Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting, 15848-15850 [2018-07545]
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15848
Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
SUPPLEMENTARY INFORMATION:
I. Background
FDA has explained and clarified,
through the guidance entitled, ‘‘The
510(k) Program: Evaluating Substantial
Equivalence in Premarket Notifications
[510(k)]’’ (Ref. 1), how it makes
substantial equivalence decisions under
section 513(i)(1)(A) of the Federal, Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360c(i)(1)(A)). Substantial
equivalence is rooted in comparisons
between new devices and predicate
devices. However, the FD&C Act does
not preclude FDA from using
performance criteria to facilitate this
comparison. If a legally marketed device
performs at certain levels relevant to its
safety and effectiveness, and a new
device meets or exceeds those levels of
performance for the same
characteristics, FDA could find the new
device as safe and effective as the
legally marketed device. Instead of
reviewing data from direct comparison
testing between the two devices, FDA
could support a finding of substantial
equivalence with data showing the new
device meets or exceeds the level of
performance of appropriate predicate
device(s). Under the approach expanded
in this guidance, a submitter could
satisfy the requirement to compare its
device with a legally marketed device
by, among other things, demonstrating
conformance to performance criteria
established in FDA-recognized
consensus standards, FDA guidance,
and/or special controls.
Use of this approach may also
streamline the review of 510(k)
submissions, thereby reducing burdens
on the Agency and possibly review
times on individual submissions. In
addition, this approach may facilitate
healthcare professionals and patients
making better informed decisions, by
helping ensure a device cleared through
this pathway meets a transparent set of
performance criteria. At the same time,
this approach satisfies the statutory
standard for demonstrating substantial
equivalence. As a result, this expanded
approach is intended to promote the
public health by helping patients gain
more timely access to new medical
devices that are high quality, safe, and
effective. FDA welcomes public input
on device types for which FDA should
consider identifying performance
criteria and evidence-based suggestions
on what the performance criteria should
be.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The draft
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guidance, when finalized, will represent
the current thinking of FDA on
‘‘Expansion of the Abbreviated 510(k)
Program: Demonstrating Substantial
Equivalence Through Performance
Criteria; Draft Guidance for Industry and
Food and Drug Administration Staff.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations. This guidance is not subject
to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
draft guidance document is also
available at either https://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
default.htm or https://
www.regulations.gov. Persons unable to
download an electronic copy of
‘‘Expansion of the Abbreviated 510(k)
Program: Demonstrating Substantial
Equivalence Through Performance
Criteria; Draft Guidance for Industry and
Food and Drug Administration Staff’’
may send an email request to CDRHGuidance@fda.hhs.gov to receive an
electronic copy of the document. Please
use the document number 17038 to
identify the guidance you are
requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations
and guidance. These collections of
information are subject to review by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520). The
collections of information in 21 CFR
807, subpart E have been approved
under OMB control number 0910–0120
and the collections of information in the
guidance document ‘‘Requests for
Feedback on Medical Device
Submissions: The Pre-Submission
Program and Meetings with Food and
Drug Administration Staff’’ have been
approved under OMB control number
0910–0756.
V. Reference
The following reference is on display
in the Dockets Management Staff (see
ADDRESSES) and is available for viewing
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by interested persons between 9 a.m.
and 4 p.m., Monday through Friday; it
is also available electronically at https://
www.regulations.gov. FDA has verified
the website address, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. ‘‘The 510(k) Program: Evaluating
Substantial Equivalence in Premarket
Notifications [510(k)]—Guidance for
Industry and Food and Drug
Administration Staff,’’ July 28, 2014,
available at: https://www.fda.gov/
MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/
UCM284443.
Dated: April 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07564 Filed 4–11–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1030]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food Allergen
Labeling and Reporting
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 May 14,
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 0910–0792. Also
include the FDA docket number found
in brackets in the heading of this
document.
