
[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]               
[Page 73936-73938]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de08-41]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0454]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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 January 
5, 2009.

ADDRESSES:  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: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0495. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT:  Jonna Capezzuto, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3794.

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--(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

[[Page 73937]]

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 when: (1) 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 (2) 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: (1) Information on the identity and the 
intended use of the food contact substance and (2) 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) specify the information that a notification must contain 
and require that: (1) A food contact notification (FCN) include FDA 
Form 3480 entitled ``Notification for New Use of a Food Contact 
Substance'' and (2) 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.
    Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the 
information that a petitioner must submit in order to: (1) Establish 
that the proposed use of an indirect food additive is safe and (2) 
secure the publication of an indirect food additive regulation in parts 
175 through 178 (21 CFR parts 175 through 178). Parts 175 through 178 
describe the conditions under which the additive may be safely used.
    In addition, FDA's guidance document entitled ``Use of Recycled 
Plastics in Food Packaging: Chemistry Considerations'' provides 
assistance to manufacturers of food packaging in evaluating processes 
for producing packaging from post-consumer recycled plastic. The 
recommendations in the guidance address the process by which 
manufacturers certify to FDA that their plastic products are safe for 
food contact.
    Description of Respondents: Manufacturers of food contact 
substances.
    In the Federal Register of August 27, 2008 (73 FR 50628), 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 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                           Annual
                 21 CFR Section                        Form No.           No. of       Frequency per     Total Annual      Hours per       Total Hours
                                                                       Respondents        Response        Responses         Response
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170.106 \2\ (Category A)                                   FDA 3479                5                1                5                2               10
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170.101 \3,7\ (Category B)                                 FDA 3480                5                1                5               25              125
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170.101 \4,7\ (Category C)                                 FDA 3480                5                2               10              120            1,200
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170.101 \5,7\ (Category D)                                 FDA 3480               33                2               66              150            9,900
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170.101 \6,7\ (Category E)                                 FDA 3480               30                1               30              150            4,500
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171.1 Indirect Food Additive Petitions            .................                2                2                2           10,995           21,990
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Guidance, ``Use of Recycled Plastics in Food      .................               10                1               10               25              250
 Packaging: Chemistry Considerations''
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Total                                                                                                                                             37,975
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\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 approximately five respondents will submit one 
notification annually for food contact substance formulations (Form FDA 
3479), for a total of five responses. FDA estimates the reporting 
burden to be 2.0 hours per response, for a total burden of 10 hours. 
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 
documentation. Thus, FDA estimates that five respondents will submit 
one such submission annually, for a total of five responses. FDA 
estimates the reporting burden to be 25.0 hours per response, for a 
total burden of 125 hours.

[[Page 73938]]

    Based on the submissions received, FDA identified three other tiers 
of FCNs that represent escalating levels of burden required to collect 
information (denoted as Categories C, D, and E in 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. FDA estimates that five respondents will submit two 
Category C submissions annually, for a total of 10 responses. FDA 
estimates the reporting burden to be 120 hours per response, for a 
total burden of 1,200 hours. FDA estimates that 33 respondents will 
submit 2 Category D submissions annually, for a total of 66 responses. 
FDA estimates the reporting burden to be 150 hours per response, for a 
total burden of 9,900 hours. FDA estimates that 30 respondents will 
submit 1 Category E submission annually, for a total of 30 responses.
    FDA estimates the reporting burden to be 150 hours per response, 
for a total burden of 4,500 hours.
    FDA estimates that two respondents will submit one indirect food 
additive petition under Sec.  171.1, for a total of two responses. FDA 
estimates the reporting burden to be 10,995 hours per response, for a 
total burden of 21,990 hours.
    FDA estimates that 10 respondents will utilize the recommendations 
in the guidance document entitled ``Use of Recycled Plastics in Food 
Packaging: Chemistry Considerations,'' to develop the additional 
information for one such submission annually, for a total of 10 
responses. FDA estimates the reporting burden to be 25 hours per 
response, for a total burden of 250 hours.

    Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28694 Filed 12-3-08; 8:45 am]

BILLING CODE 4160-01-S
