Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing to you today as an individual consumer requesting an extension of the comment period for the FDA'S Proposed Rule Deeming Tobacco Product to be subject to the Federal Food, Drug and Cosmetic Act. I'm very concerned about the 75-day comment period and I am requesting  an extension of an additional 105 days.

The Proposed Rule is asking many question I may want to respond to and since a 75-day period may seem adequate to you my time needed for the research of the rulings and addressing a response may take a little longer. Our feedback is very important as consumers since it may be our only opportunity to do so.

E-cigarettes has saved me from a very dismal future and has given my my life back. In the mist of your rulings I want to provide you with my personal story and scientific based evidence to your questions so you can take my comment into account. The FDA has granted extensions in the past therefore I'm asking you do it here.


[Federal Register: March 11, 2010 (Volume 75, Number 47)]
[Notices]
[Page 11528]
[DOCID:fr11mr10-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2244-000]

Energy Northwest; Notice of Authorization for Continued Project
Operation

March 4, 2010.
    On March 7, 2008, Energy Northwest, licensee for the Packwood Lake
Hydroelectric Project, filed an Application for a New License pursuant
to the Federal Power Act (FPA) and the Commission's regulations
thereunder. The Packwood Lake Hydroelectric Project is located on Lake
Creek, a tributary to the Cowlitz River, in Lewis County in
southwestern Washington.
    The license for Project No. 2244 was issued for a period ending
February 28, 2010. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2244 is issued to
Energy Northwest for a period effective March 1, 2010 through February
28, 2011, or until the issuance of a new license for the project or
other disposition under the FPA, whichever comes first. If issuance of
a new license (or other disposition) does not take place on or before
February 28, 2011, notice is hereby given that, pursuant to 18 CFR
16.18(c), an annual license under section 15(a)(1) of the FPA is
renewed automatically without further order or notice by the
Commission, unless the Commission orders otherwise. If the project is
not subject to section 15 of the FPA, notice is hereby given that
Energy Northwest is authorized to continue operation of the Packwood
Lake Hydroelectric Project, until such time as the Commission acts on
its application for a subsequent license.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-5204 Filed 3-10-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46740-46742]
[FR Doc No: 2018-19993]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-2936]

Recognition and Withdrawal of Voluntary Consensus Standards;
Draft Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of the draft guidance entitled
``Recognition and Withdrawal of Voluntary Consensus Standards.'' This
draft guidance identifies the principles FDA uses for recognizing a
standard, and it explains the extent of recognition and other
supplementary information. It provides information on how you may
request recognition as well as circumstances under which FDA may
withdraw recognition. This draft guidance also responds to a provision
of the 21st Century Cures Act (Cures Act) by updating published
guidance on these topics. This draft guidance is not final nor is it in
effect at this time.

