 42 U.S.C. 262a(a)(1)(B): Captain, U.S. Coast Guard, Alternate Captain will be available for public inspection (1) ‘‘The effect on human health of exposure of the Port, San Francisco. Monday through Friday, except for legal to the agent or toxin’’ [FR Doc. 2020–05174 Filed 3–16–20; 8:45 am] holidays, from 9 a.m. until 5 p.m. at (2) ‘‘The degree of contagiousness of the BILLING CODE 9110–04–P 1600 Clifton Road NE, Atlanta, GA, agent or toxin and the methods by which 30329. Please call ahead to 1–866–694– the agent or toxin is transferred to 4867 and ask for a representative in the humans’’ Division of Select Agents and Toxins (3) ‘‘The availability and effectiveness of DEPARTMENT OF HEALTH AND pharmacotherapies to treat or HUMAN SERVICES (DSAT) to schedule your visit. Please be immunizations to prevent any illness aware that comments and other resulting from infection by the agent or 42 CFR Part 73 submissions from members of the public exposure to the toxin’’ are made available for public viewing (4) ‘‘Any other criteria including the needs of [Docket No. CDC–2020–0024] without changes. children and other vulnerable populations’’ and any other criteria that RIN 0920–AA71 FOR FURTHER INFORMATION CONTACT: the commenter believes should be Samuel S. Edwin Ph.D., Director, considered. Possession, Use, and Transfer of Division of Select Agents and Toxins, Select Agents and Toxins; Biennial Centers for Disease Control and Comments received, including Review Prevention, 1600 Clifton Road NE, attachments and other supporting materials, are part of the public record AGENCY: Centers for Disease Control and Mailstop H21–7, Atlanta, Georgia 30329. Telephone: (404) 718–2000. and subject to public disclosure. Prevention (CDC), Department of Health Commenters should not include any SUPPLEMENTARY INFORMATION: and Human Services (HHS). The information in their comments or ACTION: Advance notice of proposed preamble to this advance notice of supporting materials that they consider rulemaking and request for comments. proposed rulemaking is organized as confidential or inappropriate for public follows: disclosure. HHS/CDC will carefully SUMMARY: In accordance with section I. Public Participation consider all comments submitted. 351a of the Public Health Service Act, II. Background the Centers for Disease Control and III. Modifications to the List of Select Agents II. Background Prevention (CDC) in the Department of and Toxins Being Considered Under the Public Health Security and Health and Human Services (HHS; A. Agents and Toxins Under Consideration Preparedness and hereafter referred to as HHS/CDC) has i. Botulinum Neurotoxin Producing Response Act of 2002 (Bioterrorism initiated a review of the HHS list of Species of Clostridium Response Act) (42 U.S.C. 262a(a)(1)), the biological agents and toxins that have ii. iii. HHS Secretary must establish by the potential to pose a severe threat to regulation a list of biological agents and public health and safety (HHS select iv. Bacillus anthracis (Pasteur Strain) v. Brucella Abortus, Brucella Melitensis, toxins that have the potential to pose a agents and toxins). This review was and Brucella Suis severe threat to public health and safety. initiated within two years of the vi. Venezuelan Equine Encephalitis Virus In determining whether to include a completion of the previous review. In (VEEV) 1AB and 1C or toxin on the list, the reviewing the list, HHS/CDC is vii. Short, Paralytic Alpha Bioterrorism Response Act (42 U.S.C. considering whether to propose viii. Diacetoxyscirpenol 262a(a)(1)(B)) requires that the HHS amending the HHS list of select agents ix. Staphylococcal Secretary consider the following and toxins. x. New World Hantaviruses: criteria: The effect on human health of 1. Sin Nombre Virus DATES: Comments should be received on 2. Andes Virus exposure to an agent or toxin; the degree or before May 18, 2020. xi. Old World Hantaviruses: of contagiousness of the agent and the ADDRESSES: You may submit comments, 1. Hantaan Virus methods by which the agent or toxin is identified by Docket No. CDC–2020– 2. Dobrava Virus transferred to humans; the availability 0024 or Regulation Identifier Number B. Toxins Being Considered for Revision to and effectiveness of pharmacotherapies (RIN) 0920–AA71, by any of the Exclusion Amounts (i.e., the Amount and