[Federal Register Volume 61, Number 109 (Wednesday, June 5, 1996)]
[Proposed Rules]
[Pages 28524-28525]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14053]



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[[Page 28525]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 70, 73, 74, 80, 81, 82, 101, 178, 201, and 701

[Docket Nos. 79N-0043 and 92N-0334]


Permanent Listing of Color Additive Lakes; 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 is extending to August 3, 
1996, the comment period for a proposed rule that published March 4, 
1996 (61 FR 8372). The document proposed to list certain color additive 
lakes permanently as suitable and safe for use in foods, drugs, and 
cosmetics. FDA is taking this action in response to a request for 
additional time to review and understand the details of the proposed 
rule.

Dates: Written comments by August 3, 1996.

Addresses: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857. Process descriptions, identity information for anions in 
precipitants, and ingredient specifications for substrata (including 
rosin), and rosin samples to the Colors Technology Branch (HFS-126), 
Food and Drug Administration, 200 C St. SW., Washington, DC 20204.

For Further Information Contact:
    Regarding proposed certification procedures and proposed product 
ingredient declarations: Julie N. Barrows, Center for Food Safety and 
Applied Nutrition (HFS-105), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-205-4662.
    Regarding other issues: Arthur L. Lipman, Center for Food Safety 
and Applied Nutrition (HFS-217), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3073.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 4, 1996 (61 
FR 8372), FDA issued a proposed rule to list certain color additive 
lakes permanently as suitable and safe for use in foods, drugs, and 
cosmetics. The proposed rule modified a July 21, 1995, proposed rule 
regarding label declaration of FD&C Yellow No. 6 (60 FR 37611). 
Interested persons were given until June 3, 1996, to submit written 
comments on the proposal.
    The agency has received a request from the Cosmetic, Toiletry, and 
Fragrance Association (CTFA) for an extension of the comment period for 
the proposal. Although FDA's general policy is not to extend such 
comment periods so that necessary regulations can be issued as 
expeditiously as possible, in this case the agency agrees that the 
requestor and others may need additional time to study the 
ramifications of this complex proposal in order to submit meaningful 
comments. Therefore, after careful consideration, FDA is extending the 
comment period for the proposal for an additional 60 days, until August 
3, 1996.
    Interested persons may, on or before August 3, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Four copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number of the rulemaking or rulemakings to which the 
comment is relevant. As stated in the March 4, 1996, proposed rule (61 
FR 8372 at 8406), comments on modifications to the July 21, 1995 (60 FR 
37611), proposal regarding label declaration of FD&C Yellow No. 6 
should be identified with both docket numbers found in brackets in the 
heading of this document; comments on other aspects of the proposed 
rule should be identified with docket number 79N-0043 only. Received 
comments may be seen in the office above between 9 a.m. and 4 p.m., 
Monday through Friday.
    In addition, interested persons may, on or before August 3, 1996, 
submit to the Office of Cosmetics and Colors (address above) written 
comments containing process information relating to the identity and 
current use of substrata (including rosin) in lakes, and samples of 
such substrata. Written comments regarding the use of anions other than 
chloride and sulfate in precipitants may also be submitted to this 
address. Two copies of each comment and one 5-pound sample are to be 
submitted, and each submission is to be identified with the docket 
number (79N-0043) found in brackets in the heading of this document.

    Dated: May 29, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-14053 Filed 5-31-96; 12:12 pm]
BILLING CODE 4160-01-F