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Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations, 49778-49780 [2014-19957]
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49778
Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Notices
CMS with reasonable assurance that the
accrediting organization requires the
accredited provider entities to meet
requirements that are at least as
stringent as the Medicare conditions.
Our regulations concerning the approval
of accrediting organizations are set forth
at § 488.4 and § 488.8(d)(3). The
regulations at § 488.8(d)(3) require
accrediting organizations to reapply for
continued approval of its accreditation
program every 6 years or sooner as
determined by us.
ACHC’s current term of approval for
their HHA accreditation program
expires February 24, 2015.
tkelley on DSK3SPTVN1PROD with NOTICES
II. Approval of Deeming Organizations
Section 1865(a)(2) of the Act and our
regulations at § 488.8(a) require that our
findings concerning review and
approval of a national accrediting
organization’s requirements consider,
among other factors, the applying
accrediting organization’s requirements
for accreditation; survey procedures;
resources for conducting required
surveys; capacity to furnish information
for use in enforcement activities;
monitoring procedures for provider
entities found not in compliance with
the conditions or requirements; and
ability to provide CMS with the
necessary data for validation.
Section 1865(a)(3)(A) of the Act
further requires that we publish, within
60 days of receipt of an organization’s
complete application, a notice
identifying the national accrediting
body making the request, describing the
nature of the request, and providing at
least a 30-day public comment period.
We have 210 days from the receipt of a
complete application to publish notice
of approval or denial of the application.
The purpose of this proposed notice
is to inform the public of ACHC’s
request for continued approval of its
HHA accreditation program. This notice
also solicits public comment on whether
ACHC’s requirements meet or exceed
the Medicare conditions of participation
(CoPs) for HHAs.
III. Evaluation of Deeming Authority
Request
ACHC submitted all the necessary
materials to enable us to make a
determination concerning its request for
continued approval of its HHA
accreditation program. This application
was determined to be complete on June
27, 2014. Under section 1865(a)(2) of the
Act and our regulations at § 488.8
(Federal review of accrediting
organizations), our review and
evaluation of ACHC will be conducted
in accordance with, but not necessarily
limited to, the following factors:
VerDate Mar<15>2010
16:23 Aug 21, 2014
Jkt 232001
• The equivalency of ACHC’s
standards for HHAs as compared with
Medicare’s HHA CoPs.
• ACHC’s survey process to
determine the following:
++ The composition of the survey
team, surveyor qualifications, and the
ability of the organization to provide
continuing surveyor training.
++ The comparability of ACHC’s
processes to those of state agencies,
including survey frequency, and the
ability to investigate and respond
appropriately to complaints against
accredited facilities.
++ ACHC’s processes and procedures
for monitoring a HHA found out of
compliance with ACHC’s program
requirements. These monitoring
procedures are used only when ACHC
identifies noncompliance. If
noncompliance is identified through
validation reviews or complaint
surveys, the state survey agency
monitors corrections as specified at
§ 488.7(d).
++ ACHC’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ ACHC’s capacity to provide CMS
with electronic data and reports
necessary for effective validation and
assessment of the organization’s survey
process.
++ The adequacy of ACHC’s staff and
other resources, and its financial
viability.
++ ACHC’s capacity to adequately
fund required surveys.
++ ACHC’s policies with respect to
whether surveys are announced or
unannounced, to assure that surveys are
unannounced.
++ ACHC’s agreement to provide
CMS with a copy of the most current
accreditation survey together with any
other information related to the survey
as CMS may require (including
corrective action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995.
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Dated: August 12, 2014.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2014–19697 Filed 8–21–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0084]
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,
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
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
22, 2014.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0562. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002 PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22AUN1.SGM
22AUN1
Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Notices
collection of information to OMB for
review and clearance.
tkelley on DSK3SPTVN1PROD with NOTICES
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 (the 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
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
VerDate Mar<15>2010
16:23 Aug 21, 2014
Jkt 232001
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 egg products and most meat and
poultry 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 which were lawful
under FIFRA.
In the Federal Register of May 18,
2005 (70 FR 28544), we announced the
availability of a 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
pursuant to dietary risk considerations.
The guidance can be found at the
following link: https://www.fda.gov/
Food/GuidanceRegulation/
GuidanceDocuments
RegulatoryInformation/
ChemicalContaminantsMetalsNatural
ToxinsPesticides/ucm077918.htm. We
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
49779
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 document.
