[Federal Register Volume 78, Number 45 (Thursday, March 7, 2013)]
[Proposed Rules]
[Pages 14740-14746]
[FR Doc No: 2013-05254]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Parts 204 and 206

[Docket ID FEMA-2013-0004]
RIN 1660-AA78

Disaster Assistance; Fire Management Assistance Grant (FMAG)
Program--Deadline Extensions and Administrative Corrections

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule.

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SUMMARY: FEMA proposes to revise its Fire Management Assistance Grant
(FMAG) program regulations to lengthen the potential extension for the
grantee's submission of its grant application to FEMA from up to 3
months to up to 6 months. FEMA also proposes to lengthen the potential
extension for a subgrantee to submit a project worksheet from up to 3
months to up to 6 months. These proposed deadline extensions provide
increased flexibility to applicants who may benefit from additional
time to prepare the documentation necessary to support a grant
application and may reduce or eliminate financial losses due to delayed
invoices by third parties that exceed the maximum 3-month deadline
extension. In addition, FEMA proposes to exempt project worksheets
claiming only administrative costs from the $1,000 minimum. FEMA also
proposes to make additional minor administrative changes to its FMAG
regulations to reflect current statutory and regulatory requirements
and clarify grant application procedures.

DATES: Comments must be submitted by May 6, 2013.

ADDRESSES: You may submit comments, identified by Docket ID FEMA-2013-
0004, by one of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
    Mail/Hand Delivery/Courier: Regulatory Affairs Division, Office of
Chief Counsel, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472-3100.
    Instructions: All submissions received must include the agency name
and docket ID. Regardless of the method used for submitting comments or
material, all submissions will be posted, without change, to the
Federal eRulemaking Portal at http://www.regulations.gov, and will
include any personal information you provide. Therefore, submitting
this information makes it public. You may wish to read the Privacy
Notice that is available via a link on the homepage of
www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments received, go to the Federal eRulemaking Portal at http://www.regulations.gov, click on ``Advanced Search,'' then enter ``FEMA-
2013-0004'' in the ``By Docket ID'' box, then select ``FEMA'' under
``By Agency,'' and then click ``Search.'' Submitted comments may also
be inspected at FEMA, Office of Chief Counsel, Regulatory Affairs
Division, 500 C Street SW., Washington, DC 20472-3100.

FOR FURTHER INFORMATION CONTACT: William Roche, Director, Public
Assistance Division, Federal Emergency Management Agency, 500 C Street
SW., Washington, DC 20472-3100, (phone)<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Fire Management Assistance Grant (FMAG) Program is authorized
by section 420 of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act \1\ (Stafford Act). Section 420 authorizes the President
to provide assistance, including grants, equipment, supplies, and
personnel to any State or local government \2\ for the mitigation,
management, and control of any fire on public or private forest land or
grassland that threatens destruction that would constitute a major
disaster.\3\
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    \1\ Disaster Relief Act of 1974, Public Law 93-288, section 417,
88 Stat. 158 (1974), redesignated as section 420 by the Stafford
Act, Public Law 100-107, section 106(j), 102 Stat. 4705 (1988);
codified as amended at 42 U.S.C. 5187.
    \2\ Disaster Mitigation Act of 2000, Public Law 106-390, section
303, 42 U.S.C. 5121, added ``local government'' to section 420 of
the Stafford Act. Section 102(7) of the Stafford Act includes ``an
Indian tribe or authorized tribal organization, or Alaska Native
Village or organization'' in its definition of ``local government.''
    \3\ A major disaster under the Stafford Act is any natural
catastrophe or, regardless of cause, any fire, flood, or explosion
which in the determination of the President causes damage of
sufficient severity and magnitude to warrant major disaster
assistance to supplement the efforts and available resources of
States, local governments, and disaster relief organizations in
alleviating the damage, loss, hardship, or suffering caused thereby.
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    In order to receive funding for a fire management assistance grant
(FMAG), a State \4\ must submit a request for an FMAG declaration. See
44 CFR 204.22. If FEMA approves the request and issues the declaration,
the grantee \5\ may begin preparing a grant application package for
submission to the FEMA Regional Administrator. State agencies, Tribal
governments, and local governments interested in applying for FMAG
subgrants must submit a Request for Fire Management Assistance to the
grantee. Once FEMA determines that the subgrantee meets the eligibility
criteria, FEMA Regional staff begin to work with the grantee and local
staff to prepare project worksheets. See 44 CFR 204.52(b). The project
worksheet identifies actual costs incurred by the subgrantee or grantee
as a result of firefighting activities, and is the mechanism by which
FEMA reimburses eligible costs.
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    \4\ Pursuant to FEMA regulations at 44 CFR 204.22, only the
Governor of a State or the Governor's Authorized Representative can
request an FMAG declaration.
    \5\ The grantee is usually a State; however, an Indian Tribal
government may also be the grantee, in which case it takes on the
same responsibilities as the State. See 44 CFR 204.3.
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    Under the FMAG program, certain administrative costs are
reimbursable. Grantees and subgrantees may claim direct costs (i.e.,
those costs directly attributable to a particular project) associated
with requesting, obtaining, and administering a grant for a declared
fire, including regular and overtime pay and travel expenses for
permanent, reassigned, temporary, and contract employees who assist in
administering the fire management assistance grant. Other direct
administrative costs incurred by the grantee or subgrantee, such as
equipment and supply purchases, may be eligible, but must be reviewed
by the grantee and FEMA Regional Administrator. Indirect costs incurred
by the grantee during the administration of a grant are allowed in
accordance with the provisions of 44 CFR part 13 and OMB Circular A-87;
subgrantees may not claim indirect administrative costs.
    To be eligible for reimbursement, costs reported on project
worksheets must total $1,000 or more. 44 CFR 204.52(c)(5).
    Subgrantees must submit all of their project worksheets to the
grantee for review. The grantee determines the deadline for subgrantees
to submit completed project worksheets, but the

deadline must be no later than 6 months from the close of the incident
period.\6\ At the request of the grantee, the Regional Administrator
may grant an extension of up to 3 months for the submission of the
project worksheet. The grantee must include a justification in its
request for an extension. See 44 CFR 204.52(c).
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    \6\ The incident period is the time interval during which the
declared fire occurs.
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    The grantee submits the subgrantee project worksheets to the FEMA
Regional Administrator as part of its grant application. See 44 CFR
204.51(b)(4) and 204.52(c). The grantee must submit its grant
application within 9 months of the FMAG declaration. Upon receipt of a
written request from the grantee, the Regional Administrator may grant
an extension for up to 3 months. The grantee's request must include a
justification for the extension. See 44 CFR 204.51(a).

II. Discussion of the Rule

A. Deadline Extensions

    FEMA proposes to revise 44 CFR 204.52(c)(3) to allow the Regional
Administrator to grant up to a 6-month extension for a subgrantee to
submit the project worksheet. The current regulations allow for a
maximum 3-month extension. In addition, FEMA proposes to lengthen the
3-month deadline extension for the grantee's submission of its grant
application to FEMA in 44 CFR 204.51(a)(2) to a maximum 6-month
extension.
    As part of its application for a subgrant, a subgrantee must submit
a project worksheet and its supporting documentation. The grantee then
submits these project worksheets as part of its grant application. Any
delays in compiling, organizing, and submitting invoices and billings
can hinder a grantee's or subgrantee's ability to meet established
deadlines. Financial losses may result when billable services and
equipment employed in fire-suppression and related activities are not
identified due to time constraints. FEMA proposes allowing an extension
of up to 6 months to help alleviate some of the time pressure of
completing necessary documentation following an FMAG declaration.
    When the FMAG regulations were originally issued in 2001, the time
requirements to gather and verify required documentation were informed
estimates. Experience has shown that additional time is often necessary
to complete these tasks. In practice, many States need to request an
extension due to delays in obtaining costs, as documented on project
worksheets, and a number of those States do not meet the deadline even
with the 3-month extension.
    There are several reasons for the need for additional time. There
has been an overall increase in the number of fires and a decrease in
the number of personnel available to gather and verify documents such
as timesheets, equipment usage, supplies, and other resources. The
longer fire seasons place greater demands on personnel, resulting in
delays in compiling documentation as resources are employed for longer
periods in support of fire-fighting operations. Wildfires occur without
notice, and may spread and remain uncontrolled for a long time. The
people, equipment, and other resources necessary to combat such fires
are sent immediately and may involve numerous agencies, various
political/municipal divisions, and numerous public and private
organizations. Resources are tracked during fire suppression
operations, but the task of reconstructing when and what equipment and
resources were utilized for fire suppression efforts can be complex and
time consuming. This is more pronounced when operations against
multiple fires have been conducted, as documentation must be reviewed
to ensure the service and equipment is billed toward the correct fire.
This reconstruction must be done for proper preparation of the project
worksheet. The proposed deadline extension will provide increased
flexibility to subgrantees and grantees, who may benefit from
additional time to prepare project worksheets and assemble the grant
application package, and may reduce or eliminate financial losses due
to delayed invoices by third parties.

B. Technical Changes To Clarify When Subgrantees Apply to the FMAG
Program

    Section 204.52(a) currently states that ``State, local, and tribal
governments interested in applying for subgrants under an approved fire
management assistance grant must submit a Request for Fire Management
Assistance to the Grantee in accordance with State procedures and
timelines.'' (emphasis added) FEMA proposes to remove ``under an
approved fire management assistance grant'' from this paragraph in
order to clarify that subgrants are actually submitted before a fire
management assistance grant is approved. That is, when the grantee
receives all of the subgrantee project worksheets, it submits them in a
package to FEMA for approval as part of its grant application. This
revision is not a substantive change to the FMAG Program.
    In 44 CFR 204.52(c)(1), the regulations currently state that
applicants should submit all project worksheets through the grantee for
approval and transmittal to the Regional Administrator as amendments to
the State's application. FEMA proposes to change the term ``amendments
to'' to ``part of'' the State's application. This proposed change
clarifies that the grantee submits the subgrantee project worksheets
along with its grant application. This revision is not a substantive
change to the FMAG Program.

