Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; and Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Final Guidance for Industry, 73561-73565 [2022-26110]
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Federal Register / Vol. 87, No. 229 / Wednesday, November 30, 2022 / Notices
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Steven Fleischer, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0809,
Steven.Fleischer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
draft GFI #276 entitled ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Products
Proposed for the Prevention of
Heartworm Disease in Dogs.’’ The
recommended approach to demonstrate
substantial evidence of effectiveness of
an investigational new animal drug
intended for the prevention of
heartworm disease in dogs is for the
sponsor to conduct two laboratory dose
confirmation studies and one multisite
field effectiveness study in accordance
with the principles of good clinical
practice as described in GFI #85 (VICH
GL9), ‘‘Good Clinical Practice.’’ This
draft guidance provides detail regarding
FDA’s recommendations for the
effectiveness evaluation of drugs
indicated for the prevention of
heartworm disease caused by Dirofilaria
immitis in dogs. This guidance is
informed by comments FDA received in
response to the ‘‘Evaluation of
Approaches To Demonstrate
Effectiveness of Heartworm
Preventatives for Dogs; Request for
Comments,’’ which published in the
Federal Register on May 24, 2018 (83
FR 24122).
This level 1 draft guidance is being
issued consistent with FDA’s good
guidance practices regulation (21 CFR
10.115). The draft guidance, when
finalized, will represent the current
thinking of FDA on ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Products
Proposed for the Prevention of
Heartworm Disease in Dogs.’’ 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.
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II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
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The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: November 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26059 Filed 11–29–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2855]
Mylan Institutional, Inc.; Withdrawal of
Approval of a New Drug Application for
SULFAMYLON® (Mafenide Acetate,
USP) Powder for 5% Topical Solution
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Frm 00023
Fmt 4703
NDA 019832’s accelerated approval
was ‘‘subject to the requirement that the
applicant study the drug further, to
verify and describe its clinical benefit,
where there is uncertainty as to the
relation of the surrogate endpoint to
clinical benefit, or of the observed
clinical benefit to ultimate outcome’’ (21
CFR 314.510). To date, however, Mylan
has not completed the required
confirmatory study. Mylan
acknowledged in its December 10, 2021,
letter requesting withdrawal of approval
that a successful confirmatory study was
necessary to fulfill the accelerated
approval requirements, but stated that
conducting such a study is not feasible.
Mylan thus requested that NDA 019832
be withdrawn under 21 CFR 314.150(d),
and waived its right to a hearing.
Thus, for the reasons discussed above,
under 21 CFR 314.150(d), approval of
NDA 019832 for SULFAMYLON®
(Mafenide Acetate, USP) Powder for 5%
Topical Solution, and all amendments
and supplements thereto, is withdrawn.
Distribution of SULFAMYLON®
(Mafenide Acetate, USP) Powder for 5%
Topical Solution in interstate commerce
without an approved application is
illegal and subject to regulatory action
(see sections 505(a) and 301(d) of the
FD&C Act (21 U.S.C. 355(a) and 331(d)).
Dated: November 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26057 Filed 11–29–22; 8:45 am]
The Food and Drug
Administration (FDA) is withdrawing
approval of new drug application (NDA)
019832 for SULFAMYLON® (Mafenide
Acetate, USP) Powder for 5% Topical
Solution, held by Mylan Institutional,
Inc., a Viatris company (Mylan). Mylan
has voluntarily requested withdrawal of
this application and has waived its
opportunity for a hearing.
DATES: Applicable November 30, 2022.
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Office of Regulatory
Policy, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6262, Silver Spring,
MD 20993, 301–796–3601.
SUPPLEMENTARY INFORMATION: On June 5,
1998, the Food and Drug Administration
(FDA) approved NDA 019832 for
SULFAMYLON® (Mafenide Acetate,
USP) Powder for 5% Topical Solution,
under the Agency’s accelerated approval
regulations (see generally 21 CFR
subpart H). It was approved for ‘‘for use
as an adjunctive topical antimicrobial
agent to control bacterial infection when
used under moist dressings over meshed
autografts on excised burn wounds.’’
