Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food, 48542-48544 [2020-17506]
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48542
Federal Register / Vol. 85, No. 155 / Tuesday, August 11, 2020 / Notices
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document. [For
multi-center guidances, add appropriate
addresses. No more than four addresses
in this section per 1998 Document
Drafting Handbook.]
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1670,
Silver Spring, MD 20993–0002, 240–
402–7930, elizabeth.giaquinto@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ’’
Marketing Status Notifications Under
Section 506I of the Federal Food, Drug,
and Cosmetic Act; Content and Format.’’
This guidance is intended to assist
holders of NDAs and ANDAs approved
under the FD&C Act with their
submission of required marketing status
notifications. The FDA Reauthorization
Act of 2017 (Pub. L. 115–52) (FDARA)
added section 506I to the FD&C Act (21
U.S.C. 356i), which imposes additional
reporting requirements on NDA and
ANDA holders regarding the marketing
status of approved drug products. This
guidance identifies the required content
for these marketing status notifications
and the format by which these
notifications should be submitted to the
Agency.
This guidance finalizes the draft
guidance entitled Marketing Status
Notifications Under Section 506I of the
Federal Food, Drug, and Cosmetic Act;
Content and Format issued on January
31, 2019 (84 FR 749). FDA considered
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comments received on the draft
guidance as the guidance was finalized.
Changes from the draft to the final
guidance were made to address requests
for clarity in complying with the
reporting requirements of section 506I
of the FD&C Act.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Marketing Status
Notifications Under Section 506I of the
Federal Food, Drug, and Cosmetic Act;
Content and Format.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
FDA regulations require NDA and
ANDA holders to notify the Agency of
the marketing status of drug products
approved under NDAs and ANDAs.
FDARA added section 506I to the FD&C
Act, which imposes marketing status
reporting requirements for notification
of withdrawal from sale; notification of
drugs not available for sale, and reports
on marketing status. This guidance
contains no collection of information.
Therefore, clearance by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501–3521) is not
required. However, this guidance refers
to previously approved FDA collections
of information. These collections of
information are subject to review by
OMB under the PRA. The collections of
information have been approved under
OMB control numbers 0910–0001 and
0910–0759.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: August 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17463 Filed 8–10–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0501]
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) 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 September
10, 2020.
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.
SUMMARY:
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
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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
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Federal Register / Vol. 85, No. 155 / Tuesday, August 11, 2020 / Notices
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
0910–0643.
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
48543
collected under these regulations 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
questions 20 and 21 of the guidance
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 14,
2020 (85 FR 28951), we published a 60day 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
respondents
Activity
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).
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Number of
disclosures per
respondent
Total annual
disclosures
Average burden
per disclosure
Total hours
1,200
1
1,200
0.6 (36 minutes) .......
720
1,200
1
1,200
0.6 (36 minutes) .......
720
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48544
Federal Register / Vol. 85, No. 155 / Tuesday, August 11, 2020 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
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).
Total .................................................................
1 There
Number of
disclosures per
respondent
Number of
respondents
Activity
Total annual
disclosures
Average burden
per disclosure
Total hours
1,200
1
1,200
0.6 (36 minutes) .......
720
1,200
1
1,200
0.6 (36 minutes) .......
720
........................
..........................
........................
...................................
2,880
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Third Party Disclosure: We estimate
that approximately 1,200 reportable
food events with mandatory reporters
occur annually. Based on past FDA
experiences, we estimate that we could
receive 200 to 1,200 ‘‘reportable’’ food
reports annually from 200 to 1,200
mandatory and voluntary users of the
electronic reporting system. We utilized
the upper-bound estimate of 1,200 for
these calculations.
We estimate that notifying the
immediate previous source(s) takes 0.6
hours per reportable food and notifying
the immediate subsequent recipient(s)
takes 0.6 hours per reportable food. We
also estimate that it takes 0.6 hours for
the immediate previous source and/or
the immediate subsequent recipient to
also notify their immediate previous
source(s) and/or immediate subsequent
recipient(s). The Agency bases its
estimate on its experience with
mandatory and voluntary reports
submitted to FDA.
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.
