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: Jeannine Kausch<PHONE_NUMBER>

SUBMISSION: Email the completed template to<EMAIL_ADDRESS> TEMPLATE: Symborg, Inc. Petition number: XXXXXX

	EPA has received a pesticide petition (XXXXXX) from Symborg, Inc. PO Box 12810 San Luis Obispo, CA 93406 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 Trichoderma harzianum strain T78. Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Symborg, Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by Symborg, 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. Symborg, Inc. Petition Summary        	XXXXXXX

A. Product Name and Proposed Use Practices

      TrichoSym Biological Fungicide (EP)

      Trichoderma harzianum T78 is an Active Ingredient AI proposed for use only in TrichoSym Biological Fungicide. It is not being proposed as a manufacturing use product.               TrichoSym Biological Fungicide, a formulated end-use product, is a preventative biofungicide for control of plant diseases, such as Sclerotinia, Pythium, Rhizoctonia, Fusarium, Macrophomina and Thielaviopsis.

B. Product Identity/Chemistry

     Identity of the pesticide and corresponding residues. Trichoderma harzianum strain T78 (CAS No. Not applicable): Trichoderma spp. are fungi that are present in nearly all soils and other diverse habitats. In soil, they frequently are the most prevalent culturable fungi.      Magnitude of residues at the time of harvest and method used to determine the residue. It is expected that, when used as proposed, Trichoderma harzianum strain T78 would not result in residues that are of toxicological concern.              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, Trichoderma harzianum strain T78 would not result in residues that are of toxicological concern

C. Mammalian Toxicological Profile	Studies to evaluate the safety to mammals were conducted on the technical grade active ingredient (TGAI) and are summarized below.

 Acute Oral Toxicity/Pathogenicity (OCSPP 885.3050): Trichoderma harzianum T-78 showed no evidence of toxicity, infectivity or pathogenicity following a single oral dose of 2.25  -  3.56 x 10[8] cfu/animal to rats. Over the study period there was no evidence of any proliferation, infectivity or pathogenicity of the test item, Trichoderma harzianum T-78, within blood, organs or intestinal contents of treated rats and that rapid clearance of the test item was achieved with 8 days following oral dosing. There were no deaths of subjects during the study. (MRID: 510647-05)         Acute Pulmonary Toxicity/Pathogenicity (OPPTS 885.3150): Trichoderma harzianum T-78 showed no evidence of toxicity, infectivity or pathogenicity following a single intratracheal dose of 6.68 x 107 cfu/animal to rats. No clinical signs of death were observed throughout the study following administration of the live or autoclaved test item. (MRID: 510647-06)

 Acute Intraperitoneal Toxicity/Pathogenicity (OPPTS 885.3200): Trichoderma harzianum T-78 showed no evidence of toxicity, infectivity or pathogenicity following a single intraperitoneal dose of 1.96 x 10[7]  -  3.55 x 10[7] cfu/animal to rats. No clinical signs of death were observed throughout the study following administration of the live or autoclaved test item. (MRID: 510647-07)

 Hypersensitivity Incidents (OCSPP 885.3400): The registrant has noted that no incidents of hypersensitivity or any other adverse effects have occurred through the research, development or testing of the active ingredient and its related end-use product. Should any incidents occur, they will be reported per FIFRA Section 6(a)(2).

The results of toxicity testing show there is no risk to human health from the active ingredient. Trichoderma harzianum strain T78is not toxic, pathogenic, or infective to mammals.

D. Aggregate Exposure

	1. Dietary exposure.

      i. Food. Dietary exposure from use of Trichoderma harzianum T78, as proposed, is expected to be minimal because the product is intended for application to soil, not to growing crops (see Product Label). The residues on food crops are anticipated to be to be insignificant because this pesticide is applied to soils by drip irrigation systems. The intended use of Trichoderma harzianum T78 is as a biological fungicide to soils for the purposes of disease control.              The results of toxicity testing indicate there is no risk to human health or the environment from Trichoderma harzianum T78. Trichoderma spp. are common and widespread soil fungi that inhabit soil and root ecosystems that are generally recognized as beneficial to plant species.               The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

