[Federal Register Volume 76, Number 92 (Thursday, May 12, 2011)]
[Notices]
[Page 27744]
[FR Doc No: 2011-11577]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Eighty-Fifth Meeting: RTCA Special Committee 159: Global
Positioning System (GPS)

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of RTCA Special Committee 159 meeting: Global
Positioning System (GPS).

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SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Special Committee 159: Global Positioning System (GPS).

DATES: The meeting will be held May 26, 2011, from 9 a.m. to 11:45 a.m.

ADDRESSES: The meeting will be held at RTCA, Inc., NBAA--McIntosh and
ATA--Hilton Conference Rooms, 1828 L Street, NW., Suite 805,
Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: RTCA Secretariat, 1828 L Street, NW.,
Suite 805, Washington, DC 20036; telephone<PHONE_NUMBER>; fax (202)
833-9434; Web site http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App 2), notice is
hereby given for a Special Committee 159: Global Positioning System
(GPS) meeting. The agenda will include:

Plenary Session

May 26, 2011

     Chairman's Introductory Remarks.
     Approval of Summary of the Eighty-Fourth Meeting held
February 11, 2011, RTCA Paper No. 082-11/SC159-991.
     Review/Approval of Proposed Final Report--Assessement of
the LightSquared Ancillary Terrestrial Component Radio Frequency
Interference Impact on GNSS L1 Band Airborne Receiver Operations.
     Other Business.
     Date and Place of Next Meeting.
     Adjourn.

Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on May 6, 2011.
Robert L. Bostiga,
RTCA Advisory Committee.
[FR Doc. 2011-11577 Filed 5-11-11; 8:45 am]
BILLING CODE 4910-13-P


1 Environmental Effects Assessment for WideStrike   ,

MXB 13 Cotton Zig Vaituzis, Ph. D., Senior Scientist Biopesticides and Pollution Prevention Division 2 Outline   Introduction   Background of Risk Assessment Process   Summary of WideStrike   Environmental Assessment   SAP Questions on Environmental Effects Assessment 3 INTRODUCTION   Pesticide:

  WideStrike   cotton expressing Cry1F and Cry1Ac to control several lepidopteran pests 4 INTRODUCTION   Assessment includes:

  Effects on wildlife   Gene flow to related wild plants   Development of weediness   Fate of Cry1F/ Cry1Ac in environment   Effects on endangered species   Assessment based on:

  Data submitted to the Agency   FIFRA SAP recommendations,

  Consultations with scientific experts, and   Public comments 5 HAZARD ASSESSMENT PROCESS   Assess toxicity to representative non target organisms by a tiered testing system   Start with Tier I single species, high dose laboratory data   Mortality as end point   Maximum Hazard Dose ( MHD) approach developed by AIBS ° 1996 approved by SAP for naturally occurring and altered MPCAs and toxins,

° 1999 approved by SAP for protein Plant Incorporated Protectants ( PIP).

° [ Cry proteins are bacterial toxins] 6 HAZARD ASSESSMENT PROCESS   Negative results by Tier I limit testing provide a high degree of confidence that no unreasonable adverse effects are likely to occur   ( PIP) Bt Cry proteins are tested by Tier I for short term hazard assessment   Long term adverse effects are ascertained by higher Tier long term field testing   2000 SAP and the NAS ( 2000) recommended direct field testing   2002 SAP recommended Tier I and field testing with emphasis on Tier I testing of agricultural field invertebrates 7 RISK ASSESSMENT PROCESS   Risk assessment based on:

Safety Factor X Expected Environmental Concentration ( EEC)

  Data that establishes an LC50, ED50, or LD50 that is >

MHD ( e. g. LD50 > 10 X EEC) is sufficient to evaluate adverse effects   Levels of concern ( LOC):

  Terrestrial: LD 50 < 5X EEC ( EEC/ LD 50 = RQ = 0.2)

  Aquatic: LC 50 < 10X EEC ( EEC/ LC 50 = RQ = 0.1)

