[Federal Register Volume 75, Number 38 (Friday, February 26, 2010)]
[Notices]
[Pages 8960-8963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4003]
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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
and Management Budget Review; Comment Request; Third Party Disclosure
and Recordkeeping Requirements for Reportable Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 March
29, 2010.
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 e-mailed to [email protected]. 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: Denver Presley Jr., Office of
Information Management (P150-400B), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-796-3793
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
On September 27, 2007, the President signed into law the Food and
Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85).
Section 1005 of FDAAA amends the Federal Food, Drug, and Cosmetic Act
(the act) by creating a new section 417 (21 U.S.C. 350f), among other
things. Section 417 of the act requires the Secretary of Health and
Human Services (the Secretary) to establish within the Food and Drug
Administration (FDA) a Reportable Food Registry (the Registry). The
Secretary has delegated to the Commissioner of FDA the responsibility
for administering the act, including section 417.
Section 417 of the act 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 act). Section 417 of the act
requires FDA to establish an electronic portal (the Reportable Food
electronic portal) by which instances of reportable food must be
submitted to FDA by responsible parties and may be submitted by public
health officials. FDA made the decision that the most efficient and
cost effective means to implement the requirements of section 417 of
the act relating to the Registry was to utilize the business enterprise
system currently under development within the agency: The MedWatchPlus
Portal. The electronic portal became operational on September 8, 2009.
The collection of information associated with the submission of
reportable food reports to FDA using the MedWatchPlus electronic portal
has been approved under OMB Control No. 0910-0645.
In addition, section 1005(f) of FDAAA required FDA to issue
guidance to industry about submitting reports through the electronic
portal of instances of reportable food and providing notifications to
other persons in the supply chain of such article of food. FDA issued
guidance containing questions and answers relating to the requirements
under section 417 of the 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 agency announced the availability of
the guidance document titled ``Questions and Answers Regarding the
Reportable Food Registry as Established by the Food and Drug
Administration Amendments Act of 2007,'' on September 9, 2009 (74 FR
46434). The guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
question 28 of the guidance have been approved under OMB Control No.
0910-0249.
Section 417 of the act established third party disclosure and
recordkeeping burdens associated with the Reportable Food Registry.
Specifically, FDA may require the responsible party to notify the
immediate previous source(s) and/or immediate subsequent recipient(s)
of the reportable food (sections 417(d)(6)(B)(i) and 417(d)(6)(B)(ii)
of the act). Similarly, FDA 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 the reportable food
(sections 417(d)(7)(C)(i) and 417(d)(7)(C)(ii) of the 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 e-mail, 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
FDA recommends that such notifications also be confirmed by one of the
above methods and/or documented in an appropriate manner. FDA 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 sections
417(d)(6)(B) or 417(d)(7)(C) of the 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 act or required to report under section
417(d)(7)(A) of the act; and (10) the unique number described in
section 417(d)(4) of the act. (sections 417(d)(6)(B)(iii)(I),
417(d)(7)(C)(iii)(I), and 417(e) of the act). FDA may also require that
the notification provide information about the actions that the
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recipient of the notification shall perform and/or any other
information FDA may require. (sections 417(d)(6)(B)(iii)(II) and
417(d)(6)(B)(iii)(III), 417(d)(7)(C)(iii)(II), and
417(d)(7)(C)(iii)(III) of the act).
Section 417(g) of the act requires that responsible persons
maintain records related to reportable foods reports and notifications
under section 417 of the act 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''
(Pubic Law 110-085, section 1005(a)(4)). The third party disclosure 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. FDA uses the information
collected to help ensure that such products are quickly and efficiently
removed from the market.
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 accordance with 5 CFR 1320.8(d), in the Federal Register of
October 20, 2009 (74 FR 53746), FDA published a 60-day notice
requesting public comment on the proposed collection of information.
FDA received two letters in response to the notice before the close of
the comment period, each containing one or more comments.
(Comment 1) One comment argued that FDA underestimated the burden
of notifying the immediate previous source(s) and the immediate
subsequent recipient(s) of the article of food because it
underestimated the potential number of such sources and recipients that
may require notification. The comment stated that there could be more
than 12,500 different sources for the grain portion of a single
shipment of finished feed, and more than 80 different immediate
previous sources for the other feed ingredients present. Similarly,
another comment argued that FDA underestimated the burden of notifying
the immediate previous source(s) and the immediate subsequent
recipient(s) of the article of food because it assumed only one
previous source and one subsequent recipient.
(Response) FDA appreciates the data provided in the comment.
However, the agency notes that the comment did not provide any proposed
change to the burden hours set forth. Thus, FDA has not changed the
burden hour estimate in table 1 of this document. Please note that we
expect to be able to obtain relevant data from the electronic reporting
system that we can use to better estimate the burden of this reporting.
