[Federal Register: July 14, 2006 (Volume 71, Number 135)]
[Notices]
[Page 40088-40089]
[DOCID:fr14jy06-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP06-407-000, CP06-408-000 and CP06-409-000]

Missouri Interstate Gas, LLC; Missouri Gas Company, LLC; Missouri
Pipeline Company, LLC; Notice of Applications for Certificates of
Public Convenience and Necessity and Abandonment Authorizations

July 6, 2006.
    Take notice that on June 28, 2006, Missouri Interstate Gas, LLC
(Missouri Interstate), Missouri Gas Company, LLC (Missouri Gas), and
Missouri Pipeline Company, LLC (Missouri Pipeline), each located at 110
Algana Court, St. Peters, Missouri, 63376, filed in the above
referenced dockets, pursuant to section 7 of the Natural Gas Act (NGA)
and Part 157 of the Commission's regulations, several applications for
certificates of public convenience and necessity and abandonment
authorizations. The applications seek approval to consolidate certain
facilities owned by the affiliated companies in order to form a new
interstate pipeline to be owned by Missouri Gas, which would be subject
to the jurisdiction of the Commission.
    These filings are on file with Commission and open to public
inspection. They may be viewed on the web 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. There is also
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, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or TTY,

contact<PHONE_NUMBER>.
    Any questions regarding the applications should be directed to
David J. Ries, President, Missouri Interstate Gas, LLC, 110 Algana
Court, St. Peters, Missouri, 63376; Phone<PHONE_NUMBER>.
    Docket No. CP06-407-000 is assigned to the requests to authorize
facilities acquisition and operation, for approval for the provision of
interstate natural gas transportation services and for the approval of
abandonments. Docket No. CP06-408-000 is assigned to the part 157,
subpart F blanket certificate request and Docket No. CP06-409-000 is
assigned to the part 284, subpart G blanket certificate request.
    The Applicants state that upon implementation of the mergers, if
approved under the requested authorizations, their proposal will expand
access to the interstate gas transportation grid for the Applicants'
customers on standardized terms and conditions, make such grid more
efficient, offer better supply and pricing options, facilitate future
pipeline expansions within and outside the State of Missouri, and
establish a single regulatory forum at the Commission to review any
expansions and new services proposed in the future and to set a single
rate for service on the new system.
    The Applicants state that their proposed acquisition of the
facilities and the integration of the Applicants' assets into a single
interstate pipeline system will allow the Applicants to provide open
access, non-discriminatory transportation consistent with the NGA and
the Commission's regulations and policies. As an integrated interstate
company, the Applicants say that the proposed Missouri Gas will be
better able to serve Missouri and Illinois customers and respond to
interstate demand, particularly in Illinois. In addition, the
Applicants say that consolidation of the companies will eliminate
inefficiencies, enabling Missouri Gas to improve service to existing
and potential new customers.
    Specifically, the Applicants seek the Commission's authorization
for: (1) Missouri Interstate to abandon its tariff and services and to
abandon its facilities by transfer to Missouri Pipeline; (2) Missouri
Pipeline to acquire and operate as part of its existing system, all of
Missouri Interstate's facilities; and (3) Missouri Pipeline to
subsequently abandon by transfer, and Missouri Gas to acquire and
operate as part of its existing system, all of the facilities of
Missouri Pipeline, upon Missouri Pipeline's commencement of interstate
service.
    In addition, Applicants request: (1) Issuance of a blanket
certificate of public convenience and necessity under part 284, subpart
G of the Commission's regulations to Missouri Gas, authorizing it to
provide open access interstate transportation services to the
Applicants' existing transportation customers and to potential new
customers located inside and outside the State of Missouri, and a
determination that Missouri Gas's proposed initial firm and
interruptible rates are in the public interest; (2) issuance of a
blanket certificate of public convenience and necessity under part 157,
subpart F of the Commission's regulations to Missouri Gas authorizing
certain routine construction and operation activities and abandonment;
and (3) approval of the initial rates and pro forma tariff proposed
herein along with acceptance of Applicants' existing service agreements
as non-conforming service agreements.
    The Applicants state that as a result of these transactions, all of
the facilities currently owned and operated individually by Missouri
Interstate and Missouri Pipeline prior to the transactions will be
owned and operated by Missouri Gas. They promise that no later than 18
months after the integrated Missouri Gas commences operations pursuant
to the Commission issued certificates proposed in these proceedings,
Missouri Gas will file a rate case to establish just and reasonable
rates under section 4 of the NGA to replace the initial rates requested
for approval in these proceedings.
    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 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 comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicants. On or before the comment date, it is
not necessary to serve motions to intervene or protests on persons
other than the Applicants.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the

``e-Filing'' 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.
    Comment Date: 5 p.m. Eastern Time on July 26, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-11176 Filed 7-13-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 37 (Friday, February 26, 2021)]
[Proposed Rules]
[Pages 11667-11670]
[FR Doc No: 2021-03745]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0101; Project Identifier MCAI-2020-01084-T]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for certain Bombardier, Inc., Model BD-100-1A10 airplanes. This
proposed AD was prompted by a report that the inboard multi-function
spoiler (MFS) surfaces failed to deploy, which was caused by missing
notches on the piston seal of the MFS power control units (PCUs). This
proposed AD would require an inspection to determine if affected MFS
PCUs are installed, and replacement of affected MFS PCUs. The FAA is
proposing this AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by April 12,
2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact
Bombardier, Inc., 200 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 2A3, Canada; North America toll-free phone: 1-866-538-1247 or
direct-dial phone: 1-514-855-2999; email<EMAIL_ADDRESS>
internet: http://www.bombardier.com. You may view this service
information at the FAA, Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th St., Des Moines, WA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0101; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Siddeeq Bacchus, Aerospace Engineer,
Mechanical Systems and Administrative Services Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone:
516-228-7362; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under ADDRESSES. Include ``Docket No. FAA-2021-0101; Project Identifier
MCAI-2020-01084-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
the proposal because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal

contact received about this proposed AD.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this NPRM contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this NPRM, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this NPRM. Submissions containing CBI should be sent to
Siddeeq Bacchus, Aerospace Engineer, Mechanical Systems and
Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; phone:<PHONE_NUMBER>; fax: 516-
794-5531; email<EMAIL_ADDRESS>Any commentary that the FAA
receives which is not specifically designated as CBI will be placed in
the public docket for this rulemaking.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued TCCA AD CF-2020-26, dated August 4,
2020 (referred to after this as the Mandatory Continuing Airworthiness
Information, or the MCAI), to correct an unsafe condition for certain
Bombardier, Inc., Model BD-100-1A10 airplanes. You may examine the MCAI
in the AD docket on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0101.
    This proposed AD was prompted by a report that the inboard MFS
surfaces failed to deploy, which was caused by missing notches on the
piston seal of the MFS PCUs. The FAA is proposing this AD to address
MFS PCUs with improperly configured piston seals, which could cause
degraded proportional lift dumping (PLD) function and could hinder the
airplane from carrying out an emergency descent, resulting in
structural damage and injury to occupants. See the MCAI for additional
background information.

