[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Pages 65674-65676]
[FR Doc No: 2023-20678]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0457; FRL-11399-01-OCSPP]

Pesticides; Request for Stakeholder Input on the Proposed Design
of a New Grant Program Regarding the Health Care Provider (HCP)
Training Program; Notice of Availability and Opportunity for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of a Request for Information (RFI) that seeks public
comment on a proposed design for the new grant program related to the
Health Care Provider (HCP) Training Program, a cooperative agreement to
help medical professionals better prevent, recognize, treat, and manage
pesticide-related illness. The Pesticide Registration Improvement Act
of 2022 (referred to as PRIA 5) included set-asides of up to $2.5
million for fiscal years 2023-2027 to fund the HCP Training Program.
PRIA 5 also requires EPA to seek input from

persons who conduct farmworker education and training, or technical
assistance and training of healthcare providers, to inform the design
of the grant program. EPA has previously solicited input on the HCP
Training Program design through its Federal advisory committees, which
include representatives of these stakeholders. The purpose of this RFI
is to solicit additional stakeholder feedback from a broad array of
individuals and organizations with knowledge and expertise related to
the goals of the HCP Training Program. Additional public input,
including environmental justice perspectives, will help the Agency
refine the HCP Training Program and design a grant program to more
effectively support populations that have historically been at high
risk from pesticide-related illness.

DATES: Submit your comments on or before November 24, 2023.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0457, through the Federal eRulemaking
Portal at https://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. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Aidan Black, Office of Chemical Safety
and Pollution Prevention, Pesticide Re-evaluation Division (7508M),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

    This notice is directed to the general public and may be of
specific interest to entities that conduct education and training of
farmworkers, or technical assistance and training of healthcare
providers (e.g., governmental and non-governmental organizations, non-
profits, community-based organizations, academic institutions, research
institutions, medical institutions, medical associations, community
health centers and clinics, public health administration and
environmental health administration programs, Indian Tribes, and
private sector entities). Because others may also be interested in this
notice, EPA has not attempted to describe all the entities that may be
interested in the subject covered in this notice.

B. What is the Agency's authority for taking this action?

    The Pesticide Registration Improvement Act of 2022 (referred to as
PRIA 5), Public Law 117-328, amended the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., to
include up to $2,500,000 of set-aside funds for an HCP Training
Program. Funds are for fiscal years 2023 through 2027.
    Under PRIA section 703(a)(1)(H)(i), the HCP Training Program should
provide grants to nonprofit organizations to help medical professionals
better prevent, recognize, treat, and manage pesticide-related illness
through technical assistance and training; the development of
informational materials for technical assistance and training; and the
development of outreach and delivery methods.
    PRIA section 703(a)(1)(H)(ii) specifies that only nonprofit
organizations with demonstrated experience in providing training and
technical assistance to health care providers who serve farmworker
populations are eligible to receive this funding.

C. Why is EPA taking this action?

    This action satisfies PRIA section 703(a)(1)(K)(iv) which requires
that EPA seek, in an open and transparent manner that does not provide
a competitive advantage to any person or persons, input from persons
who conduct farmworker education and training, or technical assistance
and training of healthcare providers.

D. What should I consider as I prepare my comments?

    1. Submitting CBI. Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your
comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the
part or all of the information that you claim to be CBI. In addition to
one complete version of the comment that includes information claimed
as CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

II. Background

    EPA previously solicited feedback from the Farmworker and Clinician
Training Workgroup of the Pesticide Programs Dialogue Committee (PPDC),
a Federal advisory committee group. The PPDC workgroup--which included
representatives of community-based organizations that serve
farmworkers, healthcare providers, and Indian Tribes; university
extension programs; industry; State regulators; farm bureaus; other
Federal agencies; and current grantees under EPA cooperative
agreements--met monthly for most of a year and formulated a set of nine
recommendations (the recommendations can be found at https://www.epa.gov/system/files/documents/2021-10/presentation-farmworker-and-clinician-training-workgroup-recommendations.pdf). The National
Environmental Justice Advisory Council and the Children's Health
Protection Advisory Committee provided related anecdotes and reiterated
some of the recommendations of the PPDC workgroup. EPA has incorporated
these recommendations into the proposed program design. The Request for
Information (RFI), which is available in the docket, seeks additional
feedback to build upon those recommendations.

III. Request for Public Comment

A. What feedback does EPA hope to gain from the public comments?

    In the RFI, the Agency has proposed a design for the HCP Training
Program and has posed a series of questions on that design. Generally,
EPA is interested in comments about the types of activities the program
could support; about populations at high risk of pesticide-related
illness (and who would thus benefit from more highly trained
clinicians); and about additional ways to ensure that training and
technical assistance under the program accounts for the cultural
context, social determinants of health, and vulnerabilities of those
populations.
    The project objectives are: (1) Administer a national training and
technical assistance program to improve the prevention, recognition,
treatment, management, and reporting of pesticide-related illness by
HCP; and (2) Administer a partnership program to inform the Objective 1
activities and ensure they have both national reach

and local applicability. Each objective has both subobjectives and
suggested emphasis areas. For the complete program design, please
consult the RFI. EPA's questions are as follows:
     How can EPA and future grantees expand upon the work done
through previous cooperative agreements to build HCP capacity,
capitalize on existing resources, and avoid duplicating efforts?
     What populations--besides farmworkers, pesticide handlers,
and applicators--are at high risk of pesticide-related illness and
would benefit from more highly trained HCPs?
     How can EPA ensure that activities under Objective 1
(training and technical assistance) are responsive to the social
determinants of health, cultural context, and vulnerabilities of
patients at high risk of pesticide-related illness?
     What steps can future grantees take to ensure that
recognition, treatment, and management of pesticide-related illness
continue to improve at local partner organizations after the project
has concluded? What steps can they take to ensure that reporting
continues to improve?
     What networks, organizations, and stakeholders are
examples of collaborators under Objective 2 (partnership program)?
Which could be effective at monitoring and evaluating the project?
     What are examples of activities that this cooperative
agreement could support under Objective 1 (training and technical
assistance)? Under Objective 2 (partnership program)?
     Do the objectives, as written, exclude any collaborators
or activities that would support the program goals?

