Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices 42723 

considered in preparation of the final 

EA. 

The major milestones, including those 

for preparing the EA, are as follows: 

Major milestone Date 

License Application Filed ....................................................................................................................................................... August 30, 2011. 

Ready for Environmental Analysis Notice Issued ................................................................................................................. December 9, 2011. 

Deadline for Filing Comments, Recommendations and Agency Terms and Conditions/Prescriptions—extended .............. April 6, 2012. 

Draft EA Issued ...................................................................................................................................................................... September 2012. 

Comments on draft EA Due .................................................................................................................................................. October 2012. 

Final EA Issued ...................................................................................................................................................................... December 2012. 

Dated: July 13, 2012. 

Kimberly D. Bose, 

Secretary. 

[FR Doc. 2012–17652 Filed 7–19–12; 8:45 am] 

BILLING CODE 6717–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2011–0704; FRL–9520–9] 

Agency Information Collection 

Activities; Submission to OMB for 

Review and Approval; Comment 

Request 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act (PRA) this 

document announces that the following 

Information Collection Request (ICR) 

has been forwarded to the Office of 

Management and Budget (OMB) for 

review and approval: Submission of 

Protocols and Study Reports for 

Environmental Research Involving 

Human Subjects; EPA ICR No. 2195.04, 

OMB Control No. 2070–0169. This is a 

request to renew an existing approved 

collection. The ICR, which is abstracted 

below, describes the nature of the 

information collection and its estimated 

burden and cost. 

DATES: Additional comments may be 

submitted on or before August 20, 2012. 

ADDRESSES: Submit your comments, 

referencing Docket ID No. EPA–HQ– 

OPP–2011–0704, to (1) EPA online 

using http://www.regulations.gov (our 

preferred method), or by mail to: OPP 

Docket, EPA Docket Center (EPA/DC), 

EPA West, Room 3334, 1301 

Constitution Ave. NW., Washington, 

DC., 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. 

FOR FURTHER INFORMATION CONTACT: Lily 

G. Negash, Field & External Affairs 

Division (7605P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave. NW., 

Washington, DC 20460; telephone 

number: 703–347–8515; fax number: 

703–305–5884; email address: 

negash.lily@epa.gov. 

SUPPLEMENTARY INFORMATION: EPA has 

submitted the following ICR to OMB for 

review and approval under the PRA, 

44 U.S.C. 3501 et. seq., and according to 

the procedures prescribed in 5 CFR 

1320.12. On December 7, 2011 (76 FR 

76399), EPA sought comments on this 

ICR pursuant to 5 CFR 1320.8(d). EPA 

received no comments. Any additional 

comments on this ICR should be 

submitted to EPA and OMB within 30 

days of this notice. 

EPA has established a public docket 

for this ICR under Docket ID number 

EPA–HQ–OPP–2011–0704, 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. The EPA/DC Public Reading Room 

is open from 8 a.m. to 4:30 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

Reading Room is 202–566–1744, and the 

telephone number for the OPP Docket is 

703–305–5805. 

Use EPA’s electronic docket and 

comment system at http:// 

www.regulations.gov, to submit or view 

public comments, access the index 

listing of the contents of the docket, and 

to access those documents in the docket 

that are available electronically. Once in 

the system, select ‘‘docket search,’’ then 

key in the docket ID number identified 

above. Please note that EPA’s policy is 

that public comments, whether 

submitted electronically or in paper, 

will be made available for public 

viewing at http://www.regulations.gov 

as EPA receives them and without 

change, unless the comment contains 

copyrighted material, Confidential 

Business Information (CBI), or other 

information whose public disclosure is 

restricted by statute. For further 

information about the electronic docket, 

go to http://www.regulations.gov. 

Title: Submission of Protocols and 

Study Reports for Environmental 

Research Involving Human Subjects. 

ICR numbers: EPA ICR No. 2195.04, 

OMB Control No. 2070–0169. 

ICR Status: OMB approval of this ICR 

is currently scheduled to expire on 

August 31, 2012. Under OMB 

regulations, the Agency may continue to 

conduct or sponsor the collection of 

information while this submission is 

pending at OMB. An 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 numbers for EPA’s 

regulations in title 40 of the CFR, after 

appearing in the Federal Register when 

approved, are listed in 40 CFR part 9, 

are displayed either by publication in 

the Federal Register or by other 

appropriate means, such as on the 

related collection instrument or form, if 

applicable. 

Abstract: 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, EPA 

regulations at 40 CFR part 26 protect 

subjects of ‘‘third-party’’ human 

research (i.e., research that is not 

conducted or supported by EPA). In 

addition to other protections, the 

regulations require affected entities to 

submit information to EPA and an 

Institutional Review Board (IRB) prior to 

initiating, and to EPA upon the 

completion of, certain studies that 

involve human research participants. 

The information collection activity 

consists of activity-driven reporting and 

recordkeeping requirements for those 

who intend to conduct research for 

submission to EPA under the pesticide 

laws. If such research involves 

intentional dosing of human subjects, 

these individuals (respondents) are 

required to submit study protocols to 

EPA and a cognizant local Human 

Subjects IRB before such research is 

initiated so that the scientific design 

and ethical standards that will be 

employed during the proposed study 

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42724 Federal Register / Vol. 77, No. 140 / Friday, July 20, 2012 / Notices 

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. 

Burden Statement: The annual public 

reporting and recordkeeping burden for 

this collection of information is 

estimated to average 2119 hours per 

response for research involving 

exposure of human subjects, and 12 

hours per response for all other 

submitted research with human 

subjects. Burden is defined in 5 CFR 

1320.3(b). 

Respondents/Affected Entities: Any 

entity that submits protocols and study 

reports for environmental research 

involving human subjects under FIFRA 

and/or FFDCA. 