Related Service Information Under 1 CFR Part 51

    Bombardier has issued the following service information. This
service information describes procedures for an inspection to determine
if affected MFS PCUs are installed, and replacement of affected MFS
PCUs. These documents are distinct since they apply to different
airplane configurations.
     Bombardier Service Bulletin 100-27-17, Revision 03, dated
June 19, 2020.
     Bombardier Service Bulletin 350-27-010, dated June 19,
2020.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is proposing this AD
because the FAA evaluated all the relevant information and determined
the unsafe condition described previously is likely to exist or develop
on other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Costs of Compliance

    The FAA estimates that this proposed AD affects 630 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
              Labor cost                      Parts cost            Cost per product      Cost on U.S. operators
----------------------------------------------------------------------------------------------------------------
Up to 19 work-hours x $85 per hour =   Up to $19,600 (up to 4   Up to $21,215 (up to 4   Up to $13,365,450 (up
 Up to $1,615.                          MFS PCUs per airplane).  MFS PCUs per airplane).  to 4 MFS PCUs per
                                                                                airplane).
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in the cost estimate.

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.
    The FAA is 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

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would 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 this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Would not affect intrastate aviation in Alaska, and
    (3) Would not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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:

Bombardier, Inc.: Docket No. FAA-2021-0101; Project Identifier MCAI-
2020-01084-T.

(a) Comments Due Date

    The FAA must receive comments on this airworthiness directive
(AD) action by April 12, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc., Model BD-100-1A10
airplanes, certificated in any category, serial numbers 20003
through 20457 inclusive, and 20501 through 22999 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls.

(e) Reason

    This AD was prompted by a report that the inboard multi-function
spoiler (MFS) surfaces failed to deploy, which was caused by missing
notches on the piston seal of the MFS power control units (PCUs).
The FAA is issuing this AD to address MFS PCUs with improperly
configured piston seals, which could cause degraded proportional
lift dumping (PLD) function. This condition could hinder the
airplane from carrying out an emergency descent, resulting in
structural damage and injury to occupants.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Definition of Affected Part

    For the purpose of this AD, an affected MFS PCU is an MFS PCU
that has a serial number of 0001 through 1410 inclusive, except for
those MFS PCUs having the serial numbers listed in figure 1 to
paragraph (g) of this AD and except for those with the suffix ``A''
at the end of the serial number (i.e., serial number 1025A).
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[GRAPHIC] [TIFF OMITTED] TP26FE21.000

BILLING CODE 4910-13-C

(h) Required Actions

    (1) Within 12 months after the effective date of this AD: Do an
inspection to determine if affected MFS PCUs are installed on the
airplane in accordance with Paragraph 2.B. of Bombardier Service
Bulletin 100-27-17, Revision 03, dated June 19, 2020; or Bombardier
Service Bulletin 350-27-010, dated June 19, 2020; as applicable. A
review of airplane maintenance records is acceptable in lieu of this
inspection if the serial number of the MFS PCU can be conclusively
determined from that review.
    (2) Within 12 months after the effective date of this AD:
Replace any affected MFS PCUs with MFS PCUs that are not affected,
in accordance with Paragraphs 2.C., 2.D., 2.E., and 2.F., as
applicable, of Bombardier Service Bulletin 100-27-17, Revision 03,
dated June 19, 2020; or Bombardier Service Bulletin 350-27-010,
dated June 19, 2020; as applicable.

(i) Parts Installation Prohibition

    As of the effective date of this AD, no person may install an
affected MFS PCU, on any airplane.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York ACO Branch, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. In
accordance with 14 CFR 39.19, send your request to your principal
inspector or responsible Flight Standards Office, as appropriate. If
sending information directly to the manager of the certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before
using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or
Bombardier, Inc.'s TCCA Design Approval Organization (DAO). If
approved by the DAO, the approval must include the DAO-authorized
signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) TCCA AD CF-2020-26, dated August 4, 2020, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2021-0101.
    (2) For more information about this AD, contact Siddeeq Bacchus,
Aerospace Engineer, Mechanical Systems and Administrative Services
Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (3) For service information identified in this AD, contact
Bombardier, Inc., 200 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 2A3, Canada; North America toll-free phone: 1-866-
538-1247 or direct-dial phone: 1-514-855-2999; email:
<EMAIL_ADDRESS>internet: http://www.bombardier.com. You
may view this service information at the FAA, Airworthiness Products
Section, Operational Safety Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued on February 18, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-03745 Filed 2-25-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 72 (Tuesday, April 14, 2020)]
[Notices]
[Pages 20696-20698]
[FR Doc No: 2020-07816]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3380]

Developing and Labeling In Vitro Companion Diagnostic Devices for
a Specific Group of Oncology Therapeutic Products; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Developing
and Labeling In vitro Companion Diagnostic Devices for a Specific Group
of Oncology Therapeutic Products'' and encourages the submission of
premarket approval application (PMA) supplements containing the needed
information to modify the intended use of specific companion
diagnostics as described in this notice (i.e., companion diagnostics
that identify patients with nonsmall cell lung cancer (NSCLC) whose
tumors have epidermal growth factor receptor (EGFR) exon 19 deletions
or exon 21 (L858R) substitution mutations and are suitable for
treatment with a tyrosine kinase inhibitor approved by FDA for that
indication). This guidance describes considerations for the development
and labeling of in vitro companion diagnostic devices (referred to as
companion diagnostics in this document) to support the indicated uses
of multiple drug or biologic oncology products (referred to as
therapeutic products or oncology therapeutic products in this
document), when appropriate. The guidance includes factors for
considering when broader labeling (i.e., labeling that is expanded) of
a companion diagnostic would be appropriate. Oncology companion
diagnostics with broader indications will optimally facilitate clinical
use. The guidance announced in this notice finalizes the draft guidance
entitled ``Developing and Labeling In Vitro Companion Diagnostic
Devices for a Specific Group or Class of Oncology Therapeutic
Products'' dated December 2018.

