Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects; EPA ICR No. 2195.03, OMB Control No. 2070-0169, 75707-75709 [E8-29483]
Download as PDF
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Notices
jlentini on PROD1PC65 with NOTICES
assigned to this action in the subject
line on the first page of your response.
You may also provide the name, date,
and Federal Register citation.
What Information Collection Activity or
ICR Does This Apply to?
Docket ID No. EPA–HQ–SFUND–
2005–0008.
Affected entities: Entities potentially
affected by this action are those which
have a threshold planning quantity of an
extremely hazardous substance (EHS)
listed in 40 CFR Part 355, Appendix A
and those which have a release of any
of the EHS above a reportable quantity.
Entities more likely to be affected by
this action may include chemical
manufacturers, non-chemical
manufacturers, retailers, petroleum
refineries, utilities, etc.
Title: Emergency Planning and
Release Notification Requirements
under Emergency Planning and
Community Right-to-Know Act Sections
302, 303, and 304.
ICR number: EPA ICR No. 1395.07,
OMB Control No. 2050–0092.
ICR status: This ICR is currently
scheduled to expire on May 31, 2009.
An Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information, unless it
displays a currently valid OMB control
number. The OMB control numbers for
EPA’s regulations in title 40 of the CFR,
after appearing in the Federal Register
when approved, are listed in 40 CFR
part 9, are displayed either by
publication in the Federal Register or
by other appropriate means, such as on
the related collection instrument or
form, if applicable. The display of OMB
control numbers in certain EPA
regulations is consolidated in 40 CFR
part 9.
Abstract: The authority for these
requirements is sections 302, 303, and
304 of the Emergency Planning and
Community Right-to-Know Act
(EPCRA), 1986 (42 U.S.C. 11002, 11003,
and 11004). EPCRA established broad
emergency planning and facility
reporting requirements. Section 302
requires facilities to notify their state
emergency response commission (SERC)
that the facility is subject to emergency
planning. This activity has been
completed; this ICR covers only new
facilities that are subject to this
requirement. Section 303 requires the
local emergency planning committees
(LEPCs) to prepare emergency plans for
facilities that are subject to section 302.
This activity has been also completed;
this ICR only covers any updates needed
for these emergency response plans.
Section 304 requires facilities to report
to SERCs and LEPCs releases in excess
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17:56 Dec 11, 2008
Jkt 217001
of the reportable quantities listed for
each extremely hazardous substance
(EHS). This ICR also covers the
notification and the written follow-up
required under this section. The
implementing regulations and the list of
substances for emergency planning and
emergency release notification are
codified in 40 CFR part 355.
On November 3, 2008 (73 FR 64452),
EPA has revised some of the
requirements in 40 CFR part 355,
specifically, the requirements related to
emergency planning notification. EPA is
now requiring facilities to notify their
LEPC within 30 days of any changes
occurring at the facility that may be
relevant to emergency planning. This
revision should not impose any
additional burden on facilities subject to
emergency planning. Prior to the
November 3, 2008 final rule, facilities
were required to provide any changes to
the LEPC promptly. This final rule now
requires facilities to provide any
changes within 30 days. Other revisions
finalized on November 3, 2008 do not
impose any burden on facilities subject
to Section 302 and 304 requirements.
Burden Statement: The burden and
costs stated below are from the current
approved ICR. The average reporting
burden for a limited number of existing
facilities, to inform the LEPC of any
changes at the facility that may affect
emergency planning (1.50 hours). The
average reporting burden for facilities
reporting releases under 40 CFR 355.40
is estimated to average approximately 5
hours per release, including the time for
determining if the release is a reportable
quantity, notifying the LEPC and SERC,
or the 911 operator, and developing and
submitting a written follow-up notice.
There are no record keeping
requirements for facilities under EPCRA
Sections 302–304. The total burden to
facilities over three years is 229,473
hours at a cost of $11.1 million.
The average burden for emergency
planning activities is 21 hours per plan
for LEPCs, and 16 hours per plan for
SERCs. Each SERC and LEPC is also
estimated to incur an annual record
keeping burden of 10 hours. The total
burden to LEPC and SERC over three
years is 320,568 hours at a cost of $8.1
million.
