[Federal Register Volume 77, Number 63 (Monday, April 2, 2012)]
[Notices]
[Pages 19670-19672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7764]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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 Substance Notification Program, 
including revisions to Form FDA 3480, new Form FDA 3480A, and 
electronic submission via the Electronic Submission Gateway (ESG).

DATES: Submit either electronic or written comments on the collection 
of information by May 29, 2012.

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: 
    With regard to the information collection: Denver Presley, Jr., 
Office of Information Management, Food and Drug Administration, 1350 
Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-3793.
    With regard to the Food Contact Substance Notification Program: 
Kenneth A. McAdams, Center for Food Safety and Applied Nutrition, Food 
and Drug Administration, 5100 Paint Branch Pkwy (HFS-275), College 
Park, MD 20740, 240-402-1224, Fax: 301-436-2965, email: 
<a href="/cdn-cgi/l/email-protection#1259777c7c77667a3c7f717376737f61527476733c7a7a613c757d64"><span class="__cf_email__" data-cfemail="98d3fdf6f6fdecf0b6f5fbf9fcf9f5ebd8fefcf9b6f0f0ebb6fff7ee">[email protected]</span></a>.

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

    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 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 (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

[[Page 19671]]

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:
    <bullet> Date of submission;
    <bullet> Whether the notifier has determined that all files 
provided in an electronic transmission are free of computer viruses;
    <bullet> Whether the submission is an amendment to an FCN 
submission, a pre-notification consultation, or a master file;
    <bullet> The format of the submission (i.e., ESG, transmission on 
electronic physical media such as CD-ROM or DVD, or paper);
    <bullet> The name of and contact information for the submitter, 
including the identity of the contact person and the company name (if 
applicable);
    <bullet> The name of and contact information for any agent or 
attorney who is authorized to act on behalf of the notifier; and
    <bullet> A brief description of the information provided and the 
purpose(s) of the amendment.
    Section 171.1 (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 Master    FDA 3480....................              60               1              60              0.5              30
 File (concerning a food contact
 substance) \8\
Amendment to an existing notification      FDA 3480A...................              50               1              50              0.5              25
 (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 Petitions...  N/A.........................               1               1               1         10,995            10,995
Use of Recycled Plastics in Food           N/A.........................              10               1              10             25               250
 Packaging: Chemistry Considerations.
                                          --------------------------------------------------------------------------------------------------------------
    Total................................  ............................  ..............  ..............  ..............  ...............          27,035
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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 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.


[[Page 19672]]

    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 via 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 2.0 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 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 25.0 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 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 burden to be 25 hours per 
response, for a total burden of 250 hours.
    As noted, FDA estimates that all of the future Form FDA 3479, 3480, 
and 3480A submissions will be made electronically via 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-$30.

    Dated: March 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-7764 Filed 3-30-12; 8:45 am]
BILLING CODE 4160-01-P


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