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
SUMMARY:
E:\FR\FM\12APN1.SGM
12APN1
Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices
20852, 301–796–5733, 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.
sradovich on DSK3GMQ082PROD with NOTICES
Food Allergen Labeling and Reporting
OMB Control Number 0910–0792—
Extension
This information collection supports
third-party disclosure requirements of
food allergen labeling, as well as the
reporting associated with the
submission of petitions and
notifications seeking exemptions from
the labeling requirements for
ingredients derived from major food
allergens under section 403(w)(6) and
(7) of the FD&C Act (21 U.S.C. 343(w)(6)
and (7)). The Food Allergen Labeling
and Consumer Protection Act of 2004
(FALCPA) (Title II, Pub. L. 108–282)
amended the FD&C Act by defining the
term ‘‘major food allergen’’ and stating
that foods regulated under the FD&C Act
are misbranded unless they declare the
presence of each major food allergen on
the product label using the name of the
food source from which the major food
allergen is derived. Section 403(w)(1) of
the FD&C Act sets forth the
requirements for declaring the presence
of each major food allergen on the
product label. Section 201(qq) of the
FD&C Act (21 U.S.C. 321(qq)) defines a
major food allergen as ‘‘[m]ilk, egg, fish
(e.g., bass, flounder, or cod), Crustacean
shellfish (e.g., crab, lobster, or shrimp),
tree nuts (e.g., almonds, pecans, or
walnuts), wheat, peanuts, and
soybeans’’ and also as a food ingredient
that contains protein derived from such
foods. The definition excludes any
highly refined oil derived from a major
food allergen and any ingredient
derived from such highly refined oil.
In some cases, the production of an
ingredient derived from a major food
allergen may alter or eliminate the
allergenic proteins in that derived
ingredient to such an extent that it does
not contain allergenic protein. In
addition, a major food allergen may be
used as an ingredient or as a component
of an ingredient such that the level of
allergenic protein in finished food
products does not cause an allergic
response that poses a risk to human
health. Therefore, FALCPA provides
two mechanisms through which such
ingredients may become exempt from
the labeling requirement of section
403(w)(1) of the FD&C Act. An
ingredient may obtain an exemption
through submission and approval of a
petition containing scientific evidence
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that demonstrates that the ingredient
‘‘does not cause an allergic response
that poses a risk to human health’’
(section 403(w)(6) of the FD&C Act).
Alternately, an ingredient may become
exempt through submission of a
notification containing scientific
evidence showing that the ingredient
‘‘does not contain allergenic protein’’ or
that there has been a previous
determination through a premarket
approval process under section 409 of
the FD&C Act (21 U.S.C. 348) that the
ingredient ‘‘does not cause an allergic
response that poses a risk to human
health’’ (section 403(w)(7) of the FD&C
Act).
A. Third-Party Disclosure
The labeling requirements of section
403(w)(1) of the FD&C Act apply to all
packaged foods sold in the United States
that are regulated under the FD&C Act,
including both domestically
manufactured and imported foods. As
noted, section 403(w)(1) of the FD&C
Act requires that the label of a food
product declare the presence of each
major food allergen. We estimate the
information collection burden of the
third-party disclosure associated with
food allergen labeling under section
403(w)(1) of the FD&C Act as the time
needed for a manufacturer to review the
labels of new or reformulated products
for compliance with the requirements of
section 403(w)(1) of the FD&C Act and
the time needed to make any needed
modifications to the labels of those
products.
The primary user of the allergen
information disclosed on the label or
labeling of food products is the
consumer that purchases the food
product. Consumers will use the
information to help them make choices
concerning their purchase of a food
product, including choices related to
substances that the consumer wishes to
avoid due to their potential to cause
adverse reactions. Additionally, we
intend to use the information to
determine whether a manufacturer or
other supplier of food products is
meeting its statutory obligations. Failure
of a manufacturer or other supplier of
food products to label its products in
compliance with section 403(w)(1) of
the FD&C Act may result in a product
being misbranded under the FD&C Act
and the manufacturer or packer and the
product subject to regulatory action.