  When LD50 is below the safety factor ( a LOC), lower dose testing is necessary to establish a definitive LD50 and a Lowest Observable Effect Concentration ( LOEC) 8 RISK ASSESSMENT PROCESS   Risk assessment is made by comparing the LOEC to the EEC   When EEC is < LOEC, a " no adverse effect" assessment is made   2000 SAP thought that Tier I laboratory tests showing no detrimental effects are sufficient to make a short term hazard assessment and field studies ( as higher Tier testing) be conducted when Tier I tests show toxicity   Bt Cry endotoxins are proteins and do not have the potential to bioaccumulate resulting in delayed adverse effects   Accumulation through the food chain is not expected to take place and therefore, chronic effects testing of protein substances is not routinely performed. 9 NON TARGET WILDLIFE TOXICITY TESTING   SAP reports ( 2000 & 2002 ) recommended:

  testing of species related to the susceptible pest   focus on invertebrates exposed to the crop   However, testing was performed to comply with:

  all published Tier I microbial toxin requirements   Direct field census data on the abundance of invertebrates in the field were also requested,

received and evaluated to supplement the findings of the MHD Tier I testing 10 NON TARGET WILDLIFE TOXICITY TESTING   Mammalian & avian wildlife   Aquatic organisms   Plants   Adult & larval honey bees   Parasitic wasp   Green lacewings   Lady beetles   Collembola ( springtail)

  Monarch butterfly   Earthworms Toxicity has been evaluated for:

Reproductive and developmental observations made on:

  Collembola, honey bee and green lacewing larval maturation studies 11 TEST SUBSTANCE   Form of test substances used in the studies:

  plant material ( leaves, pollen)

  purified bacterially produced Cry1F/ Cry1Ac ( separately and in combination)

  2000 SAP guidance:

  plant material preferred   bacterially derived protein also valid where:

° the test animals do not consume plant tissue ° large amounts of Cry protein are needed for MHD testing ° plant material toxic, e. g gossypol in cotton   Adult insect studies are generally of 30 days duration or until negative control mortality reaches 20%.

  Larval studies are through pupation and adult emergence 12 MAMMALIAN WILDLIFE   No significant toxicity to rodents from acute oral testing at the MHD ( Cry1F > 600 mg a. i./ kg and Cry1Ac > 700 mg a. i./ kg.)

  No hazard to mammalian wildlife is anticipated 13 AVIAN HAZARD   Acute single MHD oral LD50 for Cry1F/ Cry1Ac ( 7.9: 1 ratio) is > 128 mg a. i./ kg   Avian 8 day dietary with 10 % cotton seed showed clinical symptoms attributed to gossypol, ( 8X 10X the maximum allowable in animal feeds) LC50 > 100,000 ppm   8 day study insufficient to assess hazards from chronic exposure   Requested a 6 week broiler study with Cry1F/ Cry1Ac corn ( no gossypol) 14 AQUATIC SPECIES   No evidence for sensitivity of aquatic ( including endangered) species to antilepidopteran Cry proteins   Aquatic exposure from Bt cotton is extremely small  Freshwater and Estuarine and Marine Animal Hazard   Eight day dietary toxicity to the rainbow trout with a basal fish diet with 100 mg a. i./ kg diet of Cry1F/ Cry1Ac in a ratio of 7.9: 1   No mortality or sublethal effects observed   No fish hazard is expected from the proposed uses of WideStrike   cotton 15 AQUATIC SPECIES  Aquatic Invertebrate Hazard   Acute toxicity of microbial produced 510  g Cry1F/ L + 2500  g Cry1Ac/ L of test solution to Daphnia magna was > 298X and > 23,000X the EEC for Cry1F and Cry1Ac protein   No immobility or other adverse effects were seen during the study   No hazard to aquatic invertebrates is expected from incidental exposure to WideStrike   cotton pollen 16 AQUATIC SPECIES  Aquatic and Terrestrial Plant Hazard   The active ingredient is an insect toxin ( Bt endotoxin) that has never shown any toxicity to plants   Studies have been waived   Outcrossing issues will be addressed separately 17 TERRESTRIAL INVERTEBRATE HAZARD   Soil Invertebrates   General issues   October 2000 SAP concluded that earthworms and springtails ( Collembola) are appropriate indicator species for Cry protein testing despite the specific nature of the Cry protein toxicity to select target species.

  Such soil organisms may be subject to long term exposure.

However, data received by EPA indicate that such proteins degrade rapidly in field soils.

