Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program, 3468-3470 [2019-01977]
Download as PDF
<![CDATA[
3468
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
Therefore, approval of the
applications listed in the table and all
amendments and supplements thereto,
are hereby withdrawn as of March 14,
2019. Introduction or delivery for
introduction into interstate commerce of
products without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on March 14, 2019
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: February 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02032 Filed 2–11–19; 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) 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: Fax written comments on the
collection of information by March 14,
2019.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0495. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
SUMMARY:
VerDate Sep<11>2014
18:30 Feb 11, 2019
Jkt 247001
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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.
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
Currently, interested persons transmit
an FCN submission to the Office of Food
Additive Safety in the Center for Food
Safety and Applied Nutrition using
Form FDA 3480 whether it is submitted
in electronic or paper format. We
estimate that the amount of time for
respondents to complete Form FDA
3480 will continue to be the same.
In addition to its required use with
FCNs, Form FDA 3480 is recommended
to be used to organize information
within a Pre-notification Consultation or
Master File submitted in support of an
FCN according to the items listed on the
form. Master Files can be used as
repositories for information that can be
referenced in multiple submissions to
FDA, thus minimizing paperwork
burden for food contact substance
authorizations. We estimate that the
amount of time for respondents to
complete the Form FDA 3480 for these
types of submissions is 0.5 hours.
FDA recommends using Form FDA
3480A for each submission of additional
information (i.e., amendment) to an FCN
submission currently under Agency
review. Form FDA 3480A helps the
respondent organize the submission to
focus on the information needed for
FDA’s safety review.
FDA’s guidance documents entitled:
(1) ‘‘Preparation of Food Contact
Notifications: Administrative,’’ (2)
‘‘Preparation of Food Contact
Notifications and Food Additive
Petitions for Food Contact Substances:
Chemistry Recommendations,’’ and (3)
‘‘Preparation of Food Contact
Notifications for Food Contact
Substances: Toxicology
Recommendations’’ provide assistance
to industry regarding the preparation of
an FCN and a petition for a food contact
substances (FCSs). FDA has also
developed a draft guidance entitled,
‘‘Preparation of Food Contact
Notifications for Food Contact
Substances in Contact with Infant
Formula and/or Human Milk.’’ Once
finalized, the guidance will provide our
current thinking on how to prepare an
FCN for FDA review and evaluation of
the safety of FCSs used in contact with
infant formula and/or human milk.
These guidances are available at https://
www.fda.gov/Food/
GuidanceRegulation/
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
E:\FR\FM\12FEN1.SGM
12FEN1
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
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, the guidance entitled
‘‘Use of Recycled Plastics in Food
Packaging: Chemistry Considerations,’’
provides assistance to manufacturers of
food packaging in evaluating processes
for producing packaging from post-
consumer recycled plastic. The
recommendations in the guidance
address the process by which
manufacturers certify to us that their
plastic products are safe for food
contact.
Description of Respondents: The
respondents to this information
collection are manufacturers of food
contact substances sold in the United
3469
States. Respondents are from the private
sector (for-profit businesses).
In the Federal Register of September
13, 2018 (83 FR 46493), we published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
unrelated to the information collection
and therefore is not discussed here.
We estimate the burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR Section; Activity
FDA Form 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.
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.
FDA
FDA
FDA
FDA
FDA
FDA
Total ...................................................
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
3479
3480
3480
3480
3480
3480
10
6
6
42
38
190
2
1
2
2
1
1
20
6
12
84
38
190
2 ...................
25 .................
120 ...............
150 ...............
150 ...............
0.5 (30 minutes).
40
150
1,440
12,600
5,700
95
FDA 3480A
100
1
100
0.5 (30 minutes).
N/A
N/A
1
10
1
1
1
10
10,995 ..........
25 .................
10,995
250
........................
2
1
2
5 ...................
10
........................
........................
........................
........................
......................
31,330
50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Notifications for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479
(‘‘Notification for a Food Contact Substance Formulation’’) only.
3 Duplicate notifications for uses of food contact substances.
4 Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
5 Notifications for uses that are the subject of moderately complex food additive petitions.
6 Notifications for uses that are the subject of very complex food additive petitions.
7 These notifications require the submission of Form FDA 3480.
8 These notifications recommend the submission of Form FDA 3480.
9 These notifications recommend the submission of Form FDA 3480A.
The estimates are based on our
current experience with the Food
Contact Substance Notification Program
and informal communication with
industry. Our estimated burden for the
information collection reflects an
overall increase of 10 hours and a
corresponding increase of 2 responses
from the currently approved burden. We
attribute this adjustment to reviewing
and submitting FCNs consistent to the
draft guidance entitled, ‘‘Preparation of
Food Contact Notifications for Food
Contact Substances in Contact with
Infant Formula and/or Human Milk.’’