DATES: Submit either electronic or written comments on the draft
guidance by November 13, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
on the collection of information by November 13, 2018.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-2936 for ``Recognition and Withdrawal of Voluntary Consensus
Standards.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Recognition and Withdrawal of Voluntary Consensus Standards'' to the
Office of the Center Director, Guidance and Policy Development, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002 or the Office of Communication, Outreach and Development, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA's standards recognition program furthers the aim of
international harmonization because the same standards (or
international equivalents) are relied upon by sponsors to meet other
countries' regulatory requirements when appropriate. This draft
guidance describes the procedures that FDA follows and the actions FDA
may take during its review and evaluation of requests for standards
recognition or the withdrawal of recognition. This draft guidance
provides further clarity and explanation about the regulatory
framework, policies, and practices when evaluating requests for
recognition. This draft guidance also responds to section 3053 of the
Cures Act by updating published guidance on these topics (Pub. L. 114-
255). When final, this draft guidance will supersede the guidance
``CDRH Standard Operating Procedures for the Identification and
Evaluation of Candidate Consensus Standards for Recognition,'' issued
on September 17, 2007.
    FDA generally considers for recognition voluntary consensus
standards, which are created by standards development organizations
that follow a consensus process. A document issued by the Office of
Management and Budget (OMB) entitled ``Federal Participation in the
Development and Use of Voluntary Consensus Standards and in Conformity
Assessment Activities,'' commonly called OMB Circular A-119, defines
the attributes or elements of a consensus process (Ref. 1). This draft
guidance explains those elements and how they pertain to FDA's
consideration of a standard for recognition.
    The draft guidance describes the process leading up to and
including recognition. We list common purposes to recognize voluntary
consensus standards as well as the essential information that FDA will
provide in the supplemental information sheet for the recognition of a
standard. This draft guidance also discusses when FDA may withdraw
recognition.
    You may also request that FDA recognize a specific voluntary
consensus standard. This draft guidance recommends the information you
would submit to do so, and it summarizes the actions we may take to act
on such a request.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on recognition
and withdrawal of voluntary consensus standards. It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft
guidance is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Persons unable to
download an electronic copy of ``Recognition and Withdrawal of
Voluntary Consensus Standards'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 616 to identify the guidance you are
requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3520),
Federal Agencies must obtain approval from the OMB for each collection
of information they conduct or sponsor. ``Collection of information''
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency
requests or requirements that members of the public submit reports,
keep records, or provide information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information set forth
in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Request for Recognition of a Voluntary Consensus Standard

OMB Control Number 0910--NEW

    The draft guidance for industry and FDA staff entitled
``Recognition and Withdrawal of Voluntary Consensus Standards''
provides guidance to industry and FDA staff about the procedures the
Center for Devices and Radiological Health follows when a request for
recognition of a voluntary consensus standard is received. The guidance
outlines justifications for why a standard may be recognized wholly,
partly, or not at all, as well as reasons

and rationales for withdrawing a standard. The guidance also provides
that any interested party may request recognition of a standard. The
draft guidance recommends that for recognition of a standard the
request should, at a minimum, contain the following information:
     Name and electronic or mailing address of the requestor;
     Title of the standard;
     Any reference number and date;
     Proposed list of devices for which a declaration of
conformity should routinely apply;
     Basis for recognition, e.g., including the scientific,
technical, regulatory, or other basis for such request; and
     A brief identification of the testing or performance or
other characteristics of the device(s) or process(es), that would be
addressed by a declaration of conformity.
    Based on previous requests for recognition of standards, we
estimate that FDA will receive nine requests annually. We estimate that
each request will take less than 1 hour to prepare.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for recognition of a voluntary consensus standard..........               9                1                9                1                9
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

V. Reference

    The following reference is on display with the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. OMB, ``Federal Participation in the Development and Use of
Voluntary Consensus Standards and in Conformity Assessment
Activities,'' Circular A-119 (revised). January 22, 2016. Available
at: https://www.nist.gov/sites/default/files/revised_circular_a-119_as_of_01-22-2016.pdf.

    Dated: September 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19993 Filed 9-13-18; 8:45 am]
 BILLING CODE 4164-01-P


EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: Mike Mendelsohn, Acting Branch Chief,<PHONE_NUMBER>

SUBMISSION: Email the completed template to<EMAIL_ADDRESS>
TEMPLATE:

Adjuvants Plus, Inc.

[7F8594]

	EPA has received a pesticide petition ([7F8594]) from Adjuvants Plus, Inc., 1755 Division Road N., Kingsville, ON N9Y 2Y8  requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from the requirement of a tolerance for microbial pesticide  Clonostachys rosea strain 88-710 TGAI.

Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, Adjuvants Plus, Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Adjuvants Plus, Inc. and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

I. Adjuvants Plus, Inc.  Petition Summary

   	[7F8594]

A. Product Name and Proposed Use Practices

	Clonostachys rosea strain 88-710 TGAI

The intended use of products that contain the active ingredient Clonostachys rosea strain 88-710 is as: 1) a seed treatment in the control of soil and seed borne pathogens such as Pythophthora sp., Fusarium sp., Pythium sp., Rhizoctonia sp., Alternaria sp., Sclerotinia sp., by the suppression of spore production, and 2)  as a spray, dip, drench or bee-vectored pest agent for the control of Botrytis cinerea ("Grey Mold"), Botrytis allii, (Neck Rot), Rhizopus sp., Alternaria sp. (Early Blight), Monilinia sp., (Brown Rot),Sclerotinia sp. (White Mold or Sclerotinia Berry Drop), Phomopsis canker, Fusicladium effusum (Pecan Scab), Venturia sp. (Apple Scab), Taphrina deformans (Leaf Curl), Colletotrichum sp. (Anthracnose), Cercospora sp. (Leaf Spot), Phoma sp. (Black Leg), Didymella sp. (Black Rot), Fusarium sp. (Fusarium Wilt) and other fungal pests by the suppression of spore production [and] [or] removal of disease organisms] in fruiting and flowering plants.

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues.

Clonostachys rosea is ubiquitous in the environment and has been identified in tissue from a variety of terrestrial plants, aquatic plants and all types of soils (MRID No. 501756-01).  Information regarding the name, identity and composition has been submitted to EPA (MRID No. 501756-14).

Clonostachys rosea is a beneficial endophyte that is used to control and prevent spore production of Botrytis sp. and other similar plant diseases in plant tissues and is used to enhance the plant's natural resistance (induced systemic resistance (ISR)).  Hyphae have been found to coil around, penetrate and grow inside the hyphae and conidia of Botrytis sp. (MRID No. 501756-01).

	2. Magnitude of residues at the time of harvest and method used to determine the residue.  N/A--Remove

	3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed.

An analytical method for residues is not applicable.  It is expected that, when used as proposed, Clonostachys rosea strain 88-710 would not result in residues that are of toxicological concern.

C. Mammalian Toxicological Profile

Studies to evaluate the safety to mammals were conducted on Clonostachys rosea strain 88-710 TGAI and are summarized herein  (see Table 1).  The studies performed include an acute oral toxicity/pathogenicity study in the rat, acute dermal toxicity study in the rat,  acute pulmonary toxicity study in the rat, acute eye irritation study in the rabbit, and acute dermal irritation study in the rabbit.

    Table 1. Summary of C. rosea strain 88-710 TGAI Mammalian Toxicity Data
                                     Test
                                    Species
                                  Dose Tested
                           Results (Date Completed)
                       Acute Oral Toxicity/Pathogenicity
                                      Rat
                                >5,000 mg/kg
                             Non-toxic Category IV
                                 June 3, 2016
                             Acute Dermal Toxicity
                                      Rat
                                >5,050 mg/kg
                             Non-toxic Category IV
                                 June 3, 2016
                    Acute Pulmonary Toxicity/Pathogenicity
                                      Rat
                             3.9x10[7] CFU/mL or
                             1.2x10[7] CFU per rat
                     Non-toxic Category IV  July 20, 2016
                            Primary Eye Irritation
                                    Rabbit
                        100 mg undiluted test substance
                   Mildly irritating, Toxicity Category III
                                 June 3, 2016
                           Primary Dermal Irritation
                                    Rabbit
             500 mg test substance moistened with deionized water
                     Non-irritating, Toxicity Category IV
                                 June 3, 2015

The results of toxicity testing of the organism show there is no risk to human health from the active ingredient.  Clonostachys rosea strain 88-710 is not toxic, pathogenic, infective or irritating to animals.

Literature searches have demonstrated that there are no reports of ecological or human health hazards caused by Clonostachys rosea.  It does not produce recognized toxins, enzymes, or virulence factors normally associated with mammalian invasiveness or toxicity.

As has been demonstrated, dietary exposure to Clonostachys rosea strain 88-710 meets the FQPA 1996 safety standard.  Studies submitted with this petition showed no evidence of toxicity, pathogenicity or infectivity when this strain was tested in laboratory animals.  It is important to note as well that the strains that Adjuvants Plus, Inc., seeks to register grow well at 25°C (77°F) but not at all at 37°C (98.6°F), the temperature of the human body.

