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Supporting Statement for

An Information Collection Request (ICR)

1. IDENTIFICATION OF THE INFORMATION COLLECTION

1(a). Title and Number of the Information Collection

TITLE: Submission of Protocols and Study Reports for Environmental 

Research Involving Human Subjects

OMB Control No. 2070-0169; EPA ICR No. 2195.05

1(b). Short Characterization

The U.S. Environmental Protection Agency (EPA) is responsible for the regulation of 

pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the 

Federal Food, Drug, and Cosmetic Act (FFDCA). As revised in 2006 and 2013, EPA regulations

at 40 CFR Part 26 protect subjects of “third-party” human research (i.e., research that is not 

conducted or supported by EPA.1 In addition to other protections, the regulations require

affected entities to submit information to EPA and an institutional review board (IRB) prior to 

initiating, and to EPA upon the completion of, certain studies that involve human research 

participants. The information collection activity consists of activity-driven reporting and 

recordkeeping requirements for those who intend to conduct research for submission to EPA 

under the pesticide laws. If such research involves intentional dosing of human subjects, these 

individuals (respondents) are required to submit study protocols to EPA and a cognizant local 

Human Subjects IRB before such research is initiated so that the scientific design and ethical 

standards that will be employed during the proposed study may be reviewed and approved. 

Also, respondents are required to submit information about the ethical conduct of completed 

research that involved human subjects when such research is submitted to EPA.

This renewal ICR estimates the third party response burden from complying with the 

requirements in 40 CFR Part 26, as amended in 2006 and 2013. Once approved, this ICR 

renewal would cover the timeframe of September 2016 through August 2019. Information is 

typically submitted by registrants of pesticide products to support the federal registration of their 

products.

2. NEED FOR AND USE OF THE COLLECTION

2(a). Need/Authority for the Collection

The 2006 Appropriations Act, Public Law No. 109-54, required EPA to issue a final rule

addressing third-party intentional dosing human toxicity studies for pesticides, and EPA conduct 

 

1

 To access the revised regulation go to: http://www.gpo.gov/fdsys/pkg/FR-2013-02-14/html/2013-03456.htm
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of intentional dosing human toxicity studies for pesticides (see Attachment B). This ICR applies 

to all of the information collection activities identified in the 2006 rule that EPA promulgated in 

response to the Congressional mandate and which amended 40 CFR Part 26. The 2013 revisions 

do not change information provided in this ICR because the revisions did not result in changes to 

the information collection activities and related burden estimates. EPA’s statutory authority to 

require and collect the information identified already existed under FIFRA and FFDCA.

Sections 3(c)(5), 3(g) and 4(g)(2)(D) of FIFRA generally require EPA to determine that a 

pesticide would not present any “unreasonable adverse effects on the environment”

2 when 

deciding to grant a new or amended pesticide registration or to continue an existing registration. 

Section 4(g)(2)(E) of FIFRA and section 408(b)(2)(A)(ii) of FFDCA generally require EPA to 

determine that there is a reasonable certainty that no harm will result from aggregate exposure to 

the residue of a pesticide chemical, including all anticipated dietary exposures and all other 

exposures for which there is reliable information when making pesticide tolerance decisions. 

FIFRA Section 12(a)(2)(P) forbids any person “to use any pesticide in tests on human beings 

unless such human beings (i) are fully informed of the nature and purposes of the test and of any 

physical and mental health consequences which are reasonably foreseeable from, and (ii) freely 

volunteer to participate in the test.” EPA established this collection of information as part of the 

2006 final rule as authorized under section 25 of FIFRA and section 408(e)(1)(C) of FFDCA to:

(1) ensure that sound and appropriate scientific data are available to EPA when 

making regulatory decisions about pesticides as described in the previous 

paragraph; and,

(2) protect the interests, rights and safety of human research subjects, as required 

under FIFRA section 12(a)(2)(P).

Sections 3(c)(5), 3(g), 4(g)(2), and 25 of FIFRA and sections 408(b)(2)(A)(ii) and 

408(e)(1)(C) of FFDCA are included as Supporting Statement attachments C and D, 

respectively. 