We also note that this burden is imposed by the law itself. The
reporting to immediate previous source(s) and immediate subsequent
recipient(s) of a reportable food is authorized by sections
417(d)(6)(B)(i), 417(d)(6)(B)(ii), 417(d)(7)(C)(i), and
417(d)(7)(C)(ii) of the act. FDA has no way of knowing how long each
supply chain is or how many ingredients will be involved with each
reportable event. However, we did attempt to account for this
reporting. We estimated burdens assuming two immediate previous sources
and two immediate subsequent recipients for each of the 1,200 estimated
annual reportable food events.
(Comment 2) One comment argued that FDA underestimated the burden
of notifying the immediate previous source(s) and the immediate
subsequent recipient(s) of the article of food, arguing that the 0.6
hours estimated by the agency does not adequately allow for recall
notification writing, editing, review and approval by the notifying
entity and FDA. The comment estimated that it would take a minimum of 4
hours to prepare an FDA-approved Class I recall notification. The
comment further argued that recall followup activities and
communications between the affected entity(ies) and the FDA will take
additional time.
(Response) FDA disagrees and notes that the comment references the
Class I recall procedures governed by part 7 of FDA's regulations (21
CFR part 7). We did not estimate a burden for this process because the
procedures and the associated burden estimates have already been
approved under OMB control number 0910-0249 (FDA Recall Regulations, 21
CFR part 7).
(Comment 3) One comment argued that FDA underestimated the burden
of notifying the immediate previous source(s) and the immediate
subsequent recipient(s) of the article of food because it assumed that
one form of notification, noting that multiple methods of notification
are typically necessary: E-mail, facsimile, and postal mail.
(Response) FDA disagrees. With regard to the method of notification
for the purposes of this information collection, as described elsewhere
in this document, notification may be accomplished by electronic
communication methods such as e-mail, 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 FDA
recommends that notifications also be confirmed or documented in an
appropriate manner. Multiple forms of notifications are not required
and, therefore, were not included in the burden estimate.
Third Party Disclosure
FDA estimates that approximately 1,200 reportable food events with
mandatory reporters will occur annually. FDA received 625 voluntary
food complaints leading to adverse events from January 1, 2008, to June
30, 2008, and there were 206 and 182 Class 1 Recalls for human food in
Fiscal Years 2006 and 2007, respectively. Based on these experiences,
FDA estimates that FDA could receive 200 to 1,200 ``reportable'' food
reports annually from 200 to 1,200 mandatory and voluntary users of the
electronic reporting system. FDA will utilize the upper-bound estimate
of 1,200 for these calculations (73 FR 63153 at 63157 (October 23,
2008); 74 FR 23721 at 23727 (May 20, 2009)).
FDA estimates 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. FDA
also estimates 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 recently submitted to FDA that would be considered
reportable food reports in the future. (73 FR at 63157).
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,
FDA estimates that the total
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burden of notifying the immediate previous source(s) and immediate
subsequent recipient(s) under sections 417(d)(6)(B)(i) and
417(d)(6)(B)(ii) and 417(d)(7)(C)(i) and 417(d)(7)(C)(ii) of the 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).
FDA estimates the burden of this collection of information as
follows:
Table 1.-- Estimated Annual Third Party Disclosure Burden\1\
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No. of Annual Frequency Total Annual Hours per
Activity Respondents of Disclosure Disclosures Disclosure Total Hours
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Notifying immediate 1,200 1 1,200 0.6 720
previous source of the
article of food under
section 417(d)(6)(B)(i)
of the act
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Notifying immediate 1,200 1 1,200 0.6 720
subsequent recipient of
the article of food under
section 417(d)(6)(B)(ii)
of the act
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Notifying immediate 1,200 1 1,200 0.6 720
previous source of the
article of food under
section 417(d)(7)(C)(i)
of the act
----------------------------------------------------------------------------------------------------------------
Notifying immediate 1,200 1 1,200 0.6 720
subsequent recipient of
the article of food under
section 417(d)(7)(C)(ii)
of the act
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Total 2,880
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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 act requires that
responsible persons maintain records related to reportable foods
reports and notifications under section 417 of the act for a period of
2 years. 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. FDA bases its estimate on
its experience with recordkeeping for food and cosmetics derived from
cattle materials (71 FR 59653 at 59667; October 11, 2006). 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 FDA estimates 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 is shown in table 2 of
this document.
Table 2--Estimated Annual Recordkeeping Burden\1\
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No. of Annual Frequency Total Annual
Activity Recordkeepers per Recordkeeping Records\2\ Hours per Record Total Hours
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Maintenance of reportable food records under section 1,200 1 1,200 0.25 300
417(g) of the act--Mandatory reports
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Maintenance of reportable food records under section 600 1 600 0.25 150
417(g) of the 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.
[[Page 8963]]
Dated: February 23, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4003 Filed 2-25-10; 8:45 am]
BILLING CODE 4160-01-S