C. Technical Change Regarding Submission of the Grant Application

    The regulations currently state that States ``should'' submit their
grant applications within 9 months of the declaration. See 44 CFR
204.51(a)(2). FEMA proposes to change the word ``should'' to ``must''
to clarify that it is a requirement, and not an option, for States to
submit their grant applications within 9 months of the declaration in
order to receive FMAGs. This revision is in keeping with the regulatory
scheme which allows for an extension to the deadline. If the deadline
were optional, there would be no need for an extension provision. This
revision is not a substantive change to the FMAG Program, as FEMA
currently treats the 9-month deadline as mandatory, and approves
requests for extensions on a regular basis.

D. Requirement That the Request for a Grantee's Time Extension To
Submit the Project Worksheet Be in Writing

    In 44 CFR 204.52, FEMA proposes to add that a grantee's request and
justification for a time extension to submit the project worksheet must
be in writing. This is a nonsubstantive change that mirrors the
requirement in 44 CFR 204.51 that the grantee must provide
justification in writing for its request for a time extension to submit
the grant application. FEMA currently requires the request and
justification to be in writing; therefore this is not a substantive
change.

E. Technical Change To Clarify Project Worksheet Deadline and Extension

    In 44 CFR 204.52(c)(4), FEMA proposes to revise the paragraph to
read that project worksheets will not be accepted after the deadline in
paragraph (c)(2) has expired, or, if applicable, after an extension
specified in paragraph (c)(3) has expired. This is a nonsubstantive
change that clarifies that the deadline is required but an extension
may be requested and

granted. It does not reflect any change to the FMAG Program.

F. Elimination of the $1,000 Project Worksheet Minimum for
Administrative Costs

    In 44 CFR 204.52(c)(5), FEMA proposes to revise the paragraph to
indicate that the $1,000 project worksheet minimum does not apply to
project worksheets that only request reimbursement for either grantee
or subgrantee allowable administrative costs as defined in 44 CFR
204.63. This is a substantive change. Currently, FEMA does not allow
reimbursement for administrative costs if the applicant submits them on
a project worksheet that totals less than $1000. This proposed revision
would allow for reimbursement for those costs. This ensures that
grantees and subgrantees can be reimbursed for all eligible
administrative expenses.

G. Technical Change To Clarify That Administrative Costs Under FMAG Are
Not Subject to Management Cost Requirements

    FEMA proposes to specify in 44 CFR 204.63 that allowable costs for
the direct and indirect administration of an FMAG are only subject to
part 13 and not to 44 CFR part 207. This is a nonsubstantive change
that clarifies current regulatory authority; it does not reflect any
change to the FMAG program.

H. Technical Change To Conform to the Statutory Requirement That the
Fire or Fire Complex be on Public or Private Forest Land or Grassland

    FEMA proposes to specify in 44 CFR 204.21(a) that the fire or fire
complex must be on public or private forest land or grassland in order
for a State to receive a fire declaration. FEMA inadvertently omitted
this requirement from the regulations; the requirement is mandated by
section 420 of the Stafford Act. In practice, FEMA has been meeting
this requirement and therefore the proposed revision is not
substantive; it does not reflect any change to the FMAG program.

I. Nomenclature

1. Office of Management and Budget (OMB) Form Numbers
    FEMA proposes to remove Office of Management and Budget (OMB)
approved form numbers that appear throughout 44 CFR part 204.
Throughout 44 CFR part 204, FEMA refers to forms such as the Standard
Form (SF) 424, Request for Federal Assistance, and FEMA Form 90-91, for
the project worksheet. FEMA proposes to remove the form numbers and
refer only to the title of the form, because the form numbers may
change as OMB approves revised forms in the future. This is a
nonsubstantive change.
2. Definitions
    FEMA proposes to remove the definitions of ``FEMA Form 90-91'' and
``Standard Form (SF) 424'' because FEMA is proposing to remove all
references to OMB form numbers in this regulation. Therefore, these
definitions are no longer necessary. FEMA also proposes to change the
title of the definition of ``Request for Federal Assistance'' to
``Application for Federal Assistance'' to reflect the proper title of
this form.
    FEMA proposes to remove the definition of ``we, our, us''; those
terms refer to ``FEMA'' throughout part 204. However, FEMA is proposing
to change all such references in part 204 to ``FEMA''. Therefore, this
definition would no longer be necessary.
    Finally, FEMA proposes to remove the words ``in block 13'' from the
definition of ``performance period'' since the format and numbering of
the form may change in the future. By removing ``in block 13,'' FEMA
will not need to revise the regulation if the format and numbering of
the form changes.
3. Removal of the Word ``Including'' in 44 CFR 204.42(b)(1)
    FEMA proposes to remove the word ``including'' in 44 CFR
204.42(b)(1). Section 204.42(b) lists six separate categories of costs
that FEMA considers eligible equipment and supplies costs. The use of
the word ``including'' after the first category is a typographical
error.

I. Removal of Part 206, Subpart L--Fire Suppression Assistance

    FEMA proposes to remove subpart L, Fire Suppression Assistance,
from part 206, Federal Disaster Assistance, because it is no longer
necessary. The Disaster Mitigation Act of 2000 established the Fire
Management Assistance Grant Program under Section 420 of the Stafford
Act. The Fire Management Assistance Grant Program replaced the Fire
Suppression Assistance Program. Part 204 of 44 CFR contains the current
regulations for fire assistance authorized by section 420 of the
Stafford Act.

III. Regulatory Analysis

A. Executive Order 12866, ``Regulatory Planning and Review'' and
Executive Order 13563, ``Improving Regulation and Regulatory Review''

    Executive Orders 13563 and 12866 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This rule has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866.
Accordingly, the rule has not been reviewed by the Office of Management
and Budget.
Summary
    This rule does not impose mandatory costs on grantees and
subgrantees. This rule does provide Regional Administrators increased
flexibility to assist grantees and subgrantees who submit FMAG
applications and warrant an extension. In addition, the exemption from
the $1,000 project worksheet minimum would allow grantees and
subgrantees not previously reimbursed for eligible program
administrative expenses to receive additional compensation from FEMA
and the Disaster Relief Fund. FEMA estimates this exemption would
transfer between $10,000 and $50,000 in administrative costs over the
next ten years (undiscounted) from grantees and subgrantees to FEMA.
Total Costs and Benefits of This Rule
    There are no direct monetary costs associated with the increased
extensions identified in the proposed rule. The cost of existing
requirements (i.e., grant application submission) has the potential to
be shifted, but not changed, by this rule. However, an extension may
indirectly impact a grantee's or subgrantee's cash flow. For instance,
if funds needed to reimburse fire suppression services (per a mutual
aid fiscal agreement) are delayed due to an extension, then a grantee
would have to use alternative means to avoid a budgetary shortfall.
Regardless, it is the grantee's choice whether or not to apply for an
extension and the grantee would need to consider if it was more
beneficial to expend extra efforts to submit its FMAG application
without an extension or to find alternative means to

cover any associated shortfalls. Based on previous FMAG application
submittals, FEMA expects approximately twenty 6-month grantee
extensions to be granted over the next 10 years. As is current practice
(44 CFR 204.52(c)(3)), subgrantee extensions are at the request of the
grantee. Our estimate of grantee extensions includes any subgrantee
extension requests that may be included as part of the grantee's
request. A grantee request may cover multiple subgrantee extensions.
    The exemption from the $1000 project worksheet minimum, for those
project worksheets submitted only to claim administrative costs, would
transfer eligible administrative costs from grantees and subgrantees to
FEMA and the Disaster Relief Fund. This would allow grantees and
subgrantees not previously reimbursed for eligible program
administrative expenses to receive compensation. FEMA subject matter
experts from FEMA's Recovery Directorate estimate an average of 1 to 5
such project worksheets would be submitted a year. FEMA assumes for
this analysis that the cost of such project worksheets to be $1,000.
The resulting total additional transfer to grantees and subgrantees,
over 10 years, ranges between $10,000 and $50,000 (undiscounted).
    Benefits of the proposed rule would include increased flexibility
to grantees and subgrantees for submitting their respective
applications. A longer application period may also allow applicants to
use lengthier but more cost efficient grant application preparation
methods. The proposed rule would also more accurately reflect the
operational and administrative demands of the FMAG grant process. In
addition, the proposed rule's nonsubstantive modifications would
improve regulatory clarity.
Retrospective Review
    To facilitate the periodic review of existing regulations,
Executive Order 13563 requires agencies to consider how best to promote
retrospective analysis of rules that may be outmoded, ineffective,
insufficient, or excessively burdensome, and to modify, streamline,
expand, or repeal them in accordance with what has been learned. The
Executive Order requires agencies to issue a retrospective review plan,
consistent with law and the agency's resources and regulatory
priorities, under which the agency will periodically review its
existing significant regulations to determine whether any such
regulations should be modified, streamlined, expanded, or repealed so
as to make the agency's regulatory program more effective or less
burdensome in achieving the regulatory objectives. Review of FEMA's
existing FMAG regulations revealed that they could be modified to
provide for greater flexibility for FEMA to account for extenuating
circumstances that may delay applications. Therefore, FEMA is
increasing available extension times by 3 months for both grantee and
subgrantee FMAG submissions. In addition, FEMA has decided to expand
coverage of administrative costs by exempting the $1000 project
worksheet minimum for those project worksheets submitted only to claim
eligible program administrative costs.