immunizations to treat and prevent following methods: Below Which the Toxin Is Not Subject to illnesses resulting from an agent or • Federal eRulemaking Portal: http:// Regulatory Oversight) toxin; and any other criteria including www.regulations.gov. Follow the i. the needs of children and other ii. instructions for submitting comments. vulnerable populations that the HHS • iii. Botulinum neurotoxin Mail: Division of Select Agents and C. Designating Nipah Virus as a Tier 1 Secretary deems relevant. Toxins, Centers for Disease Control and Under 42 U.S.C. 262a(a)(2), the HHS Prevention, 1600 Clifton Road NE, IV. References Secretary must review and republish the Mailstop H21–7, Atlanta, Georgia 30329, list of HHS select agents and toxins at ATTN: RIN 0920–AA71. I. Public Participation least biennially. For this review, HHS/ Instructions: All submissions received Interested persons or organizations CDC evaluated as discussed below each must include the agency name and RIN are invited to participate by submitting agent and toxin based on: The degree of for this rulemaking. All relevant written views, recommendations, and pathogenicity (ability of an organism to comments received will be posted data. Comments are welcomed on any cause disease); dissemination efficacy; without change to http:// topic related to this advance notice of aerosol stability; matrix stability; ease of www.regulations.gov, including any proposed rulemaking. production; ability to genetically personal information provided. In addition, HHS/CDC invites manipulate or alter; severity of illness; Docket Access: For access to the comments specifically as to whether case fatality rate; long-term health docket to read background documents there are additional biological agents or effects; rate of transmission; available or comments received, or to download toxins that should be added or removed treatment; status of host immunity (e.g. an electronic version of the advance from the HHS list of select agents and whether an individual has already been

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exposed to the agent and generated an peer reviewed research data, that will used to vaccinate U.S. researchers who immune response); vulnerability of better inform us as to whether there are: were at risk (Seqiris Pty Ltd PV, 2014). special populations; decontamination (1) Any biological agents or toxins that Should C. burnetii be removed or and restoration (the extent remediation should be added to the select agents and retained as an HHS select agent? Please efforts are needed due to agent toxin list because they have the provide a detailed explanation for your persistence in the environment and potential to pose a severe threat to response. population); and the burden or impact public health and safety; and (2) iii. Rickettsia prowazekii on the health care system. biological agents or toxins currently on The results of the previous biennial the list that should be removed because Rickettsia prowazekii causes epidemic review, discussed in a final rule they would no longer be considered to typhus, which is a louse-borne disease. published in the Federal Register on have the potential to pose a severe In 2012, HHS/CDC decided to retain R. January 19, 2017 (82 FR 6278), were that threat to public health and safety. prowazekii based in part in anticipation HHS/CDC would make no changes to In addition, HHS/CDC is seeking of studies being conducted that would the list of HHS select agents and toxins comment on the following specific help HHS/CDC to better understand the at that time. Given that HHS/CDC is changes to the list of HHS and overlap potential risk of an intentional release of again considering whether to remove select agents under consideration: this organism. As of 2019, these studies select agents and toxins as proposed in had not been conducted. Based on the a previous notice of proposed A. Select Agents and Toxins Under criteria for listing select agents specified rulemaking (81 FR 2805, January 19, Consideration under 42 U.S.C. 262a(a)(1)(B), HHS/CDC 2016), HHS/CDC will consider the 35 i. Botulinum Neurotoxin Producing is seeking comments from the public to public comments received from that Species of Clostridium provide any information not included notice as part of this biennial review. below to help inform