Notice of Temporary Suspension of Dogs Entering the United States From Egypt

Citation84 FR 20628
Record Number2019-09654
Published date10 May 2019
SectionNotices
CourtCenters For Disease Control And Prevention,Health And Human Services Department
Federal Register, Volume 84 Issue 91 (Friday, May 10, 2019)
[Federal Register Volume 84, Number 91 (Friday, May 10, 2019)]
                [Notices]
                [Pages 20628-20632]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2019-09654]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Centers for Disease Control and Prevention
                Notice of Temporary Suspension of Dogs Entering the United States
                From Egypt
                AGENCY: Centers for Disease Control and Prevention (CDC), Department of
                Health and Human Services (HHS).
                ACTION: Notice.
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                SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
                Department of Health and Human Services (HHS) announces that, effective
                immediately, it is temporarily suspending the importation of dogs from
                Egypt. This includes dogs originating in Egypt that are imported from
                third-party countries if the dogs have been present in those countries
                for less than six months. CDC is taking this action in response to an
                increase of imported cases of rabies in dogs from Egypt. This action is
                needed to prevent the reintroduction of canine rabies virus variant
                (CRVV), which has been eliminated from the United States. This
                suspension will remain in place until appropriate veterinary controls
                have been established in Egypt to prevent the export of rabid dogs. CDC
                will coordinate with other federal agencies and entities as necessary
                to implement this action.
                DATES: This notice is applicable May 10, 2019.
                FOR FURTHER INFORMATION CONTACT: For information regarding this notice
                contact: Ashley A. Altenburger, J.D., Division of Global Migration and
                Quarantine, Centers for Disease Control and Prevention, 1600 Clifton
                Road NE, MS-H16-4, Atlanta, GA 30329.
                 For information regarding CDC operations related to this notice
                contact: Kendra Stauffer, D.V.M., Division of Global Migration and
                Quarantine, Centers for Disease Control and- Prevention, 1600 Clifton
                Road NE, MS-V-18-2, Atlanta, GA 30329. Either person may also be
                reached by telephone 404-498-1600 or email [email protected].
                SUPPLEMENTARY INFORMATION
                I. Background
                 Rabies, one of the deadliest zoonotic diseases, accounts for an
                estimated 59,000 human deaths globally each year \1\--which equates to
                one human
                [[Page 20629]]
                death every 9 minutes. The virus can infect any mammal, and once
                clinical signs appear, the disease is usually fatal.\2\ In September
                2007, at the Inaugural World Rabies Day Symposium, HHS/CDC declared the
                United States to be free of canine rabies virus variant (CRVV).
                However, this rabies virus variant remains a serious public health
                threat in many other countries where laboratory and epidemiologic
                surveillance for CRVV is not as strong as in the United States. Many
                other countries also do not maintain a robust rabies vaccination
                program for dogs. Preventing the entry of animals infected with CRVV
                into the United States is a public health priority. Globally, CRVV is
                responsible for 98% of the estimated 59,000 human rabies deaths
                worldwide each year (WHO, 2004 [Page 116]).
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                 \1\ Hampson K, Coudeville L, Lembo T, et al. Estimating the
                global burden of endemic canine rabies. PLoS Negl Trop Dis
                2015;9:e0003709.
                 \2\ Fooks AR, Banyard AC, Horton DL, Johnson N, McElhinney LM,
                Jackson AC. Current status of rabies and prospects for elimination.
                Lancet 2014;384:1389-99.
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                 On January 29, 2019, a shipment of 26 dogs was imported from Egypt
                to the United States through Canada by a Kansas-based rescue
                organization. All 26 dogs were placed into foster care or adopted in
                the Kansas City metro area of Kansas and Missouri. On February 25,
                2019, one of the imported dogs, after biting a veterinary technician
                and exhibiting signs of illness, tested positive for rabies. Testing
                performed at CDC revealed that the rabid dog was infected with CRVV.
                Molecular characterization of the rabies virus also determined that it
                was most similar to a clade (group of organisms with a common ancestor)
                found in Egypt. This laboratory testing confirms that the dog was
                infected in Egypt prior to arrival in the United States.