2(b). Practical Utility/Users of the Data

In order to ensure the availability of sound and appropriate scientific data in its decisions, 

and to protect the interests, rights and safety of human research subjects, in 2006 EPA extended

the requirements of the Agency’s 1991 Common Rule, 40 CFR Part 26, prospectively to thirdparty research intended for submission to EPA under the pesticide laws and involving intentional 

exposure of non-pregnant, non-nursing adult human subjects. The information provided allows 

EPA and the Human Studies Review Board (HSRB) to review protocols and related information 

before covered research involving human subjects is initiated, but after it has been reviewed and 

approved by a local IRB. In addition, anyone who submits to EPA a report of research with 

human subjects must submit concurrently documentation of the ethical conduct of the research. 

 

2 Defined in FIFRA section 2(bb) as “. . . (1) any unreasonable risk to man or the environment, taking into 

account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human 

dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard 

under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) . . .”
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This information collection activity allows EPA to ensure all human subjects in research 

conducted by EPA (first party), conducted by entities with support from EPA (second parties), or 

conducted by third parties with the intention to submit it to EPA, are treated ethically.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION 

CRITERIA

3(a). Non duplication

The information requirements identified in the regulations at 40 CFR part 26 do not 

duplicate other federal agency information collections. Other federal agencies have adopted the 

Common Rule and FDA has established requirements similar to those in the Common Rule for 

third-party researchers who perform human testing intended for submission to FDA. None of 

those requirements, however, apply to third-party research that is intended for submission to 

EPA.

3(b). Public Notice Required Prior to ICR submission to OMB

Pursuant to 5 CFR 1320.8(d), EPA is publishing a Federal Register (FR) Notice soliciting 

comment on this information collection activity and the Agency’s intent to renew the OMB 

approval of this ICR. The FR Notice and the proposed renewal ICR as well as any public 

comments are located in the docket for this action, which can be accessed at:

http://www.regulations.gov using the docket ID number EPA-HQ-OPP-2011-0704. 

3(c). Consultations

Under 5 CFR 1320.8(d)(1), agencies are required to consult with potential ICR 

respondents and data users about specific aspects of ICR’s before submitting an original or 

renewal ICR to OMB for review and approval. During the development of this ICR, EPA staff 

will contact appropriate stakeholders and ask them for their assessment of the regulatory burden 

estimates expressed by the Agency in this ICR. A summary of these consultations will be 

provided in the supporting statement during the second comment period. 

3(d). Effects of Less Frequent Collection

Not applicable. This is an event-driven information collection activity and is conducted 

only as information is submitted to EPA for consideration. As such there is no set collection 

frequency for the collection of this information.

3(e). General Guidelines

The only guideline established under the Paperwork Reduction Act (PRA) that may be 

exceeded in this collection is the time period for retaining records. EPA’s requirement at 40 

CFR 169.2(k) states that records containing research data relating to registered pesticides be 

retained for as long as the registration is valid and the producer remains in business. 

Registrations are valid until they are either voluntarily canceled or withdrawn by the registrant or 
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until EPA has cause to suspend or cancel the registration. Since the average period of 

marketability of a pesticide ranges from 15 to 30 years, the PRA guidelines specifying that data 

other than health, medical or tax records not be required to be retained for more than three years 

will be exceeded in this collection activity. This is an existing requirement that was not changed 

by the 2006 final rule. In any case, the recordkeeping requirement merely codifies the usual and 

customary business practices of IRBs and third-party researchers; therefore no burden is 

attributed to the activity.

OMB regulations require agencies to provide a statement indicating whether the

collection of information involves the use of automated, electronic, mechanical, or other 

technological collection techniques or other forms of information technology, e.g., permitting 

electronic submission of responses, and an explanation of the decision (5 CFR 1320.5(a)(iii)(E)). 

