2011-1278. The National Antimicrobial Resistance Monitoring System Strategic Plan 2011-2015; Request for Comments

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments.

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: [e-mail].

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 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.