[Federal Register Volume 61, Number 45 (Wednesday, March 6, 1996)]
[Notices]
[Pages 8960-8961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5212]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0288]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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, 
Federal agencies are required to publish a notice in the Federal 
Register concerning each 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 May 6, 1996.

ADDRESSES: Submit written comments on the information collection 
requirements to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All 
comments should be identified with the docket number found in brackets 
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Mark L. Pincus, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-443-4055.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (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. ``Collection of information'' 
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information listed below.
    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.
Sections 70.25 Labeling requirements for color additives (other than 
hair dyes) (21 CFR 70.25) and 71.1 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) 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 approved 
already. Section 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 require 
that color additives that are to be used in foods, drugs, devices, or 
cosmetics be 

[[Page 8961]]
labeled with sufficient information to ensure their safe use.
    FDA estimates the burden of complying with the information 
collection provisions of the agency's color additive regulations as 
follows:

                                                                                                                                                        
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                                                            Estimated Annual Reporting Burden                                                           
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                                           Annual Frequency per       Total Annual                                                Total Operating &     
 21 CFR Section    No. of Respondents            Response              Responses        Hours Per Response     Total Hours        Maintenance Costs     
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70.25            2                       1                         2                  .....................  ..............  ...........................
71.1             2                       1                         2                  1,700                  3,415           $6,000                     
Total            2                       ........................  .................  .....................  3,415           $6,000                     
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There are no capital costs associated with this collection.                                                                                             

    This estimate is based on the number of new color additive 
petitions received in 1994. 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.

    Dated: February 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-5212 Filed 3-5-96; 8:45 am]
BILLING CODE 4160-01-F