2195.04_Attachment E

AMERICAN CHEMISTRY COUNCIL
Antimicrobial Exposure Assessment Task Force II
Consultation for OPP ICR Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects (OMB Control #2070-0169)
March 5, 2012
1.

Publicly Available Data
a.

Are the data that the Agency seeks available from any public source, or already
collected by another office at EPA or by another agency?
In some cases publically available data may exist. However, any existing public
data are reviewed by AEATF II to determine if they meet the technical needs and
the current quality standards prior to generation of new data.

b.

If yes, where can you find the data? Is the available data truly duplicative, or are
only certain data elements available which may not address our data requirements
very well?
Publically available data can be found in the published literature and publically
available databases. Typically the available data are not truly duplicative as
many critical elements are missing or they are not representative of the scenario
being investigated or they are lacking quality control aspects.

2.

Frequency of Collection
a.

Can the Agency collect the information less frequently and still produce the same
outcome?
This is not applicable to the AEATF II.

3.

Clarity of Instructions
a.

The rule is intended to require respondents to provide certain data for the
Agency’s use. Is it clear from the regulations and other Agency guidance what
you are required to submit and how to submit it? If not, what suggestions do you
have to clarify the information?
The rule gives a general explanation of the process, but does not specify what
needs to be submitted, how it needs to be submitted, and the steps leading up to
the submission. In addition, the required changes to human subject recruitment
and consenting processes since 2006 are not clearly documented. It would be
helpful if EPA would identify all of these new procedures and requirements in a
revision to the OCSPP Series 875 Test Guidelines.

1

b.

Do you understand that you are required to maintain records?
Yes, keeping detailed records is standard practice for the AEATF II as part of the
GLP regulations. However, the volume of records that need to be kept has
increased significantly. The number of pages in study protocols and final reports
has increased 10 to 15 fold as a result of the final rule.

c.

Is it difficult to format the information for submission so that it is clear, logical
and easy to understand?
The issue with formatting the submission is that it is very time-consuming due to
the large number of documents required for each study submission (e.g., protocol,
informed consent form, survey reports, detailed sampling plans, SOPs, IRB
correspondence, IRB review reports, recruitment flyers, researcher CVs, Spanish
translations, etc.). Prior to the final rule, protocol submissions consisted of about
40 pages. After the final rule became effective, that submission has increased to
over 500 pages which are arranged in several volumes to make the review of the
submission more manageable. Just the specific process of arranging and
checking the final documents for a protocol submission involves a minimum of
two people, one technical and one clerical, for approximately two to four days.

d.

Are there forms associated with this process? If so, do you use them? Are they
clear, logical, and easy to complete?
The only form provided by EPA is a short checklist of items from the Rule (40
CFR 26.1125) that must be included in each protocol submission. The form is
taken directly from the Rule and is not especially difficult or time-consuming to
complete once all of the documents have been formatted into the submission
volumes. There is some duplication of information requested on this form. The
form could be improved as it does not have sufficient detail to clearly capture all
of the key information that a reviewer might need especially if the protocol has
been reviewed by the IRB multiple times.

4.

Electronic Reporting and Record Keeping
The Government Paperwork Elimination Act requires that agencies make available
electronic reporting alternatives to paper-based submissions. Entities that submit study
protocols and/or reports in response to EPA’s 2006 final rule may elect to submit the
information either on paper, or electronically, via email, CD, or DVD.
a.

What do you think of electronic alternatives to hard-copy data submissions?
The AEATF II is almost paperless in its documentations, so it definitely prefers
electronic submissions.

b.

Are you keeping your records electronically? If yes, in what format?

2

Yes, records are kept in several forms including MS Word, Excel, Adobe Acrobat,
JPEG, and e-mail files.
c.

Does electronic submission benefit you by reducing your burden or permitting
greater efficiency in compiling the information?
Since almost all documents associated with the protocol or a study report are
generated and stored electronically, making an electronic submission is easier.
The AEATF II submits final reports “electronically”, although three hard copies
are also required for submission to the EPA Document Processing Office. The
burden of making electronic submissions could be reduced significantly by totally
eliminating the need for paper hard copies.

5.

Burden and Costs
a.

