Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program, 7190-7192 [2022-02620]
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7190
Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices
registered. If an owner or operator
changes, the new owner or operator
creates a new owner or operator account
and transfers the ownership of the
establishment to their owner or operator
account. Once they create an owner or
operator account, they use the account
for as long as the company is registered.
Under § 807.22(b)(4), changes to listing
information may be made at times
outside of the annual listing
requirement period, such as when a
change is made to a previously listed
device.
The draft guidance document entitled
‘‘Transfer of a Premarket Notification
(510(k)) Clearance—Questions and
Answers’’ (December 2014), which
contained instructions for the proposed
voluntary information collection, has
recently been withdrawn. While
notification of transfer of ownership
information is not currently required,
our medical device registration and
listing website 1 communicates
procedures for notifying FDA of the
transfer of a premarket notification
(510(k)) clearance from one person to
another. The notification is used to
ensure public information in FDA’s
databases about the current 510(k)
holder for a specific device(s) is
accurate and up to date. Although
submission of information regarding the
transfer of a 510(k) clearance is not
required under the regulations, we
regularly receive such notifications from
respondents.
FDA estimates that annually 78
percent of 510(k)s may be initially listed
or updated outside of the annual
registration requirement (about 4,080
510(k)s per year). FDA estimates that it
will take approximately 15 minutes for
each listing, for a total reporting burden
of 1,020 hours.
FDA estimates it will have 2,033
instances of more than one party
claiming to be a 510(k) holder for a
specific device as part of annual
registration and listing. FDA reached
this estimate by identifying the average
number of unique 510(k) device listings
entered in FURLS between fiscal years
2017 and 2019 that conflict with a
listing already entered by another party
(5,304), dividing that number by the
number of years (3) and multiplying by
the average number of parties claiming
to be the 510(k) holder when there is a
conflict in the current FURLS database
(2.3), then dividing the result by 2
(because only one company per listing
will submit the appropriate
1 https://www.fda.gov/medical-devices/howstudy-and-market-your-device/device-registrationand-listing.
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documentation to show that they are the
current 510(k) holder).
The registration and listing website
identifies potential documentation a
party could submit to FDA to establish
the transfer of a 510(k) clearance to a
new owner or operator. Based on the
amount of time to locate the
information, copy it, and submit a copy,
FDA estimates it will take respondents
approximately 4 hours to establish the
transfer of a 510(k) clearance.
The estimate for § 807.25(d) in table 2
of this document (recordkeeping
burden) reflects the requirement that
owners or operators maintain a
historical file containing the labeling
and advertisements in use. The estimate
for § 807.26 reflects the requirement that
owners or operators keep a list of
officers, directors, and partners for each
establishment. Owners or operators will
need to provide this information only
when requested by FDA. However, it is
assumed that some effort will need to be
expended to keep such records current.
The recurring burden for the data
collection under § 807.41 (importrelated information provided by foreign
companies exporting to the United
States) was estimated based on data
from previous years. Foreign companies
identify one importer and one person
who imports or offers for import with
readily available contact information at
the time of registration. After
completing their initial registration,
they are required to review the importer
information annually. When they
review the importer information
annually, they simply verify the
importer information is accurate. If it is
and no changes are needed, the foreign
establishment’s official correspondent
checks the certification and submits the
annual registration. If they need to make
changes to the importer information,
they can do so at any time and use a
spreadsheet to update more than one
importer at a time to their registration.
The use of the spreadsheet reduces the
burden to the official correspondent of
the foreign establishment.
Our estimated burden for the
information collection reflects an
overall increase of 10,880 hours and a
corresponding increase of 28,430
responses/records. We attribute this
adjustment to an increase in the number
of submissions we received over the last
few years. Additionally, we have
included non-substantive changes,
incorporating the burden previously
approved under OMB control number
0910–0852 into OMB control number
0910–0625, as approved by OMB in May
2021.
PO 00000
Frm 00107
Fmt 4703
Sfmt 4703
Dated: February 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–02600 Filed 2–7–22; 8:45 am]
BILLING CODE 4164–01–P
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.
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 https://
www.reginfo.gov/public/do/PRAMain.
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, 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.
