Document ID: EPA-HQ-OPP-2015-0713-0010
Agency: epa
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Submission of Protocols and Study Reports for Environmental Research Involving Human Subjects
Posted Date: 2016-08-29T04:00Z

[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Notices]
[Pages 59224-59225]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20605]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0713; FRL-9948-78-OEI]

Agency Information Collection Activities; Submitted to OMB for 
Review and Approval; Comment Request; Submission of Protocols and Study 
Reports for Environmental Research Involving Human Subjects

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: EPA has submitted the following information collection request 
(ICR) to the Office of Management and Budget (OMB) for review and 
approval in accordance with the Paperwork Reduction Act (PRA): 
``Submission of Protocols and Study Reports for Environmental Research 
Involving Human Subjects'' (EPA ICR No. 2195.05, OMB Control No. 2070-
0169). This is a request to renew the approval of an existing ICR, 
which is currently approved through August 31, 2016. EPA did not 
receive any comments in response to the previously provided public 
review opportunity issued in the Federal Register of December 24, 2015 
(80 FR 80360). With this submission, EPA is providing an additional 30 
days for public review.

DATES: Comments must be received on or before September 28, 2016.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2015-0713, to both EPA and OMB as follows:
     To EPA online using http://www.regulations.gov (our 
preferred method) or by mail to: EPA Docket Center, Environmental 
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460.
     To OMB via email to oira_submission@omb.eop.gov. Address 
comments to OMB Desk Officer for EPA.
    EPA's policy is that all comments received will be included in the 
docket without change, including any personal information provided, 
unless the comment includes profanity, threats, information claimed to 
be Confidential Business Information (CBI), or other information for 
which disclosure is

[[Page 59225]]

restricted by statute. Do not submit electronically any information you 
consider to be CBI or other information for which disclosure is 
restricted by statute.

FOR FURTHER INFORMATION CONTACT: Ram[eacute] Cromwell, Field and 
External Affairs Division (7605P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 308-9068; email 
address: cromwell.rame@epa.gov.

SUPPLEMENTARY INFORMATION:
    Docket: Supporting documents, including the ICR that explains in 
detail the information collection activities and the related burden and 
cost estimates that are summarized in this document, are available in 
the docket for this ICR. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, West William 
Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., 
Washington, DC. The telephone number for the Docket Center is (202) 
566-1744. For additional information about EPA's public docket, visit 
http://www.epa.gov/dockets.
    ICR status: This ICR is currently scheduled to expire on August 31, 
2016. Under OMB regulations, the Agency may continue to conduct or 
sponsor the collection of information while this submission is pending 
at OMB.
    Under the PRA, 44 U.S.C. 3501 et seq., 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 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 for certain EPA regulations is consolidated in 40 CFR 
part 9.
    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 and 
2013, EPA regulations at 40 CFR part 26 protect the 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 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.
    Respondents/Affected Entities: Entities potentially affected by 
this ICR are any entities that submits protocols and study reports for 
environmental research involving human subjects under FIFRA and/or 
FFDCA.
    Respondent's obligation to respond: Mandatory (40 CFR part 26).
    Estimated total number of potential 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: On occasion.
    Estimated total burden: 10,242 hours (per year). Burden is defined 
at 5 CFR 1320.3(b).
    Estimated total costs: $ 923,121 (per year), includes $0 annualized 
capital investment or maintenance and operational costs.
    Changes in the estimates: There is a decrease of 4,711 hours in the 
total estimated respondent burden compared with that identified in the 
ICR currently approved by OMB. This decrease is due to a reduction in 
the preparation of protocols and studies. This change is an adjustment.

    Authority: 44 U.S.C. 3501 et seq.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2016-20605 Filed 8-26-16; 8:45 am]
 BILLING CODE 6560-50-P