[Federal Register Volume 61, Number 176 (Tuesday, September 10, 1996)]
[Notices]
[Page 47756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23098]



[[Page 47756]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0222]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

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 
October 10, 1996.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., rm. 10235, 725 17th St. NW., Washington, DC 20503, 
Attention: Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the 
following proposed collection of information to OMB for review and 
clearance: Secs. 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--Reinstatement).
    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 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:

                                        Estimated Annual Reporting Burden                                       
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                                                                                                        Total   
                                     No. of          Annual       Total Annual     Hours     Total   Operating &
         21 CFR Section            Respondents    Frequency per     Responses       per      Hours   Maintenance
                                                    Response                     Response               Costs   
----------------------------------------------------------------------------------------------------------------
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 number 
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: September 3, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-23098 Filed 9-9-96; 8:45 am]
BILLING CODE 4160-01-F