Respondents who submit study protocols and/or reports to EPA may elect to submit 

certain eligible information electronically. OPP launched the Pesticide Submission Portal (PSP) 

to leverage the Agency’s Central Data Exchange (CDX) platform and allow pesticide registrants 

to submit a wide variety of regulatory actions to EPA electronically, forgoing the need to submit 

either paper or CDs/DVDs. The type of eligible information and regulatory actions that can be 

submitted via the PSP is explained on EPA’s website. The PSP is a critical step in achieving the 

vision of a fully electronic work environment. If registrants want to submit paper copies of study

data to EPA or CDs, they can still do so. EPA believes that the promotion and facilitation of the 

electronic submission option will make its pesticide regulation operations more efficient. This 

option can increase the efficiency of operations such as the delivery, review, data interchange 

capability, and archiving of data supporting national pesticide registration. The Agency expects 

that registrants will spend less time and money preparing copies and sending their submissions 

using the electronic submission option, and stand to benefit from the efficiencies that EPA 

expects to experience during data reviews.

3(f). Confidentiality

EPA has implemented procedures to protect any confidential, trade secret or proprietary

information from disclosure that provide strict instructions regarding access to and contact with 

documents confidential business information (CBI). These procedures comply with EPA’s CBI 

regulations at 40 CFR Part 2, Subpart B.

3(g). Sensitive Questions

This information collection activity complies with the provisions of the Privacy Act of 

1974 and OMB Circular A-108. No information of a sensitive or private nature is requested in 

conjunction with this information collection activity. The protection of human research subjects’ 

privacy is a basic, long-standing principle within the scientific community. Reports of human 

research submitted to federal agencies should not identify subjects by name, or include 

recognizable photographs, or otherwise identify them. On the rare occasion that the Agency

receives identifying information, such information will be treated as confidential and not 

released to third parties unless required by law.
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4. THE RESPONDENTS AND THE INFORMATION REQUESTE

4(a). Respondents/NAICS Codes

This collection of information applies to any entity that submits to EPA protocols and 

study reports for environmental research involving human subjects under FIFRA and/or FFDCA. 

Although EPA has only received such third-party research in conjunction with FIFRA from 

pesticide registrants, it is conceivable that other entities could submit such information to EPA 

under FIFRA and/or FFDCA in the future. The North American Industrial Classification System 

(NAICS) code for the principal respondents to this ICR is 541710 (Research and Development in 

the Physical, Engineering, Life Sciences).

4(b). Information Requested

(i) Data items, including record keeping requirements

The regulation sets forth those additional information activities that are necessary to 

ensure the protection of human subjects of research when such research is submitted to EPA for 

consideration under FIFRA and/or FFDCA.

(ii) Respondent Activities

The following information activities are required:

 Rule Familiarization and Training - read, and understand what data are to be submitted 

and understand the protocols must be developed to comply with the Common Rule.

 Submit Protocol to an IRB and EPA – Prepare and submit a proposal for test protocol to 

IRB for review. After approval by the IRB, submit the proposal and related 

documentation, including a record of the IRB approval, to EPA.

 Prepare and Submit Ethics Information for EPA Review - once a study is conducted, 

compile applicable records to document ethical conduct of the research.

 Store, File and Maintain Information – ensure that research information is placed in 

central records as required by FIFRA and consistent with section 3(e) of this ICR.

5. THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION 

METHODOLOGY, AND INFORMATION MANAGEMENT

5(a). Agency Activities

EPA’s information-related activities associated with this collection consist of the 

following:
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 Conduct Prior Review on Study Protocol – review and comment on study protocol, 

document comments/review.

 Review Ethical Aspect of a Protocol and Study Report – make formal EPA determination 

on usefulness and ethical aspects of the study.

 Record and Report Information – Document any formal decisions made.

 Store, File and Maintain Information – compile information into appropriate databases 

and archive. 

5(b). Collection Methodology and Management

EPA’s Office of Pesticide Programs (OPP) completed a major review of its information 

tracking systems to improve their efficiency and accuracy. This review resulted in improvements 

to the information system, which will improve the quality of the Agency's databases and allows 

the EPA to respond more timely and accurately to queries from registrants and the public, 

including requests made under the FOIA.