D. Aggregate Exposure

	1. Dietary exposure.

	i. Food.

Dietary exposure from use of products containing Clonostachys rosea strain 88-710, as proposed, is minimal.  The intended use of products containing Clonostachys rosea strain 88-710 is to growing agricultural crops for the purposes of control of fungal plant diseases.

The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain 88-710.  There are no reports of ecological or human health hazards cause by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

	ii. Drinking water.

Similarly, exposure to humans from residues of Clonostachys rosea strain 88-710 in consumed drinking water would be unlikely.  Potential exposure to surface water would be negligible and exposure to drinking water (well or ground water) would be impossible to measure.  Clonostachys rosea is ubiquitous in the environment and has been identified in tissue from a variety of terrestrial plants, aquatic plants and all types of soils. (MRID No. 501756-01)

The intended use of Clonostachys rosea strain 88-710 is application via seed treatment and foliar/drench applications.  Formulated end use products with this active ingredient are not expected to increase levels of the microbe above natural levels.  Additionally, the fungus would not tolerate the conditions water is subjected to in a drinking water facility (including: chlorination, pH adjustments, high temperatures and/or anaerobic conditions.)

The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain 88-710.  There are no reports of ecological or human health hazards caused by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

	2. Non-dietary exposure.

The potential for non-dietary exposure to the U.S. general population, including infants and children, is unlikely as the proposed use sites are agricultural.  The intended use of products containing Clonostachys rosea strain 88-710 is to agricultural crops for the purposes of control of fungal plant diseases.  Formulated end-use products with this active ingredient would not be expected to increase levels of the microbe above natural levels.  Personal Protective Equipment (PPE) mitigates the potential for exposure to applicators and handlers of the proposed products, when used in agricultural settings.

The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain 88-710.  There are no reports of ecological or human health hazards caused by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

E. Cumulative Effects

It is not expected that, when used as proposed, products containing Clonostachys rosea strain 88-710 would result in residues that are of toxicological concern.  The intended use of Clonostachys rosea strain 88-710 is to agricultural crops for the purpose of control of fungal plant diseases.  Formulated end-use products with this active ingredient would not be expected to increase levels of the microbe above natural levels. The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain 88-710.  There are no reports of ecological or human health hazards caused by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

F. Safety Determination

	1. U.S. population.

Acute toxicity studies have shown that Clonostachys rosea strain 88-710 is not toxic, pathogenic, or irritating to mammals.  The intended use of Clonostachys rosea strain 88-710 is to agricultural crops for the purposes of insect control.  Formulated end-use products with this active ingredient would not be expected to increase levels of the microbe above natural levels. The results of toxicity testing indicate there is no risk to human health or the environment from Clonostachys rosea strain 88-710.  There are no reports of ecological or human health hazards caused by the microorganism Clonostachys rosea.  It does not produce recognized toxins, enzymes or virulence factors normally associated with mammalian invasiveness or toxicity.  The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.  There is a reasonable certainty of no harm to the general population from exposure to this active ingredient.

	2. Infants and children.

As mentioned above, it is not expected that, when used as proposed, Clonostachys rosea strain 88-710 would result in residues that are of toxicological concern.  There is a reasonable certainty of no harm for infants and children from exposure to Clonostachys rosea strain 88-710.

G. Effects on the Immune and Endocrine Systems

To date there is no evidence to suggest that Clonostachys rosea strain 88-710 functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

H. Existing Tolerances

US EPA Tolerance -
There is no U.S. EPA tolerance or tolerance exemption for Clonostachys rosea strain 88-710.

I. International Tolerances

International -
A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established for Clonostachys rosea strain 88-710.


