Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food, 44422-44424 [2017-20283]
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44422
Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
We base our estimate on our review
of the certification requests received
over the past 3 fiscal years (FY). The
annual burden estimate for this
information collection is 3,536 hours.
The estimated reporting burden for this
information collection is 1,655 hours
and the estimated recordkeeping burden
for this information collection is 1,881
hours. From FY 2014 to FY 2016, we
processed an average of 7,524 responses
(requests for certification of batches of
color additives) per year. There were 38
different respondents, corresponding to
an average of approximately 198
responses from each respondent per
year. Using information from industry
personnel, we estimate that an average
of 0.22 hour per response is required for
reporting (preparing certification
requests and accompanying samples)
and an average of 0.25 hour per
response is required for recordkeeping.
FDA’s web-based Color Certification
information system allows submitters to
request color certification online, follow
their submissions through the process,
and obtain information on account
status. The system sends back the
certification results electronically,
allowing submitters to sell their
certified color before receiving hardcopy
certificates. Any delays in the system
result only from shipment of color
additive samples to FDA’s Office of
Cosmetics and Colors for analysis.
Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20245 Filed 9–21–17; 8:45 am]
BILLING CODE 4164–01–P
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.
SUMMARY:
VerDate Sep<11>2014
18:11 Sep 21, 2017
Jkt 241001
Fax written comments on the
collection of information by October 23,
2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0643. Also
include the FDA docket number found
in brackets in the heading of this
document.
DATES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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 (the 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
0910–0643.
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
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Fmt 4703
Sfmt 4703
responsible party to notify the
immediate previous source(s) and/or
immediate subsequent recipient(s) of a
reportable food (section 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 (section 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),
(d)(7)(C)(iii)(II) and (III) of the FD&C
Act).
Section 417(g) of the FD&C Act
requires that responsible persons
E:\FR\FM\22SEN1.SGM
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Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
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 provisions 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 document entitled,
‘‘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/Food/
GuidanceRegulation/Guidance
DocumentsRegulatoryInformation/
ucm180761.htm. 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
44423
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 June 7, 2017
(82 FR 26489), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
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).
Total ................................................................
1 There
Number of
disclosures
per
respondent
Number of
respondents
Activity/section
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
1
1,200
0.6 (36
minutes)
1,200
1
1,200
0.6 (36 minutes) ..........
720
........................
........................
........................
.....................................
2,880
720.
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
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18:11 Sep 21, 2017
Jkt 241001
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
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Fmt 4703
Sfmt 4703
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) and (ii), (d)(7)(C)(i) and
(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.
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Federal Register / Vol. 82, No. 183 / Friday, September 22, 2017 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/section
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Maintenance of reportable food records under
section 417(g) of the FD&C Act—mandatory reports.
Maintenance of reportable food records under
section 417(g) of the FD&C Act—voluntary reports.
1,200
1
1,200
0.25 (15 minutes) ........
300
4
1
4
0.25 (15 minutes) ........
1
Total ................................................................
........................
........................
........................
.....................................
301
1 There
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 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 × 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
four voluntary reports we expect to
receive annually. The recordkeeping
burden associated with voluntary
reports is thus estimated to be 1 hour
annually (4 × 0.25 hours). The estimated
total annual recordkeeping burden will
be 301 hours annually (1,200 × 0.25
hours) + (4 × 0.25 hours). This annual
burden is shown in table 2.
Dated: September 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–20283 Filed 9–21–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0019]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Customer/Partner
Service Surveys
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:11 Sep 21, 2017
Jkt 241001
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by October 23,
2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0360. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Customer/Partner Service Surveys
Food and Drug Administration
AGENCY:
ACTION:
OMB Control Number 0910–0360—
Extension
Under section 903 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
393), FDA is authorized to conduct
research and public information
programs about regulated products and
responsibilities of the Agency.
Executive Order 12862, entitled,
‘‘Setting Customer Service Standard,’’
directs Federal Agencies that ‘‘provide
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
significant services directly to the
public’’ to ‘‘survey customers to
determine the kind and quality of
services they want and their level of
satisfaction with existing services.’’ FDA
is seeking OMB clearance to conduct a
series of surveys to implement
Executive Order 12862. Participation in
the surveys is voluntary. This request
covers customer/partner service surveys
of regulated entities, such as food
processors; cosmetic drug, biologic and
medical device manufacturers;
consumers; and health professionals.
The request also covers ‘‘partner’’ (State
and local governments) customer
service surveys.
FDA will use the information from
these surveys to identify strengths and
weaknesses in service to customers/
partners and to make improvements.
The surveys will measure timeliness,
appropriateness and accuracy of
information, and courtesy and problem
resolution in the context of individual
programs.
FDA estimates conducting 15
customer/partner service surveys per
year, each requiring an average of 15
minutes for review and completion. We
estimate respondents to these surveys to
be between 100 and 20,000 customers.
Some of these surveys will be repeats of
earlier surveys for purposes of
monitoring customer/partner service
and developing long-term data.
In the Federal Register of June 7, 2017
(82 FR 26497), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
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]]>Agencies
[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44422-44424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20283]
-----------------------------------------------------------------------
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: Fax written comments on the collection of information by October
23, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0643.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Third Party Disclosure and Recordkeeping Requirements for Reportable
Food--21 U.S.C. 350f
OMB Control Number 0910-0643--Extension
The Federal Food, Drug, and Cosmetic Act (the 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 0910-0643.
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 (section 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 (section 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),
(d)(7)(C)(iii)(II) and (III) of the FD&C Act).
Section 417(g) of the FD&C Act requires that responsible persons
[[Page 44423]]
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 provisions 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 document entitled, ``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/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm180761.htm. 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 June 7, 2017 (82 FR 26489), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/section Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notifying immediate previous source of the 1,200 1 1,200 0.6 (36 minutes)........................... 720
article of food under section
417(d)(6)(B)(i) of the FD&C Act (mandatory
reporters only).
Notifying immediate subsequent recipient of 1,200 1 1,200 0.6 (36 minutes)........................... 720
the article of food under section
417(d)(6)(B)(ii) of the FD&C Act
(mandatory reporters only).
Notifying immediate previous source of the 1 1,200 0.6 (36 720........................................
article of food under section minutes)
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: 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) and (ii), (d)(7)(C)(i) and (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.
[[Page 44424]]
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
Activity/section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Maintenance of reportable food records 1,200 1 1,200 0.25 (15 minutes).......................... 300
under section 417(g) of the FD&C Act--
mandatory reports.
Maintenance of reportable food records 4 1 4 0.25 (15 minutes).......................... 1
under section 417(g) of the FD&C Act--
voluntary reports.
------------------------------------------------ ---------------
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 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 four 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 will be 301 hours annually (1,200 x 0.25
hours) + (4 x 0.25 hours). This annual burden is shown in table 2.
Dated: September 19, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-20283 Filed 9-21-17; 8:45 am]
BILLING CODE 4164-01-P