                 Official notification of this event was made to the appropriate
                Egyptian ministry officials through the World Health Organization (WHO)
                International Health Regulation (IHR) rabies national focal point, the
                World Organization for Animal Health (OIE) delegate to Egypt, and
                through the CDC country office in Egypt. OIE develops guidance for
                importation requirements of animals, control of rabies in animals, and
                oversees an OIE member country's self-declaration of rabies-free
                status. It can revoke a country's self-declaration of rabies-free
                status and make notifications to OIE member countries if it is
                concerned about a threat to animal health.
                 This incident is the most recent example of cases of rabies in dogs
                imported from Egypt that have occurred in the last four years. On May
                30, 2015, a shipment of 8 dogs and 27 cats arrived at John F. Kennedy
                (JFK) International Airport in New York City from Cairo, Egypt. The
                animals were distributed in New Jersey, Pennsylvania, Maryland, and
                Virginia to several animal rescue groups and one permanent adoptive
                home. On May 31, 2015, four dogs from the shipment were further
                distributed to three foster homes in Virginia that were connected with
                a Virginia-based rescue group.
                 On June 3, 2015, an adult female stray dog imported by an animal
                rescue group as part of this shipment became ill. The dog had been
                imported with an unhealed fracture of the left forelimb and 4 days
                after arriving at a foster home in Virginia developed clinical signs
                consistent with rabies. Because of concern about rabies, a veterinarian
                euthanized the dog on June 5, 2015, and submitted brain tissue for
                rabies testing. On June 8, 2015, the Virginia Department of General
                Services Division of Consolidated Laboratory Services confirmed rabies
                infection by laboratory testing. A tissue sample was sent to CDC for
                further testing (i.e., molecular characterization), which can help
                determine where the rabies virus originated. Testing performed at CDC
                revealed that the rabid dog was infected with CRVV, and molecular
                characterization of the rabies virus determined that it was most
                similar to a clade found in Egypt.\3\ This laboratory testing confirms
                that the dog was infected in Egypt prior to arrival in the United
                States.
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                 \3\ Sinclair JR, Wallace RM, Gruszynski K, et al. Rabies in a
                dog imported from Egypt with a falsified rabies vaccination
                certificate--Virginia, 2015. MMWR Morb Mortal Wkly Rep 2015;64:1359-
                62.
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                 On December 20, 2017, a shipment of four dogs exported by a U.S.-
                based animal rescue group in Cairo, Egypt arrived at JFK. Two
                transporters and one owner retrieved the dogs, with planned
                distribution to foster homes and permanent owners in Connecticut,
                Maryland, and Virginia. A fifth dog on the flight was temporarily
                housed in New Jersey and West Virginia before reaching its destination
                in Washington State. This dog was traveling with a separate handler and
                was not part of the shipment, but shared the cargo hold with other
                animals.
                 On December 21, 2017, one of the four dogs exhibited hyperesthesia
                (increased sensitivity to stimuli) and paresis (muscle weakness) upon
                assessment at a Connecticut veterinary clinic. The dog bit a veterinary
                technician during a blood draw procedure and died shortly thereafter.
                On December 26, 2017, the Connecticut Department of Public Health
                Laboratory confirmed rabies virus infection by laboratory testing. On
                December 28, 2017, testing performed at CDC revealed that the rabid dog
                was infected with CRVV and molecular characterization of the rabies
                virus determined that it was most similar to a clade found in Egypt.
                This laboratory testing confirms that the dog was infected in Egypt
                prior to arrival in the United States.
                 Staff members with the state health department interviewed dog
                caretakers, volunteers, and employees associated with the involved
                rescue groups and veterinary hospital staff members for potential
                exposure to rabid dogs in all three cases. Post-exposure prophylaxis
                was recommended and administered to those individuals considered
                exposed. No human rabies cases nor dog-to-dog transmission cases
                resulted due to prompt diagnosis and public health interventions.
