[Federal Register Volume 72, Number 34 (Wednesday, February 21, 2007)]
[Rules and Regulations]
[Pages 7825-7826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-2857]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 1240

[Docket No. 2003N-0400]
RIN 0910-ZA21


Control of Communicable Diseases; Restrictions on African 
Rodents, Prairie Dogs, and Certain Other Animals

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Interim final rule; supplement and partial reopening of 
comment period.

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SUMMARY:  The Food and Drug Administration (FDA) is reopening the 
comment period for the interim final rule on the capture, transport, 
sale, barter, exchange, distribution, and release of African rodents, 
prairie dogs, and certain other animals, which was published in the 
Federal Register of November 4, 2003 (68 FR 62353). FDA is taking this 
action because it is adding new information, primarily in the form of 
peer-reviewed scientific literature, to the administrative record. FDA 
is reopening the comment period for 30 days for the sole purpose of 
inviting public comments on the information being added to the 
administrative record.

DATES:  Submit written or electronic comments by March 23, 2007.

ADDRESSES: You may submit comments, identified by Docket No. 2003N-0400 
and/or RIN number 0910-ZA21, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following ways:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.

Written Submissions

    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described previously, in 
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and docket number and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.fda.gov/ohrms/dockets/default.htm, including any personal 
information provided. For additional information on submitting 
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Philip L. Chao, Office of Policy and 
Planning (HF-23), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0587.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of November 4, 2003 (68 FR 62353), the 
Centers for Disease Control and Prevention (CDC) and FDA issued an 
interim final rule to establish new restrictions and modify existing 
restrictions on the import, capture, transport, sale, barter, exchange, 
distribution, and release of African rodents, prairie dogs, and certain 
other animals in order to prevent the spread of monkeypox, a 
communicable disease, in the United States. The CDC regulation is 
codified at 42 CFR 71.56, and FDA's regulation is codified at 21 CFR 
1240.63.
    Since the publication of the interim final rule in the Federal 
Register, additional scientific information has appeared regarding the 
2003 monkeypox outbreak. In general, the scientific information adds to 
our knowledge about the 2003 monkeypox outbreak in the United States, 
including information about the virus and how the disease affected or 
affects humans and animals.
    FDA is adding the following documents to the administrative record 
for the interim final rule:
    1. Anderson, M.G., et al., ``A Case of Severe Monkeypox Virus 
Disease in an American Child: Emerging Infections and Changing 
Professional Values,'' Pediatric Infectious Disease Journal, 2003; 
22:1093-1096.
    2. Bernard, S.M. and Anderson, S.A., ``Qualitative Assessment of 
Risk for Monkeypox Associated with Domestic Trade in Certain Animal 
Species, United States'' Emerging Infectious Diseases, 2006; 12: 1827-
1833.
    3. Di Giulio, D.B. and Eckburg, P.B., ``Human Monkeypox: An 
Emerging Zoonosis,'' Lancet Infectious Diseases, 2004; 4:15-25.
    4. Fleischauer, A.T., et al., ``Evaluation of Human-to-Human 
Transmission of Monkeypox from Infected Patients to Health Care 
Workers,'' Clinical Infectious Diseases, 2005; 40:689-694.
    5. Guarner, J., et al., ``Monkeypox Transmission and Pathogenesis 
in Prairie Dogs,'' Emerging Infectious Diseases, 2004; 10:426-431.
    6. Hammarlund, E., et al., ``Multiple Diagnostic Techniques 
Identify Previously Vaccinated Individuals With Protective Immunity 
Against Monkeypox,'' Nature Medicine, 2005; 11:1005-1011.
    7. Huhn, G.D., et al., ``Clinical Characteristics of Human 
Monkeypox, and Risk Factors for Severe Disease,'' Clinical Infectious 
Diseases, 2005; 41:1742-1751.
    8. Huhn, G.D., et al., ``Monkeypox in the Western Hemisphere,'' New 
England Journal of Medicine, 2004; 350:1790-1791.
    9. Jamieson, D.J., et al., ``Emerging Infections and Pregnancy: 
West Nile Virus, Monkeypox, Severe Acute Respiratory Syndrome, and 
Bioterrorism,'' Clinics in Perinatology, 2005; 32:765-776.
    10. Kile, J.C., et al., ``Transmission of Monkeypox Among Persons 
Exposed to Infected Prairie Dogs in Indiana in 2003,'' Archives of 
Pediatrics and Adolescent Medicine, 2005; 159:1022-1025.
    11. Likos, A.M., et al., ``A Tale of Two Clades: Monkeypox 
Viruses,'' Journal of General Virology, 2005; 86:2661-2672.
    12. Nalca, A., et al., ``Reemergence of Monkeypox: Prevalence, 
Diagnostics, and Countermeasures,'' Clinical Infectious Diseases, 2005; 
41:1765-1771.
    13. Reed, K.D., et al., ``The Detection of Monkeypox in Humans in 
the Western Hemisphere,'' New England Journal of Medicine, 2004; 
350:342-350.
    14. Reynolds, Gretchen, ``Why Were Doctors Afraid to Treat Rebecca 
McLester?'' New York Times, April 18, 2004.

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    15. Reynolds, M.G., et al., ``Clinical Manifestations of Human 
Monkeypox Influenced by Route of Infection,'' Journal of Infectious 
Diseases, 2006; 773-780.
    16. Sejvar, J.J., et al., ``Human Monkeypox Infection: A Family 
Cluster in the Midwestern United States,'' Journal of Infectious 
Diseases, 2004; 190:1833-1840.
    17. Xiao, S., et al., ``Experimental Infection of Prairie Dogs with 
Monkeypox Virus,'' Emerging Infectious Diseases, 2005; 11:539-545.

II. Comments

    Through this document, FDA is announcing the addition of the 
previous materials to the administrative docket and inviting comment 
limited to these publications. FDA believes that a 30-day comment 
period is sufficient in this case, as the agency is specifically 
limiting its reopening of the comment period to comments on how the 
agency should consider the information being added to the 
administrative docket in relation to FDA's interim final rule. Comments 
are invited, and will be considered, only to the extent they are 
focused on the specific information being added to the record of FDA's 
interim final rule.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the documents 
listed above. Submit a single copy of electronic comments or two copies 
of any mailed comments, except that individuals may submit one paper 
copy. Comments should be identified with the docket number found in 
brackets in the heading of this document. Received comments are 
available for public examination in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 9, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2857 Filed 2-20-07; 8:45 am]
BILLING CODE 4160-01-S