Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food, 31946-31948 [2014-12823]
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31946
Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Notices
We expect the total number of
pesticide tolerances that are revoked,
suspended, or modified by EPA
pursuant to dietary risk considerations
in the next 3 years to remain at a low
level, as there have been no changes to
the safety standard for pesticide
residues in food since 1996. Thus, we
expect the number of submissions we
will receive pursuant to the guidance
document will also remain at a low
level. However, to avoid counting this
burden as zero, we have estimated the
burden at one respondent making one
submission a year for a total of one
annual submission.
We based our estimate of the hours
per response on the assumption that the
information requested in the guidance is
readily available to the submitter. We
expect that the submitter will need to
gather information from appropriate
persons in the submitter’s company and
to prepare this information for
submission to FDA. The submitter will
almost always merely need to copy
existing documentation. We believe that
this effort should take no longer than 3
hours per submission.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Activity
Number of
recordkeepers
Number of
records per
recordkeeping
Total annual
records
Average
burden per
record
Total hours
Develop documentation process .........................................
1
1
1
16
16
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In determining the estimated annual
recordkeeping burden, we estimated
that at least 90 percent of firms maintain
documentation, such as packing codes,
batch records, and inventory records, as
part of their basic food production or
import operations. Therefore, the
recordkeeping burden was calculated as
the time required for the 10 percent of
firms that may not be currently
maintaining this documentation to
develop and maintain documentation,
such as batch records and inventory
records. In previous information
collection requests, this recordkeeping
burden was estimated to be 16 hours per
record. We have retained our prior
estimate of 16 hours per record for the
recordkeeping burden. As shown in
Table 1 of this document, we estimate
that one respondent will make one
submission per year. Although we
estimate that only 1 out of 10 firms will
not be currently maintaining the
necessary documentation, to avoid
counting the recordkeeping burden for
the 1 submission per year as 1/10 of a
recordkeeper, we estimate that 1
recordkeeper will take 16 hours to
develop and maintain documentation
recommended by the guidance.
Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12819 Filed 6–2–14; 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; 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 we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (the 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
invites comments on the information
collection provisions of FDA’s third
party disclosure and recordkeeping
requirements for reportable food.
DATES: Submit either electronic or
written comments on the collection of
information by August 4, 2014.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
SUMMARY:
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docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), 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, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
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Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Notices
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
sroberts on DSK4SPTVN1PROD with NOTICES
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.’’ (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
0910–0645.
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,
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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),
(d)(6)(B)(iii)(III), (d)(7)(C)(iii)(II), and
(d)(7)(C)(iii)(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 the Food and Drug
Administration to target limited
inspection resources to protect the
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31947
public health’’ (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 draft guidance document
entitled, ‘‘Questions and Answers
Regarding the Reportable Food Registry
as Established by the Food and Drug
Administration Amendments Act of
2007 (Edition 2),’’ which is available at
https://www.fda.gov/Food/Guidance
Regulation/GuidanceDocuments
RegulatoryInformation/RFR/
ucm212793.htm. The draft 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 D5 and D6 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.
We estimate the burden of this
collection of information as follows:
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Federal Register / Vol. 79, No. 106 / Tuesday, June 3, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity/Section
Number of
disclosures
per respondent
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
We estimate that approximately 1,200
reportable food events with mandatory
reporters will 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) will take
0.6 hours per reportable food and
notifying the immediate subsequent
recipient(s) will take 0.6 hours per
reportable food. We also estimate that it
will take 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
FDAAA section 1005 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 will 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), (d)(6)(B)(ii), (d)(7)(C)(i),
and (d)(7)(C)(ii) of the FD&C Act for
1,200 reportable foods will be 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
Number of
recordkeepers
Activity/section
Number of
records per
recordkeeping
Total annual
records 2
Average burden
per record
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
600
1
600
0.25 (15 minutes) ..
150
Total ..............................................................................
........................
..........................
........................
...............................
450
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
purposes of estimating number of records and hours per record, a ‘‘record’’ means all records kept for an individual reportable food by
the responsible party or a voluntary reporter.