Burden means the total time, effort, or
financial resources expended by persons
to generate, maintain, retain, or disclose
or provide information to or for a
Federal agency. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
and systems for the purposes of
collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
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75707
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements which have subsequently
changed; train personnel to be able to
respond to a collection of information;
search data sources; complete and
review the collection of information;
and transmit or otherwise disclose the
information.
The ICR provides a detailed
explanation of the Agency’s estimate,
which is only briefly summarized here:
Estimated total number of potential
respondents: 84,215.
Frequency of response: Occasionally.
Estimated total average number of
responses for each respondent: Once.
Estimated total annual burden hours:
183,347.
Estimated total annual costs: $27,000
includes annualized capital or O&M
costs.
What Is the Next Step in the Process for
This ICR?
EPA will consider the comments
received and amend the ICR as
appropriate. The final ICR package will
then be submitted to OMB for review
and approval pursuant to 5 CFR
1320.12. At that time, EPA will issue
another Federal Register notice
pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to
OMB and the opportunity to submit
additional comments to OMB. If you
have any questions about this ICR or the
approval process, please contact the
technical person listed under FOR
FURTHER INFORMATION CONTACT.
Dated: December 5, 2008.
Deborah Y. Dietrich,
Director, Office of Emergency Management.
[FR Doc. E8–29469 Filed 12–11–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPP–2008–0414; FRL–8751–2]
Agency Information Collection
Activities; Submission to OMB for
Review and Approval; Comment
Request; Submission of Protocols and
Study Reports for Environmental
Research Involving Human Subjects;
EPA ICR No. 2195.03, OMB Control No.
2070–0169
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: In compliance with the
Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document
E:\FR\FM\12DEN1.SGM
12DEN1
jlentini on PROD1PC65 with NOTICES
75708
Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Notices
announces that an Information
Collection Request (ICR) has been
forwarded to the Office of Management
and Budget (OMB) for review and
approval. This is a request to renew an
existing approved collection. The ICR,
which is abstracted below, describes the
nature of the information collection and
its estimated burden and cost.
DATES: Additional comments may be
submitted on or before January 12, 2009.
ADDRESSES: Submit your comments,
referencing Docket ID No. EPA–HQ–
OPP–2008–0414, to (1) EPA online
using www.regulations.gov (our
preferred method), by e-mail to
opp.ncic@epa.gov, or by mail to: OPP
Regulatory Public Docket (7502P),
Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460, and (2) OMB by mail to:
Office of Information and Regulatory
Affairs, Office of Management and
Budget (OMB), Attention: Desk Officer
for EPA, 725 17th Street, NW.,
Washington, DC 20503.
FOR FURTHER INFORMATION CONTACT:
Joseph Hogue, Field and External
Affairs Division, Office of Pesticide
Programs, (7506P), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460;
telephone number: 703–308–9072; fax
number: 703–305–5884; e-mail address:
hogue.joe@epa.gov.
SUPPLEMENTARY INFORMATION: EPA has
submitted the following ICR to OMB for
review and approval according to the
procedures prescribed in 5 CFR 1320.12.
On June 13, 2008 (73 FR 33811), EPA
sought comments on this ICR pursuant
to 5 CFR 1320.8(d). EPA received two
comments during the comment period,
which are addressed in the ICR. Any
additional comments on this ICR should
be submitted to EPA and OMB within
30 days of this notice.
EPA has established a public docket
for this ICR under Docket ID No. EPA–
HQ–OPP–2008–0414, which is available
for online viewing at
www.regulations.gov, or in person
viewing at the OPP Regulatory Public
Docket in Rm. S–4400, One Potomac
Yard (South Building), 2777 S. Crystal
Drive, Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The docket telephone number
is (703) 305–5805.
Use EPA’s electronic docket and
comment system at
www.regulations.gov, to submit or view
public comments, access the index
listing of the contents of the docket, and
to access those documents in the docket
that are available electronically. Once in
VerDate Aug<31>2005
17:56 Dec 11, 2008
Jkt 217001
the system, select ‘‘docket search,’’ then
key in the docket ID number identified
above. Please note that EPA’s policy is
that public comments, whether
submitted electronically or in paper,
will be made available for public
viewing at www.regulations.gov as EPA
receives them and without change,
unless the comment contains
copyrighted material, confidential
business information (CBI), or other
information whose public disclosure is
restricted by statute. For further
information about the electronic docket,
go to www.regulations.gov.
Title: Submission of Protocols and
Study Reports for Environmental
Research Involving Human Subjects.
