Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations, 47801-47803 [2020-17174]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
information about presubmission of
promotional materials.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Limited Population
Pathway for Antibacterial and
Antifungal Drugs.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no new
collection of information. Therefore,
additional clearance by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act (PRA) of
1995 (44 U.S.C. 3501–3521) is not
required.
However, this guidance refers to
previously approved FDA collections of
information. These collections of
information were reviewed by OMB
under the PRA. The collections of
information in 21 CFR part 314 for the
submission of new drug applications
(NDAs) under the LPAD pathway,
including the submission of labeling
under § 314.50(e)(2)(ii) and (l)(1)(i) and
advertisements and promotional
labeling under § 314.81(b)(3)(i), have
been approved under OMB control
number 0910–0001. The submission of
biologics license applications (BLAs)
under the LPAD pathway has been
approved under OMB control number
0910–0338.
The submission of prescription drug
labeling in 21 CFR 201.56 and 201.57
has been approved under OMB control
number 0910–0572. The submission of
medication guides in 21 CFR part 208
has been approved under OMB control
number 0910–0393. The submission of
prescription drug advertisements in 21
CFR 202.1 has been approved under
OMB control number 0910–0686.
The collections of information in 21
CFR part 312, including submissions
under subpart E, have been approved
under OMB control number 0910–0014.
The collections of information in FDA’s
draft guidance for industry entitled
‘‘Formal Meetings Between the FDA and
Sponsors and Applicants for PDUFA
Products’’ (available at https://
www.fda.gov/media/109951/download),
including requests for pre-NDA and preBLA meetings and other meetings
pertaining to the LPAD pathway, have
been approved under OMB control
number 0910–0429.
The collections of information in
FDA’s final guidance for industry
entitled ‘‘Expedited Programs for
VerDate Sep<11>2014
17:13 Aug 05, 2020
Jkt 250001
Serious Conditions—Drugs and
Biologics’’ (available at https://
www.fda.gov/media/86377/download)
have been approved under OMB control
number 0910–0765.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, or https://
www.regulations.gov.
Dated: July 31, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–17109 Filed 8–5–20; 8:45 am]
BILLING CODE 4164–01–P
47801
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
SUPPLEMENTARY INFORMATION:
Channels of Trade Policy for
Commodities With Residues of
Pesticide Chemicals, for Which
Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
OMB Control Number 0910–0562—
Extension
Food and Drug Administration
The Food Quality Protection Act of
1996, which amended the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and the Federal Food, Drug,
and Cosmetic Act (FD&C Act),
established a new safety standard for
pesticide residues in food, with an
emphasis on protecting the health of
infants and children. The
Environmental Protection Agency (EPA)
is responsible for regulating the use of
pesticides (under FIFRA) and for
establishing tolerances or exemptions
from the requirement for tolerances for
residues of pesticide chemicals in food
commodities (under the FD&C Act).
EPA may, for various reasons, e.g., as
part of a systematic review or in
response to new information concerning
the safety of a specific pesticide,
reassess whether a tolerance for a
pesticide residue continues to meet the
safety standard in section 408 of the
FD&C Act (21 U.S.C. 346a). When EPA
determines that a pesticide’s tolerance
level does not meet that safety standard,
the registration for the pesticide may be
canceled under FIFRA for all or certain
uses. In addition, the tolerances for that
pesticide may be lowered or revoked for
the corresponding food commodities.
Under section 408(l)(2) of the FD&C
Act, when the registration for a
pesticide is canceled or modified due to,
in whole or in part, dietary risks to
humans posed by residues of that
pesticide chemical on food, the effective
date for the revocation of such tolerance
(or exemption in some cases) must be no
later than 180 days after the date such
cancellation becomes effective or 180
[Docket No. FDA–2017–N–2021]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Channels of Trade
Policy for Commodities With Residues
of Pesticide Chemicals, for Which
Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Submit written comments
(including recommendations) on the
collection of information by September
8, 2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0562. Also include
SUMMARY:
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
E:\FR\FM\06AUN1.SGM
06AUN1
47802
Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices
days after the date on which the use of
the canceled pesticide becomes
unlawful under the terms of the
cancellation, whichever is later.