B. What is the request for information?

    In addition to soliciting comment on the questions posed in Unit
III.A. of this document, EPA is seeking stakeholder input on the RFI
document that is available in the docket. Specifically, EPA is
interested in comments about the types of activities the program could
support; about populations at high risk of pesticide-related illness
(and who would thus benefit from more highly trained clinicians); and
about additional ways to ensure that training and technical assistance
under the program accounts for the cultural context, social
determinants of health, and vulnerabilities of these populations.
    EPA encourages all potentially interested parties, including
individuals, professional associations, governmental and non-
governmental organizations, academic institutions, research
institutions, medical institutions, non-profits, community-based
organizations, Indian Tribes, and private sector entities to provide
responses to any or all questions. To the extent possible, the Agency
asks commenters to please cite any public data related to or that
supports the responses, and to the extent permissible, describe any
supporting data that is not publicly available.
    Authority: 7 U.S.C. 136 et seq.

    Dated: September 19, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-20678 Filed 9-22-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 12 (Thursday, January 19, 2012)]
[Notices]
[Page 2716]
[FR Doc No: 2012-908]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-40-000]

Questar Pipeline Company; Notice of Application

    Take notice that on January 4, 2012, Questar Pipeline Company
(Questar), 180 East 100 South, P.O. Box 45360, Salt Lake City, Utah
84145-0360, filed an application in Docket No. CP12-40-000 pursuant to
section 7(c) of the Natural Gas Act (NGA), and Part 157 of the
Commission's regulations requesting authorization to construct and
modify natural gas facilities located on Questar's southern
transmission system in Duchesne and Uintah Counties, Utah, all as more
fully set forth in the application which is on file with the Commission
and open to public inspection. This filing is available for review at
the Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, please
contact FERC Online Support at<EMAIL_ADDRESS>or toll free
at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.
    Any questions regarding this application should be directed to L.
Bradley Burton, General Manager, Federal Regulatory Affairs and Chief
Compliance Officer, Questar Pipeline Company, 180 East 100 South, P.O.
Box 45360, Salt Lake City, Utah 84145-0360, or by calling (801) 324-
2459 (telephone<EMAIL_ADDRESS>or to Tad M. Taylor, Division
Counsel, Questar Pipeline Company, 180 East 100 South, P.O. Box 45360,
Salt Lake City, Utah 84145-0360, or by calling<PHONE_NUMBER>
(telephone<EMAIL_ADDRESS>    Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 1, 2012.

    Dated: January 11, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-908 Filed 1-18-12; 8:45 am]
BILLING CODE 6717-01-P


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Final Review Checklist for ICR Desk Officers  -  New, renewal and revision ICR Packages
INSTRUCTIONS: Complete Final Review Checklist for all new, renewal and revision ICRs. Provide checklist to Team Lead with the final ICR package.

ICR Information
ICR Title
Treatment of Indian Tribes in a Similar Manner as States for Purposes of Section 303(d) of the Clean Water Act (Renewal)
EPA ICR Number
2553.04
OMB Control Number
2040-0290
ICR Desk Officer
Teddy

Supporting Statement

                            Comments for Team Lead
                                      ☑
The Supporting Statement contains all major sections listed in the template.

                                      ☑
The title of the ICR is consistent with what it has been in the past or the ICR Owner has provided an explanation as to why it has changed.

                                      ☑
All Terms of Clearance from the previous ICR have been addressed.

                                      ☑
Section 3(b) includes the following information about the 1[st] FR Notice - publication date, FR citation, description of the comments received (if any), and EPA's response to the comments.

                                      ☑
Section 3(c) includes a description of the consultations conducted for this specific renewal package.

                                      ☑
Sections 6(b) and (c) include updated, loaded wage rates.

                                      ☑
Section 6(f) includes a detailed explanation of the reason for change and whether this change is a program change or an adjustment.
Note: If the ICRAS has both a program change and an adjustment, the change in hours and costs must be split accordingly between the two types of change.

                                      ☑
Section 6(g) includes the proper template language.

                                      ☑
The document contains tracked changes for all changes made.

                                      ☑
The document has one-inch margins, Times New Roman/12 point font.

                                      ☑
The document contains page numbers.

                                      ☑
The document is type is ".docx".

                                      ☑
The document name is in the following format - ####ss## if no changes were made or ####ss##initialsdate (e.g., 2000.01ck9-25-19) if changes were made.

Federal Register Notice

                            Comments for Team Lead
                              Header Information
                                      ☑
The document cites the correct (6560-50-P) billing code in the top right corner.

                                      ☑
The document cites the correct FRL Number.

                                      ☑
The ICR title matches exactly what is in the Supporting Statement.

                                    Summary
                                      ☑
The document cites the correct ICR Number, OMB Control Number, expiration date, and publication date of the 1[st] FR Notice.

                                      ☑
The summary section does not include any legal citations (i.e., CFR or USC references).

                           Supplementary Information
                                      ☑
The Abstract includes a comprehensive, but brief, description of the information collection.

                                      ☑
The form numbers listed are consistent with the form numbers listed in ICRAS, Part 2.

                                      ☑
The hour and cost burden matches exactly what is in the Supporting Statement and the total cost burden is split between labor costs and non-labor costs (capital and O&M costs)

                                      ☑
The Changes in the Estimates section addresses the amount of change, whether the change is an adjustment or program change, and a high-level explanation of the change.

                            Formatting, Edits, Etc.
                                      ☑
All of the standard template language is included and has not been changed.

                                      ☑
The document contains tracked changes for all changes made.

                                      ☑
All blue instructional language has been removed from the document.

                                      ☑
The document has one-inch margins, Times New Roman/12 point font.

                                      ☑
The document contains page numbers and is 4 pages or less in length.

                                      ☑
The document is type is ".docx".

                                      ☑
The document name is in the following format - ####fr## if no changes were made or ####fr##initialsdate (e.g., 2000.01ck9-25-19) if changes were made.

ICRAS Entry

                            Comments for Team Lead
                                    Part 1
                                      ☑
The ICR title matches exactly what is in the Supporting Statement.

                                      ☑
If program changes are being made, Type of Request is "revision a currently approved collection."

                                    Part 2
                                      ☑
There is a separate IC for each "Affected Public" type and each "Obligation to Respond" type.

                                      ☑
The number of ICs is the same as the previous ICR or the ICR Owner has provided an explanation as to why it has changed.