ICR numbers: EPA ICR No. 2195.03,
OMB Control No. 2070–0169.
ICR Status: This ICR is scheduled to
expire on January 31, 2009. Under OMB
regulations, the Agency may continue to
conduct or sponsor the collection of
information while this submission is
pending at OMB. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information, unless it displays a
currently valid OMB control number.
The OMB control numbers for EPA’s
regulations in title 40 of the CFR, after
appearing in the Federal Register when
approved, are listed in 40 CFR part 9,
are displayed either by publication in
the Federal Register or by other
appropriate means, such as on the
related collection instrument or form, if
applicable. The display of OMB control
numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
Abstract: In January 2006, EPA issued
a final rule to amend the Federal Policy
for the Protection of Human Subjects
(also known as the Common Rule) at 40
CFR part 26. EPA’s final rule
significantly strengthened and
expanded the protections for subjects of
‘‘third-party’’ human research (i.e.,
research that is not conducted or
supported by EPA). Affected entities are
required to submit information to EPA
and an institutional review board (IRB)
prior to initiating, and to EPA upon the
completion of, certain studies that
involve human research participants.
The information collection activity
imposed by this final rule consists of
activity-driven reporting and
recordkeeping requirements for those
who intend to conduct research for
submission to EPA under the pesticide
laws. If such research involves
intentional dosing of human subjects,
these individuals (respondents) are
required to submit study protocols to
EPA and a cognizant local Human
Subjects IRB before such research is
initiated so that the scientific design
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Fmt 4703
Sfmt 4703
and ethical standards that will be
employed during the proposed study
may be reviewed and approved. Also,
respondents are required to submit
information about the ethical conduct of
completed research that involved
human subjects when such research is
submitted to EPA.
This renewal ICR estimates the third
party response burden from complying
with the January 2006 final rule.
Information is typically submitted by
registrants of pesticide products to
support the registration of their
products. Responses to this collection of
information are mandatory. The
authority for this information collection
is provided under section 25 of FIFRA
and 40 CFR part 26.
Burden Statement: The annual public
reporting and recordkeeping burden for
this collection of information is
estimated to average 598 hours per
response for research involving
intentional exposure of human subjects,
and 12 hours per response for all other
submitted research with human
subjects. Burden means the total time,
effort, or financial resources expended
by persons to generate, maintain, retain,
or disclose or provide information to or
for a Federal agency. This includes the
time needed to review instructions;
develop, acquire, install, and utilize
technology and systems for the purposes
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements which have subsequently
changed; train personnel to be able to
respond to a collection of information;
search data sources; complete and
review the collection of information;
and transmit or otherwise disclose the
information.
Respondents/Affected Entities:
Pesticide registrants.
Estimated Number of Responses: 54.
Frequency of Response: On occasion.
Estimated Total Annual Hour Burden:
20,572.
Estimated Total Annual Cost:
$1,579,098, includes $0 annualized
capital or O&M costs.
Changes in the Estimates: There is an
increase of 19,168 hours in the total
estimated burden currently identified in
the OMB Inventory of Approved ICR
Burdens. This increase is an adjustment
to the estimate, based on input received
during the consultation process from
entities that have submitted human
subjects research since the
implementation of the rule. The burden
estimates in the previous (new) ICR
were developed before the rule was
E:\FR\FM\12DEN1.SGM
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Federal Register / Vol. 73, No. 240 / Friday, December 12, 2008 / Notices
implemented, and were based on EPA’s
predictions of how long it would take
study sponsors to prepare submissions.
Based on the information provided in
the consultation responses, it appears
that the actual amount of time necessary
to comply with the paperwork and
recordkeeping requirements is higher
than originally estimated.
Dated: December 8, 2008.
John Moses,
Acting Director, Collection Strategies
Division.
[FR Doc. E8–29483 Filed 12–11–08; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[EPA–HQ–OPPT–2008–0864; FRL–8393–4]
Certain New Chemicals; Receipt and
Status Information
jlentini on PROD1PC65 with NOTICES
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: Section 5 of the Toxic
Substances Control Act (TSCA) requires
any person who intends to manufacture
(defined by statute to include import) a
new chemical (i.e., a chemical not on
the TSCA Inventory) to notify EPA and
comply with the statutory provisions
pertaining to the manufacture of new
chemicals. Under sections 5(d)(2) and
5(d)(3) of TSCA, EPA is required to
publish a notice of receipt of a
premanufacture notice (PMN) or an
application for a test marketing
exemption (TME), and to publish
periodic status reports on the chemicals
under review and the receipt of notices
of commencement to manufacture those
chemicals. This status report, which
covers the period from October 20, 2008
through October 31, 2008, consists of
the PMNs or expired, and the notices of
commencement to manufacture a new
chemical that the Agency has received
under TSCA section 5 during this time
period.
