Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), Submission of Information to a Master File in Support of Petitions; and Electronic Submission Using Food and Drug Administration Form 3503, 15188-15190 [2020-05447]
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<![CDATA[
15188
Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB—Continued
OMB
Control
No.
Title of collection
Unique Device Identification System .......................................................................................................................
Animal Feed Regulatory Program Standards .........................................................................................................
Dated: March 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 18, 2020. 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.
Food and Drug Administration
Electronic Submissions
[FR Doc. 2020–05354 Filed 3–16–20; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2020–N–0908]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Submission of
Petitions: Food Additive, Color
Additive (Including Labeling),
Submission of Information to a Master
File in Support of Petitions; and
Electronic Submission Using Food and
Drug Administration Form 3503
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 provisions of FDA’s
regulations for submission of petitions,
including food and color additive
petitions (FAPs and CAPs) (including
labeling) submission of information to a
master file in support of petitions, and
electronic submission using Form FDA
3503.
DATES: Submit either electronic or
written comments on the collection of
information by May 18, 2020.
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 May 18, 2020.
The https://www.regulations.gov
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:32 Mar 16, 2020
Jkt 250001
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–
PO 00000
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0910–0720
0910–0760
Date
approval
expires
2/28/2023
2/28/2023
2020–N–0908 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Submission of Petitions: Food Additive,
Color Additive (Including Labeling),
Submission of Information to a Master
File in Support of Petitions; and
Electronic Submission Using Food and
Drug Administration Form 3503.’’
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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
E:\FR\FM\17MRN1.SGM
17MRN1
Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
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:
OMB Control Number 0910–0016—
Revision
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.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
khammond on DSKJM1Z7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:32 Mar 16, 2020
Jkt 250001
Submission of Petitions: Food Additive,
Color Additive (Including Labeling);
Submission of Information to a Master
File in Support of Petitions; Electronic
Submission Using FDA Form 3503—21
CFR 70.25, 71.1, 171.1, 172, 173, 179,
and 180
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe,
unless: (1) The additive and its use, or
intended use, are in conformity with a
regulation issued under § 409 that
describes the condition(s) under which
the additive may be safely used; (2) the
additive and its use, or intended use,
conform to the terms of an exemption
for investigational use; or (3) a food
contact notification submitted under
§ 409(h) is effective. FAPs are submitted
by individuals or companies to obtain
approval of a new food additive or to
amend the conditions of use permitted
under an existing food additive
regulation. Section 171.1 of FDA’s
regulations (21 CFR 171.1) specifies the
information that a petitioner must
submit in order to establish that the
proposed use of a food additive is safe
and to secure the publication of a food
additive regulation describing the
conditions under which the additive
may be safely used. Parts 172, 173, 179,
and 180 (21 CFR parts 172, 173, 179,
and 180) contain labeling requirements
for certain food additives to ensure their
safe use.
Section 721(a) of the FD&C Act (21
U.S.C. 379e(a)) provides that a color
additive shall be deemed to be unsafe
unless the additive and its use are in
conformity with a regulation that
describes the condition(s) under which
the additive may safely be used, or the
additive and its use conform to the
terms of an exemption for
investigational use issued under
§ 721(f). CAPs are submitted by
individuals or companies to obtain
approval of a new color additive or a
change in the conditions of use
permitted for a color additive that is
already approved. Section 71.1 of the
Agency’s regulations (21 CFR 71.1)
specifies the information that a
petitioner must submit to establish the
safety of a color additive and to secure
the issuance of a regulation permitting
its use. FDA’s color additive labeling
requirements in § 70.25 (21 CFR 70.25)
require that color additives that are to be
used in food, drugs, devices, or
cosmetics be labeled with sufficient
information to ensure their safe use.
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15189
FDA scientific personnel reviews
FAPs to ensure the safety of the
intended use of the additive in or on
food, or that may be present in food as
a result of its use in articles that contact
food. Likewise, FDA personnel review
CAPs to ensure the safety of the color
additive prior to its use in food, drugs,
cosmetics, or medical devices.