B. Reporting
Under section 403(w)(6) and (7) of the
FD&C Act, interested parties may
request from us a determination that an
ingredient is exempt from the labeling
requirement of section 403(w)(1) of the
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15849
FD&C Act. An ingredient may obtain an
exemption through submission and
approval of a petition containing
scientific evidence that demonstrates
that the ingredient ‘‘does not cause an
allergic response that poses a risk to
human health’’ (section 403(w)(6) of the
FD&C Act). This section also states that
the burden shall be on the petitioner to
provide scientific evidence (including
the analytical method used to produce
the evidence) that demonstrates that
such food ingredient, as derived by the
method specified in the petition, does
not cause an allergic response that poses
a risk to human health. Alternately, an
ingredient may become exempt through
submission of a notification containing
scientific evidence showing that the
ingredient ‘‘does not contain allergenic
protein’’ or that there has been a
previous determination through a
premarket approval process under
section 409 of the FD&C Act that the
ingredient ‘‘does not cause an allergic
response that poses a risk to human
health’’ (section 403(w)(7) of the FD&C
Act).
Our document entitled ‘‘Food
Allergen Labeling Exemption Petitions
and Notifications: Guidance for
Industry,’’ sets forth our
recommendations with regard to the
information that an interested party
should submit in such a petition or
notification. The guidance states that to
evaluate these petitions and
notifications, we will consider scientific
evidence that describes: (1) The identity
or composition of the ingredient; (2) the
methods used to produce the ingredient;
(3) the methods used to characterize the
ingredient; (4) the intended use of the
ingredient in food; and (5) either (a) for
a petition—data and information,
including the expected level of
consumer exposure to the ingredient,
that demonstrate that the ingredient,
when manufactured and used as
described, does not cause an allergic
response that poses a risk to human
health; or (b) for a notification, data and
information that demonstrate that the
ingredient, when manufactured as
described, does not contain allergenic
protein, or documentation of a previous
determination under a process under
section 409 of the FD&C Act that the
ingredient does not cause an allergic
response that poses a risk to human
health.
We use information submitted in
petitions and notifications to determine
whether the ingredient satisfies the
criteria of section 403(w)(6) and (7) of
the FD&C Act for granting the
exemption.
In the Federal Register of December
12, 2017 (82 FR 58407), we published a
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12APN1
15850
Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices
60-day notice inviting public comment
on the proposed extension of this
collection of information. One comment
was received that expressed support for
the information collection but did not
otherwise respond to the topics
solicited, nor did the comment suggest
we revise our burden estimate. We
therefore retain the currently approved
estimate of the associated burden for the
information collection, which is as
follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
403(w)(1); review labels for compliance with food allergen
labeling requirements .......................................................
403(w)(1); redesign labels to comply with food allergen labeling requirements ..........................................................
Total ..............................................................................
1There
Number of
disclosures
per
respondent
Number of
respondents
FD&C act section/activity
Average
burden per
disclosure
Total annual
disclosures
Total hours
77,500
1
77,500
1
77,500
3,875
1
3,875
16
62,000
........................
........................
........................
........................
139,500
are no capital costs or operating and maintenance costs associated with this collection of information.
Using a labeling cost model to
estimate the number of new or
reformulated products sold in the
United States, annually, that are affected
by the requirements of section 403(w)(1)
of the FD&C Act, we estimate there are
690,000 Universal Product Codes
(UPCs) of FDA-regulated foods and
approximately 85,000 UPCs of FDAregulated dietary supplements for a total
of 775,000 UPCs. We assume an annual
entry rate of 10 percent for new or
reformulated UPCs (77,500), and assume
5 percent of labels may be redesigned
(3,875). We estimate an average burden
for the review of labels for compliance
with the food allergen labeling
requirements under section 403(w)(1) of
the FD&C Act to be 1 hour, and we
estimate 16 hours for the redesign of a
label. Together we estimate a total
annual hourly burden of 139,500 in
third-party disclosure.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
FD&C act section/activity
Average
burden per
response
Total annual
responses
Total hours
403(w)(6); petition for exemption .........................................
403(w)(7); notification ..........................................................
