**October 27 , 20**  **11**

Page 1 of 13 **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 N o. 2070

- 0169 EPA No. 2195. 0 4 **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)

. The applicable Sections of FIFRA and FFDCA which authoriz e the information collection activities in this I CR are discussed in Section 2(a) of this document. InJanuary 2006, EPA issued a final rule t o amend the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) at 40 CFR part 26 ( see Attachment A ) . EPA’s January 2006 final rule significantly strengthens and expands the protections for subjects of “third

- party” human r esearch (i.e., research that is not conducted or supported by

EPA) . In addition to other protections, the final rule require s affected entities to submit information to EPA and an institutional review board (IRB) prior to initiating, and to EPA upon the c ompletion 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 intentio nal 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. In addition , 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 IC R est imates the third party response burden from complying with the January 2006 final rule requirements. Information is ty pical ly 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 $ 1,712,833

. **2. NEED FOR AND USE OF THE COLLECTION**  **2(a) Need/Aut**  **hority for the Collection** Th e 2006 Appropriations Act, Pub. L . No. 109

- 54 , required EPA to issue a final rule addressing third

- party

intentional dosing human toxicity studies for pesticides, and EPA conduct**October 27 , 20**  **11**

Page 2 of 13

of intentional dosing human toxicity studies for pesticides

. This I CR 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 exist ed under FIFRA and FFDCA. Section s 3 (c)(5), 3(g) and 4(g)(2)(D) of FIFRA generall y require EPA to determine that a pesticide would not present any “unreasonable adverse effects on the environment ” 1 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 that there is a reasonable certainty that no harm will result f rom 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 sec tion 12(a)(2)(P) forbids an y person “to use an y pesticide in tests on human beings unless such human beings (i) are fully informed of the nature and purposes of the test and of an y ph ys ical and mental health consequences which are reasonably foreseeable from, and (ii) freel y volunt eer to participate in the test. ” EPA establish ed 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 requir ed 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 B and C , respectivel y. **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 extend ed the requirements of the Agency ’s Common Rule, 40 CFR Part 26, pros pectivel y to third

- party r esearch 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 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 concurrentl y documentation of the ethical conduct of the research. This information collection activity allows EPA to ensure all human subjects in research conducted b y EPA (first party), conducted b y

1 Defined at FIFRA section 2(bb) as “. . . (1) an y 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 incon sistent with the standard under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) . . . .”**October 27 , 20**  **11**

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e ntities with support from EPA (second parties), or conducted b y 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 informat ion 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 requirement s, 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 comment are located in the docket for this action, whic h can be accessed at http://www.regulations.gov using the docket identifier EPA

- HQ

- OPP

- 2011

- 0704

. **3(c) Consultations**  During preparation of this I CR renewal, EPA staff will contact respondent representatives to see k feedback on the burden estimates in the ICR and the clarity of guidance provided. Their responses to EPA’s consultation efforts will be summarized and made publicly available with the final I CR renewal request, as Attachment D
. **3(d) Effects of Less Fre**  **quent Collection** Not applicable. Th is 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 requi rement at 40 CFR 169.2(k) state s 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

c anceled or withdrawn by the registrant or until EPA has cause to suspend or cancel the registration.**October 27 , 20**  **11**

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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 ye ars will be exceeded in this collection activity

. This is an existing requirement that was not changed by the final rule. In an y 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

. 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 t echniques 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 offering a fully electronic submission option at this t ime. EPA is developing an internet portal that would adequately secure any confidential and/or sensitive information submitted electronicall y; 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 “ electronically” via compact disc. Ordinaril y, registrants would be required to submit 3 paper copies of study data to EPA. Under this hy brid option, registrants need on ly 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. OPP expects that registrants will spend less time and money preparing cop ies and sending their submissions using the hy brid paper

- electronic submission option, and stand to benefit from the efficiencies that EPA expects to experience during data reviews. **3(f) Confidentiality**  EPA has implemented proced ures to protect an y 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 regul ations 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**October 27 , 20**  **11**

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receives identifying information, such information will be treated as confidential and not released to third parties unless required b y law.

**4. THE RESPONDENTS AND THE INFORMATION REQUESTED**  **4(a) Respondents/NAICS Codes**  This collection of information appl ies to any entity that submits protocols and study reports for environmental research involving human subjects under FIFRA and/or FFDCA. Although EPA has onl y received such third

- party research in conjunction with FIFRA from pesticide registrants, it is conce ivable that other entities could submit such information to EPA under FIFRA and/or FFDCA in the future. The North American Industrial Classification Sy stem (NAICS) code for the principal respondents to this I CR is 541710 (Research an d Development in the Phy sical, Engineering, Life Sciences)

. **4(b) Information Requested**  **(i) 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.

**(ii) Respondent Activities**  The following informat ion 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 IC R
. **5. THE INFORMATION COLLECTED**  **- AGENCY ACTIVITIES,**  **COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT** **October 27 , 20**  **11**

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**5(a) Agency Activities**  EPA ’s information

- related activities associated with th is 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 an y formal decisions made

.