Respondents may transmit FAP or
CAP regulatory submissions in
electronic format or paper format to the
Office of Food Additive Safety in the
Center for Food Safety and Applied
Nutrition (CFSAN) using Form FDA
3503. Form FDA 3503 helps the
respondent organize their submission to
focus on the information needed for
FDA’s safety review. Form FDA 3503
can also be used to organize information
within a master file submitted in
support of petitions 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 the Agency,
thus minimizing paperwork burden for
food and color additive approvals. FDA
estimates that the amount of time for
respondents to complete Form FDA
3503 will continue to be 1 hour.
We are revising the information
collection to reflect ongoing
modernization efforts. We have
augmented our FDA Unified
Registration and Listing System
(FURLS) with the CFSAN Online
Submission Module (‘‘COSM’’). The
COSM provides a real-time user
interface process we believe will assist
respondents in preparing and making
submissions to Offices in CFSAN. The
COSM is a web-based tool that supports
electronic submissions, thereby
eliminating the need for printing and
mailing of paper submissions. COSM is
available 24 hours a day and seven days
a week. Information submitted to COSM
is the same information respondents
would submit to the FURLS system.
Information about COSM, including
user instruction, is available on the
internet at: https://www.fda.gov/food/
registration-food-facilities-and-othersubmissions/cfsan-online-submissionmodule-cosm.
Description of respondents:
Respondents are businesses engaged in
the manufacture or sale of food, food
ingredients, color additives, or
substances used in materials that come
into contact with food.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\17MRN1.SGM
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15190
Federal Register / Vol. 85, No. 52 / Tuesday, March 17, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
21 CFR section/form
Average
burden per
response
Total annual
responses
Total hours
Total
operating and
maintenance
costs
Color Additive Petitions
70.25, 71.1 ...............................................
2
1
2
1,337
2,674
$5,600
Food Additive Petitions
171.1 ........................................................
Form FDA 3503 .......................................
3
6
1
1
3
6
7,093
1
21,279
6
0
0
Total ..................................................
........................
........................
........................
........................
23,959
5,600
khammond on DSKJM1Z7X2PROD with NOTICES
1 There
are no capital costs associated with this collection of information.
Our estimate of burden attributable to
food additive or color additive petitions
is based on our experience with the
information collection, which has not
changed since our last review, and we
therefore retain the currently approved
burden. This estimate reflects the
average number of petitions we have
received annually over a period of 10
years. The attendant burden we estimate
also reflects an industry average,
although burden associated with
individual petitions may vary
depending on the complexity of the
petition, and the amount and type of
data needed for scientific analysis.
Color additive petitions are subject to
fees. The listing fee for a color additive
petition ranges from $1,600 to $3,000,
depending on the intended use of the
color additive and the scope of the
requested amendment. A complete
schedule of fees is set forth in § 70.19.
An average of one Category A and one
Category B color additive petition is
expected per year. The maximum color
additive petition fee for a Category A
petition is $2,600 and the maximum
color additive petition fee for a Category
B petition is $3,000. Because an average
of 2 CAPs are expected per calendar
year, the estimated total annual cost
burden to petitioners for this startup
cost would be less than or equal to
$5,600 ((1 × $2,600) + (1 × $3,000)
listing fees = $5,600). There are no
capital costs associated with CAPs. The
labeling requirements for food and color
additives were designed to specify the
minimum information needed for
labeling in order that food and color
manufacturers may comply with all
applicable provisions of the FD&C Act
and other specific labeling acts
administered by FDA. Label information
does not require any additional
information gathering beyond what is
already required to assure conformance
with all specifications and limitations in
any given food or color additive
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17:32 Mar 16, 2020
Jkt 250001
regulation. Label information does not
have any specific recordkeeping
requirements unique to preparing the
label. Therefore, because labeling
requirements under § 70.25 for a
particular color additive involve
information required as part of the CAP
safety review process, the estimate for
number of respondents is the same for
§§ 70.25 and 71.1, and the burden hours
for labeling are included in the estimate
for § 71.1. Also, because labeling
requirements under parts 172, 173, 179,
and 180 for particular food additives
involve information required as part of
the FAP safety review process under
§ 171.1, the burden hours for labeling
are included in the estimate for § 171.1.
Dated: March 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05447 Filed 3–16–20; 8:45 am]
BILLING CODE 4164–01–P
(HGH) imported from China for a
purpose other than the treatment of a
disease or other recognized medical
condition, the use of which had been
authorized by the Secretary of Health
and Human Services, and not pursuant
to an order of a physician, in violation
of the FD&C Act. The factual basis
supporting this felony conviction, as
described below, is conduct relating to
the importation into the United States of
a drug or controlled substance. Mr.