B. Regulatory Flexibility Act (RFA)

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), and
section 213(a) of the Small Business Regulatory Enforcement Fairness
Act of 1996 (5 U.S.C. 601 note) require that special consideration be
given to the effects of proposed regulations on small entities. The RFA
mandates that an agency conduct an RFA analysis when an agency is
``required by section 553 * * * to publish general notice of proposed
rulemaking for any proposed rule.'' See 5 U.S.C. 603(a). As the
proposed rule imposes no direct monetary cost, FEMA certifies that the
proposed rule would not have a significant economic impact on a
substantial number of small entities.

C. National Environmental Policy Act (NEPA)

    Section 102 of the National Environmental Policy Act of 1969
(NEPA), 42 U.S.C. 4321 et seq., as amended, requires agencies to
consider the impacts in their decisionmaking on the quality of the
human environment. The Council on Environmental Quality's procedures
for implementing NEPA, 40 CFR part 1500 et seq., require Federal
agencies to prepare Environmental Impact Statements (EIS) for major
Federal actions significantly affecting the quality of the human
environment. Each agency can develop categorical exclusions to cover
actions that typically do not trigger significant impacts to the human
environment individually or cumulatively. Agencies develop
environmental assessments (EA) to evaluate those actions that do not
fit an agency's categorical exclusion and for which the need for an EIS
is not readily apparent. At the end of the EA process the agency will
determine whether to make a Finding of No Significant Impact (FONSI) or
whether to initiate the EIS process.
    Rulemaking is a major Federal action subject to NEPA. The List of
exclusion categories at 44 CFR 10.8(d)(2)(ii) excludes the preparation,
revision, and adoption of regulations from the preparation of an
environmental assessment or environmental impact statement, where the
rule relates to actions that qualify for categorical exclusions. This
rule deals with the FMAG program which is excluded under 44 CFR
10.8(d)(2)(xix)(N). The purpose of this rule is to lengthen the time
for the submission of grantees' and subgrantees' applications and to
provide for administrative changes that better reflect statutory
requirements. These changes are administrative-related changes that are
categorically excluded under 44 CFR 10.8(d)(2)(i). No extraordinary
circumstances exist requiring the need to develop an environmental
assessment or environmental impact statement. See 44 CFR 10.8(d)(3). An
environmental assessment will not be prepared because a categorical
exclusion applies to this rulemaking action and no extraordinary
circumstances exist.

D. Executive Order 12898, Environmental Justice

    Under Executive Order 12898, Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations, 59 FR 7629 (Feb. 16, 1994), as amended by Executive Order
12948, 60 FR 6381 (Feb. 1, 1995), FEMA incorporates environmental
justice into its policies and programs. The Executive Order requires
each Federal agency to conduct its programs, policies, and activities
that substantially affect human health or the environment, in a manner
that ensures that those programs, policies, and activities do not have
the effect of excluding persons from participation in our programs,
denying persons the benefits of our programs, or subjecting persons to
discrimination because of their race, color, or national origin.
    No action that FEMA can anticipate under this rule will have a
disproportionately high or adverse human health and environmental
effect on any segment of the population. Accordingly, the requirements
of Executive Order 12898 do not apply to this rule.

E. Unfunded Mandates Reform Act of 1995

    The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 658, 1501-1504,
1531-1536, 1571, applies to any notice of proposed rulemaking that
would implement any rule which includes a Federal mandate that may
result in the expenditure by State, local, and Tribal governments, in
the aggregate, or by the private sector, of $100 million or more

in any one year. If the rulemaking includes a Federal mandate, the Act
requires an agency to prepare an assessment of the anticipated costs
and benefits of the Federal mandate. The Act also pertains to any
regulatory requirements that might significantly or uniquely affect
small governments. Before establishing any such requirements, an agency
must develop a plan allowing for input from the affected governments
regarding the requirements.
    FEMA has determined that this rule will not result in the
expenditure by State, local, and Tribal governments, in the aggregate,
nor by the private sector, of $100 million or more in any one year as a
result of a Federal mandate, and it will not significantly or uniquely
affect small governments. Therefore, no actions are deemed necessary
under the provisions of the Unfunded Mandates Reform Act of 1995.

F. Executive Order 13132, Federalism

    Executive Order 13132, Federalism, 64 FR 43255 (Aug. 10, 1999),
sets forth principles and criteria that agencies must adhere to in
formulating and implementing policies that have federalism
implications, that is, regulations that have substantial direct effects
on the States, on the relationship between the national government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Federal agencies must closely examine
the statutory authority supporting any action that would limit the
policymaking discretion of the States, and to the extent practicable,
must consult with State and local officials before implementing any
such action. This rule involves no policies that have federalism
implications under Executive Order 13132.

G. Paperwork Reduction Act of 1995

    This rule contains collections of information that are subject to
review by OMB under the Paperwork Reduction Act of 1995, as amended, 44
U.S.C. 3501-3520. The information collections included in this rule are
approved by OMB under control numbers 1660-0058, Fire Management
Assistance Grant Program, and 1660-0025, FEMA Emergency Preparedness
and Response Directorate Grants Administration Forms. There are no new
information collections included in this proposed rule.

H. Privacy Act Analysis

    Under the Privacy Act of 1974, 5 U.S.C. 552a, an agency must
determine whether implementation of a proposed regulation will result
in a system of records. A ``record'' is any item, collection, or
grouping of information about an individual that is maintained by an
agency, including, but not limited to, his/her education, financial
transactions, medical history, and criminal or employment history and
that contains his/her name, or the identifying number, symbol, or other
identifying particular assigned to the individual, such as a finger or
voice print or a photograph. See 5 U.S.C. 552a(a)(4). A ``system of
records'' is a group of records under the control of an agency from
which information is retrieved by the name of the individual or by some
identifying number, symbol, or other identifying particular assigned to
the individual. An agency cannot disclose any record which is contained
in a system of records except by following specific procedures.
    The E-Government Act of 2002, 44 U.S.C. 3501 note, also requires
specific procedures when an agency takes action to develop or procure
information technology that collects, maintains, or disseminates
information that is in an identifiable form. This Act also applies when
an agency initiates a new collection of information that will be
collected, maintained, or disseminated using information technology if
it includes any information in an identifiable form permitting the
physical or online contacting of a specific individual.
    The information maintained and collected for the FMAG program is
covered by the Privacy Act, specifically under DHS/FEMA--004 Grants
Management Information Files System of Records, 74 FR 39705 (Aug. 7,
2009). This rule does not affect this system of records notice. DHS/
FEMA has a current Privacy Impact Assessment (PIA) addressing the
maintenance of FMAG information as required by the e-Government Act.

I. Executive Order 13175, Consultation and Coordination With Indian
Tribal Governments

    Executive Order 13175, Consultation and Coordination with Indian
Tribal Governments, 65 FR 67249 (Nov. 9, 2000), applies to agency
regulations that have Tribal implications, that is, regulations that
have substantial direct effects on one or more Indian Tribes, on the
relationship between the Federal Government and Indian Tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian Tribes. Under this Executive Order, to the extent
practicable and permitted by law, no agency shall promulgate any
regulation that has Tribal implications, that imposes substantial
direct compliance costs on Indian Tribal governments, and that is not
required by statute, unless funds necessary to pay the direct costs
incurred by the Indian Tribal government or the Tribe in complying with
the regulation are provided by the Federal Government, or the agency
consults with Tribal officials. FEMA has determined that this rule does
not have Tribal implications and does not impose substantial direct
compliance costs on Indian Tribal governments. The changes proposed by
this rule would not have substantial direct effects on one or more
Indian Tribes, on the relationship between the Federal Government and
Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes. The FMAG program is a
voluntary grant program in which Indian Tribes may participate as
grantees or subgrantees; the program provides monetary assistance to
Indian Tribes, and does not affect the relationship between the Federal
Government and Indian Tribes or the distribution of power and
responsibilities between the Federal Government and Indian Tribes.

J. Executive Order 12630, Governmental Actions and Interference With
Constitutionally Protected Property Rights

    FEMA has reviewed this rule under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights, 53 FR 8859 (Mar. 18, 1988), as supplemented by
Executive Order 13406, Protecting the Property Rights of the American
People, 71 FR 36973 (June 28, 2006). This rule will not affect the
taking of private property or otherwise have taking implications under
Executive Order 12630.

K. Executive Order 12988, Civil Justice Reform

    FEMA has reviewed this rule under Executive Order 12988, Civil
Justice Reform, 61 FR 4729 (Feb. 7, 1996). This rule meets applicable
standards to minimize litigation, eliminate ambiguity, and reduce
burden.

List of Subjects

44 CFR Part 204

    Administrative practice and procedure, Fire prevention, Grant
programs, Reporting and recordkeeping requirements.

44 CFR Part 206

    Administrative practice and procedure, Coastal zone, Community
facilities, Disaster assistance, Fire

prevention, Grant programs-housing and community development, Housing,
Insurance, Intergovernmental relations, Loan programs-housing and
community development, Natural resources, Penalties, Reporting and
recordkeeping requirements.

    For the reasons stated in the preamble, the Federal Emergency
Management Agency proposes to amend 44 CFR Chapter I as follows:

PART 204--FIRE MANAGEMENT ASSISTANCE GRANT PROGRAM

0
1. Revise the authority citation for part 204 to read as follows:

    Authority:  Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 through 5207; Homeland Security Act
of 2002, 6 U.S.C. 101 et seq.; Department of Homeland Security
Delegation 9001.1.