DATES: Comments identified by the
specific PMN number or TME number,
must be received on or before January
12, 2009.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2008–0864, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: Document Control Office
(7407M), Office of Pollution Prevention
and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania
VerDate Aug<31>2005
17:56 Dec 11, 2008
Jkt 217001
Ave., NW., Washington, DC 20460–
0001.
• Hand Delivery: OPPT Document
Control Office (DCO), EPA East Bldg.,
Rm. 6428, 1201 Constitution Ave., NW.,
Washington, DC. Attention: Docket ID
Number EPA–HQ–OPPT–2008–0864.
The DCO is open from 8 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
DCO is (202) 564–8930. Such deliveries
are only accepted during the DCO’s
normal hours of operation, and special
arrangements should be made for
deliveries of boxed information.
Instructions: Direct your comments to
docket ID number EPA–HQ–OPPT–
2008–0864. EPA’s policy is that all
comments received will be included in
the docket without change and may be
made available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through regulations.gov or email. The regulations.gov website is an
‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an e-mail comment directly
to EPA without going through
regulations.gov, your e-mail address
will be automatically captured and
included as part of the comment that is
placed in the docket and made available
on the Internet. If you submit an
electronic comment, EPA recommends
that you include your name and other
contact information in the body of your
comment and with any disk or CD-ROM
you submit. If EPA cannot read your
comment due to technical difficulties
and cannot contact you for clarification,
EPA may not be able to consider your
comment. Electronic files should avoid
the use of special characters, any form
of encryption, and be free of any defects
or viruses. For additional information
about EPA’s public docket, visit the EPA
Docket Center homepage at https://
www.epa.gov/epahome/dockets.htm.
Docket: All documents in the docket
are listed in the docket index available
in regulations.gov. To access the
electronic docket, go to https://
www.regulations.gov, select ‘‘Advanced
Search,’’ then ‘‘Docket Search.’’ Insert
the docket ID number where indicated
and select the ‘‘Submit’’ button. Follow
the instructions on the regulations.gov
website to view the docket index or
access available documents. Although
listed in the index, some information is
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75709
not publicly available, e.g., CBI or other
information whose disclosure is
restricted by statute. Certain other
material, such as copyrighted material,
will be publicly available only in hard
copy. Publicly available docket
materials are available electronically at
https://www.regulations.gov, or, if only
available in hard copy, at the OPPT
Docket. The OPPT Docket is located in
the EPA Docket Center (EPA/DC) at Rm.
3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington,
DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding
Federal holidays. The telephone number
of the EPA/DC Public Reading Room is
(202) 566–1744, and the telephone
number for the OPPT Docket is (202)
566–0280. Docket visitors are required
to show photographic identification,
pass through a metal detector, and sign
the EPA visitor log. All visitor bags are
processed through an X-ray machine
and subject to search. Visitors will be
provided an EPA/DC badge that must be
visible at all times in the building and
returned upon departure.
FOR FURTHER INFORMATION CONTACT:
Colby Lintner, Regulatory Coordinator,
Environmental Assistance Division,
Office of Pollution Prevention and
Toxics (7408M), Environmental
Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460–
0001; telephone number: (202) 554–
1404; e-mail address: TSCAHotline@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
This action is directed to the public
in general. As such, the Agency has not
attempted to describe the specific
entities that this action may apply to.
Although others may be affected, this
action applies directly to the submitter
of the premanufacture notices addressed
in the action. If you have any questions
regarding the applicability of this action
to a particular entity, consult the person
listed under FOR FURTHER INFORMATION
CONTACT.