                II. Public Health Rationale
                 A person usually becomes infected with rabies through the bite of a
                rabid animal. Once a person is bitten by a rabid animal, the virus
                enters the wound and travels through the nerves to the spinal cord and
                brain. It is also possible, but quite rare, for a person to become
                infected through infectious material from a rabid animal, such as
                saliva, contacting a person's eyes, nose, mouth, or a wound. The
                incubation period for rabies is generally between 3-12 weeks, and
                during this time, the person may show no signs of illness. Once
                symptoms appear, the person typically dies within 1-2 weeks because
                rabies is almost 100% fatal in humans that are not treated before the
                onset of clinical signs. No treatment has been found to be routinely
                effective after clinical signs of disease begin. Investigations into
                potential exposures from the import of a rabid dog can be long,
                difficult and expensive.\4\
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                 \4\ Hercules Y, Bryant NJ, Wallace RM, et al. Rabies in a Dog
                Imported from Egypt--Connecticut, 2017. MMWR Morb Mortal Wkly Rep
                2018;67:1388-1391. DOI: http://dx.doi.org/10.15585/mmwr.mm6750a3.
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                 The United States was declared CRVV free in 2007. The importation
                of just one dog infected with CRVV risks the re-introduction of the
                virus into the United States. CRVV has been highly successful at
                adapting to new host species, particularly wildlife. Importation of
                even one CRVV-infected dog could result in transmission to humans,
                transmission to other dogs, transmission to wildlife, and of particular
                concern, could result in sustained transmission in a susceptible animal
                population, thereby threatening our entire rabies
                [[Page 20630]]
                public health infrastructure. While CDC estimates that each year
                100,000 dogs are imported from various high-risk CRVV countries, since
                2015, three rabid dogs have been imported into the United States, and
                all were from Egypt.
                 To date, CDC efforts to work with Egyptian officials have proven
                unsuccessful at identifying root causes of these importation events and
                at identifying satisfactory solutions to reduce the risk of exportation
                of CRVV from Egypt. Egyptian officials failed to respond to requests
                for information pertaining to actions taken to prevent further export
                of rabies-infected dogs. In order to protect the public from rabies
                risk when the paperwork used to import a rabies-infected dog is
                suspected or confirmed to be fraudulent, good public health practice
                warrants appropriate follow-up that entails investigation of the
                responsible veterinarian or organization and possible revocation of
                license if fraud is proven. Egyptian officials have thus far not
                provided information as to whether this type of investigation and
                response have occurred. Similarly, in instances of suspected
                vaccination failures, appropriate follow-up by Egyptian officials to
                protect public health should include investigation of vaccine quality,
                the distribution chain, cold-chain maintenance, and inoculation
                methods. Egyptian officials, contrary to International Health
                Regulations and responsibilities, have thus far not provided
                information as to whether an investigation into the quality and
                management of animal rabies vaccine stocks was performed.
                 On March 6, 2019, CDC notified the World Health Organization (WHO)
                of a possible Public Health Emergency of International Concern (PHEIC)
                under the International Health Regulations. In order to notify an event
                as a PHEIC, CDC must assess the public health impact to be serious. CDC
                assesses these importations to be serious because rabies has a high
                potential to cause an epidemic, there is indication of treatment
                failure, and the importations represent a significant public health
                risk even if very few human cases are identified.
                 The worst-case outcomes for an importation of a rabid dog would
                include (1) transmission of CRVV to an unaware person because rabies is
                usually fatal once persons become symptomatic or (2) unrecognized
                spread to other wildlife species with subsequent, and possibly
                sustained, transmission in the United States.
                 The cost of re-introduction of CRVV could be especially high if
                CRVV spreads to other species of U.S. wildlife. A reintroduction of
                CRVV into the United States would require costly efforts over a number
                of years to eliminate the virus. A previous campaign to eliminate
                domestic dog-coyote rabies virus variant jointly with gray fox (Texas
                fox) rabies virus variant in Texas over the period from 1995 through
                2003 cost an undiscounted $34 million 5 6 or $52 million in
                2019 U.S. dollars. The costs to contain any reintroduction of CRVV
                would depend on how much time passed before the reintroduction was
                realized, the wildlife species in which CRVV was transmitted, and the
                geographic area over which reintroduction occurs. The above estimate is
                limited to the cost of rabies vaccination programs for targeted
                wildlife and does not include the costs to administer post-exposure
                prophylaxis to any persons exposed after the reintroduction has been
                identified.
