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

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Published

February 8, 2022

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

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

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<title>Federal Register, Volume 87 Issue 26 (Tuesday, February 8, 2022)</title>
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[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7190-7192]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-02620]

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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, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by March 10, 2022.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0495. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#124240534166737474527476733c7a7a613c757d64"><span class="__cf_email__" data-cfemail="702022312304111616301614115e1818035e171f06">[email&#160;protected]</span></a>.

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

[[Page 7191]]

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. The forms
are available at <a href="https://www.fda.gov/food/food-ingredients-packaging/packaging-food-contact-substances-fcs">https://www.fda.gov/food/food-ingredients-packaging/packaging-food-contact-substances-fcs</a>. To open field fillable forms,
they must be downloaded and then opened from your local computer (not
from a web browser).
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.
In the Federal Register of September 15, 2021 (86 FR 51358), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. Although one comment was received, it was
not responsive to the four collection of information topics solicited.
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 3480 150 1 150 0.5 (30 minutes)................. 75
Master File (concerning a food
contact substance) \8\.

[[Page 7192]]

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 N/A 1 1 1 10,995........................... 10,995
Petitions.
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: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-02620 Filed 2-7-22; 8:45 am]
BILLING CODE 4164-01-P

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