Lewicki was given notice of the
proposed debarment and, in accordance
with the FD&C Act and FDA’s
regulations, was given an opportunity to
request a hearing to show why he
should not be debarred. As of October
28, 2019 (30 days after receipt of the
notice), Mr. Lewicki had not responded.
Mr. Lewicki’s failure to respond and
request a hearing constitutes a waiver of
his right to a hearing concerning this
matter.
This order is applicable March
17, 2020.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of
Enforcement, Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, or at debarments@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
DATES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3131]
Jagen D. Lewicki: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Jagen Lewicki for a period of 5 years
from importing or offering for import
any drug into the United States. FDA
bases this order on a finding that Mr.
Lewicki was convicted, as defined in
the FD&C Act, of one felony count
under Federal law for conspiracy to
distribute Human Growth Hormone
SUMMARY:
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
I. Background
Section 306(b)(1)(D) of the FD&C Act
(21 U.S.C. 335a(b)(1)(D)) permits
debarment of an individual from
importing or offering for import any
drug into the United States if the FDA
finds, as required by section 306(b)(3)(C)
of the FD&C Act, that the individual has
E:\FR\FM\17MRN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 52 (Tuesday, March 17, 2020)]
[Notices]
[Pages 15188-15190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05447]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0908]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Submission of Petitions: Food Additive, Color Additive
(Including Labeling), Submission of Information to a Master File in
Support of Petitions; and Electronic Submission Using Food and Drug
Administration Form 3503
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 provisions of
FDA's regulations for submission of petitions, including food and color
additive petitions (FAPs and CAPs) (including labeling) submission of
information to a master file in support of petitions, and electronic
submission using Form FDA 3503.
DATES: Submit either electronic or written comments on the collection
of information by May 18, 2020.
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 May 18, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 18, 2020. 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-2020-N-0908 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Submission of Petitions: Food
Additive, Color Additive (Including Labeling), Submission of
Information to a Master File in Support of Petitions; and Electronic
Submission Using Food and Drug Administration Form 3503.'' 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the
[[Page 15189]]
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. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Submission of Petitions: Food Additive, Color Additive (Including
Labeling); Submission of Information to a Master File in Support of
Petitions; Electronic Submission Using FDA Form 3503--21 CFR 70.25,
71.1, 171.1, 172, 173, 179, and 180
OMB Control Number 0910-0016--Revision
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(a)) provides that a food additive shall be deemed
to be unsafe, unless: (1) The additive and its use, or intended use,
are in conformity with a regulation issued under Sec. 409 that
describes the condition(s) under which the additive may be safely used;
(2) the additive and its use, or intended use, conform to the terms of
an exemption for investigational use; or (3) a food contact
notification submitted under Sec. 409(h) is effective. FAPs are
submitted by individuals or companies to obtain approval of a new food
additive or to amend the conditions of use permitted under an existing
food additive regulation. Section 171.1 of FDA's regulations (21 CFR
171.1) specifies the information that a petitioner must submit in order
to establish that the proposed use of a food additive is safe and to
secure the publication of a food additive regulation describing the
conditions under which the additive may be safely used. Parts 172, 173,
179, and 180 (21 CFR parts 172, 173, 179, and 180) contain labeling
requirements for certain food additives to ensure their safe use.
Section 721(a) of the FD&C Act (21 U.S.C. 379e(a)) provides that a
color additive shall be deemed to be unsafe unless the additive and its
use are in conformity with a regulation that describes the condition(s)
under which the additive may safely be used, or the additive and its
use conform to the terms of an exemption for investigational use issued
under Sec. 721(f). CAPs are submitted by individuals or companies to
obtain approval of a new color additive or a change in the conditions
of use permitted for a color additive that is already approved. Section
71.1 of the Agency's regulations (21 CFR 71.1) specifies the
information that a petitioner must submit to establish the safety of a
color additive and to secure the issuance of a regulation permitting
its use. FDA's color additive labeling requirements in Sec. 70.25 (21
CFR 70.25) require that color additives that are to be used in food,
drugs, devices, or cosmetics be labeled with sufficient information to
ensure their safe use.