Beginning in row 1, we estimate 10
respondents will submit 2 notifications
annually for food contact substance
formulations (Form FDA 3479), for a
total of 20 responses. We calculate a
reporting burden of 2 hours per
response, for a total of 40 hours. In row
VerDate Sep<11>2014
18:30 Feb 11, 2019
Jkt 247001
2 we estimate six respondents. We
believe the hourly burden for preparing
these notifications will primarily consist
of the manufacturer or supplier
completing Form FDA 3480, verifying
that a previous notification is effective
and preparing necessary documentation.
We estimate one submission for each
respondent, for a total of six responses.
We calculate a reporting burden of 25
hours per response, for a total of 150
hours.
In rows 3, 4, and 5, we identify three
tiers of FCNs that reflect different levels
of burden applicable to the respective
information collection items (denoted as
Categories C, D, and E). We estimate 6
respondents will submit 2 Category C
submissions annually, for a total of 12
responses. We calculate a reporting
burden of 120 hours per response, for a
total burden of 1,440 hours. We estimate
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
42 respondents will submit 2 Category
D submissions annually, for a total of 84
responses. We calculate a reporting
burden of 150 hours per response, for a
total burden of 12,600 hours. We
estimate 38 respondents will submit 1
Category E submission annually, for a
total of 38 responses. We calculate a
reporting burden of 150 hours per
response, for a total burden of 5,700
hours.
In row 6, we estimate 190 respondents
will submit information to a prenotification consultation or a master file
in support of FCN submission using
Form FDA 3480. We calculate a
reporting burden of 0.5 hours per
response, for a total burden of 95 hours.
In row 7 we estimate 100 respondents
will submit an amendment (Form FDA
3480A) to a substantive or nonsubstantive request of additional
E:\FR\FM\12FEN1.SGM
12FEN1
3470
Federal Register / Vol. 84, No. 29 / Tuesday, February 12, 2019 / Notices
information to an incomplete FCN
submission, an amendment to a prenotification consultation, or an
amendment to a master file in support
of an FCN. We calculate a reporting
burden of 0.5 hours per response, for a
total burden of 50 hours.
In row 8, we estimate one respondent
will submit one indirect food additive
petition under § 171.1, for a total of one
response. We calculate a reporting
burden of 10,995 hours per response, for
a total burden of 10,995 hours.
In row 9, we estimate 10 respondents
will utilize the recommendations in the
guidance document entitled, ‘‘Use of
Recycled Plastics in Food Packaging:
Chemistry Considerations,’’ to develop
the additional information for one such
submission annually, for a total of 10
responses. We calculate a reporting
burden of 25 hours per response, for a
total burden of 250 hours.
Finally, in row 10, we estimate 2
respondents will utilize the
recommendations in the draft guidance,
once finalized, entitled, ‘‘Preparation of
Food Contact Notifications for Food
Contact Substances in Contact with
Infant Formula and/or Human Milk,’’ to
develop the additional information for
one such submission annually, for a
total of 2 responses. We calculate a
reporting burden of 5 hours per
response, for a total burden of 10 hours.
Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–01977 Filed 2–11–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–E–6739]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ZEJULA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for ZEJULA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
SUMMARY:
VerDate Sep<11>2014
18:30 Feb 11, 2019
Jkt 247001
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 15, 2019.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
August 12, 2019. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
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 April 15,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 15, 2019. 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.
DATES:
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
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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–
2017–E–6739 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; ZEJULA.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
E:\FR\FM\12FEN1.SGM
12FEN1
]]>Agencies
[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3468-3470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01977]
-----------------------------------------------------------------------
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) 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: Fax written comments on the collection of information by March
14, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0495.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
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.
