[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Notices]
[Pages 35085-35087]
[FR Doc No: 2013-13796]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Consensus Standards, Light-Sport Aircraft

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of availability; request for comments.

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

SUMMARY: This notice announces the availability of one new and seven
revised consensus standards relating to the provisions of the Sport
Pilot and Light-Sport Aircraft rule issued July 16, 2004, and effective
September 1, 2004. ASTM International Committee F37 on Light Sport
Aircraft developed the new and revised standards with Federal Aviation
Administration (FAA) participation. By this notice, the FAA finds the
new and revised standards acceptable for certification of the specified
aircraft under the provisions of the Sport Pilot and Light-Sport
Aircraft rule.

DATES: Comments must be received on or before August 12, 2013.

ADDRESSES: Comments may be mailed to: Federal Aviation Administration,
Small Airplane Directorate, Programs and Procedures Branch, ACE-114,
Attention: Terry Chasteen, Room 301, 901 Locust, Kansas City, Missouri
64106. Comments may also be emailed to<EMAIL_ADDRESS>

All comments must be marked: Consensus Standards Comments, and must
specify the standard being addressed by ASTM designation and title.

FOR FURTHER INFORMATION CONTACT: Terry Chasteen, Light-Sport Aircraft
Program Manager, Programs and Procedures Branch (ACE-114), Small
Airplane Directorate, Aircraft Certification Service, Federal Aviation
Administration, 901 Locust, Room 301, Kansas City, Missouri 64106;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This notice announces the availability of
one new and seven revised consensus standards to previously accepted
consensus standards relating to the provisions of the Sport Pilot and
Light-Sport Aircraft rule. ASTM International Committee F37 on Light
Sport Aircraft developed the new and revised standards. The FAA expects
a suitable consensus standard to be reviewed at least every two years.
The two-year review cycle will result in a standard revision or
reapproval. A standard is issued under a fixed designation (i.e.,
F2244); the number immediately following the designation indicates the
year of original adoption or, in the case of revision, the year of last
revision. A number in parentheses indicates the year of last
reapproval. A reapproval indicates a two-year review cycle completed
with no technical changes. A superscript epsilon ([egr]) indicates an
editorial change since the last revision or reapproval. A notice of
availability (NOA) will only be issued for new or revised standards.
Reapproved standards issued with no technical changes or standards
issued with editorial changes only (i.e., superscript epsilon ([egr]))
are considered accepted by the FAA without need for a NOA.
    Comments Invited: Interested persons are invited to submit such
written data, views, or arguments, as they may desire. Communications
should identify the consensus standard number and be submitted to the
address specified above. All communications received on or before the
closing date for comments will be forwarded to ASTM International
Committee F37 for consideration. The standard may be changed in light
of the comments received. The FAA will address all comments received
during the recurring review of the consensus standard and will
participate in the consensus standard revision process.
    Background: Under the provisions of the Sport Pilot and Light-Sport
Aircraft rule, and revised Office of Management and Budget (OMB)
Circular A-119, ``Federal Participation in the Development and Use of
Voluntary Consensus Standards and in Conformity Assessment
Activities'', dated February 10, 1998, industry and the FAA have been
working with ASTM International to develop consensus standards for
light-sport aircraft. These consensus standards satisfy the FAA's goal
for airworthiness certification and a verifiable minimum safety level
for light-sport aircraft. Instead of developing airworthiness standards
through the rulemaking process, the FAA participates as a member of
Committee F37 in developing these standards. The use of the consensus
standard process assures government and industry discussion and
agreement on appropriate standards for the required level of safety.

Comments on Previous Notices of Availability

    In the Notice of Availability (NOA) issued on February 22, 2012,
and published in the Federal Register on April 23, 2012 the FAA asked
for public comments on the new and revised consensus standards accepted
by that NOA. The comment period closed on June 22, 2012. No public
comments were received regarding the standards accepted by this NOA.

Consensus Standards in this Notice of Availability

    The FAA has reviewed the standards presented in this NOA for
compliance with the regulatory requirements of the rule. Any light-
sport aircraft issued a special light-sport airworthiness certificate,
which has been designed, manufactured, operated and maintained, in
accordance with this and previously accepted ASTM consensus standards
provides the public with the appropriate level of safety established
under the regulations. Manufacturers who choose to produce these
aircraft and certificate these aircraft under 14 CFR part 21,
Sec. Sec.  21.190 or 21.191 are subject to the applicable consensus
standard requirements. The FAA maintains a listing of all accepted
standards on the FAA Web site.

