[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46493-46496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19898]


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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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 information collection associated with 
the Food Contact Substance Notification Program.

DATES: Submit either electronic or written comments on the collection 
of information by November 13, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 13, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2012-N-0294 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Food

[[Page 46494]]

Contact Substance Notification Program.'' Received comments, those 
filed in a timely manner (see ADDRESSES), will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

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--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

[[Page 46495]]

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 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 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).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden \1\
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                                                                                                       Number of
                                                                                         Number of     responses      Total       Average
            21 CFR section; activity                         FDA form No.               respondents       per         annual     burden per  Total hours
                                                                                                       respondent   responses     response
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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 File     FDA 3480                                        190            1          190         *0.5           95
 (concerning a food contact substance).8
Amendment to an existing notification            FDA 3480A                                       100            1          100         *0.5           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 for    ...................................               2            1            2            5           10
 Food Contact Substances in Contact with Infant
 Formula and/or Human Milk.
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    Total......................................  ...................................  ..............  ...........  ...........  ...........       31,330
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* 30 minutes.
\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

[[Page 46496]]

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 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: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19898 Filed 9-12-18; 8:45 am]
BILLING CODE 4164-01-P