Document ID: EPA-HQ-OPP-2008-0414-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-12-12T05:00Z

Supporting Statement for

An Information Collection Request (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title of the Information Collection

Submission of Protocols and Study Reports for Environmental Research
Involving Human Subjects

OMB No. 2070-0169   	EPA No. 2195.03

1(b)	Short Characterization/Abstract

	The Environmental Protection Agency (EPA or the Agency) 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).  In January 2006, EPA issued a final rule to amend
the Federal Policy for the Protection of Human Subjects (also known as
the Common Rule) at 40 CFR part 26.  EPA’s January 2006 final rule
significantly strengthens and expands the protections for subjects of
“third-party” human research (i.e., research that is not conducted
or supported by EPA).  In addition to other protections, the final rule
requires 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 imposed by this final
rule consists of activity-driven reporting and recordkeeping
requirements for those who intend to conduct research for submission to
EPA under the pesticide laws.  If such research involves intentional
dosing of human subjects, these individuals (respondents) are required
to submit study protocols to EPA and a cognizant local Human Subjects
IRB before such research is initiated so that the scientific design and
ethical standards that will be employed during the proposed study may be
reviewed and approved.  Also, respondents are required to submit
information about the ethical conduct of completed research that
involved human subjects when such research is submitted to EPA.

This renewal ICR estimates the third party response burden from
complying with the January 2006 final rule requirements. Information is
typically submitted by registrants of pesticide products to support the
registration of their products. It is estimated that the annual response
burden is approximately 20,572 hours valued at about $1,579,098.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

The 2006 Appropriations Act, Pub. L. No. 109-54, required EPA to issue a
final rule (Attachment C) addressing third-party intentional dosing
human toxicity studies for pesticides, and EPA conduct of intentional
dosing human toxicity studies for pesticides.  This ICR applies to all
of the information collection activities identified in the final rule
EPA promulgated in response to the Congressional mandate.  EPA’s
statutory authority to require and collect information identified in the
final rule 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” 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   SEQ CHAPTER \h \r 1 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 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 A and B, 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, EPA extended the requirements of the
Agency’s Common Rule, 40 CFR Part 26, prospectively to third-party
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   SEQ CHAPTER \h \r 1 EPA to
review protocols and related information before research involving human
subjects is initiated, 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.  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 final rule 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), in preparing to renew this ICR, EPA
published a notice in the Federal Register which provided a 60-day
public notice and comment period on the draft ICR (see 73 FR 33811; June
13, 2008).  The FR notice and the proposed renewal ICR as well as the
public comments received are located in the docket for this action,
which can be accessed at   HYPERLINK "http://www.regulations.gov" 
http://www.regulations.gov  using the docket identifier
EPA-HQ-OPP-2008-0414.

The Agency received two public comments on this renewal ICR, from the
Agricultural Handler Exposure Task Force (AHETF) and Antimicrobial
Exposure Assessment Task Force II (AEATF).  These task forces also
responded to questions from the Agency, as two of five participants in
the consultation process with respondents to this ICR (see section 3(c),
below).  Both task forces’ comments and consultation responses focused
primarily on the burdens and costs associated with the human subjects
research requirements at 40 CFR part 26 and the input they provided in
their public comments was essentially the same as that included in the
consultation responses. In particular, both task forces commented that
the actual burden and costs associated with complying with the rule
substantially exceed the estimates contained in the proposed ICR. 
Copies of the comments may be accessed at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  using the
docket identifier EPA-HQ-OPP-2008-0414.

Based on the comments received, as well as the consultation responses
and EPA’s experience since the enactment of 40 CFR part 26, the Agency
acknowledges that the burden and cost estimates in the original ICR are
lower than actual costs.  Therefore, this renewal ICR contains revised
burden and cost estimates that are drawn from the five consultation
responses and the public comments.  For an explanation of the
methodology, data, and assumptions used to calculate the revised
estimated respondent burdens and costs (see Attachment G).

