Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects; EPA ICR No. 2195.03, OMB Control No. 2070-0169, 33811-33813 [E8-13346]

Download as PDF rwilkins on PROD1PC63 with NOTICES Federal Register / Vol. 73, No. 115 / Friday, June 13, 2008 / Notices filed in Docket No. CP08–414–000, a prior notice request pursuant to sections 157.205, and 157.210 of the Federal Energy Regulatory Commission’s regulations under the Natural Gas Act and its blanket authority granted in Docket No. CP82–406–000 on September 1, 1982, for authorization to replace two existing compressor units at its Gwinville Compressor Station (‘‘Gwinville’’) with one larger unit, all as more fully set forth in the application, which is on file with the Commission and open to public inspection. The filing may also be viewed on the Web at https://www.ferc.gov using the ‘‘eLibrary’’ link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at FERCOnlineSupport@ferc.gov or call toll-free, (866) 208–3676 or TTY, (202) 502–8659. Gwinville is a critical station located at the intersection of Southern’s Franklinton-Gwinville Pipelines and Southern’s South Main Pipelines. This point in Southern’s system is where the gas transported from the Gulf of Mexico interconnects with Southern’s south main system. The two existing compressor units, #10 and #12, which have a horsepower of 1,080 and 4,390, respectively, would be replaced with a new Solar Taurus 70 unit to be rated at ISO 10,310 hp. This new compressor unit is proposed to be installed in a new compressor building, which will be immediately adjacent to Unit #12. Any questions regarding the application should be directed to Patrick B. Pope, Vice President and General Counsel, Southern Natural Gas Company, Post Office Box 2563, Birmingham, Alabama 35202–2563, at (205) 325–7126 or Patricia S. Francis, Senior Counsel, Southern Natural Gas Company, Post Office Box 2563, Birmingham, Alabama 35202–2563, at (205) 325–7696. Any person may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission’s Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention. Any person filing to intervene or the Commission’s staff may, pursuant to section 157.205 of the Commission’s Regulations under the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for VerDate Aug<31>2005 16:18 Jun 12, 2008 Jkt 214001 authorization pursuant to section 7 of the NGA. The Commission strongly encourages electronic filings of comments, protests, and interventions via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission’s Web site (https:// www.ferc.gov) under the ‘‘e-Filing’’ link. Kimberly D. Bose, Secretary. [FR Doc. E8–13255 Filed 6–12–08; 8:45 am] BILLING CODE 6717–01–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPP–2008–0414; FRL–8366–3] Agency Information Collection Activities; Proposed Collection; Comment Request; Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects; EPA ICR No. 2195.03, OMB Control No. 2070–0169 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a request to renew an existing approved Information Collection Request (ICR) to the Office of Management and Budget (OMB). This ICR, entitled: ‘‘Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects’’ and identified by EPA ICR No. 2195.03 and OMB Control No. 2070–0169, is scheduled to expire on January 31, 2009. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection. DATES: Comments must be received on or before August 12, 2008. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2008–0414, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. PO 00000 Frm 00011 Fmt 4703 Sfmt 4703 33811 Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. Instructions: Direct your comments to docket ID number EPA–HQ–OPP–2008– 0414. EPA’s policy is that all comments received will be included in the docket without change and may be made available on-line at https:// www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov website is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the docket index available in regulations.gov. To access the electronic docket, go to https:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at https:// E:\FR\FM\13JNN1.SGM 13JNN1 33812 Federal Register / Vol. 73, No. 115 / Friday, June 13, 2008 / Notices www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Joseph Hogue, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460– 0001; telephone number: (703) 308– 9072; fax number: (703) 305–5884; email address: hogue.joe@epa.gov. SUPPLEMENTARY INFORMATION: rwilkins on PROD1PC63 with NOTICES I. What Information is EPA Particularly Interested in? Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits comments and information to enable it to: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility. 2. Evaluate the accuracy of the Agency’s estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used. 3. Enhance the quality, utility, and clarity of the information to be collected. 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection. II. What Should I Consider when I Prepare My Comments for EPA? You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible and provide specific examples. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data you used that support your views. VerDate Aug<31>2005 16:18 Jun 12, 2008 Jkt 214001 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the collection activity. 7. Make sure to submit your comments by the deadline identified under DATES. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. III. What Information Collection Activity or ICR Does this Action Apply to? Affected entities: Entities potentially affected by this action are those that submit protocols and study reports for environmental research involving human subjects under the pesticide laws, typically registrants of pesticide products (NAICS 325320). Title: Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects. ICR numbers: EPA ICR No. 2195.03, OMB Control No. 2070–0169. ICR status: This ICR is currently scheduled to expire on January 31, 2009. 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: 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). 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 PO 00000 Frm 00012 Fmt 4703 Sfmt 4703 EPA and a cognizant local human subjects institutional review board (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 intentional dosing of human subjects when such research is submitted to EPA. Responses to this collection of information are mandatory. Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 32 hours per response for research involving intentional exposure of human subjects, and 12 hours per response for all other submitted research with human subjects. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. The ICR provides a detailed explanation of this estimate, which is only briefly summarized here: Estimated total number of potential respondents: 62. Frequency of response: On occasion. Estimated total average number of responses for each respondent: 1. Estimated total annual burden hours: 1,404 hours. Estimated total annual costs: $84,674. This includes an estimated burden cost of $84,674 with no additional cost for capital investment or maintenance and operational costs. IV. Are There Changes in the Estimates from the Last Approval? There is no change in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. E:\FR\FM\13JNN1.SGM 13JNN1 Federal Register / Vol. 73, No. 115 / Friday, June 13, 2008 / Notices V. What is the Next Step in the Process for this ICR? EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the person listed under FOR FURTHER INFORMATION CONTACT. List of Subjects Environmental protection, Reporting and recordkeeping requirements. Dated: June 4, 2008. James B. Gulliford, Assistant Administrator, Office of Prevention, Pesticides and Toxic Substances. [FR Doc. E8–13346 Filed 6–12–08; 8:45 am] BILLING CODE 6560–50–S ENVIRONMENTAL PROTECTION AGENCY [ER–FRL–6699–8] Environmental Impact Statements and Regulations; Availability of EPA Comments rwilkins on PROD1PC63 with NOTICES Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under section 309 of the Clean Air Act and Section 102(2)(c) of the National Environmental Policy Act as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at 202–564–7167. An explanation of the ratings assigned to draft environmental impact statements (EISs) was published in FR dated April 11, 2008 (73 FR 19833). Draft EISs EIS No. 20080067, ERP No. D–FHW– F40442–MT, Detroit River International Crossing Study, Propose Border Crossing System between the International Border Cities of Detroit, Michigan and Windsor, Ontario, Wayne County, MI. Summary: EPA expressed environmental concerns about particulate matter and mobile source air toxics impacts, and recommended using energy efficiency and sustainability principles. Rating EC2. EIS No. 20080103, ERP No. D–USN– E11064–FL, Mayport