[Federal Register Volume 77, Number 113 (Tuesday, June 12, 2012)]
[Notices]
[Pages 34955-34958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0294]


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

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 July 
12, 2012.

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: 202-395-7285, or emailed to [email protected]. 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: Denver Presley, II, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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 Substance Notification Program--21 CFR 170.101, 170.106, 
and 171.1 (Control Number 0910-0495)--Extension

    Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 348(h)) establishes a premarket notification 
process for food contact substances. Section 409(h)(6) of the FD&C 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 FD&C 
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 FD&C Act is necessary to provide 
adequate assurance of safety or (2) FDA and the manufacturer or 
supplier agree

[[Page 34956]]

that an FAP should be submitted. Section 409(h)(1) of the FD&C 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 substance notification (FCN) 
include a completed and signed Form FDA 3480 and (2) a notification for 
a food contact substance formulation include a completed and signed 
Form FDA 3479. These forms serve to summarize pertinent information in 
the notification. The forms facilitate both preparation and review of 
notifications because the forms 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.
    Currently, interested persons transmit an FCN submission to the 
Office of Food Additive Safety in the Center for Food Safety and 
Applied Nutrition using Form FDA 3480 whether it is submitted in 
electronic or paper format. FDA recently made minor revisions to Form 
FDA 3480 to better enable its use for electronic submission and to 
prompt FCN submitters to include certain information in a standard 
format. FDA estimates that the revisions to Form FDA 3480 will not 
change the amount of time necessary to complete the form.
    In addition to its required use with FCNs, revised Form FDA 3480 is 
recommended to be used to organize information within a Pre-
notification Consultation or Master File submitted in support of an FCN 
according to the items listed on the form. Master Files can be used as 
repositories for information that can be referenced in multiple 
submissions to the Agency, thus minimizing paperwork burden for food 
contact substance authorizations. FDA estimates that the amount of time 
for respondents to complete the revised Form FDA 3480 for these types 
of submissions will be 0.5 hours.
    FDA has recently developed a new form, which the Agency recommends 
be used with each submission of additional information (i.e. amendment) 
to an FCN submission currently under Agency review, as well as be used 
to submit an amendment to a Pre-notification Consultation, or for an 
amendment to Master File in support of an FCN, whether submitted in 
electronic format or paper format. New Form FDA 3480A is entitled 
``Amendment to an Existing Food Contact Substance Notification, a Pre-
Notification Consultation, or a Food Master File.'' The form, and 
elements that would be prepared as attachments to the form, can be 
submitted in electronic format. Form FDA 3480A helps the respondent 
organize their submission to focus on the information needed for FDA's 
safety review. FDA estimates that the amount of time for respondents to 
complete the new Form FDA 3480A will be 0.5 hours because the new form, 
used solely for transmitting an amendment, is much shorter than Form 
FDA 3480. Amendments include the following information on new Form FDA 
3480A and in attachments to the form:
     Date of submission;
     Whether the notifier has determined that all files 
provided in an electronic transmission are free of computer viruses;
     Whether the submission is an amendment to an FCN 
submission, a Pre-Notification Consultation, or a Master File;
     The format of the submission (i.e., Electronic Submissions 
Gateway (ESG), transmission on electronic physical media such as CD-ROM 
or DVD, or paper);
     The name of and contact information for the submitter, 
including the identity of the contact person and the company name (if 
applicable);
     The name of and contact information for any agent or 
attorney who is authorized to act on behalf of the notifier; and
     A brief description of the information provided and the 
purpose(s) of the amendment.
    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: The respondents to this information 
collection are manufacturers of food contact substances.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                      Number of
  21 CFR Section or other category          FDA Form No.            Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.106 \2\ (Category A)...........  FDA 3479.................                 5                 1                 5                 2                10
170.101 \3, 7\ (Category B)........  FDA 3480.................                 5                 1                 5                25               125
170.101 \4, 7\ (Category C)........  FDA 3480.................                 5                 2                10               120             1,200
170.101 \5, 7\ (Category D)........  FDA 3480.................                33                 2                66               150             9,900
170.101 \6, 7\ (Category E)........  FDA 3480.................                30                 1                30               150             4,500
Pre-notification Consultation or     FDA 3480.................                60                 1                60               0.5                30
 Master File (concerning a food
 contact substance).\8\

[[Page 34957]]

 
Amendment to an existing             FDA 3480A................                50                 1                50               0.5                25
 notification (170.101), amendment
 to a Pre-notification
 Consultation, or amendment to a
 Master File (concerning a food
 contact substance).\9\
171.1 Indirect Food Additive         N/A......................                 1                 1                 1            10,995            10,995
 Petitions.
Use of Recycled Plastics in Food     N/A......................                10                 1                10                25               250
 Packaging: Chemistry
 Considerations.
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
    Total..........................  .........................  ................  ................  ................  ................            27,035
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Form FDA 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 Form FDA 3480.
\8\ These notifications recommend the submission of Form FDA 3480.
\9\ These notifications recommend the submission of Form FDA 3480A.

    The forms in table 1 of this document, and elements that would be 
prepared as attachments to the forms, may be submitted in electronic 
format through the ESG; email, if appropriate; or may be submitted in 
paper format, or as electronic files on physical media with paper 
signature page. FDA expects that most if not all businesses filing 
these submissions in the next 3 years will choose to take advantage of 
the option of electronic submission. Thus, the burden estimates in 
Table 1 of this document are based on the expectation of 100 percent 
participation in the electronic submission process. The opportunity to 
provide the information in electronic format could reduce the Agency's 
previous estimates for the time to prepare each submission. However, as 
a conservative approach for the purpose of this analysis, FDA is 
assuming that the availability of the revised or new forms and the 
opportunity to submit the information in electronic format will have no 
effect on the average time to prepare a submission.
    These estimates are based on FDA's experience with the food contact 
substance notification program. 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 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 Form FDA 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 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 5 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 two 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 one 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.
    Based on the submissions received, FDA estimates that 60 
respondents will submit information to a Pre-notification Consultation 
or a Master File in support of FCN submission using Form FDA 3480. FDA 
estimates the reporting burden to be 0.5 hours per response, for a 
total burden of 30 hours.
    Based on the submissions received, FDA estimates that 50 
respondents will submit an amendment (Form FDA 3480A) to a substantive 
or non-substantive request of additional information to an incomplete 
FCN submission, for an amendment to a Pre-notification Consultation, or 
for an amendment to a Master File in support of an FCN. FDA estimates 
the reporting burden to be 0.5 hours per response, for a total burden 
of 25 hours.
    Based on the submissions received, FDA estimates that one 
respondent will submit one indirect food additive petition under Sec.  
171.1, for a total of one response. FDA estimates the reporting burden 
to be 10,995 hours per response, for a total burden of 10,995 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

[[Page 34958]]

burden to be 25 hours per response, for a total burden of 250 hours.
    As noted, FDA estimates that all of the future Forms FDA 3479, 
3480, and 3480A submissions will be made electronically through the 
ESG. While FDA does not charge for the use of the ESG, FDA requires 
respondents to obtain a public key infrastructure certificate in order 
to set up the account. This can be obtained in-house or outsourced by 
purchasing a public key certificate that is valid for 1 year to 3 
years. The certificate typically costs from $20 to $30.

    Dated: June 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14227 Filed 6-11-12; 8:45 am]
BILLING CODE 4160-01-P