[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
----------------------------------------------------------------------------------------------------------------
Total
No. of Annual Total Annual Hours per Operating &
21 CFR Section Respondents Frequency per Responses Response Total Hours Maintenance
Response Costs
----------------------------------------------------------------------------------------------------------------
70.25 5 1 5
71.1 5 1 5 1,866 9,330 $14,200
Total 9,330
----------------------------------------------------------------------------------------------------------------
\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
