Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification Program

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Published

September 15, 2021

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, Agency, or we) 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.

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<title>Federal Register, Volume 86 Issue 176 (Wednesday, September 15, 2021)</title>
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[Federal Register Volume 86, Number 176 (Wednesday, September 15, 2021)]
[Notices]
[Pages 51358-51360]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-19925]

[[Page 51358]]

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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, Agency, or we) 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 15, 2021.

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 15, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 15, 2021. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, 240-402-7500.

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,
<a href="/cdn-cgi/l/email-protection#69393b283a1d080f0f290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="bbebe9fae8cfdaddddfbdddfda95d3d3c895dcd4cd">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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

[[Page 51359]]

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 of Pre-
notification Consultation currently under Agency review, as well as for
Master Files. Form FDA 3480A helps the respondent organize the
submission to focus on the information needed for FDA's safety review.
We estimate that the amount of time for respondents to complete the
Form FDA 3480A for these types of submissions is 0.5 hours.
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 food contact substances
(FCSs). FDA also issued a guidance entitled, ``Preparation of Food
Contact Notifications for Food Contact Substances in Contact with
Infant Formula and/or Human Milk.'' The guidance provides assistance to
industry regarding the preparation of 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 <a href="https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/default.htm">https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/default.htm</a>.
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 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 sold in the
United States. Respondents are from the private sector.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section; activity Form FDA 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)............... 3479 10 2 20 2.............................. 40
170.101 \3\ \7\ (Category B)........... 3480 6 1 6 25............................. 150
170.101 \4\ \7\ (Category C)........... 3480 6 2 12 120............................ 1,440
170.101 \5\ \7\ (Category D)........... 3480 42 2 84 150............................ 12,600
170.101 \6\ \7\ (Category E)........... 3480 38 1 38 150............................ 5,700
Pre-notification Consultation or Master 3480 150 1 150 0.5 (30 minutes)............... 75
File (concerning a food contact
substance) \8\.

[[Page 51360]]

Amendment to an existing notification 3480A 80 1 80 0.5 (30 minutes)............... 40
(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 65 1 65 25............................. 1,625
Packaging: Chemistry Considerations.
Preparation of Food Contact .............. 2 1 2 5.............................. 10
Notifications for Food Contact
Substances in Contact with Infant
Formula and/or Human Milk.
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Total.............................. .............. .............. .............. .............. ............................... 32,675
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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.

Based on a review of the information collection since our last
request for OMB approval, we made adjustments to our burden estimate.
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 1,345 hours and a corresponding decrease of 5
responses. We attribute this adjustment to a decrease in Pre-
Notification Consultations or Master Files by 40 responses, a
subsequent decrease of amendments to Pre-Notification Consultations or
Master Files by 20 responses, and an increase of 55 respondents using
the recommendations in the guidance document entitled, ``Use of
Recycled Plastics in Food Packaging: Chemistry Considerations.'' As the
average burden for preparing recycling submissions is higher than for
Pre-notification Consultations or Master Files, this results in an
overall increase in total burden even with an overall decrease in
responses.

Dated: September 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-19925 Filed 9-14-21; 8:45 am]
BILLING CODE 4164-01-P

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