DATES: The announcement of the guidance is published in the Federal
Register on April 14, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-3380 for ``Developing and Labeling In vitro Companion
Diagnostic Devices for a Specific Group of Oncology Therapeutic
Products.'' 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)).
    Submit written requests for single copies of this guidance to the
Office Policy, 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; the Division of
Drug Information, Center for Drug Evaluation and Research, Food and
Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th
Floor, 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 requests. See the
SUPPLEMENTARY INFORMATION section for electronic access to the guidance
document.
    Submit PMA supplements to the Center for Devices and Radiological
Health Document Control Center, 10903 New Hampshire Ave., Bldg. 66, Rm.
G609, Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Reena Philip, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3316, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
Julie Schneider, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2208, 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,
240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Developing and Labeling In vitro Companion Diagnostic
Devices for a Specific Group of Oncology Therapeutic Products.'' This
guidance describes considerations for the development and labeling of
companion diagnostics to support the indicated uses of multiple
therapeutic oncology products, when appropriate. This guidance builds
upon existing policy regarding labeling of companion diagnostics. In a
prior guidance entitled ``In Vitro Companion Diagnostic Devices''
(August 2014), the Agency stated that if evidence is sufficient to
conclude that the companion diagnostic is appropriate for use with a
specific group of therapeutic products (as discussed in the guidance),
the companion diagnostic's intended use/indications for use should name
the specific group, rather than specific products. This guidance
expands on the policy statement in the 2014 guidance by recommending
that companion diagnostic developers consider a number of factors,
including but not limited to those discussed in this guidance, when
determining whether their test could be developed, or the labeling for
approved companion diagnostics could be revised through a supplement,
to support a broader labeling claim such as use with a specific group
of oncology therapeutic products (rather than listing an individual
therapeutic product(s)). To describe FDA's thinking on the topic, the
guidance discusses a specific example of companion diagnostics for a
specific biomarker, disease, and specimen type (specific epidermal
growth factor receptor mutations in tumors of patients with nonsmall
cell lung cancer in tissue specimens).
    Trials designed to support approval of a specific therapeutic
product and a specific companion diagnostic have led to companion
diagnostic labels that reference only a specific therapeutic
product(s). Such specificity in labeling can limit a potentially
broader use of a companion diagnostic that may be scientifically
appropriate. In clinical practice, an oncologist generally considers
the mutation profile of the tumor along with other factors when
determining the treatment for a patient, such as the toxicity profile
of the therapeutic product, the patient's preference, and formulary
options. When a companion diagnostic is labeled for use with a specific
therapeutic product, the clinician may need to order a different
companion diagnostic (i.e., one that includes other therapeutic
products in the labeling), obtain an additional biopsy(ies) from a
patient, or both, to have additional therapy treatment options.
    The guidance describes considerations for when broader labeling may
be scientifically appropriate and when it may not. FDA recommends
developers of therapeutic oncology products and associated companion
diagnostics collaboratively consider development programs that may
result in broader labeling of companion diagnostics that are most
clinically useful. Developers are encouraged to discuss development
programs that could result in broader labeling with the Center for
Biologics Evaluation and Research (CBER), Center for Devices and
Radiological Health (CDRH), or Center for Drug Evaluation and Research,
in coordination with the Oncology Center of Excellence, as appropriate,
early to determine if the approach described in this guidance is
appropriate for consideration.

Developers whose approved companion diagnostics may be appropriate for
broader labeling are encouraged to contact CDRH or CBER, as appropriate
to discuss. Developers of the companion diagnostics discussed in the
guidance as an example should see the ``Other Issues for
Consideration'' section of this notice for information regarding
broader labeling for those companion diagnostics.
    This guidance finalizes the draft guidance entitled ``Developing
and Labeling In Vitro Companion Diagnostic Devices for a Specific Group
or Class of Oncology Therapeutic Products'' dated December 2018 (83 FR
63166). Comments received on the draft guidance were taken into
consideration when finalizing the guidance. Based on the comments
received, clarifications were made and information regarding the
content of broader labeling was added.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Developing and Labeling In Vitro Companion
Diagnostic Devices for a Specific Group of Oncology Therapeutic
Products.'' 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.

II. Other Issues for Consideration

    Based on publicly available information, which includes valid
scientific evidence (i.e., clinical and scientific experience) with
specific companion diagnostics and the associated therapeutic products,
FDA has concluded that certain statements set forth in the FDA-approved
labels of these companion diagnostics, related to intended use with
therapeutic products, can be modified. The specific companion
diagnostics are those discussed as an example in the guidance announced
in this notice (i.e., companion diagnostics that identify patients with
NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R)
substitution mutations and are suitable for treatment with a tyrosine
kinase inhibitor approved by FDA for that indication). FDA believes it
is appropriate for sponsors to consider modifying the intended use of
these companion diagnostics to describe the specific group of oncology
therapeutic products, rather than listing individual therapeutic
product(s). The guidance states that, rather than listing individual
therapeutic product(s), the intended use for the indication for the
specific companion diagnostics would be, ``identifying patients with
NSCLC whose tumors have EGFR exon 19 deletions or exon 21 (L858R)
substitution mutations and are suitable for treatment with a tyrosine
kinase inhibitor approved by FDA for that indication.'' It is possible
for the companion diagnostics to also have other indications, not
captured by the broader indication. FDA encourages the submission of
PMA supplements, identifying the change and referring to this notice as
the reason for the change, to request modification of the intended use
of these companion diagnostics. This broader labeling may enable
greater flexibility for clinicians in choosing the most appropriate
therapeutic product based on a patient's biomarker status.
    In the Federal Register document that announced the availability of
the draft guidance, FDA requested feedback on specific issues,
including challenges with developing the evidence needed to support
broader companion diagnostic labeling, challenges with submitting a PMA
supplement to broaden the labeling of an approved companion diagnostic
and actions FDA can take to facilitate or encourage broader companion
diagnostic labeling in oncology. Comments that stakeholders submitted
to the docket for the draft guidance are generally supportive of the
concept of broader labeling for companion diagnostics in oncology to
facilitate the treatment of patients with cancer. To encourage
implementation of broader labeling of companion diagnostics in
oncology, FDA is finalizing the guidance and encouraging submission of
PMA supplements containing the needed information for FDA review of the
modified labeling of the companion diagnostics discussed in the
guidance as an example.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations and guidance. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521). The collections of information in 21 CFR parts 801 and 809 have
been approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
814, subparts A through E, have been approved under OMB control number
0910-0231; the collections of information in 21 CFR part 814, subpart H
have been approved under OMB control number 0910-0332; the collections
of information in the guidance document ``Requests for Feedback and
Meetings for Medical Device Submissions: The Q-Submission Program''
have been approved under OMB control number 0910-0756; and the
collections of information in the guidance ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844.

IV. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics,
or https://www.regulations.gov.

    Dated: April 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-07816 Filed 4-13-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Proposed Rules]
[Pages 3100-3101]
[FR Doc No: 2018-01026]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 83, No. 15 / Tuesday, January 23, 2018 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-1091; Airspace Docket No. 17-AWP-26]

Proposed Amendment of Class D and Class E Airspace; Atwater, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class D airspace, and Class E
airspace extending upward from 700 feet above the surface at Castle
Airport, Atwater, CA, to accommodate airspace redesign due to the
decommissioning of the El Nido VHF Omnidirectional Range/Distance
Measuring Equipment (VOR/DME) as the FAA transitions from ground-based
to satellite-based navigation. Also, this action would update the
airport's geographic coordinates to match the FAA's aeronautical
database. This action also would make an editorial change to the Class
D airspace legal description replacing ``Airport/Facility Directory''
with the term ``Chart Supplement''. These actions are necessary for the
safety and management of instrument flight rules (IFR) operations at
the airport.

