62353 Rules and Regulations Federal Register Vol. 68, No. 213 Tuesday, November 4, 2003 This section of the FEDERAL REGISTER Submit electronic comments to http:// were reported to have been hospitalized; contains regulatory documents having general www.fda.gov/dockets/ecomments. however, some of these hospitalizations applicability and legal effect, most of which For CDC: Send written comments on were for isolation purposes unrelated to are keyed to and codified in the Code of the information collection to Anne illness. Among those hospitalized, two Federal Regulations, which is published under O’Connor, CDC Assistant Reports were children who required intensive 50 titles pursuant to 44 U.S.C. 1510. Clearance Officer, 1600 Clifton Rd., MS care, one for severe monkeypox- The Code of Federal Regulations is sold by E11, Atlanta, GA 30333. Comments on associated encephalitis (encephalitis is the Superintendent of Documents. Prices of the rule itself should be sent to FDA’s an inflammation of the brain), and one new books are listed in the first FEDERAL Division of Dockets Management (see with profound painful cervical and REGISTER issue of each week. FDA addresses). tonsillar adenopathy (adenopathy refers FOR FURTHER INFORMATION CONTACT: to an enlargement of the glands) and For information regarding FDA: Philip diffuse pox lesions, including lesions in DEPARTMENT OF HEALTH AND L. Chao, Office of Policy and Planning the oropharynx. Both children HUMAN SERVICES (HF–23), Food and Drug recovered from their illness. Administration, 5600 Fishers Lane, In the United States, individuals Food and Drug Administration Rockville, MD 20857, 301–827–0587. apparently began contracting For information regarding CDC: James monkeypox in early May, 2003, 21 CFR Parts 16 and 1240 E. Barrow, National Center for Infectious primarily as a result of contact with [Docket No. 2003N–0400] Diseases, Centers for Disease Control prairie dogs that had contracted and Prevention, Mailstop C–14, 1600 monkeypox from diseased African RIN 0910–ZA21 Clifton Rd., Atlanta, GA 30333, 404– rodents. Investigations indicate that a 498–1600. Texas animal distributor imported a Centers for Disease Control and SUPPLEMENTARY INFORMATION: shipment of approximately 800 small Prevention mammals from Ghana on April 9, 2003, I. What Is Monkeypox, and How Did It and that shipment contained 762 42 CFR Part 71 Spread in the United States? African rodents, including rope Monkeypox is a rare, zoonotic, viral squirrels (Funiscuirus sp.), tree squirrels Control of Communicable Diseases; disease that occurs primarily in the rain (Heliosciurus sp.), Gambian giant Restrictions on African Rodents, forest countries in central and west pouched rats (Cricetomys sp.), brushtail Prairie Dogs, and Certain Other Africa. (A zoonotic disease is a disease porcupines (Atherurus sp.), dormice Animals of animals that can be transmitted to (Graphiurus sp.), and striped mice humans under natural conditions.) The (Hybomys sp.). Some animals were AGENCIES: Centers for Disease Control and Prevention, Food and Drug illness was first noted in monkeys in infected with monkeypox, and CDC Administration (HHS). 1958 (which explains its name), but, in laboratory testing confirmed the Africa, serologic evidence of presence of monkeypox in several ACTION: Interim final rule; opportunity monkeypox infection has been found in rodent species, including one Gambian for public comment. many other species, including some giant pouched rat, three dormice, and SUMMARY: The Centers for Disease species of primates, rodents, and two rope squirrels (Ref. 4). Of the 762 Control and Prevention (CDC) and the lagomorphs (which includes such rodents from the original shipment, 584 Food and Drug Administration (FDA) animals as rabbits). African rodents are have been traced to distributors in six are issuing this interim final rule to considered to be the most likely natural states. A total of 178 African rodents amend their regulations to establish new host of the monkeypox virus (Ref. 1). could not be traced beyond the point of restrictions and modify existing In humans, monkeypox is marked by entry in Texas because records were not restrictions on the import, capture, rashes that are similar to those seen in available (Ref. 4). The number of transport, sale, barter, exchange, smallpox; other signs and symptoms animals traced may change as the distribution, and release of African include a temperature at or above 99.3 investigation continues. degrees, chills and/or sweats, headache, rodents, prairie dogs, and certain other II. What Actions Have Been Taken to backache, lymphadenopathy (a disease animals. We are taking this action to Prevent the Spread of Monkeypox? prevent the spread of monkeypox, a of the lymph nodes), sore throat, cough, communicable disease, in the United and shortness of breath (Ref. 2). The Non-native animal species, such as States. disease’s incubation period is the African rodents, can create serious approximately 12 days (Ref. 3). In public health problems when they DATES: The interim final rule is effective Africa, monkeypox has a mortality rate