Jason P. Folster - Comment

Document ID: FDA-2012-N-1037-0015
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: June 27 2013, at 12:00 AM Eastern Daylight Time
Date Posted: July 1 2013, at 12:00 AM Eastern Standard Time
Comment Start Date: June 12 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: August 12 2013, at 11:59 PM Eastern Standard Time
Tracking Number: 1jx-8650-pt92
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This comment relates to a paragraph that begins at the bottom of page 24: "My only concern is in the G. Enterobacteriaceae section, the wording suggests that increases in antimicrobial resistance have been seen in Shigella only abroad and in “certain isolates” of Salmonella. There are plenty of examples of increased resistance in Shigella seen in the U.S and I think it would be best to generalize increases in resistance in Salmonella in general. I have made edits to the attached document and suggested a few references. " Here is the paragraph with suggested edits that begins on page 24 of the proposed regulation: "Antimicrobial resistance is already a problem for many genera in this family. For example, enteropathic E. coli strains “are often resistant to multiple antibiotics” (Ref. 4 at p. 2824 (internal citation omitted)) and “resistant mutants are already present in most patients with Enterobacter infections before initiation of therapy” (Ref. 4 at p. 2827). Increased resistance in Shigella strains has been well documented in the U.S (NARMS or Sjölund Karlsson M Outbreak of Infections caused by Shigella sonnei with Reduced Susceptibility to Azithromycin, United States. AAC. 2012 or Wong et al. Antimicrobial resistance trends of Shigella serotypes in New York City, 2006-2009. Microb Drug Resist. 2010) and abroad (Ref. 44), as has increased resistance in Salmonella (NARMS or Alcaine et al. Antimicrobial resistance in nontyphoidal Salmonella). J Food Prot. 2007, Ref. 45). “In addition, nosocomial isolates [of Klebsiella pneumoniae] are frequently resistant to numerous” antibacterial drugs “as a result of the acquisition of multidrug-resistant plasmids. For example, K. pneumoniae is one of the most common organisms to carry plasmids encoding extended-spectrum [beta]-lactamases, and bacteremia with such strains is associated with higher rates of treatment failure and death” (Ref. 4 at p. 2826 (internal citation omitted)).

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Total: 2
Jason P. Folster - Comment
Public Submission    Posted: 07/01/2013     ID: FDA-2012-N-1037-0015

Aug 12,2013 11:59 PM ET
Marla Kathleen Cheezem, RN - Comment
Public Submission    Posted: 06/24/2013     ID: FDA-2012-N-1037-0014

Aug 12,2013 11:59 PM ET