DATES: Comments must be received on or before March 9, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone: 1
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2017-1091; Airspace Docket No. 17-AWP-26, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Tom Clark, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW, Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    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
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 would amend Class D and Class E airspace at Castle Airport,
Atwater, CA, to accommodate airspace redesign in support of IFR
operations at the airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2017-1091; Airspace Docket No. 17-AWP-26) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for address
and phone number).
    Persons wishing the FAA to acknowledge receipt of their comments on
this notice must submit with those comments a self-addressed, stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2017-1091/Airspace Docket No. 17-AWP-26.'' The postcard will be
date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this notice may be changed in light of
the comments received. A report summarizing each substantive public
contact with FAA personnel concerned with this rulemaking will be filed
in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at  http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays, at the
Northwest Mountain Regional Office of the Federal Aviation
Administration, Air Traffic Organization, Western Service Center,
Operations Support Group, 1601 Lind Avenue SW, Renton, WA 98057.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 for airspace redesign by modifying Class D
airspace to a 4.6-mile radius (from a 4.5-mile radius) of the airport
from the airport 297[deg] bearing clockwise to the airport 164[deg]
bearing, thence direct to the point of beginning. This modification
would provide additional Class D airspace south of the airport and
would remove Class D airspace southwest and northwest of the airport,
thereby containing instrument IFR departure aircraft until reaching 700
feet above the surface, and removing airspace not required by IFR
operations. Also, this action would remove the reference to the El Nido
VOR/DME in the legal description due to its planned decommissioning as
the FAA transitions from ground-based to satellite-based navigation.
    Class E airspace extending upward from 700 feet above the surface
would be modified to a 7.2-mile (from a 7-mile) radius of the airport,
and would remove the 23-mile extension northwest of the airport.
    Additionally, the airport's geographic coordinates would be updated
to match the FAA's aeronautical database for the Class D and Class E
airspace areas. An editorial change also would be made to the Class E
surface area airspace legal description replacing ``Airport/Facility
Directory'' with the term ``Chart Supplement''.
    These actions are necessary for the safety and management of IFR
operations at this airport.
    Class E airspace designations are published in paragraph 6002, and
6005, respectively, of FAA Order 7400.11B, dated August 3, 2017 and
effective September 15, 2017, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designation listed in this document will
be published subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (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) 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 proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 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 14 CFR part 71 continues to read as
follows:

     Authority:  49 U.S.C. 106(f), 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 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AWP CA D Atwater, CA [Amended]

Castle Airport, CA
    (Lat. 37[deg]22'50'' N, long. 120[deg]34'06'' W)

    That airspace extending upward from the surface up to but not
including 2,000 feet MSL within a 4.6-mile radius of Castle Airport
beginning at the 297[deg] bearing from the airport clockwise to the
164[deg] bearing, thence to the point of beginning. This Class D
airspace area is effective during the specific dates and times
established in advance by a Notice to Airmen. The effective date and
time will thereafter be continuously published in the Chart
Supplement.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AWP CA E5 Atwater, CA [Amended]

Castle Airport, CA
    (Lat. 37[deg]2250 N, long. 120[deg]34'06'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.2-mile radius of Castle Airport.

    Issued in Seattle, Washington, on January 11, 2018.
Shawn M. Kozica,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2018-01026 Filed 1-22-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: August 9, 2010 (Volume 75, Number 152)]
[Notices]
[Page 47883-47886]
[DOCID:fr09au10-103]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2010-0187]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemptions; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 21 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. If granted, the exemptions would enable these
individuals to qualify as drivers of commercial motor vehicles (CMVs)
in interstate commerce without meeting the Federal vision standard.

DATES: Comments must be received on or before September 8, 2010.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2010-0187 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington,

DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal
Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this Notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the Federal Docket
Management System published in the Federal Register on January 17, 2008
(73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/
E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m., Monday
through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to, or greater than, the level that would be
achieved absent such exemption.'' FMCSA can renew exemptions at the end
of each 2-year period. The 21 individuals listed in this Notice have
each requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

Qualifications of Applicants

Randall J. Benson

    Mr. Benson, age 40, has had amblyopia in his left eye since
childhood. The best corrected visual acuity in his right eye is 20/15
and in his left eye, 20/50. Following an examination in 2010, his
optometrist noted, ``This patient does not present any greater risk in
driving tasks than other drivers and, given his record, he should have
sufficient vision to perform the driving tasks required for a
commercial vehicle.'' Mr. Benson reported that he has driven straight
trucks for 4 years, accumulating 60,000 miles. He holds a Class D
operator's license from Minnesota. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Larry D. Brown

    Mr. Brown, 53, has had complete loss of vision in his left eye
since 1985. The best corrected visual acuity in his right eye is 20/20.
Following an examination in 2010, his optometrist noted, ``In my
professional opinion Mr. Larry Brown has sufficient vision to perform
the driving task of a commercial vehicle based on his vision and prior
work experience.'' Mr. Brown reported that he has driven straight
trucks for 19 years, accumulating 47,500 miles. He holds a Class B
Commercial Driver's License (CDL) from Maryland. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Julian W. Collins

    Mr. Collins, 49, has had macular scarring in his right eye due to a
traumatic injury sustained in 1996. The best corrected visual acuity in
his right eye is 20/400 and in his left eye, 20/15. Following an
examination in 2010, his ophthalmologist noted, ``I certify that Mr.
Collins's eye exam today is stable and that in my medical opinion he
has sufficient vision to perform the driving tasks required to operate
a commercial vehicle.'' Mr. Collins reported that he has driven
straight trucks for 8 years, accumulating 40,000 miles and tractor
trailer combinations for 23 years, accumulating 414,000 miles. He holds
a Class A CDL from Georgia. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

James G. Etheridge

    Mr. Etheridge, 45, has had complete loss of vision in his right eye
since 1971 due to trauma. The best corrected visual acuity in his left
eye is 20/20. Following an examination in 2010, his optometrist noted,
``Patient's vision is sufficient to drive a commercial vehicle.'' Mr.
Etheridge reported that he has driven straight trucks for 12 years,
accumulating 240,000 miles. He holds a Class B CDL from Texas. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Jerry A. Evans

    Mr. Evans, 63, has had a prosthetic right eye due to trauma since
1980. The best corrected visual acuity in his left eye is 20/25.
Following an examination in 2010, his ophthalmologist noted, ``It is my
medical opinion that Mr. Evans has the ability to perform driving tasks
necessary to operate a commercial vehicle.'' Mr. Evans reported that he
has driven straight trucks for 30 years, accumulating 507,000 miles. He
holds a Class C operator's license from Georgia. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Guy R. Flowers, Jr.

    Mr. Flowers, 57, has had complete loss of vision in his left eye
since 2005 due to trauma. The best corrected visual acuity in his right
eye is 20/20. Following an examination in 2010, his optometrist noted,
``In my opinion, providing he utilizes adequate rear-view mirror and
side-view mirrors on both sides of his vehicle, he should have
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Flowers reported that he has driven tractor-
trailer combinations for 27 years, accumulating 2.1 million miles. He
holds a Class A CDL from Alaska. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Jeremy L. Fricke

    Mr. Fricke, 27, has had complete loss of vision in his right eye
since 2000 due to trauma. The best corrected visual acuity in his left
eye is 20/15. Following an examination in 2010, his optometrist noted,
``His vision in the left eye is excellent uncorrected and, in my
opinion, is sufficient to perform the driving tasks required to operate
a

commercial vehicle.'' Mr. Fricke reported that he has driven straight
trucks for 11 years, accumulating 27,500 miles and tractor-trailer
combinations for 7 years, accumulating 54,600 miles. He holds a Class D
operator's license from North Dakota. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Richard W. Gleiforst