Sec.  204.1  [Amended]

0
2. Remove the words ``We (FEMA)'' and add, in their place, the word
``FEMA''.

Sec.  204.3  [Amended]

0
3. In Sec.  204.3--
0
a. In the definition of ``Applicant'', remove the word ``us'' and add,
in its place, the word ``FEMA'';
0
b. In the definition of ``Hazard mitigation plan'', remove the word
``We'', and add, in its place, the word ``FEMA'', and remove the word
``address'' and add, in its place, the word ``addresses'';
0
c. In the definition of ``Performance period'', remove the words
``(Standard Form 424)'' and ``in block 13'';
0
d. In the definition of ``Project worksheet'', remove the words ``FEMA
Form 90-91, which identifies'', and add, in their place, the words
``The form which identifies'';
0
e. Remove the definitions of ``FEMA Form 90-91'', ``Request for Federal
Assistance'', ``Standard Form (SF) 424'', and ``We, our, us''; and
0
f. Add a definition of ``Application for Federal Assistance'' in
alphabetical order to read as follows:

Sec.  204.3  Definitions used throughout this part.

* * * * *
    Application for Federal Assistance. The form the State submits to
apply for a grant under a fire management assistance declaration.

Sec.  204.21  [Amended]

0
4. In Sec.  204.21-
0
a. In paragraphs (a) and (b) introductory text, remove the word ``We''
and add, in its place, the word ``FEMA''; and
0
b. In paragraph (a), after the word ``complex'', add the words ``on
public or private forest land or grassland''.

Sec.  204.22  [Amended]

0
5. In Sec.  204.22, remove the word ``we'' and add, in its place, the
word ``FEMA''; and remove the words ``(FEMA Form 90-58)''.

Sec.  204.25  [Amended]

0
6. In Sec.  204.25 paragraph (b), remove the word ``we'' and add, in
its place, the word ``FEMA''.

Sec.  204.42  [Amended]

0
7. In Sec.  204.42-:
0
a. In paragraph (b)(1), after the word ``safety'', remove the comma and
add, in its place, a period, and remove the word ``including:'';
0
b. In paragraphs (b)(5) and (f), remove the word ``We'' and add, in its
place, the word ``FEMA''; and
0
c. In paragraph (b)(5), remove the word ``we'' and add, in its place,
the word ``FEMA''; and remove the word ``determine'', and add, in its
place, the word ``determines''.

Sec.  204.51  [Amended]

0
8. In Sec.  204.51-
0
a. In paragraph (a), remove the space after the word ``Administrator'';
remove the words ``SF 424 (Request for Federal Assistance)'' and add,
in their place, the words ``Application for Federal Assistance''; and
remove the words ``(FEMA Form 20-16a (Summary of Assurances--Non-
construction Programs)'' and add, in their place, the words ``Summary
of Assurances--Non-construction Programs'';
0
b. In paragraph (a)(2), remove the word ``should'' and add, in its
place, the word ``must''; and remove the number ``3'' and add, in its
place, the number ``6'';
0
c. In paragraphs (b)(1) and (b)(5), remove the word ``We'' and add, in
its place, the word ``FEMA'';
0
d. In paragraphs (b)(1) and (d), remove the word ``we'' and add, in its
place, the word ``FEMA'';
0
e. In paragraph (b)(1), remove the word ``determine'', and add, in its
place, the word ``determines'', and
0
f. In paragraph (d), after the words ``Regional Administrator'', remove
the space wherever they appear; and remove the word ``approve'', and
add, in its place, the word ``approves''.

Sec.  204.52  [Amended]

0
9. In Sec.  204.52-
0
a. In paragraph (b)(1), remove the words ``(FEMA Form 90-91)'';
0
b. In paragraph (c)(1), remove the words ``amendments to'' and add, in
their place, the words ``part of'';
0
c. In paragraph (c)(5), remove the word ``we'' and add, in its place,
the word ``FEMA'' wherever it appears; and
0
d. Revise paragraphs (a) and (c)(3), (4), and (5) to read as follows:

Sec.  204.52  Application and approval procedures for a subgrant under
a fire management assistance grant.

    (a) Request for Fire Management Assistance. (1) State, local, and
tribal governments interested in applying for fire management
assistance subgrants must submit a Request for Fire Management
Assistance subgrant to the Grantee in accordance with State procedures
and within timelines set by the Grantee, but no longer than 30 days
after the close of the incident period.
* * * * *
    (c) * * *
    (3) At the request of the Grantee, the Regional Administrator may
extend the time limitations in this section for up to 6 months when the
Grantee justifies and makes a request in writing.
    (4) Project Worksheets will not be accepted after the deadline in
paragraph (c)(2) of this section has expired, or, if applicable, after
an extension specified by the Regional Administrator in paragraph
(c)(3) of this section has expired.
    (5) $1,000 Project Worksheet minimum. When the costs reported are
less than $1,000, that work is not eligible and FEMA will not approve
that Project Worksheet. This minimum threshold does not apply to
Project Worksheets submitted for the direct and indirect costs of
administration of a fire grant, as defined in 44 CFR 204.63.

Sec.  204.53  [Amended]

0
10. In Sec.  204.53 paragraph (a), remove the word ``us'' and add, in
its place, the word ``FEMA''.

Sec.  204.54  [Amended]

0
11. In Sec.  204.54-
0
a. In the introductory paragraph, remove the word ``we'' and add, in
its place, the word ``FEMA''; remove the word ``make'' and add, in its
place, the word ``makes'', and
0
b. In paragraph (a), after the words ``Regional Administrator'', remove
the space wherever they appear.

Sec.  204.62  [Amended]

0
12. In Sec.  204.62-
0
a. In paragraphs (a), (b), (c), and (d), remove the word ``We''
wherever it appears and add, in its place, the word ``FEMA'';
0
b. In paragraph (a), remove the word ``provide'' and add, in its place,
the word ``provides'';

0
c. In paragraph (c), remove the word ``consider'' and add, in its
place, the word ``considers'';
0
d. In paragraph (d), remove the word ``incur'' and add, in its place,
the word ``incurs'';
0
e. In paragraphs (c) and (d), remove the word ``we'' wherever it
appears and add, in its place, the word ``FEMA''; and
0
f. In paragraphs (a), (b), and (d), remove the word ``us'' wherever it
appears and add, in its place, the word ``FEMA''.

Sec.  204.63  [Amended]

0
13. In Sec.  204.63-
0
a. In paragraphs (a) and (b), remove the word ``We'' wherever it
appears and add, in its place, the word ``FEMA'';
0
b. Add a new paragraph (c) to read as follows:

Sec.  204.63  Allowable costs.

* * * * *
    (c) Management costs as defined in 44 CFR part 207 do not apply to
this section.

Sec.  204.64  [Amended]

0
14. In Sec.  204.64 paragraph (a), remove the words ``(FEMA Form 20-
10)''.

PART 206--FEDERAL DISASTER ASSISTANCE

0
15. The authority citation for part 206 continues to read as follows:

    Authority: Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121 through 5207; Homeland Security Act
of 2002, 6 U.S.C. 101 et seq.; Department of Homeland Security
Delegation 9001.1.

Subpart L--[Removed and reserved]

0
16. Remove and reserve subpart L, consisting of Sec. Sec.  206.390
through 206.395.

    Dated: February 8, 2013.
W. Craig Fugate
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-05254 Filed 3-6-13; 8:45 am]
BILLING CODE 9110-23-P


DR. CHAMBERS:  If this were a lab study, I think that would be
perfectly feasible.  But what concerns me about that is that this is a
field study, and don't they have to have a little flexibility for
changing environmental conditions and being able to make modifications?
And if it's too detailed, then it's just going to be a whole series of
deviations that are going to have to be dealt with, I think.  Right?

		DR. JOHNSON:  Well, I don't think so.  I think if I listened to what
Dr. Gupta was saying about the kinds of experiments that he runs, it
seems like he does field experiments, and I think he does them in a well
designed way, from what I can tell. And where he may have some
deviations from that, may have some missing data that shows up from
time-to-time, there's still that basic structure that underlines the
process he's going to go through.  And if he's not able to complete all
the issues that are involved with that, then you deal with that at the
end.  But there's still this plan what you're going to do.

		And I think I'm probably saying the things that sounds like Alicia
might have said last time.  And sort of in agreement with what I think
she probably said.  And I just think that I realize it's a field
experiment and most of the Army stuff that we deal with are all field
experiments. And --

		CHAIR FISHER:  Let me place this into whether we're being consistent.

		As I understand how we evaluated the last study, we said that because
of all these design problems it could not be used in terms of efficacy
or comparison of products, right?  And at minimum it could be used in
terms of some kind of estimate of design.

		So it sounds like we're being consistent, not inconsistent in saying
-- because it sounds like the purpose of this study is actually to
compare the products.

		MR. CARLEY:  No.

		CHAIR FISHER:  It's not?  I'm sorry.

		MR. CARLEY:  The purpose of this study is to get a value for complete
protection time for each of the three substances.  There are no
comparisons whatsoever between products or between products and controls
proposed in his protocol.

		CHAIR FISHER:  Okay.

		DR. PARKIN:  Celia?

		CHAIR FISHER:  Yes.