 Store, File and Maintain Information

– compile information into appropriate databases and archive. **5(b) Collection Methodology and Management**  OPP completed a major review of its information tracking s ys tems to improve their efficiency and accuracy . This review resulted in the development of a new integrated information sy stem, which, when complete, will improve the quality of the Agency's databases and allows the EPA to respond more timely and accurate ly

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 a ctivities. 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 an d 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 OPPI N bibliographies through the National Pesticides Information Retrieval System (NPIRS). NPIRS supports searches of the PDMS database by chemica l, 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 comparative ly small p ortion 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**October 27 , 20**  **11**

Page 7 of 13

human studies will be impacted b y these act ivities each ye ar. 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 periodic collection schedule is not appropriate for the information collection activ ity

. The information collection activity is initiated by

the respondents and therefore EPA expects that respondents will engage in the activities described in this I CR only once , whenever developing and performing a given research study that involves human subjects as governed b y 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 Rul e in this I CR nor the paperwork burden associated with the generation of certain study data that is already covered b y other ICRs, such as those requested b y EPA in a Data Call

- In under FIFRA section 3(c)(2)(B). EPA does assume that IRBs are already in co mpliance 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 in previous ye ars 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 e xposure of human subjects. See Attachment E for an explanation of the methodology , data, and assumptions used to calculate and revise previous estimates of respondent burdens and costs. EPA also expects to receive other types of pesticide research involv ing 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 I CR include: preparing and submitting p rotocols, 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**October 27 , 20**  **11**

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ma de 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 relie d 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 w as essentiall y 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. 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**  **Technical Clerical**  **Hours Cost ($)**  **$152.89 $78.54**  **$45.43** Rule familiarization and training 2 4 2 8 711 Prepare and submit protocol for IRB review 31 83 33 147 12,758 Prepare and submit protocol for EPA and HSRB review 25 181 37 243 19,719 Document ethical conduct of a completed study

for which EPA and the HSRB have reviewed the protocol 19 113 21 153 12,734 Document ethical conduct of a pre - rule study for which EPA and the HSRB have not reviewed the protocol 5 16 8 29 2,385 Store, file, maintain records 4 8 6 18 1,512 Total per response 86 405 107 598 49,818**October 27 , 20**  **11**

Page 9 of 13

Annual Burden: 598 hours per protocol or completed study * 34 protocols or completed studies per year = 20,332 hours Annual Costs: $4 9 , 818 per study * 34 protocols or completed studies per year = $1, 693 ,8 21 **Table 2. Respondent Burden and Cost Estimates** 

**– All Other Submitted Research**  **with Human Subjects**

**Activities Average Burden Hours Per**  **Response Total Per Response**  **Management Technical**  **Clerical Hours**  **Cost ($) $152.89**  **$78.54 $45.43**  Rule familiarization and training 1 1 0 2 231 Prepare and Submit Ethics In formation of Completed Human Studies to EPA 0 8 1 9 674 Store, file, and maintain records 0 0 1 1 45 Total per response 1 9 2 12 951 Annual Burden: 12 hours per study * 20 studies submitted per year = 240 hours Annual Costs: $951 per study * 20 studies submitted per year = $1 9 , 012 **6(b) Estimating**  **Respondent Costs** The estimated annual cost for all respondents is $ 1,712,833 . Respondent labor rates are estimated to be $1 53 , $7 9 , and $4 5 per hour, respectivel y, for managerial, technical and clerical labor. These labor rates were derived from the Bureau of Labor Statistics’ May 20 10 National Industry

- Specific Occupational Employ ment and Wage Estimates for NAICS code 541710 (Research and D evelopment in the Phy sical, Engineering, and Life Sciences)

. 2 These labor rates are full y loaded and include benefits and overhead costs, using a methodology developed by OPP’s Biological and Economic Analy sis Division (see Attachment F ). **6(c) Estimating**  **Agency Burden and Cost** The total estimated Agency annual cost is $6 44 ,0 38 ( see Table 5) . 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, fil e, and track the submissions.

2 Bureau of Labor Statistics. “May 2010 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

.**October 27 , 20**  **11**

Page 10 of 13

Agency labor rates are $1 20, $72, and $43 per hour for management, technical, and clerical staff, respectively. These labor rates were derived from the Bureau of Labor Statistics’ May 20 10 National In dustry

- Specific Occupational Employ ment and Wage Estimates for NAI CS code 999100 (Federal Executive Branch)

. 3 These labor rates are fully loaded and include benefits and overhead costs, using a methodology developed by

OPP’s Biological and Economic Anal ys is Division (see Attachment G ). 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**  **Technical Clerical**  **Hours Cost ($)**  **$120 $72**  **$43** Rule familiarization and training 2 2 0 4 383 Primary Review of Scientific and Ethical Aspects of a Protocol 1 113 0 114 8,208 Primary Review of Ethical Aspects of a Completed Study