             ii. Drinking water. Exposure to humans from residues of Trichoderma harzianum T78 in consumed drinking water would be unlikely because the product is not applied to water. The normal habitat of the genus is soil and herbaceous tissue, not water (Chaverri et al. 2003). Potential exposure to surface water would be negligible and exposure to drinking water (well or groundwater) would be impossible to measure. The intended use of Trichoderma harzianum T78 is in soils for the purposes of disease control. The risk of the microorganism passing through the soil to groundwater is minimal to unlikely because the growing organism forms a cottony web that is stationary, and the spores are not of the type that are able to survive unfavorable conditions (water), that is no chlamydospores are formed (Chaverri et al. 2003). 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 Trichoderma harzianum T78. The absence of acute toxicity or pathogenicity of Trichoderma harzianum T78 in laboratory animals demonstrates the benign nature of this strain.

             2. Non-dietary exposure. The potential for non-dietary exposure to the general population, including infants and children, is unlikely as the proposed use sites are agricultural. The intended use of Trichoderma harzianum T78 is to soils and for the purposes of disease control. Personal Protective Equipment (PPE) mitigates the potential for exposure to applicators and handlers of the proposed products, when used in agricultural settings.              The lack of acute oral toxicity, infectivity, and pathogenicity support an exemption from the requirement of a tolerance for Trichoderma harzianum T78. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain. Non-dietary exposures would not be expected to pose any quantifiable risk due to a lack of residues of toxicological concern.

       E. Cumulative Effects

It is not expected that, when used as proposed, Trichoderma harzianum T78 would result in residues that are of toxicological concern. The intended use of Trichoderma harzianum T78 is to soils for the purposes of disease control. The results of toxicity testing indicate there is no risk to human health or the environment from Trichoderma harzianum T78. The absence of acute toxicity or pathogenicity in laboratory animals demonstrates the benign nature of this strain.

F. Safety Determination

      1. U.S. population. It is not expected that, when used as proposed, Trichoderma harzianum T78 would result in residues that are of toxicological concern. The intended use of Trichoderma harzianum T78 is to soils for the purposes of disease control. The results of toxicity testing indicate there is no risk to human health or the environment from Trichoderma harzianum T78. 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 US population from exposure to this ingredient.

             2. Infants and children. As mentioned above, it is not expected that, when used as proposed, Trichoderma harzianum T78 would result in residues that are of toxicological concern. There is a reasonable certainty of no harm for infants and children from exposure to Trichoderma harzianum T78 from the proposed uses. --------------------------------------------------------------------------------

G. Effects on the Immune and Endocrine Systems

To date there is no evidence to suggest that Trichoderma harzianum T78 functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

H. Existing Tolerances

There is no US EPA tolerance or tolerance exemption for Trichoderma harzianum T78.

I. International Tolerances

A Codex Alimentarium Commission Maximum Residue Level (MRL) is not established for Trichoderma harzianum T78 .


[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Notices]
[Page 26745]
[DOCID:fr12my10-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR10-18-000]

ONEOK Gas Transportation, LLC; Notice of Baseline Filing

May 5, 2010.
    Take notice that on April 28, 2010, ONEOK Gas Transportation, LLC
(OGT) submitted its baseline filing of its Statement of Operating
Conditions for transportation services provided under section 311(a)(2)
of the Natural Gas Policy Act of 1978 (NGPA).
    Any person desiring to participate in this rate proceeding must
file a motion 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 and 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 date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    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 Friday, May 14, 2010 .