Naval Station VerDate Aug<31>2005 16:18 Jun 12, 2008 Jkt 214001 Project, Proposed Homeporting of Additional Surface Ships, Several Permits, Mayport, FL. Summary: EPA expressed environmental concerns about to the magnitude of proposed dredged material and the capacity and management limitations of existing ocean dredged material disposal sites to handle this additional material. EPA recommends additional mitigation measures for other on-shore environmental impacts related to the proposed homeporting. Rating EC2. EIS No. 20080115, ERP No. D–UAF– E15001–FL, Eglin Air Force Base Program, Base Realignment and Closure (BRAC) 2005 Decisions and Related Action, Implementation, FL. Summary: EPA expressed environmental concerns about impacts to air quality, low-income/minority populations, aquatic habitats, water quality and noise impacts and recommended several mitigation measures. Rating EC2. EIS No. 20080120, ERP No. D–USN– ELL065–FL, Naval Surface Warfare Center Panama City Division (NSWC PCD), Capabilities to Conduct New and Increased Mission Operations for the Department of Navy (DON) and Customers within the three Military Operating Area and St. Andrew Bay (SAB), Gulf of Mexico, FL. Summary: EPA expressed concerns about impacts to marine mammals, sea turtles, and marine fish. Rating EC2. EIS No. 20080137, ERP No. D–AFS– L65552–OR, East Maury Fuels and Vegetation Management Project, Proposed Fuels and Vegetation Treatments Reduce the Risk of Stand Loss, Lookout Mountain Ranger District, Ochoco National Forest, Crook County, OR. Summary: EPA expressed environmental concerns about potential impacts to water quality from mass wasting associated with road construction in management units with dormant landslide terrain. EPA requested additional information regarding road closures and stream crossings. Rating EC2. EIS No. 20080144, ERP No. D–CGD– E03019–FL, Port Dolphin LLC Liquefied Natural Gas Deepwater Port License Application, Proposes to Own, Construct and Operate a Deepwater Port, Outer Continental Shelf, Manatee County, FL. Summary: EPA expressed environmental concerns about construction impacts to hard bottom habitat and port operation impacts to icthyoplankton. Rating EC2. PO 00000 Frm 00013 Fmt 4703 Sfmt 4703 33813 EIS No. 20080184, ERP No. D–FHW– H40193–IA, I–29 Improvements in Sioux City, Construction from Burlington Northern Santa Fe Rail Road (BNSF) Bridge over the Missouri River to Existing Hamilton Boulevard Interchange, Woodbury County, IA. Summary: EPA does not object to the proposed action. Rating LO. EIS No. 20080128, ERP No. DS–MMS– A02245–00, Gulf of Mexico Outer Continental Shelf Oil and Gas Lease Sales: 2009–2012 Western Planning Area Sales: 210 in 2009, 215 in 2010, and 218 in 2011, and Central Planning Area Sales: 208 in 2009, 213 in 2010, 216 in 2011, and 222 in 2012, TX, LA, MS, AL, and FL. Summary: EPA does not object to the proposed action. Rating LO. Final EISs EIS No. 20080052, ERP No. F–FTA– E40816-FL, Tier 1 Programmatic— Jacksonville Rapid Transit System (RTS), Improvement to Transportation in Four Primary Transit Corridors Radiating from Downtown Jacksonville, Duval County, FL. Summary: EPA expressed environmental concerns about indirect impacts, and requested additional information on cumulative, and irreversible/irretrievable impacts. EIS No. 20080147, ERP No. F–AFS– J65479–MT, Trapper Bunk House Land Stewardship Project, Reduce Risk from Stand-Replacing and Uncontrollable Fires, Improve Resiliency and Provide Forest Products, Fuel Reduction Research and Watershed Improvement, Bitterroot National Forest, Darby Ranger District, Ravalli County, MT. Summary: EPA supports project objectives to reduce fire risk, improve vegetative resiliency, conduct fuel reduction research, provide timber and improve watersheds. However, EPA expressed environmental concerns about water quality impacts from sediment transport and a budget process that requires commercial timber harvest to provide funding for road maintenance or decommissioning. EIS No. 20080155, ERP No. F–AFS– J65502–MT, Cooney McKay Forest Health and Fuels Reduction Project, Proposed to Restore Desirable Vegetative Conditions, Swan Valley near Condon, Swan Lake Ranger District, Flathead National Forest, Lake and Missoula Counties, MT. Summary: EPA supports activities to reduce hazardous fuels and fire risk in wildland urban interface areas, but expressed environmental concerns E:\FR\FM\13JNN1.SGM 13JNN1