SUMMARY:
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BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0099]
Questions and Answers Regarding
Food Allergens, Including the Food
Allergen Labeling Requirements of the
Federal Food, Drug, and Cosmetic Act
(Edition 5): Draft Guidance for
Industry; Availability; Agency
Information Collection Activities;
Proposed Collection; Comment
Request; and Questions and Answers
Regarding Food Allergens, Including
the Food Allergen Labeling
Requirements of the Federal Food,
Drug, and Cosmetic Act (Edition 5):
Final Guidance for Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
SUMMARY:
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Federal Register / Vol. 87, No. 229 / Wednesday, November 30, 2022 / Notices
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guidance for industry entitled
‘‘Questions and Answers Regarding
Food Allergens, Including the Food
Allergen Labeling Requirements of the
Federal Food, Drug, and Cosmetic Act
(Edition 5): Draft Guidance for
Industry.’’ The draft guidance, when
finalized, will explain FDA’s current
thinking on a number of issues related
to the labeling of food allergens,
including requirements in the Food
Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA) and
the Food Allergy Safety, Treatment,
Education, and Research Act of 2021
(FASTER Act). The draft guidance is a
revision of a currently issued guidance,
entitled ‘‘Questions and Answers
Regarding Food Allergens, Including the
Food Allergen Labeling and Consumer
Protection Act of 2004 (Edition 4).’’ This
draft guidance is not final nor is it in
effect at this time. In addition, the FDA
is announcing availability of a final
guidance entitled ‘‘Questions and
Answers Regarding Food Allergens,
Including the Food Allergen Labeling
Requirements of the Federal Food, Drug,
and Cosmetic Act (Edition 5): Final
Guidance for Industry.’’ This final
guidance includes the questions and
answers from the currently issued
guidance that remain substantively
unchanged.
DATES: Submit either electronic or
written comments on the draft guidance
by January 30, 2023 to ensure that we
consider your comment on the draft
guidance before we begin work on the
final version of the guidance. Submit
electronic or written comments on the
proposed collection of information in
the draft guidance by January 30, 2023.
ADDRESSES: You may submit comments
on any guidance at any time 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
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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–
2022–D–0099 for ‘‘Questions and
Answers Regarding Food Allergens,
Including the Food Allergen Labeling
Requirements of the Federal Food, Drug,
and Cosmetic Act (Edition 5): Draft
Guidance for Industry.’’ Received
comments 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, 240–402–7500.
• 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.’’ We
will review this copy, including the
claimed confidential information, in our
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
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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
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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance documents to the
Office of Nutrition and Food Labeling,
Division of Food Labeling and
Standards, Center for Food Safety and
Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
documents.
FOR FURTHER INFORMATION CONTACT:
With regard to the guidance
documents: Carol D’Lima, Office of
Nutrition and Food Labeling (HFS–800),
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2371;
or Denise See, Office of Regulations and
Policy (HFS–024), Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2378.
With regard to the proposed collection
of information: Domini Bean, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
5733, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FALCPA (Pub. L. 108–282) was
enacted in August 2004 and, in part,
amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) by
defining the term ‘‘major food allergen’’
and requiring that the presence of any
major food allergen be declared on the
labels of FDA-regulated foods. FALCPA
defined a major food allergen as milk,
egg, fish (e.g., bass, flounder, or cod),
crustacean shellfish (e.g., crab, lobster,
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or shrimp), tree nuts (e.g., almonds,
pecans, or walnuts), wheat, peanuts,
and soybeans and as a food ingredient
that contains protein derived from these
foods (section 201(qq) (21 U.S.C.
321(qq)) of the FD&C Act). In addition,
the FASTER Act (Pub. L. 117–11) was
enacted in April 2021 and, in part,
amended the definition of major food
allergen in the FD&C Act to include
sesame, effective January 1, 2023.
Exceptions to the definition include
highly refined oil derived from a major
food allergen and any ingredient
derived from the highly refined oil.
FALCPA also amended the FD&C Act to
include provisions to request an
exemption from the food allergen
labeling requirements through a petition
process when a food ingredient is
demonstrated to not cause an allergic
response that poses a risk to human
health or through a notification process
when processing of a food ingredient
results in the removal of the allergenic
protein (section 403(w)(6) and (7) of the
FD&C Act (21 U.S.C. 343(w)(6) and (7))).