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-11236 Filed 5-11-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: October 1, 2010 (Volume 75, Number 190)]
[Rules and Regulations]
[Page 60614-60616]
[DOCID:fr01oc10-8]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0035; Directorate Identifier 2009-NM-066-AD;
Amendment 39-16447; AD 2010-20-12]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 747-400, 747-
400D, and 747-400F Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Model
747-400, 747-400D, and 747-400F series airplanes. This AD requires
installing a hot short protector (HSP) for the fuel quantity indicating
system (FQIS) of the center fuel tank and, for certain airplanes, the
horizontal stabilizer fuel tank. This AD results from fuel system
reviews conducted by the manufacturer. We are issuing this AD to
prevent an electrical hot short from a source outside the FQIS to the
densitometer wiring from causing failure of the FQIS densitometer
resistors, which could result in an ignition source inside the center
or horizontal stabilizer fuel tanks. An ignition source, in combination
with flammable fuel vapors, could result in a fuel tank explosion and
consequent loss of the airplane. This AD is effective November 5, 2010.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of November 5,
2010.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Georgios Roussos, Aerospace Engineer,
Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft
Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain Model 747-400, 747-400D, and 747-400F series airplanes. That
NPRM

was published in the Federal Register on February 11, 2010 (75 FR
6821). That NPRM proposed to require installing a hot short protector
for the fuel quantity indicating system of the center fuel tank and,
for certain airplanes, the horizontal stabilizer fuel tank.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from The Boeing Company.

Request To Revise Preamble of the NPRM

    Boeing requests the following changes to sections of the preamble
of the NPRM:
     In the section ``Relevant Service Information,'' revise
``We have received Boeing Service Bulletin 74728A2266, Revision 1,
dated December 10, 2009 (for the CWTs)'' to ``We have received Boeing
Service Bulletin 74728A2266, Revision 1, dated December 10, 2009 (for
all airplanes),'' because there are no configurations of the Model 747-
400 without the center fuel tank.
     Revise ``Relevant Service Information'' to add the phrase
``(for airplanes with horizontal stabilizer tanks)'' to ``Boeing Alert
Service Bulletin 747-28A2267, dated December 18, 2008.'' Boeing states
that this service bulletin adds a hot short protector on the horizontal
stabilizer tank (HST).
    We acknowledge the commenter's requests. While the commenter's
suggestions may clarify information that the NPRM contained, these
sections are not included in the final rule. As a result, we have not
changed the AD in regard to these issues.

Request To Clarify the FQIS Wire Separation Requirement

    Boeing requests that we clarify the requirement of the FQIS wire
separation from the wiring of the other systems as a result of
implementing the actions required by this AD. Boeing requests that we
revise the Discussion section of the NPRM to state that after the
actions required by the AD are implemented, then no further actions are
required to separate the FQIS wire from the wiring of other systems.
    We agree with the commenter that no action is required for the
undisturbed portion of the densitometer wiring from the HSP to the fuel
quantity processor unit at the electrical equipment bay. This final
rule requires the installation of the HSP according to the
accomplishment instructions of the applicable service bulletins. No
part of this AD implies or requires action for the undisturbed portion
of the densitometer wiring. Therefore, we have not changed the final
rule in regard to this issue.

Request To Add Service Bulletin to Credit Paragraph

    Boeing requests that we revise paragraph (h) of the NPRM to include
Boeing Alert Service Bulletin 747-28A2266, Revision 1, dated December
10, 2009.
    We do not agree to revise the AD, because such a revision is
unnecessary. Paragraph (h) of this AD exists to give credit for actions
accomplished before the effective date of this AD using Boeing Alert
Service Bulletin 747-28A2266, dated December 18, 2008, and paragraph
(g) of this AD requires that Revision 1 of this service bulletin is
used for the action specified in that paragraph. We have not changed
the AD in regard to this issue.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD as proposed.

Costs of Compliance

    We estimate that this AD affects 80 airplanes of U.S. registry. The
following table provides the estimated costs for U.S. operators to
comply with this AD.

                                                                 Table--Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Average labor
               Action                        Work hours         rate per hour            Parts               Cost per product           Fleet cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
Installation\1\.....................  6 to 17................             $85   $15,821 to $30,650.....  $16,331 to $32,095.....  $1,306,480 to
                                                                                $2,567,600.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Work hours and parts costs depend on airplane configuration.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2010-20-12 The Boeing Company: Amendment 39-16447; Docket No. FAA-
2010-0035; Directorate Identifier 2009-NM-066-AD.

