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