3(c)	Consultations

		During preparation of this ICR renewal, EPA staff contacted the
following respondent representatives to seek feedback on the burden
estimates in the ICR and the clarity of guidance provided.  

David Johnson

Agricultural Handlers Exposure Task Force

1720 Prospect Drive, Macon, MO 63552

E-mail: davejohn@marktwain.net

Tel. No.:  660-395-9590

	Scott Carroll

Carroll-Loye Biological Research

711 Oak Avenue, Davis, CA 95616

E-mail:   spcarroll@ucdavis.edu

Tel. No.:   530-297-6080

Hasmukh Shah

Antimicrobial Exposure Assessment Task Force II;  

1300 Wilson Boulevard, Arlington, VA 22209

E-mail: Has_Shah@americanchemistry.com 

Tel. No.:   703-741-5637	

Robin Todd

ICR, Inc.

1330 Dillon Heights Avenue, Baltimore, MD 21228

E-mail:   rtodd@icrlab.com

Tel. No.:  410-747-4500

 

Joel Panara

Grayson Research LLC

1040 Grayson Farm Rd, Creedmoor, NC , 27522

E-mail:   jpanara@graysonfarm.com

Tel. No.:   919-528-4925

Full copies of the respondents’ responses to EPA’s consultation
efforts are contained in Attachment D, which may be accessed at  
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov 
using the docket identifier EPA-HQ-OPP-2008-0414.

		All five of the parties consulted agreed that the respondent burden
and cost estimates included in the proposed ICR renewal were
considerably lower than the actual paperwork burden and costs associated
with complying with the rule.  As stated above, in section 3(b), this
renewal ICR contains revised burden and cost estimates that are drawn
from the five consultation responses and the public comments.  For an
explanation of the methodology, data, and assumptions used to calculate
the revised estimated respondent burdens and costs (see Attachment G). 
Additionally, the parties consulted stated that the data collected is
not available from another source and the frequency of collection could
not be reduced and still produce the same outcome.  The consultation
participants explained that the instructions to respondents on what to
submit and how to submit it are not entirely clear.  Some consulted said
that the Agency’s draft guidance has helped, but that once the
procedure is fully refined EPA should provide final guidance.  The
Agency is considering the need to issue further guidance.

3(d)	Effects of Less Frequent Collection

  SEQ CHAPTER \h \r 1 	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

		  SEQ CHAPTER \h \r 1 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 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 final rule.  In any
case, EPA asserts that recordkeeping requirement merely codifies the
usual and customary business practices of IRBs and third-party
researchers; therefore no burden is attributed to the activity. 

  SEQ CHAPTER \h \r 1 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)).  EPA is not   SEQ CHAPTER \h \r 1 offering a fully
electronic submission option at this time.  EPA is developing an
internet portal that would adequately secure any confidential and/or
sensitive information submitted electronically; however, EPA is not yet
ready to accept such information in this way.

		Respondents that submit study protocols and/or reports to EPA may
elect to submit certain information  SEQ CHAPTER \h \r 1 
“electronically” via compact disc.  Ordinarily, registrants would be
required to submit 3 paper copies of study data to EPA.  Under this
hybrid option, registrants need only submit 2 paper copies if they
submit the required study data in Adobe Acrobat Portable Document Format
(PDF) on a compact disc.  Once EPA staff have become familiar with the
electronic submission process and the technology, OPP believes that this
option will allow the Agency to achieve operating efficiencies in the
regulation of pesticides through the promotion and facilitation of the
electronic submission process, including the delivery, review, data
interchange capability and archiving of data supporting national
pesticide registration.    SEQ CHAPTER \h \r 1 OPP expects that
registrants will spend less time and money preparing copies and sending
their submissions using the hybrid paper-electronic submission option,
and stand to benefit from the efficiencies that EPA expects to
experience during data reviews.

