
[Federal Register: February 26, 2010 (Volume 75, Number 38)]
[Notices]               
[Page 8960-8963]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26fe10-71]                         

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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 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: 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

[[Page 8961]]

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

[[Page 8962]]

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
----------------------------------------------------------------------------------------------------------------
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