our deliberations The current list of HHS select agents Botulism is a serious paralytic disease regarding R. prowazekii: and toxins can be found at 42 CFR 73.3 caused by a neurotoxin produced during • Transmissibility from person-to- (HHS select agents and toxins) and 42 the growth of the spore-forming person is low because R. prowazekii is CFR 73.4 (Overlap select agents and bacterium Clostridium botulinum (or usually transmitted via blood, although toxins), and is available at https:// rarely, C. argentinense (Puig de Centorbi it can be spread through inhalation of et al., 1997), C. butyricum, or C. baratii) www.selectagents.gov/SelectAgentsand louse feces (ID50), the concentration for ToxinsList.html. (Sobel, 2005). As such, the organism human inhalation routes is unknown, As noted above, the list of HHS select itself does not normally cause disease. but is estimated to be 103–106 organisms agents and toxins is divided into two HHS/CDC is seeking any information based on non-human primate and other sections. The biological agents and that will help inform our deliberations animal studies (Eremeeva et al., 2005, toxins listed in 42 CFR 73.3 (HHS select regarding if Clostridium botulinum Pike, 1976 and Walker, 2003, Reynolds agents and toxins) have the potential to should be treated consistently with the et al., 2003 and International pose a severe threat to human health regulation of other select toxins in Cooperation in Animal Biologics, 2004). and safety and are regulated only by which a toxin is regulated but not the • This agent is difficult to grow and HHS. The biological agents listed in organism that produces the toxin. For purify in quantities that would make it § 73.4 (overlap select agents and toxins) example, Staphylococcus aureus is not a viable biological weapon (Woodman et have not only the potential to pose a listed as a select agent, yet al., 1977). severe threat to human health and Staphylococcal enterotoxins A,B,C,D,E • R. prowazekii is susceptible to safety; but have been determined by the subtypes are regulated toxins. readily available antibiotics and can be USDA, pursuant to USDA’s authority Should Botulinum neurotoxin treated with a single dose of under the Agriculture Bioterrorism producing species of Clostridium be doxycycline when symptoms are Protection Act of 2002 (7 U.S.C. 8401), removed or retained as an HHS select present (Raoult et al., 1991). to have the potential to pose a severe agent? Please provide a detailed • When grown in a laboratory, it is threat to animals and animal products. explanation for your response. difficult to maintain the stability of the Accordingly, these biological agents are ii. Coxiella burnetii organism and therefore it would be jointly regulated by HHS and USDA as difficult to disseminate efficiently to ‘‘overlap’’ select agents. The Q fever is a disease caused by the cause mass exposure or disease that Bioterrorism Response Act defines the bacteria Coxiella burnetii. Q fever is an would have a significant public health term ‘‘overlap agent or toxin’’ to mean acute febrile disease that varies in impact (Bovarnick et al., 1950). a biological agent or toxin that is listed severity and duration. Based on the Should R. prowazekii be removed or pursuant to 42 U.S.C. 262a and is listed criteria for listing select agents specified retained as an HHS select agent? Please pursuant to 7 U.S.C. 8401. See 7 U.S.C. under 42 U.S.C. 262a(a)(1)(B), HHS/CDC provide a detailed explanation for your 8411. If HHS/CDC removes any overlap is seeking comments from the public to response. select agents from its list, these agents provide any information not included iv. Bacillus anthracis (Pasteur Strain) might still be regulated as USDA select below to help inform our deliberations agents dependent on the outcome of regarding C. burnetii: Bacillus anthracis is the bacteria that USDA biennial review. • Q fever has a low mortality rate causes anthrax, an acute disease in (≤2%) with antibiotic treatment (Rolain animals and humans. In order to cause III. Modifications to the List of Select et al., 2005). C. burnetii is susceptible to the disease anthrax, B. anthracis Agents and Toxins Being Considered a number of readily available antibiotics requires two plasmids, pX01 and pX02, The purpose of this advance notice of including tetracycline or doxycycline which carry toxin and capsule genes proposed rulemaking is to seek public (Rolain et al., 2005). (Luna et al., 2006). B. anthracis (Pasteur comment on potential changes to the • Only 0.2–0.5% of the Q fever cases strain) lacks the pX01 plasmid that is current list of HHS and overlap select progress past the acute infection stage needed to cause the disease (Ivins et al., agents and toxins. Specifically, we are (Cutler, 2007). 