Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food, 26489-26492 [2017-11821]
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Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
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SUPPLEMENTARY INFORMATION:
Agenda: During the morning session,
the committee will discuss biologics
license application (BLA) 761028 for
ABP 215, a proposed biosimilar to
Genentech/Roche’s AVASTIN
(bevacizumab), submitted by Amgen
Inc. The proposed indications/uses for
this product are: (1) For the first- or
second-line treatment of patients with
metastatic carcinoma of the colon or
rectum in combination with intravenous
5-fluorouracil-based chemotherapy; (2)
in combination with fluoropyrimidineirinotecan- or fluoropyrimidineoxaliplatin-based chemotherapy, for the
second-line treatment of patients with
metastatic colorectal cancer who have
progressed on a first-line ABP 215containing regimen; (3) for the first-line
treatment of unresectable, locally
advanced, recurrent or metastatic nonsquamous, non-small cell lung cancer in
combination with carboplatin and
paclitaxel; (4) for the treatment of
glioblastoma with progressive disease in
adult patients following prior therapy as
a single agent; (5) for the treatment of
metastatic renal cell carcinoma in
combination with interferon alfa; and
(6) in combination with paclitaxel and
cisplatin or paclitaxel and topotecan for
the treatment of persistent, recurrent, or
metastatic carcinoma of the cervix.
During the afternoon session, the
committee will discuss BLA 761074 for
MYL–1401O, a proposed biosimilar to
Genentech Inc.’s HERCEPTIN
(trastuzumab), submitted by Mylan
GmbH. The proposed indications/uses
for this product are: (1) For adjuvant
treatment of HER2 overexpressing node
positive or node negative (ER/PR
negative or with one high risk feature)
breast cancer; (a) as part of a treatment
regimen consisting of doxorubicin,
cyclophosphamide, and either
paclitaxel or docetaxel; (b) with
docetaxel and carboplatin; or (c) as a
single agent following multimodality
anthracycline based therapy; (2) in
combination with paclitaxel for firstline treatment of HER2-overexpressing
metastatic breast cancer; (3) as a single
agent for treatment of HER2overexpressing breast cancer in patients
who have received one or more
chemotherapy regimens for metastatic
disease; and (4) in combination with
cisplatin and capecitabine or 5fluorouracil, for the treatment of
patients with HER2 overexpressing
metastatic gastric or gastroesophageal
junction adenocarcinoma who have not
received prior treatment for metastatic
disease.1
1 This
indication is protected by orphan drug
exclusivity expiring on October 20, 2017. See the
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FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
docket (see the ADDRESSES section) on or
before June 26, 2017, will be provided
to the committee. Oral presentations
from the public will be scheduled
between approximately 10:45 a.m. to
11:15 a.m., and 3:45 p.m. to 4:15 p.m.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before June 16, 2017. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by June 19, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require special accommodations
due to a disability, please contact Jay R.
Fajiculay at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
Orphan Drug Designations and Approvals database
at https://www.accessdata.fda.gov/scripts/
opdlisting/oopd/index.cfm.
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26489
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11819 Filed 6–6–17; 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 we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (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.
SUMMARY:
Submit either electronic or
written comments on the collection of
information by August 7, 2017.
DATES:
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 August 7,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 7, 2017. 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.
ADDRESSES:
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Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
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’’).
sradovich on DSK3GMQ082PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 ‘‘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
Division of Dockets Management
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
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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 Division of Dockets
Management. 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 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852, 301–
796–7726, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
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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 (the FD&C Act), as amended by the
Food and Drug Administration
Amendments Act of 2007 (FDAAA)
(Pub. L. 110–85), requires the
establishment of a Reportable Food
Registry (the Registry) by which
instances of reportable food must be
submitted to FDA by responsible parties
and may be submitted by public health
officials. Section 417 of the FD&C Act
(21 U.S.C. 350f) defines ‘‘reportable
food’’ as an ‘‘article of food (other than
infant formula) for which there is a
reasonable probability that the use of, or
exposure to, such article of food will
cause serious adverse health
consequences or death to humans or
animals.’’ (Section 417(a)(2) of the FD&C
Act.) We believe that the most efficient
and cost effective means to implement
the Registry is by utilizing our
electronic Safety Reporting Portal. The
information collection provisions
associated with the submission of
reportable food reports has been
approved under OMB control number
0910–0643.