                                      ☑
Each form associated with the ICR was uploaded as a separate file with a unique form number.  The files from the last ICR renewal were deleted and replaced for forms that were updated.

                                      ☑
The Annual Cost Burden includes only capital and O&M costs (not labor costs).

                                      ☑
The change in burden was correct split among the Program Change and Adjustment columns.

                                      ☑
The Annual Number of Responses, Annual Hour Burden and Annual Cost Burden in the Summary of Burden table matches exactly what is in the supporting statement.

                                     Files
                                      ☑
All files were uploaded into ICRAS, including the Supporting Statement, FR Notice, Supplemental Tables/Documents, and Typesetting Request


[Federal Register: August 23, 2010 (Volume 75, Number 162)]
[Rules and Regulations]
[Page 51662-51663]
[DOCID:fr23au10-9]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0365; Airspace Docket No. 10-AAL-12]
RIN 2120-AA66

Amendment of Colored Federal Airway B-38; Alaska

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Colored Federal Airway Blue 38 (B-38), in
Alaska. Specifically, this action removes a segment of B-38 from Haines
Non-directional Beacon (NDB) to the Whitehorse, Yukon Territories
Canada (XY NDB). The FAA is taking this action in preparation of the
eventual decommissioning of XY NDB by the Canadian Air Authority NAV
CANADA.

DATES: Effective date 0901 UTC, November 18, 2010. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Ken McElroy, Airspace and Rules Group,
Office of System Operations Airspace and AIM, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On June 7, 2010, the FAA published in the Federal Register a notice
of proposed rulemaking (NPRM) to amend Colored Federal Airway B-38 in
Alaska, (75 FR 32117). Interested parties were invited to participate
in this rulemaking effort by submitting written comments on the
proposal. No comments were received. This amendment is the same as that
proposed in the NPRM.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by modifying Colored Federal Airway B-38, Alaska, terminating
the airway at the HNS NDB, AK, instead of the XY NDB, Canada. The
Canadian Air Authority NAV CANADA recently conducted a study to
determine the feasibility of keeping the XY NDB operational. NAV CANADA
determined it is no longer feasible and will be decommissioning the XY
NDB.
    Blue Federal Airways are published in paragraph 6009(d) of FAA
Order 7400.9T, signed August 27, 2009 and effective September 15, 2009,
which is incorporated by reference in 14 CFR 71.1. The Colored Federal
Airway listed in this document will be published subsequently in the
Order.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as the anticipated impact is so
minimal. Since this is a routine matter that will only affect air
traffic procedures and air navigation, it is certified that this rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it modifies a Colored Federal Airway in Alaska.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, Environmental Impacts: Polices and Procedures,
paragraph 311a. This airspace action is not expected to cause any
potentially significant environmental impacts, and no extraordinary
circumstances exist that warrant preparation of an environmental
assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9T,
Airspace Designations and Reporting Points, signed August 27, 2009, and
effective September 15, 2009, is to be amended as follows:

Paragraph 6009 (d) Blue Federal airways.

* * * * *

B-38 [Amended]

    From Elephant, AK, NDB, to Haines, AK, NDB.

    Issued in Washington, DC, on August 12, 2010.
Edith V. Parish,
Manager, Airspace and Rules Group.
[FR Doc. 2010-20807 Filed 8-20-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 237 (Friday, December 9, 2011)]
[Notices]
[Pages 76978-76980]
[FR Doc No: 2011-31609]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0457]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Experimental Study of
Comparative Direct-to-Consumer Advertising

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January
9, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910--New and
title, ``Experimental Study of Comparative Direct-to-Consumer
Advertising.'' Also include the FDA docket number found in brackets in
the heading of this document.

FOR FURTHER INFORMATION CONTACT:  Juanmanuel Vilela, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Experimental Study of Comparative Direct-to-Consumer Advertising--(OMB
Control Number 0910--New)

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 903(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    Regulations specify that sponsors cannot make comparative efficacy
claims in advertising for prescription drugs without substantial
evidence, most often in the form of well-controlled clinical trials, to
support such claims (21 CFR 202.1(e)(6)(ii); 21 CFR 314.126). FDA has
permitted some comparisons based on labeled attributes, such as
indication, dosing, and mechanism of action. When substantial evidence
does not yet exist, sponsors have used communication techniques that
invite implicit comparisons, such as making indirect comparisons, using
comparative visuals, and using vaguer language. This study is designed
to apply the existing comparative advertising literature to direct-to-
consumer (DTC) advertising, where little research has been conducted to
date.
    Moreover, as part of the American Recovery and Reinvestment Act of
2009 (Pub. L. 111-5), the Agency for Healthcare Research and Quality is
in the process of securing a large compendium of information on the
comparative effectiveness of medical treatments in 14 priority medical
conditions, including arthritis, cancer, dementia, depression,
diabetes, and substance abuse (Ref. 1). As part of this process, they
will fund a set of CHOICE (Clinical and Health Outcomes Initiative in
Comparative Effectiveness) studies designed to explore comparative
effectiveness. When this large project is completed, FDA will have
additional information to consider when regulating DTC advertising. It
is possible that more DTC advertising will be comparative in nature. In
preparation for this change, FDA is embarking on the proposed research
to ensure that it has adequate information to assess whether
comparative DTC ads provide truthful and nonmisleading information to
consumers.

A. Comparative Advertising

    Comparative advertisements typically compare two or more named or
recognizably presented brands of the same product category, although
some comparative advertisements implicitly compare a product to other
brands by making superiority statements (e.g., ``Only Brand A can be
cooked in five minutes or less.''). These ads are frequently used for
commercial products, such as electronics, food products, and
automobiles.
    Marketing and advertising studies have investigated the influence
of comparative ads, particularly in contrast to noncomparative ads
(Refs. 2 to 5). Research specifically investigating the effects of
comparative advertising on consumer attitudes--including attitudes
toward the ad, the brand, and product use--has produced mixed results
(Refs. 4 and 6). The research findings on the superiority of
comparative versus noncomparative ads on purchase intentions, however,
have been more conclusive. Relative to noncomparative ads, comparative
ads were shown to result in greater purchase intentions (Refs. 2 to 4
and7). Finally, other evidence suggests that there may be more
potential for consumers to confuse brands when viewing comparative
versus noncomparative ads. Brands advertised in a comparative format
were shown to be more likely to be perceived as similar to the leading
brand than brands advertised in a noncomparative format (Refs. 8 to
10).