The Revised Consensus Standard and Effective Period of Use

    The following previously accepted consensus standards have been
revised, and this NOA is accepting the later revision. Either the
previous revision or the later revision may be used for the initial
certification of special light-sport aircraft until December 11, 2013.
This overlapping period of time will allow aircraft that have started
the initial certification process using the previous revision level to
complete that process. After December 11, 2013, manufacturers must use
the later revision and must identify the later revision in the
Statement of Compliance for initial certification of special light-
sport aircraft unless the FAA publishes a specific notification
otherwise. The following Consensus Standards may not be used after
December 11, 2013:
    ASTM Designation F2243-05, titled: Standard Specification for
Required Product Information to be Provided with Powered Parachute
Aircraft
    ASTM Designation F2245-11, titled: Standard Specification for
Design and Performance of a Light Sport Airplane
    ASTM Designation F2316-08, titled: Standard Specification for
Airframe Emergency Parachutes
    ASTM Designation F2355-10, titled: Standard Specification for
Design and Performance Requirements for Lighter-Than-Air Light Sport
Aircraft
    ASTM Designation F2483-05, titled: Standard Practice for
Maintenance and the Development of Maintenance Manuals for Light Sport
Aircraft
    ASTM Designation F2626-07, titled: Standard Terminology for Light
Sport Aircraft

The Consensus Standards

    The FAA finds the following new and revised consensus standards
acceptable for certification of the specified aircraft under the
provisions of the Sport Pilot and Light-Sport Aircraft rule. The
following consensus standards become effective June 11, 2013 and may be
used unless the FAA publishes a specific notification otherwise:
    ASTM Designation F2243-11, titled: Standard Specification for
Required Product Information to be Provided with Powered Parachute
Aircraft
    ASTM Designation F2245-12d, titled: Standard Specification for
Design and Performance of a Light Sport Airplane
    ASTM Designation F2316-12, titled: Standard Specification for
Airframe Emergency Parachutes
    ASTM Designation F2355-12, titled: Standard Specification for
Design and Performance Requirements for Lighter-Than-Air Light Sport
Aircraft
    ASTM Designation F2483-12, titled: Standard Practice for
Maintenance and the Development of Maintenance Manuals for Light Sport
Aircraft
    ASTM Designation F2626-12, titled: Standard Terminology for Light
Sport Aircraft
    ASTM Designation F2746-12, titled: Standard Specification for
Pilot's Operating Handbook (POH) for Light Sport Airplane

    ASTM Designation F2930-12, titled: Standard Guide for Compliance
with Light Sport Aircraft Standards

Availability

    These consensus standards are copyrighted by ASTM International,
100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959.
Individual reprints of a standard (single or multiple copies, or
special compilations and other related technical information) may be
obtained by contacting ASTM at this address, or at<PHONE_NUMBER>
(phone),<PHONE_NUMBER> (fax), through<EMAIL_ADDRESS>(email), or
through the ASTM Web site at www.astm.org. To inquire about standard
content and/or membership or about ASTM International Offices abroad,
contact Christine DeJong, Staff Manager for Committee F37 on Light
Sport Aircraft:<PHONE_NUMBER><EMAIL_ADDRESS>
    Issued in Kansas City, Missouri on May 31, 2013.
Earl Lawrence,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. 2013-13796 Filed 6-10-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 17, 2006 (Volume 71, Number 136)]
[Notices]
[Page 40506-40507]
[DOCID:fr17jy06-60]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OA-2006-0278; FRL-8197-6]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Minority Business Enterprise/
Woman Business Enterprise (MBE/WBE) Utilization Under Federal Grants,
Cooperative Agreements, and Interagency Agreements (Renewal); EPA ICR
No. 2212.02, OMB Control No. 2090-0025

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that an Information
Collection Request (ICR) has been forwarded to the Office of Management
and Budget (OMB) for review and approval. This is a request to renew an
existing approved collection. The ICR, which is abstracted below,
describes the nature of the information collection and its estimated
burden and cost.

