Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food, 32775-32777 [2023-10880]
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Federal Register / Vol. 88, No. 98 / Monday, May 22, 2023 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1272]
Agency Information Collection
Activities; Proposed Collection;
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 Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s thirdparty disclosure and recordkeeping
requirements for reportable food.
DATES: Either electronic or written
comments on the collection of
information must be submitted by July
21, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
July 21, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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
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Jkt 259001
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–
2023–N–1272 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Third
Party Disclosure and Recordkeeping
Requirements for Reportable Food.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the 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
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32775
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-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.
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, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
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,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
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Federal Register / Vol. 88, No. 98 / Monday, May 22, 2023 / Notices
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.
ddrumheller on DSK120RN23PROD with NOTICES1
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
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18:54 May 19, 2023
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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
PO 00000
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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
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
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.
We estimate the burden of this
collection of information as follows:
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Federal Register / Vol. 88, No. 98 / Monday, May 22, 2023 / Notices
32777
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
Maintenance of reportable
tion 417(g) of the FD&C
Maintenance of reportable
tion 417(g) of the FD&C
Total annual
records
Average burden per
recordkeeping
Total hours
food records under secAct—mandatory reports.
food records under secAct—voluntary reports.
1,200
1
1,200
0.25 (15 minutes) ...
300
4
1
4
0.25 (15 minutes) ...
1
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: May 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10880 Filed 5–19–23; 8:45 am]
BILLING CODE 4164–01–P
ddrumheller on DSK120RN23PROD with NOTICES1
Number of
records per
recordkeeper
Number of
recordkeepers
Activity
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 1009 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 contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; Biological and Emerging
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18:54 May 19, 2023
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Infections Research Resources Program (BEI–
RRP).
Date: June 14, 2023.
Time: 10 a.m. to 2 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F52A,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Shilpakala Ketha, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F52A, Rockville, MD
20852, (301) 761–6821, shilpa.ketha@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: May 16, 2023.
Tyeshia M. Roberson-Curtis,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–10843 Filed 5–19–23; 8:45 am]
BILLING CODE 4140–01–P
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]]>Agencies
[Federal Register Volume 88, Number 98 (Monday, May 22, 2023)]
[Notices]
[Pages 32775-32777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10880]
[[Page 32775]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-1272]
Agency Information Collection Activities; Proposed Collection;
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 Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's third-party disclosure and recordkeeping requirements for
reportable food.
DATES: Either electronic or written comments on the collection of
information must be submitted by July 21, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 21, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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-2023-N-1272 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Third Party Disclosure and
Recordkeeping Requirements for Reportable Food.'' Received comments,
those filed in a timely manner (see ADDRESSES), 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.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the 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.
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: Under the 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, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4)
[[Page 32776]]
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.
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 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.
We estimate the burden of this collection of information as
follows:
[[Page 32777]]
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents 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: May 17, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10880 Filed 5-19-23; 8:45 am]
BILLING CODE 4164-01-P