Effective Date

    (a) This AD is effective November 5, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to The Boeing Company Model 747-400, 747-
400D, and 747-400F series airplanes, certificated in any category;
as identified in the service bulletins listed in paragraphs (c)(1)
and (c)(2) of this AD.
    (1) Boeing Service Bulletin 747-28A2266, Revision 1, dated
December 10, 2009.
    (2) Boeing Alert Service Bulletin 747-28A2267, dated December
18, 2008.

Subject

    (d) Air Transport Association (ATA) of America Code 28: Fuel.

Unsafe Condition

    (e) This AD results from fuel system reviews conducted by the
manufacturer. The Federal Aviation Administration is issuing this AD
to prevent an electrical hot short from a source outside the fuel
quantity indicating system (FQIS) to the densitometer wiring from
causing failure of the FQIS densitometer resistors, which could
result in an ignition source inside the center or horizontal
stabilizer fuel tanks. An ignition source, in combination with
flammable fuel vapors, could result in a fuel tank explosion and
consequent loss of the airplane.

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Installation of Hot Short Protector (HSP)

    (g) Within 60 months after the effective date of this AD: Do the
applicable installations of the HSP specified in paragraphs (g)(1)
and (g)(2) of this AD.

    Note 1:  Boeing Service Bulletin 747-28A2266, Revision 1, dated
December 10, 2009; and Boeing Alert Service Bulletin 747-28A2267,
dated December 18, 2008; refer to Cinch Service Bulletin CN1036-28-
01, Revision C, dated January 18, 2007, as an additional source of
guidance for installing the HSP in the fuel tanks which must be done
before or concurrently with the actions specified in Boeing Service
Bulletin 747-28A2266, Revision 1, dated December 10, 2009; and
Boeing Alert Service Bulletin 747-28A2267, dated December 18, 2008.

    (1) For all airplanes: Install the HSP in the center wing tank,
in accordance with the Accomplishment Instructions of Boeing Service
Bulletin 747-28A2266, Revision 1, dated December 10, 2009.
    (2) For airplanes identified in Boeing Alert Service Bulletin
747-28A2267, dated December 18, 2008: Install the HSP in the
horizontal stabilizer tank, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 747-28A2267, dated
December 18, 2008.

Credit for Installation Previously Accomplished in Accordance With
Previous Issue of Service Bulletin

    (h) Actions accomplished before the effective date of this AD
according to Boeing Alert Service Bulletin 747-28A2266, dated
December 18, 2008, are considered acceptable for compliance with the
corresponding action specified in this AD, provided that Cinch
Service Bulletin CN1036-28-01, Revision C, dated January 18, 2007,
is used as an additional source of guidance.

Alternative Methods of Compliance (AMOCs)

    (i)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
ATTN: Georgios Roussos, Aerospace Engineer, Systems and Equipment
Branch, ANM-130S, FAA, Seattle Aircraft Certification Office, 1601
Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6482; fax<PHONE_NUMBER>. Or, e-mail information to 9-ANM-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.

Material Incorporated by Reference

    (j) You must use Boeing Service Bulletin 747-28A2266, Revision
1, dated December 10, 2009; or Boeing Alert Service Bulletin 747-
28A2267, dated December 18, 2008; as applicable; to do the actions
required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (3) You may review copies of the service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (4) You may also review copies of the service information that
is incorporated by reference at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/
ibr_locations.html.

    Issued in Renton, Washington, on September 16, 2010.
Robert D. Breneman,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-24169 Filed 9-30-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 94 (Monday, May 16, 2011)]
[Notices]
[Pages 28301-28302]
[FR Doc No: 2011-11959]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2010-0124]

Reports, Forms, and Record Keeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notice with a 60-day comment period was
published on September 3, 2010, at 75 FR 54217.

DATES: Comments must be received on or before June 15, 2011.

ADDRESSES: Send comments, within 30 days, to the Office of Information
and Regulatory Affairs, Office of Management and Budget, 725 17th
Street, NW., Washington, DC 20503, Attention: NHTSA Desk Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.
    A Comment to OMB is most effective if OMB receives it within 30
days of publication.