Estimated Number of Respondents: 7 

annually for research involving 

intentional exposure of human subjects, 

and 10 annually for all other submitted 

research with human subjects. 

Frequency of Response: Occasional. 

Estimated Total Annual Burden: 

14,833 hours for research involving 

intentional exposure of human subjects, 

and 120 hours for all other submitted 

research with human subjects. 

Estimated Total Annual Cost: 

$1,299,759, which includes $0 

annualized capital or O&M costs. 

Changes in the Estimates: There is a 

decrease of 5,619 hours in the total 

estimated burden currently identified in 

the OMB Inventory of Approved ICR 

Burdens. This decrease is due to a 

decrease in the anticipated number of 

responses per year. This change is an 

adjustment. 

John Moses, 

Director, Collection Strategies Division. 

[FR Doc. 2012–17746 Filed 7–19–12; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OAR–2005–0121; FRL 9520–7] 

Agency Information Collection 

Activities; Submission to OMB for 

Review and Approval; Comment 

Request; Exclusion Determinations for 

New Nonroad Spark-Ignited Engines, 

New Nonroad Compression-Ignited 

Engines, and New On-Road Heavy 

Duty Engines (Renewal) 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: In compliance with the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), this document 

announces that an Information 

Collection Request (ICR) has been 

forwarded to the Office of Management 

and Budget (OMB) for review and 

approval. This is a request to renew an 

existing approved collection. The ICR, 

which is abstracted below, describes the 

nature of the information collection and 

its estimated burden and cost. 

DATES: Additional comments may be 

submitted on or before August 20, 2012. 

ADDRESSES: Submit your comments, 

referencing docket ID number EPA–HQ– 

OAR–2005–0121, to (1) EPA online 

using www.regulations.gov (our 

preferred method), by email to a-and-rDocket@epa.gov, or by mail to EPA 

Docket Center, Environmental 

Protection Agency, Air and Radiation 

Docket Center (mailcode 28221T), 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. 

FOR FURTHER INFORMATION CONTACT: 

Nydia Yanira Reyes-Morales, 

Environmental Protection Agency, 1200 

Pennsylvania Avenue, Mail Code 6403J 

NW., Washington, DC 20460; telephone 

number: 202–343–9264; fax number: 

202–343–2804; email address: reyesmorales.nydia@epa.gov. 

SUPPLEMENTARY INFORMATION: EPA has 

submitted the following ICR to OMB for 

review and approval according to the 

procedures prescribed in 5 CFR 1320.12. 

On March 28, 2012 (77 FR 18803), EPA 

sought comments on this ICR pursuant 

to 5 CFR 1320.8(d). EPA received no 

comments during the comment period. 

Any additional comments on this ICR 

should be submitted to EPA and OMB 

within 30 days of this notice. 

EPA has established a public docket 

for this ICR under Docket ID No. EPA– 

HQ–OAR–2005–0121, which is 

available for online viewing at 

www.regulations.gov, or in person 

viewing at the Air Docket in the EPA 

Docket Center (EPA/DC), EPA West, 

Room 3334, 1301 Constitution Ave. 

NW., Washington, DC. The EPA/DC 

Public Reading Room is open from 

8:30 a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Reading Room 

is 202–566–1744, and the telephone 

number for the Air Docket is 202–566– 

1742. 

Use EPA’s electronic docket and 

comment system at 

www.regulations.gov, to submit or view 

public comments, access the index 

listing of the contents of the docket, and 

to access those documents in the docket 

that are available electronically. Once in 

the system, select ‘‘docket search,’’ then 

key in the docket ID number identified 

above. Please note that EPA’s policy is 

that public comments, whether 

submitted electronically or in paper, 

will be made available for public 

viewing at www.regulations.gov as EPA 

receives them and without change, 

unless the comment contains 

copyrighted material, confidential 

business information (CBI), or other 

information whose public disclosure is 

restricted by statute. For further 

information about the electronic docket, 

go to www.regulations.gov. 

Title: Exclusion Determinations for 

New Nonroad Spark-ignited Engines, 

New Nonroad Compression-ignited 

Engines, and New On-road Heavy Duty 

Engines (Renewal). 

ICR numbers: EPA ICR No. 1852.05, 

OMB Control No. 2060–0395. 

ICR Status: This ICR is scheduled to 

expire on July 31, 2012. Under OMB 

regulations, the Agency may continue to 

conduct or sponsor the collection of 

information while this submission is 

pending at OMB. An 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 numbers for EPA’s 

regulations in title 40 of the CFR, after 

appearing in the Federal Register when 

approved, are listed in 40 CFR part 9, 

are displayed either by publication in 

the Federal Register or by other 

appropriate means, such as on the 

related collection instrument or form, if 

applicable. The display of OMB control 

numbers in certain EPA regulations is 

consolidated in 40 CFR part 9. 

Abstract: Under the provisions of the 

Clean Air Act (CAA), the Administrator 

is required to promulgate regulations to 

control air pollutant emissions from 

motor vehicles and nonroad engines, as 

defined in the CAA. Motor vehicles and 

non-road engines not meeting the 

applicable definitions are excluded from 

compliance with current regulations. A 

manufacturer may make an exclusion 

determination by itself; however, 

manufacturers and importers may 

request EPA to make such 

determination to ensure that their 

determination does not differ from the 

Agency’s. To request an exclusion 

determination, manufacturers submit a 

letter with a description of the engine 

and/or vehicle (engine type, horsepower 

rating, intended usage, etc.) and sales 

brochures or pictures. The request must 

be submitted to either the Gasoline 

Engine Compliance Center (GECC) or 

the Diesel Engine Compliance Center 

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