2195.04_Attachment F

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON D.C., 20460

OFFICE OF
CHEMICAL SAFETY AND POLLUTION
PREVENTION

MEMORANDUM
SUBJECT:

Information Collection Request (ICR) for the Human Studies Rule
Calculation of Burden and Cost

TO:

File

FROM:

Kelly Sherman
Human Research Ethics Reviewer
Office of Pesticide Programs

DATE:

March 27, 2012

Burden Hours for Respondents
EPA sent consultation questions about the burden and cost estimates to three
respondents – the Agricultural Handler Exposure Task Force (AHETF), the
Antimicrobial Exposure Assessment Task Force II (AEATF), and Carroll-Loye
Biological Research (CLBR). These three organizations are experienced in submitting
human subjects research to OPP, and are expected to make additional submissions over
the next several years. The consultation responses received from these respondents
indicated that EPA’s previous estimates of the burden and cost were too low. To
calculate new burden and cost estimates for this renewal ICR, EPA relied upon the
estimates provided in the three consultation responses. EPA calculated a weighted
average of the different responses, recognizing that some study types are more
complicated and costly to conduct than others.
The respondent burden and cost estimates that appear in Table 1 in the ICR, for
research involving intentional exposure of human subjects, are the weighted averages of
the values in Table A (burden hour estimates for agricultural handler studies, from the
AHETF’s consultation response), Table B (burden hour estimates for antimicrobial
exposure studies, from the AEATF’s consultation response), and Table C (burden hour
estimates for insect repellant studies, from CLBR’s consultation response). The weighted
average was calculated by multiplying the burden hour estimates that appear in Tables A,
B, and C by the expected number of each type of study, and then dividing the sum of
those products by the total number of studies of all types expected per year. The
expected number of studies per year was also determined from the consultation
responses.
1

The respondent burden and cost estimates that appear in Table 2 in the ICR, for
all other submitted research with human subjects, are based on the consultation response
from Joel Panara at Grayson in 2008. Mr. Panara is familiar with submitting completed
study reports to EPA for pre-rule research for which HSRB protocol review is not
required, and his consultation response was based on his billing records for work
performed on several studies to generate the reports necessary to meet the requirements
of the rule. None of these types of studies was submitted to EPA over the past three
years, so Mr. Panara’s estimates from the previous ICR renewal process are still the most
accurate prediction of costs.
Hourly Rates for Respondents
Two of the three respondents indicated that the hourly rates used by EPA for
calculating the estimated costs are too low. In determining the rates, OPP uses a single
source of data, the Bureau of Labor Statistics’ National Industry-Specific Occupational
Employment and Wage Estimates, and selects the appropriate occupational category.
Using the BLS data allows EPA to be consistent between across sectors and occupations.
If OPP were to separately research wages for each ICR, the methodology in determining
the wages would not be consistent and the wage rates could not be compared between
sectors and occupations. Some wages would be biased high, while others would be
biased low. The BLS wages are categorized by North American Industry Classification
System (NAICS) codes, and therefore are industry-specific. They are, however, national
averages. Therefore, some of the high wages earned by specialists in high cost localities
are offset by others who are less specialized in lower cost localities.
The wage rates EPA used to estimate costs for regulated entities for this renewal
ICR were from NAICS 541710 (Research and Development in the Physical, Engineering,
and Life Sciences). 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.
Agency Burden and Costs
The estimated burden and costs to the Agency are derived from input from EPA
staff members who have prepared reviews for studies that were presented to the HSRB.
Recognizing that some study types are more complicated and time consuming to review
that others, EPA calculated a weighted average using the staff time estimates and the
expected frequency of receiving different types of studies. The values calculated based
on the staff input appear in Tables E and F. The weighted averages are provided in ICR
Tables 3 and 4. The wage rates EPA used to estimate Agency costs for this renewal ICR
were from NAICS 999100 (Federal Executive Branch). The BLS fully-loaded hourly
rates for Agency staff are $120/hour for management, $71/hour for technical staff, and
$45/hour for clerical staff.
Number of Transactions
The estimated number of transactions is based heavily on the consultation
responses from the three respondents, as well as EPA’s historical experience and
knowledge of upcoming submissions.
2

RESPONDENT BURDEN HOUR ESTIMATES
Table A. Agricultural Handler Exposure Studies – Burden Hour Estimates from
AHETF’s Consultation Response
Average Burden Hours Per
Total Per
Occurrence
Response
Activities
Management Technical Clerical
Cost
Hours
$153
$79
$45
($)
Rule familiarization and
5
5
5
15
1,385
training
Prepare and submit protocol
25
300
50
375
29,775
for IRB review
Prepare and submit protocol
40
900
60
1,000 79,920
for EPA and HSRB review
Document ethical conduct
of a completed study for
which EPA and the HSRB
have reviewed the protocol;
60
2500
50
2,610 208,930
prepare and submit
completed study for IRB,
EPA, and HSRB Review
Store, file, and maintain
5
5
5
15
1,385
records
TOTALS
135
3,710
170
3,515 321,395
Table B. Antimicrobial Exposure Studies – Burden Hour Estimates from AEATF’s
Consultation Response
Average Burden Hours Per
Total Per
Occurrence
Response
Activities
Management Technical Clerical
Cost
Hours
$153
$79
$45
($)
Rule familiarization and
5
5
5
15
1,385
training
Prepare and submit protocol
20
200
30
225
20,210
for IRB review
Prepare and submit protocol
200
600
40
840
79,800
for EPA and HSRB review
Document ethical conduct
of a completed study for
which EPA and the HSRB
have reviewed the protocol;
40
1,000
40
1,080 86,920
prepare and submit
completed study for IRB,
EPA, and HSRB Review
Store, file, and maintain
10
40
10
60
5,140
records
TOTALS
275
1,845
125
2,245 193,455
3