DATES: Additional comments may be submitted on or before August 16,
2006.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OA-
2006-0278, (1) to EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA Docket

Center, Environmental Protection Agency, MBE/WBE Utilization Under
Federal Grants, Cooperative Agreements, and Interagency Agreements,
Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460,
and (2) OMB by mail to: Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB), Attention: Desk Officer for EPA,
725 17th Street, NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Kimberly Y. Patrick, Office of Small
and Disadvantaged Business Utilization, Mailcode: 1230N, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On April 3, 2006 (71 FR 16574), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OA-2006-0278, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Office of

Environmental Information Docket in the EPA Docket Center (EPA/DC), EPA
West, Room B102, 1301 Constitution Ave., NW., Washington, DC. The EPA/
DC Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Reading
Room is<PHONE_NUMBER>, and the telephone number for the Office of
Environmental Information Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at >http://www.regulations.gov as EPA receives

them and without change, unless the comment contains copyrighted
material, Confidential Business Information (CBI), or other information
whose public disclosure is restricted by statute. For further
information about the electronic docket, go to http://www.regulations.gov.

    Title: Minority Business Enterprise/Woman Business Enterprise (MBE/
WBE) Utilization Under Federal Grants, Cooperative Agreements, and
Interagency Agreements (Renewal).
    ICR numbers: EPA ICR No. 2212.02, OMB Control No. 2090-0025.
    ICR Status: This ICR is scheduled to expire on August 31, 2006.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: All EPA financial assistance agreement recipients are
required to make good faith efforts to assure that small, minority and
women owned businesses are used, when possible, as sources of
construction, services, equipment, and supplies. The completion and
submission of EPA Form 5700-52A is mandatory. The information collected
by EPA Form 5700-52A is used to compile data concerning the utilization
of minority and women owned businesses as contractors and
subcontractors under procurements funded by EPA financial assistance
agreements pursuant to Executive Orders 11625, 12138, and 12432, and
Public Laws 101-507 and 102-389. The effectiveness of EPA's MBE/WBE
Program is measured through this reporting requirement. The
modifications to the form were made to simplify and shorten the form
itself. The instructions in the modified form also provide more
information about questions frequently asked by respondents.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 1.5
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and

maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized here:
    Estimated total number of potential respondents: 3600.
    Frequency of response: Depending on the type of financial
assistance received, respondents either report on an annual or
quarterly basis.
    Estimated total average number of responses for each respondent:
2.5 average responses per year, including annual and quarterly
respondents.
    Estimated total annual burden hours: 10,800.
    Estimated total annual costs: $548,532. This includes $0 annualized
capital startup costs, $0 annualized O&M costs, and $548,532 annualized
labor costs.
    Changes in the Estimates: The estimates reflect an increase in
Respondent burden hours and costs due to extra time needed to review
the new instructions for the form. Even though we received no comments
regarding the form from our consultation efforts, or from public
comments, hours to gather information to complete the form were
increased in response to past comments about the form. The total change
in burden represents an increase from 1 burden hour to 1.5 burden
hours.

    Dated: July 8, 2006.
Oscar Morales,
Director, Collection Strategies Division.
 [FR Doc. E6-11250 Filed 7-14-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: November 1, 2006 (Volume 71, Number 211)]
[Rules and Regulations]
[Page 64128-64132]
[DOCID:fr01no06-8]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 174

[EPA-HQ-OPP-2006-0784; FRL-8096-4]

Bacillus Thuringiensis Modified Cry3A Protein and the Genetic
Material Necessary for Its Production in Corn; Exemption from the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes a permanent exemption from the
requirement of a tolerance for residues of the Bacillus thuringiensis
modified Cry3A protein (mCry3A) and the genetic material necessary for
its production in corn on field corn, sweet corn, and popcorn when
applied/used as a plant-incorporated protectant. Syngenta Seeds, Inc.
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA), requesting an exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of Bacillus thuringiensis modified Cry3A protein
(mCry3A) and the genetic material necessary for its production in corn.

DATES: This regulation is effective November 1, 2006. Objections and
requests for hearings must be received on or before January 2, 2007,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2006-0784. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,

if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket telephone
number is<PHONE_NUMBER>.

