83 FR 15848 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 71 (April 12, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 71 (April 12, 2018)
| Page Range | 15848-15850 | |
| FR Document | 2018-07545 |
[Federal Register Volume 83, Number 71 (Thursday, April 12, 2018)] [Notices] [Pages 15848-15850] From the Federal Register Online [www.thefederalregister.org] [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\ ---------------------------------------------------------------------------------------------------------------- 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); petition for 5 1 5 100 500 exemption...................... 403(w)(7); notification......... 5 1 5 68 340 ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 840 ---------------------------------------------------------------------------------------------------------------- \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
![15848 Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices
SUPPLEMENTARY INFORMATION: guidance, when finalized, will represent by interested persons between 9 a.m.
the current thinking of FDA on and 4 p.m., Monday through Friday; it
I. Background
‘‘Expansion of the Abbreviated 510(k) is also available electronically at https://
FDA has explained and clarified, Program: Demonstrating Substantial www.regulations.gov. FDA has verified
through the guidance entitled, ‘‘The Equivalence Through Performance the website address, as of the date this
510(k) Program: Evaluating Substantial Criteria; Draft Guidance for Industry and document publishes in the Federal
Equivalence in Premarket Notifications Food and Drug Administration Staff.’’ It Register, but websites are subject to
[510(k)]’’ (Ref. 1), how it makes does not establish any rights for any change over time.
substantial equivalence decisions under person and is not binding on FDA or the 1. ‘‘The 510(k) Program: Evaluating
section 513(i)(1)(A) of the Federal, Food, public. You can use an alternative Substantial Equivalence in Premarket
Drug, and Cosmetic Act (FD&C Act) (21 approach if it satisfies the requirements Notifications [510(k)]—Guidance for
U.S.C. 360c(i)(1)(A)). Substantial of the applicable statutes and Industry and Food and Drug
equivalence is rooted in comparisons regulations. This guidance is not subject Administration Staff,’’ July 28, 2014,
between new devices and predicate to Executive Order 12866. available at: https://www.fda.gov/
devices. However, the FD&C Act does MedicalDevices/DeviceRegulation
not preclude FDA from using III. Electronic Access andGuidance/GuidanceDocuments/
performance criteria to facilitate this Persons interested in obtaining a copy UCM284443.
comparison. If a legally marketed device of the draft guidance may do so by Dated: April 9, 2018.
performs at certain levels relevant to its downloading an electronic copy from Leslie Kux,
safety and effectiveness, and a new the internet. A search capability for all Associate Commissioner for Policy.
device meets or exceeds those levels of Center for Devices and Radiological
[FR Doc. 2018–07564 Filed 4–11–18; 8:45 am]
performance for the same Health guidance documents is available
BILLING CODE 4164–01–P
characteristics, FDA could find the new at https://www.fda.gov/MedicalDevices/
device as safe and effective as the DeviceRegulationandGuidance/
legally marketed device. Instead of GuidanceDocuments/default.htm. This DEPARTMENT OF HEALTH AND
reviewing data from direct comparison draft guidance document is also HUMAN SERVICES
testing between the two devices, FDA available at either https://www.fda.gov/
could support a finding of substantial BiologicsBloodVaccines/Guidance Food and Drug Administration
equivalence with data showing the new ComplianceRegulatoryInformation/
device meets or exceeds the level of default.htm or https:// [Docket No. FDA–2014–N–1030]
performance of appropriate predicate www.regulations.gov. Persons unable to
device(s). Under the approach expanded Agency Information Collection
download an electronic copy of
in this guidance, a submitter could Activities; Submission for Office of
‘‘Expansion of the Abbreviated 510(k)
satisfy the requirement to compare its Management and Budget Review;
Program: Demonstrating Substantial
device with a legally marketed device Comment Request; Food Allergen
Equivalence Through Performance
by, among other things, demonstrating Labeling and Reporting
Criteria; Draft Guidance for Industry and
conformance to performance criteria Food and Drug Administration Staff’’ AGENCY: Food and Drug Administration,
established in FDA-recognized may send an email request to CDRH- HHS.
consensus standards, FDA guidance, Guidance@fda.hhs.gov to receive an ACTION: Notice.
