Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food, 72486-72487 [2023-23117]
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Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices
NOTIFICATION PROCEDURES:
An individual who wishes to know if
this system of records contains a record
about him or her must submit a written
notification request to the relevant
System Manager at the address
indicated in the ‘‘System Manager(s)’’
section above, in accordance with the
Department’s Privacy Act
implementation regulations in 45 CFR.
The request must contain the requester’s
full name, address, date of birth, and
signature. The individual must verify
his or her identity in the same manner
required for an access request.
EXEMPTIONS PROMULGATED FOR THE SYSTEM:
None.
HISTORY:
83 FR 11213 (Mar. 14, 2018).
[FR Doc. 2023–23147 Filed 10–19–23; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1272]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Third Party
Disclosure and Recordkeeping
Requirements for Reportable Food
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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: Submit written comments
(including recommendations) on the
collection of information by November
20, 2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0643. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
18:20 Oct 19, 2023
Jkt 262001
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Third Party Disclosure and
Recordkeeping Requirements for
Reportable Food—21 U.S.C. 350f
OMB Control Number 0910–0643—
Extension
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Food and Drug Administration
Amendments Act of 2007 (FDAAA)
(Pub. L. 110–85), requires the
establishment of a Reportable Food
Registry (the Registry) by which
instances of reportable food must be
submitted to FDA by responsible parties
and may be submitted by public health
officials. Section 417 of the FD&C Act
(21 U.S.C. 350f) defines ‘‘reportable
food’’ as an article of food (other than
infant formula) for which there is a
reasonable probability that the use of, or
exposure to, such article of food will
cause serious adverse health
consequences or death to humans or
animals. (See section 417(a)(2) of the
FD&C Act.) We believe that the most
efficient and cost-effective means to
implement the Registry is by utilizing
our electronic Safety Reporting Portal.
The information collection provisions
associated with the submission of
reportable food reports has been
approved under OMB control number
0910–0291.
In conjunction with the reportable
foods requirements, section 417 of the
FD&C Act also establishes third-party
disclosure and recordkeeping burdens.
Specifically, we may require the
responsible party to notify the
immediate previous source(s) and/or
immediate subsequent recipient(s) of a
reportable food (sections 417(d)(6)(B)(i)
to (ii) of the FD&C Act). Similarly, we
may also require the responsible party
that is notified (i.e., the immediate
previous source and/or immediate
subsequent recipient) to notify their
own immediate previous source(s) and/
or immediate subsequent recipient(s) of
a reportable food (sections
417(d)(7)(C)(i) to (ii) of the FD&C Act).
Notification to the immediate
previous source(s) and immediate
subsequent recipient(s) of the article of
food may be accomplished by electronic
communication methods such as email,
fax, or text messaging or by telegrams,
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
mailgrams, or first-class letters.
Notification may also be accomplished
by telephone call or other personal
contacts, but we recommend that such
notifications also be confirmed by one
of the previous methods and/or
documented in an appropriate manner.
We may require that the notification
include any or all of the following data
elements: (1) the date on which the
article of food was determined to be a
reportable food; (2) a description of the
article of food including the quantity or
amount; (3) the extent and nature of the
adulteration; (4) the results of any
investigation of the cause of the
adulteration if it may have originated
with the responsible party, if known; (5)
the disposition of the article of food,
when known; (6) product information
typically found on packaging including
product codes, use-by dates, and the
names of manufacturers, packers, or
distributors sufficient to identify the
article of food; (7) contact information
for the responsible party; (8) contact
information for parties directly linked in
the supply chain and notified under
section 417(d)(6)(B) or 417(d)(7)(C) of
the FD&C Act, as applicable; (9) the
information required by FDA to be
included in the notification provided by
the responsible party involved under
section 417(d)(6)(B) or 417(d)(7)(C) of
the FD&C Act or required to report
under section 417(d)(7)(A) of the FD&C
Act; and (10) the unique number
described in section 417(d)(4) of the
FD&C Act (section 417(d)(6)(B)(iii)(I),
(d)(7)(C)(iii)(I), and (e) of the FD&C Act).