5
5
1
1
5
5
100
68
500
340
Total ..............................................................................
........................
........................
........................
........................
840
sradovich on DSK3GMQ082PROD with NOTICES
1There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the number of petitions and
notifications received in recent years,
we assume that we will receive five
petitions and five notifications
annually, over the next 3 years.
Assuming an association of one
respondent to each petition or
notification, we estimate that five
respondents will each submit one
petition and five respondents will each
submit one notification, as reported in
table 2, rows 1 and 2.
We base our estimate of the average
burdens per response reported in table
2 on our experience with other petition
processes. We estimate that a petition
would take, on average, 100 hours to
develop and submit. Therefore, we
estimate that the burden associated with
petitions will be 500 hours annually (5
petitions × 100 hours per petition).
The burden of a notification involves
collecting documentation that a food
ingredient does not pose an allergen
risk. Either we can make a
determination that the ingredient does
not cause an allergic response that poses
a risk to human health under a
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Jkt 244001
premarket approval or notification
program under section 409 of the FD&C
Act, or the respondent would submit
scientific evidence demonstrating that
the ingredient when manufactured as
described does not contain allergenic
protein. We estimate that it would take
a respondent 20 hours to prepare and
submit a notification based on our
determination under a process under
section 409 of the FD&C Act that the
ingredient does not cause an allergic
response. We estimate that it would take
a respondent approximately 100 hours
to prepare a notification submitting
scientific evidence (including the
analytical method used) that
demonstrates that the food ingredient
(as derived by the method specified in
the notification, where applicable) does
not contain allergenic protein. We have
no data on how many notifications
would be based on our determination
that the ingredient does not cause an
allergic response or based on scientific
evidence that demonstrates that the food
ingredient does not contain allergenic
protein. Therefore, we estimate that
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Fmt 4703
Sfmt 9990
three of the five notifications would be
based on scientific evidence, and two of
the five notifications would be based on
our determination. The average time per
notification is then estimated to be 68
hours (2 × 20 hours + 3 × 100 hours)/
5). Therefore, we estimate that the
burden associated with notifications
will be 340 hours annually (5
notifications × 68 hours per
notification), as reported in table 2. The
burden estimate has not increased since
the initial OMB approval.
Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07545 Filed 4–11–18; 8:45 am]
BILLING CODE 4164–01–P
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12APN1
]]>Agencies
[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)]
[Notices]
[Pages 15848-15850]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07545]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1030]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food Allergen
Labeling and Reporting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by May 14,
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 [email protected]. All
comments should be identified with the OMB control number 0910-0792.
Also include the FDA docket number found in brackets in the heading of
this document.
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
[[Page 15849]]
20852, 301-796-5733, [email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Food Allergen Labeling and Reporting
OMB Control Number 0910-0792--Extension
This information collection supports third-party disclosure
requirements of food allergen labeling, as well as the reporting
associated with the submission of petitions and notifications seeking
exemptions from the labeling requirements for ingredients derived from
major food allergens under section 403(w)(6) and (7) of the FD&C Act
(21 U.S.C. 343(w)(6) and (7)). The Food Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA) (Title II, Pub. L. 108-282) amended the
FD&C Act by defining the term ``major food allergen'' and stating that
foods regulated under the FD&C Act are misbranded unless they declare
the presence of each major food allergen on the product label using the
name of the food source from which the major food allergen is derived.
Section 403(w)(1) of the FD&C Act sets forth the requirements for
declaring the presence of each major food allergen on the product
label. Section 201(qq) of the FD&C Act (21 U.S.C. 321(qq)) defines a
major food allergen as ``[m]ilk, egg, fish (e.g., bass, flounder, or
cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts
(e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans'' and
also as a food ingredient that contains protein derived from such
foods. The definition excludes any highly refined oil derived from a
major food allergen and any ingredient derived from such highly refined
oil.
