
[Federal Register: August 27, 2008 (Volume 73, Number 167)]
[Notices]               
[Page 50628-50630]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27au08-52]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Agency Information Collection Activities; Proposed Collection; 
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 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

[[Page 50629]]

with the Food Contact Substances Notification System.

DATES:  Submit written or electronic comments on the collection of 
information by October 27, 2008.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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:  Jonna Capezzuto, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3794.

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, 170.106, 
and 171.1 (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 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                        No. of        Annual Frequency     Total Annual      Hours per
           21 CFR Section                       Form No.              Respondents       per Response         Responses       Response       Total Hours
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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         .............................               2                     2               2          10,995          21,990
 Petitions
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[[Page 50630]]


Guidance
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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.
    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 ten 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: August 20, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-19843 Filed 8-26-08; 8:45 am]

BILLING CODE 4160-01-S