  Therefore the potential for significant soil buildup and adverse effects to non target soil organisms are not anticipated. Post registration soil persistence confirmatory data, however, are required. 18 TERRESTRIAL INVERTEBRATE HAZARD   Single Species Laboratory Testing   General Comments   The test material in several of the studies is purified microbial Cry1F and Cry1Ac protein in a ratio equivalent to the Cry1F and Cry1Ac proteins in whole WideStrike   cotton plants.

  In Summary: Toxicity tests conducted with non target arthropods and soil invertebrates indicate that no adverse effects are expected when exposed to Cry1F and Cry1Ac protein concentrations exceeding the EECs. 19 TERRESTRIAL INVERTEBRATE HAZARD  Effects on Honey Bee Larvae   Methods:

° Exposed to sucrose solutions containing:

  genetically modified pollen ( Cry1F only)

  genetically modified pollen ( Cry1Ac only)

  Bt with both Cry1F and Cry1Ac expression ° Potassium arsenate served as a positive control ° Honey bee larva were scored for survival to capping and adult emergence   Results:

° Treatment groups were not statistically different from the negative control ( sucrose only) which had a survival of 95% to capping and 93.75% to adult emergence 20 TERRESTRIAL INVERTEBRATE HAZARD  Effects on Honey Bee Larvae   Results ( cont.):

° At 1.98  g Cry1F + 11.94  g Cry1Ac per mL sugar water no effect on survival of larvae to adult emergence was seen ° LC50 is > 4X expression in pollen.

° No hazard to honey bee larvae and adult bee emergence is anticipated. 21 TERRESTRIAL INVERTEBRATE HAZARD  Effects on Parasitic Hymenoptera ( wasp)*

  A 40% mortality was observed in the Cry1F +

Cry1Ac group at 32X the EEC.

  The EPA LOC for terrestrial wildlife is an LC50 less than 5X the field exposure ( EEC/ LC50 = RQ > 0.2)

  The LC50 in this study is greater than 32X the EEC   No hazard to parasitic Hymenoptera is expected at field exposures ( which are minimal to nonexistent * The August 27, 2002 SAP concluded that parasitic Hymenoptera testing was not appropriate. Testing another beneficial organism rather than a parasitoid was recommended as more suitable. 22 TERRESTRIAL INVERTEBRATE HAZARD  Effects on Green Lacewing Larvae   Mortality was increased and pupation was affected in the Cry1F/ Cry1Ac at 32X the concentration found in pollen ( LC50 > 14X pollen expression)

  No effect is noted at Cry protein levels expressed in pollen that would be encountered by green lacewings in the field   August 2002 SAP questioned the appropriateness of testing green lacewing and recommended testing an alternate natural enemy such as the minute pirate bug ( Orius insidiosus) because:

° typically occurs in fields as egg predators ° typically feed on pollen. 23 INVERTEBRATE HAZARD ASSESSMENT

Effects on Lady Beetles   No adverse effect was seen at limit dose testing ( LC 50 > 780X Cry1F pollen expression and > 8X Cry1Ac pollen expression)

  No hazard to H. convergens is expected when feeding on WideStrike   cotton pollen in the field

Effects on Collembola ( spring tail)

  Lyophilized Cry1Ac cotton leaf at 5% or 50% of the diet did not cause mortality or have adverse effects on reproduction   Combination of Cry1F and Cry1Ac showed no effect at up to 10X the anticipated field level of expression.

  No hazard to decomposers represented by Collembola is expected from exposure to WideStrike   cotton in the field 24 INVERTEBRATE HAZARD ASSESSMENT

Effects on Earthworms   14 day limit dose study was conducted on earthworms exposed to soils treated with microbial produced Cry1Ac and Cry 1F, individually and in combination   There were no overt signs of toxicity to earthworms exposed to soils containing nominal concentrations of Cry1F and Cry1Ac at 50x the expected worst case EEC