FOR FURTHER INFORMATION CONTACT:  Kil-Jae Hong, NHTSA, 1200 New Jersey
Avenue, SE., W52-232, NPO-520, Washington, DC 20590. Ms. Hong's
telephone number is<PHONE_NUMBER> and e-mail address is<EMAIL_ADDRESS>    Docket: For access to the docket to read background documents, go
to http://www.regulations.gov, or the street address listed above.
Follow the online instructions for accessing the dockets.

SUPPLEMENTARY INFORMATION: In compliance with Paperwork Reduction Act
of 1995, NHTSA previously conducted a public meeting and opened a
docket for a 60-day comment period. Based upon comments at the public
meeting and to the docket, NHTSA revised its research plan. This notice
announces that the ICR abstracted below has been forwarded to OMB for
review and comment. The ICR describes the nature of the information
collections and their expected burden. This is a request for new
collection.
    Title: 49 CFR 575--Consumer Information Regulations (section 106)
Qualitative Research--Retailer Interviews.
    OMB Control Number: Not Assigned.
    Form Number: None.
    Type of Request: New collection.
    Affected Public: Passenger vehicle tire consumers and tire
retailers.
    Requested Expiration Date of Approval: Three years from approval
date.
    Abstract: The Energy Independence and Security Act of 2007 (EISA),
enacted in December 2007, included a requirement that NHTSA develop a
national tire fuel efficiency program to educate consumers about the
effect of tires on automobile fuel efficiency, safety and durability. A
critical step in developing the consumer information program is to
conduct proper market research to understand consumers' knowledge of
tire maintenance and performance, understand the tire purchase process
from both the consumer and retailer's perspectives, evaluate
comprehension of ratings, explore the clarity, meaningfulness and the
likely resulting behaviors, and evaluate the creative and the channels
for communication. NHTSA proposes a multi-phased research project to
gather the data and apply analyses and results from the project to
develop the consumer information program. The entire research plan is
posted to this docket.
    Estimated Annual Burden: 15.
    Number of Respondents: 30.
    NHTSA will conduct two research phases. For the first phase, NHTSA
will conduct two types of qualitative research. One research project
will consist of two (2) focus groups in three (3) cities. Each group
will have eight (8) participants and will last two (2) hours for a
total of 96 participant hours. This project is addressed by a separate
notice published today. For the second research project in this phase,
NHTSA will conduct on-site interviews at various tire retailers. NHTSA
anticipates 30 respondents, with each interview taking 30 minutes for a
total of approximately 15 participant hours. This is the project which
is the subject of this notice. The results of both projects in this
research phase will be used to finalize the content of an online survey
NHTSA will conduct in the second research phase.
    On September 3, 2010 (75 FR 54217), NHTSA published the required
60-day notice requesting comments on both projects in the first
research phase.\1\ NHTSA received six comments in response to this
notice: One unsigned, one each from LANXESS Corporation, Tire Industry
Association (TIA), and Michelin North America and two from Rubber
Manufacturers Association (RMA). LANXESS Corporation (a specialty
chemicals company) and TIA indicated their support of this information
collection request, noting the importance of providing consumers with
related information, while the unsigned comment was opposed to this
spending, but did not provide a reason why. RMA offered detailed
comments on the contents of the research package. A more extensive
discussion of the comments received and changes NHTSA has made to the
research plan can be found in the supporting statement placed in the
docket for this notice.
---------------------------------------------------------------------------

    \1\ NHTSA published an amendment to this notice on September 27,
2010 (75 FR 59319) and extended the comment period in a notice
published on November 24, 2010 (75 FR 71789).
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    The estimated annual burden hour for the retailer interviews is 15
hours. Based on the Bureau of Labor and Statistics' median hourly wage
(all occupations) in the May 2009 National Occupational Employment and
Wage Estimates, NHTSA estimates that it will take an average of $15.95
per hour for professional and clerical staff to gather data, distribute
and print material.

Therefore, the agency estimates that the cost associated with the
---------------------------------------------------------------------------
burden hours is $239.25 ($15.95 per hour x 15 burden hours).

