November 9, 2015

Page 1 of 14 **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 N**  **o. 2070**  **- 0169**  **; EPA**  **ICR No.**  **2195. 0**  **5 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 no t conducted or supported by EPA. 1 Inaddition 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 th at 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 IC R estimates the third party response burden from complying with the requirements in 40 CFR P art 26, as amended in 2006 and 2013

. Once approved, this I CR renewal would cover the timeframe of September 2 016 through August 2019. In formation is ty pical ly 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** Th e 2006 Appropriations Act, Pub lic L aw 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.htmNovember 9, 2015

Page 2 of 14 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 I CR 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 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 ” 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 S ec tion 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 phy sical and mental health consequences which are reasonabl y foreseeable from, and (ii) freel y volunt eer to participate in the test. ” EPA establish ed 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 a

bout 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, 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 prote ct the interests, rights and safety of human research subjects, in 2006 EPA extend ed the requirements of the Agency ’s 1991 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 EPA and the Human Studies Review Board (HSRB) to review protocols and related in formation before covered research involving human subjects is initiated, but after it has been reviewed and approved b y 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.

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) . . .”November 9, 2015

Page 3 of 14 This information collection activity allows EPA to ensure all human subjects in research conducted b y EPA (first party), conducted b y entities 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 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 th ose requirements, however, appl y 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) N otice soliciting comment on this information collection activity and the Agency ’s intent to ren ew 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 I CR’s before submitting an original or renewal I CR to OMB for review and approval. During the development of this I CR, EPA st aff 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 peri od. **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 collec tion 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) 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

canceled or withdrawn by the registrant orNovember 9, 2015

Page 4 of 14 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 specifyingthat 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. Inany case, the recordkeeping requirement merel y 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 col lection 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 electronicall y, forgoing the need to submit either paper or CDs/DVDs. The ty pe 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 d ata 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 operatio ns 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 effi ciencies 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 in formation will be treated as confidential and not released to third parties unless required b y law.November 9, 2015

Page 5 of 14 **4. THE RESPONDENTS AND THE INFORMATION REQUESTE**  **4(a) .**  **Respondents/NAICS Codes** This collection of information appl ies 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 onl y 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 Sy stem (NAICS) code for the principal respondents to this I CR is 541710 (Research and Development in the Phy sical, 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 subm itted 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 I CR
. **5. THE INFORMATION COLLECTED**  **- AGENCY ACTIVITIES,**  **COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT**  **5(a) .**  **Agency Activities** EPA ’s information

- related activities associated with th is collection consist of the following :November 9, 2015

Page 6 of 14  Conduct Prior Revi ew on S tud y 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 s ys tems to improve their efficiency and accuracy . This review resulted in improvements to the information sy stem, which will improve the quality of the Agency's databases and allows the EPA to respond more timely and accuratel y 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 fed eral ag encies, 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 OPPI N 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 ty

pe . The public may

request copies of studies that are non

- confidential by submitting a F reedom of Information Act (F OIA) 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 human studies will be impacted b y these activities 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 anyNovember 9, 2015

Page 7 of 14 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 I CR only once , whenever developing and performing a given research study that involves human subjects as governe d 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 I CR. The burden and cost estimates for this renewal I CR 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 th e methodology used to calculate the respondent burden, and burden and cost estimates are listed in Table s 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 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 compliance with the 199 1 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

- ye ar period covered b y this ICR renewal (September 2016 through August 2019) , based on historical data anal ys is, 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.) B ased on past experience, EPA also expects to receive other ty pes 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 compl y 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.November 9, 2015

Page 8 of 14 Respondent activities that are within the scope of this I CR include: preparing and submitting protocols, supporting documents, and completed study reports for IRB, EPA, and HSRB review; communicating with IRB and EPA s taff 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 re quirements 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 I CR. To account for the fact that some study typ es are more complex than others and difference s in the preparation of protocols versus co mpleted 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 appropri ate, 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 burd en for this information collection activity

is estimated to be 10,715 hours.November 9, 2015

Page 9 of 14 **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 $16**  **8 /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 r eview 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 Burd en: 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 25 5 Prepare and s ubmit ethics i nformation of completed human s tudies to EPA 0 8 1 9 746 Store, file, and maintain records 0 0 1 1 50November 9, 2015

Page 10 of 14 **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, respectivel y, 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 Employ ment and Wage Estimates, and selects the appropriate occupational category

. The labor rates were derived from the Bureau of Labor Statistics’ May 201 4 National Industry

- Specific Occupational Employ ment an d Wage Estimates for NAICS code 541710 (Research and Development in the Phy sical, 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 I CR, 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 b y North American Industry Classification S ys tem (NAI CS) codes, and therefore are industry

- specific. They are, however, national avera ges. Therefore, some of the high wages earned b y specialists in high cost localities are offset b y 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 activ ities 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 $ 12 4, $82 , and $4 6 per hour for management, technical, and clerical staff, respectively . The labor rates were derived from the Bureau of Labor Statistics’ May 201 4 National Industry

- Specific Occupational Emplo ym ent and Wage Estimates for NAICS code 999100 (Federal Executive Branch)

. 4 These labor rates are fully loaded and include benefits and overhead cost s (see Attachment F ). The details of the calculations are i dentified 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/na ics4_999100.htm

.November 9, 2015

Page 11 of 14 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 $12**  **4 /hr**  **Technical**

**$8 2**  **/hr Clerical** 

**$46 /hr**  **Hours Cost** 

**($)** Rule familiarization and training 1 2 0 3 28 8 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 23 8 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 9 2 **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 $5 9 /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 $ 8 2 /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

.November 9, 2015

Page 12 of 14 **Table 4 .**  Weighted Average Agency Burden and Cost Estimates

– Research Involving Intentional Exposure

– All Other Submitted Research with Hum an 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 = **$9,84 0**  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 c onsistent 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) 4,28 0 $235,010 All Other Submitted Research with Human Subjects (Table 4) 120 $9,840 **Agency Total 4,40**  **0 $244,850** November 9, 2015

Page 13 of 14 **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 curr ently approved IC R 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 ye ar perio d covered b y the I CR renewal (namel y S eptember 2016 through August 2019) . The anticipated number of responses per ye ar 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 th at have submitted human subject research since the implementation of the rule were also taken into account in the preparation of this I CR
. During the comment period for this I CR, 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 I CR. The overall estimated annual Agency burden is expected to decrease slightl y due to the number of responses which we expect to receive durin g the timeframe for this I CR 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 con duct 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. The Agency

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

- HQ
- OPP
201 5
- 07 13 , 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 holiday s. 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 techniq ues. Submit your comments, referencing Docket ID No. EPA

- HQ
- OPP
- 20 1 5
- 07 13 and OMB Control No. 2070

- 01 69 , to (1) EPA online using www.regulations.gov (our preferred method), or b y mail to: EPA Docket Center, Environmental Protection Agency , Office of Pesti cide Programs (OPP) Regulatory

Public Docket (7502P), 1200 Pennsylvania Ave., NW, Washington, DC 20460 , and (2) OMB b y m ail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th S treet, NW, Washington, DC 20503.November 9, 2015

Page 14 of 14 **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
- 20 1 5
- 07 13 . 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) **Attachmen t E**  **:** Estimated Wage Rates for Pesticide Registrants Using BL S NAICS

541710 **Attachment F :**  Standard Wages for the Federal Government Using BL S NAICS 999100 **Attachment G :**  Display Related to OMB Control #2070

- 0169
- Li stings of Related Regulations in 40 CFR 9.1