In some cases, the production of an ingredient derived from a major
food allergen may alter or eliminate the allergenic proteins in that
derived ingredient to such an extent that it does not contain
allergenic protein. In addition, a major food allergen may be used as
an ingredient or as a component of an ingredient such that the level of
allergenic protein in finished food products does not cause an allergic
response that poses a risk to human health. Therefore, FALCPA provides
two mechanisms through which such ingredients may become exempt from
the labeling requirement of section 403(w)(1) of the FD&C Act. An
ingredient may obtain an exemption through submission and approval of a
petition containing scientific evidence that demonstrates that the
ingredient ``does not cause an allergic response that poses a risk to
human health'' (section 403(w)(6) of the FD&C Act). Alternately, an
ingredient may become exempt through submission of a notification
containing scientific evidence showing that the ingredient ``does not
contain allergenic protein'' or that there has been a previous
determination through a premarket approval process under section 409 of
the FD&C Act (21 U.S.C. 348) that the ingredient ``does not cause an
allergic response that poses a risk to human health'' (section
403(w)(7) of the FD&C Act).
A. Third-Party Disclosure
The labeling requirements of section 403(w)(1) of the FD&C Act
apply to all packaged foods sold in the United States that are
regulated under the FD&C Act, including both domestically manufactured
and imported foods. As noted, section 403(w)(1) of the FD&C Act
requires that the label of a food product declare the presence of each
major food allergen. We estimate the information collection burden of
the third-party disclosure associated with food allergen labeling under
section 403(w)(1) of the FD&C Act as the time needed for a manufacturer
to review the labels of new or reformulated products for compliance
with the requirements of section 403(w)(1) of the FD&C Act and the time
needed to make any needed modifications to the labels of those
products.
The primary user of the allergen information disclosed on the label
or labeling of food products is the consumer that purchases the food
product. Consumers will use the information to help them make choices
concerning their purchase of a food product, including choices related
to substances that the consumer wishes to avoid due to their potential
to cause adverse reactions. Additionally, we intend to use the
information to determine whether a manufacturer or other supplier of
food products is meeting its statutory obligations. Failure of a
manufacturer or other supplier of food products to label its products
in compliance with section 403(w)(1) of the FD&C Act may result in a
product being misbranded under the FD&C Act and the manufacturer or
packer and the product subject to regulatory action.
B. Reporting
Under section 403(w)(6) and (7) of the FD&C Act, interested parties
may request from us a determination that an ingredient is exempt from
the labeling requirement of section 403(w)(1) of the FD&C Act. An
ingredient may obtain an exemption through submission and approval of a
petition containing scientific evidence that demonstrates that the
ingredient ``does not cause an allergic response that poses a risk to
human health'' (section 403(w)(6) of the FD&C Act). This section also
states that the burden shall be on the petitioner to provide scientific
evidence (including the analytical method used to produce the evidence)
that demonstrates that such food ingredient, as derived by the method
specified in the petition, does not cause an allergic response that
poses a risk to human health. Alternately, an ingredient may become
exempt through submission of a notification containing scientific
evidence showing that the ingredient ``does not contain allergenic
protein'' or that there has been a previous determination through a
premarket approval process under section 409 of the FD&C Act that the
ingredient ``does not cause an allergic response that poses a risk to
human health'' (section 403(w)(7) of the FD&C Act).
Our document entitled ``Food Allergen Labeling Exemption Petitions
and Notifications: Guidance for Industry,'' sets forth our
recommendations with regard to the information that an interested party
should submit in such a petition or notification. The guidance states
that to evaluate these petitions and notifications, we will consider
scientific evidence that describes: (1) The identity or composition of
the ingredient; (2) the methods used to produce the ingredient; (3) the
methods used to characterize the ingredient; (4) the intended use of
the ingredient in food; and (5) either (a) for a petition--data and
information, including the expected level of consumer exposure to the
ingredient, that demonstrate that the ingredient, when manufactured and
used as described, does not cause an allergic response that poses a
risk to human health; or (b) for a notification, data and information
that demonstrate that the ingredient, when manufactured as described,
does not contain allergenic protein, or documentation of a previous
determination under a process under section 409 of the FD&C Act that
the ingredient does not cause an allergic response that poses a risk to
human health.
