[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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