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

I. General Information

A. Does this Action Apply to Me?

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

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. You must file your objection or
request a hearing on this regulation in accordance with the
instructions provided in 40 CFR part 178. To ensure proper receipt by
EPA, you must identify docket ID number EPA-HQ-OPP-2006-0784 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before January 2, 2007.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2006-0784, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of October 27, 2004 (69 FR 62688) (FRL-
7370-1), EPA issued a notice pursuant to section 408(d)(3) of the
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
tolerance petition (PP 4F6838) by Syngenta Seeds, Inc., P.O. Box 12257,
3054 Cornwallis Road, Research Triangle Park, NC 27709-2257. The
petition requested that 40 CFR part 174 be amended by establishing a
permanent exemption from the requirement of a tolerance for residues of
modified Cry3A protein (mCry3A) and the genetic material necessary for
its production in corn. This notice included a summary of the petition
prepared by the petitioner Syngenta Seeds, Inc. One comment was
received in response to the notice of filing from the National Corn
Growers Association.

They supported the petition and requested EPA to quickly issue the
final rule.
    On March 14-15, 2006, EPA held a FIFRA Scientific Advisory Panel
(SAP) meeting, at http://www.epa.gov/scipoly/sap/meetings/2006/index.htm#march
 to address the scientific issues that arose during the

risk assessment of mCry3A. EPA asked the SAP to comment on the
equivalence of the mCry3A proteins from corn event MIR604 and from
recombinant E. coli - specifically the presence of two forms in the
bacterial-produced mCry3A protein and the differences in bioactivity in
the WCRM bioassay. The majority of the Panel concluded that the two
forms of the mCry3A are of relatively comparable biological activity
for the purposes of the human health assessments based on the amino
acid sequence identity, lack of glycosylation, and general stability.
    EPA also asked the SAP to comment on EPA's conclusions regarding
the lack of mammalian toxicity and allergenicity of the mCry3A protein-
specifically the impact of the less potent mCry3A form on the results
of the acute oral toxicity tests and the usefulness of in vitro
digestibility studies and amino acid sequence homology analysis as part
of the risk assessment. Overall, the Panel was more concerned with the
quality of data, i.e. inadequately described methods and poor
reproduction of data images. The Panel specifically noted that the
amino acid sequence analysis to known toxins and allergens were missing
the following data: Specification of which version of NCBI database was
utilized; descriptions of parameters utilized; and dates accessed for
the BLAST search. EPA recognizes that these are important parameters to
include in a description of an amino acid analysis and is requiring
submission of additional information by Syngenta Seeds, Inc. in order
to confirm the method used. However, EPA maintains that the conclusions
of the amino acid sequence analysis are still valid for the purpose of
the risk assessment. EPA reached this decision based on the following:
(1) Lack of mammalian toxicity of mCry3A protein as shown by the acute
oral mouse study; (2) mCry3A protein is rapidly digested in SGF; (3)
mCry3A protein originates from a non-allergenic source; (4) lack of
sequence identity of mCry3A protein with eight contiguous amino acids
or more than 35% identity over 80 amino acids with known toxins or
allergens; and (5) mCry3A protein is not glycosylated when expressed in
corn.
    Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of the FFDCA
defines ``safe'' to mean that ``there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical
residue, including all anticipated dietary exposures and all other
exposures for which there is reliable information.'' This includes
exposure through drinking water and in residential settings, but does
not include occupational exposure. Pursuant to section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C), which require EPA to give special consideration
to exposure of infants and children to the pesticide chemical residue
in establishing a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .''
Additionally, section 408(b)(2)(D) of the FFDCA requires that the
Agency consider ``available information concerning the cumulative
effects of a particular pesticide's residues '' and ``other substances
that have a common mechanism of toxicity.''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed
the available scientific data and other relevant information in support
of this action and considered its validity, completeness, and
reliability and the relationship of this information to human risk. EPA
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
    Data have been submitted demonstrating the lack of mammalian
toxicity at high levels of exposure to the mCry3A protein alone. These
data demonstrate the safety of the products at levels well above
maximum possible exposure levels that are reasonably anticipated in the
crops. This is similar to the Agency position regarding toxicity and
the requirement of residue data for the microbial Bacillus
thuringiensis products from which this plant-incorporated protectant
was derived (See 40 CFR 158.740(b)(2)(i)). For microbial products,
further toxicity testing and residue data are triggered by significant
acute effects in studies such as the mouse oral toxicity study, to
verify the observed effects and clarify the source of these effects
(Tiers II and III).
    An acute oral toxicity study was submitted for the mCry3A protein.
The acute oral toxicity data submitted support the prediction that the
mCry3A protein would be non-toxic to humans. Male and female mice (5 of
each) were dosed with 2,377 milligrams/kilograms bodyweight (mg/kg bwt)
of mCry3A protein. With the exception of one female in the test group
that was euthanized on day 2 (due to adverse clinical signs consistent
with a dosing injury), all other mice survived the study, gained
weight, had no test material-related clinical signs, and had no test
material-related findings at necropsy.
    When proteins are toxic, they are known to act via acute mechanisms
and at very low dose levels (Sjoblad, Roy D., et al. ``Toxicological
Considerations for Protein Components of Biological Pesticide
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)).
Therefore, since no effects were shown to be caused by the plant-
incorporated protectants, even at relatively high dose levels, the
mCry3A protein is not considered toxic. Further, amino acid sequence
comparisons showed no similarity between the mCry3A protein and known
toxic proteins available in public protein data bases. According to the
Codex Alimintarius guidelines, the assessment of potential toxicity
also includes stability to heat (FAO/WHO Standards Programme, 2001).
Further data demonstrate that mCry3A is inactivated against Western
corn rootworm, when heated to 95 [deg]C for 30 minutes.
    Since mCry3A is a protein, allergenic sensitivities were
considered. Current scientific knowledge suggests that common food
allergens tend to be resistant to degradation by acid, and proteases;
may be glycosylated; and present at high concentrations in the food.
Data have been submitted that demonstrate that the mCry3A protein is
rapidly degraded by gastric fluid in vitro. In a solution of simulated
gastric fluid 1 milligrams/milliliter (mg/mL) mCry3A test protein mixed
with simulated gastric fluid (pH 1.2, containing 2 mg/mL NaCl, 14 [mu]L
6 N HCl, and 2.7 mg/mL pepsin) resulting in 10 pepsin activity units/
microgram ([mu]g) protein (complies with year 2000 U.S. Pharmacopoeia
recommendations),

