[Federal Register Volume 66, Number 119 (Wednesday, June 20, 2001)]
[Notices]
[Pages 33101-33102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15441]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-1075]


Public Health Impact of Vibrio Parahaemolyticus in Raw Molluscan 
Shellfish; Draft Risk Assessment Document; Availability; Reopening of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until July 
18, 2001, the comment period on its draft risk assessment on the 
relationship between Vibrio parahaemolyticus in raw molluscan shellfish 
and human health (66 FR 5517, January 19, 2001). Interested persons 
were initially given until March 20, 2001, with an extension to May 21, 
2001 (66 FR 13546, March 6, 2001), to comment on the draft risk 
assessment. This reopening of the comment period is in response to a 
request from the National Fisheries Institute (NFI) on behalf of the 
Gulf Oyster Industry Council, the Pacific Coast Shellfish Growers 
Association, and the Molluscan Shellfish Institute. The agency does not 
anticipate further extensions of the comment period for this draft risk 
assessment.

DATES: Submit written comments by July 18, 2001.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
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-32), 
Food and Drug Administration, 200 C St., SW., Washington, DC 20204, 
202-260-3984, FAX 202-260-9653, e-mail: [email protected].

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 draft risk 
assessment. In the Federal Register of March 6, 2001, FDA extended the 
comment period to May 21, 2001 (66 FR 13546), because a public meeting 
to receive comments on the document was scheduled for March 20, 2001 
(March 6, 2001, 66 FR 13544), the same day the comment period closed. 
The NFI, on behalf of the Gulf Oyster Industry Council, the Pacific 
Coast Shellfish Growers Association, and the Molluscan Shellfish 
Institute, has requested a second extension of the comment period to 
allow additional time to review, analyze, and constructively respond to 
the draft risk assessment. The extended comment period closed on May 
21, 2001. FDA, in response to the NFI request, is

[[Page 33102]]

reopening the comment period until July 18, 2001. The agency does not 
anticipate further extensions of the comment period for this draft risk 
assessment.
    You must submit written comments to the Dockets Management Branch 
(address above) by July 18, 2001, in order for those comments to be 
considered.
    A printed copy of the draft risk assessment and/or a CD-ROM of the 
risk assessment model may be requested by faxing your name and mailing 
address with the names of the documents 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 also available electronically 
at www.cfsan.fda.gov, www.foodsafety.gov, and 
www.foodriskclearinghouse.umd.edu.

    Dated: June 12, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15441 Filed 6-19-01; 8:45 am]
BILLING CODE 4160-01-S