81 FR 59224 - 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

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 167 (August 29, 2016)

Page Range		59224-59225
FR Document		2016-20605

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.

Federal Register, Volume 81 Issue 167 (Monday, August 29, 2016)

[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Notices]
[Pages 59224-59225]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-20605]


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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.

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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 [email protected]. 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: [email protected].

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

59224 Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Notices

Evaporative Emissions from New and public docket, visit http://www.epa.gov/ evaporative testing promulgated in 40
In-Use Portable Gasoline Containers dockets. CFR part 59.
(Renewal),’’ (EPA ICR No. 2213.05, Abstract: EPA is required under Courtney Kerwin,
OMB Control No. 2060–0597) to the section 183(e) of the Clean Air Act to
Office of Management and Budget Director, Regulatory Support Division.
regulate Volatile Organic Compound [FR Doc. 2016–20617 Filed 8–26–16; 8:45 am]
(OMB) for review and approval in
(VOC) emissions from the use of
accordance with the Paperwork BILLING CODE 6560–50–P
consumer and commercial products.
Reduction Act (44 U.S.C. 3501 et seq.).
This is a proposed extension of the ICR, Under regulations promulgated on
which is currently approved through February 26, 2007 (72 FR 8428) ENVIRONMENTAL PROTECTION
August 31, 2016. Public comments were manufacturers of new portable gasoline AGENCY
previously requested via the Federal containers are required to obtain [EPA–HQ–OPP–2015–0713; FRL–9948–78–
Register (81 FR 23293) on April 20, certificates of conformity with the Clean OEI]
2016 during a 60-day comment period. Air Act, effective January 1, 2009. This
This notice allows for an additional 30 ICR covers the burdens associated with Agency Information Collection
days for public comments. A fuller this certification process. EPA reviews Activities; Submitted to OMB for
description of the ICR is given below, information submitted in the Review and Approval; Comment
including its estimated burden and cost application for certification to Request; Submission of Protocols and
to the public. An Agency may not determine if the container design Study Reports for Environmental
conduct or sponsor and a person is not conforms to applicable requirements Research Involving Human Subjects
required to respond to a collection of and to verify that the required testing AGENCY: Environmental Protection
information unless it displays a has been performed. The certificate Agency (EPA).
currently valid OMB control number. holder is required to keep records on the ACTION: Notice.
DATES: Additional comments may be testing and collect and keep warranty
submitted on or before September 28, and defect information for annual SUMMARY: EPA has submitted the
2016. reporting on in-use performance of their following information collection request
products. The respondent must also (ICR) to the Office of Management and
ADDRESSES: Submit your comments, Budget (OMB) for review and approval
referencing Docket ID Number EPA– retain records on the units produced,
apply serial numbers to individual in accordance with the Paperwork
HQ–OAR–2013–0118, to (1) EPA online Reduction Act (PRA): ‘‘Submission of
using www.regulations.gov (our containers, and track the serial numbers
to their certificates of conformity. Any Protocols and Study Reports for
preferred method), or by mail to: EPA Environmental Research Involving
Docket Center, Environmental information submitted for which a claim
of confidentiality is made is safeguarded Human Subjects’’ (EPA ICR No. 2195.05,
Protection Agency, Mail Code 28221T, OMB Control No. 2070–0169). This is a
1200 Pennsylvania Ave. NW., according to EPA regulations at 40 CFR
request to renew the approval of an
Washington, DC 20460, and (2) OMB via 2.201 et seq.
existing ICR, which is currently
email to oira_submission@omb.eop.gov. Form Numbers: None. approved through August 31, 2016. EPA
Address comments to OMB Desk Officer did not receive any comments in
Respondents/affected entities:
for EPA. response to the previously provided
Manufacturers of new portable gasoline
EPA’s policy is that all comments public review opportunity issued in the
received will be included in the public containers from 0.25 to 10.0 gallons in
capacity. Federal Register of December 24, 2015
docket without change including any (80 FR 80360). With this submission,
personal information provided, unless Respondent’s obligation to respond: EPA is providing an additional 30 days
the comment includes profanity, threats, Mandatory 40 CFR part 59, subpart F. for public review.
information claimed to be Confidential Estimated number of respondents: 8 DATES: Comments must be received on
Business Information (CBI) or other (total). or before September 28, 2016.
information whose disclosure is
restricted by statute. Frequency of response: Yearly for ADDRESSES: Submit your comments,
warranty reports; at least once every five identified by docket identification (ID)
FOR FURTHER INFORMATION CONTACT: Julia
years for certificate renewals. number EPA–HQ–OPP–2015–0713, to
Giuliano, Compliance Division, Office both EPA and OMB as follows:
of Transportation and Air Quality, U.S. Total estimated burden: 250 hours
• To EPA online using http://
Environmental Protection Agency, 2000 (per year). Burden is defined at 5 CFR
www.regulations.gov (our preferred
Traverwood, Ann Arbor, Michigan 1320.3(b) method) or by mail to: EPA Docket
48105; telephone number: 734–214– Total estimated cost: $32,419.45 (per Center, Environmental Protection
4865; fax number 734–214–4869; email year), includes $20,452 annualized Agency, Mail Code 28221T, 1200
address: giuliano.julia@epa.gov. capital or operation & maintenance Pennsylvania Ave. NW., Washington,
SUPPLEMENTARY INFORMATION: costs. DC 20460.
Supporting documents which explain in Changes in Estimates: There is an • To OMB via email to oira_
detail the information that the EPA will submission@omb.eop.gov. Address
increase of 71 hours in the total
be collecting are available in the public comments to OMB Desk Officer for EPA.
estimated respondent burden compared
docket for this ICR. The docket can be EPA’s policy is that all comments
jstallworth on DSK7TPTVN1PROD with NOTICES