complete degradation of detectable mCry3A protein occurred within 2
minutes. A comparison of amino acid sequences of known allergens
uncovered no evidence of any homology with mCry3A, even at the level of
eight contiguous amino acids residues. Further, data demonstrate that
mCry3A is not glycosylated, and is present in low levels in corn
tissue. Therefore, the potential for the mCry3A protein to be a food
allergen is minimal. As noted above, toxic proteins typically act as
acute toxins with low dose levels. Therefore, since no effects were
shown to be caused by the plant-incorporated protectant, even at
relatively high dose levels, the mCry3A protein is not considered
toxic.

IV. Aggregate Exposures

    In examining aggregate exposure, section 408 of the FFDCA directs
EPA to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
    The Agency has considered available information on the aggregate
exposure levels of consumers (and major identifiable subgroups of
consumers) to the pesticide chemical residue and to other related
substances. These considerations include dietary exposure under the
tolerance exemption and all other tolerances or exemptions in effect
for the plant-incorporated protectant chemical residue, and exposure
from non-occupational sources. Exposure via the skin or inhalation is
not likely since the plant-incorporated protectant is contained within
plant cells, which essentially eliminates these exposure routes or
reduces these exposure routes to negligible. Exposure via residential
or lawn use to infants and children is also not expected because the
use sites for the mCry3A protein are all agricultural for control of
insects. Oral exposure, at very low levels, may occur from ingestion of
processed corn products and, potentially, drinking water. However, oral
toxicity testing done at a dose in excess of 2 grams/kilogram (gm/kg)
showed no adverse effects. Furthermore, the expression of the modified
Cry3A protein in corn kernals has been shown to be in the parts per
million range, which makes the expected dietary exposure several orders
of magnitude lower than the amounts of mCry3A protein shown to have no
toxicity. Therefore, even if negligible aggregate exposure should
occur, the Agency concludes that such exposure would present reasonable
certainty of no harm due to the lack of mammalian toxicity and the
rapid digestibility demonstrated for the mCry3A protein.

V. Cumulative Effects

    Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered
available information on the cumulative effects of such residues and
other substances that have a common mechanism of toxicity. These
considerations included the cumulative effects on infants and children
of such residues and other substances with a common mechanism of
toxicity. Because there is no indication of mammalian toxicity,
resulting from the plant-incorporated protectant, we conclude that
there are no cumulative effects for the mCry3A protein.