Since the passage of FALCPA, FDA
has received numerous questions about
food allergen labeling requirements. To
explain FALCPA’s requirements as well
as FDA’s current thinking on issues
relating to the regulation of food
allergens, on October 5, 2005, FDA
issued the first edition of a guidance
entitled ‘‘Guidance for Industry:
Questions and Answers Regarding Food
Allergens, including the Food Allergen
Labeling and Consumer Protection Act
of 2004.’’ We subsequently updated the
guidance in December 2005 (Edition 2),
April 2006 (Edition 3), and October
2006 (Edition 4).
FDA is issuing a draft guidance for
industry entitled ‘‘Questions and
Answers Regarding Food Allergens,
Including the Food Allergen Labeling
Requirements of the Federal Food, Drug,
and Cosmetic Act (Edition 5).’’ The draft
guidance is a revision of Edition 4
originally entitled ‘‘Questions and
Answers Regarding Food Allergens,
Including the Food Allergen Labeling
and Consumer Protection Act of 2004’’
that contains revised and new questions
and answers relating to food allergens,
including questions and answers about
FALCPA and the FASTER Act. Editorial
changes, such as renumbering and
organizational changes have also been
made in this revision.
FDA is also issuing a final guidance,
‘‘Questions and Answers Regarding
Food Allergens, Including the Food
Allergen Labeling Requirements of the
Federal Food, Drug, and Cosmetic Act
(Edition 5),’’ that contains the questions
and answers from Edition 4 that remain
unchanged, with the exception of
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editorial changes such as renumbering
and organizational changes, and are
therefore being reissued as final
guidance. FDA is issuing the draft
guidance document to receive
comments on the new or revised
questions and answers, and, as
appropriate, will move the questions
and answers to the final guidance
document, after reviewing comments
and incorporating any changes to the
questions and answers, when
appropriate. Note that some questions
and answers that were in Edition 4 of
the final guidance have been withdrawn
and moved to the draft guidance
document if FDA determined that the
question and answer should be revised
in some respect and reissued in draft for
comment. For ease of reference, a
question retains the same number when
it moves from the draft guidance to the
final guidance and we use the term
‘‘RESERVED’’ after some question
numbers, where appropriate, to
facilitate this process.
We are issuing these guidance
documents consistent with our good
guidance practices regulation (21 CFR
10.115). The guidance documents do
not establish any rights for any person
and are not binding on FDA or the
public. You can use an alternate
approach if it satisfies the requirements
of the applicable statutes and
regulations.
The draft guidance (‘‘Questions and
Answers Regarding Food Allergens,
Including the Food Allergen Labeling
Requirements of the Federal Food, Drug,
and Cosmetic Act (Edition 5)’’ responds
to new questions about food allergen
labeling requirements, including, but
not limited to, the labeling of sesame,
milk, eggs, incidental additives, highly
refined oils, dietary supplement
products, and certain specific packing
and labeling situations (e.g., individual
units within a multiunit package). For
example, we have included draft
questions and answers regarding our
historical interpretation of the terms
‘‘milk’’ and ‘‘eggs;’’ for purposes of the
definition of a ‘‘major food allergen’’
under section 201(qq) of the FD&C Act
and complying with the food allergen
labeling requirements of the FD&C Act.
FDA has historically interpreted ‘‘milk’’
as milk from the domesticated cow and
‘‘eggs’’ as eggs from the domesticated
chicken.
Since 2005, when we first issued the
guidance document, there have been
changes in our laws as well as in the
overall food marketplace. For example,
in 2011, the FDA Food Safety
Modernization Act (FSMA) added new
allergen control provisions for major
food allergens. We are also aware that,
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73563
while the market in the United States
for milk and eggs from species other
than domesticated cows and chickens
remains limited, it has increased in
recent years. Given that, we are
considering whether we should modify
our historical interpretations of ‘‘milk’’
and ‘‘eggs’’ for purposes of the
definition of ‘‘major food allergen’’
under 201(qq) of the FD&C Act and
complying with the food allergen
labeling requirements of the FD&C Act
as set forth in the guidance document.
For example, for ‘‘milk,’’ we note that
our regulation, at 21 CFR 131.110,
defines ‘‘milk’’ as the lacteal secretion,
practically free from colostrum,
obtained by the complete milking of one
or more healthy cows, and our historical
interpretation of ‘‘milk’’ in the context
of a major food allergen under the FD&C
Act has been consistent with this
definition. However, we are aware that
foods from ruminant species such as
goat’s milk, sheep’s milk and buffalo’s
milk are sold or used in human food,
and that allergic reactions associated
with consumption of milk from other
ruminants have been reported in some
individuals. While consumption of such
foods in the United States is limited, in
light of the risk of allergic reactions
associated with consumption of milk
from other ruminants, we invite
comment on whether we should revise
our interpretation of ‘‘milk’’ for this
guidance, what a revised interpretation
should be, and the potential
implications or impact of a revised
interpretation.