viewed online at www.regulations.gov with the ICR currently approved by received will be included in the docket
or in person at the EPA Docket Center, OMB. This increase of the estimated without change, including any personal
WJC West, Room 3334, 1301 burden and cost estimates is due to a information provided, unless the
Constitution Ave. NW., Washington, change in the estimated cost of labor comment includes profanity, threats,
DC. The telephone number for the and additional testing requirements for information claimed to be Confidential
Docket Center is 202–566–1744. For new portable fuel container families to Business Information (CBI), or other
additional information about EPA’s comply with the requirements for information for which disclosure is

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Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Notices 59225

restricted by statute. Do not submit consists of activity-driven reporting and SUMMARY: In accordance with the
electronically any information you recordkeeping requirements for those Federal Advisory Committee Act
consider to be CBI or other information who intend to conduct research for (FACA), this notice advises interested
for which disclosure is restricted by submission to EPA under the pesticide persons that the Federal
statute. laws. If such research involves Communications Commission’s (FCC)
FOR FURTHER INFORMATION CONTACT: intentional dosing of human subjects, Task Force on Optimal Public Safety
Ramé Cromwell, Field and External these individuals (respondents) are Answering Point (PSAP) Architecture
Affairs Division (7605P), Office of required to submit study protocols to (Task Force) will hold its eighth
Pesticide Programs, Environmental EPA and a cognizant local Human meeting.
Protection Agency, 1200 Pennsylvania Subjects IRB before such research is DATES: September 23, 2016.
Ave. NW., Washington, DC 20460–0001; initiated so that the scientific design ADDRESSES: Federal Communications
telephone number: (703) 308–9068; and ethical standards that will be Commission, Room TW–C305
email address: cromwell.rame@epa.gov. employed during the proposed study (Commission Meeting Room), 445 12th
may be reviewed and approved. Also, Street SW., Washington, DC 20554.
SUPPLEMENTARY INFORMATION:
Docket: Supporting documents, respondents are required to submit
FOR FURTHER INFORMATION CONTACT:
including the ICR that explains in detail information about the ethical conduct of Timothy May, Federal Communications
the information collection activities and completed research that involved Commission, Public Safety and
the related burden and cost estimates human subjects when such research is Homeland Security Bureau, 202–418–
that are summarized in this document, submitted to EPA. 1463, email: timothy.may@fcc.gov.
are available in the docket for this ICR. Respondents/Affected Entities:
SUPPLEMENTARY INFORMATION: The
The docket can be viewed online at Entities potentially affected by this ICR
meeting will be held on September 23,
http://www.regulations.gov or in person are any entities that submits protocols
2016, from 1:00 p.m. to 4:00 p.m. in the
at the EPA Docket Center, West William and study reports for environmental
Commission Meeting Room of the FCC,
Jefferson Clinton Bldg., Rm. 3334, 1301 research involving human subjects
Room TW–305, 445 12th Street SW.,
Constitution Ave. NW., Washington, under FIFRA and/or FFDCA.
Washington, DC 20554. The Task Force
DC. The telephone number for the Respondent’s obligation to respond:
is a Federal Advisory Committee that
Docket Center is (202) 566–1744. For Mandatory (40 CFR part 26).
studies and reports findings and
Estimated total number of potential
additional information about EPA’s recommendations on PSAP structure,
respondents: 7 annually for research
public docket, visit http://www.epa.gov/ architecture, operations, and funding to
involving intentional exposure of
dockets. promote greater efficiency of PSAP
