Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food, 28951-28954 [2020-10351]
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
Application No.
Drug
Applicant
NDA 021611 ..........
Opana (oxymorphone HCl) Tablets, 5mg and 10mg .............
NDA 022321 ..........
Embeda (morphine sulfate and naltrexone HCl) ExtendedRelease Capsules, 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/
2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, and 100 mg/4 mg.
Abstral (fentanyl) Sublingual Tablets,100 micrograms (mcg),
200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg.
Monodox (doxycycline monohydrate) Capsules, EQ 50mg
base, EQ 75mg base, and EQ 100mg base.
Endo Pharmaceuticals, Inc., 1400 Atwater Dr., Malvern, PA
19355.
Alpharma Pharmaceuticals, LLC, 235 East 42nd St., New
York, NY 10017.
NDA 022510 ..........
NDA 050641 ..........
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of June 15, 2020.
Approval of each entire application is
withdrawn, including any strengths and
dosage forms inadvertently missing
from the table. Introduction or delivery
for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in the table that
are in inventory on June 15, 2020 may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: May 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–10367 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
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Sentynl Therapeutics, Inc., 420 Stevens Ave., Suite 200,
Solana Beach, CA 92075.
Aqua Pharmaceuticals, LLC, 707 Eagleview Blvd., Suite
200, Exton, PA 19341.
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of FDA’s thirdparty 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’’).
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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
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
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-201509-18/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
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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
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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.
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Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
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-andanswers-regarding-reportable-foodregistry-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
28953
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
Number of
disclosures per
respondent
Number of
respondents
Activity
Average
burden per
disclosure
Total annual
disclosures
Total hours
Notifying immediate previous source of the article of
food under section 417(d)(6)(B)(i) of the FD&C
Act (mandatory reporters only)..
Notifying immediate 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 source of the article of
food under section 417(d)(7)(C)(i) of the FD&C
Act (mandatory reporters only)..
Notifying immediate subsequent recipient of the article of food under section 417(d)(7)(C)(ii) of the
FD&C Act (mandatory reporters only)..
1,200
1
1,200
0.6 (36 minutes) ..
720
1,200
1
1,200
0.6 (36 minutes) ..
720
1,200
1
1,200
0.6 (36 minutes) ..
720
1,200
1
1,200
0.6 (36 minutes) ..
720
Total ....................................................................
........................
............................
........................
.............................
2,880
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 ×
0.6 hours) + (1,200 × 0.6 hours) + (1,200
× 0.6 hours) + (1,200 × 0.6 hours). This
annual burden is shown in table 1.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
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Activity
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Maintenance of reportable food records under section
417(g) of the FD&C Act—mandatory reports..
Maintenance of reportable food records under section
417(g) of the FD&C Act—voluntary reports..
1,200
1
1,200
0.25 (15 minutes)
300
4
1
4
0.25 (15 minutes)
1
Total ........................................................................
........................
........................
........................
1 There
.............................
are no capital costs or operating and maintenance costs associated with this collection of information.
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28954
Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Notices
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 2year 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 × 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 ×
0.25 hours). The estimated total annual
recordkeeping burden is 301 hours
annually (1,200 × 0.25 hours) + (4 × 0.25
hours). This annual burden is shown in
table 2.
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by June 15,
2020.
Dated: April 28, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2020–10351 Filed 5–13–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0084]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse Event
Program for Medical Devices (Medical
Product Safety Network)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
SUMMARY:
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 0910–0471. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Adverse Event Program for Medical
Devices (Medical Product Safety
Network (MedSun))—OMB Control
Number 0910–0471—Extension
Section 519 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360i) authorizes FDA to require (1)
manufacturers to report medical devicerelated deaths, serious injuries, and
malfunctions; and (2) user facilities to
report device-related deaths directly to
manufacturers and FDA and serious
injuries to the manufacturer. Section
213 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) amended section
519(b) of the FD&C Act relating to
mandatory reporting by user facilities of
deaths, serious injuries, and serious
illnesses associated with the use of
medical devices. This amendment
legislated the replacement of universal
user facility reporting by a system that
is limited to a ‘‘. . .subset of user
facilities that constitutes a
representative profile of user reports’’
for device-related deaths and serious
injuries. This amendment is reflected in
section 519(b)(5)(A) of the FD&C Act.
This legislation provides FDA with the
opportunity to design and implement a
national surveillance network,
composed of well-trained clinical
facilities, to provide high-quality data
on medical devices in clinical use. This
system is called the Medical Product
Safety Network (MedSun).
FDA is seeking OMB clearance to
continue to use electronic data
collection to obtain the information on
Form FDA 3500A (approved under
OMB control number 0910–0291)
related to medical devices and tissue
products from the user facilities
participating in MedSun, to obtain a
demographic profile of the facilities,
and for additional questions, which will
permit FDA to better understand the
cause of reported adverse events.
Participation in the program is
voluntary and includes approximately
300 facilities.
In addition to collecting data on the
electronic adverse event report form,
MedSun collects additional information
from participating sites about reported
problems emerging from the MedSun
hospitals. This data collection is also
voluntary and is collected on the same
website as the report information.
The burden estimate is based on the
number of facilities participating in
MedSun (300). FDA estimates an
average of 18 reports per site annually.
This estimate is based on MedSun
working to promote reporting in general
from the sites, as well as promoting
reporting from specific parts of the
hospitals, such as the pediatric
intensive care units, the
electrophysiology laboratories, and the
hospital laboratories.
In the Federal Register of September
20, 2019 (84 FR 49526), we published a
60-day notice requesting public
comment on the proposed collection of
information. One comment was received
offering general support for the
collection but offered no suggested
changes to the burden estimate.
We estimate the burden of this
collection of information as follows:
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Adverse event reporting .................................................
1 There
Number of
responses per
respondent
300
18
Average
burden per
response
Total annual
responses
5,400
0.50 (30 minutes)
are no capital costs or operating and maintenance costs associated with this collection of information
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Total hours
2,700
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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)..
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
[[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