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                 \5\ TJ Sidwa et al. (2005) Evaluation of oral rabies vaccination
                programs for control of rabies epizootics in coyotes and gray foxes:
                1995-2003. Journal of the American Veterinary Medicine Association;
                227(5):785-92.
                 \6\ R.T. Sterner et al. (2009) Tactics and Economics of Wildlife
                Oral Rabies Vaccination, Canada and the United States. Emerging
                Infectious Diseases; 15(8):
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                 Even under the best-case scenario in which a dog with CRVV is
                imported, but quickly identified, costs would be incurred for the
                public health response to provide post exposure prophylaxis for exposed
                persons and monitor exposed animals. The HHS/CDC Poxvirus and Rabies
                Branch estimates that each importation could require an intensive
                public health response comprising of 800 staff-hours.\7\
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                 \7\ Personal communication: Ryan M Wallace and Jesse D Blanton
                U.S. Centers for Disease Control and Prevention, Poxvirus and Rabies
                Branch; February 23, 2018.
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                 In addition, HHS/CDC estimates that each rabid dog importation
                event would result in approximately 15.5 human
                exposures.8 9 10 11 Each human exposure would be expected to
                require post-exposure prophylaxis to ensure that people do not develop
                rabies, which is usually fatal once symptoms appear. Rabies post-
                exposure prophylaxis includes one dose of rabies immune globulin plus
                four doses of rabies vaccine. The total cost including office visits
                was estimated at about $8,500 per exposed individual, although actual
                costs would depend on where a person receives post exposure
                prophylaxis.
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                 \8\ Sinclair JR, Wallace RM, Gruszynski K, Freeman MB, Campbell
                C, et al. Rabies in a Dog Imported with Falsified Rabies Vaccination
                Certificate-- Virgiania, 2015. MMWR Morb Mort Wkly Rep 2015; 64
                (49): 1359-62.
                 \9\ Castrodale L, Walker V, Baldwin J, Hofmann J, Hanlon C.
                Rabies in a puppy imported from India to the USA, March 2007.
                Zoonoses Public Health 2008;55:427-30.
                 \10\ CDC. Rabies in a Dog Imported from Iraq-- New Jersey, June
                2008. MMWR Mob Mort Wkly Rep 2008; 57(39):1076-1078.
                 \11\ CDC. An Imported Case of Rabies in an Immunized Dog. MMWR
                Morb Mort Wkly Rep 1987; 36(7): 94-96.
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                 An imported dog with CRVV may also expose other animals. HHS/CDC's
                Poxvirus and Rabies Branch estimates that approximately 29.6 animals
                11 12 13 14 would be exposed for each imported dog with CRVV
                and that the average cost per exposed animal would be $1,000.\15\
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                 \11\ Sinclair JR, Wallace RM, Gruszynski K, Freeman MB, Campbell
                C, et al. Rabies in a Dog Imported with Falsified Rabies Vaccination
                Certificate--Virgiania, 2015. MMWR Morb Mort Wkly Rep 2015; 64 (49):
                1359-62.
                 \12\ Castrodale L, Walker V, Baldwin J, Hofmann J, Hanlon C.
                Rabies in a puppy imported from India to the USA, March 2007.
                Zoonoses Public Health 2008;55:427-30.
                 \13\ CDC. Rabies in a Dog Imported from Iraq-- New Jersey, June
                2008. MMWR Mob Mort Wkly Rep 2008; 57(39):1076-1078.
                 \14\ CDC. An Imported Case of Rabies in an Immunized Dog. MMWR
                Morb Mort Wkly Rep 1987; 36(7): 94-96.
                 \15\ Personal communication: Ryan M Wallace and Jesse D Blanton
                U.S. Centers for Disease Control and Prevention, Poxvirus and Rabies
                Branch; February 23, 2018.