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 (section 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
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Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
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 (section 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),
(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 the Food and Drug
Administration to target limited
inspection resources to protect the
public health’’ (FDAAA, section
1005(a)(4)). The reporting and
recordkeeping requirements described
previously are designed to enable FDA
to quickly identify and track an article
of food (other than infant formula) for
which there is a reasonable probability
that the use of or exposure to such
article of food will cause serious adverse
health consequences or death to humans
or animals. We use the information
collected under these regulations to
help ensure that such products are
quickly and efficiently removed from
the market.
26491
As required under section 1005(f) of
FDAAA and to assist industry, we have
issued the guidance document entitled,
‘‘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/Food/
GuidanceRegulation/Guidance
DocumentsRegulatoryInformation/
ucm180761.htm. 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
respondents
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Activity/Section
Number of
disclosures
per
respondent
Total
annual
disclosures
Average burden per
disclosure
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.
Third Party Disclosure: We estimate
that approximately 1,200 reportable
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food events with mandatory reporters
will occur annually. Based on past FDA
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experiences, we estimate that we could
receive 200 to 1,200 ‘‘reportable’’ food
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reports annually from 200 to 1,200
mandatory and voluntary users of the
electronic reporting system. We utilized
the upper-bound estimate of 1,200 for
these calculations.
We estimate that notifying the
immediate previous source(s) will take
0.6 hours per reportable food and
notifying the immediate subsequent
recipient(s) will take 0.6 hours per
reportable food. We also estimate that it
will take 0.6 hours for the immediate
previous source and/or the immediate
subsequent recipient to also notify their
burden will not affect voluntary
reporters of reportable food events.
Therefore, we estimate that the total
burden of notifying the immediate
previous source(s) and immediate
subsequent recipient(s) under section
417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and
(ii) of the FD&C Act for 1,200 reportable
foods will be 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.
immediate previous source(s) and/or
immediate subsequent recipient(s). The
Agency bases its estimate on its
experience with mandatory and
voluntary reports submitted to FDA.
Although it is not mandatory under
FDAAA, section 1005 that responsible
persons notify the sources and
recipients of instances of reportable
food, for purposes of the burden
estimate we are assuming FDA would
exercise its authority and require such
notifications in all such instances for
mandatory reporters. This notification
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/Section
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 ...............................................................
........................
........................
........................
.......................................
301
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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 under section
417 of the FD&C Act for a period of 2
years. Based on past FDA experiences,
we estimate that each mandatory report
and its associated notifications will
require 30 minutes of recordkeeping for
the 2-year period, or 15 minutes per
record per year. The annual
recordkeeping burden for mandatory
reportable food reports and their
associated notifications is thus
estimated to be 300 hours (1,200 × 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
four 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 will
be 301 hours annually (1,200 × 0.25
hours) + (4 × 0.25 hours). This annual
burden is shown in table 2.
Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11821 Filed 6–6–17; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2734]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
advisory committee meeting of the
Oncologic Drugs Advisory Committee.
The general function of the committee is
to provide advice and recommendations
to the Agency on FDA’s regulatory
issues. The meeting will be open to the
public. FDA is establishing a docket for
public comment on this document.
DATES: The public meeting will be held
on July 12, 2017, from 8 a.m. to 5 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
SUMMARY:
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AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–2734.
The docket will close on July 10, 2017.
Submit either electronic or written
comments on this public meeting by
July 10, 2017. Late, untimely filed
comments will not be considered.
Electronic comments must be submitted
on or before July 10, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight eastern time, July 10, 2017.
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.
Comments received on or before June
26, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
You may submit comments as
follows:
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
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Agencies
[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Pages 26489-26492]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11821]
-----------------------------------------------------------------------
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 we) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(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 August 7, 2017.
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 August 7, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 7, 2017. 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.
[[Page 26490]]
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 ``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 Division of Dockets Management
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 Division of Dockets Management. 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 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.gpo.gov/fdsys/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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, 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 (the FD&C Act), as amended
by the Food and Drug Administration Amendments Act of 2007 (FDAAA)
(Pub. L. 110-85), requires the establishment of a Reportable Food
Registry (the Registry) by which instances of reportable food must be
submitted to FDA by responsible parties and may be submitted by public
health officials. Section 417 of the FD&C Act (21 U.S.C. 350f) defines
``reportable food'' as an ``article of food (other than infant formula)
for which there is a reasonable probability that the use of, or
exposure to, such article of food will cause serious adverse health
consequences or death to humans or animals.'' (Section 417(a)(2) of the
FD&C Act.) We believe that the most efficient and cost effective means
to implement the Registry is by utilizing our electronic Safety
Reporting Portal. The information collection provisions associated with
the submission of reportable food reports has been approved under OMB
control number 0910-0643.