The labor rates EPA will use to estimate costs for regulated entities are taken from
the May 2010 National Industry-Specific Occupational Employment and Wage
Estimates for NAICS code 541710 (Research and Development in the Physical,
Engineering, and Life Sciences), published by the Bureau of Labor Statistics. The
BLS fully-loaded hourly rates for this industry are $153/hour for management,
$79/hour for technical staff, and $45/hour for clerical staff. Do you think these
labor rates are appropriate? Can you suggest another NAICS code that would be
more appropriate?
The labor rates used by EPA are significantly lower than that incurred by the
AEATF II, especially for the technical staff. The professional technical and
management work of the AEATF II is done by highly specialized research
scientists who work for the AEATF II on a consulting basis. The more
appropriate rates are $225, $175, and $50 per hour for the management,
technical, and clerical classifications respectively.

b.

EPA will estimate annual costs by multiplying the estimated average cost of
burden hours associated with each of several classes of activities by the estimated
number of times each year that class of activity is expected to be performed.
Please enter in Table 1 on the next page your estimates of the incremental
paperwork burden in hours by management, technical, and clerical staff
associated with each occurrence of each activity listed. Base your estimates on
your experience since the rule became effective in 2006, and on your projections
for the paperwork and recordkeeping burden of each activity over the period
covered by the ICR renewal—i.e., between September 1, 2012 and August 31,
2015.
Please explain how you arrived at your estimates, and please estimate only the
incremental burden imposed by the paperwork requirements associated with the
rule, not the costs of conducting the research or costs you would have incurred if
the rule were not in effect.

3

Table 1
Respondent Burden Estimates:
Unit Costs of Discrete Activities Required by the New Rule
Average Burden Hours Per
Occurrence
Management
Technical Clerical
1
$153
$79
$45
Activities
Rule familiarization and
training (per protocol)2
Prepare and submit
protocol for IRB
review3
Prepare and submit
protocol for EPA and
HSRB review4
Document ethical
conduct of a completed
study for which EPA
and the HSRB have
reviewed the protocol5
Store, file, and maintain
records6
TOTALS

Total Per Response

Total
Hours

Cost ($)
Based Based on
on EPA Industry1
Nos.
Cost ($)

5

5

5

15

1,385

2,250

20

200

30

225

20,210

41,000

200

600

40

840

79,800

152,000

40

1000

40

1,080

86,920

186,000

10

40

10

60

5,140

9,750

275

1,845

125

2,245

193,455

391,000

Notes for Table 1:
1

Rates are from the May 2010 National Industry-Specific Occupational Employment and
Wage Estimates for NAICS code 541710 (Research and Development in the Physical,
Engineering, and Life Sciences), published by the Bureau of Labor Statistics.
A column was added that reflects more representative estimated costs to the AEATF II based
on typical industry labor costs ($225, $175, and $50 per hour for the management,

technical, and clerical classifications respectively)
2

Consider this a one-time activity. Enter your estimate of what your total burden will be for
rule familiarization and training during 2012-2015. Since you are already familiar with the
rule, you may have little additional burden for this activity.
This is not totally a one-time activity due to new people coming on board, normal turn-over
of personnel, and training present personnel on changes in the process as they occur.

4

3

Estimate your average paperwork burden of preparing for a single IRB review which would
not have occurred but for the requirements of the human studies rule. Consider IRB reviews
both before and after EPA/HSRB review.

4

Estimate your average paperwork burden of preparing a single submission to EPA of a
protocol proposing research involving intentional exposure of human subjects. Treat each
repellent testing protocol as a single protocol, however many test materials may be involved.
The amount of background research required for designing and documenting the studies as
currently required by the Agency and the HSRB, has markedly increased. This is in addition
to the extra work now required to prepare the final submission package for EPA/HSRB
review. For this task “management” includes not only the task force manager, but other
sponsor company members (registrants) who make up the protocol committee and are
directly involved with the protocol development and oversight.

5

Estimate your average paperwork burden to document the ethical conduct of a single study
for submission to EPA when the protocol has already been reviewed by EPA and the HSRB.
Treat all reports reflecting a single execution of one protocol as a single activity, however
many test materials may be involved.

6

Estimate your average paperwork burden for managing and archiving records of each
submitted protocol or study report.
There is additional work now associated with managing, storing and archiving documents as
records containing confidential subject information (ICF, comprehension forms, subject
information forms) are to be kept separate from the raw data files.

c.

