
[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3468-3470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01977]


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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 March 
14, 2019.

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 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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

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

OMB Control Number 0910-0495--Extension

    This information collection supports FDA regulations regarding Food 
Contact Substance Notification, as well as associated guidance and 
accompanying forms. Section 409(h) of the Federal Food, Drug, and 
Cosmetic Act (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) 
We determine 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) we 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 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) 
includes Form FDA 3480 and (2) a notification for a food contact 
substance formulation includes 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 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.
    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. We estimate that the amount of time for 
respondents to complete Form FDA 3480 will continue to be the same.
    In addition to its required use with FCNs, 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 FDA, thus minimizing paperwork burden for food contact 
substance authorizations. We estimate that the amount of time for 
respondents to complete the Form FDA 3480 for these types of 
submissions is 0.5 hours.
    FDA recommends using Form FDA 3480A for each submission of 
additional information (i.e., amendment) to an FCN submission currently 
under Agency review. Form FDA 3480A helps the respondent organize the 
submission to focus on the information needed for FDA's safety review.
    FDA's guidance documents entitled: (1) ``Preparation of Food 
Contact Notifications: Administrative,'' (2) ``Preparation of Food 
Contact Notifications and Food Additive Petitions for Food Contact 
Substances: Chemistry Recommendations,'' and (3) ``Preparation of Food 
Contact Notifications for Food Contact Substances: Toxicology 
Recommendations'' provide assistance to industry regarding the 
preparation of an FCN and a petition for a food contact substances 
(FCSs). FDA has also developed a draft guidance entitled, ``Preparation 
of Food Contact Notifications for Food Contact Substances in Contact 
with Infant Formula and/or Human Milk.'' Once finalized, the guidance 
will provide our current thinking on how to prepare an FCN for FDA 
review and evaluation of the safety of FCSs used in contact with infant 
formula and/or human milk. These guidances are available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/default.htm.
    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

[[Page 3469]]

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, the guidance 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 us 
that their plastic products are safe for food contact.
    Description of Respondents: The respondents to this information 
collection are manufacturers of food contact substances sold in the 
United States. Respondents are from the private sector (for-profit 
businesses).
    In the Federal Register of September 13, 2018 (83 FR 46493), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received unrelated to the 
information collection and therefore is not discussed here.
    We estimate the burden of the information collection as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                Number of
          21 CFR Section; Activity            FDA Form No.      Number of     responses per   Total annual   Average burden per response    Total hours
                                                               respondents     respondent       responses
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170.106 2 (Category A).....................        FDA 3479              10               2              20  2..........................              40
170.101 3 7 (Category B)...................        FDA 3480               6               1               6  25.........................             150
170.101 4 7 (Category C)...................        FDA 3480               6               2              12  120........................           1,440
170.101 5 7 (Category D)...................        FDA 3480              42               2              84  150........................          12,600
170.101 6 7 (Category E)...................        FDA 3480              38               1              38  150........................           5,700
Pre-notification Consultation or Master            FDA 3480             190               1             190  0.5 (30 minutes)...........              95
 File (concerning a food contact substance)
 \8\.
Amendment to an existing notification             FDA 3480A             100               1             100  0.5 (30 minutes)...........              50
 (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 Packaging:             N/A              10               1              10  25.........................             250
 Chemistry Considerations.
Preparation of Food Contact Notifications    ..............               2               1               2  5..........................              10
 for Food Contact Substances in Contact
 with Infant Formula and/or Human Milk.
                                            ------------------------------------------------------------------------------------------------------------
    Total..................................  ..............  ..............  ..............  ..............  ...........................          31,330
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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.

    The estimates are based on our current experience with the Food 
Contact Substance Notification Program and informal communication with 
industry. Our estimated burden for the information collection reflects 
an overall increase of 10 hours and a corresponding increase of 2 
responses from the currently approved burden. We attribute this 
adjustment to reviewing and submitting FCNs consistent to the draft 
guidance entitled, ``Preparation of Food Contact Notifications for Food 
Contact Substances in Contact with Infant Formula and/or Human Milk.''
    Beginning in row 1, we estimate 10 respondents will submit 2 
notifications annually for food contact substance formulations (Form 
FDA 3479), for a total of 20 responses. We calculate a reporting burden 
of 2 hours per response, for a total of 40 hours. In row 2 we estimate 
six respondents. We believe the hourly burden for preparing these 
notifications will primarily consist of the manufacturer or supplier 
completing Form FDA 3480, verifying that a previous notification is 
effective and preparing necessary documentation. We estimate one 
submission for each respondent, for a total of six responses. We 
calculate a reporting burden of 25 hours per response, for a total of 
150 hours.
    In rows 3, 4, and 5, we identify three tiers of FCNs that reflect 
different levels of burden applicable to the respective information 
collection items (denoted as Categories C, D, and E). We estimate 6 
respondents will submit 2 Category C submissions annually, for a total 
of 12 responses. We calculate a reporting burden of 120 hours per 
response, for a total burden of 1,440 hours. We estimate 42 respondents 
will submit 2 Category D submissions annually, for a total of 84 
responses. We calculate a reporting burden of 150 hours per response, 
for a total burden of 12,600 hours. We estimate 38 respondents will 
submit 1 Category E submission annually, for a total of 38 responses. 
We calculate a reporting burden of 150 hours per response, for a total 
burden of 5,700 hours.
    In row 6, we estimate 190 respondents will submit information to a 
pre-notification consultation or a master file in support of FCN 
submission using Form FDA 3480. We calculate a reporting burden of 0.5 
hours per response, for a total burden of 95 hours. In row 7 we 
estimate 100 respondents will submit an amendment (Form FDA 3480A) to a 
substantive or non- substantive request of additional

[[Page 3470]]

information to an incomplete FCN submission, an amendment to a pre-
notification consultation, or an amendment to a master file in support 
of an FCN. We calculate a reporting burden of 0.5 hours per response, 
for a total burden of 50 hours.
    In row 8, we estimate one respondent will submit one indirect food 
additive petition under Sec.  171.1, for a total of one response. We 
calculate a reporting burden of 10,995 hours per response, for a total 
burden of 10,995 hours.
    In row 9, we estimate 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. We calculate a reporting burden of 25 hours per response, 
for a total burden of 250 hours.
    Finally, in row 10, we estimate 2 respondents will utilize the 
recommendations in the draft guidance, once finalized, entitled, 
``Preparation of Food Contact Notifications for Food Contact Substances 
in Contact with Infant Formula and/or Human Milk,'' to develop the 
additional information for one such submission annually, for a total of 
2 responses. We calculate a reporting burden of 5 hours per response, 
for a total burden of 10 hours.

    Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01977 Filed 2-11-19; 8:45 am]
 BILLING CODE 4164-01-P