B. What Should I Consider as I Prepare
My Comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or e-mail. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD-ROM that
you mail to EPA, mark the outside of the
disk or CD-ROM that you mail to EPA,
mark the outside of the disk or CD-ROM
as CBI and then identify electronically
E:\FR\FM\12DEN1.SGM
12DEN1
Agencies
[Federal Register Volume 73, Number 240 (Friday, December 12, 2008)]
[Notices]
[Pages 75707-75709]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29483]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2008-0414; FRL-8751-2]
Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Submission of Protocols and Study
Reports for Environmental Research Involving Human Subjects; EPA ICR
No. 2195.03, OMB Control No. 2070-0169
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document
[[Page 75708]]
announces that an Information Collection Request (ICR) has been
forwarded to the Office of Management and Budget (OMB) for review and
approval. This is a request to renew an existing approved collection.
The ICR, which is abstracted below, describes the nature of the
information collection and its estimated burden and cost.
DATES: Additional comments may be submitted on or before January 12,
2009.
ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OPP-
2008-0414, to (1) EPA online using www.regulations.gov (our preferred
method), by e-mail to opp.ncic@epa.gov, or by mail to: OPP Regulatory
Public Docket (7502P), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.
FOR FURTHER INFORMATION CONTACT: Joseph Hogue, Field and External
Affairs Division, Office of Pesticide Programs, (7506P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: 703-308-9072; fax number: 703-305-5884; e-mail
address: hogue.joe@epa.gov.
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On June 13, 2008 (73 FR 33811), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received two comments during the
comment period, which are addressed in the ICR. Any additional comments
on this ICR should be submitted to EPA and OMB within 30 days of this
notice.
EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2008-0414, which is available for online viewing at
www.regulations.gov, or in person viewing at the OPP Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S.
Crystal Drive, Arlington, VA. This docket facility is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
docket telephone number is (703) 305-5805.
Use EPA's electronic docket and comment system at
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at www.regulations.gov as EPA receives
them and without change, unless the comment contains copyrighted
material, confidential business information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to www.regulations.gov.
Title: Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects.
ICR numbers: EPA ICR No. 2195.03, OMB Control No. 2070-0169.
ICR Status: This ICR is scheduled to expire on January 31, 2009.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
Abstract: In January 2006, EPA issued a final rule to amend the
Federal Policy for the Protection of Human Subjects (also known as the
Common Rule) at 40 CFR part 26. EPA's final rule significantly
strengthened and expanded the protections for subjects of ``third-
party'' human research (i.e., research that is not conducted or
supported by EPA). Affected entities are required to submit information
to EPA and an institutional review board (IRB) prior to initiating, and
to EPA upon the completion of, certain studies that involve human
research participants. The information collection activity imposed by
this final rule consists of activity-driven reporting and recordkeeping
requirements for those who intend to conduct research for submission to
EPA under the pesticide laws. If such research involves intentional
dosing of human subjects, these individuals (respondents) are required
to submit study protocols to EPA and a cognizant local Human Subjects
IRB before such research is initiated so that the scientific design and
ethical standards that will be employed during the proposed study may
be reviewed and approved. Also, respondents are required to submit
information about the ethical conduct of completed research that
involved human subjects when such research is submitted to EPA.
This renewal ICR estimates the third party response burden from
complying with the January 2006 final rule. Information is typically
submitted by registrants of pesticide products to support the
registration of their products. Responses to this collection of
information are mandatory. The authority for this information
collection is provided under section 25 of FIFRA and 40 CFR part 26.
Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 598
hours per response for research involving intentional exposure of human
subjects, and 12 hours per response for all other submitted research
with human subjects. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
Respondents/Affected Entities: Pesticide registrants.
Estimated Number of Responses: 54.
Frequency of Response: On occasion.
Estimated Total Annual Hour Burden: 20,572.
Estimated Total Annual Cost: $1,579,098, includes $0 annualized
capital or O&M costs.
Changes in the Estimates: There is an increase of 19,168 hours in
the total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This increase is an adjustment to the estimate,
based on input received during the consultation process from entities
that have submitted human subjects research since the implementation of
the rule. The burden estimates in the previous (new) ICR were developed
before the rule was
[[Page 75709]]
implemented, and were based on EPA's predictions of how long it would
take study sponsors to prepare submissions. Based on the information
provided in the consultation responses, it appears that the actual
amount of time necessary to comply with the paperwork and recordkeeping
requirements is higher than originally estimated.
Dated: December 8, 2008.
John Moses,
Acting Director, Collection Strategies Division.
[FR Doc. E8-29483 Filed 12-11-08; 8:45 am]
BILLING CODE 6560-50-P