Please estimate in Table 2 below the frequency with which you expect to incur the
paperwork burden associated with each class of activity described in Table 1. Your
responses will be combined with those from others in EPA’s revised burden estimate.
Please explain any assumptions underlying your estimates.
Table 2
Respondent Burden Estimates: Estimated Frequency of Activities

Activities

Projected Number of
Occurrences by Year
Sept 2012- Sept 2013- Sept 2014Aug 2013
Aug 2014
Aug 2015

Prepare and submit protocol
for IRB review1
Prepare and submit protocol
for EPA and HSRB review2
Document ethical conduct of a
completed study for which
EPA and the HSRB have
reviewed the protocol3
Store, file, and maintain
records

5

2

3

3

2

3

3

2

2

2

2

3

3

Notes for Table 2:
1

Count IRB submissions that would not have occurred but for the requirements of the
human studies rule, including those both before and after EPA/HSRB review.

2

Count each repellent testing protocol as a single occurrence, however many test
materials it may involve.

3

Count each executed repellent protocol only once, however many test materials or
physical study volumes it may involve.

d.

The Agency assumes there are no capital costs within the scope of this
Information Collection Request. Do you agree?
The AEATF II agrees.

e.

Are there other activities or incremental costs associated with the paperwork
burden imposed by the human studies rule, not listed in the tables but which
should be accounted for?
New SOPs and revisions to SOPs have been required to address the changes
imposed by the human studies rule. Although a number of new and updated SOPs
now exist, continual revisions are still needed based on feedback from EPA and
the HSRB. There are management, technical, and clerical costs associated with
this activity.

6

Consultation for OPP ICR Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects (OMB Control #2070-0169)
Carroll-Loye Biological Research
February 15, 2012

1.

Publicly Available Data
a.

b.

2.

Frequency of Collection
a.

3.

Can the Agency collect the information less frequently and still produce the same
outcome?
Not in our opinion

Clarity of Instructions
a.

The rule is intended to require respondents to provide certain data for the
Agency’s use. Is it clear from the regulations and other Agency guidance what
you are required to submit and how to submit it? If not, what suggestions do you
have to clarify the information?
Clear

b.

Do you understand that you are required to maintain records?
Yes
Is it difficult to format the information for submission so that it is clear, logical
and easy to understand?
No
Are there forms associated with this process? If so, do you use them? Are they
clear, logical, and easy to complete?
None

c.

d.

4.

Are the data that the Agency seeks available from any public source, or already
collected by another office at EPA or by another agency?
No
If yes, where can you find the data? Is the available data truly duplicative, or are
only certain data elements available which may not address our data requirements
very well?

Electronic Reporting and Record Keeping
The Government Paperwork Elimination Act requires that agencies make available
electronic reporting alternatives to paper-based submissions. Entities that submit study
protocols and/or reports in response to EPA’s 2006 final rule may elect to submit the
information either on paper, or electronically, via email, CD, or DVD.
a.

What do you think of electronic alternatives to hard-copy data submissions?
1

Preferred
b.
c.

5.

Are you keeping your records electronically? If yes, in what format?
PDF
Does electronic submission benefit you by reducing your burden or permitting
greater efficiency in compiling the information?
To some extent. We are still required to submit paper hardcopy of reports in
triplicate to documents processing. This a significant burden for a small company
(Staff of 5-9)

Burden and Costs
a.

The labor rates EPA will use to estimate costs for regulated entities are taken from
the May 2010 National Industry-Specific Occupational Employment and Wage
Estimates for NAICS code 541710 (Research and Development in the Physical,
Engineering, and Life Sciences), published by the Bureau of Labor Statistics. The
BLS fully-loaded hourly rates for this industry are $153/hour for management,
$79/hour for technical staff, and $45/hour for clerical staff. Do you think these
labor rates are appropriate? Can you suggest another NAICS code that would be
more appropriate? No objection to use of code 541710

b.

EPA will estimate annual costs by multiplying the estimated average cost of
burden hours associated with each of several classes of activities by the estimated
number of times each year that class of activity is expected to be performed.
Please enter in Table 1 on the next page your estimates of the incremental
paperwork burden in hours by management, technical, and clerical staff
associated with each occurrence of each activity listed. Base your estimates on
your experience since the rule became effective in 2006, and on your projections
for the paperwork and recordkeeping burden of each activity over the period
covered by the ICR renewal—i.e., between September 1, 2012 and August 31,
2015.
Please explain how you arrived at your estimates, and please estimate only the
incremental burden imposed by the paperwork requirements associated with the
rule, not the costs of conducting the research or costs you would have incurred if
the rule were not in effect.