3(f)		Confidentiality

		  SEQ CHAPTER \h \r 1 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. 

4. 		THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents/NAICS Codes

		This collection of information applies to any entity that submits
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.    SEQ
CHAPTER \h \r 1 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

Data items, including record keeping requirements

		The final rule 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. 

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:

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

  SEQ CHAPTER \h \r 1 	OPP completed a major review of its information
tracking systems to improve their efficiency and accuracy. This review
resulted in the development of a new integrated information system,
which, when complete, 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 is also investigating 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 is consulting with industry
associations and other federal agencies, and participating in an
Agency-wide workgroup to develop electronic reporting standards intended
to facilitate collection of information from industry. 

		OPP does not publish the 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 of the PDMS database by chemical, subject,
submission date, laboratory, guideline number, and document type, and
the public may request copies of studies that are non-confidential by
submitting a 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 special flexibility for small entities.

5(d)	Collection Schedule

		A   SEQ CHAPTER \h \r 1 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

6(a)	Estimating Respondent Burden

		EPA is estimating only the incremental burden imposed upon respondents
for compliance with the paperwork requirements established in the 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
final rule and discussed in this document.

		Based upon responses received to the Agency’s consultation
questions, as well as historical data, EPA anticipates that respondents
will submit to OPP an average of 34 pesticide research studies per year
under FIFRA and/or FFDCA that will involve intentional exposure of human
subjects.  EPA also expects to receive other types of pesticide research
involving human subjects; an average of 20 studies 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 final
rule.

		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 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.

	The consultation responses indicated that EPA’s previous estimates
significantly underestimated the actual burden and costs.  Thus, to
calculate new burden and cost estimates for this renewal ICR, EPA relied
upon the figures provided in the five consultation responses.  Two of
the five participants in the consultation process were also the two
parties that submitted comments during the public comment period; the
input they provided in their public comments was essentially the same as
that included in the consultation responses.  EPA calculated a weighted
average of the estimates contained in each of the responses, to account
for the fact that some study types are more complex than others.  See
Attachment G for an explanation of the methodology, data, and
assumptions used to calculate the revised estimated respondent burdens
and costs used in this ICR renewal.

As shown in Tables 1 and 2, the total annual estimated burden associated
with this information collection activity is 20,332 hours for all
submitted pesticide research that involves intentional exposure of human
subjects, and 240 hours for all other pesticide research that involves
human subjects.  Therefore the total annual burden for this information
collection activity is estimated to be 20,572 hours.

Table 1. Respondent Burden and Cost Estimates – Research Involving
Intentional Exposure of Human Subjects

Activities	Average Burden Hours Per Response	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Rule familiarization and training	2	4	2	8	652

Prepare and submit protocol for IRB review	31	83	33	147	11,723

Prepare and submit protocol for EPA and HSRB review	25	181	37	243	18,217

Document ethical conduct of a completed study for which EPA and the HSRB
have reviewed the protocol	19	113	21	153	11,753

Document ethical conduct of a pre-rule study for which EPA and the HSRB
have not reviewed the protocol	5	16	8	29	2,194

Store, file, and maintain records	4	8	6	18	1,388

Total per response	86	405	107	598	45,927

Annual Burden:	598 hours per protocol or completed study * 34 protocols
or 				completed studies per year = 20,332 hours

Annual Costs:		$45,927 per study * 34 protocols or completed studies per
year = 				$1,561,518

Table 2. Respondent Burden and Cost Estimates – All Other Submitted
Research with Human Subjects

Activities	Average Burden Hours Per Response	Total Per Response

	Management

$138	Technical

$73	Clerical

$42	Hours	Cost ($)

Rule familiarization and training	1	1	0	2	211

Prepare and Submit Ethics Information of Completed Human Studies to EPA
0	8	1	9	626

