[Federal Register Volume 66, Number 63 (Monday, April 2, 2001)]
[Proposed Rules]
[Page 17517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7996]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 66, No. 63 / Monday, April 2, 2001 / Proposed 
Rules  

[[Page 17517]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 192 and 592

[Docket No. 00N-1396]
RIN 0910-AC15


Premarket Notice Concerning Bioengineered Foods; Extension of 
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to May 3, 
2001, the comment period for a proposed rule published in the Federal 
Register of January 18, 2001. The proposed rule would require the 
submission to the agency of data and information regarding plant-
derived bioengineered foods that would be consumed by humans or 
animals. This action is being taken in response to a request for more 
time to submit comments to FDA.

DATES: Submit written comments on the proposed rule by May 3, 2001.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, or via e-mail to [email protected]. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document.

FOR FURTHER INFORMATION CONTACT:
Regarding human food issues: Linda S. Kahl, Center for Food Safety and 
Applied Nutrition (HFS-206), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-418-3101.
Regarding animal feed issues: William D. Price, Center for Veterinary 
Medicine (HFV-200), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6652.

SUPPLEMENTARY INFORMATION:

I. Extension of Comment Period

    In the Federal Register of January 18, 2001 (66 FR 4706), FDA 
published a proposed rule that, if finalized, would require the 
submission to the agency of data and information regarding plant-
derived bioengineered foods that would be consumed by humans or 
animals. FDA proposed that this submission be made at least 120 days 
prior to the commercial distribution of such foods. FDA took this 
action to ensure that it would have the appropriate amount of 
information about bioengineered foods to help to ensure that all market 
entry decisions by the industry are made consistently and in full 
compliance with the law. The proposed action would permit the agency to 
assess on an ongoing basis whether plant-derived bioengineered foods 
comply with the standards of the Federal Food, Drug, and Cosmetic Act.
    In the January 18, 2001, proposed rule, FDA announced that the 
timeframe for public comments would be 75 days from the date of 
publication in the Federal Register. On March 15, 2001, FDA received a 
request to allow an additional 60 days for interested persons to 
comment. In the requester's view, the time period of 75 days was 
insufficient to prepare thoughtful and responsive comments in light of 
the variety of difficult legal, procedural, and scientific issues 
raised by the proposed rule.
    FDA believes that an extension of the comment period is appropriate 
given the variety of legal, procedural, and scientific issues raised by 
the proposed rule. However, FDA does not agree that an additional 60 
days is warranted, because FDA announced its intent to conduct this 
rulemaking more than 8 months prior to publication of the proposed rule 
(Ref. 1). Therefore, FDA is extending the comment period for an 
additional 30 days, until May 3, 2001. This extension will provide the 
public with a total of 105 days to submit comments.

II. How to Submit Comments

    You may submit to the Dockets Management Branch (address above) 
written comments regarding the proposed rule by May 3, 2001. You must 
submit two copies of any comments, except that if you are an individual 
you may submit one copy. You must identify comments with the docket 
number found in brackets in the heading of this document. You may view 
received comments in the Dockets Management Branch between 9 a.m. and 4 
p.m., Monday through Friday.
    You may also send comments to the Dockets Management Branch via e-
mail to [email protected]. You should annotate and organize your 
comments to identify the specific issues to which they refer.

III. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Press Release, U.S. Department of Health and Human Services, 
``FDA to Strengthen Pre-market Review of Bioengineered Foods,'' May 
3, 2000, available at http://vm.cfsan.fda.gov.

    Dated: March 27, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-7996 Filed 3-30-01; 8:45 am]
BILLING CODE 4160-01-S