Table C. Insect Repellant Studies – Burden Hour Estimates from the Consultation
Response from Carroll-Loye Biological Research
Average Burden Hours Per
Total Per
Occurrence
Response
Activities
Management Technical Clerical
Cost
Hours
$153
$79
$45
($)
Rule familiarization and
1
2
2
5
401
training
Prepare and submit protocol
7
25
10
42
3,496
for IRB review
Prepare and submit protocol
5
3
7
15
1,317
for EPA and HSRB review
Document ethical conduct
of a completed study for
which EPA and the HSRB
5
10
5
20
1,771
have reviewed the protocol;
prepare and submit
completed study for IRB,
EPA, and HSRB Review
Store, file, and maintain
2
0
10
12
756
records
TOTALS
20
40
34
94
7,741

Table D. Documentation of Ethical Conduct of a Completed Study for which EPA
and HSRB have NOT reviewed the Protocol (per requirements at §26.1303) – Using
information compiled during previous ICR renewal process
Average Burden Hours Per
Total Per
Occurrence
Response
Activities
Management Technical Clerical
Cost
Hours
$153
$75
$45
($)
Document ethical conduct
of a completed study for
which EPA and the HSRB
2
24
2
28
2,563
have not reviewed the
protocol

4

For ICR Table 1
Table 1. Weighted Average Burden and Cost Estimates for Respondents – Research
Involving Intentional Exposure of Human Subjects
Average Burden Hours Per
Total Per
Response
Response
Activities
Management Technical Clerical
Cost
Hours
$153
$79
$45
($)
Rule familiarization and
4
4
4
12
1,108
training
Prepare and submit protocol
17
175
30
222
17,776
for IRB review
Prepare and submit protocol
82
501
36
619
53,745
for EPA and HSRB review
Document ethical conduct
of a completed study for
which EPA and the HSRB
35
1,170
32
1,237 99,225
have reviewed the protocol;
prepare and submit
completed study for IRB,
EPA, and HSRB Review
Store, file, and maintain
6
15
8
29
2,463
records
Total per response
144
1,865
110
2,119 174,317
Annual Burden:
2,119 hours per response * 7 responses per year = 14,833 hours
Annual Costs:
$174,317 per response * 7 responses per year = $1,220,219
For ICR Table 2
Table 2. Respondent Burden and Cost Estimates – All Other Submitted Research
with Human Subjects
Average Burden Hours Per
Total Per
Response
Response
Activities
Management Technical Clerical
Cost
Hours
$153
$79
$45
($)
Rule familiarization and
1
1
0
2
232
training
Prepare and Submit Ethics
Information of Completed
0
8
1
9
677
Human Studies to EPA
Store, file, and maintain
0
0
1
1
45
records
Total per response
1
9
2
12
954
Annual Burden:
12 hours per study * 10 studies submitted per year = 120 hours
Annual Costs:
$954 per study * 10 studies submitted per year = $9,540

5

Agency Burden Hour Estimates: Technical Staff 1
Table E. Protocol + Completed Study Review
Estimated
Estimated
Number of
Number
Protocols +
of Hours
Study Type
Completed
Per
Reports per
Protocol
year
Review
AHETF
2
160
AEATF
2
160
Repellant Efficacy
2
120
Other Types of Post-Rule
1
120
Intentional Exposure
Studies

Estimated
Number of
Hours Per
Completed
Study
Review
340
300
120
80

Weighted Average Number of Hours per Response
Estimated Annual Number of Responses

Total
Number of
Hours
1000
920
480
200

371 hours
per response
7

Table F. Ethics Reviews for Pre-Rule Completed Studies Not Requiring HSRB
Review
Average Annual Avg. Number of
Annual
Study Type
Number of
Hours Per
Burden Hour
Reviews 2
Review
Estimate
Pre-Rule completed studies
that do NOT measure or
20
4
80 hours
identify a toxic effect

Burden Hour Estimates: Management and Clerical
Management:
•
Assume 3 hours for Protocol Reviews and Completed Study Reviews
•
Assume zero hours for Ethics Reviews for studies not requiring HSRB Review
Clerical
•
Assume 2 hours for Protocol Reviews and Completed Study Reviews
•
Assume 0 hour for Ethics Reviews for studies not requiring HSRB Review

1

Ag handler study estimates based on information from M. Crowley, J. Evans, and B. Sarkar and K.
Sherman (EPA/OPP). Antimicrobial exposure study estimates based on information from T. Leighton and
K. Sherman (EPA/OPP). Insect repellant study estimates based on information from C. Fuentes, K.
Sweeney, and K. Sherman (EPA/OPP). Other study type estimates based on information from K. Sherman.
2
Assumed that 10 of 20 studies are submitted from outside parties and the remaining 10 are located by
EPA at the Agency’s own initiative (and therefore not subject to 40 CFR 26.1303).

