[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,
[email protected].
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)..
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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
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Number of
Activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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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..
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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