    Mr. Gleiforst, 48, has had a prosthetic left eye due to trauma
since 1993. The best corrected visual acuity in his right eye is 20/15.
Following an examination in 2010, his optometrist noted, ``In my
medical opinion Richard Gleiforst has sufficient vision to operate a
commercial vehicle as he has been for the last ten years.'' Mr.
Gleiforst reported that he has driven straight trucks for 4 years,
accumulating 17,600 miles and tractor-trailer combinations for 11
years, accumulating 1.1 million miles. He holds a Class A CDL from
Colorado. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Edward P. Hynes, II

    Mr. Hynes, 52, has had amblyopia in his right eye since birth. The
best corrected visual acuity in his right eye is 20/400 and in his left
eye, 20/20. Following an examination in 2010, his optometrist noted,
``Mr. Hynes can recognize the colors of traffic control signals and
devices showing red, green and amber; and in my medical opinion he has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Hynes reported that he has driven straight
trucks for 25 years, accumulating 2 million miles. He holds an
operator's license from Virginia. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Keith R. Jordan

    Mr. Jordan, 40, has had retinal scarring in his right eye since
1990. The best corrected visual acuity in his right eye is 20/400 and
in his left eye, 20/20. Following an examination in 2010, his
optometrist noted, ``Since Mr. Jordan has had this condition for a long
time, and it is stable, it is my opinion that his vision is sufficient
to do the tasks needed to operate a commercial vehicle.'' Mr. Jordan
reported that he has driven straight trucks for 22 years, accumulating
22,000 miles and tractor trailer combinations for 15 years,
accumulating 840,000 miles. He holds a Class A CDL from Ohio. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Theodore D. Kirby

    Mr. Kirby, 30, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20 and in his
left eye, 20/400. Following an examination in 2010, his ophthalmologist
noted, ``In my medical opinion, Mr. Kirby has sufficient vision to
perform the driving tasks required to operate a commercial vehicle.''
Mr. Kirby reported that he has driven straight trucks for 3 years,
accumulating 45,000 miles. He holds a Class B CDL from Maryland. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Joseph A. Leigh, Jr.

    Mr. Leigh, 48, has had amblyopia in his right eye since childhood.
The best corrected visual acuity in his right eye is 20/200 and in his
left eye, 20/20. Following an examination in 2009, his optometrist
noted, ``I do believe that Mr. Leigh has sufficient vision to perform
the driving tasks required to operate a commercial vehicle.'' Mr. Leigh
reported that he has driven straight trucks for 20 years, accumulating
1.5 million miles. He holds a Class A CDL from North Carolina. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

John L. Lethcoe

    Mr. Lethcoe, 57, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20 and in his
left eye, hand-motion vision only. Following an examination in 2010,
his ophthalmologist noted, ``In my opinion, his vision is sufficient to
continue to operate a commercial vehicle.'' Mr. Lethcoe reported that
he has driven straight trucks for 5.5 years, accumulating 198,000
miles. He holds a Class A CDL from North Carolina. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Ronald J. McTague

    Mr. McTague, 53, has had amblyopia in his left eye since birth. The
best corrected visual acuity in his right eye is 20/20 and in his left
eye, 20/400. Following an examination in 2010, his optometrist noted,
``My opinion is that Mr. McTague should have no restrictions on him in
regards to operating a commercial vehicle.'' Mr. McTague reported that
he has driven straight trucks for 12 years, accumulating 900,000 miles
and tractor-trailer combinations for 17 years, accumulating 2.5 million
miles. He holds a Class A CDL from Ohio. His driving record for the
last 3 years shows one crash and no convictions for moving violations
in a CMV.

Benito Saldana

    Mr. Saldana, 52, has retinal detachment in his left eye due to a
traumatic injury sustained in 1981. The best corrected visual acuity in
his right eye is 20/20 and in his left eye, 20/200. Following an
examination in 2010, his ophthalmologist noted, ``It is my medical
opinion that this gentleman has proven that he can drive a commercial
vehicle and he can continue doing his job.'' Mr. Saldana reported that
he has driven tractor-trailer combinations for 34 years, accumulating
4.4 million miles. He holds a Class A CDL from Texas. His driving
record for the last 3 years shows no crashes and one conviction for a
moving violation in a CMV. He exceeded the speed limit by 14 miles per
hour (mph).

Julius Simmons, Jr.

    Mr. Simmons, 40, has had loss of vision in his right eye since 1988
due to trauma. The best corrected visual acuity in his right eye is
hand-motion only and in his left eye, 20/20. Following an examination
in 2010, his optometrist noted, ``I do believe that the issues
involving the right eye do not affect his ability to safely operate a
commercial vehicle.'' Mr. Simmons reported that he has driven tractor-
trailer combinations for 14 years, accumulating 1.6 million miles. He
holds a Class A CDL from South Carolina. His driving record for the
last 3 years shows two crashes, one for which he was not cited, and no
convictions for moving violations in a CMV.

Kenneth J. Weaver

    Mr. Weaver, 31, has had hamartoma in his right eye since birth. The
best corrected visual acuity in his right eye is light perception only
and in his left eye, 20/20. Following an examination in 2010, his
optometrist noted, ``Kenneth Weaver has sufficient vision to perform
the driving tasks required to operate a commercial vehicle.'' Mr.
Weaver reported that he has driven tractor-trailer combinations for 3
years accumulating 75,750 miles. He holds a Class A CDL from Wyoming.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Carl V. Wheeler

    Mr. Wheeler, 54, has had a prosthetic left eye since 1980. The best
corrected

visual acuity in his right eye is 20/20. Following an examination in
2010, his ophthalmologist noted, ``In my medical opinion, Mr. Wheeler
has sufficient vision to perform the driving tasks required to operate
a commercial vehicle.'' Mr. Wheeler reported that he has driven
straight trucks for 35 years, accumulating 437,500 miles and tractor-
trailer combinations for 10 years, accumulating 42,500 miles. He holds
a Class A CDL from North Carolina. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Stephen B. Whitt

    Mr. Whitt, 44, has had pseudoangioma in his right eye since 1994.
The best corrected visual acuity in his right eye is 20/80 and in his
left eye, 20/20. Following an examination in 2009, his optometrist
noted, ``It is my medical opinion that Stephen Whitt has sufficient
vision to perform the task of driving a commercial vehicle.'' Mr. Whitt
reported that he has driven straight trucks for 15 years, accumulating
750,000 miles and tractor-trailer combinations for 20 years,
accumulating 3 million miles. He holds a Class A CDL from North
Carolina. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Darrell F. Woosley

    Mr. Woosley, 66, has had loss of vision since 2006 due to a central
retinal vein occlusion. The best corrected visual acuity in his right
eye is 20/200 and in his left eye, 20/25. Following an examination in
2010, his ophthalmologist noted, ``It is my opinion that Mr. Darrell
Woosley's vision is sufficient to allow him to drive a commercial
vehicle based on his testing in the clinic.'' Mr. Woosley reported that
he has driven tractor-trailer combinations for 44 years, accumulating
3.1 million miles. He holds a Class A CDL from Illinois. His driving
record for the last 3 years shows no crashes and two convictions for
moving violations in a CMV. On the first occasion, he was cited for
failure to obey a traffic sign and on the second occasion, he exceeded
the speed limit by 9 mph.