B. Comparative Prescription Drug Advertisements

    Despite extensive research on comparative advertising of consumer
products and a limited number of studies on how DTC ads could help
consumers compare drugs (Refs. 11 and 12), very little research has
been conducted on comparative prescription drug advertisements (Ref.
13). Consequently, it is unclear whether these findings are applicable
to comparative drug ads or how such claims influence consumers'
perceived efficacy of advertised drugs.
    Currently, most DTC ad comparisons focus on drug attributes, such
as differences in dosing or administration method (see 21 CFR 314.126).
Because few head-to-head clinical trials have been conducted, very few
DTC ads include efficacy-based comparisons (Ref. 13). The present study
aims to investigate how consumers interpret and react to DTC
comparative drug ads. Specifically, the study will explore two types of
drug comparisons in DTC ads: (1) Drug efficacy comparisons and (2)
other evidence-based comparisons, such as dosing, mechanism of action,
and indication. The study findings will inform FDA of relevant consumer
issues relating to comparative DTC advertising.

 C. Design Overview

    The proposed research will occur in two concurrent phases. The goal
of Phase I is to: (1) Explore how consumers understand and interpret
print and

broadcast ads that explicitly compare the efficacy of two similar
drugs; and (2) learn whether named comparisons are more likely than
unnamed comparisons to promote accurate recall, comprehension, and
perceptions. For the purposes of the research described here, named
comparisons are ones in which the ad explicitly compares the drug's
efficacy to another named medication (e.g., Drug A was shown to be more
effective than Drug B at lowering high cholesterol). Unnamed
comparisons are ones in which the ad implicitly compares the drug's
efficacy to other medications (e.g., Compared to other medications,
Drug A lowered cholesterol in more patients). These different types of
comparisons will be examined in print and television ads and will
include appropriate control conditions in a 2 (ad type: print or
broadcast) x 3 (comparison type: named, unnamed, or none) design as
shown below.

                                                 Table 1--Design
----------------------------------------------------------------------------------------------------------------
              Ad type                  Named comparison     Unnamed comparison            Control group
----------------------------------------------------------------------------------------------------------------
Print Ad..........................  Arm 1.......  Arm 3......  Arm 5.
Broadcast Ad......................  Arm 2.......  Arm 4......  Arm 6.
----------------------------------------------------------------------------------------------------------------

    The goal of Phase II is to (1) determine if consumers infer that
one drug is better or more effective than another from ads that include
different types of drug label comparisons (i.e., indication, dosing,
mechanism of action, drug risk), and (2) if consumers consider
switching medications based on these comparisons in advertisements. We
will examine four types of drug comparisons that are currently being
used in DTC prescription drug ads. An indication-to-indication
comparison highlights the approved indications of the advertised drug
and the comparator drug (e,g., Drug X is approved to prevent and treat
osteoporosis; Drug B is approved to treat osteoporosis). Dosing
comparisons are those that compare the dosing schedule or dosing
characteristics of two drugs (e.g., You can take Drug A in pill form;
Drug B must be injected in a medical office). Mechanism of action
comparisons involve differences in the way the two drugs work (e.g.,
Drug A works by targeting the build up of fat in the arteries; Drug B
works by targeting that fat and by disintegrating tangier cells in the
esophagus). Finally, risk comparisons involve ads that compare the risk
profiles of more than one drug or the specific risks of more than one
drug (e.g., Drug A has been known to cause liver failure in rats; Drug
B has not shown liver damage in rats).
    We will also explore whether conveying these comparisons with
visual images moderates these results. Half of the participants will
examine a print ad and the other half will view a television ad. We
propose two fully-factorial 2 (comparison type: named or unnamed) x 2
(visual: present or absent) x 4 (drug aspect: indication, dosing,
mechanism of action, drug risk) designs, one for print ads and one for
television ads, as shown below. This design also includes two
appropriate control groups.
    For print ads:

                                                              Table 2--Design for Print Ads
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Mechanism of
        Comparison type              Visual type         Indication            Dosing              action            Drug risks         Control group
--------------------------------------------------------------------------------------------------------------------------------------------------------
Named..........................  Visual............  Arm 1....  Arm 5....  Arm 9....  Arm 13...  Arm 17.
Unnamed........................  Visual............  Arm 2....  Arm 6....  Arm 10...  Arm 14...
Named..........................  No Visual.........  Arm 3....  Arm 7....  Arm 11...  Arm 15...
Unnamed........................  No Visual.........  Arm 4....  Arm 8....  Arm 12...  Arm 16...
--------------------------------------------------------------------------------------------------------------------------------------------------------

    For television ads:

                                                           Table 3--Design for Television Ads
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Mechanism of
        Comparison type              Visual type         Indication            Dosing              action            Drug risks         Control group
--------------------------------------------------------------------------------------------------------------------------------------------------------
Named..........................  Visual............  Arm 1....  Arm 5....  Arm 9....  Arm 13...  Arm 17.
Unnamed........................  Visual............  Arm 2....  Arm 6....  Arm 10...  Arm 14...
Named..........................  No Visual.........  Arm 3....  Arm 7....  Arm 11...  Arm 15...
Unnamed........................  No Visual.........  Arm 4....  Arm 8....  Arm 12...  Arm 16...
--------------------------------------------------------------------------------------------------------------------------------------------------------

    All parts of this study will be administered over the Internet.
Participants will be randomly assigned to view one version of a DTC
prescription drug print ad or a prescription drug television ad.
Following their perusal of this document or video, they will answer
questions about their recall and understanding of the benefit and risk
information, their perceptions of the benefits and risks of the drug,
and their intent to ask a doctor about the medication. The entire
procedure is expected to last approximately 20 minutes. A total of
9,560 participants will be involved in the study. This will be a one-
time (rather than annual) information collection.
    In the Federal Register of July 1, 2011 (76 FR 38663), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received two public comments. One
commenter failed to attach any comment, and the other commenter
discussed issues far outside the scope of the proposed research (i.e.,
about morning-after contraception). Thus, the

design presented in this notice reflects only changes suggested by
external peer reviewers and further discussion among research team
members.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 4--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                           Activity                                 Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Screener......................................................            19,120                 1            19,120              0.03               637
                                                                                (2 min.)
Pretest.......................................................               900                 1               900              0.33               300
                                                                                (20 min.)
Main Study....................................................             8,660                 1             8,660              0.33             2,887
                                                                                (20 min.)
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................             3,824
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