We may also require that the
notification provides information about
the actions that the recipient of the
notification will perform and/or any
other information we may require
(section 417(d)(6)(B)(iii)(II) and (III) and
(d)(7)(C)(iii)(II) and (III) of the FD&C
Act).
Section 417(g) of the FD&C Act
requires that responsible persons
maintain records related to reportable
foods for a period of 2 years.
The congressionally-identified
purpose of the Registry is to provide a
reliable mechanism to track patterns of
adulteration in food which would
support efforts by FDA to target limited
inspection resources to protect the
public health (see FDAAA, section
1005(a)(4)). The reporting and
recordkeeping requirements described
previously are designed to enable FDA
to quickly identify and track an article
of food (other than infant formula) for
which there is a reasonable probability
that the use of or exposure to such
article of food will cause serious adverse
health consequences or death to humans
or animals. We use the information
E:\FR\FM\20OCN1.SGM
20OCN1
Federal Register / Vol. 88, No. 202 / Friday, October 20, 2023 / Notices
collected under these authorities to help
ensure that such products are quickly
and efficiently removed from the
market.
As required under section 1005(f) of
FDAAA and to assist industry, we have
issued the guidance entitled, ‘‘Guidance
for Industry: Questions and Answers
Regarding the Reportable Food Registry
as Established by the Food and Drug
Administration Amendments Act of
2007,’’ which is available at https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents/
guidance-industry-questions-andanswers-regarding-reportable-foodregistry-established-food-and-drug. The
guidance contains questions and
answers relating to the requirements
72487
a domestic or foreign facility engaged in
manufacturing, processing, packing, or
holding food for consumption in the
United States (‘‘responsible parties’’)
who have information on a reportable
food. Voluntary respondents to this
collection of information are Federal,
State, and local public health officials
who have information on a reportable
food.
In the Federal Register of May 22,
2023 (88 FR 32775), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
under section 417 of the FD&C Act,
including: (1) how, when, and where to
submit reports to FDA; (2) who is
required to submit reports to FDA; (3)
what is required to be submitted to
FDA; and (4) what may be required
when providing notifications to other
persons in the supply chain of an article
of food. The guidance also refers to
previously approved collections of
information found in FDA regulations.
The collections of information in 21
CFR 7.46 of FDA’s regulations have
been approved under OMB control
number 0910–0249.
Description of Respondents:
Mandatory respondents to this
collection of information are the
owners, operators, or agents in charge of
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
disclosures
per
respondent
Number of
respondents
Activity
Total
annual
disclosures
Average
burden per
disclosure
Total
hours
Notifying immediate previous source of the article of food under section
417(d)(6)(B)(i) of the FD&C Act (mandatory reporters only).
Notifying immediate subsequent recipient of the article of food under
section 417(d)(6)(B)(ii) of the FD&C Act (mandatory reporters only).
Notifying immediate previous source of the article of food under section
417(d)(7)(C)(i) of the FD&C Act (mandatory reporters only).
Notifying immediate subsequent recipient of the article of food under
section 417(d)(7)(C)(ii) of the FD&C Act (mandatory reporters only).
1,200
1
1,200
0.6 (36 minutes) .........
720
1,200
1
1,200
0.6 (36 minutes) .........
720
1,200
1
1,200
0.6 (36 minutes) .........
720
1,200
1
1,200
0.6 (36 minutes) .........
720
Total ..................................................................................................
........................
........................
........................
.....................................
2,880
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Third Party Disclosure: Although it is
not mandatory under section 1005 of
FDAAA that responsible persons notify
the sources and recipients of instances
of reportable food, for purposes of the
burden estimate we are assuming FDA
would exercise its authority and require
such notifications in all such instances
for mandatory reporters. This
notification burden does not affect
voluntary reporters of reportable food
events.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity
Total
annual
records
Average
burden per
recordkeeping
Total
hours
Maintenance of reportable food records under section 417(g) of the
FD&C Act—mandatory reports.