ICR status: This ICR is currently human subjects and 10 annually for all
operations, security, and cost
scheduled to expire on August 31, 2016. other submitted research with human
containment during the deployment of
Under OMB regulations, the Agency subjects.
Next Generation 911 systems. On
may continue to conduct or sponsor the Frequency of response: On occasion.
December 2, 2014, pursuant to the
collection of information while this Estimated total burden: 10,242 hours
FACA, the Commission established the
submission is pending at OMB. (per year). Burden is defined at 5 CFR
Task Force charter for a period of two
Under the PRA, 44 U.S.C. 3501 et 1320.3(b). years, through December 2, 2016. At this
seq., an agency may not conduct or Estimated total costs: $ 923,121 (per
meeting, the Task Force will hear
sponsor, and a person is not required to year), includes $0 annualized capital
updates on 2016 tasks from the Task
respond to, a collection of information, investment or maintenance and
Force’s three working groups: Working
unless it displays a currently valid OMB operational costs.
Group 1—Optimal Approach to
control number. The OMB control Changes in the estimates: There is a
Cybersecurity; Working Group 2—
numbers are displayed either by decrease of 4,711 hours in the total
Optimal Approach to NG911
publication in the Federal Register or estimated respondent burden compared
Architecture Implementation; and
by other appropriate means, such as on with that identified in the ICR currently
Working 3—Optimal Approach to
the related collection instrument or approved by OMB. This decrease is due
NG911 Resource Allocation.
form, if applicable. The display of OMB to a reduction in the preparation of Members of the general public may
control numbers for certain EPA protocols and studies. This change is an attend the meeting. The FCC will
regulations is consolidated in 40 CFR adjustment. attempt to accommodate as many
part 9. Authority: 44 U.S.C. 3501 et seq. attendees as possible; however,
Abstract: EPA is responsible for the admittance will be limited to seating
Courtney Kerwin,
regulation of pesticides under the availability. The Commission will
Federal Insecticide, Fungicide, and Director, Regulatory Support Division.
provide audio and/or video coverage of
Rodenticide Act (FIFRA) and the [FR Doc. 2016–20605 Filed 8–26–16; 8:45 am]
the meeting over the Internet from the
Federal Food, Drug, and Cosmetic Act BILLING CODE 6560–50–P FCC’s Web page at https://www.fcc.gov/
(FFDCA). As revised in 2006 and 2013, general/live.
EPA regulations at 40 CFR part 26 Open captioning will be provided for
protect the subjects of ‘‘third-party’’ FEDERAL COMMUNICATIONS this event. Other reasonable
human research (i.e., research that is not COMMISSION accommodations for people with
conducted or supported by EPA). In disabilities are available upon request.
addition to other protections, the Public Safety and Homeland Security Requests for such accommodations
jstallworth on DSK7TPTVN1PROD with NOTICES

regulations require affected entities to Bureau; Federal Advisory Committee should be submitted via email to
submit information to EPA and an Act; Task Force on Optimal Public fcc504@fcc.gov or by calling the
institutional review board (IRB) prior to Safety Answering Point Architecture Consumer & Governmental Affairs at
initiating, and to EPA upon the AGENCY: Federal Communications (202) 418–0432 (TTY). Such requests
completion of, certain studies that Commission. should include a detailed description of
involve human research participants. the accommodation requested. In
ACTION: Notice of public meeting.
The information collection activity addition, please include a way the FCC

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Document Created: 2016-08-26 23:49:25
Document Modified: 2016-08-26 23:49:25

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Comments must be received on or before September 28, 2016.
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
FR Citation		81 FR 59224