[Federal Register Volume 85, Number 155 (Tuesday, August 11, 2020)]
[Notices]
[Pages 48542-48544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17506]


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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: Submit written comments (including recommendations) on the 
collection of information by September 10, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0643. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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 (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

[[Page 48543]]

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. (See 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 0910-0643.
    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) and (III) and 
(d)(7)(C)(iii)(II) and (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 FDA to target limited inspection 
resources to protect the public health (see 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 guidance entitled, ``Guidance for Industry: 
Questions and Answers Regarding the Reportable Food Registry as 
Established by the Food and Drug Administration Amendments Act of 
2007,'' which is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-reportable-food-registry-established-food-and-drug. The 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 20 and 21 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 May 14, 2020 (85 FR 28951), we 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 Number of
                  Activity                       Number of    disclosures per   Total annual         Average burden  per disclosure         Total hours
                                                respondents      respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
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            1,200                1           1,200  0.6 (36 minutes).........................             720
 the article of food under section
 417(d)(6)(B)(ii) of the FD&C Act (mandatory
 reporters only).

[[Page 48544]]

 
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            1,200                1           1,200  0.6 (36 minutes).........................             720
 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.

    Based on a review of the information collection since our last 
request for OMB approval, we have made no adjustments to our burden 
estimate.
    Third Party Disclosure: We estimate that approximately 1,200 
reportable food events with mandatory reporters 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) takes 
0.6 hours per reportable food and notifying the immediate subsequent 
recipient(s) takes 0.6 hours per reportable food. We also estimate that 
it takes 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 section 1005 of FDAAA 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 does 
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) and (ii), (d)(7)(C)(i) and (ii) of the FD&C Act for 
1,200 reportable foods is 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                       Number of      records per    Total annual        Average burden per recordkeeping         Total hours
                                               recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
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               4               1               4  0.25 (15 minutes).........................               1
 section 417(g) of the FD&C Act--voluntary
 reports.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ..............  ..............  ..........................................             301
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 FD&C Act 
requires that responsible persons maintain records related to 
reportable foods reports and notifications for a period of 2 years. 
Based on past FDA experiences, we estimate that each mandatory report 
and its associated notifications requires 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 4 voluntary reports we expect to receive annually. The 
recordkeeping burden associated with voluntary reports is thus 
estimated to be 1 hour annually (4 x 0.25 hours). The estimated total 
annual recordkeeping burden is 301 hours annually (1,200 x 0.25 hours) 
+ (4 x 0.25 hours). This annual burden is shown in table 2.

    Dated: July 30, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17506 Filed 8-10-20; 8:45 am]
BILLING CODE 4164-01-P