1986). HHS/CDC excluded the B. providing an opportunity for interested • A whole-cell killed vaccine (Q-Vax) anthracis (Sterne strain) in 2003 persons to submit comments, including is licensed in Australia and has been because the strain lacks the pX02

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plasmid that encodes for the capsule. third reported to a clinic or hospital, via the inhalation route to achieve a However, HHS/CDC has retained B. and 3,000 (4%) were hospitalized for toxic effect, the LD50 (dose required to anthracis (Pasteur strain) to date neuroinvasive disease (sequelae), kill half the members of a tested because of a concern that someone demonstrating that two-thirds of the population after a specified test working in a laboratory could combine cases [in the 1995 outbreak] were mild duration) is estimated at 20 mg/kg by the Pasteur strain with the Sterne strain or asymptomatic (Rivas et al., 1997). inhalation (Thapa et al., 2014). to produce the wild type phenotype B. • While it is theoretically possible for Should conotoxins (short, paralytic anthracis de novo, a select agent. Based VEEV to be spread between humans alpha conotoxins containing the on the criteria for listing select agents since the virus is found in the pharynx following amino acid sequence specified under 42 U.S.C. 262a(a)(1)(B), of 6 to 40% of acutely ill patients, there X1CCX2PACGX3X4X5X6CX7) be removed HHS/CDC is seeking comments from the is no documented evidence of human- or retained as a select toxin? If retained, public to provide any information to to-human transmission (Smith et al., should the exclusion amount for help inform our deliberations regarding 2009). conotoxins be increased or decreased? • if B. anthracis (Pasteur strain) should be An effective equine vaccine is Please provide a detailed explanation removed or retained as an HHS select available and a range of humanized for your response. monoclonal antibodies are currently agent? Please provide a detailed viii. Diacetoxyscirpenol (DAS) explanation for your response. available for emergency use (Weaver et al., 1996). Restricted animal movement, DAS, a derivative of tetracyclic v. Brucella abortus, Brucella melitensis, insecticide application, and equine sesquiterpenes called trichothecenes, is and Brucella suis vaccinations are a part of effective produced from strains of Fusarium Based on the criteria for listing select control measures to contain VEE sambucinum and related species that agents specified under 42 U.S.C. outbreaks and mitigate the spread of grow on barley, corn, oats, rye, or wheat. 262a(a)(1)(B), HHS/CDC is seeking disease from equine to humans. In 2005, HHS/CDC retained DAS comments from the public to provide Should VEEV 1AB and 1C be removed because of limited understanding of the any information not included below to or retained as an HHS select agent? risk at the time of whether DAS has the help inform our deliberations regarding Please provide a detailed explanation potential to pose a severe threat to B. abortus, B. melitensis, and B. suis: for your response. public health. The estimated LD50 of • Brucella infections have a low case vii. Short, Paralytic Alpha Conotoxins DAS for rodents is 2 to 16 mg/kg fatality rate, with an untreated fatality (Knutsen, H.K., et al., 2018). rate usually ranging from 1–2% of those Predatory cone snails (genus Conus) Based on the criteria for listing select identified with the infection (Spickler, produce a rich array of venoms agents specified under 42 U.S.C. 2018). (conotoxins) that collectively contain an 262a(a)(1)(B), HHS/CDC is seeking • Disease caused by these bacteria is estimated 100,000 small, disulfide-rich comments from the public to provide treatable with antibiotics (Spickler, peptides neurotoxins (Bulaj, 2008). any information to help inform our 2018). Short, paralytic alpha conotoxins deliberations regarding