[Federal Register: March 28, 2008 (Volume 73, Number 61)]
[Notices]
[Page 16667]
[DOCID:fr28mr08-65]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER08-194-000; ER08-194-001; ER08-194-002]

Duquesne Light Company; Notice of Filing

March 21, 2008.
    Take notice that on March 18, 2008, the PJM Power Providers Group,
tendered for filing an Emergency Request for Ruling regarding the
treatment of the capacity resources in the Duquesne zone for purposes
of the upcoming Reliability Pricing Model.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of 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 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>.
    Comment Date: 5 p.m. Eastern Time on March 26, 2008.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-6313 Filed 3-27-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 24 (Thursday, February 5, 2015)]
[Notices]
[Pages 6524-6525]
[FR Doc No: 2015-02231]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2015-0007; OMB No. 1660-NEW]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Ready PSA Campaign Creative Testing Research.

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a new information collection. In accordance with the
Paperwork Reduction Act of 1995, this notice seeks comments concerning
the Ready campaign, which is a national public service advertising
(PSA) campaign in support of FEMA's mission and is designed to educate
and empower Americans to prepare for and respond to emergencies
including natural and man-made disasters.

DATES: Comments must be submitted on or before April 6, 2015.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2015-0007. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., Room 8NE, Washington, DC
20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore,

submitting this information makes it public. You may wish to read the
Privacy Act notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Aretha Carter, External Affairs
Specialist, Federal Emergency Management Agency,<PHONE_NUMBER>,
<EMAIL_ADDRESS>You may contact the Records Management
Division for copies of the proposed collection of information at
facsimile number<PHONE_NUMBER> or email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This collection is in accordance with
Executive Orders 12862 and 13571 requiring all Federal agencies to
survey customers to determine the kind and quality of services they
want and their level of satisfaction with existing services. The
Government Performance and Results Act (GPRA) requires Federal agencies
to set missions and goals and to measure agency performance against
them. The GPRA Modernization Act of 2010 requires quarterly performance
assessments of government programs for the purposes of assessing agency
performance and improvement. The Federal Emergency Management Agency is
collecting information through focus groups to improve its public
service advertising campaign on disaster preparedness.

Collection of Information

    Title: Ready PSA Campaign Creative Testing Research.
    Type of Information Collection: New information collection.
    OMB Number: 1660-NEW.
    FEMA Forms: FEMA Form 008-0-21, Recruitment Screener; FEMA Form
008-0-22, Focus Group Discussion Guide.
    Abstract: FEMA proposes conducting qualitative research in the form
of focus groups in order to test creative concepts developed for FEMA's
national Ready public service advertising campaign, which aims to
educate and empower Americans to prepare for and respond to
emergencies. The research will help determine the clarity, relevance,
and motivating appeal of the concepts prior to final production of the
advertising.
    Affected Public: Individuals or households.
    Number of Respondents: 50.
    Number of Responses: 90.
    Estimated Total Annual Burden Hours: 58 hours.

                                                       Estimated Annualized Burden Hours and Costs
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                                                                     Number of                                        Total                     Total
                                                        Number of    responses      Total     Average  burden per     annual      Average       annual
       Type of respondent          Form name/form No.  respondents      per       number of       response (in      burden (in  hourly wage   respondent
                                                                     respondent   responses          hours)           hours)        rate         cost
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Individuals or Households.......  Recruitment                   50            1           50  0.1667 (10 minutes)            8       $31.26      $250.08
                                   Screener (survey
                                   script)/FEMA Form
                                   008-0-21.
Individuals or Households.......  Focus Group                   40            1           40  1.25 hours (75                50        31.26        1,563
                                   Discussion Guide/                                           minutes).
                                   FEMA Form 008-0-22.
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    Total.......................  ...................           50  ...........           90  ...................           58  ...........     1,813.08
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 Note: The ``Avg. Hourly Wage Rate'' for each respondent includes a 1.4 multiplier to reflect a fully-loaded wage rate.

    Estimated Cost: The estimated annual cost to respondents for the
hour burden is $1,813.08. There are no annual costs to respondents'
operations and maintenance costs for technical services. There are no
annual start-up or capital costs. The cost to the Federal Government is
$53,383.12.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) 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.

    Dated: January 28, 2015.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2015-02231 Filed 2-4-15; 8:45 am]
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