Food Contact Substance Notification Program--21 CFR 170.101, 170.106,
and 171.1
OMB Control Number 0910-0495--Extension
This information collection supports FDA regulations regarding Food
Contact Substance Notification, as well as associated guidance and
accompanying forms. Section 409(h) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 348(h)) establishes a premarket
notification process for food contact substances. Section 409(h)(6) of
the FD&C Act defines a ``food contact substance'' as ``any substance
intended for use as a component of materials used in manufacturing,
packing, packaging, transporting, or holding food if such use is not
intended to have any technical effect in such food.'' Section 409(h)(3)
of the FD&C Act requires that the notification process be used for
authorizing the marketing of food contact substances except when: (1)
We determine that the submission and premarket review of a food
additive petition (FAP) under section 409(b) of the FD&C Act is
necessary to provide adequate assurance of safety or (2) we and the
manufacturer or supplier agree that an FAP should be submitted. Section
409(h)(1) of the FD&C Act requires that a notification include: (1)
Information on the identity and the intended use of the food contact
substance and (2) the basis for the manufacturer's or supplier's
determination that the food contact substance is safe under the
intended conditions of use.
Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101
and 170.106) specify the information that a notification must contain
and require that: (1) A food contact substance notification (FCN)
includes Form FDA 3480 and (2) a notification for a food contact
substance formulation includes Form FDA 3479. These forms serve to
summarize pertinent information in the notification. The forms
facilitate both preparation and review of notifications because the
forms will serve to organize information necessary to support the
safety of the use of the food contact substance. The burden of filling
out the appropriate form has been included in the burden estimate for
the notification.
Currently, interested persons transmit an FCN submission to the
Office of Food Additive Safety in the Center for Food Safety and
Applied Nutrition using Form FDA 3480 whether it is submitted in
electronic or paper format. We estimate that the amount of time for
respondents to complete Form FDA 3480 will continue to be the same.
In addition to its required use with FCNs, Form FDA 3480 is
recommended to be used to organize information within a Pre-
notification Consultation or Master File submitted in support of an FCN
according to the items listed on the form. Master Files can be used as
repositories for information that can be referenced in multiple
submissions to FDA, thus minimizing paperwork burden for food contact
substance authorizations. We estimate that the amount of time for
respondents to complete the Form FDA 3480 for these types of
submissions is 0.5 hours.
FDA recommends using Form FDA 3480A for each submission of
additional information (i.e., amendment) to an FCN submission currently
under Agency review. Form FDA 3480A helps the respondent organize the
submission to focus on the information needed for FDA's safety review.
FDA's guidance documents entitled: (1) ``Preparation of Food
Contact Notifications: Administrative,'' (2) ``Preparation of Food
Contact Notifications and Food Additive Petitions for Food Contact
Substances: Chemistry Recommendations,'' and (3) ``Preparation of Food
Contact Notifications for Food Contact Substances: Toxicology
Recommendations'' provide assistance to industry regarding the
preparation of an FCN and a petition for a food contact substances
(FCSs). FDA has also developed a draft guidance entitled, ``Preparation
of Food Contact Notifications for Food Contact Substances in Contact
with Infant Formula and/or Human Milk.'' Once finalized, the guidance
will provide our current thinking on how to prepare an FCN for FDA
review and evaluation of the safety of FCSs used in contact with infant
formula and/or human milk. These guidances are available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/default.htm.
Section 171.1 of FDA's regulations (21 CFR 171.1) specifies the
information that a petitioner must submit in order to: (1) Establish
that the proposed use of an indirect food additive is safe and (2)
secure the publication of an indirect
[[Page 3469]]
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, the guidance entitled ``Use of Recycled Plastics in
Food Packaging: Chemistry Considerations,'' provides assistance to
manufacturers of food packaging in evaluating processes for producing
packaging from post-consumer recycled plastic. The recommendations in
the guidance address the process by which manufacturers certify to us
that their plastic products are safe for food contact.
Description of Respondents: The respondents to this information
collection are manufacturers of food contact substances sold in the
United States. Respondents are from the private sector (for-profit
businesses).
In the Federal Register of September 13, 2018 (83 FR 46493), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received unrelated to the
information collection and therefore is not discussed here.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section; Activity FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
170.106 2 (Category A)..................... FDA 3479 10 2 20 2.......................... 40
170.101 3 7 (Category B)................... FDA 3480 6 1 6 25......................... 150
170.101 4 7 (Category C)................... FDA 3480 6 2 12 120........................ 1,440
170.101 5 7 (Category D)................... FDA 3480 42 2 84 150........................ 12,600
170.101 6 7 (Category E)................... FDA 3480 38 1 38 150........................ 5,700
Pre-notification Consultation or Master FDA 3480 190 1 190 0.5 (30 minutes)........... 95
File (concerning a food contact substance)
\8\.
Amendment to an existing notification FDA 3480A 100 1 100 0.5 (30 minutes)........... 50
(170.101), amendment to a Pre-notification
Consultation, or amendment to a Master
File (concerning a food contact substance)
\9\.
