[Federal Register: June 14, 2002 (Volume 67, Number 115)]
[Notices]
[Page 40947-40948]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jn02-88]
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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