Similarly, some FDA documents
interpret ‘‘eggs’’ as coming solely from
chickens, and our historical
interpretation in the context of a major
food allergen under the FD&C Act has
been to consider eggs as coming from
chickens. However, we are aware that
eggs from various bird species (such as
turkey, duck, goose, and guinea) can be
purchased and are used as human food.
In addition, we are aware that allergic
reactions associated with eggs from
birds other than chickens have been
reported in some individuals. Thus, we
invite comment on whether we should
revise our interpretation of ‘‘eggs’’ for
this guidance, what a revised
interpretation should be, and the
potential implications or impact of a
revised interpretation.
We also have revised several
questions and answers to update and
clarify information presented in
previous editions, including, among
other things, questions related to the
labeling of tree nuts, fish, and
crustacean shellfish. We also invite
comments on these draft questions and
answers.
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Federal Register / Vol. 87, No. 229 / Wednesday, November 30, 2022 / Notices
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (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
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.
Questions and Answers Regarding Food
Allergens, Including the Food Allergen
Labeling Requirements of the Federal
Food, Drug, and Cosmetic Act (Edition
5): Guidance for Industry
OMB Control Number 0910–0792—
Revision
The draft guidance, when finalized,
will explain FDA’s current thinking on
the labeling requirements in FALCPA
and the FASTER Act. The draft
guidance will assist food manufacturers
to comply with new requirements under
the FASTER Act for treating sesame as
a major allergen and declaring sesame
on the label of food products, effective
January 1, 2023.
Description of respondents: The
respondents to this collection of
information are manufacturers and
packers of packaged foods sold in the
United States.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
403(w)(1) (FALCPA); Review labels to comply with sesame labeling requirements pursuant to the FASTER Act
403(w)(1) (FALCPA); Redesign labels to comply with sesame labeling requirements pursuant to the FASTER Act
Total .............................................................................
1 There
Number of
disclosures per
respondent
Number of
respondents
FD&C act section; activity
Average
burden per
disclosure
Total annual
disclosures
Total hours
Total capital
costs
77,500
1
77,500
1
77,500
0
775
1
775
16
12,400
$1,414,375
........................
..............................
........................
........................
89,900
1,414,375
are no operating and maintenance costs associated with this collection of information.
We base these estimates from our
experience with our food allergen
labeling program and our labeling cost
model. We estimate that there are
approximately 775,000 Universal
Product Codes (UPCs) of FDA-regulated
foods. Using FDA’s labeling cost model,
we estimate the entry rate of new UPCs
to be approximately 8 percent per year.
Based on the approximate entry rate of
new UPCs, we estimate the rate of new
or reformulated UPCs to be
approximately 10 percent per year, or
77,500 products (775,000 × 10 percent).
Thus, we estimate that 77,500 new or
reformulated products are sold annually
in the United States. Assuming an
association of one respondent to each of
the 77,500 new or reformulated
products, we estimate that 77,500
respondents will each review the label
of one of the 77,500 new or
reformulated products, as reported in
table 1, row 1. We have no data on how
many label reviews would identify the
need to redesign the label. Therefore, we
further estimate, for the purposes of this
analysis, that 1 percent of the reviewed
labels of new or reformulated products,
or 775 labels (77,500 × 1 percent) would
need to be redesigned to comply with
the labeling requirements of the
FASTER Act. Assuming an association
of one respondent to each of the 775
labels, we estimate that 775 respondents
will each redesign one label. Using our
labeling cost model, we estimate that it
will take an average of 16 hours to
complete the administration and
internal design work for the redesign of
a label to comply with the labeling
requirements of the FASTER Act.
Consequently, the burden of redesigning
the 775 labels of new or reformulated
products is 12,400 hours, as reported in
table 1, row 2. Thus, the total thirdparty disclosure burden would be
89,900 hours.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
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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) (FALCPA); petition for exemption for sesame .....................................