When EPA takes such actions, food
derived from a commodity that was
lawfully treated with the pesticide may
not have cleared the channels of trade
by the time the revocation or new
tolerance level takes effect. The food
could be found by FDA, the Agency that
is responsible for monitoring pesticide
residue levels and enforcing the
pesticide tolerances in most foods (the
U.S. Department of Agriculture has
responsibility for monitoring residue
levels and enforcing pesticide tolerances
in meat, poultry, catfish, and certain egg
products), to contain a residue of that
pesticide that does not comply with the
revoked or lowered tolerance. We would
normally deem such food to be in
violation of the law by virtue of it
bearing an illegal pesticide residue. The
food would be subject to FDA
enforcement action as an ‘‘adulterated’’
food. However, the channels of trade
provision of the FD&C Act addresses the
circumstances under which a food is not
unsafe solely due to the presence of a
residue from a pesticide chemical for
which the tolerance has been revoked,
suspended, or modified by EPA. The
channels of trade provision (section
408(l)(5) of the FD&C Act) states that
food containing a residue of such a
pesticide shall not be deemed
‘‘adulterated’’ by virtue of the residue, if
the residue is within the former
tolerance, and the responsible party can
demonstrate to FDA’s satisfaction that
the residue is present as the result of an
application of the pesticide at a time
and in a manner that were lawful under
FIFRA.
In the Federal Register of May 18,
2005 (70 FR 28544), we announced the
availability of a final guidance
document entitled ‘‘Channels of Trade
Policy for Commodities With Residues
of Pesticide Chemicals, for Which
Tolerances Have Been Revoked,
Suspended, or Modified by the
Environmental Protection Agency
Pursuant to Dietary Risk
Considerations.’’ The guidance
represents FDA’s current thinking on its
planned enforcement approach to the
channels of trade provision of the FD&C
Act and how that provision relates to
FDA-regulated products with residues
of pesticide chemicals for which
tolerances have been revoked,
suspended, or modified by EPA under
dietary risk considerations. The
guidance can be found at the following
link: https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-channelstrade-policy-commodities-residuespesticide-chemicals.
We anticipate that food bearing
lawfully applied residues of pesticide
chemicals that are the subject of future
EPA action to revoke, suspend, or
modify their tolerances, will remain in
the channels of trade after the
applicable tolerance is revoked,
suspended, or modified. If we encounter
food bearing a residue of a pesticide
chemical for which the tolerance has
been revoked, suspended, or modified,
we intend to address the situation in
accordance with provisions of the
guidance. In general, we anticipate that
the party responsible for food found to
contain pesticide chemical residues
(within the former tolerance) after the
tolerance for the pesticide chemical has
been revoked, suspended, or modified
will be able to demonstrate that such
food was handled, e.g., packed or
processed, during the acceptable
timeframes cited in the guidance by
providing appropriate documentation to
FDA as discussed in the guidance. We
are not suggesting that firms maintain
an inflexible set of documents where
anything less or different would likely
be considered unacceptable. Rather, we
are leaving it to each firm’s discretion to
maintain appropriate documentation to
demonstrate that the food was so
handled during the acceptable
timeframes.
Examples of documentation that we
anticipate will serve this purpose
consist of documentation associated
with packing codes, batch records, and
inventory records. These are types of
documents that many food processors
routinely generate as part of their basic
food-production operations.
Accordingly, under the PRA, we are
requesting the extension of OMB
approval for the information collection
provisions in the guidance.
Description of Respondents: The
likely respondents to this collection of
information are firms in the produce
and food processing industries that
handle food products that may contain
residues of pesticide chemicals after the
tolerances for the pesticide chemicals
have been revoked, suspended, or
modified.
In the Federal Register of May 13,
2020 (85 FR 28639), we published a 60day notice requesting public comment
on the proposed collection of
information. Four comments were
received. Three comments offering
general support for the information
collection and one comment was non
responsive to the information collection
topics solicited. None of the comments
suggested that we revise our burden
estimate.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Submission of Documentation .............................................
1
1
1
3
3
jbell on DSKJLSW7X2PROD with NOTICES
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.
We expect the total number of
pesticide tolerances that are revoked,
suspended, or modified by EPA under
dietary risk considerations in the next 3
years to remain at a low level, as there
have been no changes to the safety
standard for pesticide residues in food
VerDate Sep<11>2014
17:13 Aug 05, 2020
Jkt 250001
since 1996. Thus, we expect the number
of submissions we receive under the
guidance document to also remain at a
low level. However, to avoid counting
this burden as zero, we have estimated
the burden at one respondent making
one submission a year for a total of one
annual submission.