OPP also investigated the possibility of providing optional electronic data transfer 

services to the industry as a means of minimizing the burden of registration activities. The

Agency's pesticide program, along with the pesticide industry, recognizes the advantages in 

terms of accuracy, speed, cost and personnel from electronic data transfer technologies. In 

addition, OPP consulted with industry associations and other federal agencies, and participated in 

an Agency-wide workgroup to develop electronic reporting standards intended to facilitate 

collection of information from industry. 

OPP does not publish any studies submitted. However, it maintains records of each study

in the Office of Pesticide Programs Information Network (OPPIN), and provides public access to 

OPPIN bibliographies through the National Pesticides Information Retrieval System (NPIRS). 

NPIRS supports searches for technical documents submitted to EPA by registrants. Information 

is categorized by chemical, subject, submission date, laboratory, guideline number, and 

document type. The public may request copies of studies that are non-confidential by submitting 

a Freedom of Information Act (FOIA) request

5(c). Small Entity Flexibility

Although the Agency cannot predict whether or how many small entities might engage in 

the subject matter research, the burden and related cost for researchers to comply with these 

information collection activities is estimated to be a comparatively small portion of the overall 

cost of performing such studies. After reviewing the history of EPA’s consideration on human 

research in its various program offices, EPA estimates that only a limited number of third-party

human studies will be impacted by these activities each year. Because both the number of 

affected studies is relatively small and the estimated current costs of compliance with the 

Common Rule are low, the potential overall burden and costs from these activities to third parties 

are also estimated to be small, regardless of their size. As a result, EPA has not provided any
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special flexibility for small entities.

5(d). Collection Schedule

A periodic collection schedule is not appropriate for the information collection activity. 

The information collection activity is initiated by the respondents and therefore EPA expects that 

respondents will engage in the activities described in this ICR only once, whenever developing 

and performing a given research study that involves human subjects as governed by EPA’s 

regulations.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

The activities imposed by the rule consist of reporting and record-keeping requirements. 

Respondents’ activities are detailed in Section 4(b)(ii) of this ICR. The burden and cost 

estimates for this renewal ICR were calculated using recent data on submissions of human 

research and weighted averages of time estimates provided by respondents during the last 

consultation period. Section 6(a) of this ICR explains the methodology used to calculate the 

respondent burden, and burden and cost estimates are listed in Tables 1, 2 and 5. EPA’s burden 

estimates and methodology are detailed in Section 6(c). 

6(a). Estimating Respondent Burden

EPA is estimating only the incremental burden imposed upon respondents for compliance 

with the paperwork requirements established in the 2006 final rule. EPA is neither estimating, 

de novo, the estimated paperwork burden for compliance with the 1991 Common Rule in this 

ICR nor the paperwork burden associated with the generation of certain study data that is already

covered by other ICRs, such as those requested by EPA in a Data Call-In under FIFRA section 

3(c)(2)(B). EPA does assume that IRBs are already in compliance with the 1991 Common Rule 

requirements and therefore believes that there is no additional burden imposed upon IRBs for 

compliance with the paperwork requirements established in the 2006 final rule and discussed in 

this document.

Over the three-year period covered by this ICR renewal (September 2016 through August 

2019), based on historical data analysis, EPA estimates that respondents will submit to OPP an 

average of 5 pesticide protocols and 5 completed studies per year under FIFRA and/or FFDCA 

that will involve intentional exposure of human subjects. (Some years may involve a higher 

number of submissions, while other years may involve lower numbers depending on the timing 

of when studies must be completed.) Based on past experience, EPA also expects to receive 

other types of pesticide research involving human subjects; an average of 10 of these types of 

studies may be submitted annually. While EPA assumes that researchers conducting these 

studies would already be required to comply with the 1991 Common Rule requirements, they

will be subject to some additional paperwork requirements under EPA’s amendments. 