171.1 Indirect Food Additive Petitions..... N/A 1 1 1 10,995..................... 10,995
Use of Recycled Plastics in Food Packaging: N/A 10 1 10 25......................... 250
Chemistry Considerations.
Preparation of Food Contact Notifications .............. 2 1 2 5.......................... 10
for Food Contact Substances in Contact
with Infant Formula and/or Human Milk.
------------------------------------------------------------------------------------------------------------
Total.................................. .............. .............. .............. .............. ........................... 31,330
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Notifications for food contact substance formulations and food contact articles. These notifications require the submission of Form FDA 3479
(``Notification for a Food Contact Substance Formulation'') only.
\3\ Duplicate notifications for uses of food contact substances.
\4\ Notifications for uses that are the subject of exemptions under 21 CFR 170.39 and very simple food additive petitions.
\5\ Notifications for uses that are the subject of moderately complex food additive petitions.
\6\ Notifications for uses that are the subject of very complex food additive petitions.
\7\ These notifications require the submission of Form FDA 3480.
\8\ These notifications recommend the submission of Form FDA 3480.
\9\ These notifications recommend the submission of Form FDA 3480A.
The estimates are based on our current experience with the Food
Contact Substance Notification Program and informal communication with
industry. Our estimated burden for the information collection reflects
an overall increase of 10 hours and a corresponding increase of 2
responses from the currently approved burden. We attribute this
adjustment to reviewing and submitting FCNs consistent to the draft
guidance entitled, ``Preparation of Food Contact Notifications for Food
Contact Substances in Contact with Infant Formula and/or Human Milk.''
Beginning in row 1, we estimate 10 respondents will submit 2
notifications annually for food contact substance formulations (Form
FDA 3479), for a total of 20 responses. We calculate a reporting burden
of 2 hours per response, for a total of 40 hours. In row 2 we estimate
six respondents. We believe the hourly burden for preparing these
notifications will primarily consist of the manufacturer or supplier
completing Form FDA 3480, verifying that a previous notification is
effective and preparing necessary documentation. We estimate one
submission for each respondent, for a total of six responses. We
calculate a reporting burden of 25 hours per response, for a total of
150 hours.
In rows 3, 4, and 5, we identify three tiers of FCNs that reflect
different levels of burden applicable to the respective information
collection items (denoted as Categories C, D, and E). We estimate 6
respondents will submit 2 Category C submissions annually, for a total
of 12 responses. We calculate a reporting burden of 120 hours per
response, for a total burden of 1,440 hours. We estimate 42 respondents
will submit 2 Category D submissions annually, for a total of 84
responses. We calculate a reporting burden of 150 hours per response,
for a total burden of 12,600 hours. We estimate 38 respondents will
submit 1 Category E submission annually, for a total of 38 responses.
We calculate a reporting burden of 150 hours per response, for a total
burden of 5,700 hours.
In row 6, we estimate 190 respondents will submit information to a
pre-notification consultation or a master file in support of FCN
submission using Form FDA 3480. We calculate a reporting burden of 0.5
hours per response, for a total burden of 95 hours. In row 7 we
estimate 100 respondents will submit an amendment (Form FDA 3480A) to a
substantive or non- substantive request of additional
[[Page 3470]]
information to an incomplete FCN submission, an amendment to a pre-
notification consultation, or an amendment to a master file in support
of an FCN. We calculate a reporting burden of 0.5 hours per response,
for a total burden of 50 hours.
In row 8, we estimate one respondent will submit one indirect food
additive petition under Sec. 171.1, for a total of one response. We
calculate a reporting burden of 10,995 hours per response, for a total
burden of 10,995 hours.
In row 9, we estimate 10 respondents will utilize the
recommendations in the guidance document entitled, ``Use of Recycled
Plastics in Food Packaging: Chemistry Considerations,'' to develop the
additional information for one such submission annually, for a total of
10 responses. We calculate a reporting burden of 25 hours per response,
for a total burden of 250 hours.
Finally, in row 10, we estimate 2 respondents will utilize the
recommendations in the draft guidance, once finalized, entitled,
``Preparation of Food Contact Notifications for Food Contact Substances
in Contact with Infant Formula and/or Human Milk,'' to develop the
additional information for one such submission annually, for a total of
2 responses. We calculate a reporting burden of 5 hours per response,
for a total burden of 10 hours.
Dated: February 6, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01977 Filed 2-11-19; 8:45 am]
BILLING CODE 4164-01-P