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

A. Toxicity and Allergenicity Conclusions

    The data submitted and cited regarding potential health effects for
the mCry3A protein include the characterization of the expressed mCry3A
protein in corn, as well as the acute oral toxicity, and in vitro
digestibility of the proteins. The results of these studies were
determined applicable to evaluate human risk, and the validity,
completeness, and reliability of the available data from the studies
were considered.
    Adequate information was submitted to show that the mCry3A protein
test material derived from microbial cultures was biochemically and
functionally similar to the protein produced by the plant-incorporated
protectant ingredients in corn. Production of microbially produced
protein was chosen in order to obtain sufficient material for testing.
    The acute oral toxicity data submitted supports the prediction that
the mCry3A protein would be non-toxic to humans. As mentioned above,
when proteins are toxic, they are known to act via acute mechanisms and
at very low dose levels (Sjoblad, Roy D., et al. ``Toxicological
Considerations for Protein Components of Biological Pesticide
Products,'' Regulatory Toxicology and Pharmacology 15, 3-9 (1992)).
Since no effects were shown to be caused by mCry3A protein, even at
relatively high dose levels (2,377 mg/kg bwt), the mCry3A protein is
not considered toxic. This is similar to the Agency position regarding
toxicity and the requirement of residue data for the microbial Bacillus
thuringiensis products from which this plant-incorporated protectant
was derived. (See 40 CFR 158.740(b)(2)(i). Moreover, mCry3A showed no
sequence similarity to any known toxin and was inactivated by heat
against Western corn rootworm. No further toxicity testing and residue
data were required because for microbial products, further toxicity
testing and residue data requirements are triggered by significant
acute effects in studies such as the mouse oral toxicity study to
verify the observed effects and clarify the source of these effects
(Tiers II and III).
    Modified Cry3A protein residue chemistry data were not required for
a human health effects assessment of the subject plant-incorporated
protectant ingredients because of the lack of mammalian toxicity.
However, data submitted demonstrated low levels of mCry3A in corn
tissues with less than 2 [mu]g mCry3A protein/gram dry weight in
kernals and less than 30 [mu]g mCry3A protein/gram dry weight of whole
corn plant.
    Since modified Cry3A is a protein, its potential allergenicity is
also considered as part of the toxicity assessment. Data considered as
part of the allergenicity assessment include that the modified Cry3A
protein came from Bacillus thuringiensis which is not a known
allergenic source, showed no sequence similarity to known allergens,
was readily degraded by pepsin, and was not glycosylated when expressed
in the plant. Therefore, there is a reasonable certainty that modified
Cry3A protein will not be an allergen.
    Neither available information concerning the dietary consumption
patterns of consumers (and major identifiable subgroups of consumers
including infants and children) nor safety factors that are generally
recognized as appropriate for the use of animal experimentation data
were evaluated. The lack of mammalian toxicity at high levels of
exposure to the mCry3A protein, as well as the minimal potential to be
a food allergen demonstrate the safety of the product at levels well
above possible maximum exposure levels anticipated in the crop.
    The genetic material necessary for the production of the plant-
incorporated protectant active ingredients are the nucleic acids (DNA,
RNA) which comprise genetic material encoding these proteins and their
regulatory regions. The genetic material (DNA, RNA), necessary for the
production of mCry3A protein has been exempted under the blanket
exemption for all nucleic acids (40 CFR 174.475).

B. Infants and Children Risk Conclusions

    FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues and the cumulative effects on infants and children of
the residues and other substances with a common mechanism of toxicity.
    In addition, FFDCA section 408(b)(2)(C) also provides that EPA
shall apply an additional tenfold margin of safety, also referred to as
margins of exposure (MOEs), for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the data base unless EPA determines that a
different MOE will be safe for infants and children.
    In this instance, based on all the available information, the
Agency concludes that there is a finding of no toxicity for the mCry3A
protein and the genetic material necessary for their production. Thus,
there are no threshold effects of concern to infants and children when
the mCry3A protein is used as a plant-incorporated protectant.
Accordingly, the Agency concludes that the additional MOE is not
necessary to protect infants and children, and that not adding any
additional MOE will be safe for infants and children.

C. Overall Safety Conclusion

    There is a reasonable certainty that no harm will result from
aggregate exposure to the U.S. population, including infants and
children, to the mCry3A protein and the genetic material necessary for
its production. This includes all anticipated dietary exposures and all
other exposures for which there is reliable information.
    The Agency has arrived at this conclusion because, as discussed
above, no toxicity to mammals has been observed, nor any indication of
allergenicity potential for the plant-incorporated protectant.