SUMMARY:
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
E:\FR\FM\08FEN1.SGM
08FEN1
Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / Notices
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 https://www.fda.gov/food/
food-ingredients-packaging/packagingfood-contact-substances-fcs. 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
7191
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/
GuidanceDocuments
RegulatoryInformation/
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 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.
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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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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PO 00000
Number of
respondents
3479
3480
3480
3480
3480
3480
Frm 00108
Number of
responses per
respondent
10
6
6
42
38
150
Fmt 4703
Sfmt 4703
Total annual
responses
2
1
2
2
1
1
E:\FR\FM\08FEN1.SGM
20
6
12
84
38
150
Average burden per
response
2 ..................................
25 ................................
120 ..............................
150 ..............................
150 ..............................
0.5 (30 minutes) .........
08FEN1
Total hours
40
150
1,440
12,600
5,700
75
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Federal Register / Vol. 87, No. 26 / Tuesday, February 8, 2022 / 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
Total annual
responses
Average burden per
response
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.
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 Prenotification 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]
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BILLING CODE 4164–01–P
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remotely will be posted. In-person
NACNHSC meetings will be held at
5600 Fishers Lane, Rockville, Maryland
Health Resources and Services
20857. For meeting information
Administration
updates, go to the meetings page on the
NACNHSC website at https://
Meeting of the National Advisory
www.hrsa.gov/advisory-committees/
Council on the National Health Service national-health-service-corps/meetings.
Corps
FOR FURTHER INFORMATION CONTACT:
Diane Fabiyi-King, Designated Federal
AGENCY: Health Resources and Services
Official, Division of National Health
Administration (HRSA), Department of
Service Corps, HRSA, 5600 Fishers
Health and Human Services.
Lane, Rockville, Maryland 20857; phone
ACTION: Notice.
(301) 443–3609; or
SUMMARY: In accordance with the
NHSCAdvisoryCouncil@hrsa.gov.
Federal Advisory Committee Act, this
SUPPLEMENTARY INFORMATION: The
notice announces that the National
NACNHSC consults with, advises, and
Advisory Council on the National
makes recommendations to the
Health Service Corps (NACNHSC) will
Secretary of Health and Human Services
hold public meetings for the 2022
with respect to the Secretary’s
calendar year (CY). Information about
responsibilities in carrying out Subpart
NACNHSC, agendas, and materials for
II, Part D of Title III of the Public Health
these meetings can be found on the
Service Act (42 U.S.C. 254d–254k), as
NACNHSC website at: https://
amended, including the designation of
www.hrsa.gov/advisory-committees/
areas of the United States with health
national-health-service-corps.
professional shortages and assignment
DATES: NACNHSC meetings will be held of National Health Service Corps
on:
(NHSC) clinicians to improve the
• March 29, 2022, 9:00 a.m.–5:00 p.m. delivery of health services in health
Eastern Time (ET) and March 30, 2022,
professional shortage areas. Since
9:00 a.m.–2:00 p.m. ET;
priorities dictate meeting times, be
• June 28, 2022, 9:00 a.m.–5:00 p.m.
advised that start times, end times, and
ET and June 29, 2022, 9:00 a.m.–2:00
agenda items are subject to change.
p.m. ET; and
Refer to the meeting website listed
• November 15, 2022, 9:00 a.m.–5:00
above for any meeting updates.
p.m. ET and November 16, 2022, 9:00
For CY 2022 meetings, agenda items
a.m.–2:00 p.m. ET.
may include, but are not limited to, the
identification of NHSC priorities for
ADDRESSES: Meetings may be held infuture program issues and concerns;
person, by teleconference, and/or
proposed policy changes by using the
ZOOM. For updates on how meetings
varying levels of expertise represented
will be held, visit the NACNHSC
website 30 business days before the date on the NACNHSC to advise on specific
program areas; updates from clinician
of the meeting, where instructions for
workforce experts; and education and
joining meetings either in-person or
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
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]]>Agencies
[Federal Register Volume 87, Number 26 (Tuesday, February 8, 2022)]
[Notices]
[Pages 7190-7192]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-02620]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://www.reginfo.gov/public/do/PRAMain. 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,
[email protected].
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 https://www.fda.gov/food/food-ingredients-packaging/packaging-food-contact-substances-fcs. 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 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.
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 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
