[Federal Register Volume 64, Number 69 (Monday, April 12, 1999)]
[Notices]
[Pages 17672-17673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8954]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0670]


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 a notice in the 
Federal Register concerning each collection of information, including 
each proposed extension of an existing collection of information, and 
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 comments on the information collection 
requirements by June 8, 1999.

ADDRESSES: 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, 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 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 Number 0910-0185--
Extension)
     Description: 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 (Pub. L. 94-295). If FDA stopped 
accepting color additive petitions or stopped requiring them to contain 
the information specified in Sec. 71.1, the number of new color 
additives approved would decrease.
     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.
    Description of Respondents: Business or other for profit.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                                                                       Total
                      No. of          Annual       Total Annual    Average Hours                    Operating &
 21 CFR Section     Respondents    Frequency per     Responses     per Response     Total Hours     Maintenance
                                     Response                                                          Costs
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70.25                   5               1               5
71.1                    5               1               5           1,866           9,330         $14,200
Total                   5                               5                           9,330         $14,200
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\1\ There are no capital costs associated with this collection of information.


[[Page 17673]]

     This estimate is based on the average number of new color additive 
petitions received in 1997 and 1998. 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 two Category A and 
three 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. Because an average of five color additive petitions are 
expected per calendar year, the estimated total annual cost burden to 
petitioners for this startup cost would be less than or equal to 
$14,200 (2 x $2,600 + 3 x $3,000 listing fees = $14,200).

    Dated: April 5, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-8954 Filed 4-9-99; 8:45 am]
BILLING CODE 4160-01-F