Maintenance of reportable food records under section 417(g) of the
FD&C Act—voluntary reports.
1,200
1
1,200
0.25 (15 minutes) .......
300
4
1
4
0.25 (15 minutes) .......
1
Total ..................................................................................................
........................
........................
........................
.....................................
301
1 There
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
records per
recordkeeper
are no capital costs or operating and maintenance costs associated with this collection of information.
Recordkeeping: As noted previously,
section 417(g) of the FD&C Act requires
that responsible persons maintain
records related to reportable foods
reports and notifications for a period of
2 years. However, we do not expect that
records will always be kept in relation
to voluntary reportable food reports.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: October 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–23117 Filed 10–19–23; 8:45 am]
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HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–0745]
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Recognition Program for Regenerative
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AGENCY:
ACTION:
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Food and Drug Administration,
HHS.
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Notice of availability.
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]]>Agencies
[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72486-72487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-23117]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1272]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Third Party
Disclosure and Recordkeeping Requirements for Reportable Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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: Submit written comments (including recommendations) on the
collection of information by November 20, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0643. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Third Party Disclosure and Recordkeeping Requirements for Reportable
Food--21 U.S.C. 350f
OMB Control Number 0910-0643--Extension
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by
the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub.
L. 110-85), requires the establishment of a Reportable Food Registry
(the Registry) by which instances of reportable food must be submitted
to FDA by responsible parties and may be submitted by public health
officials. Section 417 of the FD&C Act (21 U.S.C. 350f) defines
``reportable food'' as an article of food (other than infant formula)
for which there is a reasonable probability that the use of, or
exposure to, such article of food will cause serious adverse health
consequences or death to humans or animals. (See section 417(a)(2) of
the FD&C Act.) We believe that the most efficient and cost-effective
means to implement the Registry is by utilizing our electronic Safety
Reporting Portal. The information collection provisions associated with
the submission of reportable food reports has been approved under OMB
control number 0910-0291.
In conjunction with the reportable foods requirements, section 417
of the FD&C Act also establishes third-party disclosure and
recordkeeping burdens. Specifically, we may require the responsible
party to notify the immediate previous source(s) and/or immediate
subsequent recipient(s) of a reportable food (sections 417(d)(6)(B)(i)
to (ii) of the FD&C Act). Similarly, we may also require the
responsible party that is notified (i.e., the immediate previous source
and/or immediate subsequent recipient) to notify their own immediate
previous source(s) and/or immediate subsequent recipient(s) of a
reportable food (sections 417(d)(7)(C)(i) to (ii) of the FD&C Act).
Notification to the immediate previous source(s) and immediate
subsequent recipient(s) of the article of food may be accomplished by
electronic communication methods such as email, fax, or text messaging
or by telegrams, mailgrams, or first-class letters. Notification may
also be accomplished by telephone call or other personal contacts, but
we recommend that such notifications also be confirmed by one of the
previous methods and/or documented in an appropriate manner. We may
require that the notification include any or all of the following data
elements: (1) the date on which the article of food was determined to
be a reportable food; (2) a description of the article of food
including the quantity or amount; (3) the extent and nature of the
adulteration; (4) the results of any investigation of the cause of the
adulteration if it may have originated with the responsible party, if
known; (5) the disposition of the article of food, when known; (6)
product information typically found on packaging including product
codes, use-by dates, and the names of manufacturers, packers, or
distributors sufficient to identify the article of food; (7) contact
information for the responsible party; (8) contact information for
parties directly linked in the supply chain and notified under section
417(d)(6)(B) or 417(d)(7)(C) of the FD&C Act, as applicable; (9) the
information required by FDA to be included in the notification provided
by the responsible party involved under section 417(d)(6)(B) or
417(d)(7)(C) of the FD&C Act or required to report under section
417(d)(7)(A) of the FD&C Act; and (10) the unique number described in
section 417(d)(4) of the FD&C Act (section 417(d)(6)(B)(iii)(I),
(d)(7)(C)(iii)(I), and (e) of the FD&C Act). We may also require that
the notification provides information about the actions that the
recipient of the notification will perform and/or any other information
we may require (section 417(d)(6)(B)(iii)(II) and (III) and
(d)(7)(C)(iii)(II) and (III) of the FD&C Act).