DAS. Should • There is no indication that Brucella containing the following amino acid DAS be removed or retained as a select is transmitted between people by casual sequence X1CCX2PACGX3X4X5X6CX7 toxin? If retained, should the DAS contact under ordinary condition. are a group of neurotoxic peptides exclusion amount be increased or Humans are typically infected from isolated from the venom of the marine decreased? Please provide a detailed exposure to animal reservoirs or animal cone snail, genus Conus. Based on the explanation for your response. products; transmission to humans from criteria for listing select agents specified ix. Staphylococcal Enterotoxins wildlife is a rare event unless an under 42 U.S.C. 262a(a)(1)(B), HHS/CDC individual directly handles infected is seeking comments from the public to Staphylococcus aureus produces a animals, such as in butchering meat provide any information not included number of exotoxins, one of which is (Godfroid et al., 2013). below to help inform our deliberations Staphylococcal B, or SEB. • Brucellosis causes mild clinical regarding short, paralytic alpha SEB normally exerts its effect on the symptoms (flu-like illness); incubation conotoxins: intestines and therefore is referred to as • periods typically range from 1 to 4 Production of pure preparations an enterotoxin. SEB is one of the weeks, but can extend to 6 months (chemical synthesis of larger quantities pyrogenic toxins (causing fever) that (Olsen et al., 2018). of appropriately folded peptides) is a commonly causes food poisoning in Should B. abortus, B. melitensis, and challenge due to the thermodynamic humans after the toxin is produced in B. suis be removed or retained as an instability of many conotoxins (Purcell improperly handled foodstuffs and HHS select agent? Please provide a et al., 2012) and most alpha-conotoxins subsequently ingested. Based on the detailed explanation for your response. harvested from the venom bulbs of cone criteria for listing select agents specified snails are inactive precursors that are under 42 U.S.C. 262a(a)(1)(B), HHS/CDC vi. Venezuelan Equine Encephalitis not in the functional form of the select is seeking comments from the public to Virus (VEEV) 1AB and 1C toxin. To generate the functional form, provide any information not included VEEV usually causes mild to severe soluble peptides of the appropriate below to help inform our deliberations influenza-like symptoms. Based on the amino acid sequence must be treated regarding Staphylococcal enterotoxins: criteria for listing select agents specified with proteases to properly fold and • The estimated annual number of under 42 U.S.C. 262a(a)(1)(B), HHS/CDC activate the toxin, which requires domestically acquired foodborne is seeking comments from the public to higher-level technical expertise and is a hospitalization (6% hospitalization rate) provide any information not included slow process involving several months and deaths (<0.1% death rate) caused by below to help inform our deliberations (Wu et al., 2013). S. aureus is low. (Scallan et al., 2011). • regarding VEEV 1AB and 1C: The optimal route of exposure for • The ED50 (concentration of a drug • Case fatality rate is less than 0.7%. toxicity for conotoxins is through that produces a biological response) for Serosurvey data from the 1995 injection. However, even though there is Staphylococcal enterotoxins: Venezuelan 1C outbreak indicated that, currently no published literature to Æ Intravenously: ED50 0.03 mg/kg of 75,000 estimated human cases, one- support conotoxins being administered (rhesus monkeys) (Bergdoll, 1979)

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Æ Ingestion: ED50 1 mg/kg (rhesus of the disease as well as clinical patterns by inhalation; 0.0013–0.0024 ug/kg by monkeys) (Bergdoll, 1979) can manifest as mild, moderate or injection (Guzman et al., 2001) Æ Intragastrically: ED 1.7 mg/kg (5 severe disease, depending upon the 50 D. Designating Nipah Virus as a Tier 1 ug/monkey for 3 kg rhesus monkeys) causative virus. HFRS caused by Select Agent (Donnelly et al., 1967) Hantaan and Dobrava viruses is more Should Staphylococcal enterotoxins severe, while HFRS caused by Seoul Executive Order 13546 ‘‘Optimizing be removed or retained as a select toxin? virus is more moderate and by Puumala the Security of Biological Select