2 For
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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 under section 417 of the
FD&C Act for a period of 2 years. Based
on past FDA experiences, we estimate
that each mandatory report and its
associated notifications will require 30
minutes of recordkeeping for the 2-year
period, or 15 minutes per record per
year. The annual recordkeeping burden
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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
600 of the 1,200 voluntary reports we
expect to receive annually. The
recordkeeping burden associated with
voluntary reports is thus estimated to be
150 hours annually (600 × 0.25 hours).
The estimated total annual
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recordkeeping burden will be 450 hours
annually (1,200 × 0.25 hours) + (600 ×
0.25 hours). This annual burden is
shown in Table 2.
Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–12823 Filed 6–2–14; 8:45 am]
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]]>Agencies
[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Pages 31946-31948]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12823]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0501]
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 we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the 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 invites comments on the information collection
provisions of FDA's third party disclosure and recordkeeping
requirements for reportable food.
DATES: Submit either electronic or written comments on the collection
of information by August 4, 2014.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on
[[Page 31947]]
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.'' (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 0910-0645.
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), (d)(6)(B)(iii)(III),
(d)(7)(C)(iii)(II), and (d)(7)(C)(iii)(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 the Food and Drug Administration
to target limited inspection resources to protect the public health''
(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 draft guidance document entitled, ``Questions and
Answers Regarding the Reportable Food Registry as Established by the
Food and Drug Administration Amendments Act of 2007 (Edition 2),''
which is available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/RFR/ucm212793.htm. The draft
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 D5 and D6 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.
We estimate the burden of this collection of information as
follows:
[[Page 31948]]
Table 1--Estimated Annual Third Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/Section Number of disclosures Total annual Average burden per Total
respondents per respondent disclosures disclosure hours
----------------------------------------------------------------------------------------------------------------
Notifying immediate previous 1,200 1 1,200 0.6 (36 minutes)....... 720
source of the article of
food under section
417(d)(6)(B)(i) of the FD&C
Act (mandatory reporters
only).
Notifying immediate 1,200 1 1,200 0.6 (36 minutes)....... 720
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 1,200 1 1,200 0.6 (36 minutes)....... 720
source of the article of
food under section
417(d)(7)(C)(i) of the FD&C
Act (mandatory reporters
only).
Notifying immediate 1,200 1 1,200 0.6 (36 minutes)....... 720
subsequent recipient of 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
We estimate that approximately 1,200 reportable food events with
mandatory reporters will 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) will
take 0.6 hours per reportable food and notifying the immediate
subsequent recipient(s) will take 0.6 hours per reportable food. We
also estimate that it will take 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 FDAAA section 1005 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 will
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), (d)(6)(B)(ii), (d)(7)(C)(i), and (d)(7)(C)(ii) of the
FD&C Act for 1,200 reportable foods will be 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\
----------------------------------------------------------------------------------------------------------------
Number of
Activity/section Number of records per Total annual Average burden per Total
recordkeepers recordkeeping records \2\ record hours
----------------------------------------------------------------------------------------------------------------
Maintenance of reportable 1,200 1 1,200 0.25 (15 minutes)...... 300
food records under section
417(g) of the FD&C Act--
mandatory reports.
Maintenance of reportable 600 1 600 0.25 (15 minutes)...... 150
food records under section
417(g) of the FD&C Act--
voluntary reports.
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Total................... .............. ............... .............. ....................... 450
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ For purposes of estimating number of records and hours per record, a ``record'' means all records kept for
an individual reportable food by the responsible party or a voluntary reporter.
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 under section 417 of the FD&C Act for a
period of 2 years. Based on past FDA experiences, we estimate that each
mandatory report and its associated notifications will require 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 600 of the 1,200 voluntary reports we expect to
receive annually. The recordkeeping burden associated with voluntary
reports is thus estimated to be 150 hours annually (600 x 0.25 hours).
The estimated total annual recordkeeping burden will be 450 hours
annually (1,200 x 0.25 hours) + (600 x 0.25 hours). This annual burden
is shown in Table 2.
Dated: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12823 Filed 6-2-14; 8:45 am]
BILLING CODE 4160-01-P