2

Table 1
Respondent Burden Estimates:
Unit Costs of Discrete Activities Required by the New Rule

Activities
Rule familiarization and
training (per protocol)2
Prepare and submit
protocol for IRB review3
Prepare and submit
protocol for EPA and
HSRB review4
Document ethical
conduct of a completed
study for which EPA and
the HSRB have reviewed
the protocol5
Store, file, and maintain
records6

Average Burden Hours Per Occurrence
Management
Technical
Clerical
$1531
$79
$45

Total Per Response
Total
Hours

Cost ($)

1

2

2

5

401

7

25

10

42

3496

5

3

7

15

1317

5

10

5

20

1771

2

0

10

12

756

Notes for Table 1: The bulk of the work of preparing the protocol is completed prior to IRB
review so that the IRB reviews essentially the same packet of documents provided for EPA and
HSRB review. We find protocol preparation for IRB or EPA/HSRB submission to be a technical
task, with the burden of the hours of work completed by staff working at technical grade.
1

Rates are from the May 2010 National Industry-Specific Occupational Employment and Wage Estimates for
NAICS code 541710 (Research and Development in the Physical, Engineering, and Life Sciences),
published by the Bureau of Labor Statistics.

2

Consider this a one-time activity. Enter your estimate of what your total burden will be for rule
familiarization and training during 2012-2015. Since you are already familiar with the rule, you may have
little additional burden for this activity.

3

Estimate your average paperwork burden of preparing for a single IRB review which would not have occurred
but for the requirements of the human studies rule. Consider IRB reviews both before and after EPA/HSRB
review.

4

Estimate your average paperwork burden of preparing a single submission to EPA of a protocol proposing
research involving intentional exposure of human subjects. Treat each repellent testing protocol as a single
protocol, however many test materials may be involved.

5

Estimate your average paperwork burden to document the ethical conduct of a single study for submission to
EPA when the protocol has already been reviewed by EPA and the HSRB. Treat all reports reflecting a
single execution of one protocol as a single activity, however many test materials may be involved.

5

Estimate your average paperwork burden for managing and archiving records of each submitted protocol or
study report.

3

c.

Please estimate in Table 2 below the frequency with which you expect to incur the
paperwork burden associated with each class of activity described in Table 1. Your
responses will be combined with those from others in EPA’s revised burden estimate.
Please explain any assumptions underlying your estimates.

Table 2
Respondent Burden Estimates: Estimated Frequency of Activities

Activities

Projected Number of
Occurrences by Year
Sept 2012- Sept 2013- Sept 2014Aug 2013
Aug 2014
Aug 2015

Prepare and submit protocol
for IRB review1
Prepare and submit protocol
for EPA and HSRB review2
Document ethical conduct of a
completed study for which
EPA and the HSRB have
reviewed the protocol3
Store, file, and maintain
records

2

2

2

2

2

2

2
2

2
2

2
2

Answers based on average yearly research activity combined with consideration of anticipated
future study activities.
Notes for Table 2:
1

Count IRB submissions that would not have occurred but for the requirements of the
human studies rule, including those both before and after EPA/HSRB review.

2

Count each repellent testing protocol as a single occurrence, however many test
materials it may involve.

3

Count each executed repellent protocol only once, however many test materials or
physical study volumes it may involve.

d.

The Agency assumes there are no capital costs within the scope of this
Information Collection Request. Do you agree?
Yes

e.

Are there other activities or incremental costs associated with the paperwork
burden imposed by the human studies rule, not listed in the tables but which
should be accounted for?
No

4

Consultation for OPP ICR Submission of Protocols and Study Reports for Environmental
Research Involving Human Subjects (OMB Control #2070-0169)
Response by Agricultural Handlers Exposure Task Force (AHETF)
February 24, 2012

1.

Publicly Available Data
a.

Are the data that the Agency seeks available from any public source, or already
collected by another office at EPA or by another agency?
No. Any existing public data are reviewed by AHETF for applicability to its
needs prior to generation of new data.

b.

If yes, where can you find the data? Is the available data truly duplicative, or are
only certain data elements available which may not address our data requirements
very well?
This is not applicable to the AHETF.

2.

Frequency of Collection
a.

Can the Agency collect the information less frequently and still produce the same
outcome?
This is not applicable to the AHETF.

3.

Clarity of Instructions
a.