                ---------------------------------------------------------------------------
                 The total cost per event (Table 1) including public health
                response, human exposures, and animal exposures is estimated at
                slightly less than $214,000. Lower bound and upper bound estimates were
                calculated by multiplying by 80% and 120% since the public health
                response time, persons and animals exposed may vary considerably for
                any given importation of a dog with CRVV. The estimated range in costs
                is from $171,000 to $257,000.
                [[Page 20631]]
                 Table 1--Estimated Public Health Response, Human Post-Exposure Prophylaxis and Animal Exposure Costs Estimated per Importation of a Dog With Canine
                 Rabies Virus Variant (CRVV), Assuming No Transmission to U.S. Humans or Animals
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                 Public health response cost
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                Number of hours per importation Public health.................. Overhead cost estimate... Cost per Lower bound (- Upper bound
                (A) \a\ department employee hourly cost (C)...................... importation 20%) (+20%)
                 (B) \b\........................ (A x B x (100% + C))
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                800............................... $32.21......................... 100% of wage rate........ $51,536 $41,229 $61,843
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                 Human post-exposure prophylaxis cost
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                Number of exposed people Average cost for post-exposure prophylaxis per person (E) Cost per Lower bound (- Upper bound
                (D) \a\ \c\ importation 20%) (+20%)
                 (D x E)
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                15.6.............................. $8,508 $132,727 $106,182 $159,272
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                Number of exposed animals per Average cost per exposed animal (G) \a\ Cost per Lower bound (- Upper bound
                 importation importation 20%) (+20%)
                (F) \a\ (F x G)
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                29.6.............................. $1,000 $29,570 $23,656 $35,484
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                 Total cost per importation
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                 Total cost per importation event.......................................................... $213,833 $171,066 $256,599
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                \a\ Personal communication: Ryan M. Wallace and Jesse D. Blanton U.S. Centers for Disease Control and Prevention, Poxvirus and Rabies Branch; February
                 23, 2018.
                \b\ Bureau of Labor Statistics, May 2017 National Occupational Employment and Wage Estimates United States, Occupation codes 29-1131, 19-1041, 29-1141,
                 29-2061, 43-0000.
                \c\ Rabies immune globulin and vaccine Red Book Online [database online]. Greenwood Village, CO: Truven Health Analytics. http://www.micromedexsolutions.com/. Accessed June 25, 2018.
                Centers for Medicare and Medicaid Services. 2017 Medicare Physician Fee Schedule. http://www.cms.gov/apps/physician-fee-schedule/overview.aspx. Accessed
                 June 25, 2018.
                P. Dhankhar, SA. Vaidya, DB Fishbien, MI Meltzer (2008) Cost effectiveness of rabies post-exposure prophylaxis in the United States. Vaccine 26: 4251-
                 4255.
                S.M. Kreindel, M. McGuill, M. Meltzer, C. Rupprecht, A. DeMaria Jr. (1998) The cost of rabies postexposure prophylaxis: one state's experience. Public
                 Health Rep 113:247-51.
                IV. Authority and Operations
                 Under 42 CFR 71.51, HHS/CDC requires each imported dog from a
                country with a high risk of CRVV to appear healthy and be accompanied
                by a valid rabies vaccination certificate indicating that the animal
                has been vaccinated against rabies prior to entry into the United
                States. The exception to this requirement is for dogs imported for
                scientific research purposes when rabies vaccination would interfere
                with the purpose of the research. Additionally, under 42 CFR 71.63, the
                CDC Director may temporarily suspend the entry of animals, articles, or
                things from designated foreign countries and places into the United
                States when the Director has determined there exists in a foreign
                country a communicable disease that would threaten the public health of
                the United States and the entry of imports from that country would
                increase the risk that the communicable disease may be introduced.
                Under 42 CFR 71.51(e), the CDC Director may also exclude dogs coming
                into the United States from areas determined to have high rates of
                rabies.
                 CDC has identified countries and political units that are
                considered high risk for importing CRVV into the United States. Egypt
                has been identified as one such country.\12\ Therefore, under 42 CFR
                71.51, any dogs coming from Egypt must be accompanied by valid rabies
                vaccine certificates to enter the United States. All of the dogs in the
                January 29, 2019 shipment entered with what appeared to be valid rabies
                certificates, suggesting a systemic failure of the rabies vaccination
                system in Egypt.