We use information submitted in petitions and notifications to
determine whether the ingredient satisfies the criteria of section
403(w)(6) and (7) of the FD&C Act for granting the exemption.
In the Federal Register of December 12, 2017 (82 FR 58407), we
published a
[[Page 15850]]
60-day notice inviting public comment on the proposed extension of this
collection of information. One comment was received that expressed
support for the information collection but did not otherwise respond to
the topics solicited, nor did the comment suggest we revise our burden
estimate. We therefore retain the currently approved estimate of the
associated burden for the information collection, which is as follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average
FD&C act section/activity respondents per disclosures burden per Total hours
respondent disclosure
----------------------------------------------------------------------------------------------------------------
403(w)(1); review labels for 77,500 1 77,500 1 77,500
compliance with food allergen
labeling requirements..........
403(w)(1); redesign labels to 3,875 1 3,875 16 62,000
comply with food allergen
labeling requirements..........
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 139,500
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Using a labeling cost model to estimate the number of new or
reformulated products sold in the United States, annually, that are
affected by the requirements of section 403(w)(1) of the FD&C Act, we
estimate there are 690,000 Universal Product Codes (UPCs) of FDA-
regulated foods and approximately 85,000 UPCs of FDA-regulated dietary
supplements for a total of 775,000 UPCs. We assume an annual entry rate
of 10 percent for new or reformulated UPCs (77,500), and assume 5
percent of labels may be redesigned (3,875). We estimate an average
burden for the review of labels for compliance with the food allergen
labeling requirements under section 403(w)(1) of the FD&C Act to be 1
hour, and we estimate 16 hours for the redesign of a label. Together we
estimate a total annual hourly burden of 139,500 in third-party
disclosure.
Table 2--Estimated Annual Reporting Burden \1\
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Number of Average
FD&C act section/activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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403(w)(6); petition for 5 1 5 100 500
exemption......................
403(w)(7); notification......... 5 1 5 68 340
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Total....................... .............. .............. .............. .............. 840
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the number of petitions and notifications received in
recent years, we assume that we will receive five petitions and five
notifications annually, over the next 3 years. Assuming an association
of one respondent to each petition or notification, we estimate that
five respondents will each submit one petition and five respondents
will each submit one notification, as reported in table 2, rows 1 and
2.
We base our estimate of the average burdens per response reported
in table 2 on our experience with other petition processes. We estimate
that a petition would take, on average, 100 hours to develop and
submit. Therefore, we estimate that the burden associated with
petitions will be 500 hours annually (5 petitions x 100 hours per
petition).
The burden of a notification involves collecting documentation that
a food ingredient does not pose an allergen risk. Either we can make a
determination that the ingredient does not cause an allergic response
that poses a risk to human health under a premarket approval or
notification program under section 409 of the FD&C Act, or the
respondent would submit scientific evidence demonstrating that the
ingredient when manufactured as described does not contain allergenic
protein. We estimate that it would take a respondent 20 hours to
prepare and submit a notification based on our determination under a
process under section 409 of the FD&C Act that the ingredient does not
cause an allergic response. We estimate that it would take a respondent
approximately 100 hours to prepare a notification submitting scientific
evidence (including the analytical method used) that demonstrates that
the food ingredient (as derived by the method specified in the
notification, where applicable) does not contain allergenic protein. We
have no data on how many notifications would be based on our
determination that the ingredient does not cause an allergic response
or based on scientific evidence that demonstrates that the food
ingredient does not contain allergenic protein. Therefore, we estimate
that three of the five notifications would be based on scientific
evidence, and two of the five notifications would be based on our
determination. The average time per notification is then estimated to
be 68 hours (2 x 20 hours + 3 x 100 hours)/5). Therefore, we estimate
that the burden associated with notifications will be 340 hours
annually (5 notifications x 68 hours per notification), as reported in
table 2. The burden estimate has not increased since the initial OMB
approval.
Dated: April 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07545 Filed 4-11-18; 8:45 am]
BILLING CODE 4164-01-P