IV. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but FDA is not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)

1. Agency for Healthcare Research and Quality (AHRQ), AHRQ Home
Page, ``Fact Sheets on Recovery Act Investments in Comparative
Effectiveness Research'' (http://www.ahrq.gov/fund/cerfactsheets/).
Last accessed May 23, 2011.
2. Ang, S.H. and S.B. Leong, ``Comparative Advertising: Superiority
Despite Interference?'' Asia Pacific Journal of Management, vol. 11,
pp. 33-46, 1994.
3. Demirdjian, Z.S., ``Sales Effectiveness of Comparative
Advertising: An Experimental Field Investigation,'' Journal of
Consumer Research, vol. 10, pp. 362-364, 1983.
4. Grewal, D., S. Kavanoor, E.F. Fern, et al., ``Comparative Versus
Noncomparative Advertising: A Meta-Analysis,'' Journal of Marketing,
vol. 61, pp. 1-15, 1997.
5. Priester, J.R., J. Godek, D.J. Nayakankuppum, et al., ``Brand
Congruity and Comparative Advertising: When and Why Comparative
Advertisements Lead to Greater Elaboration,'' Journal of Consumer
Psychology, vol. 14, pp. 115-123, 2004.
6. Rogers, J.C. and T.G. Williams, ``Comparative Advertising
Effectiveness: Practitioners' Perceptions Versus Academic Research
Findings,'' Journal of Advertising Research, vol. 29, pp. 22-37,
1989.
7. Miniard, P.W., M.J. Barone, R.L. Rose, et al., ``A Re-Examination
of the Relative Persuasiveness of Comparative and Noncomparative
Advertising,'' Advances in Consumer Research, vol. 21, pp. 299-303,
1994.
8. Droge, C. and R.Y. Darmon, ``Associative Positioning Strategies
Through Comparative Advertising: Attribute Versus Overall Similarity
Approaches,'' Journal of Marketing Research, vol. 24, pp. 377-388,
1987.
9. Gorn, G.J. and C.B.Weinberg, ``The Impact of Comparative
Advertising on Perception and Attitude: Some Positive Findings,''
Journal of Consumer Research, vol. 11, pp. 719-727, 1984.
10. Iyer, E.S. ``The Influence of Verbal Content and Relative
Newness on the Effectiveness of Comparative Advertising,'' Journal
of Advertising, vol. 17, pp. 15-21, 1988.
11. Schwartz, L.M., S. Woloshin, and H.G. Welch, ``Using a Drug
Facts Box to Communicate Drug Benefits and Harms: Two Randomized
Trials.'' Annals of Internal Medicine, vol. 150, pp. 516-527, 2009.
12. Hauber, A.B., A.F. Mohamed, F.R. Johnson, et al., ``Treatment
Preferences and Medication Adherence of People With Type 2 Diabetes
Using Oral Glucose-Lowering Agents,'' Diabetic Medicine: A Journal
of the British Diabetic Association, vol. 26, pp. 416-424, 2009.
13. Mitra, A., J. Swasy,, and K. Aikin, ``How Do Consumers Interpret
Market Leadership Claims in Direct-to-Consumer Advertising of
Prescription Drugs?'' Advances in Consumer Research, vol. 33, pp.
381-387, 2006.

    Dated: December 5, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31609 Filed 12-8-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 40 (Tuesday, March 1, 2016)]
[Notices]
[Page 10687]
[FR Doc No: 2016-04440]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Submission for OMB Review; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Form F-1, SEC File No. 270-249, OMB Control No. 3235-0258.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') this request for an extension of the previously
approved collection of information discussed below.
    Form F-1 (17 CFR 239.31) is the form used by foreign private
issuers to register the offer and sale of securities under the
Securities Act of 1933 (15 U.S.C. 77a et seq.) when no other form is
authorized or prescribed. The information collected is intended to
ensure that the information required to be filed by the Commission
permits verification of compliance with securities law requirements and
assures the public availability of such information. Form F-1 takes
approximately 1,709 hours per response and is filed by approximately 63
respondents. We estimate that 25% of the 1,709 hours per response
(427.25 hours) is prepared by the registrant for a total annual
reporting burden of 26,917 hours (427.25 hours per response x 63
responses).
    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 public may view the background documentation for this
information collection at the following Web site, www.reginfo.gov .
Comments should be directed to: (i) Desk Officer for the Securities and
Exchange Commission, Office of Information and Regulatory Affairs,
Office of Management and Budget, Room 10102, New Executive Office
Building, Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549 or send an email
to<EMAIL_ADDRESS>Comments must be submitted to OMB within 30
days of this notice.

    Dated: February 24, 2016.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-04440 Filed 2-29-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: February 27, 2009 (Volume 74, Number 38)]
[Notices]
[Page 8932-8933]
[DOCID:fr27fe09-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-693-000]

Kentucky MSW1 LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request for Blanket Section 204 Authorization

February 20, 2009.
    This is a supplemental notice in the above-referenced proceeding of
Kentucky MSW1 LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of

