[Federal Register Volume 67, Number 40 (Thursday, February 28, 2002)]
[Notices]
[Pages 9297-9298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-4859]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0054]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on requirements relating to the 
approval and labeling of color additives.

DATES: Submit written or electronic comments on the collection of 
information by April 29, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane., rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-26; Rockville, MD 20857, 
301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed extension of a collection of 
information including each proposed extension of an existing collection 
of information, before submitting the collection to OMB for approval. 
To comply with this requirement, FDA is publishing notice of the 
proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Labeling Requirements for Color Additives (other than hair dyes)--
21 CFR 70.25 and Petitions--21 CFR 71.1 (OMB Control No. 0910-
01850--Extension

    Section 721(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 379e) 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden \1\
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                                                   Annual Frequency per      Total Annual      Average Hours per     Total Operating &
    21 CFR Section        No. of Respondents             Response              Responses            Response         Maintenance Costs     Total Hours
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70.25                                        3                         1                 3                                                            3
71.1                                         3                         1                 3                  2,000               $8,600            6,000

[[Page 9298]]

 
  Total                                                                                  3                                      $8,600            6,003
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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 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: February 22, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-4859 Filed 2-27-02; 8:45 am]
BILLING CODE 4160-01-S