Section 417(g) of the FD&C Act requires that responsible persons
maintain records related to reportable foods for a period of 2 years.
The congressionally-identified purpose of the Registry is to
provide a reliable mechanism to track patterns of adulteration in food
which would support efforts by FDA to target limited inspection
resources to protect the public health (see FDAAA, section 1005(a)(4)).
The reporting and recordkeeping requirements described previously are
designed to enable FDA to quickly identify and track an article of food
(other than infant formula) for which there is a reasonable probability
that the use of or exposure to such article of food will cause serious
adverse health consequences or death to humans or animals. We use the
information
[[Page 72487]]
collected under these authorities to help ensure that such products are
quickly and efficiently removed from the market.
As required under section 1005(f) of FDAAA and to assist industry,
we have issued the guidance entitled, ``Guidance for Industry:
Questions and Answers Regarding the Reportable Food Registry as
Established by the Food and Drug Administration Amendments Act of
2007,'' which is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-reportable-food-registry-established-food-and-drug. The guidance contains questions and answers relating to the
requirements under section 417 of the FD&C Act, including: (1) how,
when, and where to submit reports to FDA; (2) who is required to submit
reports to FDA; (3) what is required to be submitted to FDA; and (4)
what may be required when providing notifications to other persons in
the supply chain of an article of food. The guidance also refers to
previously approved collections of information found in FDA
regulations. The collections of information in 21 CFR 7.46 of FDA's
regulations have been approved under OMB control number 0910-0249.
Description of Respondents: Mandatory respondents to this
collection of information are the owners, operators, or agents in
charge of a domestic or foreign facility engaged in manufacturing,
processing, packing, or holding food for consumption in the United
States (``responsible parties'') who have information on a reportable
food. Voluntary respondents to this collection of information are
Federal, State, and local public health officials who have information
on a reportable food.
In the Federal Register of May 22, 2023 (88 FR 32775), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notifying immediate previous source of the 1,200 1 1,200 0.6 (36 minutes)......................... 720
article of food under section
417(d)(6)(B)(i) of the FD&C Act (mandatory
reporters only).
Notifying immediate subsequent recipient of 1,200 1 1,200 0.6 (36 minutes)......................... 720
the article of food under section
417(d)(6)(B)(ii) of the FD&C Act (mandatory
reporters only).
Notifying immediate previous source of the 1,200 1 1,200 0.6 (36 minutes)......................... 720
article of food under section
417(d)(7)(C)(i) of the FD&C Act (mandatory
reporters only).
Notifying immediate subsequent recipient of 1,200 1 1,200 0.6 (36 minutes)......................... 720
the article of food under section
417(d)(7)(C)(ii) of the FD&C Act (mandatory
reporters only).
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 2,880
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Third Party Disclosure: Although it is not mandatory under section
1005 of FDAAA that responsible persons notify the sources and
recipients of instances of reportable food, for purposes of the burden
estimate we are assuming FDA would exercise its authority and require
such notifications in all such instances for mandatory reporters. This
notification burden does not affect voluntary reporters of reportable
food events.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Maintenance of reportable food records under 1,200 1 1,200 0.25 (15 minutes)........................ 300
section 417(g) of the FD&C Act--mandatory
reports.
Maintenance of reportable food records under 4 1 4 0.25 (15 minutes)........................ 1
section 417(g) of the FD&C Act--voluntary
reports.
----------------------------------------------------------------------------------------------------------
Total.................................... .............. .............. .............. ......................................... 301
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Recordkeeping: As noted previously, section 417(g) of the FD&C Act
requires that responsible persons maintain records related to
reportable foods reports and notifications for a period of 2 years.
However, we do not expect that records will always be kept in relation
to voluntary reportable food reports.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: October 16, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-23117 Filed 10-19-23; 8:45 am]
BILLING CODE 4164-01-P