future issuances of securities and assumptions of liability, is March
12, 2009.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-4170 Filed 2-26-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 211 (Thursday, October 31, 2019)]
[Notices]
[Pages 58381-58382]
[FR Doc No: 2019-23720]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2018-0241; FRL-10001-73-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Contaminant Occurrence Data in Support of
the EPA's Fourth Six-Year Review of National Primary Drinking Water
Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR) for Contaminant Occurrence Data in
Support of the EPA's Fourth Six-Year Review of National Primary
Drinking Water Regulations (EPA ICR Number 2574.01, OMB Control Number
2040-NEW) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
request for approval of a new collection. Public comments were
previously requested via the Federal Register on October 5, 2018,
during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is below
including its estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before December 2,
2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OW-2018-0241, to: (1) The EPA online, using https://www.regulations.gov/ (our preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
the EPA.
    The EPA's policy is that all comments received will be included in
the public 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 whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Jini Mohanty at<PHONE_NUMBER> or
Nicole Tucker at<PHONE_NUMBER>, Office of Ground Water and Drinking
Water, Standards and Risk Management Division, 4607M, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
https://www.regulations.gov/ or in person at the EPA Docket Center, WJC
West, Room 3334, 1301 Constitution Ave. NW, Washington, DC 20004. The
telephone number for the Docket Center is<PHONE_NUMBER>. For additional
information about the EPA's public docket, visit https://www.epa.gov/dockets.
    Abstract: The EPA is required by the Safe Drinking Water Act
(SDWA), as amended in 1996, to review existing National Primary
Drinking Water Regulations (NPDWRs) no less often than every six years.
This routine evaluation is referred to as the ``Six-Year Review of
National Primary Drinking Water Regulations'' or simply, the ``Six-Year
Review.'' Throughout the Six-Year Review process, the EPA assesses new
data to determine risks to human health posed by regulated drinking
water contaminants and identifies NPDWRs that may be appropriate for
revision.
    The EPA completed and published review results for the first Six-
Year Review cycle (1996-2002) on July 18, 2003 (68 FR 42908). The
occurrence assessments for the first Six-Year Review were based on
compliance monitoring from a cross-section of 16 States, collected from
1993 to 1997, which were voluntarily provided by the States.
    The EPA completed and published review results for the second Six-
Year Review cycle (2003-2009) on March 29, 2010 (75 FR 15500). The
occurrence assessments conducted for the second Six-Year Review are
based on data collected between 1998 and 2005, voluntarily submitted by
States and other drinking water primary enforcement (primacy) agencies
(i.e., the District of Columbia, the Commonwealth of Puerto Rico, the
Virgin Islands, Guam, American Samoa, the Commonwealth of the Northern
Mariana Islands, the Trust Territory of the Pacific Islands, or an
eligible Indian tribe).
    The EPA completed and published review results for the third Six-
Year Review cycle (2010-2016) on January 11, 2017 (82 FR 3518). The
occurrence assessments conducted for the third Six-Year Review are
based on contaminant occurrence and treatment techniques data collected
between 2006 and 2011, voluntarily submitted by States and other
drinking water primacy agencies.
    The EPA created this new ICR to continue to engage States and other
drinking water primacy agencies in data collection efforts. For this
ICR, the EPA is soliciting States and other primacy agencies to
(voluntarily) provide historical, compliance monitoring (contaminant
occurrence) data for community water systems (CWSs) and non-transient
non-community water systems (NTNCWSs) to the Agency in support of the
fourth Six-Year Review. The EPA is requesting contaminant occurrence
and treatment technique data collected from 2012 to 2019 for all
regulated chemical, radiological, and microbial contaminants, including
data collected for the Revised Total Coliform Rule, newly promulgated
since the third Six-Year Review information collection.
    The compliance monitoring records for this information collection
(including all results for analytical detections and non-detections)
provide the data needed to conduct statistical estimates of national
occurrence for regulated contaminants and evaluate treatment technique
information associated with the control of pathogens, disinfectants,
and disinfection byproducts. The national occurrence estimates and
information on treatment techniques will support the EPA's review of
existing NPDWRs as required by the SDWA, section 1412(b)(9). In
addition, the SDWA, section 1445(g), requires the EPA to maintain a
national drinking water contaminant occurrence database (i.e., the
National Contaminant Occurrence Database (NCOD)), using occurrence data
for both regulated and unregulated contaminants in public water systems
(PWSs). This data collection will provide new occurrence data on
regulated contaminants to maintain the NCOD.
    Form Numbers: None.
    Respondents/affected entities: States and other drinking water
primacy agencies.
    Respondent's obligation to respond: Voluntarily.
    Estimated number of respondents: 56 (total).
    Frequency of response: One-time only.
    Total estimated burden: 765 hours (per year). Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $43,021 (per year), includes $0 annualized
capital or operations and maintenance costs.
    Changes in the estimates: The new burden under this ICR is for a
one-time data collection effort in support of the fourth six-year
review of national primary drinking water regulations.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-23720 Filed 10-30-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 88 (Friday, May 6, 2011)]
[Rules and Regulations]
[Pages 26194-26198]
[FR Doc No: 2011-11030]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0194; FRL-8872-3]

Metarhizium anisopliae Strain F52; Exemption From the Requirement
of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Metarhizium anisopliae strain F52 in or
on all food commodities when applied as an insecticide, miticide, or
ixodicide and used in accordance with good agricultural practices.
Novozymes Biologicals, Inc. submitted a petition to

EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting
an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of Metarhizium anisopliae strain F52 under the FFDCA.

DATES: This regulation is effective May 6, 2011. Objections and
requests for hearings must be received on or before July 5, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2009-0194. All documents in the
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Shanaz Bacchus, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2009-0194 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 5, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2009-0194, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments.
     Mail: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of April 8, 2009 (74 FR 15969) (FRL-8407-
6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 8F7508) by Novozymes Biologicals, Inc., 5400 Corporate
Circle, Salem, VA 24153. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of Metarhizium anisopliae strain F52. This
notice referenced a summary of the petition prepared by the petitioner,
Novozymes Biologicals, Inc., which is available in the docket, via
http://www.regulations.gov. There were no comments received in response
to the notice of filing.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance exemption and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate

exposure to the pesticide chemical residue. * * *'' Additionally,
section 408(b)(2)(D) of FFDCA requires that EPA consider ``available
information concerning the cumulative effects of [a particular
pesticide's] residues and other substances that have a common mechanism
of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and has considered its validity, completeness, and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.

