[Federal Register Volume 77, Number 140 (Friday, July 20, 2012)]
[Pages 42723-42724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17746]



[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, 

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: [email protected].

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

[[Page 42724]]

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]