We based our estimate of the hours
per response on the assumption that the
information requested in the guidance is
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
readily available to the submitter. We
expect that the submitter will need to
gather information from appropriate
persons in the submitter’s company and
to prepare this information for
submission to FDA. The submitter will
almost always merely need to copy
existing documentation. We believe that
this effort should take no longer than 3
hours per submission.
E:\FR\FM\06AUN1.SGM
06AUN1
47803
Federal Register / Vol. 85, No. 152 / Thursday, August 6, 2020 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
Develop documentation Process .........................................
1
1
1
16
16
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
In determining the estimated annual
recordkeeping burden, we estimated
that at least 90 percent of firms maintain
documentation, such as packing codes,
batch records, and inventory records, as
part of their basic food production or
import operations. Therefore, the
recordkeeping burden was calculated as
the time required for the 10 percent of
firms that may not be currently
maintaining this documentation to
develop and maintain documentation,
such as batch records and inventory
records. In previous information
collection requests, this recordkeeping
burden was estimated to be 16 hours per
record. We have retained our prior
estimate of 16 hours per record for the
recordkeeping burden. As shown in
table 1, we estimate that one respondent
will make one submission per year.
Although we estimate that only 1 of 10
firms will not be currently maintaining
the necessary documentation, to avoid
counting the recordkeeping burden for
the 1 submission per year as 1/10th of
a recordkeeper, we estimate that 1
recordkeeper will take 16 hours to
develop and maintain documentation
recommended by the guidance.
Dated: July 30, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–17174 Filed 8–5–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request Information
Collection Request Title: Federal Tort
Claims Act Program Deeming
Sponsorship Application for Free
Clinics, OMB No. 0915–0293–Revision
Health Resources and Services
Administration, Department of Health
and Human Services.
ACTION: Notice.
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
SUMMARY:
VerDate Sep<11>2014
17:13 Aug 05, 2020
Jkt 250001
projects of the Paperwork Reduction Act
of 1995, the Health Resources and
Services Administration (HRSA)
announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). Prior
to submitting the ICR to OMB, HRSA
seeks comments from the public
regarding the burden estimate, below, or
any other aspect of the ICR.
DATES: Comments on this Information
Collection Request must be received no
later than October 5, 2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Federal Tort Claims Act Program
Deeming Sponsorship Application for
Free Clinics, OMB No. 0915–0293¥
Revised
Abstract: Section 224(o) of the Public
Health Service (PHS) Act (42 U.S.C.
233(o)), as amended, authorizes the
‘‘deeming’’ of certain individuals as
PHS employees for the purposes of
receiving liability protections, including
Federal Tort Claims Act (FTCA)
coverage, for the performance of
medical, surgical, dental or related
functions within the scope of deemed
employment. Section 224(o) extends
eligibility for deemed PHS employee
status to free clinic health professionals
including employees, officers, board
members, contractors, and volunteers at
qualifying free clinics. The Free Clinics
FTCA Program is administered by
HRSA’s Bureau of Primary Health Care.
Sponsoring free clinics seeking FTCA
coverage for their employees, officers,
board members, contractors, and
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
volunteers must submit deeming
applications in the specified form and
manner on behalf of named individuals
for review and approval, resulting in a
‘‘deeming determination’’ that includes
associated FTCA coverage for these
individuals.
HRSA is proposing several changes to
the FTCA Program Deeming
Applications for Free Clinics, to be used
for Free Clinic deeming sponsorship
applications for Calendar Year 2021 and
thereafter, to improve question clarity
and clarify required documentation.
Specifically, the Application includes
the following proposed changes:
• Updated application language:
Specifically, throughout the application,
alternate terminology was utilized to
provide greater clarity and specificity.
These changes were based on
stakeholder feedback and information
received from the HRSA Health Center
Program Support. These changes are not
substantive in nature.
• Added Service Type and
clarifications regarding professional
designation: Specifically, section VI of
the application was updated to include
service type which will allow HRSA to
verify whether an individual is
performing clinical or non-clinical
services. In addition to the inclusion of
service type, a note was added to
request that free clinics include the
professional designation for each
individual.