Monarch Butterfly Risk Assessment   Studies published in the Proc. Nat. Acad, Sci. ( 98 [ 21]) were used to show that the density of cotton pollen on milkweed leaves ( 11 grains of MXB 13 pollen per cm2) is 10X less than the minimum pollen density required to elicit subchronic or developmental effects on monarch butterfly larvae   Therefore monarch larvae are not expected to be adversely affected by exposure to WideStrike   cotton pollen in the field 25 INVERTEBRATE HAZARD ASSESSMENT  Activity Spectrum Study   The insecticidal activity spectrum of Cry1F and Cry1Ac was determined for nine insect species   Insects represent taxonomically diverse cotton pests   Both Cry1F and Cry1Ac activity was restricted to lepidopteran insects, lending support to the contention that the combination of two Cry proteins did not expand the insect host range Gelechiidae Curculionidae Miridae Noctuidae Coleoptera Heteroptera Lepidoptera 26 INVERTEBRATE HAZARD ASSESSMENT  Field Evaluation  Effects on Invertebrates   Beneficial arthropods in field plots of WideStrike   cotton were compared with plots of non transgenic cotton and those with and without insecticide application in LA and AZ   Preliminary results show no adverse effect on the numbers of insects from over 50 taxa. ( Chemical insecticide treatment reduced the population of some taxa at certain times of sampling).

  Field monitoring supports the the Tier I single species data showing a lack of adverse effects to non target invertebrates. 27 ENVIRONMENTAL FATE   Soil Degradation   The soil DT50 of the plant expressed Cry1F and Cry1Ac was 1.3 days in a laboratory insect bioassay with soil from a cotton growing region ( Wayside, MS)

  Soil incorporation rates with cotton leaf tissue were 0.072 mg a. i. Cry1Ac and 0.853 mg a. i. Cry1F per kg of oven dry soil ( approximately 3.2 X the EEC for incorporation of defoliated whole plants of MXB 13 into the top 15 cm of soil).

  EPA is requesting additional studies on multiseason persistence of Cry proteins in soils under actual field conditions 28 EFFECTS ON SOIL MICROORGANISMS   Published studies performed by the EPA Office of Research and Development on the impact of transgenic Cry cotton and other plants indicates that adverse effects on soil microorganisms are unlikely   No effects were seen due to the protein itself,

and only a minimal, transient increase in soil microbes attributed to the transgenic cotton plant tissue, rather than the Cry protein expressed in that tissue, was observed 29 GENE FLOW  Horizontal gene transfer ( hgt) from Bt Crops to Soil Organisms   Several experiments published in the scientific literature have been conducted to assess the likelihood of hgt and have been unable to detect gene transfer under typical field conditions.

  Hgt has only been detected under laboratory conditions designed to favor DNA transfer.

  The genes that have been engineered into the Bt crops have their origin in soil inhabiting bacteria.

Transfer of these genes or toxins to other microorganisms or plants is not known to occur.

  In considering these data, the Agency concludes that there is no significant risk of hgt from the transgenes found in Cry1F/ Cry1Ac cotton. 30 GENE FLOW  Gene Flow and Weediness Potential   In 2001 the Agency reviewed the potential for gene capture and expression of the Bt endotoxins by wild or weedy relatives of cotton in the U. S.,

its possessions or territories.

° Results of review: 1. Southern Arizona 2. Hawaiian islands 3. Southern Florida 4. Puerto Rico   There is presently either:

1. No production of commercial cotton in these locations,

or 2. A restriction on commercial cultivation has been placed where outcrossing may occur Cultivated cotton has the opportunity to outcross to wild or feral species 31 ENDANGERED SPECIES CONSIDERATIONS   Reviewed non target data confirm that WideStrike   cotton will have no adverse effect on endangered and/ or threatened species listed by the US Fish and Wildlife Service, including mammals, birds or terrestrial and aquatic plants and invertebrate species.

  Comparison of the county level distribution of endangered lepidopteran species relative to cotton producing counties in the US indicate that there will be no overlap with cotton cultivation and endangered lepidopteran breeding habitats.

  No consultation with the USFWS is required under the Endangered Species Act. 32 CONCLUSIONS   This assessment finds no hazard to the environment from cultivation of Cry1F and Cry1Ac protein expressing cotton for a timelimited registration period.

  However, there are issues that could be looked at in greater depth. The Agency believes these issues were not reasonably foreseeable at the time of registration application and initial data development.

