Agency Information Collection Activities; Proposed Collection; Comment Request; Food Contact Substance Notification Program, 46493-46496 [2018-19898]
Download as PDF
<![CDATA[
46493
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondents
Number of
respondents
Form name
57.319 Hemovigilance Adverse Reaction—Unknown Transfusion Reaction.
57.320 Hemovigilance Adverse Reaction—Other Transfusion Reaction.
57.400 Outpatient Procedure Component—Annual Facility
Survey.
57.401 Outpatient Procedure Component—Monthly Reporting Plan.
57.402 Outpatient Procedure Component Same Day Outcome Measures.
57.403 Outpatient Procedure Component—Monthly Denominators for Same Day Outcome Measures.
57.404 Outpatient Procedure Component—SSI Denominator.
57.405 Outpatient Procedure Component—Surgical Site
(SSI) Event.
57.500 Outpatient Dialysis Center Practices Survey .............
57.501 Dialysis Monthly Reporting Plan ................................
57.502 Dialysis Event .............................................................
57.503 Denominator for Outpatient Dialysis ..........................
57.504 Prevention Process Measures Monthly Monitoring
for Dialysis.
57.505 Dialysis Patient Influenza Vaccination .......................
57.506 Dialysis Patient Influenza Vaccination Denominator
57.507 Home Dialysis Center Practices Survey ....................
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–19902 Filed 9–12–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0294]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Contact
Substance Notification Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Electronic Submissions
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:20 Sep 12, 2018
response to the notice. This notice
solicits comments on the information
collection associated with the Food
Contact Substance Notification Program.
DATES: Submit either electronic or
written comments on the collection of
information by November 13, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before November 13,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of November 13, 2018.
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.
Jkt 244001
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
PO 00000
Frm 00018
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Average
burden per
response
(in hours)
500
1
20/60
500
1
20/60
5,000
1
10/60
5,000
12
20/60
1,200
25
40/60
1,200
12
40/60
5,000
540
10/60
5,000
36
35/60
7,000
7,000
7,000
7,000
2,000
1
12
60
12
12
127/60
5/60
25/60
10/60
85/60
325
325
350
75
5
1
10/60
10/60
30/60
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–N–0294 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
E:\FR\FM\13SEN1.SGM
13SEN1
daltland on DSKBBV9HB2PROD with NOTICES
46494
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
Contact Substance Notification
Program.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.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
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
VerDate Sep<11>2014
19:20 Sep 12, 2018
Jkt 244001
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Food Contact Substance Notification
Program—21 CFR 170.101, 170.106,
and 171.1
OMB Control Number 0910–0495—
Extension
This information collection supports
FDA regulations regarding Food Contact
Substance Notification, as well as
associated guidance and accompanying
forms. Section 409(h) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(h)) establishes a
premarket notification process for food
contact substances. Section 409(h)(6) of
the FD&C Act defines a ‘‘food contact
substance’’ as ‘‘any substance intended
for use as a component of materials used
in manufacturing, packing, packaging,
transporting, or holding food if such use
is not intended to have any technical
effect in such food.’’ Section 409(h)(3) of
the FD&C Act requires that the
notification process be used for
authorizing the marketing of food
contact substances except when: (1) We
determine that the submission and
premarket review of a food additive
PO 00000
Frm 00019
Fmt 4703
Sfmt 4703
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
E:\FR\FM\13SEN1.SGM
13SEN1
46495
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
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/Guidance
Regulation/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 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).
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA form
No.
21 CFR section; activity
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
3479
3480
3480
3480
3480
3480
Total annual
responses
Average
burden per
response
Total hours
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
40
150
1,440
12,600
5,700
95
100
1
100
*0.5
50
1
10
1
1
1
10
10,995
25
10,995
250
2
1
2
5
10
........................
....................
....................
....................
31,330
FDA 3480A
N/A
N/A
Total ....................................................................
Number of
responses
per
respondent
Number of
respondents
daltland on DSKBBV9HB2PROD with NOTICES
* 30 minutes.
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
VerDate Sep<11>2014
19:20 Sep 12, 2018
Jkt 244001
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
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
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
E:\FR\FM\13SEN1.SGM
13SEN1
46496
Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Notices
daltland on DSKBBV9HB2PROD with NOTICES
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 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
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: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
Current Good Manufacturing Practice
and Hazard Analysis and Risk-Based
Preventive Controls for Food for
Animals—21 CFR Part 507
[FR Doc. 2018–19898 Filed 9–12–18; 8:45 am]
BILLING CODE 4164–01–P
OMB Control Number 0910–0789—
Extension
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1857]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Current Good
Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive
Controls for Food for Animals
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 October 15,
2018.
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 0910–0789. 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.