Jason M. Zaragoza

    Mr. Zaragoza, 37, has had macular scarring in his right eye since
2003. The best corrected visual acuity in his right eye is 20/100 and
in his left eye, 20/20. Following an examination in 2010, his
ophthalmologist noted, ``I certify that in my medical opinion, Jason
Zaragoza has sufficient vision to perform the driving tasks required to
operate a commercial vehicle.'' Mr. Zaragoza reported that he has
driven straight trucks for 8 years, accumulating 208,000 miles. He
holds a Class C operator's license from California. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this Notice. The Agency will consider all comments
received before the close of business September 8, 2010. Comments will
be available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should monitor the public
docket for new material.

    Issued on: July 29, 2010.
 Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. 2010-19594 Filed 8-6-10; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Notices]
[Page 4045]
[FR Doc No: 2018-01526]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Friendswood Energy Genco, LLC, EG18-1-000; NTE Carolinas II, LLC,
EG18-2-000; Bladen Solar, LLC, EG18-3-000; Bullock Solar, LLC, EG18-4-
000; Voyager Wind II, LLC, EG18-5-000; PowerFin ASL 1, LLC, EG18-6-000;
PowerFin SolarMundo, LLC, EG18-7-000 ; 54KR 8me LLC, EG18-8-000;
Capricorn Bell Interconnection, LLC, EG18-9-000; CXA La Paloma, LLC,
EG18-10-000; APV Renaissance Opco, LLC, EG18-11-000; EGP Stillwater
Solar PV II, LLC, EG18-12-000; EGP Stillwater Solar, LLC, EG18-13-000]

Notice of Effectiveness of Exempt Wholesale Generator Status

    Take notice that during the month of December 2017, the status of
the above-captioned entities as Exempt Wholesale Generators became
effective by operation of the Commission's regulations. 18 CFR 366.7(a)
(2017).

    Dated: January 22, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-01526 Filed 1-26-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49959-49960]
[FR Doc No: 2018-21509]

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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:
    Regulation FD, SEC File No. 270-475, OMB Control No. 3235-0536

    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 this request for extension of the previously approved
collection of information discussed below.
    Regulation FD (17 CFR 243.100 et seq.)--Other Disclosure Materials
requires public disclosure of material information from issuers of
publicly traded securities so that investors have current information
upon which to base investment decisions. The purpose of the regulation
is to require that: (1) When an issuer intentionally discloses

material information, to do so through public disclosure, not selective
disclosure; and (2) to make prompt public disclosure of material
information that was unintentionally selectively disclosed. Regulation
FD was adopted due to a concern that the practice of selective
disclosure leads to a loss of investor confidence in the integrity of
our capital markets. All information is provided to the public for
review. The information required is filed on occasion and is mandatory.
We estimate that approximately 13,000 issuers make Regulation FD
disclosures approximately five times a year for a total of 58,000
submissions annually, not including an estimated 7,000 issuers who file
Form 8-K to comply with Regulation FD. We estimate that it takes
approximately 5 hours per response (58,000 responses x 5 hours) for a
total burden of 290,000 hours annually. In addition, we estimate that
25% of the 5 hours (1.25 hours) is prepared by the filer for an annual
reporting burden of 72,500 hours (1.25 hours per response x 58,000
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 control number.
    The public may view the background documentation for this
information collection at the following website, 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 protected]; and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Candace
Kenner, 100 F Street NE, Washington, DC 20549 or send an email to:
[email protected]. Comments must be submitted to OMB within 30 days
of this notice.

    Dated: September 27, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-21509 Filed 10-2-18; 8:45 am]
 BILLING CODE 8011-01-P


                     Bacillus licheniformis strain SB3086

                     Interim Registration Review Decision
                               Case Number 6014

                                      for
Approved by:	___________________________      					Robert C. McNally, Director
                              Biopesticides and Pollution Prevention Division

                               September 6, 2018
                      Date:			___________________________

                               Table of Contents

I.	Introduction	3
II.	Use and Usage	4
III.	Scientific Assessments	5
A.	Human Health Assessment	5
B.	Environmental Assessment	7
C.	Endocrine Disruptor Screening Program	8
IV.	Interim Registration Review Decision	9
V.	Next Steps and Timeline	9
References	10

I.	Introduction
This document is the Environmental Protection Agency's (EPA or the Agency) Interim Registration Review Decision for Bacillus licheniformis strain SB3086 (Case 6014, PC Code 006492) and is being issued pursuant to 40 CFR sections 155.56 and 155.58. A registration review decision is the Agency's determination whether a pesticide meets, or does not meet, the standard for registration in the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Agency may issue, when it determines it to be appropriate, an Interim Registration Review Decision before completing a registration review. Among other things, the interim registration review decision may:  1) require new risk mitigation measures; 2) impose interim risk mitigation measures; 3) identify data or information required to complete the review; and 4) establish schedules for submitting the required data, conducting the new risk assessment and completing the registration review. For further information on Bacillus licheniformis strain SB3086, additional documents can be found in EPA's public docket (EPA-HQ-OPP-2014-0184) at www.regulations.gov.
FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996, mandated the continuous review of existing pesticides. All pesticides distributed or sold in the United States generally must be registered by the EPA based on scientific data showing that they will not cause unreasonable risks to human health or to the environment when used as directed on product labeling. The registration review program is intended to ensure that, as the ability to assess and reduce risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects. Changes in science, public policy, and pesticide use practices will occur over time. Through the registration review program, the Agency periodically re-evaluates pesticides to ensure that as these changes occur, products in the marketplace can continue to be used safely. Information on this program is provided at www.epa.gov/pesticide-reevaluation. In 2006, the Agency implemented the registration review program pursuant to FIFRA section 3(g). The Agency will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration.
This document is organized into five sections: the Introduction, which includes this summary and a summary of any public comments and the Agency's response; Use and Usage, which describes how and why Bacillus licheniformis strain SB3086 is used and summarizes data on its use; Scientific Assessments, which summarizes the Agency's risk assessments, any revisions, and risk conclusions; Interim Registration Review Decision, which describes the regulatory rationale for the Agency's interim registration review decision; and, last, the Next Steps and Timeline for completion of this registration review case.
Summary of Bacillus licheniformis strain SB3086 Registration Review
Pursuant to 40 CFR section 155.50, EPA formally initiated registration review for Bacillus licheniformis strain SB3086 (Case 6014). The following list highlights significant events that have occurred during the registration review of Bacillus licheniformis strain SB3086. Documentation of these events for Bacillus licheniformis strain SB3086 can be found in the Agency's public docket, EPA-HQ-OPP-2014-0184, available at www.regulations.gov.
 March 28, 2014 - Publication of the Bacillus licheniformis strain SB3086 Preliminary Work Plan (PWP) in the docket for a 60-day public comment period. The comment period closed May 27, 2014. The Agency received no comments.
 September 25, 2014 - Publication of the Bacillus licheniformis strain SB3086 Final Work Plan (FWP) - The FWP confirmed that the most recent exposure and risk assessments still support the registration of pesticide products containing Bacillus licheniformis strain SB3086. It was determined that no additional data were needed for the Bacillus licheniformis strain SB3086 registration review because sufficient information was available to conduct a qualitative risk assessment, supporting a proposed interim registration review decision, pursuant to 40 CFR section 155.53(b).
 May 24, 2018  -  Publication of the Bacillus licheniformis strain SB3086 Proposed Interim Registration Review Decision for a 60-day public comment period. The comment period closed July 23, 2018. One comment was received in support of the decision in response to this publication.
 September 2018  -  The Agency is now publishing the Bacillus licheniformis strain SB3086 Interim Registration Review Decision.
Additional information on Bacillus licheniformis strain SB3086 can be found in EPA's public docket, EPA-HQ-OPP-2014-0184, available at www.regulations.gov.
II.	Use and Usage
Products containing Bacillus licheniformis strain SB3086 are registered as microbial pesticides for use as fungicides and as algaecides. Bacillus licheniformis strain SB3086 is the active ingredient in Novozymes Biofungicide Green Releaf, a microbial fungicide registered for use on lawns, conifers, tree seedlings, ornamental turf and ornamental plants in outdoor, greenhouse, and nursery sites. This product is intended to control dollar spot, anthracnose, and other plant diseases. Bacillus licheniformis is a ubiquitous, saprophytic soil bacterium that contributes to nutrient cycling and displays antifungal activity. While numbers of Bacillus licheniformis in soil are unknown and likely vary from soil to soil, the use of Bacillus licheniformis at current label rates is not expected to add substantially to the size of the naturally occurring Bacillus licheniformis populations. The acute toxicity data performed resulted in an overall classification of Toxicity Category IV (U.S. EPA, 2003). Table I provides a summary of the chemical facts for Bacillus licheniformis strain SB3086.

