81 FR 3434 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 13 (January 21, 2016)

Page Range		3434-3435
FR Document		2016-01102

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.

Federal Register, Volume 81 Issue 13 (Thursday, January 21, 2016)

[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Notices]
[Pages 3434-3435]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-01102]

[[Page 3434]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0294]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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
February 22, 2016.

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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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

Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the
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.
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 document 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.
In the Federal Register of October 8, 2015 (80 FR 60911), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section or other category FDA Form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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

[[Page 3435]]

Pre-notification Consultation or Master FDA 3480.................. 190 1 190 0.5 95
File (concerning a food contact
substance).\8\
Amendment to an existing notification FDA 3480A................. 100 1 100 0.5 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.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total.................................. .......................... .............. .............. .............. ............... 31,320
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 in table 1 are based on our current experience with
the food contact substance notification program and informal
communication with industry.
Beginning in row 1 we estimate 10 respondents will submit two
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 1Category 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 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.
Finally, in row 9 we estimate ten 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.

Dated: January 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01102 Filed 1-20-16; 8:45 am]
BILLING CODE 4164-01-P

3434 Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices

DEPARTMENT OF HEALTH AND (21 U.S.C. 348(h)) establishes a In addition to its required use with
HUMAN SERVICES premarket notification process for food FCNs, Form FDA 3480 is recommended
contact substances. Section 409(h)(6) of to be used to organize information
Food and Drug Administration the FD&C Act defines a ‘‘food contact within a Pre-notification Consultation or
[Docket No. FDA–2012–N–0294] substance’’ as ‘‘any substance intended Master File submitted in support of an
for use as a component of materials used FCN according to the items listed on the
Agency Information Collection in manufacturing, packing, packaging, form. Master Files can be used as
Activities; Submission for Office of transporting, or holding food if such use repositories for information that can be
Management and Budget Review; is not intended to have any technical referenced in multiple submissions to
Comment Request; Food Contact effect in such food.’’ Section 409(h)(3) of FDA, thus minimizing paperwork
Substance Notification Program the FD&C Act requires that the
burden for food contact substance
notification process be used for
AGENCY: Food and Drug Administration, authorizing the marketing of food authorizations. We estimate that the
HHS. contact substances except when: (1) We amount of time for respondents to
ACTION: Notice. determine that the submission and complete the Form FDA 3480 for these
premarket review of a food additive types of submissions is 0.5 hours.
SUMMARY: The Food and Drug
petition (FAP) under section 409(b) of Section 171.1 of FDA’s regulations (21
Administration (FDA) is announcing
the FD&C Act is necessary to provide CFR 171.1) specifies the information
that a proposed collection of
adequate assurance of safety or (2) we that a petitioner must submit in order
information has been submitted to the
Office of Management and Budget and the manufacturer or supplier agree to: (1) Establish that the proposed use of
(OMB) for review and clearance under that an FAP should be submitted. an indirect food additive is safe and (2)
the Paperwork Reduction Act of 1995. Section 409(h)(1) of the FD&C Act secure the publication of an indirect
requires that a notification include: (1) food additive regulation in parts 175
DATES: Fax written comments on the
Information on the identity and the through 178 (21 CFR parts 175 through
collection of information by February
intended use of the food contact 178). Parts 175 through 178 describe the
22, 2016.
substance and (2) the basis for the conditions under which the additive
ADDRESSES: To ensure that comments on manufacturer’s or supplier’s
the information collection are received, may be safely used.
determination that the food contact
OMB recommends that written substance is safe under the intended In addition, FDA’s guidance
comments be faxed to the Office of conditions of use. document entitled, ‘‘Use of Recycled
Information and Regulatory Affairs, Sections 170.101 and 170.106 of Plastics in Food Packaging: Chemistry
OMB, Attn: FDA Desk Officer, FAX: FDA’s regulations (21 CFR 170.101 and Considerations,’’ provides assistance to
202–395–7285, or emailed to oira_ 170.106) specify the information that a manufacturers of food packaging in
submission@omb.eop.gov. All notification must contain and require evaluating processes for producing
comments should be identified with the that: (1) A food contact substance packaging from post-consumer recycled
OMB control number 0910–0495. Also notification (FCN) includes Form FDA plastic. The recommendations in the
include the FDA docket number found 3480 and (2) a notification for a food
in brackets in the heading of this guidance address the process by which
contact substance formulation includes manufacturers certify to us that their
document. Form FDA 3479. These forms serve to plastic products are safe for food
FOR FURTHER INFORMATION CONTACT: FDA summarize pertinent information in the contact.
PRA Staff, Office of Operations, Food notification. The forms facilitate both
and Drug Administration, 8455 preparation and review of notifications Description of Respondents: The
Colesville Rd., COLE–14526, Silver because the forms will serve to organize respondents to this information
Spring, MD 20993–0002, PRAStaff@ information necessary to support the collection are manufacturers of food
fda.hhs.gov. safety of the use of the food contact contact substances.
SUPPLEMENTARY INFORMATION: In substance. The burden of filling out the In the Federal Register of October 8,
compliance with 44 U.S.C. 3507, FDA appropriate form has been included in 2015 (80 FR 60911), FDA published a
has submitted the following proposed the burden estimate for the notification. 60-day notice requesting public
collection of information to OMB for Currently, interested persons transmit comment on the proposed collection of
review and clearance. an FCN submission to the Office of Food information. No comments were
Additive Safety in the Center for Food received.
Food Contact Substance Notification Safety and Applied Nutrition using
Program;—21 CFR 170.101, 170.106, Form FDA 3480 whether it is submitted We estimate the burden of this
and 171.1 OMB Control Number 0910– in electronic or paper format. We collection of information as follows:
0495—Extension estimate that the amount of time for
Section 409(h) of the Federal Food, respondents to complete Form FDA
Drug, and Cosmetic Act (the FD&C Act) 3480 will continue to be the same.