403(w)(7) (FALCPA); notification for sesame .......................................................
1
1
1
1
1
1
100
68
100
68
Total ...............................................................................................................
........................
........................
........................
........................
168
1 There
are no operating and maintenance costs associated with this collection of information.
Based on the number of petitions and
notifications under FALCPA received in
VerDate Sep<11>2014
16:58 Nov 29, 2022
Jkt 259001
recent years, we estimate that we will
receive one additional petition and one
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
additional notification annually for
sesame, over the next 3 years. We base
E:\FR\FM\30NON1.SGM
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Federal Register / Vol. 87, No. 229 / Wednesday, November 30, 2022 / Notices
our estimate of the average burdens per
response reported in table 2 on our
experience with the existing FALCPA
petition process. We estimate that a
petition would take, on average, 100
hours to develop and submit.
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 (21 U.S.C. 348), or the respondent
would submit scientific evidence
demonstrating that the ingredient when
manufactured as described does not
contain allergenic protein. Based on the
existing FALCPA notification process,
we estimate that the average time to
prepare and submit a notification for
sesame is approximately 68 hours.
Thus, the total annual reporting burden
would be 168 hours over the next 3
years.
III. Electronic Access
Persons with access to the internet
may obtain the guidance documents at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, https://www.fda.gov/
FoodGuidances, or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidances.
Dated: November 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26110 Filed 11–29–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
lotter on DSK11XQN23PROD with NOTICES1
Office of the Director; Notice of Charter
Renewal
In accordance with title 42 of the U.S.
Code of Federal Regulations, section
217a, notice is hereby given that the
Charter for the National Toxicology
Program Board of Scientific Counselors
was renewed for an additional two-year
period on November 9, 2022.
It is determined that the National
Toxicology Program Board of Scientific
Counselors is in the public interest in
connection with the performance of
duties imposed on the National
Institutes of Health by law, and that
these duties can best be performed
VerDate Sep<11>2014
16:58 Nov 29, 2022
Jkt 259001
through the advice and counsel of this
group.
Inquiries may be directed to Claire
Harris, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail Stop Code 4875), Telephone (301)
496–2123, or harriscl@mail.nih.gov.
Dated: November 23, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–26061 Filed 11–29–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topics in Nephrology.
Date: December 6, 2022.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Stacey Nicole Williams,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (301) 867–5309, stacey.williams@
nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
73565
Dated: November 23, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–26063 Filed 11–29–22; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke; Amended Notice
of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Neurological Disorders and Stroke
Special Emphasis Panel, which was
published in the Federal Register on
November 03, 2022, FR Doc 2022–
23900, 87 FR 66315.
This notice is being amended to
change the dates of this two-day
meeting from November 28–29, 2022, to
December 20–21, 2022. The meeting
time remains the same. The meeting is
closed to the public.
Dated: November 23, 2022.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–26062 Filed 11–29–22; 8:45 am]
BILLING CODE 4140–01–P
INTERNATIONAL TRADE
COMMISSION
[USITC SE–22–051]
Sunshine Act Meetings
Agency Holding the Meeting: United
States International Trade Commission.
TIME AND DATE: December 1, 2022 at 2:00
p.m.
PLACE: Room 101, 500 E Street SW,
Washington, DC 20436, Telephone:
(202) 205–2000.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED:
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. Nos. 731–
TA–1082–1083 (Third Review)
(Chlorinated Isocyanurates from China
and Spain). The Commission currently
is scheduled to complete and file its
determinations and views of the
Commission on December 19, 2022.
5. Outstanding action jackets: none.
CONTACT PERSON FOR MORE INFORMATION:
William Bishop, Supervisory Hearings
and Information Officer, 202–205–2595.