		DR. PARKIN:  To respond to the point that Jan brought up.  One way
that the changes in the field can be dealt with is there can be an
understanding up front between the investigator and the IRB as to what
the most significant factors are that may effect risk.  And have a plan
laid out that if X happens and you can't do what is your plan A, you've
got a plan B that's already approved by the IRB.  So you don't have to
go and keep asking for modifications the day of.  You have a laid out
plan that says here's the ideal of what we're going to do. If for some
reason that doesn't work, this is the next step we would take or this is
the next step we would take.

		So there are ways that you can deal with anticipating field changes
that would be significant enough that would change what you would have
to do in the field and get prior approval for that sequence of decision
making.

		CHAIR FISHER:  So I'd like from the science people to let me know
where we're at.  I don't want to be in a situation in which we approve
this protocol, for whatever reason, and it comes back to us and we say
can't be interpreted but because we approved it, it's going to go
forward.

		So we've got to decide what it can actually demonstrate and what it
can't at this point given the information that we have so that we can be
absolutely clear.

		DR. JOHNSON:  Okay.  Well if the idea is to have three different
experiments and you're going to make an inference of which one, then in
some sense there could be three different protocols; one for each
product.

		And if you're not going to try to compare them, then why worry about
which subjects get randomized to which product?  In that case, you could
say --

		CHAIR FISHER:  That's where I got confused.

		DR. JOHNSON:  Yes. You can do experiment one on day one, do experiment
two on day two, do experiment three on day three.  And if that was
written in the protocol, I would have no problem with that.

		CHAIR FISHER:  That's  -- because I didn't understand why they
randomized.

		Mike --

		MR. CARLEY:  Could you do them all on one day?  Could you do part of
the ten for each substance on the same day?  Like, say, 15 people on one
day and another 15 people on the other day and make three tens out of
that?  Or is the point--

		DR. JOHNSON:  Well, you'd have to do that as long as it was written up
that that's--

		MR. CARLEY:  Yes.  Yes.  I think we can cope with the idea that the
randomization, the allocation of subjects to treatments needs to be
fully specified before the protocol goes forward.  And I think that's
pretty much what you're saying comes down, isn't it, Dr. Johnson.

		CHAIR FISHER:  Hence we're not approving it.

		DR. JOHNSON:  Right.

		MR. CARLEY:  Well-- well -- okay.

		CHAIR FISHER:  I am not comfortable saying only -- the reason I'm not
comfortable is we'll be in the same situation we were just in.  We're
saying -- you know, we recommend that you do this.  Then we have no clue
as to what's being done. Then it comes back and it's a false premise and
then we're in the same boat.  So I'm -- you know, because what you
suggested is what you're suggesting.  We don't know what the sponsor
himself is going to decide to do. And we don't know if it's going to be
a repeat of measures.  We don't know if it's between subjects design, at
cross -- I mean, we don't know what it is.

		And I'm just reluctant if we're going to come back and say -- now if
in fact we say it doesn't matter, ten subjects in each cell is enough.
We don't care if your randomizing or not, pooling or whatever.  For the
limited amount of information you're going to get from this in terms of
how many hours it takes for a mosquito to have a confirmed bite, or
whatever we're talking about here, you know then that's okay.  But
what's the outcome and how confident is everybody going to be and happy
when it comes back to us?

		DR. LEBOWITZ:  Yes.  We've spent the whole day talking basically about
design the science and the ethics of these studies.  It is not obvious
in the current proposed study or studies, or necessarily in the ethics
that we have that.

		Under other circumstances I too would say, and the groups that I work
with, study sections, et cetera, would say come back to us in three
months with a real design and we will evaluate the design at that point.
 We've given you a whole day of lesson.  You've heard all the problems,
all the objections, all the points, all the critical issues that need to
be addressed scientifically and come back to us with what you propose to
do so that we can evaluate it and make recommendations to EPA as to
whether the proposed study might be scientifically sound sufficiently to
do it.  But based on what we've seen so far today and the problems we
had, and all the discussion we had about those protocols prior to this
proposal, I would say that we're not prepared to evaluate the protocol
where there's a study to say that the proposed study would provide that
or that it was scientifically sound.

		CHAIR FISHER:  Any other comments?  Okay.  That's our conclusion.

		Should we go into the ethics?

		MR. CARLEY:  No.

		CHAIR FISHER:  No. Okay.

		MR. CARLEY:  If there are ethical issues that are raised now, so it'll
happen next time --

		CHAIR FISHER:  Yes, that would be helpful.  IF there are ethical
issues, that would be helpful. Please.  Yes.

		DR. PHILPOTT:  Mr. Carley's evaluation is spot on.

		In 30 seconds or less, three risks; the products themselves, the
bites, arthropod-borne illnesses, the products themselves, exclusion
criteria, already used product and clear stopping rules.  Bites
themselves, mosquito bites, training the people to aspirate the
mosquitoes.  The bites themselves can be treated with over-the-counter
steroidal cream.  And, you know, arthropod-borne illnesses.

		Right.  But the bites themselves are a risk to participants.  But
they're being trained to remove them before they bite, hopefully.  And
they're working in pairs to minimize that.  And if they do get bitten,
you got a steroidal cream and they're excluding people with a known
reaction, severe reaction to the bites.

		Arthropod-borne illnesses.  They've got clear criteria for
establishing using sentinel flocks and vector-borne surveillance to
choose the time and area they're doing.  And they're also doing the
molecular screening of the mosquitoes that they capture.

		So I think in overall the risks have been minimized.  You have some
risks regarding confidentiality, which we've discussed previously.  And
we've got an alternate subject approach.

		They're excluding children.  They're excluding pregnant women.
Over-the-counter pregnancy tests. Mr. Carley, once again, is spot on in
that some of those risks should be mentioned.  But I think overall the
risks have been minimized as best they can.  And the benefits to society
in coming up with new formulations of insect repellents outweigh the
minimal risks.

		CHAIR FISHER:  Okay.  I didn't hear a word you said, Sean.  But I'm
sure it was critically important.

		DR. SHARP:  I'm listed as a secondary on here.  And I think it's
important since we'll be -- Mr. Carley, I should say, will be
communicating a lot of messages back to the investigator with regard to
the series of protocols here.  And that's that with regard to ones we've
been reviewing and with regard to the two that we're looking at still
this afternoon, we really haven't been faulting the investigator for a
lot of the content of the protocol's design and the content of the
consent document.  The criticisms have been almost exclusively focused
on the communications between him and the IRB.

		And so, again, when we look at the content of this protocol before
it's been done, I don't think that there are a lot of difficulties that
I see here. But just to, again, reinforce that point that where the
problems lied in our earlier discussions were in the communication that
existed between the investigator and the IRB, particularly with
deviations.

		CHAIR FISHER:  Thank you.

		And who is our third?  Sue.  Okay.  		DR. FISH:   The only other
ethical message I think is that there are still some outstanding
information, I believe, on IIRB that we've asked for that hasn't come
forward in previous protocols.  And maybe we could ask for it once
again.

		Thank you.

		CHAIR FISHER:  Okay.  Okay.  All right.  On to the next.

		Actually, we're going to get done.  Onto the next protocol.

		MR. CARLEY:  Is it still Thursday?

		CHAIR FISHER:  We have an hour.  We have an hour in our schedule, and
I think we'll be done.

		MR. CARLEY:  You all have been talking longer than I have.

		CHAIR FISHER:  No. Talk fast. Talk fast.

		MR. CARLEY:  I'm doing my best for you.

		Next one Leshawna is SPC-002.

		We have to shift gears here. We're now going to be talking about a
very different kind of study.  This is a laboratory test of tick
repellency for the same three materials that we just looked at.  So
what's constant across these two protocols is the test materials and
some modules of the protocol. But the overall design of what we're doing
is very, very different because of the very different methods
appropriate for testing ticks.

		This slide is in error.  This first bullet should say SPC-002 is
closely similar to other Carroll-Loye protocols for tick repellency
studies that you've seen before.  It's complete.  We didn't have to get
supplements.  We noted a few deficiencies, but we think it's ripe for
your review.

		And it requires under the rule HSRB review.  So I now turn it over to
Kevin to talk about the scientific design.

		MR. SWEENEY:  Okay.  Again, the objective of course is an efficacy
test and this time it will be tick repellency in the laboratory.

		Okay.  In terms of toxicity, the test materials are exactly the same.
So you can go to slide nine.

		And just to follow up on the one question that was raised by Dr.
Chambers.  It terms of the percentage of active ingredient that's in the
product, I guess the little nuance here is when you have these towelette
products, the weight of the towelette itself is incorporated into the
calculation of the mass of the product, if you will.  So that's why the
amount of picaridin looks like it's lower, but in reality the alcohol
solution going on is pretty much exactly the same.

		Okay.  In terms of the study design, again we're sharing dosimetry
phase with SPC-001.  The standard dose is converted as the subject
specific doses and subject specific doses are applied by a technician.

		And just to make mention here, the mean dose in these six trials are
calculated for each subject.

		Okay.  That'll be it.  Next slide.

		In terms of the ticks, and this where the difference and I'll go
through this in a little more detail now.

		These are lab-reared and pathogen-free deer ticks.  Lixodes scapularis
and the American dog tick, Dermacentor viariabilis.  They're both going
to be used in this study.  There's going to be two different species,
both are know to have disease factors.

		Subjects are trained in the lab to handle and observe the ticks and to
remove them before they can bury or bite.  And I'll just say that it
takes -- the adult ticks or a lot of the ticks that are going to be used
in this study, they don't bite immediately like a mosquito.  It takes
some time for a tick to quest and bite. So you have a lot more lead time
here when you have ticks on the skin.

		After single use, each tick is destroyed.  And before use of
repellents in trial each tick must demonstrate normal questing behavior.
 And I'll discuss that here in 11 qualifying ticks.

