[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28951-28954]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10351]


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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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 solicits 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 July 13, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of July 13, 2020. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-N-0501 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Third Party Disclosure and 
Recordkeeping Requirements for Reportable Food.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you

[[Page 28952]]

must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    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.

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. (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.

[[Page 28953]]

    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.
    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
                   Activity                       Number of     disclosures per   Total annual       Average  burden per  disclosure        Total hours
                                                 respondents      respondent       disclosures
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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             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)..
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
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 28954]]

    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: April 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10351 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P