introduce a new disease, such as on November 4, 2003. Submit written or in humans ranging from 1 to 10 percent. monkeypox, to the native animal and electronic comments on this interim As of July 8, 2003, there have been 35 human populations. The transportation, final rule by January 20, 2004. laboratory-confirmed cases of sale, or distribution of an infected ADDRESSES: For FDA: Send written monkeypox in people in the United animal, or the release of an infected comments on the rule and on the States, and about another three dozen animal into the environment can result information collection to the Division of suspect and probable cases under in the further spread of disease to other Dockets Management (HFA–305), Food investigation, in Illinois, Indiana, animal species and to humans. and Drug Administration, 5630 Fishers Kansas, Ohio, Missouri, and Wisconsin Several States have issued orders or Lane, rm. 1061, Rockville, MD 20852. (Ref. 4). As of July 11, 2003, 16 persons emergency rules to prohibit the VerDate jul<14>2003 14:51 Nov 03, 2003 Jkt 203001 PO 00000 Frm 00001 Fmt 4700 Sfmt 4700 E:\FR\FM\04NOR1.SGM 04NOR1 62354 Federal Register / Vol. 68, No. 213 / Tuesday, November 4, 2003 / Rules and Regulations importation, sale, distribution, release, outbreak (Ref. 13). We now are able to and other animals that may carry the disposal, and/or display of prairie dogs provide a more detailed set of measures monkeypox virus.’’ and certain rodents (Refs. 5 through 11). aimed at creating a regulatory approach 2. What Does the Rule Prohibit? (21 CFR However, these State efforts are limited to prevent the monkeypox virus from 1240.63(a)) to their respective jurisdictions, and becoming established and spreading in some State orders or rules expire on a the United States, with exemption 21 CFR 1240.63(a)(1) contains several specific date, while others differ in the procedures to accommodate special general prohibitions. In brief, under 21 types of animals and actions that are circumstances, and are doing so by CFR 1240.63(a)(1)(i), regardless of your covered. Communicable diseases, such issuing this interim final rule. This status (such as a pet dealer, pet owner, as monkeypox, are not confined by State interim final rule supersedes the June researcher, animal trapper, zoological borders and, as shown by the presence 11, 2003, order. As appropriate, we will park administrator, etc.), you must not of the monkeypox virus in prairie dogs, amend the interim final rule in response capture, offer to capture, transport, offer may affect multiple animal species. to comments and to any new to transport, sell, barter, or exchange, Consequently, Federal action was developments in the monkeypox offer to sell, barter, or exchange, necessary to help prevent the spread of outbreak. distribute, offer to distribute, or release monkeypox. On June 11, 2003, the This interim final rule creates two into the environment: • Director of CDC and the Commissioner complementary regulations. First, with Prairie dogs (Cynomys sp.), • of Food and Drugs, under 42 CFR 70.2 respect to certain animals that are in the African Tree squirrels (Heliosciurus and 21 CFR 1240.30 respectively, issued United States, the interim final rule sp.), • Rope squirrels (Funisciurus sp.), a joint order (Ref. 12) prohibiting, until adds 21 CFR 1240.63, entitled ‘‘African • further notice, the transportation or rodents and other animals that may African Dormice (Graphiurus sp.), • Gambian giant pouched rats offering for transportation in interstate carry the monkeypox virus.’’ FDA will enforce 21 CFR 1240.63. Second, for (Cricetomys sp.), commerce, or the sale, offering for sale, • Brush-tailed porcupines (Atherurus African rodents that are being imported or offering for any other type of sp.), commercial or public distribution, or offered for import to the United • Striped mice (Hybomys sp.), or including release into the environment, States, the interim final rule adds 42 • Any other animal so prohibited by of: CFR 71.56, that is also entitled ‘‘African • order of the Commissioner of Food and Prairie dogs (Cynomys sp.); rodents and other animals that may Drugs because of that animal’s potential • Tree squirrels (Heliosciurus sp.); carry the monkeypox virus.’’ CDC will • to transmit the monkeypox virus. Rope squirrels (Funisciurus sp.); enforce 42 CFR 71.56. Together, 21 CFR For convenience, this preamble will • Dormice (Graphiurus sp.); 1240.63 and 42 CFR 71.56 are intended • refer to the above animals as ‘‘listed Gambian giant pouched rats to prevent the establishment and spread animals.’’ (Cricetomys sp.); of the monkeypox virus in the United The interim final rule covers the • Brush-tailed porcupines (Atherurus States. listed animals because animals from sp.), and Section 361 of the Public Health • those species have been associated, Striped mice (Hybomys sp.). Service Act (PHS act) (42 U.S.C. 264) either directly through laboratory tests The June 11, 2003, order did not serves as the legal authority for both 21 or indirectly through epidemiological apply to the transport of these animals CFR 1240.63 and 42 CFR 71.56.