VII. Other Considerations

A. Endocrine Disruptors

    The pesticidal active ingredient is a protein, derived from sources
that are not known to exert an influence on the endocrine system.
Therefore, the Agency is not requiring information on the endocrine
effects of the plant-incorporated protectant at this time.

B. Analytical Method(s)

    A method for extraction and ELISA analysis of mCry3A protein in
corn has been submitted and found acceptable by the Agency.

C. Codex Maximum Residue Level

    No Codex maximum residue levels exist for the plant-incorporated
protectant Bacillus thuringiensis mCry3A protein and the genetic
material necessary for its production in corn.

VIII. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a
tolerance under section 408(d) of the FFDCA in response to a petition
submitted to the Agency. The Office of Management and Budget (OMB) has
exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). Because this rule has been exempted from review under Executive
Order 12866 due to its lack of significance, this rule is not subject
to Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of the FFDCA, such as the exemption from
the requirement of a tolerance in this final rule, do not require the
issuance of a proposed rule, the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition,
the Agency has determined that this action will not have a substantial
direct effect on 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, as specified
in Executive Order 13132, entitled Federalism (64 FR 43255, August 10,
1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects 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.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this rule does not have any ``tribal implications''
as described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the

agency promulgating the rule must submit a rule report, which includes
a copy of the rule, to each House of the Congress and to the
Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: September 29, 2006.
James Jones,
Director, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 174--AMENDED

0
1. The authority citation for part 174 continues to read as follows:

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

0
2. Section 174.456 is revised to read as follows:

Sec.  174.456  Bacillus thuringiensis modified Cry3A protein (mCry3A)
and the genetic material necessary for its production in corn.

    Bacillus thuringiensis modified Cry3A protein (mCry3A) and the
genetic material necessary for its production in corn is exempt from
the requirement of a tolerance when used as plant-incorporated
protectant in the food and feed commodities of field corn, sweet corn
and popcorn. Genetic material necessary for its production means the
genetic material which comprise genetic material encoding the mCry3A
protein and its regulatory regions. Regulatory regions are the genetic
material, such as promoters, terminators, and enhancers, that control
the expression of the genetic material encoding the mCry3A protein.
[FR Doc. E6-18223 Filed 10-31-06; 8:45 am]

BILLING CODE 6560-50-S


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on February 8, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-2004-19171

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  Air Turks & Caicos (2003) Ltd., d/b/a Air Turks & Caicos
Date Filed:  January 6, 2006

Relief requested: Renew exemption authority from 49 U.S.C. § 41301 to
engage in scheduled foreign air transportation of persons, property and
mail between the Turks & Caicos Islands, on the one hand, and Puerto
Rico, the U.S. Virgin Islands and Miami and Tampa, Florida on the other
hand, via intermediate points.  Air Turks & Caicos proposes to conduct
these services using wet leased aircraft.

If renewal, date and citation of last action: November 12, 2004, in this
docket

Applicant representative:  Pierre Murphy<PHONE_NUMBER>

DOT Analyst:  Shelita A. Smith<PHONE_NUMBER>

Responsive pleadings:  None filed

	DISPOSITION

Action:  Approved								Action date:  February 8, 2006

Effective dates of authority granted:  February 8, 2006 – February 8,
2007

Basis for approval (bilateral agreement/reciprocity):  Air Services
Agreement between the United States and the United Kingdom

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X  Standard exemption conditions (Attached)

Special conditions/Partial grant/Denial basis/Remarks:

Air Turks & Caicos may not conduct operations with its own aircraft and
crews without further order of the Department.

