[Federal Register: October 24, 2005 (Volume 70, Number 204)]
[Page 61452-61453]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0209]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Food Contact Substances Notification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 23, 2005.

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

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 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

[[Page 61453]]

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.
    Description of Respondents: Manufacturers of food contact 
    In the Federal Register of June 7, 2005 (70 FR 33180), 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\
  21 CFR                                Annual Frequency per   Total Annual
 Section    No. of Respondents    Form        Response          Responses     Hours per Response    Total Hours
170.106\2                  5     FDA                    1              5                     2             10
 \                                3479
170.101\3                  5     FDA                    1              5                    25            125
 ,7\                              3480
170.101\4                  5     FDA                    2             10                   120          1,200
 ,7\                              3480
170.101\5                 33     FDA                    2             66                   150          9,900
 ,7\                              3480
170.101\6                 30     FDA                    1             30                   150          4,500
 ,7\                              3480
Total      ....................  .....  ....................  .............  ....................      15,735
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
\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
\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: October 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-21155 Filed 10-21-05; 8:45 am]