[Federal Register: June 7, 2005 (Volume 70, Number 108)]
[Page 33180-33181]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0209]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Food Contact Substances Notification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
associated with the Food Contact Substances Notification System.

DATES: Submit written or electronic comments on the collection of 
information by August 8, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857,301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (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, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

Food Contact Substances Notification System--21 CFR 170.101 and 
170.106--(OMB Control Number 0910-0495)--Extension

    Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(h)) establishes a premarket notification process 
for food contact substances. Section 409(h)(6) of the act defines a 
``food contact substance'' as ``any substance intended for use as a 
component of materials used in manufacturing, packing, packaging, 
transporting, or holding food if such use is not intended to have any 
technical effect in such food.'' Section 409(h)(3) of the act requires 
that the notification process be used for authorizing the marketing of 
food contact substances except where FDA determines that the submission 
and premarket review of a food additive petition (FAP) under section 
409(b) of the act is necessary to provide adequate assurance of safety 
or where FDA and the manufacturer or supplier agree that an FAP should 
be submitted. Section 409(h)(1) of the act requires that a notification 
include information on the identity and the intended use of the food 
contact substance and the basis for the manufacturer's or supplier's 
determination that the food contact substance is safe under the 
intended conditions of use.
    Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101 
and 170.106) require that a food contact notification (FCN) include FDA 
Form 3480 entitled ``Notification for New Use of a Food Contact 
Substance'' and that a notification for a food contact substance 
formulation include FDA Form 3479 entitled ``Notification for a Food 
Contact Substance Formulation.'' These forms will serve to summarize 
pertinent information in the notification. FDA believes that these 
forms will facilitate both preparation and review of notifications 
because the forms will serve to organize information necessary to 
support the safety of the use of the food contact substance. The burden 
of filling out the appropriate form has been included in the burden 
estimate for the notification.

[[Page 33181]]

    Description of Respondents: Manufacturers of food contact 
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                     No. of                    Annual Frequency     Total Annual        Hours per
                 21 CFR Section                    Respondents       Form        per Response        Responses           Response         Total Hours
170.106\2\ (Category A)                                       5     FDA 3479                  1                  5                  2                 10
170.101 \3,7\ (Category B)                                    5     FDA 3480                  1                  5                 25                125
170.101 \4,7\ (Category C)                                    5     FDA 3480                  2                 10                120              1,200
170.101 \5,7\ (Category D)                                   33     FDA 3480                  2                 66                150              9,900
170.101 \6,7\ (Category E)                                   30     FDA 3480                  1                 30                150              4,500
  Total                                                                                                                                           15,735
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Notifications for food contact substance formulations and food contact articles. These notifications require the submission of FDA Form 3479
  (``Notification for a Food Contact Substance Formulation'') only.
\3\ Duplicate notifications for uses of food contact substances.
\4\ Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
\5\Notifications for uses that are the subject of moderately complex food additive petitions.
\6\ Notifications for uses that are the subject of very complex food additive petitions.
\7\ These notifications require the submission of FDA Form 3480.

    These estimates are based on FDA's experience with the food contact 
substances notification system.
     Based on input from industry sources, FDA estimates that 
the agency will receive approximately five notifications annually for 
food contact substance formulations.
     FDA also has included five expected duplicate submissions 
in the second row of table 1 of this document. FDA expects that the 
burden for preparing these notifications primarily will consist of the 
manufacturer or supplier filling out FDA Form 3480, verifying that a 
previous notification is effective, and preparing necessary 
     Based on the submissions received, FDA identified three 
other tiers of FCNs that represent escalating levels of burden required 
to collect information (the third, fourth and fifth rows of table 1 of 
this document).
     FDA estimated the median number of hours necessary for 
collecting information for each type of notification within each of the 
three tiers based on input from industry sources.

    Dated: May 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11265 Filed 6-6-05; 8:45 am]