80 FR 80360 - Agency Information Collection Activities; Proposed Renewal of Collection; Comment Request

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 247 (December 24, 2015)

Page Range		80360-80361
FR Document		2015-32516

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.

Federal Register, Volume 80 Issue 247 (Thursday, December 24, 2015)

[Federal Register Volume 80, Number 247 (Thursday, December 24, 2015)]
[Notices]
[Pages 80360-80361]
From the Federal Register Online [www.thefederalregister.org]
[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: cromwell.rame@epa.gov.

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.thefederalregister.org/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]
BILLING CODE 6560-50-P

80360 Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices

Dated: December 18, 2015. FOR FURTHER INFORMATION CONTACT: appropriate means, such as on the
Janis Hastings, Ramé Cromwell, Field and External related collection instrument or form, if
Acting Director, Office of Air, Waste and Affairs Division (7605P), Office of applicable. The display of OMB control
Toxics. Pesticide Programs, Environmental numbers for certain EPA regulations is
[FR Doc. 2015–32510 Filed 12–23–15; 8:45 am] Protection Agency, 1200 Pennsylvania consolidated in 40 CFR part 9.
BILLING CODE 6560–50–P Ave., NW., Washington, DC 20460– Abstract: The U.S. Environmental
0001; telephone number: (703) 308– Protection Agency (EPA) is responsible
9068; email address: cromwell.rame@ for the regulation of pesticides under
ENVIRONMENTAL PROTECTION epa.gov. the Federal Insecticide, Fungicide, and
AGENCY Rodenticide Act (FIFRA) and the
SUPPLEMENTARY INFORMATION:
[EPA–HQ–OPP–2015–0713; FRL–9937–15] Federal Food, Drug, and Cosmetic Act
I. What information is EPA particularly (FFDCA). As revised in 2006 and 2013,
Agency Information Collection interested in? EPA regulations at 40 CFR part 26
Activities; Proposed Renewal of Pursuant to PRA section 3506(c)(2)(A) protect subjects of ‘‘third-party’’ human
Collection; Comment Request (44 U.S.C. 3506(c)(2)(A)), EPA research (i.e., research that is not
specifically solicits comments and conducted or supported by EPA).1 In
AGENCY: Environmental Protection addition to other protections, the
Agency (EPA). information to enable it to:
1. Evaluate whether the proposed regulations require affected entities to
ACTION: Notice. submit information to EPA and an
collection of information is necessary
SUMMARY: In compliance with the for the proper performance of the institutional review board (IRB) prior to
Paperwork Reduction Act (PRA), this functions of the Agency, including initiating, and to EPA upon the
document announces that EPA is whether the information will have completion of, certain studies that
planning to submit an Information practical utility. involve human research participants.
Collection Request (ICR) to the Office of 2. Evaluate the accuracy of the The information collection activity
Management and Budget (OMB). The Agency’s estimates of the burden of the consists of activity-driven reporting and
ICR, entitled: ‘‘Submission of Protocols proposed collection of information, recordkeeping requirements for those
and Study Reports for Environmental including the validity of the who intend to conduct research for
Research Involving Human Subjects’’; methodology and assumptions used. submission to EPA under the pesticide
identified by EPA ICR No. 2195.05 and 3. Enhance the quality, utility, and laws. If such research involves
OMB Control No. 2070–0169, represents clarity of the information to be intentional dosing of human subjects,
the renewal of an existing ICR that is collected. these individuals (respondents) are
scheduled to expire on August 31, 2016. 4. Minimize the burden of the required to submit study protocols to
Before submitting the ICR to OMB for collection of information on those who EPA and a cognizant local Human
review and approval, EPA is soliciting are to respond, including through the Subjects IRB before such research is
comments on specific aspects of the use of appropriate automated electronic, initiated so that the scientific design
proposed information collection that is mechanical, or other technological and ethical standards that will be
summarized in this document. The ICR collection techniques or other forms of employed during the proposed study
and accompanying material are information technology, e.g., permitting may be reviewed and approved. Also,
available in the docket for public review electronic submission of responses. In respondents are required to submit
and comment. particular, EPA is requesting comments information about the ethical conduct of
DATES: Comments must be received on from very small businesses (those that completed research that involved
or before February 22, 2016. employ less than 25) on examples of human subjects when such research is
ADDRESSES: Submit your comments, specific additional efforts that EPA submitted to EPA.
identified by docket identification (ID) could make to reduce the paperwork Burden statement: The annual public
number EPA–HQ–OPP–2015–0713, by burden for very small businesses reporting and recordkeeping burden for
one of the following methods: affected by this collection. this collection of information is
• Federal eRulemaking Portal: http:// II. What information collection activity
estimated to average 2,131 hours per
www.regulations.gov. Follow the online response. Burden is defined in 5 CFR
or ICR does this action apply to? 1320.3(b).
instructions for submitting comments.
Do not submit electronically any Title: Submission of Protocols and The ICR, which is available in the
information you consider to be Study Reports for Environmental docket along with other related
Confidential Business Information (CBI) Research Involving Human Subjects. materials, provides a detailed
or other information whose disclosure is ICR number: EPA ICR No. 2195.05. explanation of the collection activities
restricted by statute. OMB control number: OMB Control and the burden estimate that is only
• Mail: OPP Docket, Environmental No. 2070–0169. briefly summarized here:
Protection Agency Docket Center (EPA/ ICR status: This ICR is currently Respondents/Affected Entities: Any
DC), (28221T), 1200 Pennsylvania Ave. scheduled to expire on August 31, 2016. entity that submits protocols and study
NW., Washington, DC 20460–0001. An Agency may not conduct or sponsor, reports for environmental research
• Hand Delivery: To make special and a person is not required to respond involving human subjects under FIFRA
arrangements for hand delivery or to, a collection of information, unless it and/or FFDCA.
mstockstill on DSK4VPTVN1PROD with NOTICES