The Commission is holding the
meeting under the Government in the
E:\FR\FM\30NON1.SGM
30NON1
]]>Agencies
[Federal Register Volume 87, Number 229 (Wednesday, November 30, 2022)]
[Notices]
[Pages 73561-73565]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26110]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-0099]
Questions and Answers Regarding Food Allergens, Including the
Food Allergen Labeling Requirements of the Federal Food, Drug, and
Cosmetic Act (Edition 5): Draft Guidance for Industry; Availability;
Agency Information Collection Activities; Proposed Collection; Comment
Request; and Questions and Answers Regarding Food Allergens, Including
the Food Allergen Labeling Requirements of the Federal Food, Drug, and
Cosmetic Act (Edition 5): Final Guidance for Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a draft
[[Page 73562]]
guidance for industry entitled ``Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling Requirements of the
Federal Food, Drug, and Cosmetic Act (Edition 5): Draft Guidance for
Industry.'' The draft guidance, when finalized, will explain FDA's
current thinking on a number of issues related to the labeling of food
allergens, including requirements in the Food Allergen Labeling and
Consumer Protection Act of 2004 (FALCPA) and the Food Allergy Safety,
Treatment, Education, and Research Act of 2021 (FASTER Act). The draft
guidance is a revision of a currently issued guidance, entitled
``Questions and Answers Regarding Food Allergens, Including the Food
Allergen Labeling and Consumer Protection Act of 2004 (Edition 4).''
This draft guidance is not final nor is it in effect at this time. In
addition, the FDA is announcing availability of a final guidance
entitled ``Questions and Answers Regarding Food Allergens, Including
the Food Allergen Labeling Requirements of the Federal Food, Drug, and
Cosmetic Act (Edition 5): Final Guidance for Industry.'' This final
guidance includes the questions and answers from the currently issued
guidance that remain substantively unchanged.
DATES: Submit either electronic or written comments on the draft
guidance by January 30, 2023 to ensure that we consider your comment on
the draft guidance before we begin work on the final version of the
guidance. Submit electronic or written comments on the proposed
collection of information in the draft guidance by January 30, 2023.
ADDRESSES: You may submit comments on any guidance at any time 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): 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-2022-D-0099 for ``Questions and Answers Regarding Food Allergens,
Including the Food Allergen Labeling Requirements of the Federal Food,
Drug, and Cosmetic Act (Edition 5): Draft Guidance for Industry.''
Received comments 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, 240-402-7500.
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.'' We will review
this copy, including the claimed confidential information, in our
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 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, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the guidance documents
to the Office of Nutrition and Food Labeling, Division of Food Labeling
and Standards, Center for Food Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two
self-addressed adhesive labels to assist that office in processing your
request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance documents.
FOR FURTHER INFORMATION CONTACT:
With regard to the guidance documents: Carol D'Lima, Office of
Nutrition and Food Labeling (HFS-800), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2371; or Denise See, Office of
Regulations and Policy (HFS-024), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2378.
With regard to the proposed collection of information: 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:
I. Background
FALCPA (Pub. L. 108-282) was enacted in August 2004 and, in part,
amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by
defining the term ``major food allergen'' and requiring that the
presence of any major food allergen be declared on the labels of FDA-
regulated foods. FALCPA defined a major food allergen as milk, egg,
fish (e.g., bass, flounder, or cod), crustacean shellfish (e.g., crab,
lobster,
[[Page 73563]]
or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat,
peanuts, and soybeans and as a food ingredient that contains protein
derived from these foods (section 201(qq) (21 U.S.C. 321(qq)) of the
FD&C Act). In addition, the FASTER Act (Pub. L. 117-11) was enacted in
April 2021 and, in part, amended the definition of major food allergen
in the FD&C Act to include sesame, effective January 1, 2023.
Exceptions to the definition include highly refined oil derived from a
major food allergen and any ingredient derived from the highly refined
oil. FALCPA also amended the FD&C Act to include provisions to request
an exemption from the food allergen labeling requirements through a
petition process when a food ingredient is demonstrated to not cause an
allergic response that poses a risk to human health or through a
notification process when processing of a food ingredient results in
the removal of the allergenic protein (section 403(w)(6) and (7) of the
FD&C Act (21 U.S.C. 343(w)(6) and (7))).
Since the passage of FALCPA, FDA has received numerous questions
about food allergen labeling requirements. To explain FALCPA's
requirements as well as FDA's current thinking on issues relating to
the regulation of food allergens, on October 5, 2005, FDA issued the
first edition of a guidance entitled ``Guidance for Industry: Questions
and Answers Regarding Food Allergens, including the Food Allergen
Labeling and Consumer Protection Act of 2004.'' We subsequently updated
the guidance in December 2005 (Edition 2), April 2006 (Edition 3), and
October 2006 (Edition 4).