and/or special controls. electronic copy of the document. Please
Use of this approach may also use the document number 17038 to SUMMARY: The Food and Drug
streamline the review of 510(k) identify the guidance you are Administration (FDA) is announcing
submissions, thereby reducing burdens requesting. that a proposed collection of
on the Agency and possibly review information has been submitted to the
times on individual submissions. In IV. Paperwork Reduction Act of 1995 Office of Management and Budget
addition, this approach may facilitate This draft guidance refers to (OMB) for review and clearance under
healthcare professionals and patients previously approved collections of the Paperwork Reduction Act of 1995.
making better informed decisions, by information found in FDA regulations DATES: Fax written comments on the
helping ensure a device cleared through and guidance. These collections of collection of information by May 14,
this pathway meets a transparent set of information are subject to review by the 2018.
performance criteria. At the same time, Office of Management and Budget
ADDRESSES: To ensure that comments on
this approach satisfies the statutory (OMB) under the Paperwork Reduction
the information collection are received,
standard for demonstrating substantial Act of 1995 (44 U.S.C. 3501–3520). The
OMB recommends that written
equivalence. As a result, this expanded collections of information in 21 CFR
comments be faxed to the Office of
approach is intended to promote the 807, subpart E have been approved
Information and Regulatory Affairs,
public health by helping patients gain under OMB control number 0910–0120
OMB, Attn: FDA Desk Officer, Fax: 202–
more timely access to new medical and the collections of information in the
395–7285, or emailed to oira_
devices that are high quality, safe, and guidance document ‘‘Requests for
submission@omb.eop.gov. All
effective. FDA welcomes public input Feedback on Medical Device
comments should be identified with the
on device types for which FDA should Submissions: The Pre-Submission
OMB control number 0910–0792. Also
consider identifying performance Program and Meetings with Food and
include the FDA docket number found
sradovich on DSK3GMQ082PROD with NOTICES
criteria and evidence-based suggestions Drug Administration Staff’’ have been
in brackets in the heading of this
on what the performance criteria should approved under OMB control number
document.
be. 0910–0756.
FOR FURTHER INFORMATION CONTACT:
II. Significance of Guidance V. Reference Domini Bean, Office of Operations,
This draft guidance is being issued The following reference is on display Food and Drug Administration, Three
consistent with FDA’s good guidance in the Dockets Management Staff (see White Flint North, 10A–12M, 11601
practices regulation (§ 10.115). The draft ADDRESSES) and is available for viewing Landsdown St., North Bethesda, MD
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![Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices 15849
20852, 301–796–5733, PRAStaff@ that demonstrates that the ingredient FD&C Act. An ingredient may obtain an
fda.hhs.gov. ‘‘does not cause an allergic response exemption through submission and
SUPPLEMENTARY INFORMATION: In that poses a risk to human health’’ approval of a petition containing
compliance with 44 U.S.C. 3507, FDA (section 403(w)(6) of the FD&C Act). scientific evidence that demonstrates
has submitted the following proposed Alternately, an ingredient may become that the ingredient ‘‘does not cause an
collection of information to OMB for exempt through submission of a allergic response that poses a risk to
review and clearance. notification containing scientific human health’’ (section 403(w)(6) of the
evidence showing that the ingredient FD&C Act). This section also states that
Food Allergen Labeling and Reporting ‘‘does not contain allergenic protein’’ or the burden shall be on the petitioner to
OMB Control Number 0910–0792— that there has been a previous provide scientific evidence (including
Extension determination through a premarket the analytical method used to produce
approval process under section 409 of the evidence) that demonstrates that
This information collection supports the FD&C Act (21 U.S.C. 348) that the such food ingredient, as derived by the
third-party disclosure requirements of ingredient ‘‘does not cause an allergic method specified in the petition, does
food allergen labeling, as well as the response that poses a risk to human not cause an allergic response that poses
reporting associated with the health’’ (section 403(w)(7) of the FD&C a risk to human health. Alternately, an
submission of petitions and Act). ingredient may become exempt through
notifications seeking exemptions from submission of a notification containing
the labeling requirements for A. Third-Party Disclosure
scientific evidence showing that the
ingredients derived from major food The labeling requirements of section ingredient ‘‘does not contain allergenic
allergens under section 403(w)(6) and 403(w)(1) of the FD&C Act apply to all protein’’ or that there has been a
(7) of the FD&C Act (21 U.S.C. 343(w)(6) packaged foods sold in the United States previous determination through a
and (7)). The Food Allergen Labeling that are regulated under the FD&C Act, premarket approval process under
and Consumer Protection Act of 2004 including both domestically section 409 of the FD&C Act that the
(FALCPA) (Title II, Pub. L. 108–282) manufactured and imported foods. As ingredient ‘‘does not cause an allergic
amended the FD&C Act by defining the noted, section 403(w)(1) of the FD&C response that poses a risk to human
term ‘‘major food allergen’’ and stating Act requires that the label of a food health’’ (section 403(w)(7) of the FD&C
that foods regulated under the FD&C Act product declare the presence of each Act).