Therefore, EPA is estimating only the burden and costs associated with the paperwork activities 

that are described in the 2006 final rule.
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Respondent activities that are within the scope of this ICR include: preparing and 

submitting protocols, supporting documents, and completed study reports for IRB, EPA, and 

HSRB review; communicating with IRB and EPA staff regarding required changes to a protocol; 

communicating with EPA about HSRB recommendations; and documenting protocol changes 

made at the recommendation of an IRB, EPA, or the HSRB. Activities which are unrelated to 

the paperwork and recordkeeping requirements of the 2006 final rule, such as the costs of 

conducting the research, are not incremental paperwork or recordkeeping costs and therefore are 

not within the scope of this ICR.

To account for the fact that some study types are more complex than others and 

differences in the preparation of protocols versus completed studies, EPA calculated a weighted 

average of the time estimates for each activity using information provided during the last 

consultation with respondents. As necessary and appropriate, these estimates will be updated 

based on information to be received during the consultation process which will occur concurrent 

with the review period for this draft ICR. 

As shown in Tables 1 and 2, the total annual estimated burden associated with all 

submitted pesticide research that involves intentional exposure of human subjects is 10,595 

hours, and the annual estimated burden for all other pesticide research that involves human 

subjects is 120 hours. Therefore the total annual respondent burden for this information 

collection activity is estimated to be 10,715 hours.
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Table 1. Weighted average burden and cost estimates for respondents for research 

involving intentional exposure of human subjects

Activities Average Burden Hours Per 

Response Total Per Response

Management

$168/hr

Technical

$87/hr

Clerical

$50/hr Hours Cost ($)

Rule familiarization and 

training 4 4 4 12 1,220

Prepare and submit protocol 

for IRB review 17 175 30 222 19,581

Prepare and submit protocol 

for EPA and HSRB review 82 501 36 619 59,163

Document ethical conduct of a 

completed study for which 

EPA and the HSRB have 

reviewed the protocol; prepare 

and submit completed study 

for IRB, EPA, and HSRB 

review

35 1,170 32 1,237 109,270

Store, file, and maintain 

records 6 15 8 29 2,713

Total per response 144 1,865 110 2,119 191,947

Annual Burden: 2,119 hours per response * 5 responses per year = 10,595 hours

Annual Costs: $191,947 per response * 5 responses per year = $959,735

Please note that the 5 “responses” per year include 5 protocols plus 5 studies. This approach is 

consistent with that used previously for this ICR.

Table 2. Respondent burden and cost estimates for all other submitted research with human 

subjects

Activities Average Burden Hours Per Response Total Per 

Response

Management

$168/hr

Technical

$87/hr

Clerical

$50/hr Hours Cost ($)

Rule familiarization and 

training 1 1 0 2 255

Prepare and submit ethics 

information of completed 

human studies to EPA

0 8 1 9 746

Store, file, and maintain 

records 0 0 1 1 50
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Total per response 1 9 2 12 1051

Annual Burden: 12 hours per study * 10 studies submitted per year = 120 hours

Annual Costs: $1051 per study * 10 studies submitted per year = $10,510

6(b). Estimating Respondent Costs

The estimated annual cost for all respondents is $970,245. Respondent labor rates are 

estimated to be $168, $87, and $50 per hour, respectively, for managerial, technical and clerical 

labor. In determining the rates, OPP uses a single source of data, the Bureau of Labor Statistics’ 

(BLS) National Industry-Specific Occupational Employment and Wage Estimates, and selects 

the appropriate occupational category. The labor rates were derived from the Bureau of Labor 

Statistics’ May 2014 National Industry-Specific Occupational Employment and Wage Estimates 

for NAICS code 541710 (Research and Development in the Physical, Engineering, and Life 

Sciences).

3

 These labor rates are fully loaded and include benefits and overhead costs (see 

Attachment E).

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. 

6(c). Estimating Agency Burden and Cost

The estimated Agency annual cost is $244,850. EPA activities include: communicating 

with respondents, reviewing the ethical aspects of submitted study protocols and completed 

study reports, making presentations to the HSRB, documenting decisions, and information 

management activities to record, file, and track the submissions. Agency labor rates are $124, 

$82, and $46 per hour for management, technical, and clerical staff, respectively. The labor rates 

were derived from the Bureau of Labor Statistics’ May 2014 National Industry-Specific 

Occupational Employment and Wage Estimates for NAICS code 999100 (Federal Executive 

Branch).

