Document ID: EPA-HQ-OPP-2008-0414-0008
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects; EPA ICR No. 2195.03, OMB Control No. 2070-0169
Posted Date: 2008-12-12T05:00Z

[Federal Register: December 12, 2008 (Volume 73, Number 240)]
[Notices]               
[Page 75707-75709]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12de08-66]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2008-0414; FRL-8751-2]

 
Agency Information Collection Activities; Submission to OMB for 
Review and Approval; 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.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44 
U.S.C. 3501 et seq.), this document

[[Page 75708]]

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 January 12, 
2009.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OPP-
2008-0414, to (1) EPA online using www.regulations.gov (our preferred 
method), by e-mail to opp.ncic@epa.gov, or by mail to: OPP Regulatory 
Public Docket (7502P), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460, and (2) OMB by mail to: Office of Information and 
Regulatory Affairs, Office of Management and Budget (OMB), Attention: 
Desk Officer for EPA, 725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Joseph Hogue, Field and External 
Affairs Division, Office of Pesticide Programs, (7506P), Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: 703-308-9072; fax number: 703-305-5884; e-mail 
address: hogue.joe@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 June 13, 2008 (73 FR 33811), EPA sought comments on this 
ICR pursuant to 5 CFR 1320.8(d). EPA received two comments during the 
comment period, which are addressed in the ICR. 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-OPP-2008-0414, 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 Building), 2777 S. 
Crystal Drive, Arlington, VA. This docket facility is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
docket telephone number is (703) 305-5805.
    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: 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 scheduled to expire on January 31, 2009. 
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: 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 final rule significantly 
strengthened and expanded the protections for subjects of ``third-
party'' human research (i.e., research that is not conducted or 
supported by EPA). Affected entities are required to submit information 
to EPA and an institutional review board (IRB) prior to initiating, and 
to EPA upon the completion of, certain studies that involve human 
research participants. The information collection activity imposed by 
this final rule consists of activity-driven reporting and recordkeeping 
requirements for those who intend to conduct research for submission to 
EPA under the pesticide laws. If such research involves intentional 
dosing of human subjects, these individuals (respondents) are required 
to submit study protocols to EPA and a cognizant local Human Subjects 
IRB before such research is initiated so that the scientific design and 
ethical standards that will be employed during the proposed study may 
be reviewed and approved. Also, respondents are required to submit 
information about the ethical conduct of completed research that 
involved human subjects when such research is submitted to EPA.
    This renewal ICR estimates the third party response burden from 
complying with the January 2006 final rule. Information is typically 
submitted by registrants of pesticide products to support the 
registration of their products. Responses to this collection of 
information are mandatory. The authority for this information 
collection is provided under section 25 of FIFRA and 40 CFR part 26.
    Burden Statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 598 
hours per response for research involving intentional exposure of human 
subjects, and 12 hours per response for all other submitted research 
with human subjects. 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.
    Respondents/Affected Entities: Pesticide registrants.
    Estimated Number of Responses: 54.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 20,572.
    Estimated Total Annual Cost: $1,579,098, includes $0 annualized 
capital or O&M costs.
    Changes in the Estimates: There is an increase of 19,168 hours in 
the total estimated burden currently identified in the OMB Inventory of 
Approved ICR Burdens. This increase is an adjustment to the estimate, 
based on input received during the consultation process from entities 
that have submitted human subjects research since the implementation of 
the rule. The burden estimates in the previous (new) ICR were developed 
before the rule was

[[Page 75709]]

implemented, and were based on EPA's predictions of how long it would 
take study sponsors to prepare submissions. Based on the information 
provided in the consultation responses, it appears that the actual 
amount of time necessary to comply with the paperwork and recordkeeping 
requirements is higher than originally estimated.

    Dated: December 8, 2008.
John Moses,
Acting Director, Collection Strategies Division.
[FR Doc. E8-29483 Filed 12-11-08; 8:45 am]

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