• Deleted remark in section IX: It has
been determined that the information
requested in this section, which related
to offsite events and particularized
determinations is no longer necessary to
evaluate eligibility for deeming.
Need and Proposed Use of the
Information: Deeming applications must
address certain criteria required by law
in order for the Secretary to deem an
individual sponsored by a qualifying
free clinic as a PHS employee for
purposes of liability protections,
including FTCA coverage. This
determination cannot be made without
the collection of this information.
Specifically, the deeming sponsorship
application form seeks information
verifying that the free clinic meets the
criteria to sponsor a deeming
application and that the individual
being sponsored is eligible to be deemed
E:\FR\FM\06AUN1.SGM
06AUN1
]]>Agencies
[Federal Register Volume 85, Number 152 (Thursday, August 6, 2020)]
[Notices]
[Pages 47801-47803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17174]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2021]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Channels of Trade
Policy for Commodities With Residues of Pesticide Chemicals, for Which
Tolerances Have Been Revoked, Suspended, or Modified by the
Environmental Protection Agency Pursuant to Dietary Risk Considerations
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by September 8, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0562. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Channels of Trade Policy for Commodities With Residues of Pesticide
Chemicals, for Which Tolerances Have Been Revoked, Suspended, or
Modified by the Environmental Protection Agency Pursuant to Dietary
Risk Considerations
OMB Control Number 0910-0562--Extension
The Food Quality Protection Act of 1996, which amended the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug, and Cosmetic Act (FD&C Act), established a new safety
standard for pesticide residues in food, with an emphasis on protecting
the health of infants and children. The Environmental Protection Agency
(EPA) is responsible for regulating the use of pesticides (under FIFRA)
and for establishing tolerances or exemptions from the requirement for
tolerances for residues of pesticide chemicals in food commodities
(under the FD&C Act). EPA may, for various reasons, e.g., as part of a
systematic review or in response to new information concerning the
safety of a specific pesticide, reassess whether a tolerance for a
pesticide residue continues to meet the safety standard in section 408
of the FD&C Act (21 U.S.C. 346a). When EPA determines that a
pesticide's tolerance level does not meet that safety standard, the
registration for the pesticide may be canceled under FIFRA for all or
certain uses. In addition, the tolerances for that pesticide may be
lowered or revoked for the corresponding food commodities.
Under section 408(l)(2) of the FD&C Act, when the registration for
a pesticide is canceled or modified due to, in whole or in part,
dietary risks to humans posed by residues of that pesticide chemical on
food, the effective date for the revocation of such tolerance (or
exemption in some cases) must be no later than 180 days after the date
such cancellation becomes effective or 180
[[Page 47802]]
days after the date on which the use of the canceled pesticide becomes
unlawful under the terms of the cancellation, whichever is later.
When EPA takes such actions, food derived from a commodity that was
lawfully treated with the pesticide may not have cleared the channels
of trade by the time the revocation or new tolerance level takes
effect. The food could be found by FDA, the Agency that is responsible
for monitoring pesticide residue levels and enforcing the pesticide
tolerances in most foods (the U.S. Department of Agriculture has
responsibility for monitoring residue levels and enforcing pesticide
tolerances in meat, poultry, catfish, and certain egg products), to
contain a residue of that pesticide that does not comply with the
revoked or lowered tolerance. We would normally deem such food to be in
violation of the law by virtue of it bearing an illegal pesticide
residue. The food would be subject to FDA enforcement action as an
``adulterated'' food. However, the channels of trade provision of the
FD&C Act addresses the circumstances under which a food is not unsafe
solely due to the presence of a residue from a pesticide chemical for
which the tolerance has been revoked, suspended, or modified by EPA.
The channels of trade provision (section 408(l)(5) of the FD&C Act)
states that food containing a residue of such a pesticide shall not be
deemed ``adulterated'' by virtue of the residue, if the residue is
within the former tolerance, and the responsible party can demonstrate
to FDA's satisfaction that the residue is present as the result of an
application of the pesticide at a time and in a manner that were lawful
under FIFRA.
