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Request; Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations, 28484-28486 [E8-10985]
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<![CDATA[
28484
Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices
Dated: May 8, 2008.
Joseph Henderson,
Acting Chief Operating Officer, Centers for
Disease Control and Prevention.
[FR Doc. E8–10986 Filed 5–15–08; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–R–267]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, Department of
Health and Human Services.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Advantage Program: Application and
Contract Requirements; Use: The
information collection requirements are
mandated by 42 CFR 422. Section 4001
of the Balanced Budget Act of 1997
added sections 1851 through 1859 to the
Social Security Act to establish this new
program. The Medicare, Medicaid, and
SCHIP Benefits Improvement Act and
Protection Act of 2000 and sections
201–204 of the Medicare Prescription
Drug, Improvement, and Modernization
Act of 2003 (MMA) added new
requirements. Medicare Advantage
(MA) organizations (formerly M+C
organizations) and potential MA
organizations (applicants) use the
information to comply with the
application requirements and the MA
sroberts on PROD1PC70 with NOTICES
AGENCY:
VerDate Aug<31>2005
16:18 May 15, 2008
Jkt 214001
contract requirements. CMS will use
this information to approve contract
applications, monitor compliance with
contract requirements, make proper
payment to MA organizations,
determine compliance with the new
prescription drug benefit requirements
established by the MMA, and to ensure
that correct information is disclosed to
Medicare beneficiaries, both potential
enrollees and enrollees. The reported
change in burden is due to program
growth and revisions to the Medicare
Advantage and Prescription Drug
Benefit. Form Number: CMS–R–267
(OMB# 0938–0753); Frequency: Yearly;
Affected Public: Business or other forprofit and Not-for-profit institutions,
and Individuals or households; Number
of Respondents: 9,000,670; Total
Annual Responses: 9,000,670; Total
Annual Hours: 8,529,541.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on June 16, 2008.
OMB Human Resources and Housing
Branch, Attention: Carolyn Raffaelli,
New Executive Office Building, Room
10235, Washington, DC 20503, Fax
Number: (202) 395–6974.
Dated: May 7, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–10664 Filed 5–15–08; 8:45 am]
BILLING CODE 4120–01–P
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0094]
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 June 16,
2008.
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:
202–395–6974, or e-mailed to
baguilar@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:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
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 (FQPA), which amended the
Frm 00061
Fmt 4703
Sfmt 4703
E:\FR\FM\16MYN1.SGM
16MYN1
28485
Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act
(the 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 act). EPA, in
accordance with the FQPA, is in the
process of reassessing the pesticide
tolerances and exemptions which were
in effect when the FQPA was signed
into law. When EPA determines that a
pesticide’s tolerance level does not meet
the safety standard under section 408 of
the act (21 U.S.C. 346a), 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 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 (USDA)
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. FDA 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 act
(section 408(l)(5) of the 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 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), FDA 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 the agency’s current thinking
on its planned enforcement approach to
the channels of trade provision of the
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 https://
www.cfsan.fda.gov/guidance.html. FDA
anticipates 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
FDA encounters food bearing a residue
of a pesticide chemical for which the
tolerance has been revoked, suspended,
or modified, it intends to address the
situation in accordance with provisions
of the guidance. In general, FDA
anticipates 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 the
agency as discussed in the guidance
document. FDA is not suggesting that
firms maintain an inflexible set of
documents where anything less or
different would likely be considered
unacceptable. Rather, the agency is
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
FDA anticipates 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.
FDA is 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 February
25, 2008 (73 FR 10033), FDA published
a 60-day notice requesting public
comment on the information collection
provisions. No comments were received.
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
No. of
Respondents
Submission of documentation
sroberts on PROD1PC70 with NOTICES
1There
Annual Frequency
per Response
1
Total Annual
Responses
1
Hours per
Response
1
Total Hours
3
3
are no capital costs or operating and maintenance costs associated with this collection of information.
FDA expects the total number of
pesticide tolerances that are revoked,
suspended, or modified by EPA in the
next 3 years to significantly decrease, as
VerDate Aug<31>2005
16:18 May 15, 2008
Jkt 214001
EPA concludes its review activity. Thus,
the previous estimates for respondents
and numbers of responses in table 1 of
this document are based on the
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
submissions that the agency has
received in the past 3 years and the
expectation that the number of
submissions will significantly decrease
E:\FR\FM\16MYN1.SGM
16MYN1
28486
Federal Register / Vol. 73, No. 96 / Friday, May 16, 2008 / Notices
in the next 3 years. However, to avoid
counting this burden as zero, FDA has
estimated the burden at one respondent
making one submission a year for a total
of one annual submission.
The hours per response values were
estimated as follows: First, we assumed
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 BURDEN1
No. of
Recordkeepers
Activity
Develop documentation process
1There
Annual Frequency
per Recordkeeping
1
Total Annual
Records
1
1
Total Hours
16
16
are no capital costs or operating and maintenance costs associated with this collection of information.