Gregory A. Walter,
Senior Associate Administrator, Policy and Operations.
[FR Doc. 2011-11959 Filed 5-13-11; 8:45 am]
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[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31117-31118]
[FR Doc No: 2014-12534]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0575]

Guidance for Industry on Expedited Programs for Serious
Conditions--Drugs and Biologics; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Expedited Programs
for Serious Conditions--Drugs and Biologics.'' The purpose of this
guidance is to provide a single resource for information on FDA's
policies and procedures related to expedited drug development and
review programs. The following programs are intended to facilitate and
expedite development and review of new drugs to address unmet medical
need in the treatment of a serious or life-threatening condition
(expedited programs): Fast track designation, breakthrough therapy
designation, accelerated approval, and priority review designation.
This guidance finalizes the draft guidance issued in June 2013.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002; or the Office
of Communication, Outreach and Development, Center for Biologics
Evaluation and Research (CBER), 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 requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Melissa Robb, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6360, Silver Spring, MD 20993-0002, 301-
796-2500; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Expedited Programs for Serious Conditions--Drugs and
Biologics.'' This guidance provides a single resource for information
on FDA's policies and procedures related to the following expedited
programs for serious conditions: (1) Fast track designation, (2)
breakthrough therapy designation, (3) accelerated approval, and (4)
priority review designation. The guidance describes threshold criteria
generally applicable to expedited programs, including what is meant by
serious condition, unmet medical need, and available therapy. This
guidance also discusses considerations for expedited development and
review such as manufacturing and product quality, nonclinical studies,
and clinical inspections. In addition, this guidance aligns CDER's
criteria for priority review designation with CBER's criteria. Only
products intended to treat a serious condition are eligible for
priority review (unless otherwise eligible under specific statutory
provisions).
    For over 30 years, expediting the availability of promising
therapies to patients with serious conditions has been a priority for
FDA. With the passage of the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Public Law 112-122), FDA is expanding its
efforts to expedite development and review of therapies intended to
treat patients with serious conditions. This guidance is intended to
satisfy the statutory requirements of sections 901(c)(2) and
902(b)(1)(A) of FDASIA.
    Section 901(c)(2) of FDASIA requires FDA to issue a final guidance
document to implement amendments to the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) made by section 901 of

FDASIA (Enhancement of Accelerated Approval Access to New Medical
Treatments) within 1 year of the date the draft guidance issues. The
discussions of accelerated approval, and other more broadly applicable
provisions in this guidance, are intended to meet this requirement.
    Section 902(b)(1)(A) of FDASIA requires FDA to issue a guidance
document to implement requirements of section 902 (Breakthrough
Therapies) within 1 year of the date the comment period closes for the
draft guidance. The breakthrough therapy discussion and other more
broadly applicable provisions in this guidance are intended to meet
this requirement.
    In the Federal Register of June 26, 2013 (78 FR 38349), FDA
announced the availability of the draft guidance entitled ``Expedited
Programs for Serious Conditions--Drugs and Biologics.'' The notice gave
the public an opportunity to comment by August 26, 2013. FDA carefully
considered all comments received in developing the final guidance. This
guidance addresses the applicability of expedited programs to rare
diseases, clarification on available therapy, and additional detail on
possible flexibility in manufacturing and product quality. The guidance
also includes clarification on the qualifying criteria for breakthrough
therapy designation and examples of surrogate endpoints and
intermediate clinical endpoints used to support accelerated approval.
This guidance finalizes the draft guidance issued in June 2013.
    The provisions of this guidance relating to fast track development
and other issues such as serious condition and unmet medical need,
replace the guidance for industry entitled ``Fast Track Drug
Development Programs--Designation, Development, and Application
Review.'' The provisions of this guidance pertaining to available
therapy replace the guidance for industry entitled ``Available
Therapy.''
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on expedited programs for serious
conditions--drugs and biologics. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 202.1, certain parts of 21 CFR
part 314, 21 CFR part 601, and sections 506(b)(1), 735, and 736 of the
FD&C Act (21 U.S.C. 356(b)(1), 379g, and 379h) have been approved under
OMB control numbers 0910-0686, 0910-0001, 0910-0338, 0910-0389, 0910-
0297, and 0910-0765.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: May 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12534 Filed 5-29-14; 8:45 am]
BILLING CODE 4160-01-P