[Federal Register Volume 69, Number 189 (Thursday, September 30, 2004)]
[Proposed Rules]
[Page 58371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22013]



[[Page 58371]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 170

[Docket No. 2001N-0234]


Food Additives: Food Contact Substance Notification System; 
Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; withdrawal.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal of our advance notice of proposed rulemaking (ANPRM) 
published in the Federal Register of May 21, 2002 (67 FR 35764). The 
ANPRM requested input on whether the agency should establish 
regulations permitting the licensing of the rights to manufacture and 
market a food contact substance (FCS) for a use that is the subject of 
an effective food contact notification (FCN). FDA is withdrawing the 
ANPRM based upon comments indicating that such a regulation would not 
be necessary.

DATES: The advance notice of proposed rulemaking is withdrawn September 
30, 2004.

FOR FURTHER INFORMATION CONTACT: Kenneth McAdams, Center for Food 
Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3392, e-
mail: [email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of May 21, 2002 (67 
FR 35764), FDA published an ANPRM requesting input on whether the 
agency should establish regulations permitting the licensing of the 
rights to manufacture and market an FCS for a use that is the subject 
of an effective FCN. We received five comments on the ANPRM. Three of 
the comments, from individuals, concerned unrelated issues and did not 
address the ANPRM. The other two comments, from the American Plastics 
Council and the Society of the Plastics Industry, stated that a 
procedure to transfer or license the rights to an FCN is not needed 
because of the speed and efficiency of the current FCN system. Both 
comments also stated that if regulations for such a procedure are 
issued, they should be kept simple, requiring only notification that 
the transfer has occurred.
    After careful consideration of these comments, FDA has concluded 
that a procedural regulation for transferring or licensing the rights 
to an FCN is not needed. Therefore, FDA is withdrawing our ANPRM.

    Dated: September 17, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-22013 Filed 9-29-04; 8:45 am]
BILLING CODE 4160-01-S