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 (section 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
[[Page 26491]]
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 (section 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),
(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 the Food and Drug Administration
to target limited inspection resources to protect the public health''
(FDAAA, section 1005(a)(4)). The reporting and recordkeeping
requirements described previously are designed to enable FDA to quickly
identify and track an article of food (other than infant formula) for
which there is a reasonable probability that the use of or exposure to
such article of food will cause serious adverse health consequences or
death to humans or animals. We use the information collected under
these regulations to help ensure that such products are quickly and
efficiently removed from the market.
As required under section 1005(f) of FDAAA and to assist industry,
we have issued the guidance document entitled, ``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/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm180761.htm. 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/Section Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Notifying immediate previous 1,200 1 1,200 0.6 (36 minutes) 720
source of the article of food
under section 417(d)(6)(B)(i)
of the FD&C Act (mandatory
reporters only).
Notifying immediate subsequent 1,200 1 1,200 0.6 (36 minutes) 720
recipient of the article of
food under section
417(d)(6)(B)(ii) of the FD&C
Act (mandatory reporters
only).
Notifying immediate previous 1,200 1 1,200 0.6 (36 minutes) 720
source of the article of food
under section 417(d)(7)(C)(i)
of the FD&C Act (mandatory
reporters only).
Notifying immediate subsequent 1,200 1 1,200 0.6 (36 minutes) 720
recipient of 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.
Third Party Disclosure: We estimate that approximately 1,200
reportable food events with mandatory reporters will occur annually.
Based on past FDA experiences, we estimate that we could receive 200 to
1,200 ``reportable'' food
[[Page 26492]]
reports annually from 200 to 1,200 mandatory and voluntary users of the
electronic reporting system. We utilized the upper-bound estimate of
1,200 for these calculations.
We estimate that notifying the immediate previous source(s) will
take 0.6 hours per reportable food and notifying the immediate
subsequent recipient(s) will take 0.6 hours per reportable food. We
also estimate that it will take 0.6 hours for the immediate previous
source and/or the immediate subsequent recipient to also notify their
immediate previous source(s) and/or immediate subsequent recipient(s).
The Agency bases its estimate on its experience with mandatory and
voluntary reports submitted to FDA.
Although it is not mandatory under FDAAA, section 1005 that
responsible persons notify the sources and recipients of instances of
reportable food, for purposes of the burden estimate we are assuming
FDA would exercise its authority and require such notifications in all
such instances for mandatory reporters. This notification burden will
not affect voluntary reporters of reportable food events. Therefore, we
estimate that the total burden of notifying the immediate previous
source(s) and immediate subsequent recipient(s) under section
417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and (ii) of the FD&C Act for
1,200 reportable foods will be 2,880 hours annually (1,200 x 0.6 hours)
+ (1,200 x 0.6 hours) + (1,200 x 0.6 hours) + (1,200 x 0.6 hours). This
annual burden is shown in table 1.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity/Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Maintenance of reportable food 1,200 1 1,200 0.25 (15 300
records under section 417(g) minutes).
of the FD&C Act--mandatory
reports.
Maintenance of reportable food 4 1 4 0.25 (15 1
records under section 417(g) minutes).
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 under section 417 of the
FD&C Act for a period of 2 years. Based on past FDA experiences, we
estimate that each mandatory report and its associated notifications
will require 30 minutes of recordkeeping for the 2-year period, or 15
minutes per record per year. The annual recordkeeping burden for
mandatory reportable food reports and their associated notifications is
thus estimated to be 300 hours (1,200 x 0.25 hours).
We do not expect that records will always be kept in relation to
voluntary reportable food reports. Therefore, we estimate that records
will be kept for four 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 will be 301 hours annually (1,200 x 0.25
hours) + (4 x 0.25 hours). This annual burden is shown in table 2.
Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11821 Filed 6-6-17; 8:45 am]
BILLING CODE 4164-01-P