Agents If retained, should the Staphylococcal virus is mild (Jonsson et al., 2010). The and Toxins in the United States’’ enterotoxins exclusion amount be clinical picture for Dobrava virus is directed the HHS Secretary to designate increased or decreased? Please provide severe with more hemorrhagic a subset of the select agents and toxins a detailed explanation for your complications, shock (21 to 28%), list that present the greatest risk of response. oliguric renal failure (30 to 47%), and deliberate misuse with the most abdominal and pleural effusions (Maes significant potential for mass casualties B. Biological Agents Under et al., 2009). Due to the severity of or devastating effects to the economy, Consideration for Being Added to the disease with Hantaan virus and Dobrava critical infrastructure, or public HHS Select Agent and Toxin List virus, HHS/CDC is considering the confidence. This subset of select agents i. New World Hantaviruses addition of Hantaan virus and Dobrava and toxins is identified as Tier 1. HHS/ virus to the list of select agents because: CDC is seeking public comment on Some New World Hantaviruses can • HFRS caused by Hantaan and whether Nipah virus should be cause Hantavirus Pulmonary Syndrome Dobrava viruses are more severe than (HPS) in humans. HPS is an acute identified as a Tier 1 select agent. HHS/ infection caused by other Old World CDC is considering whether the Nipah febrile illness with a symptoms Hantaviruses such as Seoul, Puumala, consisting of fever, chills, myalgia, virus should be designated as a Tier 1 Sangassou, and Saaremma viruses (Maes agent because the public health threat headache, and gastrointestinal et al., 2009 and Avsic-Zupanc et al., symptoms (Hooper et al., 2013). Based posed by Nipah virus is similar to that 2019). of Marburg and Ebola viruses which are on the results of the ISATTAC • For Hantaan viruses, inhalation evaluation of New World Hantaviruses, both currently Tier 1, with infectious dose (ID50), is very low and in characteristics such as: HHS/CDC is considering the addition of rats was 0.3–0.7 plaque-forming unit Sin Nombre virus (SNV) and Andes • Human transmissibility (person-to- (Nuzum et al., 1988). person transmission has occurred) virus to the list of select agents because: Should Hantaan virus and Dobrava • (Centers for Disease Control and The average case fatality rate in the virus be added to the select agent list? Prevention, 2014; Gurley et al., 2007; United States from 1993 to 2016 is 36% Should other Old World Hantaviruses (Centers for Disease Control and Luby et al., 2012; and Luby et al., 2009). be regulated as select agents? In • Prevention, 2017). addition, HHS/CDC is seeking High case fatality rate (estimated • Andes virus is capable of person-to- comments regarding the potential between 40–100%) (World Health person transmission (Martinez et al., burden and time needed for an entity Organization, 2017 and Harcourt et al., 2005 and Vitek et al., 1996). possessing the Hantaan or Dobrava virus 2004). • • The infectious and lethal doses are to come into compliance with the select Low infectious dose (ranging from very low. For Andes virus in hamsters, agents and toxins regulatory 100–107 plaque forming units the infectious dose is estimated to be requirements. Please provide a detailed depending on route of infection) (DeWit between 1–10 virus particles, and the explanation for your response. et al., 2014; Geisbert et al., 2010; and lethal dose is estimated to be between Mathieu et al., 2012). 10–100 virus particles (Hooper et al., C. Exclusion Limits Being Considered • High severity of illness (fever, 2001 and Hooper et al., 2008). for the Following Toxins headache, dizziness, vomiting, cough, • There are no FDA-approved Based on the criteria for listing select reduced levels of consciousness, vaccines or drugs to prevent or treat toxins specified under 42 U.S.C. respiratory distress, and death) (Hoh et infection with Andes or SNV. 262a(a)(1)(B), HHS/CDC is seeking al., 2000; Hossain et al., 2008; and Lo et Supportive care is the only current comments from the public to provide al., 2008). method of treatment for patients with any information that will help inform • Severe long-term effects HPS (Avsic-Zupanc et al., 2019). our deliberations regarding this biennial (neurological sequelae including