A. Overview of Metarhizium Anisopliae Strain F52

    Metarhizium anisopliae strain F52 (called MetF52), a
deuteromycetous and entomopathogenic fungus that is found worldwide,
infects numerous insect (primarily Coleoptera of the families
Elateridae and Curculionidae), mite, and tick species that are
contacted by it. Once spores of Metarhizium anisopliae strain F52
attach to the surface of the target pest, they germinate, grow,
penetrate the target pest's exoskeleton, continue to grow in the target
pest, and eventually cause death. Susceptible insects, mites, or ticks
that come into contact with other insects, mites, or ticks that have
been infected with Metarhizium anisopliae strain F52 also become
infected with the fungus, thus continuing this microbe's pesticidal
effect.
    Given this distinct capability and efficiency in controlling
various insects, mites, and ticks, Metarhizium anisopliae strain F52 is
currently recognized as the active ingredient in several microbial
pesticide products, which were conditionally registered under section 3
of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in
June 2003 to Earth BioSciences, Inc. Since the registration of these
pesticide products in 2003, they have been labeled specifically for
non-food applications in urban and suburban (residential) areas to
control various insects (e.g., thrips and root weevils), mites, and
ticks. In 2006, the Metarhizium anisopliae strain F52-containing
registrations were transferred from Earth BioSciences, Inc. to
Novozymes Biologicals, Inc. (TAE-001 Technical Bioinsecticide, EPA Reg.
No. 70127-7; Taenure Granular Bioinsecticide, EPA Reg. No. 70127-8;
Tick-EX G, EPA Reg. No. 70127-9; Tick-EX EC, EPA Reg. No. 70127-10).
    After maintaining the registrations with non-food uses for several
years, Novozymes Biologicals, Inc. has now petitioned EPA to establish
an exemption from the requirement of a tolerance for residues of
Metarhizium anisopliae strain F52 in or on all food commodities.
Accordingly, EPA has reevaluated an assessment of the mammalian
toxicology data that were submitted prior to 2003 to support the
initial applications for Metarhizium anisopliae strain F52 pesticide
products. The overall conclusions from these data are described in Unit
III.B., while more in-depth synopses of the study results can be found
in a 2001 risk assessment, the 2003 Metarhizium anisopliae strain F52
Biopesticides Registration Action Document (BRAD), and the 2011
Addendum to the Metarhizium anisopliae strain F52 BRAD provided as
references in Unit IX. (Refs. 1, 2, and 3).

B. Microbial Pesticide Toxicology Data Requirements

    All mammalian toxicology data requirements supporting the request
for an exemption from the requirement of a tolerance for residues of
Metarhizium anisopliae strain F52 in or on all food commodities have
been fulfilled with acceptable studies.
    1. Acute oral toxicity and pathogenicity--rat (Harmonized Guideline
885.3050; Master Record Identification Number (MRID No.) 448447-09). An
acceptable acute oral toxicity and pathogenicity study demonstrated
that Metarhizium anisopliae strain F52 was not toxic and/or pathogenic
to rats when dosed at approximately 1.04 x 10\8\ colony-forming units
(cfu)/animal.
    2. Acute dermal toxicity--rabbit (Harmonized Guideline 885.3100;
MRID No. 448447-10). An acceptable acute dermal toxicity study
demonstrated that Metarhizium anisopliae strain F52 was not toxic to
rabbits when dosed at 3.63-4.42 x 10\10\ cfu/animal (median lethal dose
(LD50) > 2,000 milligrams per kilogram (mg/kg); Toxicity
Category III).
    3. Acute pulmonary toxicity and pathogenicity--rat (Harmonized
Guideline 885.3150; MRID No. 448447-11). An acceptable acute pulmonary
toxicity and pathogenicity study demonstrated that Metarhizium
anisopliae strain F52 was not toxic and/or pathogenic to rats when
dosed intratracheally at approximately 1.17 x 10\8\ cfu/animal.
    4. Acute injection toxicity and pathogenicity--rat (Harmonized
Guideline 885.3200; MRID No. 448447-12). An acceptable acute injection
toxicity and pathogenicity study demonstrated that Metarhizium
anisopliae strain F52 was not toxic and/or pathogenic to rats when
dosed intraperitoneally at approximately 1 x 10\7\ cfu/animal.
    5. Acute eye irritation--rabbit (Harmonized Guideline 870.2400;
MRID No. 448447-13). An acceptable acute eye irritation study
demonstrated that Metarhizium anisopliae strain F52 was moderately
irritating (i.e., the test substance caused corneal opacity, iritis,
and conjunctival irritation with resolution by day 4) to rabbits when
dosed at 6.3 x 10\8\ cfu/eye/animal (Toxicity Category III).
    6. Dermal sensitization--guinea pig (Harmonized Guideline 870.2600;
MRID No. 448447-15). An acceptable dermal sensitization study
demonstrated that Metarhizium anisopliae strain F52 was not a dermal
sensitizer to guinea pigs when induced and challenged at 2.37 x 10\9\
cfu.
    7. Hypersensitivity incidents (Harmonized Guideline 885.3400; MRID
No. 448447-14). No hypersensitivity incidents involving Metarhizium
anisopliae strain F52 and occurring during fermentation, processing,
formulation, research, or application have been reported to EPA.

IV. Aggregate Exposure

    In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).

A. Dietary Exposure

    Dietary exposure to this microbial pesticide may occur (more likely
through food than drinking water), but the lack of acute oral toxicity,
infectivity, and/or pathogenicity, as exhibited in a toxicology test on
rats presented in Unit III.B., supports the establishment of a
tolerance exemption for residues of Metarhizium anisopliae strain F52.

    1. Food. Exposure to this microbial active ingredient through food
is expected to be minimal. When applied in accordance with good
agricultural practices, Metarhizium anisopliae strain F52, a known
pathogen of various insects, mites, and ticks, is unlikely to persist
on plants. Any spores on plants due to pesticide application would
presumably decrease over time, similar to other fungal entomopathogens
and microbial pest control agents, because of environmental factors
such as rainfall, ultraviolet radiation, and temperature (Refs. 4 and
5). For example, several studies, designed to evaluate the
susceptibility of Metarhizium spores to sunlight, showed that
ultraviolet radiation (UV-A and UV-B) quickly causes inactivation of
these spores, both with and without the use of substances intended to
act as sunscreens (Ref. 6). In the unlikely event that the applied
fungus grew on the edible portions of treated crops, the results of the
toxicology testing demonstrated that no toxicity, infectivity, and/or
pathogenicity in treated animals occurred, even when dosed with high
levels of Metarhizium anisopliae strain F52 by the oral route of
exposure (see additional discussion in Unit III.B.). In conclusion,
there are no concerns for Metarhizium anisopliae strain F52 exposure
through food.
    2. Drinking water exposure. Much like dietary exposure, drinking
water exposure is expected to be negligible, albeit for slightly
different reasons. Given the terrestrial use sites, the application
methods with reduced chance for offsite movement of Metarhizium
anisopliae strain F52 (e.g., soil incorporation), and low application
rates, it is not likely that use of Metarhizium anisopliae strain F52
products, when good agricultural practices are followed, will result in
significant increase in fungal spore exposure in drinking water. With
regard to percolation through the soil, Zimmerman (2007) suggests that
Metarhizium anisopliae is a typical soil-borne fungus as it has mostly
been isolated from the upper soil layer. Further, Zimmerman (2007) also
goes on to describe field tests in which many sprayed Metarhizium
anisopliae spores were found in upper layers of loamy soil and humus,
thereby supporting the soil adhesion theory and the absence of
significant spore percolation down to ground water. In the unlikely
event of exposure to Metarhizium anisopliae strain F52 spores through
drinking water, the results of the oral toxicology testing, as
described in Unit III.B., demonstrated that no toxicity, infectivity,
and/or pathogenicity in treated animals occurred. As was concluded for
food exposure, there are no concerns for Metarhizium anisopliae strain
F52 exposure through drinking water.