Therefore, we estimate that the total
burden of notifying the immediate
previous source(s) and immediate
subsequent recipient(s) under section
417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and
(ii) of the FD&C Act for 1,200 reportable
foods is 2,880 hours annually (1,200 ×
0.6 hours) + (1,200 × 0.6 hours) + (1,200
× 0.6 hours) + (1,200 × 0.6 hours). This
annual burden is shown in table 1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Maintenance
tion 417(g)
Maintenance
tion 417(g)
Average
burden per
recordkeeping
Total annual
records
Total hours
reportable food records under secthe FD&C Act—mandatory reports.
reportable food records under secthe 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
of
of
of
of
Number of
records per
recordkeeper
Number of
recordkeepers
Activity
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. Based on past FDA experiences,
we estimate that each mandatory report
and its associated notifications requires
30 minutes of recordkeeping for the 2year period, or 15 minutes per record
per year. The annual recordkeeping
burden for mandatory reportable food
reports and their associated
notifications is thus estimated to be 300
hours (1,200 × 0.25 hours).
We do not expect that records will
always be kept in relation to voluntary
reportable food reports. Therefore, we
estimate that records will be kept for 4
voluntary reports we expect to receive
annually. The recordkeeping burden
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associated with voluntary reports is thus
estimated to be 1 hour annually (4 ×
0.25 hours). The estimated total annual
recordkeeping burden is 301 hours
annually (1,200 × 0.25 hours) + (4 × 0.25
hours). This annual burden is shown in
table 2.
Dated: July 30, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–17506 Filed 8–10–20; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Vaccines and Related Biological
Products Advisory Committee
(VRBPAC). The general function of the
SUMMARY:
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]]>Agencies
[Federal Register Volume 85, Number 155 (Tuesday, August 11, 2020)]
[Notices]
[Pages 48542-48544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17506]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0501]
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) 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 September 10, 2020.
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: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: 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
[[Page 48543]]
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 0910-0643.
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 regulations 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 questions 20 and 21 of
the guidance 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 14, 2020 (85 FR 28951), we 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 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).
[[Page 48544]]
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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Third Party Disclosure: We estimate that approximately 1,200
reportable food events with mandatory reporters occur annually. Based
on past FDA experiences, we estimate that we could receive 200 to 1,200
``reportable'' food reports annually from 200 to 1,200 mandatory and
voluntary users of the electronic reporting system. We utilized the
upper-bound estimate of 1,200 for these calculations.
We estimate that notifying the immediate previous source(s) takes
0.6 hours per reportable food and notifying the immediate subsequent
recipient(s) takes 0.6 hours per reportable food. We also estimate that
it takes 0.6 hours for the immediate previous source and/or the
immediate subsequent recipient to also notify their immediate previous
source(s) and/or immediate subsequent recipient(s). The Agency bases
its estimate on its experience with mandatory and voluntary reports
submitted to FDA.
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. Therefore, we
estimate that the total burden of notifying the immediate previous
source(s) and immediate subsequent recipient(s) under section
417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and (ii) of the FD&C Act for
1,200 reportable foods is 2,880 hours annually (1,200 x 0.6 hours) +
(1,200 x 0.6 hours) + (1,200 x 0.6 hours) + (1,200 x 0.6 hours). This
annual burden is shown in table 1.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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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.
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Total................................... .............. .............. .............. .......................................... 301
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\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.
Based on past FDA experiences, we estimate that each mandatory report
and its associated notifications requires 30 minutes of recordkeeping
for the 2-year period, or 15 minutes per record per year. The annual
recordkeeping burden for mandatory reportable food reports and their
associated notifications is thus estimated to be 300 hours (1,200 x
0.25 hours).
We do not expect that records will always be kept in relation to
voluntary reportable food reports. Therefore, we estimate that records
will be kept for 4 voluntary reports we expect to receive annually. The
recordkeeping burden associated with voluntary reports is thus
estimated to be 1 hour annually (4 x 0.25 hours). The estimated total
annual recordkeeping burden is 301 hours annually (1,200 x 0.25 hours)
+ (4 x 0.25 hours). This annual burden is shown in table 2.
Dated: July 30, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17506 Filed 8-10-20; 8:45 am]
BILLING CODE 4164-01-P
