[Federal Register: June 4, 2004 (Volume 69, Number 108)]
[Page 31617]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0481]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Food Additive 

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: Fax written comments on the collection of information by July 6, 

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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.

Food Additive Petitions--21 CFR Part 571

    Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348 (a)), provides that a food additive shall be deemed 
to be unsafe unless its use is permitted by a regulation which 
prescribes the condition(s) under which it may safely be used, or 
unless it is exempted by regulation for investigational use. Section 
409(b) of the act specifies the information that must be submitted by a 
petition in order to establish the safety of a food additive and to 
secure the issuance of a regulation permitting its use.
    To implement the provision of section 409 of the act, procedural 
regulations have been issued under part 571 (21 CFR part 571). These 
procedural regulations are designed to specify more thoroughly the 
information that must be submitted to meet the requirement set down in 
broader terms by the law. The regulations add no substantive 
requirements to those indicated in the law, but attempt to explain the 
requirements and provide a standard format for submission to speed the 
processing of the petition. Labeling requirements for food additives 
intended for animal consumption are also set forth in various 
regulations contained in 21 CFR parts 572, 573, and 580. The labeling 
regulations are considered by FDA to be cross referenced to Sec.  
571.1, which is the subject of this same OMB clearance for food 
additive petitions.
    In the Federal Register of November 12, 2003 (68 FR 64110), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                            Number of                                           Total Annual     Hours per   Total
     21 CFR Section        Respondents    Annual Frequency     Per Response      Responses       Response    Hours
----------------------------------------------------------------------------------------------------------- -------
571.1(c) moderate                    1                   1                1            1,800         1,800
571.1(c) complex                     1                   1                1            6,000         6,000
571.6                                2                   2                4            1,300         5,200
Total                                4                   4                6            9,100        13,000
\1\ There are no capital costs or operating and maintenence costs associated with this collection of

    Dated: May 27, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12686 Filed 6-3-04; 8:45 am]