		Now each subject here serves as his or her own control, verifying
trackness to each tick before using it in a repellency trial.  And so
the subject places the hand to be treated on on a laboratory bench and
holds the arm upright.

		Every 15 minutes a fresh tick is placed on a mark near the subject
wrist.  Normal ticks will move upwards seeking a site to bury and bite.
Okay.  So generally they have a behavior where they want to go up.

		Ticks that move at least three centimeters towards the elbow on a
subject's untreated arm, and then the three minutes qualify repellency
testing on the treated arm.  So we have one untreated arm that qualifies
the ticks.  One treated arm that's actually being used in the test.

		Okay.  In terms of repellency testing.  Again, we have intervals every
15 minutes.  A newly qualified tick gets placed on the mark three
centimeters below the treated area on the subject's wrist.  So you've
got a line across the wrist.  Three centimeters below that is where the
tick's going to be placed. The arm is kept up.  And basically the
evaluation of repellency is to look if the tick crosses at least three
centimeters into the treated area within three minutes it's scores as a
crossing.

		Again, tick behavior is different than mosquito behavior.  I mean,
ticks might cross to the edge of the treated zone, and in this case the
repellency is a lot more to do with contact.  It takes a little bit of
time before they actually are repelled.

		So a crossing followed by another crossing within either of the
subsequent two exposure period is considered a confirmed crossing.  And
this is similar to what we've discussed before.

		Okay.  Variables and end points.  Again, the measured variables will
be very similar to what we discussed before.  Weighted test materials,
deliver the dosimetry, subject's limb, lotion and cause dosimetry.  The
questing behavior of the tick is something different now.  The response
of each qualified tick to repellent and in time to all crossings.

		And the duration of efficacy is going to be measured as complete
detection time for each subject.  And it'll be the time from the
treatment to the first confirmed crossing into the treated area.

		And in the meantime the first confirmed crossing across all subjects
with standard deviation 95 percent confidence will be calculated for
each test material.  And, again, we'll look at Kaplan-Meier survival
analysis for the median time to first confirmed crossing.

		Next slide.

		In terms of the sample size -- I'm sorry. I'm on slide 14.  Okay.

		Ten subjects treated with each formulation will participate in the
repellency trial.  Again, the subject size and recommendations is pretty
much the same as we discussed before.

		In terms of deficiencies that were noted in my review.  The
composition of the lotion product, which is the combo sunscreen
picaridin combo wasn't incorrectly characterized, and we said before we
fully described that in the application.

		One other point I brought up about the ticks themselves, and this
really only applies to the American dog tick, and I haven't read Dr.
Carroll's sent us a response yet, but I haven't had a chance to look
over it.  But essentially the only concern we had was what the source of
the ticks were, whether they were all from one colony that was reared,
or whether they were known to be pathogen-free for such amount of time.
Because some of the pathogens they can transmit will pass from one
generation to the next.

		And in terms of risk to subjects and just tick bites in generally,
they're very low.  The insurance of ticks or Rocky Mountain spotted
fever should a subject be bitten.  And then what action would be taken
in the unlikely event of a tick bite, and that really isn't
characterized.

		Compliance with scientific standards.  To sum it up, I think that
generally, and I think the Board's already reviewed at least one tick
study and this is quite similar.  Provided that Dr. Carroll were to
address those deficiencies we noted, I feel that this would yield
scientifically reliable data.

		MR. CARLEY:  Probably subject to some of the same reservations about
the adequacy of the description of allocation of subjects to treatments
that we've talked about before.

		And my ethics assessment, once again I'm going to skip the value to
society.  		The subject section is going to be essentially the same as
it was for the field tests.

		The same pool of candidates.

		The qualitative risks in this case are a little different.  There are
similarly risks from the repellents themselves.  There is a potential
risk of tick bites. There is a -- I'm not sure exactly what to call it.
Negligible -- I'm uncomfortable with zero.  But there's an incredibly
low, vanishingly low risk of disease from a tick bite.  And the risk
from the tick bite itself, as Kevin said, it takes several minutes for a
tick to pick a site and bury and bite.  So the chance of a bite is
extremely low as well.

		And as with the earlier protocol, there's no discussion about the
potential risk of embarrassment from the results of the pregnancy test.

		And I would note in passing, Dr. Philpott, neither the last one nor
this is one that uses alternate subjects as a way of dealing with that.
That was the other investigator.

		The risks have been minimized from the test materials by basically
watching things very carefully and applying the repellent by
technicians.  The risk from tick bites are minimized by excluding phobic
candidates and training them to handle the ticks and to remove them
before they can bury or bite.  And the risks of disease are minimized by
using lab raised ticks, which with the exception that Kevin mentioned,
are clearly pathogen-free.

		There's also a mention of undefined measures to make sure that ticks
are removed before they have an opportunity to bury in the skin.  Those
measures are not themselves specified, nor is the assignment of
responsibility to take them.  And that is a point that could be done
better.

		The probability of harm is vanishingly small.

		Benefits are similar to other studies of this type.  No direct benefit
to subject, primary benefit to the sponsor and potential benefit to
repellent user.

		Similar summary assessment are the risk benefit balance is the last
one.  I've seen specifications with respect to the independent ethics
review, same IRB, same status.

		The protocol description of the recruiting and consent processes is
complete and satisfactory.  The consent form is weak in its discussion
of risks.  It is one thing to say that there is a very low risk of tick
bites, it's another to say nothing at all about tick bites.  And in this
case this version of the consent document says nothing at all.

		And as before, there is no mention of the possibility of embarrassment
or surprise in the face of the results of the pregnancy test.

		And the consent form from which I drew that earlier quotation about
these measures to ensure ticks are removed before they can bury, it's in
there in the context of reassuring the subjects that they're really not
going to get tick bites.  But if they don't say who is going to take
what measures, and I'd like to see that expanded.

		There is no distinction between treated and untreated subjects in this
protocol because every subject serves as their own control with that
pre-qualification step that Kevin described.

		No problems here with respect for subjects.  The usual standards
apply.

		Here are the deficiencies that I noted.  Again, there is no data
collection form provided to record the actual efficacy data testing.

		Again, it would be helpful to have product labels to guide the
subjects when they are being expected to apply a typical consumer dose.

		The risks of tick bites and exposure to tick-borne disease, which are
mentioned in the protocol, should also be mentioned in the consent form
along with a statement that they're very, very low probability risks.

		And the measures, as I said a couple of times, to ensure that ticks
don't bury and bite them, they would be implemented and need to be
explained.

		It meets the complete standards, it appears to meet the various
decision rules. And if it's further revised to correct the remaining
deficiencies, I think it will meet the applicable requirements of
subparts K and L.

		CHAIR FISHER:  Sean?

		DR. PHILPOTT:  And actually a point of clarification on your point of
clarification.

		In 001 it's section 9.1.8 and in 002 it's section 9.1.7 about the
enrollment of alternate subjects, three of them in order to protect
individual privacies.

		MR. CARLEY:  I beg your pardon.  I don't know what got into me, Mr.
Philpott.

		DR. FISH:  I'm not sure if this is a question for Mr. Sweeney or Mr.
Carley.  But the enrollment criteria, the upper end of the enrollment
age is 55.  And I know that in the mosquito studies it has been said
that West Nile Virus is a greater risk for people over 55 if it should
contracted.  And that's the reason for the upper limit.

		In tick studies is there any -- especially in the laboratory, is there
any reason to have an upper limit?  It relates to the justice principle.

		MR. CARLEY:  Yes.  No.  In a lab story with captive lab breed
pathogen-free populations that concern about heightened susceptibility
to certain pathogens above a certain age doesn't come into play.  It's
worth bearing in mind that as a practical manner from what Dr. Carroll
has told us about the age distribution in his pool, this isn't going to
make any difference.

		CHAIR FISHER:  But these are pathogen-free ticks.

		DR. FISH:  Right.

		MR. CARLEY:  Yes. Yes. Lab studies with captive populations that are
pathogen-free don't raise a concern that would lead us to cap the age
range just in general. It doesn't matter whether they're mosquitoes or
stable flies or ticks, or anything.

		CHAIR FISHER:  Okay.  Jan?

		DR. CHAMBERS:  This is very similar, as you noted --

		CHAIR FISHER:  Wait.  I keep forgetting public comments.  Anything,
Dr. Carroll?

		DR, CARROLL:  No.

		CHAIR FISHER:  Okay.  Jan?

		DR. CHAMBERS:  One more time.

		As noted, this is very, very similar to a couple of protocols we saw
earlier and so it really doesn't deviate terribly from those.

		I think the two deficiencies that were noted with respect to the
science I concur with, just more information about the lotion product
and assurance that the ticks are pathogen-free.

		Thank you, Kevin for clarifying the percent on the products and
everything.  However, I still have the same concern because in terms of
applying from a toilette and using a pump spray could yield a different
amount of active ingredient on them. And so this doesn't really alter
this protocol at all, but it could alter the interpretation as to
whether or not these data sets are applicable to the towelette
formulation or not.  So that's really just kind of an after the fact
caveat.  But I have no other concerns.

		I assume that since this is a lab study, it will be much more
controllable than the field studies we've been reviewing up until now.
So certainly the design that the statisticians have been talking about
should be implemented much, much more easily with this study.

		CHAIR FISHER:  Jan, can I ask you a question?  In terms of the problem
with extrapolation for the toilette, I understand that you're saying
that the dosimetry doesn't show that it's the same and the extrapolation
would be a problem.  How important is extrapolation to this study, or
it's not an important part?  If it can't be extrapolated what are the
implications when we see it?