Store, file, and maintain records	0	0	1	1	42

Total per response	1	9	2	12	879

Annual Burden:	12 hours per study * 20 studies submitted per year = 240
hours

Annual Costs:		$879 per study * 20 studies submitted per year = $17,580

6(b)	Estimating Respondent Costs

The estimated annual cost for all respondents is $1,579,098.  Respondent
labor rates are estimated to be $138, $73, and $42 per hour,
respectively, for managerial, technical and clerical labor.  These labor
rates were derived from the Bureau of Labor Statistics’ May 2007
National Industry-Specific Occupational Employment and Wage Estimates
for NAICS code 541710 (Research and Development in the Physical,
Engineering, and Life Sciences).  These labor rates are fully loaded and
include benefits and overhead costs, using a methodology developed by
OPP’s Biological and Economic Analysis Division (see Attachment E).

6(c)	Estimating Agency Burden and Cost

The estimated Agency annual cost is $636,060.  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.    SEQ
CHAPTER \h \r 1 Agency labor rates are $103, $71, and $41 per hour for
management, technical, and clerical staff, respectively.  These labor
rates were derived from the Bureau of Labor Statistics’ May 2007
National Industry-Specific Occupational Employment and Wage Estimates
for NAICS code 999100 (Federal Executive Branch).  These labor rates are
fully loaded and include benefits and overhead costs, using a
methodology developed by OPP’s Biological and Economic Analysis
Division (see Attachment E).

 The details of the calculations are identified in Tables 3 and 4.

Table 3. Agency Burden & Cost Estimates – Review of Research Involving
Intentional Exposure of Human Subjects 

Activities	Average Burden Hours Per Response	Total Per Response

	Management

$103	Technical

$71	Clerical

$41	Hours	Cost ($)

Rule familiarization and training	2	2	0	4	348

Primary Review of Scientific and Ethical Aspects of a Protocol	1	113	0
114	8,126

Primary Review of Ethical Aspects of a Completed Study Report	1	57	0	58
4,150

Secondary Review of Scientific and Ethical Aspects of a Protocol or
Review of Ethical Aspects of a Completed Study

4,144*

Store, file, and maintain records	0	0	2	2	82

Total per protocol or completed study	4	172	2	178	16,850

Cost of HSRB members working on the HSRB report (collectively spending
240 hours per HSRB report in FY 2008, compensated at the rate of
$53/hour), plus the cost of EPA Office of the Science Advisor technical
staff working on the HSRB report (171 hours per report, at the technical
staff rate of $71/hour).  Each HSRB report covers an average of 6
protocols and/or completed studies per report.

240 hours/HSRB Members/report * $53/hour = $12,720/report

171 hours/OSA Staff/report*$71/hour = $12,141/report

Total Cost for HSRB Member and OSA Staff Review Time Per Report =
$12,720 + $12,141 = $24,861

If 1 report = 6 protocols

Total Cost for HSRB Member and OSA Staff Review Time Per Protocol =
$24,861/6 = $4,144/protocol

 

Annual Burden:  	178 hours per study or protocol * 34 protocols or
completed studies = 6,052 hours

Annual Costs:		16,850 * 34 protocols or completed studies = $572,900

Table 4. Agency Burden & Cost Estimates – Review of All Other
Submitted Research with Human Subjects

Activities 	Average Burden Hours Per Study	Total Per Study 

	Mgmt. $103/hr 	Tech. $71/hr 	Cler. $41/hr 	Hours 	Cost ($) 

Rule Familiarization And Training 	1 	1 	0 	2 	174 

Primary Review Ethical Aspects of a Completed Study Report 	1 	40 	0 	41
	2,943 

Store, File and Maintain Information 	0 	0 	1 	1 	41 

Total per study	2 	41 	1 	44 	$3,158 

	Annual Burden:	44 hours/study * 20 studies = 880 hours

	Annual Costs:		$3,158/study * 20 studies = $63,160

6(d)	Bottom Line Burden Hours and Cost Tables

		  SEQ CHAPTER \h \r 1 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   SEQ CHAPTER \h \r 1 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)
20,332	$1,561,518