    Table 1. Bacillus licheniformis strain SB3086 Use and Usage Information
Summary of Use
Microbial pesticide registered for use as a biofungicide and algaecide
Use Sites
For use on greenhouse plants, turf, golf courses and lawns; algaecide in ornamental fish ponds and water gardens
Summary of Usage
N/A
Formulation Type
Liquid formulation; user adds water
Application Method
Foliar spray, soil drench, chemigation, direct application to ornamental ponds
Technical Registrants
None. (Registrant for end-use product with highest AI concentration: Novozymes)
No. of Registrations
3 FIFRA Section 3 products
Restricted Use
No

III.	Scientific Assessments
A summary of the Agency's human health, environmental and ecological risk assessments for Bacillus licheniformis strain SB3086 is presented below. The most recent assessments were conducted in September 2002 for the first registration of a pesticide product containing this active ingredient. Additional data were submitted by a second registrant for the registration of the algaecide product in 2007. For the detailed risk assessments, see the Bacillus licheniformis strain SB3086 public docket (EPA-HQ-OPP-2014-0184) at www.regulations.gov.

 Human Health Assessment
 Hazard Characterization and Risk
The toxicological database is considered complete for characterizing hazard and assessing risk from Bacillus licheniformis strain SB3086. No additional studies are anticipated to be needed for registration review. All data requirements, per 40 CFR 158.2050, have been fulfilled for Bacillus licheniformis strain SB3086. Hazard and exposure data, agency risk assessments and other information on this active ingredient were evaluated against standards established by FIFRA and the Agency's regulations and scientific policies.
All acute toxicity data requirements for Bacillus licheniformis strain SB3086 have been satisfied with guideline studies. Acute oral toxicity, primary eye irritation, acute dermal toxicity, and primary dermal irritation are all Toxicity Category IV. The products are not considered to be dermal sensitizers. Subchronic and chronic toxicity data were not required because survival, replication, infectivity, toxicity, or persistence of the microbial agent was not observed in the test animals treated in the acute oral infectivity test (U.S. EPA, 2003).
Based on existing use patterns and personal protection equipment (PPE) requirements of the active ingredient, exposure is expected to be minimal. When used as a fungicide or algaecide in accordance with their respective labels, Bacillus licheniformis strain SB3086-containing products are not expected to cause unreasonable adverse effects to humans. Therefore, it was determined that there is no need to conduct an additional human health risk assessment at this time.

 Dietary Exposure and Risk Assessment
A quantitative dietary (food and drinking water) exposure and risk assessment was not conducted since Bacillus licheniformis strain SB3086 demonstrated low toxicity at the levels of exposure relative to its anticipated pesticidal use. A qualitative risk assessment was considered adequate. The present use sites for products containing Bacillus licheniformis strain SB3086 do not include food or feed sites; therefore, dietary exposure and risk from the consumption of residues are likely to be minimal to non-existent for the general population including infants and children.
The microorganism Bacillus licheniformis is ubiquitous in the natural environment; and it is not considered to be a risk to drinking water. Accordingly, drinking water is not being screened for Bacillus licheniformis strain SB3086 as a potential indicator of microbial contamination or as a direct pathogenic contaminant. Both percolation through soil and municipal treatment of drinking water would reduce the possibility of exposure to Bacillus licheniformis strain SB3086 through drinking water. Altogether, the potential of significant exposure to Bacillus licheniformis strain SB3086 in drinking water is expected to be negligible; and the potential of minimal exposure notwithstanding, there is no significant risk of dietary toxicity relative to pesticidal exposure to Bacillus licheniformis strain SB3086. Therefore, the continued use of Bacillus licheniformis strain SB3086 as a pesticide does not present any dietary concern to the Agency.
Food Tolerances
Currently, there are no registered products for food or feed use that contain Bacillus licheniformis strain SB3086 as an active ingredient. Whether it is used as a fungicide to control plant diseases on turf or ornamentals or as an algaecide to control green water algae, food and feed uses are explicitly prohibited on the labels. Therefore, the EPA did not require a tolerance or an exemption from the requirement of a tolerance for residues of Bacillus licheniformis strain SB3086 found on or in food and feed (U.S. EPA, 2003).

Residential and Occupational Exposure and Risk
In residential and day care settings, children may be exposed to this pesticide on treated lawns, ornamental turf, recreational fields and ornamental plants; however, any exposure is expected to be negligible. Bacillus licheniformis strain SB3086 is a natural soil isolate. The general population, including infants and children, are exposed to Bacillus licheniformis strain SB3086 and other strains of these Bacilli in untreated soils on a regular basis without hazard (U.S. EPA, 2003).

The potential for occupational and residential risk is expected to be minimal based on the evaluations of submitted Tier I acute toxicity tests. For occupational uses, potential risks from regular occupational exposure will be mitigated through the use of appropriate Personal Protective Equipment (PPE). Labels for these EPs currently require the following PPE for applicators/handlers: long sleeve shirt, long pants, shoes, socks, waterproof gloves, protective eyewear, and for exposure in enclosed areas or outdoors, a particulate-filtering NIOSH-approved respirator. No significant residential or occupational exposure is anticipated; no potential cumulative effects have been identified; and there is no concern for aggregate exposure (U.S. EPA, 2003).
 Human Incidents
A search of the Office of Pesticide Programs' (OPP) Incident Data System (IDS) on January 25, 2018, revealed no reported human health incidents associated with the currently registered products containing Bacillus licheniformis strain SB3086 from February 1, 2003 through January 25, 2018. This database contains information dating back to the 1970s and is continuously updated as incidents are reported.
 Environmental Assessment
All ecological data requirements have been fulfilled. Hazard and exposure data on this chemical were evaluated against current standards established by the Agency's scientific policies and regulations. Bacillus licheniformis is a ubiquitous, saprophytic soil microbe that contributes to nutrient cycling and displays antifungal activity. While numbers of Bacillus licheniformis in soil are unknown and likely vary from soil to soil, the numbers of total Bacillus organisms are estimated at 1x10[7] cfu/g soil (U.S. EPA, 1997). The added soil density of Bacillus licheniformis from the proposed use rates would be 0.42% to 1.5% (U.S. EPA, 2003). This represents a very small proportion of the naturally occurring bacilli in the soil and therefore is not expected to add substantially to the effects of the naturally occurring Bacillus populations (U.S. EPA, 2003).

