Listeria Monocytogenes Guidance Documents
April 16, 2008
FDA recently announced the availability for public comment of two draft guidance documents regarding Listeria monocytogenes (73 FR 7293; February 7, 2008). One document is entitled "Compliance Policy Guide Sec. 555.320 Listeria monocytogenes" (the draft CPG) (Docket No. FDA-2008-D-0058). The second document is entitled "Guidance for Industry: Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods" (the draft Guidance for Industry) (originally Docket No. 2007D-0474; now Docket FDA-2008-D-0096). We also announced a public meeting, to be held on March 28, 2008, to discuss the draft CPG (73 FR 7298; February 7, 2008).
When we announced the availability of the draft guidance documents and of the public meeting, we requested comment on the two draft documents. Although you may comment on any FDA guidance document at any time (see 21 CFR 10.115(g)(5)), the Notice of Availability (NOA) for FDA’s draft Compliance Policy Guide on Listeria monocytogenes requested that written or electronic comments on the draft guidance be submitted by April 7, 2008 (the NOA date) (73 FR 7293; February 7, 2008). In that NOA, we advised that written comments should be submitted to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and that electronic comments should be submitted to http://www.regulations.gov.
At the March 28, 2008, FDA public meeting, we noted that we do not expect to finalize the draft CPG until there has been a reasonable time for the public to access the transcript, and emphasized that comments on a FDA guidance document may be submitted at any time, including after the date identified in the corresponding NOA. Given the relationship between the draft CPG and the draft Guidance for Industry, we would expect to finalize the Guidance for Industry after the same period of access.
FDA subsequently learned that the time frame for submitting electronic comments ordinarily closes on the NOA date. After the NOA date, the customary process has been to submit comments in writing to the Division of Dockets Management at the address noted above.
On April 14, 2008, FDA implemented a new process to enable stakeholders to continue to submit electronic comments on guidance documents after the NOA date. To submit comments on the draft CPG at www.regulations.gov, go to Document FDA-2008-D-0058-0005 (Compliance Policy Guide Sec. 555.320 Listeria monocytogenes - Draft Guidance) and click on the icon "Send a Comment or Submission." To submit comments on the draft Guidance to Industry at www.regulations.gov, go to Document FDA-2008-D-0096-0002 (Guidance for Industry - Control of Listeria monocytogenes in Refrigerated or Frozen Ready-To-Eat Foods - Draft Guidance) and click on the icon "Send a Comment or Submission."
FDA apologizes for any inconvenience due to the closure of the electronic portal during April 8 – 13, 2008.
Please direct any questions about this Update to Mary.Losikoff@fda.hhs.gov or call 301-436-1412.