B. Other Non-Occupational Exposure

    Deuteromycetous fungi, such as Metarhizium anisopliae strain F52,
are naturally occurring and found worldwide. As a pesticidal active
ingredient, Metarhizium anisopliae strain F52 has historically been
applied in residential areas. Because of the use patterns and low
application rates, there will not likely be a significant increase in
exposure over the background levels of Metarhizium anisopliae strain
F52 in these residential areas. Furthermore, there is no evidence of
any concern for inhalation or dermal toxicity at exposure levels
several orders of magnitude higher than would be expected to be
encountered by a typical residential end user (see Unit III.B.).
Finally, given that this deuteromycetous fungi affects only certain
species of insects, mites, and ticks, and that no recognized
relationships exist between the Metarhizium genus and any pathogen of
humans and animals, no adverse effects to humans from inhalation or
dermal exposure to this widespread fungus have been reported or are
anticipated.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, EPA consider
``available information concerning the cumulative effects of [a
particular pesticide's] residues and other substances that have a
common mechanism of toxicity.''
    EPA has not found Metarhizium anisopliae strain F52 to share a
common mechanism of toxicity with any other substances, and Metarhizium
anisopliae strain F52 does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has assumed that Metarhizium anisopliae strain
F52 does not have a common mechanism of toxicity with other substances.
Following from this, therefore, EPA concludes that there are no
cumulative effects associated with Metarhizium anisopliae strain F52
that need to be considered. For information regarding EPA's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http:// www.epa.gov/pesticides/cumulative.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure (safety), which are often referred to
as uncertainty factors, are incorporated into EPA risk assessments,
either directly, or through the use of a margin of exposure analysis,
or by using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk.
    Based on the acute toxicity and pathogenicity data discussed in
Unit III.B., as well as use of Metarhizium anisopliae strain F52 as a
microbial pesticide for approximately eight years without reported
adverse effects to humans, EPA concludes that there is a reasonable
certainty that no harm will result to the U.S. population, including
infants and children, from aggregate exposure to the residues of
Metarhizium anisopliae strain F52. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. EPA has arrived at this conclusion because the data and
information available on Metarhizium anisopliae strain F52 do not
demonstrate toxic, pathogenic, and/or infective potential to mammals.
Thus, there are no threshold effects of concern and, as a result, an
additional margin of safety is not necessary.

VII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
EPA is establishing an exemption from the requirement of a tolerance
without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever

possible, consistent with U.S. food safety standards and agricultural
practices. In this context, EPA considers the international maximum
residue limits (MRLs) established by the Codex Alimentarius Commission
(Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius
is a joint U.N. Food and Agriculture Organization/World Health
Organization food standards program, and it is recognized as an
international food safety standards-setting organization in trade
agreements to which the United States is a party. EPA may establish a
tolerance that is different from a Codex MRL; however, FFDCA section
408(b)(4) requires that EPA explain the reasons for departing from the
Codex level.
    The Codex has not established a MRL for Metarhizium anisopliae
strain F52.

VIII. Conclusions

    EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of Metarhizium anisopliae strain
F52. Therefore, an exemption is established for residues of Metarhizium
anisopliae strain F52 in or on all food commodities when applied as an
insecticide, miticide, or ixodicide and used in accordance with good
agricultural practices.

IX. References

1. U.S. EPA. 2011. Addendum to Metarhizium anisopliae strain F52
Biopesticides Registration Action Document dated March 2011
(available as ``Supporting & Related Materials'' within docket ID
number EPA-HQ-OPP-2010-0081 at http://www.regulations.gov).
2. U.S. EPA. 2003. Metarhizium anisopliae strain F52 Biopesticides
Registration Action Document.
3. U.S. EPA. 2001. Review of Toxicology Data for Metarhizium
anisopliae F52 in Support of a Section Three Registration for
Metarhizium anisopliae F52 from Taensa, Inc., Fairfield, CT.
Memorandum from C.A. Wozniak, PhD and J.L. Kough, PhD to L. Cole
dated December 11, 2001 (available as ``Supporting & Related
Materials'' within docket ID number EPA-HQ-OPP-2010-0081 at http://www.regulations.gov).
4. Jaronski ST. 2010. Ecological factors in the inundative use of
fungal entomopathogens. Biocontrol 55:159-185.
5. U.S. EPA. 1996. Microbial Pesticide Test Guidelines--Background
for Residue Analysis of Microbial Pest Control Agents (OPPTS
885.2000). Available from: http://www.epa.gov/ocspp/pubs/frs/publications/Test_Guidelines/series885.htm.
6. Zimmermann G. 2007. Review of safety of the entomopathogenic
fungus Metarhizium anisopliae. Biocontrol Sci Techn 17(9):879-920.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance exemption under section
408(d) of FFDCA in response to a petition submitted to EPA. The Office
of Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance
exemption in this final rule, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, EPA has determined that this
action will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, EPA has determined that
Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000), do not apply to this final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would
require EPA consideration of voluntary consensus standards pursuant to
section 12(d) of the National Technology Transfer and Advancement Act
of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).

XI. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: April 28, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. Section 180.1303 is added to subpart D to read as follows:

Sec.  180.1303  Metarhizium anisopliae strain F52; exemption from the
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Metarhizium anisopliae strain F52 in or on all food
commodities when applied as an insecticide, miticide, or ixodicide and
used in accordance with good agricultural practices.
[FR Doc. 2011-11030 Filed 5-5-11; 8:45 am]
BILLING CODE 6560-50-P