Should Sin Nombre virus and Andes review including increasing or encephalopathy, cranial nerve palsies, virus be added to the select agent list? decreasing the exclusion limit for the and dystonia) (Sejvar et al., 2007 and Lo Should other New World Hantaviruses following toxins: et al., 2008). For entities that are • be regulated as HHS select agents? In Saxitoxin based on the LD50 by currently registered to possess Nipah addition, HHS/CDC is seeking ingestion is estimated as 0.3–1.0 mg/ virus, they are also in possession of comments regarding the potential person (Burrows et al., 1999) and other Tier 1 select agents. Therefore, burden and time needed for an entity estimated mortality rate of 15% for designating Nipah virus as Tier 1 select possessing SNV or Andes virus to come Paralytic Shellfish Poisoning (Rodrique, agent would not require an entity to into compliance with the select agents et al., 1990 and Hallegraeff, et al. 1995) meet additional requirements associated • and toxins regulatory requirements. Tetrodotoxin based on LD50 with Tier 1 agents. Should Nipah virus Please provide a detailed explanation estimated 15–60 mg/kg by ingestion be identified as a Tier 1 select agent? for your response. (Burrows et al., 1999); 2 mg/kg by Please provide a detailed explanation inhalation; 8–14 mg/kg by injection ii. Old World Hantaviruses for your response. (mouse, dog, rabbit) (Bane et al., 2014) Some highly pathogenic Old World and the recent puffer fish poisoning in V. References Hantaviruses can cause severe 2008 Bangladesh involved 141 cases Arnon, S.S., et al., as a Hemorrhagic Fever with Renal with 17 deaths (Islam et al., 2011) biological weapon: Medical and public Syndrome (HFRS). HFRS is a • Botulinum neurotoxin estimated at health management. JAMA, 2001. 285(8): generalized infection, and the severity 1 ug/kg by ingestion; 0.01–0.012 ug/kg p. 1059–70.

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World Health Organization, Nipah Virus No. 20–34; WC Docket No. 19–126; WC Alternative formats are available to Outbreaks in the WHO South-East Asia Docket No. 10–90. persons with disabilities by sending an Region. 2017. Retrieved from • Paper Filers: Parties who choose to email to [email protected] or by calling www.searo.who.int/entity/emerging_ _ _ _ file by paper must file an original and the Consumer & Governmental Affairs diseases/links/nipah virus outbreaks one copy of each filing. If more than one Bureau at (202) 418–0530 (voice), (202) sear/en/. Wu, X., et al. Optimal Cleavage and docket or rulemaking number appears in 418–0432 (TTY). Pursuant to sections Oxidative Folding of Alpha-Conotoxin the caption of this proceeding, filers 1.415 and 1.419 of the Commission’s TxIB as a Therapeutic Candidate must submit two additional copies for rules, 47 CFR 1.415, 1.419, interested Peptide. Mar Drugs, 2013. 11(9): p. 3537– each additional docket or rulemaking parties may file comments and reply 53. number. Filings can be sent by hand or comments on or before the dates Dated: February 21, 2020. messenger delivery, by commercial indicated in the Auction 904 Comment Alex M. Azar II, overnight courier, or by first-class or Public Notice in AU Docket No. 20–34; overnight U.S. Postal Service mail. All WC Docket 19–126; and WC Docket 10– Secretary. filings must be addressed to the 90. [FR Doc. 2020–05477 Filed 3–16–20; 8:45 am] Commission’s Secretary, Office of the I. Introduction BILLING CODE 4163–18–P Secretary, Federal Communications Commission. 1. By the Auction 904 Comment All hand-delivered or messenger- Public Notice, the Commission initiates FEDERAL COMMUNICATIONS delivered paper filings for the the pre-auction process for Phase I of COMMISSION Commission’s Secretary must be the Rural Digital Opportunity Fund delivered to FCC Headquarters at 445 auction (auction or Auction 904). The 47 CFR Parts 1 and 54 12th St. SW, Room TW–A325, auction will award up to $16 billion [AU Docket No. 20–34; WC Docket Nos. 10– Washington, DC 20554. The filing hours over 10 years to service providers that 90, 19–126; FCC 20–21; FRS 16543] are 8:00 a.m. to 7:00 p.m. All hand commit to offer voice and broadband deliveries must be held together with services to fixed locations in eligible Comment Sought on Competitive rubber bands or fasteners. Any unserved high-cost census blocks. Bidding Procedures and Certain envelopes and boxes must be disposed Bidding is expected to begin on October Program Requirements for the Rural of before entering the building. 