FDA is issuing a draft guidance for industry entitled ``Questions
and Answers Regarding Food Allergens, Including the Food Allergen
Labeling Requirements of the Federal Food, Drug, and Cosmetic Act
(Edition 5).'' The draft guidance is a revision of Edition 4 originally
entitled ``Questions and Answers Regarding Food Allergens, Including
the Food Allergen Labeling and Consumer Protection Act of 2004'' that
contains revised and new questions and answers relating to food
allergens, including questions and answers about FALCPA and the FASTER
Act. Editorial changes, such as renumbering and organizational changes
have also been made in this revision.
FDA is also issuing a final guidance, ``Questions and Answers
Regarding Food Allergens, Including the Food Allergen Labeling
Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5),''
that contains the questions and answers from Edition 4 that remain
unchanged, with the exception of editorial changes such as renumbering
and organizational changes, and are therefore being reissued as final
guidance. FDA is issuing the draft guidance document to receive
comments on the new or revised questions and answers, and, as
appropriate, will move the questions and answers to the final guidance
document, after reviewing comments and incorporating any changes to the
questions and answers, when appropriate. Note that some questions and
answers that were in Edition 4 of the final guidance have been
withdrawn and moved to the draft guidance document if FDA determined
that the question and answer should be revised in some respect and
reissued in draft for comment. For ease of reference, a question
retains the same number when it moves from the draft guidance to the
final guidance and we use the term ``RESERVED'' after some question
numbers, where appropriate, to facilitate this process.
We are issuing these guidance documents consistent with our good
guidance practices regulation (21 CFR 10.115). The guidance documents
do not establish any rights for any person and are not binding on FDA
or the public. You can use an alternate approach if it satisfies the
requirements of the applicable statutes and regulations.
The draft guidance (``Questions and Answers Regarding Food
Allergens, Including the Food Allergen Labeling Requirements of the
Federal Food, Drug, and Cosmetic Act (Edition 5)'' responds to new
questions about food allergen labeling requirements, including, but not
limited to, the labeling of sesame, milk, eggs, incidental additives,
highly refined oils, dietary supplement products, and certain specific
packing and labeling situations (e.g., individual units within a
multiunit package). For example, we have included draft questions and
answers regarding our historical interpretation of the terms ``milk''
and ``eggs;'' for purposes of the definition of a ``major food
allergen'' under section 201(qq) of the FD&C Act and complying with the
food allergen labeling requirements of the FD&C Act. FDA has
historically interpreted ``milk'' as milk from the domesticated cow and
``eggs'' as eggs from the domesticated chicken.
Since 2005, when we first issued the guidance document, there have
been changes in our laws as well as in the overall food marketplace.
For example, in 2011, the FDA Food Safety Modernization Act (FSMA)
added new allergen control provisions for major food allergens. We are
also aware that, while the market in the United States for milk and
eggs from species other than domesticated cows and chickens remains
limited, it has increased in recent years. Given that, we are
considering whether we should modify our historical interpretations of
``milk'' and ``eggs'' for purposes of the definition of ``major food
allergen'' under 201(qq) of the FD&C Act and complying with the food
allergen labeling requirements of the FD&C Act as set forth in the
guidance document.
For example, for ``milk,'' we note that our regulation, at 21 CFR
131.110, defines ``milk'' as the lacteal secretion, practically free
from colostrum, obtained by the complete milking of one or more healthy
cows, and our historical interpretation of ``milk'' in the context of a
major food allergen under the FD&C Act has been consistent with this
definition. However, we are aware that foods from ruminant species such
as goat's milk, sheep's milk and buffalo's milk are sold or used in
human food, and that allergic reactions associated with consumption of
milk from other ruminants have been reported in some individuals. While
consumption of such foods in the United States is limited, in light of
the risk of allergic reactions associated with consumption of milk from
other ruminants, we invite comment on whether we should revise our
interpretation of ``milk'' for this guidance, what a revised
interpretation should be, and the potential implications or impact of a
revised interpretation.
Similarly, some FDA documents interpret ``eggs'' as coming solely
from chickens, and our historical interpretation in the context of a
major food allergen under the FD&C Act has been to consider eggs as
coming from chickens. However, we are aware that eggs from various bird
species (such as turkey, duck, goose, and guinea) can be purchased and
are used as human food. In addition, we are aware that allergic
reactions associated with eggs from birds other than chickens have been
reported in some individuals. Thus, we invite comment on whether we
should revise our interpretation of ``eggs'' for this guidance, what a
revised interpretation should be, and the potential implications or
impact of a revised interpretation.
