01-5461. Public Health Impact of Vibrio Parahaemolyticus in Raw Molluscan Shellfish; Draft Risk Assessment Document; Availability; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA) published a notice of availability of a draft risk assessment on the relationship between Vibrio parahaemolyticus in raw shellfish and human health in the Federal Register of January 19, 2001 (66 FR 5517). Interested persons were given until March 20, 2001, to comment on the draft risk assessment. Because a public meeting has been scheduled close to the end of the comment period, FDA is extending the comment period until May 21, 2001, in order to allow additional time for public comment.

DATES:

Submit written comments by May 21, 2001.

ADDRESSES:

Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1060, Rockville, MD 20852. Two copies of comments are to be submitted, except that individuals may submit one copy. Comments must be identified with the docket number found in brackets in the heading of this document. Received comments may be reviewed at the Dockets Management branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Sherri B. Dennis, Risk Assessment Coordinator, Center for Food Safety and Applied Nutrition (HFS-032), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-260-3984, FAX [phone], or e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

In the Federal Register of January 19, 2001 (66 FR 5517), FDA announced the availability of a draft risk assessment on the relationship between Vibrio parahaemolyticus in raw molluscan shellfish and human health. Comments were sought on the technical aspects of the draft risk assessment in the following areas: (1) The assumptions made, (2) the modeling technique, (3) the data used, and (4) the transparency of the draft risk assessment document. Interested persons were given until March 20, 2001, to comment on the risk assessment. Because a public meeting to receive comments on the draft risk assessment has been scheduled close to the end of the comment period, FDA is extending the comment period until May 21, 2001, to allow additional time for public comment.

To be considered, written comments must be received by May 21, 2001, by the agency's Dockets Management Branch (address above).

A printed copy of the draft risk assessment may be requested by faxing your name and mailing address with the name of the document you are requesting to the CFSAN Outreach and Information Center at 1-877-366-3322. The documents may be reviewed at the Dockets Management Branch at the address and hours noted above. The draft risk assessment is available electronically as follows: www.cfsan.fda.gov,, www.foodsafety.gov,, and www.foodriskclearinghouse.umd.edu.

Dated: February 28, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.