are misbranded unless they declare the major food allergen. We estimate the Our document entitled ‘‘Food
presence of each major food allergen on information collection burden of the Allergen Labeling Exemption Petitions
the product label using the name of the third-party disclosure associated with and Notifications: Guidance for
food source from which the major food food allergen labeling under section Industry,’’ sets forth our
allergen is derived. Section 403(w)(1) of 403(w)(1) of the FD&C Act as the time recommendations with regard to the
the FD&C Act sets forth the needed for a manufacturer to review the information that an interested party
requirements for declaring the presence labels of new or reformulated products should submit in such a petition or
of each major food allergen on the for compliance with the requirements of notification. The guidance states that to
product label. Section 201(qq) of the section 403(w)(1) of the FD&C Act and evaluate these petitions and
FD&C Act (21 U.S.C. 321(qq)) defines a the time needed to make any needed notifications, we will consider scientific
major food allergen as ‘‘[m]ilk, egg, fish modifications to the labels of those evidence that describes: (1) The identity
(e.g., bass, flounder, or cod), Crustacean products. or composition of the ingredient; (2) the
shellfish (e.g., crab, lobster, or shrimp), The primary user of the allergen methods used to produce the ingredient;
tree nuts (e.g., almonds, pecans, or information disclosed on the label or (3) the methods used to characterize the
walnuts), wheat, peanuts, and labeling of food products is the ingredient; (4) the intended use of the
soybeans’’ and also as a food ingredient consumer that purchases the food ingredient in food; and (5) either (a) for
that contains protein derived from such product. Consumers will use the a petition—data and information,
foods. The definition excludes any information to help them make choices including the expected level of
highly refined oil derived from a major concerning their purchase of a food consumer exposure to the ingredient,
food allergen and any ingredient product, including choices related to that demonstrate that the ingredient,
derived from such highly refined oil. substances that the consumer wishes to when manufactured and used as
In some cases, the production of an avoid due to their potential to cause described, does not cause an allergic
ingredient derived from a major food adverse reactions. Additionally, we response that poses a risk to human
allergen may alter or eliminate the intend to use the information to health; or (b) for a notification, data and
allergenic proteins in that derived determine whether a manufacturer or information that demonstrate that the
ingredient to such an extent that it does other supplier of food products is ingredient, when manufactured as
not contain allergenic protein. In meeting its statutory obligations. Failure described, does not contain allergenic
addition, a major food allergen may be of a manufacturer or other supplier of protein, or documentation of a previous
used as an ingredient or as a component food products to label its products in determination under a process under
of an ingredient such that the level of compliance with section 403(w)(1) of section 409 of the FD&C Act that the
allergenic protein in finished food the FD&C Act may result in a product ingredient does not cause an allergic
products does not cause an allergic being misbranded under the FD&C Act response that poses a risk to human
response that poses a risk to human and the manufacturer or packer and the health.
health. Therefore, FALCPA provides
sradovich on DSK3GMQ082PROD with NOTICES
product subject to regulatory action. We use information submitted in
two mechanisms through which such petitions and notifications to determine
ingredients may become exempt from B. Reporting whether the ingredient satisfies the
the labeling requirement of section Under section 403(w)(6) and (7) of the criteria of section 403(w)(6) and (7) of
403(w)(1) of the FD&C Act. An FD&C Act, interested parties may the FD&C Act for granting the
ingredient may obtain an exemption request from us a determination that an exemption.