In determining the estimated annual
recordkeeping burden, FDA 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. FDA has retrained its prior
estimate of 16 hours per record for the
recordkeeping burden. As shown in
table 1 of this document, FDA estimates
that one respondent will make one
submission per year. Although FDA
estimates 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, FDA estimates that 1
recordkeeper will take 16 hours to
develop and maintain documentation
recommended by the guidance.
Dated: May 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–10985 Filed 5–15–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
collection of information to OMB for
review and clearance.
Food and Drug Administration
Adverse Experience Reporting for
Licensed Biological Products; and
General Records—(OMB Control
Number 0910–0308)—Extension
Under the Public Health Service Act
(42 U.S.C. 262), FDA is required to
ensure the marketing of only those
biological products which are safe and
effective. FDA must, therefore, be
informed of all adverse experiences
occasioned by the use of licensed
biological products. FDA issued the
adverse experience reporting (AER)
requirements in part 600 (21 CFR part
600) to enable FDA to take actions
necessary for the protection of the
public health in response to reports of
adverse experiences related to licensed
biological products. The primary
purpose of FDA’s AER system is to flag
potentially serious safety problems with
licensed biological products, focusing
especially on newly licensed products.
Although premarket testing discloses a
general safety profile of a biological
product’s comparatively common
adverse effects, the larger and more
diverse patient populations exposed to
the licensed biological product provides
the opportunity to collect information
on rare, latent, and long-term effects.
Reports are obtained from a variety of
sources, including patients, physicians,
foreign regulatory agencies, and clinical
investigators. Information derived from
the AER system contributes directly to
increased public health protection
because such information enables FDA
to recommend important changes to the
product’s labeling (such as adding a
new warning), to initiate removal of a
biological product from the market
when necessary, and to assure the
manufacturer has taken adequate
corrective action if necessary.
The regulation in § 600.80(c)(1)
requires licensed manufacturers to
report each adverse experience that is
both serious and unexpected, whether
[Docket No. FDA–2008–N–0073]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
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 June 16,
2008.
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:
202–395–6974, or e-mailed to
baguilar@omb.eop.gov. All comments
should be identified with the OMB
control number 0910–0308. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
sroberts on PROD1PC70 with NOTICES
Hours per
Record
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–250), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
4659.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUPPLEMENTARY INFORMATION:
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16:18 May 15, 2008
Jkt 214001
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
E:\FR\FM\16MYN1.SGM
16MYN1
]]>Agencies
[Federal Register Volume 73, Number 96 (Friday, May 16, 2008)]
[Notices]
[Pages 28484-28486]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10985]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0094]
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 June
16, 2008.
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: 202-395-6974, or e-mailed to baguilar@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: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 (FQPA), which amended the
[[Page 28485]]
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the
Federal Food, Drug, and Cosmetic Act (the 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 act). EPA, in accordance with the FQPA,
is in the process of reassessing the pesticide tolerances and
exemptions which were in effect when the FQPA was signed into law. When
EPA determines that a pesticide's tolerance level does not meet the
safety standard under section 408 of the act (21 U.S.C. 346a), 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 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 (USDA) 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. FDA 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
act (section 408(l)(5) of the 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 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), FDA
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 the agency's current thinking
on its planned enforcement approach to the channels of trade provision
of the 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 https://www.cfsan.fda.gov/
guidance.html. FDA anticipates 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 FDA encounters food bearing a residue of a
pesticide chemical for which the tolerance has been revoked, suspended,
or modified, it intends to address the situation in accordance with
provisions of the guidance. In general, FDA anticipates 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 the agency as discussed in the guidance
document. FDA is not suggesting that firms maintain an inflexible set
of documents where anything less or different would likely be
considered unacceptable. Rather, the agency is 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 FDA anticipates 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.
FDA is 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 February 25, 2008 (73 FR 10033), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
Activity Respondents per Response Responses 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.
FDA expects the total number of pesticide tolerances that are
revoked, suspended, or modified by EPA in the next 3 years to
significantly decrease, as EPA concludes its review activity. Thus, the
previous estimates for respondents and numbers of responses in table 1
of this document are based on the submissions that the agency has
received in the past 3 years and the expectation that the number of
submissions will significantly decrease
[[Page 28486]]
in the next 3 years. However, to avoid counting this burden as zero,
FDA has estimated the burden at one respondent making one submission a
year for a total of one annual submission.
The hours per response values were estimated as follows: First, we
assumed 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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
Activity Recordkeepers per Recordkeeping Records Hours per Record 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, FDA
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. FDA has retrained its prior estimate of 16 hours per record for
the recordkeeping burden. As shown in table 1 of this document, FDA
estimates that one respondent will make one submission per year.
Although FDA estimates 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, FDA estimates that 1 recordkeeper will take 16 hours to
develop and maintain documentation recommended by the guidance.
Dated: May 8, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-10985 Filed 5-15-08; 8:45 am]
BILLING CODE 4160-01-S