22, 2020. Digital Opportunity Fund Auction Commercial overnight mail (other 2. Auction 904 will be the (Auction 904) than U.S. Postal Service Express Mail Commission’s second auction to award and Priority Mail) must be sent to 9050 ongoing high-cost universal service AGENCY: Federal Communications support through competitive bidding in Commission. Junction Drive, Annapolis Junction, MD 20701. a multiple-round, reverse auction and ACTION: Proposed rule; proposed auction U.S. Postal Service first-class, follows the successful Connect America procedures. Express, and Priority mail must be Fund (CAF) Phase II auction (Auction 903) that was completed in 2018. As SUMMARY: addressed to 445 12th Street SW, In this document, the Federal with the CAF Phase II auction, the Washington, DC 20554. Communications Commission Commission intends to maximize the (Commission) proposes and seeks FOR FURTHER INFORMATION CONTACT: For value the American people receive for comment on the procedures to be used further information regarding this the universal service dollars the for Phase I of the Rural Digital proceeding, contact Mark Montano in Commission spends, balancing the need Opportunity Fund auction, designated the Auctions Division of the Office of for future-proofed networks and higher- as Auction 904. Economics and Analytics at (202) 418– quality services against cost efficiencies. DATES: Comments are due on or before 0660 or Heidi Lankau in the Therefore, the Commission will again March 27, 2020, and reply comments Telecommunications Access and Policy use an auction mechanism designed to are due on or before April 10, 2020. Division, Wireline Competition Bureau, select bids from providers that would ADDRESSES: Comments may be filed (202) 418–7400. deploy high-speed broadband and voice using the Commission’s Electronic SUPPLEMENTARY INFORMATION: This is a services in unserved communities for Comment Filing System (ECFS) or by summary of the Commission’s lower relative levels of support. filing paper copies. Electronic Filing of document (Auction 904 Comment 3. The pre-auction and bidding Documents in Rulemaking Proceedings, Public Notice), AU Docket No. 20–34; procedures and processes proposed for 63 FR 24121 (May 1, 1998). All filings WC Docket Nos. 19–126 and 10–90; FCC this auction are similar to those that in response to the Auction 904 20–21, adopted on February 28, 2020 proved effective in the CAF Phase II Comment Public Notice must refer to and released on March 2, 2020. The auction. The Commission is proposing AU Docket No. 20–34; WC Docket No. complete text of this document is some new pre-auction and bidding 19–126; and WC Docket No. 10–90. The available for public inspection and procedures and processes that would be Commission strongly encourages copying from 8:00 a.m. to 4:30 p.m. expected to materially improve upon interested parties to file comments Eastern Time (ET) Monday through the Auction 904 based upon its electronically. Thursday or from 8:00 a.m. to 11:30 a.m. experience with Auction 903. • Electronic Filers: Comments may be ET on Fridays in the FCC Reference 4. The Commission proposes and filed electronically using the internet by Information Center, 445 12th Street SW, seeks comment in this Public Notice on accessing the ECFS: https:// Room CY–A257, Washington, DC 20554. the procedures to be used in Auction www.fcc.gov/ecfs/. Filers should follow The complete text is also available on 904, including (i) how an applicant can the instructions provided on the website the Commission’s website at http:// become qualified to participate in the for submitting comments. In completing www.fcc.gov/auction/904/ or by using auction, (ii) how bidders will submit the transmittal screen, filers should the search function for AU Docket No. bids, and (iii) how bids will be include their full name, U.S. Postal 20–34, WC Docket 19–126, or WC processed to determine winners and Service mailing address, and the Docket 10–90 on the Commission’s assign support amounts. The applicable docket numbers, AU Docket ECFS web page at www.fcc.gov/ecfs/. Commission also seeks comment on,

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