SUMMARY:
The information collection supports
FDA regulations. As amended by the
FDA Food Safety Modernization Act
(FSMA) (Pub. L. 111–353), the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) enables the Agency to better protect
the public health by helping to ensure
the safety and security of the food
supply. It enables FDA to focus more on
preventing food safety problems rather
than relying primarily on reacting to
problems after they occur. FSMA
recognizes the important role industry
plays in ensuring the safety of the food
supply, including the adoption of
modern systems of preventive controls
in food production. Specifically, section
418 (21 U.S.C. 350g) of the FD&C Act
sets forth requirements for hazard
analysis and risk-based preventive
controls for facilities that produce food
for animals. To implement these
provisions, regulations were codified
under 21 CFR part 507—Current Good
Manufacturing Practice, Hazard
Analysis, And Risk-Based Preventive
Controls For Food For Animals. The
regulations establish requirements for a
written food safety plan; hazard analysis
preventive controls; monitoring;
corrective actions and corrections;
verification; supply-chain program;
recall plan; and associated records and
became effective November 16, 2015.
Currently, we continue to evaluate
burden associated with the information
collection requirements however, for
purposes of extending the information
collection we retain the currently
approved figures as shown in the
following tables.
In the Federal Register of May 24,
2018 (83 FR 24124), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. We received three
comments, however none pertained to
the information collection or underlying
regulations.
We estimate our burden of the
information collection as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section; activity
507.7 exemption: submit attestation of preventive controls or compliance with
State and local laws (non-federal).
VerDate Sep<11>2014
19:20 Sep 12, 2018
Jkt 244001
PO 00000
Frm 00021
Fmt 4703
1,120
Sfmt 4703
Number of
responses
per
respondent
Total annual
responses
0.5
E:\FR\FM\13SEN1.SGM
560
Average
burden per response
0.5 (30 minutes) .............
13SEN1
Total hours
280
]]>Agencies
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)]
[Notices]
[Pages 46493-46496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19898]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0294]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Contact Substance Notification Program
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection associated with
the Food Contact Substance Notification Program.
DATES: Submit either electronic or written comments on the collection
of information by November 13, 2018.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 13, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2012-N-0294 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food
[[Page 46494]]
Contact Substance Notification Program.'' Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Food Contact Substance Notification Program--21 CFR 170.101, 170.106,
and 171.1
OMB Control Number 0910-0495--Extension
This information collection supports FDA regulations regarding Food
Contact Substance Notification, as well as associated guidance and
accompanying forms. Section 409(h) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 348(h)) establishes a premarket
notification process for food contact substances. Section 409(h)(6) of
the FD&C Act defines a ``food contact substance'' as ``any substance
intended for use as a component of materials used in manufacturing,
packing, packaging, transporting, or holding food if such use is not
intended to have any technical effect in such food.'' Section 409(h)(3)
of the FD&C Act requires that the notification process be used for
authorizing the marketing of food contact substances except when: (1)
We determine that the submission and premarket review of a food
additive petition (FAP) under section 409(b) of the FD&C Act is
necessary to provide adequate assurance of safety or (2) we and the
manufacturer or supplier agree that an FAP should be submitted. Section
409(h)(1) of the FD&C Act requires that a notification include: (1)
Information on the identity and the intended use of the food contact
substance and (2) the basis for the manufacturer's or supplier's
determination that the food contact substance is safe under the
intended conditions of use.
Sections 170.101 and 170.106 of FDA's regulations (21 CFR 170.101
and 170.106) specify the information that a notification must contain
and require that: (1) A food contact substance notification (FCN)
includes Form FDA 3480 and (2) a notification for a food contact
substance formulation includes Form FDA 3479. These forms serve to
summarize pertinent information in the notification. The forms
facilitate both preparation and review of notifications because the
forms will serve to organize information necessary to support the
safety of the use of the food contact substance. The burden of filling
out the appropriate form has been included in the burden estimate for
the notification.
Currently, interested persons transmit an FCN submission to the
Office of Food Additive Safety in the Center for Food Safety and
Applied Nutrition using Form FDA 3480 whether it is submitted in
electronic or paper format. We estimate that the amount of time for
respondents to complete Form FDA 3480 will continue to be the same.
In addition to its required use with FCNs, Form FDA 3480 is
recommended to be used to organize information within a Pre-
notification Consultation or Master File submitted in support of an FCN
according to the items listed on the form. Master Files can be used as
repositories for information that can be referenced in multiple
submissions to FDA, thus minimizing paperwork burden for food contact
substance authorizations. We estimate that the amount of time for
respondents to complete the Form FDA 3480 for these types of
submissions is 0.5 hours.
FDA recommends using Form FDA 3480A for each submission of
additional information (i.e., amendment) to an FCN submission 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
[[Page 46495]]
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 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 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).
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Number of responses Total Average
21 CFR section; activity FDA form No. respondents per annual burden per Total hours
respondent responses 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
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 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.
Preparation of Food Contact Notifications for ................................... 2 1 2 5 10
Food Contact Substances in Contact with Infant
Formula and/or Human Milk.
-------------------------------------------------------------------
Total...................................... ................................... .............. ........... ........... ........... 31,330
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 30 minutes.
\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
[[Page 46496]]
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 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: September 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19898 Filed 9-12-18; 8:45 am]
BILLING CODE 4164-01-P
