[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Notices]
[Pages 4120-4121]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-1278]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0620]
The National Antimicrobial Resistance Monitoring System Strategic
Plan 2011-2015; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for public comment of a document for The National
Antimicrobial Resistance Monitoring System (NARMS) entitled ``NARMS
Strategic Plan 2011-2015.'' The document outlines the strategic goals
and objectives for 2011 through 2015 of the NARMS program developed by
the participating Agencies (FDA, the Centers for Disease Control and
Prevention (CDC), and the United States Department of Agriculture
(USDA)) based on recommendations of an External Subcommittee of the
Science Board to FDA. The Agency is soliciting public comment on the
goals and objectives in the Strategic Plan and whether the goals and
objectives meet the recommendations of the subcommittee.
DATES: Submit either electronic or written comments by March 25, 2011.
ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Patrick McDermott, Center for
Veterinary Medicine (HFV-530), Food and Drug Administration, 8401
Muirkirk Rd., Laurel, MD 20708. 301-210-4213. e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
NARMS is a national public health surveillance program that
monitors the susceptibility of enteric bacteria to antimicrobial agents
of medical importance. The NARMS program, established in 1996, is a
collaboration between FDA, CDC, USDA, and State and local health
departments. NARMS also has established collaborations with scientists
and surveillance systems monitoring antimicrobial resistance in other
countries.
Foodborne diseases are an important cause of morbidity and
mortality worldwide. Travel, migration, and distribution of
contaminated food contribute to the problem of foodborne diseases. Non-
typhoidal Salmonella and Campylobacter are the leading bacterial causes
of foodborne illness in the United States and many countries. Each year
over two million people in the United States are infected with these
bacteria, resulting in tens of thousands of hospitalizations and
hundreds of deaths. Certain populations, such as young children (<5
years), the elderly, and the immunocompromised, are at higher risk for
infection. Most Salmonella and Campylobacter infections are self-
limited, but antimicrobial agents are essential to treat severe
illness. Antimicrobial resistance occurs among bacterial foodborne
pathogens and is recognized as a global public health hazard. NARMS
monitors antimicrobial susceptibility in enteric bacteria from humans,
retail meats, and food-producing animals. The human isolate component
of NARMS was initiated in 1996, and at that time tested only non-
typhoidal Salmonella and Escherichia coli O157 isolates. In 1997,
testing of Campylobacter isolates began, followed by Salmonella
serotype Typhi and Shigella in 1999. The animal component of NARMS
started in 1997, with monitoring of Salmonella isolated from chicken,
turkey, cattle, and swine carcasses, and later expanded to include
Campylobacter (1998), E. coli (2000), and Enterococcus (2003) isolated
from chicken carcasses. The retail meat component of NARMS started in
2002 with testing of Salmonella, Campylobacter, E. coli, and
Enterococcus isolates from meat commodities sold in retail stores.
In addition to monitoring, NARMS conducts epidemiologic and
microbiologic research studies. Some studies examine risk factors and
clinical outcomes of infections with specific bacterial serotypes or
subsets of bacteria that exhibit particular resistance patterns. NARMS
research studies also focus on understanding the genetic mechanisms of
antimicrobial resistance in enteric bacteria and the mechanisms that
permit the transfer of resistance
[[Page 4121]]
between bacteria, on improving methods for isolation and typing, and on
developing new methods for antimicrobial susceptibility testing.
Additionally, NARMS examines enteric bacteria for genetic
interrelatedness using methods such as pulsed-field gel electrophoresis
(PFGE) and multilocus sequence typing. NARMS scientists enter PFGE
results into CDC's PulseNet database or USDA's VetNet database.
In March 2007, an External Subcommittee of the Science Board to FDA
conducted a review of the NARMS program. This subcommittee made
recommendations related to four areas of work performed by NARMS: (1)
Sampling, (2) research, (3) international activities, and (4) data
management and reporting. Included in the report was a recommendation
to develop long-range strategic plans. In September 2008, NARMS held an
interagency planning meeting in Athens, GA to prioritize the Science
Board subcommittee's recommendations and implement measures to address
them. In August 2009, a second meeting was held in Rockville, MD to
report on progress, and to begin formulating the Strategic Plan that is
the subject of this notice.
NARMS has established four strategic goals: (1) To develop,
implement, and optimize a shared database, with advanced data
acquisition, analysis, and reporting tools; (2) to make sampling more
representative and more applicable to trend analysis; (3) to strengthen
collaborative research projects; and (4) to support international
activities that promote food safety, especially those that promote
mitigation of the spread of antimicrobial-resistant bacteria and
resistance determinants. These four goals are discussed more fully in
the Strategic Plan and build on the progress made since NARMS'
inception, with special emphasis on the recommendations made by the FDA
Science Board subcommittee based on its review of the NARMS program in
2007.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
either http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/default.htm or http://www.regulations.gov.
Dated: January 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-1278 Filed 1-21-11; 8:45 am]
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