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
asabaliauskas on DSK9F6TC42PROD with NOTICES

Number of Average
FDA Number of Total annual
21 CFR Section or other category responses per burden per Total hours
Form No. respondents responses
respondent response

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

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Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Notices 3435

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
FDA Number of Total annual
21 CFR Section or other category responses per burden per Total hours
Form No. respondents responses
respondent response

Pre-notification Consultation or Master File FDA 3480 190 1 190 0.5 95
(concerning a food contact substance).8
Amendment to an existing notification FDA 100 1 100 0.5 50
(170.101), amendment to a Pre-notifica- 3480A.
tion 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.

Total ........................................................ ................ ........................ ........................ ........................ .......................... 31,320
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 in table 1 are based on reporting burden of 150 hours per Dated: January 14, 2016.
our current experience with the food response, for a total burden of 5,700 Leslie Kux,
contact substance notification program hours. Associate Commissioner for Policy.
and informal communication with In row 6 we estimate 190 respondents [FR Doc. 2016–01102 Filed 1–20–16; 8:45 am]
industry.
Beginning in row 1 we estimate 10 will submit information to a pre- BILLING CODE 4164–01–P

respondents will submit two notification consultation or a master file
notifications annually for food contact in support of FCN submission using
DEPARTMENT OF HEALTH AND
substance formulations (Form FDA Form FDA 3480. We calculate a
HUMAN SERVICES
3479), for a total of 20 responses. We reporting burden of 0.5 hours per
calculate a reporting burden of 2 hours response, for a total burden of 95 hours. Food and Drug Administration
per response, for a total of 40 hours. In In row 7 we estimate 100 respondents
[Docket No. FDA–2015–P–3319]
row 2 we estimate six respondents. We will submit an amendment (Form FDA
believe the hourly burden for preparing 3480A) to a substantive or non- Determination That MEVACOR
these notifications will primarily consist substantive request of additional (Lovastatin) Tablets, 20 Milligrams and
of the manufacturer or supplier information to an incomplete FCN 40 Milligrams, Were Not Withdrawn
completing Form FDA 3480, verifying submission, an amendment to a pre- From Sale for Reasons of Safety or
that a previous notification is effective notification consultation, or an Effectiveness
and preparing necessary documentation. amendment to a master file in support
We estimate one submission for each AGENCY: Food and Drug Administration,
of an FCN. We calculate a reporting
respondent, for a total of six responses. HHS.
burden of 0.5 hours per response, for a
We calculate a reporting burden of 25 total burden of 50 hours. ACTION: Notice.
hours per response, for a total of 150
hours. In row 8 we estimate one respondent SUMMARY: The Food and Drug
In rows 3, 4, and 5 we identify three will submit one indirect food additive Administration (FDA or Agency) has
tiers of FCNs that reflect different levels petition under § 171.1, for a total of one determined that MEVACOR (lovastatin)
of burden applicable to the respective response. We calculate a reporting tablets, 20 milligrams (mg) and 40 mg,
information collection items (denoted as burden of 10,995 hours per response, for were not withdrawn from sale for
Categories C, D, and E). We estimate 6 a total burden of 10,995 hours. reasons of safety or effectiveness. This
respondents will submit 2 Category C determination means that FDA will not
Finally, in row 9 we estimate ten begin procedures to withdraw approval
submissions annually, for a total of 12 respondents will utilize the
responses. We calculate a reporting of abbreviated new drug applications
recommendations in the guidance (ANDAs) that refer to these drug
burden of 120 hours per response, for a document entitled, ‘‘Use of Recycled
total burden of 1,440 hours. We estimate products, and it will allow FDA to
asabaliauskas on DSK9F6TC42PROD with NOTICES

Plastics in Food Packaging: Chemistry continue to approve ANDAs that refer to
42 respondents will submit 2 Category
Considerations,’’ to develop the the products as long as they meet
D submissions annually, for a total of 84
responses. We calculate a reporting additional information for one such relevant legal and regulatory
burden of 150 hours per response, for a submission annually, for a total of 10 requirements.
total burden of 12,600 hours. We responses. We calculate a reporting FOR FURTHER INFORMATION CONTACT: Kate
estimate 38 respondents will submit burden of 25 hours per response, for a Greenwood, Center for Drug Evaluation
1Category E submission annually, for a total burden of 250 hours. and Research, Food and Drug
total of 38 responses. We calculate a Administration, 10903 New Hampshire

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Document Created: 2018-02-02 12:33:36
Document Modified: 2018-02-02 12:33:36

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by February 22, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		81 FR 3434

81 FR 3434 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Contact Substance Notification Program

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 13 (January 21, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration