[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.
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    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.
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    \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

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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