Report 1 57 0 58 4,200 Secondary

Review of Scientific and Ethical Aspects of a Protocol or Review of Ethical Aspects of a Completed Study 4,172* Store, file, and maintain records 0 0 2 2 86 Total per protocol or completed study 4 172 2 178 17,050 1. * The value 4,172 is computed in line 7) below. 2. Cost of HSRB members working on the HSRB report (collectivel y 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 $72/hour). Each HSRB report covers an average of 6 protocols and/or completed studies per report. 3. 240 hours/HSRB Members/report * $53/hour = $12,720/r eport 4. 172 hours/OSA Staff/report*$72/hour = $12,312/report 5. Total Cost for HSRB Member and OSA Staff Review Time Per Report = $12,720 + $12,312 = $25,032 6. If 1 report = 6 protocols 7. Total Cost for HSRB Member and OSA Staff Review Time Per Protocol = $25,032/6 = $4,172/protocol

3 Bureau of Labor Statistics. “May 2010 Nation al Industry

- Specific Occupational Employment and Wage Estimates: NAICS 999100

– Federal Executive Branch .” Accessed at http://www.bls.gov/oes/current/naics4_999100.htm

.**October 27 , 20**  **11**

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

6,052 hours Annual Costs: 17,050 * 34 protocols or completed studies = $579,684 **Table 4. Agency Burden & Cost Estimates**

**– Review of**  **All Other Subm itted Research with**  **Human Subjects**

**Activities Average Burden Hours Per Study**  **Total Per Study**

**Management Technical**  **Clerical Hours**  **Cost ($) $120**  **$72 $43**  Rule Familiarization And Training 1 1 0 2 191 Primary Review Ethical Aspects of a Completed Study

Report 1 40 0 41 2,983 Store, File and Maintain In formation 0 0 1 1 43 Total per study 2 41 1 44 3,218 Annual Burden: 44 hours/study * 20 studies = 880 hours Annual Costs: $3, 218 /study * 20 studies = $6 4 , 354 **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 tot al estimated annual burden and costs for the Agency : **Table 5**  **. Total**  **Annual Bottom Line Burden**  **a nd 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 $1,693,821

All Other Submitted Research with Human Subjects (Table 2) 240 $19,012 Respondent Total 20,572 1,712,833 Annual Agency Burden Research Involving Intentional Exposure of Human Subjects (Table 3) 6,052 $579,684

All Other Submitted Research 880 $64,354**October 27 , 20**  **11**

Page 12 of 13

with Human Subjects (Table 4) Agency Total 6,932 644,038
**6( e**  **) Reasons for Change in Burden**  There is no change in the labor hours in this I CR as compared to the previous I CR. There is, however, an increase in the estimated burden cost as currentl y identified in the OMB Inventory of Approved ICR Burdens. This is not due to any program changes. Th e change in burden cost is due to the use of the most updated labor rates. The estimates for this renewal ICR are based on the labor hours of operating the HSRB that was approved b y OMB during Fiscal Year 2008

. **6( f**  **) Burden Statement**  The total estimated annual paperwork burden to comply with this information collection activity is 20,572 hours. The average burden is estimated to be 598 hours per response for research involving intentional exposure of human subjec ts, 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 p rovide 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 currentl y 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 H ). The Agency

has established a public docket for this I CR under Docket ID No. EPA

- HQ

OPP

- 20 11

- 0 70 4 , which is available for online viewing at www.regulations.gov , or in person viewing at the OPP Regulatory Public Docket in Rm. S

- 4400, One Potomac Yard (South Bu ilding), 2777 S. Cry stal Drive, Arlington, VA. This docket facilit y is open from 8:30 a.m. to 4 p.m., Monday

through Friday , excluding legal holiday s. 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

- 20 11

- 0 70 4 and O MB Control No. 2070

- 01 69 , 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 , 120 0 Pennsylvania Ave., NW, Washington, DC 20460, and (2) OMB b y 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.**October 27 , 20**  **11**

Page 13 of 13 **ATTACHMENTS TO THE SUPP ORTING STATEMENT**  **:** Attachments to the supporting statement are available in the public docket established for this ICR under docket identification number EPA

- HQ

- OPP

- 20 11

- 0 70 4. These attachments are available for online viewing at www.regulations.gov or otherwise accessed as described in section 6(f) of the supporting statement. **Attachment A:** Final Rule; Protections for Test Subjects in Human Research **Attachment B** : FIFRA Sections 3(c)( 5), 3(g), 4(g)(2), and 25 **Attachment C:** FFDCA Sections 408(b)(2)(A)(ii) and 408(e)(1)(C) **Attachment D:** (Reserved) Record of EPA Consultations With Respondents **Attachment E:** Memorandum on Calculation of Burden and Cost **Attachment F:** Wage Rate Tables for Pesticide Registrants **Attachment G:** Work Sheet used to Calculate EPA Labor Costs **Attachment H:** Display

Related to OMB Control #2070

- 0169

- Li stings of Related Regulations in 40 CFR 9.