[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Notices]
[Pages 31946-31948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12823]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0501]


Agency Information Collection Activities; Proposed Collection; 
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 or we) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice invites comments on the information collection 
provisions of FDA's third party disclosure and recordkeeping 
requirements for reportable food.

DATES: Submit either electronic or written comments on the collection 
of information by August 4, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' ' is defined in 44 U.S.C. 3502(3) and 5 
CFR 1320.3(c) and includes Agency requests or requirements that members 
of the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, we are publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, we invite 
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

[[Page 31947]]

respondents, including through the use of automated collection 
techniques, when appropriate, and other forms of information 
technology.

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 (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 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) 
to (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) to (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 section 417(d)(6)(B) or 
417(d)(7)(C) of the FD&C Act or required to report under section 
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 (section 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 (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 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'' 
(FDAAA, 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.
    We estimate the burden of this collection of information as 
follows:

[[Page 31948]]



                           Table 1--Estimated Annual Third Party Disclosure Burden \1\
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                                                 Number of
      Activity/Section           Number of      disclosures     Total annual      Average burden per      Total
                                respondents    per respondent    disclosures          disclosure          hours
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Notifying immediate previous           1,200                1           1,200  0.6 (36 minutes).......       720
 source of the article of
 food under section
 417(d)(6)(B)(i) of the FD&C
 Act (mandatory reporters
 only).
Notifying immediate                    1,200                1           1,200  0.6 (36 minutes).......       720
 subsequent recipient of the
 article of food under
 section 417(d)(6)(B)(ii) of
 the FD&C Act (mandatory
 reporters only).
Notifying immediate previous           1,200                1           1,200  0.6 (36 minutes).......       720
 source of the article of
 food under section
 417(d)(7)(C)(i) of the FD&C
 Act (mandatory reporters
 only).
Notifying immediate                    1,200                1           1,200  0.6 (36 minutes).......       720
 subsequent recipient of the
 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\
----------------------------------------------------------------------------------------------------------------
                                                 Number of
      Activity/section           Number of      records per     Total annual     Average burden  per      Total
                               recordkeepers   recordkeeping     records \2\            record            hours
----------------------------------------------------------------------------------------------------------------
Maintenance of reportable              1,200                1           1,200  0.25 (15 minutes)......       300
 food records under section
 417(g) of the FD&C Act--
 mandatory reports.
Maintenance of reportable                600                1             600  0.25 (15 minutes)......       150
 food records under 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: May 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12823 Filed 6-2-14; 8:45 am]
BILLING CODE 4160-01-P