through submission and approval of a ingredient is exempt from the labeling In the Federal Register of December
petition containing scientific evidence requirement of section 403(w)(1) of the 12, 2017 (82 FR 58407), we published a
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![15850 Federal Register / Vol. 83, No. 71 / Thursday, April 12, 2018 / Notices
60-day notice inviting public comment the information collection but did not therefore retain the currently approved
on the proposed extension of this otherwise respond to the topics estimate of the associated burden for the
collection of information. One comment solicited, nor did the comment suggest information collection, which is as
was received that expressed support for we revise our burden estimate. We follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
FD&C act section/activity burden per Total hours
respondents per disclosures disclosure
respondent
403(w)(1); review labels for compliance with food allergen
labeling requirements ....................................................... 77,500 1 77,500 1 77,500
403(w)(1); redesign labels to comply with food allergen la-
beling requirements .......................................................... 3,875 1 3,875 16 62,000
Total .............................................................................. ........................ ........................ ........................ ........................ 139,500
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Using a labeling cost model to approximately 85,000 UPCs of FDA- with the food allergen labeling
estimate the number of new or regulated dietary supplements for a total requirements under section 403(w)(1) of
reformulated products sold in the of 775,000 UPCs. We assume an annual the FD&C Act to be 1 hour, and we
United States, annually, that are affected entry rate of 10 percent for new or estimate 16 hours for the redesign of a
by the requirements of section 403(w)(1) reformulated UPCs (77,500), and assume label. Together we estimate a total
of the FD&C Act, we estimate there are 5 percent of labels may be redesigned annual hourly burden of 139,500 in
690,000 Universal Product Codes (3,875). We estimate an average burden third-party disclosure.
(UPCs) of FDA-regulated foods and for the review of labels for compliance
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
FD&C act section/activity responses per burden per Total hours
respondents responses
respondent response
403(w)(6); petition for exemption ......................................... 5 1 5 100 500
403(w)(7); notification .......................................................... 5 1 5 68 340
Total .............................................................................. ........................ ........................ ........................ ........................ 840
1There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the number of petitions and premarket approval or notification three of the five notifications would be
notifications received in recent years, program under section 409 of the FD&C based on scientific evidence, and two of
we assume that we will receive five Act, or the respondent would submit the five notifications would be based on
petitions and five notifications scientific evidence demonstrating that our determination. The average time per
annually, over the next 3 years. the ingredient when manufactured as notification is then estimated to be 68
Assuming an association of one described does not contain allergenic hours (2 × 20 hours + 3 × 100 hours)/
respondent to each petition or protein. We estimate that it would take 5). Therefore, we estimate that the
notification, we estimate that five a respondent 20 hours to prepare and burden associated with notifications
respondents will each submit one submit a notification based on our will be 340 hours annually (5
petition and five respondents will each determination under a process under
notifications × 68 hours per
submit one notification, as reported in section 409 of the FD&C Act that the
notification), as reported in table 2. The
table 2, rows 1 and 2. ingredient does not cause an allergic
burden estimate has not increased since
We base our estimate of the average response. We estimate that it would take
a respondent approximately 100 hours the initial OMB approval.
burdens per response reported in table
2 on our experience with other petition to prepare a notification submitting Dated: April 6, 2018.
processes. We estimate that a petition scientific evidence (including the Leslie Kux,
would take, on average, 100 hours to analytical method used) that Associate Commissioner for Policy.
develop and submit. Therefore, we demonstrates that the food ingredient [FR Doc. 2018–07545 Filed 4–11–18; 8:45 am]
estimate that the burden associated with (as derived by the method specified in
BILLING CODE 4164–01–P
petitions will be 500 hours annually (5 the notification, where applicable) does
petitions × 100 hours per petition). not contain allergenic protein. We have
sradovich on DSK3GMQ082PROD with NOTICES
The burden of a notification involves no data on how many notifications
collecting documentation that a food would be based on our determination
ingredient does not pose an allergen that the ingredient does not cause an
risk. Either we can make a allergic response or based on scientific
determination that the ingredient does evidence that demonstrates that the food
not cause an allergic response that poses ingredient does not contain allergenic
a risk to human health under a protein. Therefore, we estimate that
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Document Created: 2018-11-02 08:14:30
Document Modified: 2018-11-02 08:14:30
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Fax written comments on the collection of information by May 14, 2018. | |
| Contact | Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, [email protected] | |
| FR Citation | 83 FR 15848 |
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