Agencies

[Federal Register Volume 73, Number 115 (Friday, June 13, 2008)]
[Notices]
[Pages 33811-33813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13346]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0414; FRL-8366-3]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Submission of Protocols and Study Reports for 
Environmental Research Involving Human Subjects; EPA ICR No. 2195.03, 
OMB Control No. 2070-0169

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 EPA is planning to 
submit a request to renew an existing approved Information Collection 
Request (ICR) to the Office of Management and Budget (OMB). This ICR, 
entitled: ``Submission of Protocols and Study Reports for Environmental 
Research Involving Human Subjects'' and identified by EPA ICR No. 
2195.03 and OMB Control No. 2070-0169, is scheduled to expire on 
January 31, 2009. Before submitting the ICR to OMB for review and 
approval, EPA is soliciting comments on specific aspects of the 
proposed information collection.

DATES: Comments must be received on or before August 12, 2008.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2008-0414, by one of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2008-0414. EPA's policy is that all comments received will be included 
in the docket without change and may be made available on-line at 
https://www.regulations.gov, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system, 
which means EPA will not know your identity or contact information 
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index 
available in regulations.gov. To access the electronic docket, go to 
https://www.regulations.gov, select ``Advanced Search,'' then ``Docket 
Search.'' Insert the docket ID number where indicated and select the 
``Submit'' button. Follow the instructions on the regulations.gov 
website to view the docket index or access available documents. 
Although listed in the index, some information is not publicly 
available, e.g., CBI or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available either in the electronic docket at https://

[[Page 33812]]

www.regulations.gov, or, if only available in hard copy, at the OPP 
Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 
2777 S. Crystal Dr., Arlington, VA. The hours of operation of this 
Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Joseph Hogue, Field and External 
Affairs Division (7506P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-9072; fax number: (703) 305-5884; e-
mail address: hogue.joe@epa.gov.

SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested in?

    Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits 
comments and information to enable it to:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the Agency, 
including whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimates of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to 
be collected.
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses. In particular, EPA is requesting comments from 
very small businesses (those that employ less than 25) on examples of 
specific additional efforts that EPA could make to reduce the paperwork 
burden for very small businesses affected by this collection.

II. What Should I Consider when I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible and provide specific 
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified 
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

III. What Information Collection Activity or ICR Does this Action Apply 
to?

    Affected entities: Entities potentially affected by this action are 
those that submit protocols and study reports for environmental 
research involving human subjects under the pesticide laws, typically 
registrants of pesticide products (NAICS 325320).
    Title: Submission of Protocols and Study Reports for Environmental 
Research Involving Human Subjects.
    ICR numbers: EPA ICR No. 2195.03, OMB Control No. 2070-0169.
    ICR status: This ICR is currently scheduled to expire on January 
31, 2009. 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: 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). 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 
institutional review board (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 intentional dosing of human 
subjects when such research is submitted to EPA. Responses to this 
collection of information are mandatory.
    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 32 
hours per response for research involving intentional exposure of human 
subjects, and 12 hours per response for all other submitted research 
with human subjects. Burden means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, or 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements which have subsequently changed; train 
personnel to be able to respond to a collection of information; search 
data sources; complete and review the collection of information; and 
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of this estimate, which is 
only briefly summarized here:
    Estimated total number of potential respondents: 62.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 1,404 hours.
    Estimated total annual costs: $84,674. This includes an estimated 
burden cost of $84,674 with no additional cost for capital investment 
or maintenance and operational costs.

IV. Are There Changes in the Estimates from the Last Approval?

    There is no change in the total estimated respondent burden 
compared with that identified in the ICR currently approved by OMB.

[[Page 33813]]

V. What is the Next Step in the Process for this ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce 
the submission of the ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the person listed under FOR 
FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.


    Dated: June 4, 2008.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic 
Substances.

[FR Doc. E8-13346 Filed 6-12-08; 8:45 am]
BILLING CODE 6560-50-S
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