[Federal Register Volume 79, Number 164 (Monday, August 25, 2014)]
[Notices]
[Pages 50656-50658]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-20021]


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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.

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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 
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 [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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver 
Spring, MD 20993-0002 [email protected].

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 http://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\
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                                                                    Number of
                                                    Number of      disclosures    Total  annual
                Activity/section                   respondents         per         disclosures       Average  burden  per  disclosure       Total hours
                                                                   respondent
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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
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\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
                                               ---------------------------------------------------------------------------------------------------------
    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