[Federal Register Volume 74, Number 114 (Tuesday, June 16, 2009)]
[Notices]
[Pages 28498-28501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0261]


Agency Emergency Processing Under Office of Management and Budget 
Review; Reporting and Recordkeeping Requirements for Reportable Food 
Registry

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 emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). This notice solicits 
comments on the proposed collection of information associated with 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draft guidance document entitled ``Questions and Answers Regarding the 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.'' The draft guidance, when 
finalized, will assist the industry in complying with the Reportable 
Food Registry requirements prescribed by the Food and Drug 
Administration Amendments Act of 2007 (FDAAA).

DATES: Fax written comments on the collection of information by July 
16, 2009. FDA is requesting approval of this emergency processing by 
August 17, 2009.

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: 202-395-6974. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j)) and 5 CFR 1320.13. On September 27, 2007, the 
President signed FDAAA into law (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 to establish, within FDA, a Reportable Food Registry (the 
Registry); the Registry is to be established not later than 1 year 
after the date of enactment (i.e., by September 27, 2008).
    To further the development of the Registry, section 417 of the act 
requires FDA to establish, also within 1 year after the date of 
enactment (i.e., by September 27, 2008), 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 MedWatch\Plus\ Portal. This 
would permit the agency to establish an electronic portal through which 
instances of reportable food may be submitted to the agency. However, 
FDA recognized that the MedWatch\Plus\ Portal would not be implemented 
in time to meet the September 27, 2008, deadline for establishing the 
Reportable Food electronic portal and therefore announced that it was 
delaying its implementation until spring 2009 (73 FR 30405; May 27, 
2008).
    The agency now expects the system to be operational on September 8, 
2009.
    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. In a notice published in the 
Federal Register of June 11, 2009, FDA announced the availability of 
the draft guidance document entitled ``Questions

[[Page 28499]]

and Answers Regarding the Reportable Food Registry as Established by 
the Food and Drug Administration Amendments Act of 2007.''
    Because this guidance involves a collection of information, the PRA 
is implicated. However, the delay associated with normal PRA clearance 
procedures can reasonably be anticipated to prevent the finalization of 
the agency's guidance document in advance of the launch of the portal 
on September 8, 2009. As a result, given the need for immediate action, 
FDA requests emergency processing of this collection of information 
request.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Reporting and Recordkeeping Requirements for Reportable Food 
Registry
    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.
    The draft guidance restates the requirements of section 417 of the 
act and presents FDA's recommendations for complying with section 417 
of the act. 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'' 
(Public Law 110-85, section 1005(a)(4) of FDAAA). To further the 
development of the Registry, section 417 of the act requires FDA to 
establish an electronic portal by which instances of reportable food 
must be submitted to FDA by responsible parties and may be submitted by 
public health officials.
    Responsible parties will be required to submit reports regarding 
instances of reportable food via the Reportable Food electronic portal 
established by FDA: The MedWatch\Plus\ portal. The MedWatch\Plus\ 
portal is a new electronic system for collecting, submitting and 
processing adverse event reports and other safety information for all 
FDA-regulated products and includes the Reportable Food electronic 
portal. FDA is developing and implementing the MedWatch\Plus\ portal in 
a phased fashion. Responsible parties must comply with section 417 of 
the act using the Reportable Food electronic portal on September 8, 
2009. The prohibited act provisions of the act related to the Registry 
will also apply on September 8, 2009.
    Reporting
    Under section 417(d)(1) of the act, the ``responsible party'' must 
submit a report to FDA through the Reportable Food electronic portal 
including certain information on a reportable food (``reportable food 
report''). The ``responsible party'' is defined in section 417(a)(1) of 
the act as a person that submits the registration under section 415(a) 
of the act (21 U.S.C. 360d(a)) for a food facility that is required to 
register under section 415(a), at which such article of food is 
manufactured, processed, packed, or held. Persons who are required to 
submit a facility registration under section 415 of the act are the 
owner, operator, or agent in charge of a domestic or foreign facility 
engaged in manufacturing, processing, packing, or holding food for 
consumption in the United States. A ``reportable food'' is defined in 
section 417(a)(2) of the act 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.
    The MedWatch\Plus\ Portal will provide one central point-of-entry 
for persons submitting information to FDA regarding the safety of FDA-
regulated products. The agency believes that providing one central 
point-of-entry will better enable persons to submit their information 
to FDA. In addition, mandatory reporters will be able to use the 
Internet to access the MedWatch\Plus\ Portal to report safety concerns 
about human and animal food, thus fulfilling the mandatory reporting 
requirements of FDAAA that are the subject of the draft guidance.
    In the Federal Register of October 23, 2008 (73 FR 63153), FDA 
requested public comments on a proposed collection of information 
entitled ``Electronic Data Collection Using MedWatch\Plus\ Portal and 
Rational Questionnaire.'' In that document, the agency calculated the 
reporting burden for reportable food reports. Specifically, the agency 
estimated the number of respondents and the total annual responses for 
reportable food based on the mandatory and voluntary reports recently 
submitted to FDA that would be considered reportable food reports in 
the future (73 FR 63153 at 63156 and 63157). FDA estimated that it 
would receive 200 to 1,200 reportable food reports annually from 200 to 
1,200 mandatory and voluntary users of the electronic reporting system. 
The agency based these estimates on the receipt of 625 voluntary food 
complaints leading to adverse events from January 1, 2008, to June 30, 
2008, and also on the 206 and 182 Class 1 Recalls for human food that 
took place in fiscal years 2006 and 2007, respectively. FDA utilized 
the upper-bound estimate of 1,200 reports per year for calculating the 
reportable food reporting burden. FDA estimated the reporting burden 
for a mandatory reportable food report to be 0.6 hours, for a total 
burden of 720 hours annually (1,200 reports x 0.6 hours = 720 hours). 
FDA estimated the reporting burden for a voluntary reportable food 
report to be 0.6 hours, for a total burden of 720 hours annually (1,200 
reports x 0.6 hours = 720 hours). The estimated total annual responses 
are based on initial reports and amendments to those reports. These 
burden estimates have been submitted to OMB in the proposed collection 
of information entitled ``Electronic Data Collection Using 
MedWatch\Plus\ Portal and Rational Questionnaire,'' which is currently 
under review (74 FR 23721; May 20, 2009).
    In addition to the burden estimates submitted to OMB for approval, 
the agency has subsequently determined that there will be additional 
reporting burdens associated with the Registry requirements of FDAAA. 
Specifically, FDA may require the responsible party to notify the 
immediate previous source and/or immediate subsequent recipient of the 
reportable food (section 417(d)(6)(B)(i) and (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 and/or 
immediate subsequent recipient of the reportable food (section