FDA scientific personnel reviews FAPs to ensure the safety of the
intended use of the additive in or on food, or that may be present in
food as a result of its use in articles that contact food. Likewise,
FDA personnel review CAPs to ensure the safety of the color additive
prior to its use in food, drugs, cosmetics, or medical devices.
Respondents may transmit FAP or CAP regulatory submissions in
electronic format or paper format to the Office of Food Additive Safety
in the Center for Food Safety and Applied Nutrition (CFSAN) using Form
FDA 3503. Form FDA 3503 helps the respondent organize their submission
to focus on the information needed for FDA's safety review. Form FDA
3503 can also be used to organize information within a master file
submitted in support of petitions 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 the Agency, thus minimizing
paperwork burden for food and color additive approvals. FDA estimates
that the amount of time for respondents to complete Form FDA 3503 will
continue to be 1 hour.
We are revising the information collection to reflect ongoing
modernization efforts. We have augmented our FDA Unified Registration
and Listing System (FURLS) with the CFSAN Online Submission Module
(``COSM''). The COSM provides a real-time user interface process we
believe will assist respondents in preparing and making submissions to
Offices in CFSAN. The COSM is a web-based tool that supports electronic
submissions, thereby eliminating the need for printing and mailing of
paper submissions. COSM is available 24 hours a day and seven days a
week. Information submitted to COSM is the same information respondents
would submit to the FURLS system. Information about COSM, including
user instruction, is available on the internet at: https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm.
Description of respondents: Respondents are businesses engaged in
the manufacture or sale of food, food ingredients, color additives, or
substances used in materials that come into contact with food.
We estimate the burden of this collection of information as
follows:
[[Page 15190]]
Table 1--Estimated Annual Reporting Burden \1\
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Total
Number of Number of Total annual Average burden operating and
21 CFR section/form respondents responses per responses per response Total hours maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Color Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1............................................. 2 1 2 1,337 2,674 $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
Food Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
171.1................................................... 3 1 3 7,093 21,279 0
Form FDA 3503........................................... 6 1 6 1 6 0
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. 23,959 5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
Our estimate of burden attributable to food additive or color
additive petitions is based on our experience with the information
collection, which has not changed since our last review, and we
therefore retain the currently approved burden. This estimate reflects
the average number of petitions we have received annually over a period
of 10 years. The attendant burden we estimate also reflects an industry
average, although burden associated with individual petitions may vary
depending on the complexity of the petition, and the amount and type of
data needed for scientific analysis.
Color additive petitions are subject to fees. The listing fee for a
color additive petition ranges from $1,600 to $3,000, depending on the
intended use of the color additive and the scope of the requested
amendment. A complete schedule of fees is set forth in Sec. 70.19. An
average of one Category A and one Category B color additive petition is
expected per year. The maximum color additive petition fee for a
Category A petition is $2,600 and the maximum color additive petition
fee for a Category B petition is $3,000. Because an average of 2 CAPs
are expected per calendar year, the estimated total annual cost burden
to petitioners for this startup cost would be less than or equal to
$5,600 ((1 x $2,600) + (1 x $3,000) listing fees = $5,600). There are
no capital costs associated with CAPs. The labeling requirements for
food and color additives were designed to specify the minimum
information needed for labeling in order that food and color
manufacturers may comply with all applicable provisions of the FD&C Act
and other specific labeling acts administered by FDA. Label information
does not require any additional information gathering beyond what is
already required to assure conformance with all specifications and
limitations in any given food or color additive regulation. Label
information does not have any specific recordkeeping requirements
unique to preparing the label. Therefore, because labeling requirements
under Sec. 70.25 for a particular color additive involve information
required as part of the CAP safety review process, the estimate for
number of respondents is the same for Sec. Sec. 70.25 and 71.1, and
the burden hours for labeling are included in the estimate for Sec.
71.1. Also, because labeling requirements under parts 172, 173, 179,
and 180 for particular food additives involve information required as
part of the FAP safety review process under Sec. 171.1, the burden
hours for labeling are included in the estimate for Sec. 171.1.
Dated: March 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05447 Filed 3-16-20; 8:45 am]
BILLING CODE 4164-01-P
