[Federal Register Volume 67, Number 115 (Friday, June 14, 2002)]
[Notices]
[Pages 40947-40948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15043]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0054]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Labeling Requirements for Color Additives 
(Other Than Hair Dyes) and Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by July 
15, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Labeling Requirements for Color Additives (Other Than Hair Dyes)--21 
CFR 70.25 and Petitions--21 CFR 71.1 (OMB Control Number 0910-0185)--
Extension

    Section 721(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 379e(a)) provides that a color additive shall be deemed 
to be unsafe unless the additive and its use are in conformity with a 
regulation that describes the condition(s) under which the additive may 
safely be used, or unless the additive and its use conform to the terms 
of an exemption for investigational use issued under section 721(f) of 
the act. Color additive petitions are submitted by individuals or 
companies to obtain approval of a new color additive or a change in the 
conditions of use permitted for a color additive that is already 
approved. Section 71.1 (21 CFR 71.1) specifies the information that a 
petitioner must submit in order to establish the safety of a color 
additive and to secure the issuance of a regulation permitting its use.
    FDA scientific personnel review color additive petitions to ensure 
that the intended use of the color additive in or on food, drugs, 
cosmetics, and medical devices is suitable and safe. Color additive 
petitions were specifically provided for by Congress when it enacted 
the Color Additive Amendments of 1960 (Public Law 94-295). If FDA 
stopped accepting color additive petitions or stopped requiring them to 
contain the information specified in Sec. 71.1, there would be no way 
to bring new uses of listed color additives or new color additives to 
market. FDA's color additive labeling requirements in Sec.  70.25 (21 
CFR 70.25) require that color additives that are to be used in food, 
drugs, devices, or cosmetics be labeled with sufficient information to 
ensure their safe use.
    Respondents are businesses engaged in the manufacture or sale of 
color additives for use in food, drugs, cosmetics, or medical devices.
    In the Federal Register of February 28, 2002 (67 FR 9297), the 
agency requested comments on the proposed collection of information. No 
comments were received that pertained to this collection of 
information.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                                                      Total Operating
              21 CFR Section                    No. of       Annual Frequency    Total Annual   Hours per Response    and Maintenance      Total Hours
                                              Respondents      per Response        Responses                               Costs
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70.25                                             0                 1                 0                 0                   0                  0
71.1                                              3                 1                 3             2,000              $8,600              6,000
Total                                                                                                                                      6,000
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\1\ There are no capital costs associated with this collection of information.

    This estimate is based on the number of new color additive 
petitions received in fiscal year 2000 and the total hours expended by 
petitioners to prepare the petitions. Although the burden varies with 
the type of petition submitted, a color additive petition involves 
analytical work and appropriate toxicology studies, as well as the work 
of drafting the petition itself. Because labeling requirements under 
Sec. 70.25 for a particular color additive involve information required 
as part of the color additive petition safety review process, the 
estimate for the number of respondents is the same for Sec. 70.25 as 
for Sec. 71.1, and the burden hours for labeling are included in the 
estimate for Sec. 71.1.
    Color additives are subjected to payment of fees for the 
petitioning

[[Page 40948]]

process. The listing fee for a color additive petition ranges from 
$1,600 to $3,000, depending on the intended use of the color and the 
scope of the requested amendment. A complete schedule of fees is set 
forth in 21 CFR 70.19. An average of one category A and two category B 
color additive petitions are expected per year. The maximum color 
additive petition fee for a category A petition is $2,600 and the 
maximum color additive petition fee for a category B petition is 
$3,000. Since an average of three color additive petitions are expected 
per calendar year, the estimated total annual cost burden to 
petitioners for this start-up cost would be less than or equal to 
$8,600.

    Dated: May 23, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15043 Filed 6-13-02; 8:45 am]
BILLING CODE 4160-01-S