6

For ICR Table 3
Table 3. Weighted Average Burden and Cost Estimates for Agency – Research
Involving Intentional Exposure
Average Burden Hours Per
Total Per
Response
Response
Activities
Management Technical Clerical
Cost
Hours
$120
$71
$45
($)
Rule familiarization and
1
2
0
3
262
training
Primary Review of
Scientific and Ethical
3
143
0
143
10,775
Aspects of a Protocol
Primary Review of
Scientific and Ethical
3
229
0
232
16,619
Aspects of a Completed
Study Report
Secondary Review of
Scientific and Ethical
197
4,270*
Aspects of a Protocol
Secondary Review of
Scientific and Ethical
197
4,270*
Aspects of a Completed
Report
Store, file, and maintain
0
0
2
2
90
records
Total per response
7
317
2
774
36,286
* Cost of HSRB members working on the HSRB report (collectively spending 197 hours
per HSRB report in FY 2011, compensated at the rate of $53/hour), plus the cost of EPA
Office of the Science Advisor technical staff working on the HSRB report (30 hours per
report, at the technical staff rate of $79/hour). Each HSRB report covers an average of 3
protocols and/or completed studies per report topics, so each topic costs an average of
$4,270.
Annual Burden:
Annual Costs:

774 hours per response x 7 per year = 5,418 hours
36,286 x 7 responses/year = $254,002

7

For ICR Table 4
Table 4. Weighted Average Burden and Cost Estimates for Agency – Research
Involving Intentional Exposure – All Other Submitted Research with Human
Subjects
Average Burden Hours Per
Total Per
Response
Response
Activities
Management Technical Clerical
Cost
Hours
$120
$71
$45
($)
Rule familiarization and
0
0
0
0
0
training
Primary Review of Ethical
Aspects of a Completed
0
4
0
4
284
Study Report
Store, file, and maintain
0
0
0
0
0
records
Total per response
0
4
0
4
284
Annual Burden:
4 hours per study x 20 per year = 80 hours
Annual Costs:
284 x 20 responses/year = $5,680

For ICR Table 5
Table 5. Total Annual Bottom Line Burden and Costs / Master Table
Collection Activity
Annual Respondent Burden and Costs
Research Involving Intentional
Exposure of Human Subjects (Table 1)
All Other Submitted Research with
Human Subjects (Table 2)
Respondent Total
Annual Agency Burden
Research Involving Intentional
Exposure of Human Subjects (Table 3)
All Other Submitted Research with
Human Subjects (Table 4)
Agency Total

Annual Burden Hours Annual Costs

8

14,833

$1,220,219

120

$9,540

14,953

$1,229,759

5,418

$254,002

80

$5,680

5,498

$259,682

Number of Transactions: September 2012 – August 2015
1.

AHETF Monitoring Program
•
As of March 2012, protocol generation is nearly complete. The AHETF
anticipates perhaps only 1 or 2 more protocols total.
•
There are 5 studies in the field now (protocols approved, research
ongoing)
•
Figures used in ICR: 2 “transactions” per year (2 protocols + 2
completed study reports)

2.

AEATF Monitoring Program
•
Figures used in ICR: 2 “transactions” per year (2 protocols + 2
completed study reports)

3.

Insect Repellent Efficacy Testing
•
Figures used in ICR: 2 “transactions” per year (2 protocols + 2
completed study reports)

4.

Other Post-Rule Studies
•
These could include exposure studies from sources other than the task
forces, ADME studies, skin patch tests of irritation or sensitization,
systemic toxicity tests, or others.
•
All would require submission of a protocol before execution and of a
completed report after execution; both the protocol and the report would
require both EPA and HSRB review.
•
Estimate: 1 protocol and 1 completed study per year. (This is likely an
over-estimate)

5.

Pre-Rule Completed Studies which do not measure or identify a toxic effect
•
These studies do not go to the HSRB, but they do require an EPA ethics
review.
•
Historical level: 20 reviews per year.
•
Assume workload to remain constant over the time period of the ICR
•
Estimate: 20 per year (estimated that 10 studies/year are submitted from
outside parties, and therefore subject to the requirements of 40 CFR
26.1303 requiring submitters to document the ethical conduct; estimated
that 10 studies/year are located by the Agency at its own initiative, and
therefore not subject to 40 CFR 26.1303)

TOTAL RESPONSES PER YEAR:
•
7 intentional exposure human studies (rule familiarization + protocol stage +
completed report stage + records storage)
•
20 studies/year requiring EPA ethics review, but not HSRB review (pre-rule
studies that do not measure or identify a toxic effect)

9