[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80360-80361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32516]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0713; FRL-9937-15]


Agency Information Collection Activities; Proposed Renewal of 
Collection; Comment Request

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA), this 
document announces that EPA is planning to submit an Information 
Collection Request (ICR) to the Office of Management and Budget (OMB). 
The ICR, entitled: ``Submission of Protocols and Study Reports for 
Environmental Research Involving Human Subjects''; identified by EPA 
ICR No. 2195.05 and OMB Control No. 2070-0169, represents the renewal 
of an existing ICR that is scheduled to expire on August 31, 2016. 
Before submitting the ICR to OMB for review and approval, EPA is 
soliciting comments on specific aspects of the proposed information 
collection that is summarized in this document. The ICR and 
accompanying material are available in the docket for public review and 
comment.

DATES: Comments must be received on or before February 22, 2016.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2015-0713, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

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: [email protected].

SUPPLEMENTARY INFORMATION:

I. What information is EPA particularly interested in?

    Pursuant to PRA section 3506(c)(2)(A) (44 U.S.C. 3506(c)(2)(A)), 
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 information collection activity or ICR does this action apply 
to?

    Title: Submission of Protocols and Study Reports for Environmental 
Research Involving Human Subjects.
    ICR number: EPA ICR No. 2195.05.
    OMB control number: OMB Control No. 2070-0169.
    ICR status: This ICR is currently scheduled to expire on August 31, 
2016. 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 Code of Federal Regulations (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 
for certain EPA regulations is consolidated in 40 CFR part 9.
    Abstract: The U.S. Environmental Protection Agency (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 subjects of ``third-party'' human 
research (i.e., research that is not conducted or supported by EPA).\1\ 
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.
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    \1\ To access the revised regulation go to: http://www.gpo.gov/fdsys/pkg/FR-2013-02-14/html/2013-03456.htm
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    Burden statement: The annual public reporting and recordkeeping 
burden for this collection of information is estimated to average 2,131 
hours per response. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related 
materials, provides a detailed explanation of the collection activities 
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Any entity that submits protocols 
and study reports for environmental research involving human subjects 
under FIFRA and/or FFDCA.
    Estimated total number of potential respondents: 5 annually for 
research involving intentional exposure of human subjects and 10 
annually for all

[[Page 80361]]

other submitted research with human subjects.
    Frequency of response: On occasion.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 10,595 hours for research 
involving intentional exposure of human subjects, and 120 hours for all 
other submitted research with human subjects.
    Estimated total annual costs: $948,655. This includes $0 for 
capital investment or maintenance and operational costs.

III. Changes in the Estimates

    There is a decrease of 4,238 hours in the total estimated 
respondent burden compared with that identified in the ICR currently 
approved by OMB. This decrease is due to a decrease in anticipated 
number of responses per year. This change is an adjustment.

IV. 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 document 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.

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

    Dated: December 4, 2015.
Jim Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2015-32516 Filed 12-23-15; 8:45 am]
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