		DR. CHAMBERS:  None for us, just for EPA.  If the data comes in and
it's to be extrapolated to that other product that you don't actually
end up applying as much, then the dose response curve might come into
play and it may not be as efficacious.

		CHAIR FISHER:  So you would recommend that the data is not such?  I
guess what I'm trying to say is is there a recommendation that we're
giving?  Because it sounds like we're saying should he change -- if the
dosimetry shows that it's not the same,  at that point is there
something else to do?  I guess I was just --

		DR. CHAMBERS:  I would just say that the data are not going to be
applicable to extrapolate the towelette if the dosimetry on the
toilette, which may not actually even proposed in here, I don't know,
shows that people apply a whole lot less of it.  So EPA may not be able
to use that data on that product, that complete protection time.

		CHAIR FISHER:  Okay.

		MR. CARLEY:  That's a helpful comment.  And the way we would pass that
on I think would be to say we suggest that you add the towelette to the
dosimetry phase and see whether it produces an equivalent effective
dose.  If it does, then just go forward as planned in the field phase.
But if not, you'd better test that one, too.

		CHAIR FISHER:  Good.  Okay.  That's where I wanted to go with that so
we can be helpful.

		Who is next?  Michael?

		DR. LEBOWITZ:  I'm glad Jan goes before me.  Well, yes.  I mean you
eventually get to talk.

		Yes. I don't want to talk about the number of subjects but the way in
which they're allocated needs to be specified better, as mentioned. And
whether each subject is a replicate or not in the application phase.

		What surprises me is there's no -- maybe there has been historically,
but I didn't see any control, a positive control of the inert or matrix
ingredient.  There's a blinding in the current design, but that could
have been built in as it occurs in other kinds of lab studies.

		There's no explicit control of temperature and relative humidity or
measurements of different levels of each to determine the relevance of
variability of each.

		There's something about the representativeness of the population, the
fact that it may represent the local population, but it doesn't
represent the U.S. population.  I mean, that might always be a problem.

		The investigator states that individual differences in repellent
performance and attractiveness in ticks weren't very much, and so
deviations from the ideal frame will not influence the results
representativeness or their generalizablity is a statement that's not
clear-cut, not proven, no data are provided.  And I have questions,
therefore, about the statement.  And there's, again, no use of the
control data.

		I don't know if this is a standard protocol and I don't want to go
through another series of discussions with consultants about ticks as we
did with mosquitoes, but some statement as to how standard this is or
whether it meets -- how it meets EPA guidelines, et cetera, would be
useful in the protocol.  But the bottom line basically is if it's
revised sufficiently to take care of the deficiencies mentioned even in
EPA review, let alone ours, then the research appears it would be likely
to generate scientifically reliable data is hope for assessing the
efficacy of the test substances for repelling ticks.

		CHAIR FISHER:  Thanks, Mike.

		Suzanne?

		DR. FITZPATRICK:  I don't have any other comments.

		CHAIR FISHER:  KyungMann?

		DR. KIM:  Thank you.

		I think we have a similar problem as was mentioned in the previous
protocol.  But because this is a laboratory tick study I think that it's
a lot easier problem to solve, as was mentioned by Dr. Chambers.

		In the protocol they say that the patient subject will be partially
randomized.  I have no idea what that means.

		And also in the protocol it says subject will be assigned to treatment
groups on the basis of a randomly assigned subject numbers with a table
indicating that subject number one through ten will be assigned to
lotion, 11 to 20 to 7 percent pump and 21 through 30 to a 15 percent
pump.  But then in the very next section it says individual subjects may
test more than one repellent on separate days.

		And these two statements are simply inconsistent because the former
statement that these 30 distinct unique subjects will be randomized, I
mean that's the implication, whereas the latter implies that there will
be an overlap which we saw early this morning that may create all kinds
of problems depending on how the experiment is carried out.

		So if there is going to be an overlap of subject -- among test subject
on test groups, there should be an appropriate experiment to design that
needs to be employed to allow proper statistical inference.

		I think that's sort of the key issues as was pointed out with the
mosquito repellent study.

		There are other issues in terms of the specific language in the
statistical analysis such as by saying the Kaplan-Meier estimates
provide median estimates with substantially reduced error estimate,
which is simply incorrect because it can go either way. And also one
cannot make a direct comparison between the estimate obtained from
Kaplan-Meier methods and the typical method that the investigator has
been using, mainly using the mean and 95 percent confidence interval
based on normal theory.  Because depending on the extent of censoring
there is present in the data set, it could be widely different.

		And also another statement saying that the median based on
Kaplan-Meier method is less sensitive data censoring.  I think what that
meant is that Kaplan-Meier method can take care of data censoring
whereas normal theory method cannot.

		The other comment -- and there are some minor errors in the study
specific instructions for the protocols.  In the site questionnaires it
refers to mosquitoes instead of ticks.  I believe this is a
mosquitoes/tick study, right?

		And there appears to be some discrepancy in the material safety data
sheets in the document.  I wasn't so sure -- I mean, this one refers to
pump -- I mean lotion 7 percent pump, 15 percent pump. But there is some
overlap of the product item numbers given and the EPA registration
number, that appears to be different.  And so I think that needs to be
sort of clarified.

		So I believe the pontification of the efficacy of the test material
with using the normal theory and the mean and confidence interval based
on the normal theory, I think it is inadequate if there is a censoring
in the time to efficacy failure measurement. And, again, this is a
recurring theme, but discussion of the statistical power because we're
not making any comparison, there's no issue of power.  The only thing
that you can talk about is the accuracy of the estimate of the
protection times.  So that's sort of an irrelevant, sort of nonsensical
statement in the protocol.

		And, again, I mean there is really no statistical justification of the
sample size.

		I mean when you start a line of sort of investigation at the beginning
you may not have a very good sense of what the variabilities.  Now I
understand that this laboratory has been doing this studies many times
over, they should have a pretty good sense of the variability and use
that information to properly justify their sample size.  And I don't see
that happening.  I mean, this is almost --yes, more than a year, right?

		CHAIR FISHER:  Okay.  I think it's important that we be consistent.
And so I want to understand, number one, where we're going in this study
versus where we went in the last study.  The last study I think you
mentioned something about -- there are a number of problems that can
easily -- we can say it has to be more justified in terms of temperature
and the relevance of all these variabilities.  I mean, I think there are
some items that you picked up.  But the notion of partially randomized
and we're not sure what that means and the kind of an inconsistency that
they're going to be randomized but then they may be tested in more than
one.

		So it doesn't seem from that that we know how this could be analyzed,
unless -- so we just need consistency.

		Is there something about this study because it's a lab study that we
can say this is what we expect, don't use repeated measure.  You know
what I mean?  Otherwise, we have to say it's premature again.  So we
should be consistent.

		So is there a difference in this study that would lead us to a
different conclusion than the other study?

		DR. KIM:  Well, I guess it is the sensitivity that we have gained
through the experience over a year and a half.

		When you read a statement saying that there will be randomization with
such-and-such rules, my tendency is not to question whether there's
going to be sort of an overlap.  But apparently they are planning to
have some overlaps.  Then what they state in one section of the protocol
is completely inconsistent with the other part of the section. And what
I'm saying is that if there is going to be overlap, they should plan it
properly so that they could interpret the data.

		CHAIR FISHER:  Yes, Jan.

		DR. CHAMBERS:  These are three independent products again.  The design
is not to compare them, correct.

		MR. CARLEY:  No.

		DR. CHAMBERS:  So if there is an overlap of subjects between products,
it doesn't really matter, does it, because they're not going to be
compared?

		DR. KIM:  Right. But, again, the issue is because the experiment is
conducted, your design dictates how the estimate of error happens. But
with the overlap, the types that we have seen earlier, you can get into
a situation where you cannot estimate the standard errors.

		DR. CHAMBERS:  But again, I think the duration is the thing that
they're interested in for the label, right?

		DR. KIM:  Right.

		DR. CHAMBERS:  I mean, are you guys going to advise Dr. Carroll about
that.  But in my mind if the only thing you're interested in is that one
time point, then it shouldn't matter.

		DR. KIM:  Well, I would like to add to Dr. Chambers' comment that the
duration is the quantity that EPA cares about.  When one does
statistical inference, mean itself is never sufficient.  I mean, I don't
want this EPA regulation to below the level of  a USA Today.  Even they
provide the standard errors for every surveys they conduct.  And this
supposed to review the scientific sort of a criteria for the study.  And
mean is sufficient?  I don't think so.  Mean itself has no value.  You
really have to understand the variability associated with the estimate.

		CHAIR FISHER:  Let me ask a question.  How many subjects are in each
of these?  Ten.

		If in fact he used ten different subjects, would this be okay?

		DR. KIM:  Oh, Yes. Absolutely.

		CHAIR FISHER:  Okay.  So isn't that our recommendation?  Let's just --

		DR. KIM:  No.

		CHAIR FISHER:  No?  Why not?

		DR. JOHNSON:  He says he has ten subjects at each of two sites.

		DR. KIM:  No, there's no sites.  Yes.

		DR. JOHNSON:  Well, there is in the protocol.

		DR. KIM:  In the huge trial with the mosquito case --

		DR. JOHNSON:  No, but I'm looking at the tick protocol.

		DR. KIM:  Then that's in error.

		DR. JOHNSON:  Okay.  So in the other ones who actually had 20
subjects.

		DR. KIM:  Right.

		DR. JOHNSON:  Ten at each location. so now we're just going to have
ten at one location, is that right?

		DR. KIM:  In the lab.

		CHAIR FISHER:  Per condition?

		DR. JOHNSON:  Per condition.