The rule is intended to require respondents to provide certain data for the
Agency’s use. Is it clear from the regulations and other Agency guidance what
you are required to submit and how to submit it? If not, what suggestions do you
have to clarify the information?
The rule gives a general overall explanation of the process but does not cover
exactly what needs to be submitted and how it needs to be submitted. However,
after considerable interaction with EPA since 2006, the AHETF now has
determined how to submit data successfully. EPA should now document the
procedures with revised exposure guidelines.

b.

Do you understand that you are required to maintain records?
Yes, keeping detailed records is standard practice for the AHETF as part of the
GLP regulations. However, the volume of records that need to be kept has
increased significantly. The number of pages in protocols and final reports has
increased 10 to 15 fold as a result of the final rule.

Page 1 of 6

c.

Is it difficult to format the information for submission so that it is clear, logical
and easy to understand?
The format is now clear and standardized but it is still time-consuming for the
AHETF to format the submission materials due to the large number of documents
required for each study (e.g., protocol, informed consent form, input from experts,
survey reports, detailed sampling plans, SOPs, IRB correspondence, flyers, letters
to qualified study participants, Spanish translations, etc.). Prior to the final rule,
submissions contained about 40 pages. After the final rule became effective, that
number increased to over 2000 pages. The AHETF and EPA then agreed to some
efficiency that lowered the number of pages to 400 to 500 (still more than 10
times what it was before the final rule).

d.

Are there forms associated with this process? If so, do you use them? Are they
clear, logical, and easy to complete?
The only form provided by EPA is a checklist of items from the rule that must be
covered in every protocol. The form is taken directly from the rule and is not
especially difficult to complete, but does take a significant amount of time. In
order to improve the clarity and efficiency of the protocol and report submissions,
AHETF created new formats and tables to convey the information required.

4.

Electronic Reporting and Record Keeping
The Government Paperwork Elimination Act requires that agencies make available
electronic reporting alternatives to paper-based submissions. Entities that submit study
protocols and/or reports in response to EPA’s 2006 final rule may elect to submit the
information either on paper, or electronically, via email, CD, or DVD.
a.

What do you think of electronic alternatives to hard-copy data submissions?
The AHETF is almost paperless in its documentations, so it definitely prefers
electronic submissions.

b.

Are you keeping your records electronically? If yes, in what format?
Yes, records are kept in several forms including MS Word, Excel, Adobe Acrobat,
E-mail files, and CDs. Key documents are also stored on a task force server for
easy access by AHETF members and EPA.

c.

Does electronic submission benefit you by reducing your burden or permitting
greater efficiency in compiling the information?
Most of the information is generated electronically, so converting this to hard
copy for the submission is an additional burden. The AHETF submits final
reports “electronically”, although two hard copies of each report are submitted
prior to the electronic sending. It is with the hard copy submission that the MRID
number is assigned. Reducing the effort to only the electronic submission (and
Page 2 of 6

somehow obtaining the necessary MRID number prior to this) would be helpful to
the efficiency of the overall submission process.
5.

Burden and Costs
a.

The labor rates EPA will use to estimate costs for regulated entities are taken from
the May 2010 National Industry-Specific Occupational Employment and Wage
Estimates for NAICS code 541710 (Research and Development in the Physical,
Engineering, and Life Sciences), published by the Bureau of Labor Statistics. The
BLS fully-loaded hourly rates for this industry are $153/hour for management,
$79/hour for technical staff, and $45/hour for clerical staff. Do you think these
labor rates are appropriate? Can you suggest another NAICS code that would be
more appropriate?
The rates used by EPA are less than that incurred by the AHETF, especially for
the technical people. The professional technical and management work of the
AHETF is done by highly specialized research scientists who work for the AHETF
on a consulting basis, so a classification for researchers with MS or PhD degree
requirements would be more appropriate. The more applicable rates are $225,
$175, and $50 per hour for the management, technical, and clerical
classifications. This does not account for the sweat equity that goes into these
programs by representatives of the member companies whose time is not charged
to the AHETF.

b.

EPA will estimate annual costs by multiplying the estimated average cost of
burden hours associated with each of several classes of activities by the estimated
number of times each year that class of activity is expected to be performed.
Please enter in Table 1 on the next page your estimates of the incremental
paperwork burden in hours by management, technical, and clerical staff
associated with each occurrence of each activity listed. Base your estimates on
your experience since the rule became effective in 2006, and on your projections
for the paperwork and recordkeeping burden of each activity over the period
covered by the ICR renewal—i.e., between September 1, 2012 and August 31,
2015.
Please explain how you arrived at your estimates, and please estimate only the
incremental burden imposed by the paperwork requirements associated with the
rule, not the costs of conducting the research or costs you would have incurred if
the rule were not in effect.

