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, 24718-24720 [2017-11009]
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<![CDATA[
24718
Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
2017. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by July 14, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact CAPT Serina
Hunter-Thomas at least 7 days in
advance of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at:
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No FDA–2010–N–0258]
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
Food and Drug Administration,
sradovich on DSK3GMQ082PROD with NOTICES
HHS.
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the PRA), Federal Agencies are
SUMMARY:
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19:59 May 26, 2017
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ADDRESSES:
You may submit comments
Electronic Submissions
BILLING CODE 4164–01–P
ACTION:
Submit either electronic or
written comments on the collection of
information by July 31, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 31, 2017.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 31, 2017. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
as follows:
[FR Doc. 2017–10976 Filed 5–26–17; 8:45 am]
AGENCY:
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 FDA Form
3503.
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’’).
PO 00000
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Fmt 4703
Sfmt 4703
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2010–N–0258 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; Electronic
Submission Using Food and Drug
Administration Form 3503.’’ Received
comments, those filed in a timely
manner (see DATES), will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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
E:\FR\FM\30MYN1.SGM
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24719
Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov, 301–796–7726.
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.
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—Extension
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (the 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.
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.
Interested persons 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 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 FDA Form 3503 will continue
to be 1 hour.
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.
FDA estimates the burden of this
collection of information as follows:
sradovich on DSK3GMQ082PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section/FDA form
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Total
operating and
maintenance
costs
Color Additive Petitions
70.25, 71.1 ...............................................
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19:59 May 26, 2017
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2
PO 00000
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1
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2
E:\FR\FM\30MYN1.SGM
1,337
30MYN1
2,674
$5,600
24720
Federal Register / Vol. 82, No. 102 / Tuesday, May 30, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
21 CFR section/FDA form
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Total
operating and
maintenance
costs
Food Additive Petitions
171.1 ........................................................
FDA Form 3503 .......................................
3
6
1
1
3
6
7,093
1
21,279
6
0
0
Total ..................................................
........................
........................
........................
........................
23,959
$5,600
sradovich on DSK3GMQ082PROD with NOTICES
1 There
are no capital costs associated with this collection of information.
The estimate of burden for food
additive or color additive petitions is
based on FDA’s experience with the
petition process. The burden for this
information collection has changed
since the last OMB approval because the
Generally Recognized as Safe
affirmations have been removed
pursuant to the implementation of
‘‘Substances Generally Recognized as
Safe; Final Rule,’’ August 17, 2016 (81
FR 54960), 21 CFR parts 20, 25, 170,
184, 186, and 570. FDA is retaining its
prior estimate of the number of petitions
received because the average number of
petitions received annually has varied
little over the past 10 years. The figures
for hours per response are based on
estimates from experienced persons in
the Agency and in industry. Although
the estimated hour burden varies with
the type of petition submitted, an
average petition involves analytical
work and appropriate toxicological
studies, as well as the work of drafting
the petition itself. The burden varies
depending on the complexity of the
petition, including the amount and
types of data needed for scientific
analysis.
Color additives are subjected to
payment of fees for the petitioning
process. 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
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19:59 May 26, 2017
Jkt 241001
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 § 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: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11009 Filed 5–26–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2731]
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
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The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Pediatric Oncology Subcommittee of the
Oncologic Drugs Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
SUMMARY:
The public meeting will be held
on June 21, 2017, from 8 a.m. to 3:15
p.m. and June 22, 2017, from 8 a.m. to
12 noon.
DATES:
FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–2731.
The docket will close on June 20, 2017.
Submit either electronic or written
comments on this public meeting by
June 20, 2017. Late, untimely filed
comments will not be considered.
Electronic comments must be submitted
on or before June 20, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight eastern time, June 20, 2017.
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.
Comments received on or before June
7, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
ADDRESSES:
E:\FR\FM\30MYN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 102 (Tuesday, May 30, 2017)]
[Notices]
[Pages 24718-24720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11009]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No FDA-2010-N-0258]
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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (the 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 FDA Form 3503.
DATES: Submit either electronic or written comments on the collection
of information by July 31, 2017. Late, untimely filed comments will not
be considered. Electronic comments must be submitted on or before July
31, 2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of July 31,
2017. 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.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2010-N-0258 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; Electronic
Submission Using Food and Drug Administration Form 3503.'' Received
comments, those filed in a timely manner (see DATES), will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management 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 Division of Dockets Management. 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
[[Page 24719]]
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov, 301-796-
7726.
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.
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--
Extension
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
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.
Interested persons 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 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 FDA Form 3503 will
continue to be 1 hour.
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.
FDA estimates the burden of this collection of information as
follows:
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/FDA form respondents responses per responses per response Total hours maintenance
respondent costs
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Color Additive Petitions
--------------------------------------------------------------------------------------------------------------------------------------------------------
70.25, 71.1............................................. 2 1 2 1,337 2,674 $5,600
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[[Page 24720]]
Food Additive Petitions
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171.1................................................... 3 1 3 7,093 21,279 0
FDA Form 3503........................................... 6 1 6 1 6 0
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total............................................... .............. .............. .............. .............. 23,959 $5,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.
The estimate of burden for food additive or color additive
petitions is based on FDA's experience with the petition process. The
burden for this information collection has changed since the last OMB
approval because the Generally Recognized as Safe affirmations have
been removed pursuant to the implementation of ``Substances Generally
Recognized as Safe; Final Rule,'' August 17, 2016 (81 FR 54960), 21 CFR
parts 20, 25, 170, 184, 186, and 570. FDA is retaining its prior
estimate of the number of petitions received because the average number
of petitions received annually has varied little over the past 10
years. The figures for hours per response are based on estimates from
experienced persons in the Agency and in industry. Although the
estimated hour burden varies with the type of petition submitted, an
average petition involves analytical work and appropriate toxicological
studies, as well as the work of drafting the petition itself. The
burden varies depending on the complexity of the petition, including
the amount and types of data needed for scientific analysis.
Color additives are subjected to payment of fees for the
petitioning process. 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. 70.25 and Sec. 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: May 23, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11009 Filed 5-26-17; 8:45 am]
BILLING CODE 4164-01-P