In the Federal Register of May 18, 2005 (70 FR 28544), we announced
the availability of a final guidance document entitled ``Channels of
Trade Policy for Commodities With Residues of Pesticide Chemicals, for
Which Tolerances Have Been Revoked, Suspended, or Modified by the
Environmental Protection Agency Pursuant to Dietary Risk
Considerations.'' The guidance represents FDA's current thinking on its
planned enforcement approach to the channels of trade provision of the
FD&C Act and how that provision relates to FDA-regulated products with
residues of pesticide chemicals for which tolerances have been revoked,
suspended, or modified by EPA under dietary risk considerations. The
guidance can be found at the following link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-channels-trade-policy-commodities-residues-pesticide-chemicals.
We anticipate that food bearing lawfully applied residues of
pesticide chemicals that are the subject of future EPA action to
revoke, suspend, or modify their tolerances, will remain in the
channels of trade after the applicable tolerance is revoked, suspended,
or modified. If we encounter food bearing a residue of a pesticide
chemical for which the tolerance has been revoked, suspended, or
modified, we intend to address the situation in accordance with
provisions of the guidance. In general, we anticipate that the party
responsible for food found to contain pesticide chemical residues
(within the former tolerance) after the tolerance for the pesticide
chemical has been revoked, suspended, or modified will be able to
demonstrate that such food was handled, e.g., packed or processed,
during the acceptable timeframes cited in the guidance by providing
appropriate documentation to FDA as discussed in the guidance. We are
not suggesting that firms maintain an inflexible set of documents where
anything less or different would likely be considered unacceptable.
Rather, we are leaving it to each firm's discretion to maintain
appropriate documentation to demonstrate that the food was so handled
during the acceptable timeframes.
Examples of documentation that we anticipate will serve this
purpose consist of documentation associated with packing codes, batch
records, and inventory records. These are types of documents that many
food processors routinely generate as part of their basic food-
production operations. Accordingly, under the PRA, we are requesting
the extension of OMB approval for the information collection provisions
in the guidance.
Description of Respondents: The likely respondents to this
collection of information are firms in the produce and food processing
industries that handle food products that may contain residues of
pesticide chemicals after the tolerances for the pesticide chemicals
have been revoked, suspended, or modified.
In the Federal Register of May 13, 2020 (85 FR 28639), we published
a 60-day notice requesting public comment on the proposed collection of
information. Four comments were received. Three comments offering
general support for the information collection and one comment was non
responsive to the information collection topics solicited. None of the
comments suggested that we revise our burden estimate.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of Documentation........................................ 1 1 1 3 3
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
We expect the total number of pesticide tolerances that are
revoked, suspended, or modified by EPA under dietary risk
considerations in the next 3 years to remain at a low level, as there
have been no changes to the safety standard for pesticide residues in
food since 1996. Thus, we expect the number of submissions we receive
under the guidance document to also remain at a low level. However, to
avoid counting this burden as zero, we have estimated the burden at one
respondent making one submission a year for a total of one annual
submission.
We based our estimate of the hours per response on the assumption
that the information requested in the guidance is readily available to
the submitter. We expect that the submitter will need to gather
information from appropriate persons in the submitter's company and to
prepare this information for submission to FDA. The submitter will
almost always merely need to copy existing documentation. We believe
that this effort should take no longer than 3 hours per submission.
[[Page 47803]]
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Develop documentation Process...................................... 1 1 1 16 16
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In determining the estimated annual recordkeeping burden, we
estimated that at least 90 percent of firms maintain documentation,
such as packing codes, batch records, and inventory records, as part of
their basic food production or import operations. Therefore, the
recordkeeping burden was calculated as the time required for the 10
percent of firms that may not be currently maintaining this
documentation to develop and maintain documentation, such as batch
records and inventory records. In previous information collection
requests, this recordkeeping burden was estimated to be 16 hours per
record. We have retained our prior estimate of 16 hours per record for
the recordkeeping burden. As shown in table 1, we estimate that one
respondent will make one submission per year. Although we estimate that
only 1 of 10 firms will not be currently maintaining the necessary
documentation, to avoid counting the recordkeeping burden for the 1
submission per year as 1/10th of a recordkeeper, we estimate that 1
recordkeeper will take 16 hours to develop and maintain documentation
recommended by the guidance.
Dated: July 30, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-17174 Filed 8-5-20; 8:45 am]
BILLING CODE 4164-01-P