Page 3 of 6

Table 1
Respondent Burden Estimates:
Unit Costs of Discrete Activities Required by the New Rule
Average Burden Hours Per
Occurrence

Activities
Rule familiarization and
training (per protocol)2
Prepare and submit protocol
for IRB review3
Prepare and submit protocol
for EPA and HSRB review4
Document ethical conduct of
a completed study for which
EPA and the HSRB have
reviewed the protocol5
Store, file, and maintain
records6
TOTALS

Total Per Response
Cost ($)
Actual
Total
Estimated Cost ($) to
Hours
by EPA
AHETF

Mgt
$1531

Technical
$79

Clerical
$45

5

5

5

15

1,385

2,250

25

300

50

375

29,775

60,625

40

900

60

1000

79,920

169,500

60

2500

50

2610

208,930

453,500

5

5

5

15

1,385

2,250

135

3,710

170

3,515

321,395

688,125

Notes for Table 1:
1

Rates are from the May 2010 National Industry-Specific Occupational Employment and Wage
Estimates for NAICS code 541710 (Research and Development in the Physical, Engineering,
and Life Sciences), published by the Bureau of Labor Statistics.
A column was added that reflects the actual costs to the AHETF.

2

Consider this a one-time activity. Enter your estimate of what your total burden will be for rule
familiarization and training during 2012-2015. Since you are already familiar with the rule,
you may have little additional burden for this activity.
This is not totally a one-time activity due to new people coming on board, normal turn-over
of personnel, and training personnel on changes in the process as they occur.

3

Estimate your average paperwork burden of preparing for a single IRB review which would not
have occurred but for the requirements of the human studies rule. Consider IRB reviews both
before and after EPA/HSRB review.
The costs have decreased slightly since 2006 largely due to decreases in the volume of
documentation associated with IRB correspondence.

4

Estimate your average paperwork burden of preparing a single submission to EPA of a protocol
proposing research involving intentional exposure of human subjects. Treat each repellent
testing protocol as a single protocol, however many test materials may be involved.

Page 4 of 6

The amount of background research required for designing and documenting the studies as
currently required by the Agency and the HSRB, has markedly increased. Without
substantive change this aspect is expected to become even more time-consuming as the
AHETF addresses more difficult scenarios.
5

Estimate your average paperwork burden to document the ethical conduct of a single study for
submission to EPA when the protocol has already been reviewed by EPA and the HSRB.
Treat all reports reflecting a single execution of one protocol as a single activity, however
many test materials may be involved.
This cost is increasing significantly and continually due to difficulties in recruiting study
participants under the ethics rules established by the Agency and the HSRB. Some changes
in the recruitment process are being implemented, but it is not yet known how successful they
will be. The recruitment process requires very extensive documentation.

6

Estimate your average paperwork burden for managing and archiving records of each
submitted protocol or study report.

Page 5 of 6

c.

Please estimate in Table 2 below the frequency with which you expect to incur the
paperwork burden associated with each class of activity described in Table 1. Your
responses will be combined with those from others in EPA’s revised burden estimate.
Please explain any assumptions underlying your estimates.

Table 2
Respondent Burden Estimates: Estimated Frequency of Activities

Activities
Prepare and submit protocol
for IRB review1
Prepare and submit protocol
for EPA and HSRB review2
Document ethical conduct of a
completed study for which
EPA and the HSRB have
reviewed the protocol3
Store, file, and maintain
records

Projected Number of
Occurrences by Year
Sept 2012- Sept 2013- Sept 2014Aug 2013
Aug 2014
Aug 2015
1

1

1

1

1

1

5

5

5

7

7

7

Notes for Table 2:

d.

1

Count IRB submissions that would not have occurred but for the requirements of
the human studies rule, including those both before and after EPA/HSRB review.

2

Count each repellent testing protocol as a single occurrence, however many test
materials it may involve.

3

Count each executed repellent protocol only once, however many test materials or
physical study volumes it may involve.

The Agency assumes there are no capital costs within the scope of this Information
Collection Request. Do you agree?
The AHETF agrees.

e.

Are there other activities or incremental costs associated with the paperwork burden
imposed by the human studies rule, not listed in the tables but which should be
accounted for?
The AHETF is not immediately aware of applicable activities.

Page 6 of 6