The nontarget toxicity data requirements for Bacillus licheniformis strain SB3086 were fulfilled as follows: Avian Pulmonary/Inhalation, Wild Mammal, Estuarine/Marine Animal, Nontarget Plant, and Nontarget Insect requirements were waived by EPA based on a rationale demonstrating a lack of potential for exposure or toxicity to plants, insects, mammals, estuarine and marine animals, or birds. A guideline study on rainbow trout demonstrated no pathogenicity, and only showed toxicity at 117X the expected environmental concentration. Guideline studies on young mallards and daphnia each demonstrated no evidence of pathogenicity or toxicity of the test substance. Additionally, a guideline study on honey bees demonstrated no evidence of pathogenicity or toxicity of the test substance, indicating that the use of products containing Bacillus licheniformis strain SB3086 is not likely to adversely affect pollinators (U.S. EPA, 2003).

Based on the ecological reviews of the nontarget organisms and environmental fate information, the Agency has determined that unreasonable adverse effects to nontarget organisms or the environment are not likely to result when products containing Bacillus licheniformis strain SB3086 are used in accordance with their respective use directions. In addition, EPA has determined that no adverse effects will occur to bees or other nontarget insects as a result of the labeled applications of Bacillus licheniformis strain SB3086. Therefore, risk to pollinators is not expected as a result of the labeled uses. Environmental scientific reviews for Bacillus licheniformis strain SB3086 are located in the Bacillus licheniformis strain SB3086 registration review docket (EPA-HQ-OPP-2014-0184) at www.regulations.gov.
Endangered Species Assessment
There is no expectation for any registered use of Bacillus licheniformis strain SB3086 to cause direct or indirect adverse effects to threatened and endangered species. Bacillus licheniformis and other Bacillus species are naturally ubiquitous in the soil environment, and the application of Bacillus licheniformis strain SB3086 is not expected to add substantially to the effects of the naturally occurring Bacillus populations. Acute and subchronic human health toxicity studies have demonstrated no evidence of toxicity or pathogenicity. Nontarget organism studies were either waived based upon the natural occurrence of Bacillus licheniformis in the environment or demonstrated a lack of toxicity or pathogenicity in exposure to nontarget organisms.

Consequently, adverse effects to terrestrial and aquatic organisms are expected to be negligible; therefore, the Agency has come to a "No Effect" determination under the Endangered Species Act (ESA) for all listed endangered or threatened species and their designated critical habitat. As a result, the Agency has concluded that consultation with the Fish and Wildlife Service and the National Marine Fisheries Service under ESA section 7 (a)(2) is not required. The Agency anticipates conducting no further analysis of potential risks to endangered or threatened species, unless data or information are obtained during the registration review process that would indicate such an assessment would be needed to inform the Agency's decision. The Endangered Species Assessment can be found in the Registration Review docket (EPA-HQ-OPP-2014-0184).
 Ecological Incidents
A search covering the period from February 1, 2003 through January 25, 2018 of the OPP's Incident Data System (IDS) and Ecological incident information System indicated that there was one report of an adverse domestic animal incident for one of the pesticide products containing Bacillus licheniformis strain SB3086 as its active ingredient. The incident, which involved Algae Destroyer Advanced, was reported by Mars Fishcare in July 2010 and involved some pond casualties. There was insufficient information to make a determination as to whether the incident was related to the pesticidal application or whether it was anomalous.

 Endocrine Disruptor Screening Program
As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p), the Agency has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be used to test all pesticides in order to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a "naturally occurring estrogen, or other such endocrine effects as the Administrator may designate."
Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. The Agency has reviewed all of the assay data received for the List 1 chemicals and the conclusions of those reviews are available in the chemical-specific public dockets. A second list of chemicals identified for EDSP screening was published on June 14, 2013 and includes some pesticides scheduled for Registration Review and chemicals found in water. Neither of these lists should be construed as a list of known or likely endocrine disruptors. Bacillus licheniformis strain SB3086 is not on either list. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website.
In this interim decision, the Agency is making no human health or environmental safety findings associated with the EDSP screening of Bacillus licheniformis strain SB3086. As such, pursuant to Section 408(p)(4), and before completing this Registration Review, EPA will determine whether it can exempt Bacillus licheniformis strain SB3086 from the requirements of the Section 408(p) EDSP. In the event the EPA does determine to exempt this substance from the EDSP, an order will be issued.
IV.	Interim Registration Review Decision
In accordance with 40 CFR §155.56 and 155.58, the Agency is issuing this Interim Registration Review Decision. Except for the EDSP component of this case, the Agency has made the following Interim Decision: (1) no additional data are required at this time; and (2) no changes to the affected registrations and their labels are needed at this time. In this interim decision, the Agency is making no human health or environmental safety findings associated with the EDSP screening of Bacillus licheniformis strain SB3086. The Agency's final registration review decision for Bacillus licheniformis strain SB3086 will be made following completion of an EDSP FFDCA §408(p) determination.
V.	Next Steps and Timeline
A Federal Register Notice will announce the availability of this Interim Registration Review Decision for Bacillus licheniformis strain SB3086. A final decision on the Bacillus licheniformis strain SB3086 registration review case will occur after an EDSP FFDCA section 408(p) determination has been made.
                                               Activities
                                                           Estimated Month/Year
Opening the Docket/Case Development
Open Docket and 60-Day Public Comment Period
                                March 28, 2014
Close Public Comment Period
                                 May 27, 2014
Issue Final Work Plan
                              September 25, 2014
 Proposed Interim and Final Registration Review Decision

Open 60-Day Public Comment Period for Proposed Interim Registration Review Decision
                                 May 24, 2018
Close Public Comment Period
                                 July 23, 2018
Interim Registration Review Decision
                                September 2018
Final Decision*
                                      TBD
*This schedule is subject to revision should unforeseen issues arise during the registration review process. In the event an issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan will be issued at that time that will set forth a new timeline and, if applicable, any new data requirements will be included in the amended document and a Data Call-In Notice will be issued.

                                  References
U.S. EPA. 1997. TSCA Final Risk Assessment of Bacillus licheniformis. U.S. Environmental Protection Agency Office of Pollution Prevention and Toxics. February 1997. Available at: https://www.regulations.gov/docket?D=EPA-HQ-OPP-2014-0184.
U.S. EPA, 2003. Biopesticide Registration Action Document: Bacillus licheniformis Strain SB3086 (PC Code 006492). U.S. Environmental Protection Agency Office of Pesticide Programs. April 2003. Available at: https://www.regulations.gov/docket?D=EPA-HQ-OPP-2014-0184.