We also have revised several questions and answers to update and
clarify information presented in previous editions, including, among
other things, questions related to the labeling of tree nuts, fish, and
crustacean shellfish. We also invite comments on these draft questions
and answers.
[[Page 73564]]
II. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (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 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.
Questions and Answers Regarding Food Allergens, Including the Food
Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic
Act (Edition 5): Guidance for Industry
OMB Control Number 0910-0792--Revision
The draft guidance, when finalized, will explain FDA's current
thinking on the labeling requirements in FALCPA and the FASTER Act. The
draft guidance will assist food manufacturers to comply with new
requirements under the FASTER Act for treating sesame as a major
allergen and declaring sesame on the label of food products, effective
January 1, 2023.
Description of respondents: The respondents to this collection of
information are manufacturers and packers of packaged foods sold in the
United States.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
FD&C act section; activity Number of disclosures per Total annual Average burden Total hours Total capital
respondents respondent disclosures per disclosure costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
403(w)(1) (FALCPA); Review labels to comply with 77,500 1 77,500 1 77,500 0
sesame labeling requirements pursuant to the FASTER
Act.................................................
403(w)(1) (FALCPA); Redesign labels to comply with 775 1 775 16 12,400 $1,414,375
sesame labeling requirements pursuant to the FASTER
Act.................................................
--------------------------------------------------------------------------------------------------
Total............................................ .............. ................. .............. .............. 89,900 1,414,375
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
We base these estimates from our experience with our food allergen
labeling program and our labeling cost model. We estimate that there
are approximately 775,000 Universal Product Codes (UPCs) of FDA-
regulated foods. Using FDA's labeling cost model, we estimate the entry
rate of new UPCs to be approximately 8 percent per year. Based on the
approximate entry rate of new UPCs, we estimate the rate of new or
reformulated UPCs to be approximately 10 percent per year, or 77,500
products (775,000 x 10 percent). Thus, we estimate that 77,500 new or
reformulated products are sold annually in the United States. Assuming
an association of one respondent to each of the 77,500 new or
reformulated products, we estimate that 77,500 respondents will each
review the label of one of the 77,500 new or reformulated products, as
reported in table 1, row 1. We have no data on how many label reviews
would identify the need to redesign the label. Therefore, we further
estimate, for the purposes of this analysis, that 1 percent of the
reviewed labels of new or reformulated products, or 775 labels (77,500
x 1 percent) would need to be redesigned to comply with the labeling
requirements of the FASTER Act. Assuming an association of one
respondent to each of the 775 labels, we estimate that 775 respondents
will each redesign one label. Using our labeling cost model, we
estimate that it will take an average of 16 hours to complete the
administration and internal design work for the redesign of a label to
comply with the labeling requirements of the FASTER Act. Consequently,
the burden of redesigning the 775 labels of new or reformulated
products is 12,400 hours, as reported in table 1, row 2. Thus, the
total third-party disclosure burden would be 89,900 hours.
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
FD&C act section; activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
403(w)(6) (FALCPA); petition for 1 1 1 100 100
exemption for sesame...........
403(w)(7) (FALCPA); notification 1 1 1 68 68
for sesame.....................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 168
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
Based on the number of petitions and notifications under FALCPA
received in recent years, we estimate that we will receive one
additional petition and one additional notification annually for
sesame, over the next 3 years. We base
[[Page 73565]]
our estimate of the average burdens per response reported in table 2 on
our experience with the existing FALCPA petition process. We estimate
that a petition would take, on average, 100 hours to develop and
submit.
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 (21 U.S.C. 348),
or the respondent would submit scientific evidence demonstrating that
the ingredient when manufactured as described does not contain
allergenic protein. Based on the existing FALCPA notification process,
we estimate that the average time to prepare and submit a notification
for sesame is approximately 68 hours. Thus, the total annual reporting
burden would be 168 hours over the next 3 years.
III. Electronic Access
Persons with access to the internet may obtain the guidance
documents at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/FoodGuidances, or https://www.regulations.gov. Use the FDA website listed in the previous
sentence to find the most current version of the guidances.
Dated: November 23, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26110 Filed 11-29-22; 8:45 am]
BILLING CODE 4164-01-P
