[Federal Register Volume 64, Number 130 (Thursday, July 8, 1999)]
[Notices]
[Page 36885]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-17242]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


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 (the PRA).

DATES: Submit written comments on the collection of information by 
August 9, 1999.

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: 
Wendy Taylor, 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 section 3507 of the PRA 
(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's 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.
    In the Federal Register of April 12, 1999 (64 FR 17672), the agency 
requested comments on the proposed collections of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                                       Total
                      No. of          Annual       Total Annual      Hours per                      Operating &
 21 CFR Section     Respondents    Frequency per     Responses       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                                                                               9,330
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\1\ There are no capital costs associated with this collection of information.

    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 + x $3,000 listing fees = $14,200).

    Dated: June 30, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-17242 Filed 7-7-99; 8:45 am]
BILLING CODE 4160-01-F