4

 These labor rates are fully loaded and include benefits and overhead costs (see 

Attachment F). The details of the calculations are identified in Tables 3 and 4 in this section. For 

the pre-rule human research which does not require HSRB review, EPA assumes that 10 of the 

studies will be submitted by outside parties and the remaining 10 will be located by EPA at the 

 

3 Bureau of Labor Statistics. “May 2014 National Industry-Specific Occupational Employment and Wage 

Estimates: 541710 – Research and Development in the Physical, Engineering, and Life Sciences.” Accessed at 

http://www.bls.gov/oes/current/naics5_541710.htm.

4

Bureau of Labor Statistics. “May 2014 National Industry-Specific Occupational Employment and Wage 

Estimates: NAICS 999100 – Federal Executive Branch.” Accessed at 

http://www.bls.gov/oes/current/naics4_999100.htm.
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Agency’s own initiative and therefore will not be subject to 40 CFR 26.1303.

Table 3. Weighted average Agency burden and cost estimates for research involving 

intentional exposure

Activities

Average Burden Hours Per Response Total Per 

Response

Management

$124/hr

Technical

$82/hr

Clerical

$46/hr Hours Cost ($)

Rule familiarization and 

training 1 2 0 3 288

Primary Review of Scientific 

and Ethical Aspects of a 

Protocol

3 210 0 213 17,592

Primary Review of Scientific 

and Ethical Aspects of a 

Completed Study Report

3 235 0 238 19,642

Secondary Review of 

Scientific and Ethical 

Aspects of a Protocol

197 4,694*

Secondary Review of 

Scientific and Ethical 

Aspects of a Completed 

Report

197 4,694*

Store, file, and maintain 

records 0 0 2 2 92

Total per response 7 841 2 850 47,002

* HSRB members are special government employees; their time should be reflected as part of 

Agency burden. Cost of HSRB members working on the HSRB report (collectively spending 197 

hours per HSRB report in FY 2011, compensated at the 2014 rate of $59/hour), plus the cost of 

EPA Office of the Science Advisor (OSA) technical staff working on the HSRB report (30 hours 

per report, at the technical staff rate of $82/hour). Each HSRB report covers an average of 3 

protocols and/or completed studies per report, so each topic costs an average of $4,694.

Annual Burden: 850 hours per response x 5 per year = 4,250 hours plus 30 for OSA review of 

HSRB report = 4,280 hours

Annual Costs: 47,002 x 5 responses/year = $235,010

Please note that the 5 “responses” per year include 5 protocols plus 5 studies. This approach is 

consistent with that used previously for this ICR.
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Table 4. Weighted Average Agency Burden and Cost Estimates – Research Involving 

Intentional Exposure – All Other Submitted Research with Human Subjects

Activities

Average Burden Hours Per Response Total Per 

Response

Management

$124/hr

Technical

$82/hr

Clerical

$46/hr Hours Cost ($)

Rule familiarization and 

training 0 0 0 0 0

Primary Review of Ethical 

Aspects of a Completed Study 

Report

0 6 0 6 492

Store, file, and maintain 

records 0 0 0 0 0

Total per response 0 6 0 6 492

Annual Burden: 6 hours per study x 20 per year = 120 hours

Annual Costs: 492 x 20 responses/year = $9,840

Please note that, as discussed in section 6(c), for the pre-rule human research which does not require 

HSRB review, EPA assumes that 10 of the 20 studies will be located at the Agency’s own initiative 

and therefore will not be subject to 40 CFR 26.1303. This approach is consistent with that used 

previously for this ICR.