                ---------------------------------------------------------------------------
                 \12\ Factors that warrant placing a country on the list include
                documented presence of CRVV (publications or reports), inadequate or
                a lack of evidence of active control measures (mass dog
                vaccination), and consultation with regional rabies experts
                (typically OIE or WHO/PAHO regional representatives).
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                 In light of these repeated rabid dog importations, CDC has
                determined that until appropriate veterinary controls are in place in
                Egypt, a rabies vaccination certificate is not sufficient to protect
                U.S. public health against rabid dogs being imported from Egypt. For
                this reason, under 42 CFR 71.63 and 42 CFR 71.51(e), CDC is exercising
                its authority to temporarily suspend entry of imported dogs from Egypt,
                including dogs from Egypt that are imported by way of third-party
                countries if the dogs have been present in the third-party country for
                less than six months. Six months is the upper range of the incubation
                period for rabies in dogs. Thus, vaccinated dogs that have been present
                in a third-party country for more than six months may be safely
                imported into the United States, assuming all other CDC requirements
                are met. CDC will continue this suspension until appropriate veterinary
                safeguards to prevent the importation of canine rabies from Egypt have
                been established. CDC will also review this suspension on a periodic
                basis to ensure that it does not remain in place longer than is
                necessary to protect U.S. public health.
                V. Advance Written Approval
                 The provisions of this notice do not apply if advance written
                approval from the CDC has been obtained to import a
                [[Page 20632]]
                dog from Egypt, including a dog from Egypt that is being imported from
                a third-party country. Such approvals will be granted on a limited and
                case-by-case basis and at CDC's discretion.
                 Individuals seeking to import a dog from Egypt must submit the
                Application for a Permit to Import a Dog Inadequately Immunized Against
                Rabies, which is currently approved under OMB Control Number 0920-0134
                Foreign Quarantine Regulations (exp. 03/31/2022).
                 To request the advance written approval of the CDC, you must send
                an email to the Director, Division of Global Migration and Quarantine,
                at [email protected], requesting an application. Once you
                receive instructions and the permit application, your request must be
                submitted at least 10 business days before the date on which you intend
                the dog to enter the United States. A request cannot be made at the
                port of entry upon arrival into the United States. As required by the
                permit application, your request must present sufficient, reliable
                evidence conclusively demonstrating that the dog you wish to import is
                immune from rabies. Such evidence includes a valid rabies vaccination
                certificate that was issued in the United States or official government
                documents demonstrating the reliability of the vaccine, vaccine
                provider, and conditions under which the vaccine was stored. The
                evidence you present must also demonstrate the authenticity of the
                documents relied upon. Your written request must further explain how
                you intend to establish, for example, through identifying markers,
                microchip, or tattoo, that the dog being imported is the same dog
                identified in the official government documents you provided to the
                CDC. If the official government documents are not written in English,
                then they must be accompanied by English language translations of the
                official government documents, the authenticity of which has been
                attested to by a person licensed by the government to perform acts in
                legal affairs.
                 CDC will respond to your request in writing and may impose
                additional conditions in granting the approval. You must present CDC's
                written response and approval upon entry into the United States. If
                your request for advance approval is denied, CDC's written denial will
                constitute final agency action.
                VI. Terms of This Notice
                 Pursuant to 42 CFR 71.63 and 42 CFR 71.51(e), HHS/CDC hereby
                suspends, until further notice, the importation of any dog from Egypt,
                including dogs from Egypt that are imported from third-party countries
                if the dogs have been present in those countries for less than six
                months. This notice will become effective on May 10, 2019, and will be
                remain in place subject to periodic review by the CDC until appropriate
                safeguards to prevent importation of CRVV from Egypt have been
                established.
                 Dated: May 6, 2019.
                Sandra Cashman,
                Executive Secretary, Centers for Disease Control and Prevention.
                [FR Doc. 2019-09654 Filed 5-9-19; 8:45 am]
                 BILLING CODE 4163-18-P
                

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