All Other Submitted Research with Human Subjects (Table 2)	240	$17,580

Respondent Total	20,572	$1,579,098

Annual Agency Burden

Research Involving Intentional Exposure of Human Subjects (Table 3)
6,052	$572,900

All Other Submitted Research with Human Subjects (Table 4)	880	$63,160

Agency Total	6,932	$636,060

6(e)	Reasons for Change in Burden

		The estimated burden to respondents has increased, based on input
received during the consultation process from entities that have
submitted human subjects research since the implementation of the rule. 
The burden estimates in the previous ICR were developed before the rule
was implemented, and were based on EPA’s predictions of how long it
would take study sponsors to prepare submissions.  Based on the
information provided in the consultation responses, it appears that the
actual amount of time necessary to comply with the paperwork and
recordkeeping requirements is higher than originally estimated.  

		The estimated Agency burden has decreased due to the fact that the
actual cost of operating the HSRB has proven to be lower than the cost
that was estimated in the original ICR.  The estimates for this renewal
ICR are based on actual costs of operating the HSRB during Fiscal Year
2008.  

6(f)		Burden Statement

The total estimated annual paperwork burden to comply with this
information collection activity is 20,572  SEQ CHAPTER \h \r 1  hours. 
The average burden is estimated to be 598 hours per response for
research involving intentional exposure of human subjects, and 12 hours
per response for all other submitted research with human subjects.  

According to the Paperwork Reduction Act, “burden” means the total
time, effort, or financial resources expended by persons to generate,
maintain, retain, disclose, or provide information to or for a Federal
agency.  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. In addition OMB control numbers for EPA’s regulations, after
initial display in the final rule, are listed in 40 CFR Part 9 (see
Attachment F). 

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2008-0414, which is available for online viewing at  
HYPERLINK "http://www.regulations.gov"  www.regulations.gov , or in
person viewing at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA. 
This docket facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays.  The docket telephone number is (703)
305-5805.  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-2008-0414 and
OMB Control No. 2070-0169, to (1) EPA online using www.regulations.gov
(our preferred method), or by mail to: Public Information and Records
Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs
(OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460, and (2) OMB by mail to: Office of Information and
Regulatory Affairs, Office of Management and Budget (OMB), Attention:
Desk Officer for EPA, 725 17th Street, NW, Washington, DC 20503.

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-2008-0414.  These attachments are available for online
viewing at   HYPERLINK "http://www.regulations.gov_" 
www.regulations.gov  or otherwise accessed as described in section 6(f)
of the supporting statement.

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

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

Attachment C:	Final Rule; Protections for Test Subjects in Human
Research

Attachment D:	Record of EPA Consultations With Respondents Regarding the
ICR Renewal  

Attachment E:	Wage Rate Tables for Pesticide Registrants and EPA

Attachment F:	Display Related to OMB Control #2070-0169 -Listings of
Related Regulations in 40 CFR 9.1

Attachment G:	Memorandum on Calculation of Burden and Cost, from Kelly
Sherman to File, September 2, 2008.

 Defined at 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) . . . .”

 Bureau of Labor Statistics.  “May 2007 National Industry-Specific
Occupational Employment and Wage Estimates: 541710 – Research and
Development in the Physical, Engineering, and Life Sciences.” Accessed
at   HYPERLINK "http://www.bls.gov/oes/current/naics5_541710.htm" 
http://www.bls.gov/oes/current/naics5_541710.htm .

 Bureau of Labor Statistics.  “May 2007 National Industry-Specific
Occupational Employment and Wage Estimates: NAICS 999100 – Federal
Executive Branch.” Accessed at   HYPERLINK
"http://www.bls.gov/oes/current/naics4_999100.htm" 
http://www.bls.gov/oes/current/naics4_999100.htm .

November 18, 2008

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