6(d). Bottom Line Burden Hours and Cost Tables

The total estimate represents the information collection activities expected to occur 

annually over the next three years. Table 5 provides the total estimated annual burden and costs 

for respondents, as well as the total estimated annual burden and costs for the Agency:

Table 5. Total Annual Bottom Line Burden and Costs/Master Table

Collection Activity Annual Burden Hours Annual Costs

Annual Respondent Burden and Costs

Research Involving Intentional Exposure of 

Human Subjects (Table 1) 10,595 $959,735

All Other Submitted Research with Human 

Subjects (Table 2) 120 $10,510

Respondent Total 10,715 $970,245

Annual Agency Burden

Research Involving Intentional Exposure of 

Human Subjects (Table 3) 4,280 $235,010

All Other Submitted Research with 

Human Subjects (Table 4) 120 $9,840

Agency Total 4,400 $244,850
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6(e). Reasons for Change in Burden

The total annual estimated respondent burden is expected to decrease by 4,238 hours 

from 14,953 hours for the currently approved ICR to 10,715 hours for this renewal ICR. This 

change is due to a potential decrease in the overall number of responses per year over the three 

year period covered by the ICR renewal (namely September 2016 through August 2019). The 

anticipated number of responses per year is based on submissions to the Agency in the recent 

past, and recognition that some of the studies underway will be submitted prior to the start of the 

ICR renewal period; weighted average time estimates obtained during the last consultation 

process from entities that have submitted human subject research since the implementation of the 

rule were also taken into account in the preparation of this ICR. During the comment period for 

this ICR, the Agency will consult with respondents who intend to submit human research in the 

future and have submitted studies in the past; if new information is obtained by EPA during the 

consultation process, the Agency will update its burden calculations and supporting statement as 

appropriate prior to finalizing the ICR. The overall estimated annual Agency burden is expected 

to decrease slightly due to the number of responses which we expect to receive during the 

timeframe for this ICR renewal.

6(f). Burden Statement

The total estimated annual paperwork burden for respondents to comply with this 

information collection activity is 10,715 hours. The annual burden per activity is estimated to be 

2,119 hours per response for research involving intentional exposure of human subjects, and 12 

hours per response for all other submitted research with human subjects. 

In the context of the PRA, “burden” is defined at 5 CFR 1320.3(b). The agency may not 

conduct or sponsor, and a person is not required to respond to, a collection of information unless 

it displays a currently valid OMB control number. The OMB control number for this 

information collection appears at the beginning and end of this document. 

The Agency has established a docket for this ICR under Docket ID No. EPA-HQ-OPP2015-0713, which is available at http://www.regulations.gov, or in person viewing at the OPP 

Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., 

NW, Washington, DC. This docket facility is open from 8 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays. The telephone number for the reading room is 202-566-1744, 

and the docket telephone number is 703-305-5805. 

You may submit comments regarding the Agency's need for this information, the 

accuracy of the provided burden estimates and any suggested methods for minimizing 

respondent burden, including the use of automated collection techniques. Submit your 

comments, referencing Docket ID No. EPA-HQ-OPP-2015-0713 and OMB Control No. 2070-

0169, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: EPA 

Docket Center, Environmental Protection Agency, Office of Pesticide Programs (OPP) 

Regulatory Public Docket (7502P), 1200 Pennsylvania Ave., NW, Washington, DC 20460, and 

(2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and 

Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.
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ATTACHMENTS TO THE SUPPORTING STATEMENT:

Attachments to the supporting statement are available in the public docket established for this 

ICR under docket identification number EPA-HQ-OPP-2015-0713. These attachments are 

available for online viewing at http://www.regulations.gov or otherwise accessed as described in 

section 6(f) of the supporting statement, and as noted below.

Attachment A: Final Rule - 2006 Amendment of 40 Part 26; Protections for Test Subjects 

in Human Research

Attachment B: Appropriations Act, 2006, Pub. L. No. 109-54

Attachment C: FIFRA Sections 3(c)(5), 3(g), 4(g)(2), and 25

Attachment D: FFDCA Sections 408(b)(2)(A)(ii) and 408(e)(1)(C)

Attachment E: Estimated Wage Rates for Pesticide Registrants Using BLS NAICS 

541710

Attachment F: Standard Wages for the Federal Government Using BLS NAICS 999100

Attachment G: Display Related to OMB Control #2070-0169 -Listings of Related 

Regulations in 40 CFR 9.1