Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification Program, 51358-51360 [2021-19925]
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51358
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Notices
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.
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 https://www.regulations.gov
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.
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SUMMARY:
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
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17:08 Sep 14, 2021
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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
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, 240–402–7500.
• 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
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
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.govinfo.gov/content/pkg/FR-201509-18/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, 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, PRAStaff@
fda.hhs.gov.
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
E:\FR\FM\15SEN1.SGM
15SEN1
Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Notices
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:
51359
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 https://
www.fda.gov/Food/Guidance
Regulation/GuidanceDocuments
RegulatoryInformation/Ingredients
AdditivesGRASPackaging/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 postconsumer 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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21 CFR section; activity
Form FDA No.
170.106 2 (Category A) .......................
170.101 3 7 (Category B) .....................
170.101 4 7 (Category C) .....................
170.101 5 7 (Category D) .....................
170.101 6 7 (Category E) .....................
Pre-notification Consultation or Master
File (concerning a food contact substance) 8.
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Number of
respondents
3479
3480
3480
3480
3480
3480
PO 00000
Frm 00022
Number of
responses per
respondent
10
6
6
42
38
150
Fmt 4703
2
1
2
2
1
1
Sfmt 4703
Total annual
responses
20
6
12
84
38
150
E:\FR\FM\15SEN1.SGM
Average
burden
per response
2 .........................
25 .......................
120 .....................
150 .....................
150 .....................
0.5 (30 minutes)
15SEN1
Total hours
40
150
1,440
12,600
5,700
75
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Federal Register / Vol. 86, No. 176 / Wednesday, September 15, 2021 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section; activity
Form FDA No.
Amendment to an existing notification
(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
Use of Recycled Plastics in Food
Packaging: Chemistry Considerations.
Preparation of Food Contact Notifications for Food Contact Substances
in Contact with Infant Formula and/
or Human Milk.
Total .............................................
Number of
responses per
respondent
Number of
respondents
Average
burden
per response
Total annual
responses
Total hours
3480A
80
1
80
0.5 (30 minutes)
40
N/A
N/A
1
65
1
1
1
65
10,995 ................
25 .......................
10,995
1,625
........................
2
1
2
5 .........................
10
........................
........................
........................
........................
............................
32,675
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
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.
2 Notifications
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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 Prenotification 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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Biobehavioral and
Behavioral Processes Integrated Review
Group; Biobehavioral Regulation, Learning
and Ethology Study Section.
Date: October 7, 2021.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Sara Louise Hargrave,
Ph.D. Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3170,
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
Bethesda, MD 20892, (301) 443–7193,
hargravesl@mail.nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Kidney, Nutrition, Obesity and Diabetes
Study Section.
Date: October 7–8, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Steven Michael Frenk,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3141,
Bethesda, MD 20892, (301) 480–8665
frenksm@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; High-end
and Shared Instrumentation Grants.
Date: October 12, 2021.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Jonathan Arias, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5170,
MSC 7840, Bethesda, MD 20892, (301) 435–
2406, ariasj@csr.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience; Integrated Review
Group; Developmental Brain Disorders Study
Section.
Date: October 13–15, 2021.
Time: 11:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
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]]>Agencies
[Federal Register Volume 86, Number 176 (Wednesday, September 15, 2021)]
[Notices]
[Pages 51358-51360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-19925]
[[Page 51358]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.regulations.gov 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:
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 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, 240-402-7500.
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.govinfo.gov/content/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, 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,
[email protected].
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 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 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
Total.............................. .............. .............. .............. .............. ............................... 32,675
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