Action taken by:  Paul L. Gretch, Director

		     Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant was qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory

action under the Energy Policy and Conservation Act of 1975.  To the
extent not granted/deferred/dismissed, we denied all requests in the
referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Attachment

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland, except
as otherwise provided for in the U.S.-U.K. Air Services Agreement;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

												05/2004


[Federal Register Volume 85, Number 131 (Wednesday, July 8, 2020)]
[Notices]
[Pages 41030-41031]
[FR Doc No: 2020-14664]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-485-000]

Great Lakes Gas Transmission Limited Partnership; Notice of
Application

    Take notice that on June 22, 2020, Great Lakes Gas Transmission
Limited Partnership (GLGT), 700 Louisiana Street, Suite 700, Houston,
Texas 77002, filed in Docket No. CP20-485-000 an application pursuant
to section 7(b) of the Natural Gas Act (NGA) requesting authorization
to abandon firm capacity by a lease agreement with ANR Pipeline Company
(ANR). This application is related to application filed by ANR in
Docket No. CP20-484-000 to construct and operate the Alberta Xpress
Project including the authorization to acquire firm capacity from GLGT
pursuant to the capacity lease agreement between GLGT and ANR dated
June 19, 2020.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact the Federal Energy Regulatory
Commission at<EMAIL_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application may be directed to
Richard Bralow, Sr. Legal Counsel, ANR Pipeline Company, 700 Louisiana
Street, Suite 700, Houston, Texas 77002, by phone<PHONE_NUMBER>, or by
email<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9),
within 90 days of this Notice, the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule will serve to
notify federal and state agencies of the timing for the completion of
all necessary reviews, and the subsequent need to complete all federal
authorizations within 90 days of the date of issuance of the Commission
staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below, file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit five copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list and will be
notified of meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    As of the February 27, 2018 date of the Commission's order in
Docket No. CP16-4-001, the Commission will apply its revised practice
concerning out-of-time motions to intervene in any new NGA section 3 or
section 7 proceeding.\1\ Persons desiring to become a party to a
certificate proceeding are to intervene in a timely manner. If seeking
to intervene out-of-time, the movant is required to show good cause why
the time limitation should be waived, and should provide justification
by reference to factors set forth in Rule 214(d)(1) of the Commission's
Rules and Regulations.\2\
---------------------------------------------------------------------------

    \1\ Tennessee Gas Pipeline Company, L.L.C., 162 FERC 61,167 at
50 (2018).
    \2\ 18 CFR 385.214(d)(1).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using

the eFiling link at http://www.ferc.gov. Persons unable to file
electronically may mail similar pleadings to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand
delivered submissions in docketed proceedings should be delivered to
Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    Comment Date: 5:00 p.m. Eastern Standard Time on July 22, 2020.

    Dated: July 1, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-14664 Filed 7-7-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 4, 2008 (Volume 73, Number 214)]
[Notices]
[Page 65608-65609]
[DOCID:fr04no08-67]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]

Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Orthopaedic and Rehabilitation Devices Panel of
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 14, 2008, from
8:30 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Ronald P. Jean, Center for Devices and Radiological
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD, 20850,<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), code

3014512521. Please call the Information Line for up-to-date information
on this meeting. A notice in the Federal Register about last minute
modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the agency's Web site and
call the appropriate advisory committee hot line/phone line to learn
about possible modifications before coming to the meeting.
    Agenda: The committee will discuss and make recommendations on a
premarket notification application for the ReGen Collagen Scaffold
(CS), sponsored by ReGen Biologics, Inc. This device is intended for
use in surgical procedures for the reinforcement and repair of chronic
soft tissue injuries of the meniscus (one to three prior surgeries to
the involved meniscus) where weakness exists. In repairing and
reinforcing meniscal defects, the patient must have an intact meniscal
rim and anterior and posterior horns for attachment of the mesh. In
addition, the surgically prepared site for the CS must extend at least
into the red/white zone of the meniscus to provide sufficient
vascularization.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2008 and scroll down to the appropriate advisory committee
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 7, 2008. Oral presentations from the public will be scheduled
for 30 minutes at the beginning of the committee deliberations and for
30 minutes near the end of the deliberations. Those desiring to make
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before November 6, 2008. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by November 7, 2008.
    Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Ann Marie Williams,
Conference Management Staff,<PHONE_NUMBER>, at least 7 days in advance
of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/
default.htm for procedures on public conduct during advisory committee
meetings.
    FDA regrets that it was unable to publish this notice 15 days prior
to the Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee meeting. Because the agency believes there
is some urgency to bring these issues to public discussion and
qualified members of the Orthopaedic and Rehabilitation Devices Panel
of the Medical Devices Advisory Committee were available at this time,
the Commissioner of Food and Drugs concluded that it was in the public
interest to hold this meeting even if there was not sufficient time for
the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: October 29, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-26230 Filed 10-30-08; 4:15 pm]

BILLING CODE 4160-01-S