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 which 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 June 3, 2014
(79 FR 31944), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
We estimate the annual burden of this
collection of information as follows:
E:\FR\FM\22AUN1.SGM
22AUN1
49780
Federal Register / Vol. 79, No. 163 / Friday, August 22, 2014 / Notices
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
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We expect the total number of
pesticide tolerances that are revoked,
suspended, or modified by EPA
pursuant to 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
will receive pursuant to the guidance
document will 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.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Activity
Number of
recordkeepers
Number of
records per
recordkeeping
Total annual
records
Average
burden per
record
Total hours
Develop documentation process .........................................
1
1
1
16
16
tkelley on DSK3SPTVN1PROD with NOTICES
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 out of 10 firms will not be
currently maintaining the necessary
documentation, to avoid counting the
recordkeeping burden for the 1
submission per year as 1⁄10 of a
recordkeeper, we estimate that 1
recordkeeper will take 16 hours to
develop and maintain documentation
recommended by the guidance.
Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
[FR Doc. 2014–19957 Filed 8–21–14; 8:45 am]
BILLING CODE 4164–01–P
VerDate Mar<15>2010
16:23 Aug 21, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–P–0637, FDA–
2014–P–0315]
Determination That FUSILEV
(Levoleucovorin Calcium), Injection,
175 Milligrams/17.5 Milliliters and 250
Milligrams/25 Milliliters, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
that FUSILEV (levoleucovorin calcium),
Injection, 175 milligrams (mg)/17.5
milliliters (mL) and 250 mg/25 mL, were
not withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for
levoleucovorin calcium, injection, 175
mg/17.5 mL and 250 mg/25 mL, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Darren Eicken, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6206,
Silver Spring, MD 20993–0002, 240–
402–0978.
SUMMARY:
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
(the 1984 amendments), which
authorized the approval of duplicate
versions of drug products under an
ANDA procedure. ANDA applicants
must, with certain exceptions, show that
the drug for which they are seeking
approval contains the same active
ingredient in the same strength and
dosage form as the ‘‘listed drug,’’ which
is a version of the drug that was
previously approved. ANDA applicants
do not have to repeat the extensive
clinical testing otherwise necessary to
gain approval of a new drug application
(NDA).
The 1984 amendments include what
is now section 505(j)(7) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)(7)), which requires FDA to
publish a list of all approved drugs.
FDA publishes this list as part of the
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations,’’
which is known generally as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are removed from the list if the
Agency withdraws or suspends
approval of the drug’s NDA or ANDA
for reasons of safety or effectiveness or
if FDA determines that the listed drug
was withdrawn from sale for reasons of
safety or effectiveness (§ 314.162 (21
CFR 314.162)).
A person may petition the Agency to
determine, or the Agency may
SUPPLEMENTARY INFORMATION:
E:\FR\FM\22AUN1.SGM
22AUN1
]]>Agencies
[Federal Register Volume 79, Number 163 (Friday, August 22, 2014)]
[Notices]
[Pages 49778-49780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19957]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0084]
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, 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: Fax written comments on the collection of information by
September 22, 2014.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0562.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed
[[Page 49779]]
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 (the 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 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 egg products and most meat and poultry 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 which were
lawful under FIFRA.
In the Federal Register of May 18, 2005 (70 FR 28544), we announced
the availability of a 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 pursuant to dietary risk considerations.
The guidance can be found at the following link: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ChemicalContaminantsMetalsNaturalToxinsPesticides/ucm077918.htm. 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 document. 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 which 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 June 3, 2014 (79 FR 31944), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the annual burden of this collection of information as
follows:
[[Page 49780]]
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.
We expect the total number of pesticide tolerances that are
revoked, suspended, or modified by EPA pursuant to 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 will
receive pursuant to the guidance document will 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.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of records per Total annual Average burden Total hours
recordkeepers recordkeeping records per record
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 out of 10 firms will not be currently maintaining the necessary
documentation, to avoid counting the recordkeeping burden for the 1
submission per year as \1/10\ of a recordkeeper, we estimate that 1
recordkeeper will take 16 hours to develop and maintain documentation
recommended by the guidance.
Dated: August 19, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-19957 Filed 8-21-14; 8:45 am]
BILLING CODE 4164-01-P
