Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food, 50656-50658 [2014-20021]
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emcdonald on DSK67QTVN1PROD with NOTICES
50656
Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
primarily a coding worksheet designed
to facilitate data reduction and retrieval
into the ASPEN system. The
information needed to make
certification decisions is available to us
only through the use of information
abstracted from the form.
Form Numbers: CMS–1856 and CMS–
1893 (OMB control number: 0938–
0065); Frequency: Annually,
occasionally; Affected Public: Private
sector—Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 700; Total Annual
Responses: 700; Total Annual Hours:
613. (For policy questions regarding this
collection contact James Cowher at 410–
786–1948.)
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Reporting
Requirements for Grants to States for
Rate Review Cycle I, Cycle II, Cycle III,
and Cycle IV and Effective Rate Review
Program; Use: Under the section 1003 of
the Affordable Care Act (ACA) (section
2794 of the Public Health Service Act),
the Secretary, in conjunction with the
states and territories, is required to
establish a process for the annual
review, beginning with the 2010 plan
year, of unreasonable increases in
premiums for health insurance
coverage. Section 2794(c) requires the
Secretary to establish the Rate Review
Grant Program to states to assist states
to implement this provision. In
addition, section 2794(c) requires the
Rate Review Grant Program to assist
states in the establishment and
enhancement of ‘‘Data Centers’’ that
collect, analyze, and disseminate health
care pricing data to the public.
Concurrent with this information
collection request (ICR), HHS released
Cycle IV of the Rate Review Grants,
‘‘Grants to States to Support Health
Insurance Rate Review and Increase
Transparency in the Pricing of Medical
Services.’’ The purpose of Cycle IV of
the Rate Review Grant Program is to
continue the rate review successes of
Cycles I, II, and III, as well as to provide
greater support to Data Centers, thereby
enhancing medical pricing
transparency. States and territories that
apply for funds are required to complete
the grant application. States and
territories that are awarded funds under
this funding opportunity are required to
provide the Secretary with rate review
data, four quarterly reports, and one
annual report per year until the end of
the grant period detailing the state’s
progression towards a more
comprehensive and effective rate review
process. A final report is due at the end
of the grant period. This information
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collection is required for effective
monitoring of grantees and to fulfill
statutory requirements under section
2794(b)(1)(A) of the ACA that requires
grantees, as a condition of receiving a
grant authorized under section 2794(c),
to report to the Secretary information
about premium increases.
On May 23, 2011, CMS published a
final rule with comment period (76 FR
29964) to implement the annual review
of unreasonable increases in premiums
for health insurance coverage called for
by section 2794. Under the regulation, if
CMS determines that a state has an
Effective Rate Review Program in a
given market, using the criteria set forth
in the rule, CMS will adopt that state’s
determinations regarding whether rate
increases in that market are
unreasonable, provided that the state
reports its final determinations to CMS
and explains the bases of its
determinations. The final rule titled
‘‘Patient Protection and Affordable Care
Act; Health Insurance Market Rules;
Rate Review’’ (78 FR 13406; February
27, 2013) amends the standards under
the Effective Rate Review Program.
Currently, CMS relies on publicly
available information and annual calls
with individual states to obtain the
information needed to evaluate whether
a state has begun to or continues to
satisfy the Effective Rate Review
Program criteria. CMS is proposing to
instead collect the information in
writing from all states that would like to
request effective status. No comments
were received in response to the 60-day
Federal Register notice published on
June 2, 2014 (79 FR 31336). Form
Number: CMS–10380 (OMB control
number: 0938–1121); Frequency:
Annually and On occasion; Affected
Public: Public Sector and State and
Territory Governments; Number of
Respondents: 50; Total Annual
Responses: 553; Total Annual Hours:
20,951. (For policy questions regarding
this collection contact Susie Lorden at
301–492–4162.)
Dated: August 19, 2014.
Martique Jones,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2014–20041 Filed 8–22–14; 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; 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: Fax written comments on the
collection of information by September
24, 2014.
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: 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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
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
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Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
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)
and (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) and (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
sections 417(d)(6)(B) or 417(d)(7)(C) of
the FD&C Act or required to report
under sections 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 (sections 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
(sections 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’’ (Pub. L. 110–85, 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
50657
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.
In the Federal Register of June 3, 2014
(79 FR 31946), 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
respondents
emcdonald on DSK67QTVN1PROD with NOTICES
Activity/section
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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Frm 00044
Number of
disclosures
per
respondent
Average
burden
per
disclosure
Total
annual
disclosures
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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50658
Federal Register / Vol. 79, No. 164 / Monday, August 25, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL THIRD PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Activity/section
Number of
disclosures
per
respondent
Average
burden
per
disclosure
Total
annual
disclosures
Total hours
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
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
Maintenance of
tion 417(g) of
Maintenance of
tion 417(g) of
Number of
records per
recordkeeping
Total
annual
records 2
Average
burden per
record
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
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.
emcdonald on DSK67QTVN1PROD with NOTICES
2 For
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
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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
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: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–20021 Filed 8–22–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Advisory Committee Renewals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
renewal of certain FDA advisory
committees by the Commissioner of
Food and Drugs (the Commissioner).
The Commissioner has determined that
it is in the public interest to renew the
SUMMARY:
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]]>Agencies
[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50656-50658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20021]
-----------------------------------------------------------------------
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
September 24, 2014.
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: 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: 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
[[Page 50657]]
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)
and (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) and (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 sections 417(d)(6)(B) or
417(d)(7)(C) of the FD&C Act or required to report under sections
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 (sections 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 (sections 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''
(Pub. L. 110-85, 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.
In the Federal Register of June 3, 2014 (79 FR 31946), 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
Number of disclosures Total annual
Activity/section respondents per disclosures Average burden per disclosure Total hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 the 1,200 1 1,200 0.6 (36 minutes)....................... 720
article of food under section 417(d)(6)(B)(ii)
of the FD&C Act (mandatory reporters only).
[[Page 50658]]
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 the 1,200 1 1,200 0.6 (36 minutes)....................... 720
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\
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Number of
Activity/section Number of records per Total annual Average burden per record Total hours
recordkeepers recordkeeping records \2\
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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 600 1 600 0.25 (15 minutes)..................... 150
section 417(g) of the FD&C Act--Voluntary
reports.
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Total..................................... ............... ............... .............. ...................................... 450
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\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: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-20021 Filed 8-22-14; 8:45 am]
BILLING CODE 4164-01-P