delivery of boxed information, please displays a currently valid OMB control Estimated total number of potential
follow the instructions at http:// number. The OMB control numbers for respondents: 5 annually for research
www.epa.gov/dockets/contacts.html. EPA’s regulations in title 40 of the Code involving intentional exposure of
Additional instructions on commenting of Federal Regulations (CFR), after human subjects and 10 annually for all
or visiting the docket, along with more appearing in the Federal Register when
information about dockets generally, is approved, are listed in 40 CFR part 9, 1 To access the revised regulation go to: http://
available at http://www.epa.gov/ are displayed either by publication in www.gpo.gov/fdsys/pkg/FR-2013-02-14/html/2013-
dockets. the Federal Register or by other 03456.htm

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Federal Register / Vol. 80, No. 247 / Thursday, December 24, 2015 / Notices 80361

other submitted research with human IV. What is the next step in the process Dated: December 4, 2015.
subjects. for this ICR? Jim Jones,
Frequency of response: On occasion. Assistant Administrator, Office of Chemical
Estimated total average number of EPA will consider the comments Safety and Pollution Prevention.
responses for each respondent: 1. received and amend the ICR as [FR Doc. 2015–32516 Filed 12–23–15; 8:45 am]
Estimated total annual burden hours: appropriate. The final ICR package will BILLING CODE 6560–50–P
10,595 hours for research involving then be submitted to OMB for review
intentional exposure of human subjects, and approval pursuant to 5 CFR
and 120 hours for all other submitted 1320.12. EPA will issue another Federal
FEDERAL COMMUNICATIONS
research with human subjects. Register document pursuant to 5 CFR COMMISSION
Estimated total annual costs: 1320.5(a)(1)(iv) to announce the
$948,655. This includes $0 for capital submission of the ICR to OMB and the Deletion of Agenda Items From
investment or maintenance and opportunity to submit additional December 17, 2015 Open Meeting
operational costs. comments to OMB. If you have any
questions about this ICR or the approval December 17, 2015.
III. Changes in the Estimates The following items have been
process, please contact the person listed
There is a decrease of 4,238 hours in under FOR FURTHER INFORMATION deleted from the list of Agenda items
the total estimated respondent burden CONTACT. scheduled for consideration at the
compared with that identified in the ICR Thursday, December 17, 2015, Open
currently approved by OMB. This Authority: 44 U.S.C. 3501 et seq. Meeting and previously listed in the
decrease is due to a decrease in Commission’s Notice of December 10,
anticipated number of responses per 2015. These items have been adopted by
year. This change is an adjustment. the Commission.

Item No. Bureau Subject

2 ................... MEDIA ....................................................... TITLE: Amendment of Parts 73 and 74 of the Commission’s Rules to Establish
Rules for Digital Low Power Television and Television Translator Stations (MB
Docket No. 03–185); Expanding the Economic and Innovation Opportunities of
Spectrum Through Incentive Auctions (GN Docket No. 12–268); Amendment of
Part 15 of the Commission’s Rules to Eliminate the Analog Turner Requirement
(ET Docket No. 14–175) .
SUMMARY: The Commission will consider a Third Report and Order that extends
the deadline for LPTV and TV Translator Stations to Transition to Digital and
adopts measures to mitigate the impact of incentive auction displacement. The
Fourth Notice of Proposed Rulemaking seeks comment on channel sharing
issues between certain stations.

Consent Agenda consent agenda and these items will not
The Commission will consider the be presented individually:
following subjects listed below as a

1 ................... MEDIA ....................................................... TITLE: Application of Hampton Roads Educational Telecommunications Association
for a New Noncommercial Educational FM Station at Gloucester Point.
SUMMARY: The Commission will consider a Memorandum Opinion and Order con-
cerning a joint Application for Review challenging the grant of an application filed
by Hampton Roads Educational Telecommunications Association for a new NCE
FM station.
2 ................... MEDIA ....................................................... TITLE: Public Media of New England, Inc. Application for a New LPFM Station at
Haverhill, Massachusetts.
SUMMARY: The Commission will consider a Memorandum Opinion and Order con-
cerning an Application for Review filed by Boston Radio Association seeking re-
view of the grant of a construction permit for a new LPFM station to Public Media
of New England, Inc.
3 ................... MEDIA ....................................................... TITLE: Cocoa Minority Educational Media Association, Application for a New LPFM
Station at Cocoa, Florida.
SUMMARY: The Commission will consider a Memorandum Opinion and Order con-
cerning an Application for Review filed by Cocoa Minority Educational Media As-
sociation seeking review of CMEMA’s dismissed application for a new LPFM sta-
tion.
4 ................... MEDIA ....................................................... TITLE: California Association for Research and Education, Inc., Application for a
New Noncommercial Educational FM Broadcast Station at Upton, KY, and Bethel
mstockstill on DSK4VPTVN1PROD with NOTICES

Fellowship, Inc., Application for a New Noncommercial Educational FM Broadcast
Station at Cecilia, Kentucky.
SUMMARY: The Commission will consider an Order on Reconsideration in which
Bethel seeks reconsideration of a denial of its Application for Review seeking de-
nial of CARE’s noncommercial educational FM application.

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Document Created: 2015-12-24 02:25:03
Document Modified: 2015-12-24 02:25:03

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 February 22, 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		80 FR 80360