		CHAIR FISHER:  Per condition.  And if it wasn't repeated measures, if
in fact there wasn't a partial randomization, or whatever he's talking
about, if it was pure randomization of 30 subjects each one in each
condition or pure randomization of ten subjects, the order of which is
different because as you said, they're not comparing the products, is
that sufficient to get the standard deviation that you're talking about?

		DR. KIM:  Well, I mean it's really up to the investigator how they
carry out the experiment.  I'm not in a position to dictate what they
do.

		The only point I'm trying to make is that if they say that they're
going to randomize 30 distinct unique subjects, that will be perfectly
fine. If they want to use some sort of a cross over, that will ge
perfectly fine.  But it has to be planned.

		And we saw the danger of not planning and going into doing all these
--

		CHAIR FISHER:  Right.  But I'm just trying to understand the
difference between this study -- this study seems simpler to make a
recommendation for.  We didn't seem to have enough information from the
other study, which is why we said it was premature for us to be able to
look at it.

		It sounds to me like saying, look, use 30 different subjects and don't
pool your results or whatever, all the problems that were in the others,
and this looks like it will have except for some of the qualms about the
toilet -- towelettes.  Oh, I'm so tired.

		You know, we just have to be clear.  But we need to be consistent.
And so it sounds to me that this -- we can make a recommendation that if
you do this, if that's the case -- I know you don't want to make the
recommendation.  You know, I understand the discomfort with it, but I
think we have to be clear about what we will not find acceptable.  		We
will not find acceptable data which statistically can only provide means
without standard deviations.  We said in the last study that we reviewed
in which we had data that that basically was insufficient except for the
most global measure, because we didn't have the standard deviations.

		And so I think we need to articulate what is acceptable and what is
not in this particular study.  And so, I would just like us to do that.

		DR. KIM:  Well, simple answer to that question is provide an
experimental design that will provide interpretable data.

		CHAIR FISHER:  Mike?

		DR. LEBOWITZ:  Yes. I think we're giving guidance to EPA as advice as
to what they should insist in terms of what they demand of the
investigator or the sponsor.  And it's up to them to say well we won't
let you go ahead until we see a revised protocol that meets the
guidance, the advice provided by the HSRB.  Because, you know darn well
if you spend your time and effort again and money and so forth doing
this kind of study without doing that, then you're going to have the
risk, maybe a very big risk, of it being rejected.

		CHAIR FISHER:  Okay.  So I just want to clarify.  Are we saying that
this is also premature or are we saying that with letting EPA know that
one way or the other, either it's a repeated measure with whatever needs
to be there to be able to get standard deviations or it's a between
subjects design -- you know, we all have different language.  But that t
will not be acceptable if it's a partial whatever, and the randomization
has to be explicit. And there has to be a sufficient number of subjects
to have the normal -- I'm not using the right language. But the normal
estimation to allow for standard deviation because we don't want to see
a mean to which we have no idea what the real variability is.  Is that
our recommendation?

		MR. CARLEY:  A suggestion for how you frame your recommendations.  I
hope you can avoid the word "premature."  Because if you're saying that
we shouldn't have brought it you, it's not clear to us what means --

		CHAIR FISHER:  For this one I'm not saying that.

		MR. CARLEY:  -- if what you mean is -- well, for the other one as
well. If what you mean is we want to see this again before it is
executed, which I think is what you're trying to get to.

		CHAIR FISHER:  Yes. Yes.

		MR. CARLEY:  Please frame it that way rather than talking about
premature.

		CHAIR FISHER:  Okay.  So for the other study it was definitely that,
we want to see it again. But it just sounded from Mike that that's not
what we're saying for this study.  That we can be more specific in terms
of what we would see as acceptable criteria.

		So, Mike?

		DR. LEBOWITZ:  Yes. I would like some type of confidence from Mr.
Carley and/or Mr. Sweeney that if we provide that kind of advice, that
in fact that that's sufficient and useful for them to work with the
investigator or sponsor to make sure that --

		CHAIR FISHER:  I think that's an excellent question. So you heard what
our advice would be that we're not dictating a repeated measure or
between subject's design, but we are saying that whatever design it is
is not sufficient to provide some standard deviations and a statistical
analysis, that is appropriate that when it came back for us to see it,
it would not be acceptable.

		Is that helpful to you or is it not helpful to you?

		MR. SWEENEY:  That is helpful.  Yes.  And will be used because, yes, I
don't want to come back.  No.

		CHAIR FISHER:  But we want to be informative.  I mean we want to be
helpful.  That's what -- I'm glad you raised that, Mike.

		Okay.  So that's our recommendation. I can't say it again  Whatever it
was, I can't say it.  I can't say towelettes.  We all know what it is.
Okay.

		So is that where we are with this one?  Okay.

		Ethics review?

		DR. CHAMBERS:  Wait, wait, wait. I had a couple of things I wanted to
respond to about Mike. I don't know what you said about controls, but
there are no controls?  Is that --

		DR. LEBOWITZ:  That's a comment about weakness. But it's not going to
be included in the recommendation or advice we give as to how the study
should be done.

		I didn't say there weren't any controls. I said there was no analysis
in which the control data were used, as far as I could determine.  I
didn't see any analytic framework design.

		MR. CARLEY:  I agree with observation.  But you did make another
comment that you criticized the absence of testing with a vehicle --
with a matrix --

		DR. LEBOWITZ:  Yes, but that's just  a--

		MR. CARLEY:  -- which we do not require or want to see.

		DR. LEBOWITZ:  I understand that.  But that doesn't prevent me from
commenting on that.

		In the say way, let me say I said something about temperature and
relative humidity.  You know, way back when when I was doing talks we
knew the variability of response in different ranges of temperature and
relative humidity to the pollutants we were studying, and we were able
to then standardize it within a certain range of temperature and a
certain range of relative humidity. So the experiment could go on and
that was sort of accepted. And I don't know if that's true in this case.
But the issues have come up about variations based that may be related
to temperature or relative humidity, light intensity and all that jazz.
And I just make the comment in here.

		CHAIR FISHER:  Okay.  But we do understand there is no control and
there's no positive control.  And that's still -- our recommendation is
the same.

		DR. JOHNSON:  Well, they used a control arm to decide whether to use a
tick or not, is that right?  So if the tick doesn't act like it wants to
go to --

		CHAIR FISHER:  Oh, right.  Right.  Yes.  Exactly.

		DR. JOHNSON:  -- go to a host, then they throw that tick away.

		CHAIR FISHER:  Exactly.

		DR. JOHNSON:  Throw that tick away and pick a new tick.

		CHAIR FISHER:  That's right.  Thank you.  That's exactly right.

		Okay.  Let's go to the ethics.

		DR. PHILPOTT:  Okay.  And since I've been in this building now for 10(
hours, thankfully I've written this one out pretty much already.  So I'm
going to read in the hopes that I just get two dittos.

		Once the recommended changes outlined in Mr. Carley and Mr. Sweeney's
ethics and scientific review are incorporated into the protocol as
submitted, and I'm focusing on the protocol not on the potential conduct
and the issues related to interaction with the IRB, the proposed
research described should meet the applicable requirements of subparts K
and L.

		Risk to study participants are minimal and justified by the likely
societal benefits.  The risks are essentially three fold; reaction to
the test materials themselves, the exposure to biting arthropods and
possible exposure to arthropod-borne illnesses.

		The active ingredient of these formulations is already commercially
available and present in similar concentrations in other registered
products.

		Volunteers with known allergic reactions to insect repellents and
common cosmetics are excluded from participating.  So enrolled
participants are unlikely to be at increased risks of experiencing
adverse side effects upon exposure.

		Clear stopping rules have been developed as have plans for the medical
management of any side effects or adverse events associated with product
exposure.

		Bites from the ticks is probably unlikely. We won't say a zero
probability in deference to Mr. Carley, but negligible given what Mr.
Sweeney has told us about the seeking and biting behavior of these
ticks.

		Barring the EPA's concerns about Rocky Mountain Spotted Fever which
can be transmitted transovarially, the ticks used for the study are bred
and raised in a laboratory environment and are considered to be
pathogen-free which should minimize the risk of vector-bourn disease.

		I do support their recommendations, though, to look into the issue of
the Spotted Fever.

		And finally, the protocol contains several mechanisms designed to
minimize coercive recruitment in enrollment. Compensation is not so high
as to unduly influence participation.  As per the final rule's
requirements, minors and pregnant or lactating women are specifically
excluded from volunteering. And the use of so called alternate subjects
allows for volunteers to withdraw or be excluded without comprising
their confidentiality.

		I agree with Sue's comments that unless there is an explicit reason to
exclude individuals above the age of 55 from a justice perspective, that
should be changed.

		And I also agree with the recommendations that the psychosocial risks
associated with a positive pregnancy test, however unlikely or minimal
those may be, should be mentioned in the consent document. 		Done.

		CHAIR FISHER:  Richard?

		DR. SHARP:  Kudos.

		CHAIR FISHER:  Yay.  Sue?

		DR. FISH:  Sean, you included my one comment, so ditto.

		CHAIR FISHER:  Okay.  I have no idea what our recommendation is. But
it sounds like what he said, it's okay.  As long as that's followed it
goes.

		Okay.  So now I want you to know we ended 20 minutes early.

		We're not done?

		MR. CARLEY:  We have one left?

		CHAIR FISHER:  We have one left?  Oh, God.

		MR. CARLEY:  I thought we still had one to go.

		CHAIR FISHER:  You are really tired.  But 20 minutes early.  Very
good.

		(Whereupon, at 6:22 p.m. the Public Meeting was adjourned.)

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