[[Page 28500]]

417(d)(7)(C)(i) and (d)(7)(C)(ii) of the act). We estimate these 
reporting burdens in the following paragraphs.
    Notification to the immediate previous source and immediate 
subsequent recipient 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 
previously mentioned 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 section 
417(d)(6)(B) or (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 section 417(d)(6)(B) or 
(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 (section 417(d)(6)(B)(iii)(I), (d)(7)(C)(iii)(I), and (e) of 
the act). FDA may also require that the notification provide 
information about the actions that the recipient of the notification 
shall perform and/or any other information FDA may require (section 
417(d)(6)(B)(iii)(II), (d)(6)(B)(iii)(III), (d)(7)(C)(iii)(II), and 
(d)(7)(C)(iii)(III) of the act).
    FDA estimates that notifying the immediate previous recipient will 
take 0.6 hours per reportable food and notifying the immediate 
subsequent recipient 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 and/or immediate subsequent recipient. 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 63153 at 63157).
    FDA estimates that all mandatory reports will require that the 
immediate previous source and subsequent recipient be notified. We do 
not expect that this notification burden will apply to voluntary 
reporters of reportable foods. Therefore, the total estimated burden of 
notifying the immediate previous source and immediate subsequent 
recipient under section 417(d)(6)(B)(i), (d)(6)(B)(ii), (d)(7)(C)(i), 
and (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's utilization of an upper-bound 
estimate of 1,200 reports and 0.6 hours per report is likely an 
overestimate of the number of reports that may be received and an 
overestimate of the time necessary to notify 1 immediate previous 
source and 1 immediate subsequent recipient. However, these 
overestimates may be justified because FDA cannot know how often 
multiple immediate previous sources or immediate subsequent recipients 
may need to be notified for each reportable food event. FDA requests 
comment on these burden estimates.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                      No. of        Annual Frequency      Total Annual          Hours per
   Activity        Respondents        per Response          Responses            Response         Total Hours
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Notifying                   1,200                  1                 1,200                0.6                720
 immediate
 previous
 source of the
 article of
 food under
 section
 417(d)(6)(B)(
 i) of the act
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Notifying                   1,200                  1                 1,200                0.6                720
 immediate
 subsequent
 recipient of
 the article
 of food under
 section
 417(d)(6)(B)(
 ii) of the
 act
----------------------------------------------------------------------------------------------------------------
Notifying                   1,200                  1                 1,200                0.6                720
 immediate
 previous
 source of the
 article of
 food under
 section
 417(d)(7)(C)(
 i) of the act
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Notifying                   1,200                  1                 1,200                0.6                720
 immediate
 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 or operating and maintenance costs associated with this collection of information.

    Recordkeeping
    The agency has determined that there will be recordkeeping burdens 
associated with FDAAA. 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 a similar ``per event'' type of recordkeeping for 
food and cosmetics derived from cattle materials. For that recurring 
recordkeeping burden, which involves sending, verifying, and storing 
documents regarding shipments of cattle material used in human food and 
cosmetics, we estimated that the recurring recordkeeping burden would 
be about

[[Page 28501]]

15 minutes per week (71 FR 59653 at 59667; October 11, 2006).
    The annual recordkeeping burden for mandatory 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 reporting, nor is any such recordkeeping required by section 
417 of the act. 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 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.

    The draft 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.

    Dated: June 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.

[FR Doc. E9-14048 Filed 6-15-09; 8:45 am]
BILLING CODE 4160-01-S