  These supplemental, primarily long term effects studies would provide added weight to support the Agency's conclusions. 33 Additional Data Requirements:

  A six week broiler dietary study ( Cry1F/ Cry1Ac Corn may be used)

  A Tier I laboratory toxicity test with Orius insidiosus ( minute pirate bug)  a non target insect more appropriate for cotton fields   Additional invertebrate field surveys on large plots that have been planted with Cry1F/ Cry1Ac cotton for at least three consecutive years   Additional long range soil persistence field studies 34 Questions on the Environmental Effects Assessment 1) WideStrike cotton is a product expressing pyramided Cry1F and Cry1Ac Bt proteins. The submitted non target effects studies examined the effects of the Cry1F and Cry1Ac proteins separately and in combination to detect any synergistic effects on non target wildlife. No synergistic effects or increase in non target host range were seen as a result of combining these two proteins in the same product.

The Panel is requested to comment on the need for nontarget hazard data development on the combinations of Cry proteins being considered for registration when data on the effects of the individual Cry proteins are readily available and show no adverse effects. 35 Questions on the Environmental Effects Assessment 2) The weight of evidence from the reviewed data indicates that there will not be a hazard to wildlife from the commercialization of WideStrike cotton. Although the Bt proteins expressed by WideStrike are known to affect only lepidopteran insect species, the Agency evaluated studies of potential effects on a wide variety of non target organisms that might be exposed to the Cry1F and Cry1Ac protein, i. e., wild mammals, birds, invertebrates, and aquatic species. EPA concluded that aquatic and terrestrial wildlife was not likely to be harmed and that WideStrike cotton was not likely to threaten the long term survival of any non target wildlife populations.

The Panel is requested to comment on the Agency's analysis of the currently available data on the potential impacts of WideStrike cotton on non target species. 36 Questions on the Environmental Effects Assessment 3) The Agency has sufficient information to conclude that there is no hazard from the proposed uses of WideStrike   cotton to non target wildlife, aquatic and soil organisms. However, the Agency is requesting additional, primarily long term effects data that were recommended by previous Panels for PIP corn.

The supplementary studies would provide additional weight to support the Agency's conclusions.

The Panel is asked to comment on:

( a) the scientific value of the proposed additional studies that are identified at the end of the Environmental Assessment section, including avian chronic exposure testing and multi year field and soil persistence/ terrestrial expression studies, and ( b) the applicability of these data to PIP cotton.


[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Notices]
[Page 10490]
[FR Doc No: 2010-4813]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Joint Meeting of the Arthritis Drugs Advisory Committee and the
Drug Safety and Risk Management Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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    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 Committees: Arthritis Drugs Advisory Committee and the Drug
Safety and Risk Management Advisory Committee.
    General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 12, 2010, from 8
a.m. to 5 p.m.
    Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
    Contact Person: Anuja Patel, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857,
301-827-7001, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area), codes<PHONE_NUMBER> and 304512535. 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: On May 12, 2010, the committees will discuss new drug
application (NDA) 22-478, naproxcinod0 375 milligram capsule, sponsored
by NicOx S.A., a non-steroidal anti-inflammatory drug (NSAID) product
indicated for the treatment of the signs and symptoms of
osteoarthritis.
    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/AdvisoryCommittees/Calendar/default.htm. 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
April 28, 2010. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. 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 April 20, 2010. 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 April 21,
2010.
    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 Anuja Patel 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/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: March 2, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-4813 Filed 3-5-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Notices]
[Pages 57732-57734]
[FR Doc No: 2018-25063]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4002]

Electronic Submission of Adverse Event Reports to the Food and
Drug Administration Adverse Event Reporting System Using International
Council for Harmonisation E2B(R3) Standards; Public Meetings; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meetings; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing three public meetings entitled ``Electronic Submission of
Adverse Event Reports to FDA Adverse Event Reporting System (FAERS)
Using International Council for Harmonisation (ICH) E2B(R3)
Standards.'' The purpose of these public meetings is to provide the
pharmaceutical industry and other interested parties with information
on the plans, progress, and technical specifications to upgrade
electronic submission standards for drug, biological, and drug/
biologic-led combination products for the premarket and postmarket
safety surveillance programs managed by the Center for Drug Evaluation
and Research (CDER) and the Center for Biologics Evaluation and
Research (CBER). These meetings will focus on enhancements to
electronic submission of Individual Case Safety Reports (ICSRs) in
FAERS using ICH E2B(R3) standards.
    FDA is seeking input from stakeholders as it fulfills its
commitment to implement ICH E2B(R3) standards by holding three public
meetings. FDA will use the information provided by the public to inform
the enhancements to FAERS required for the implementation of ICH
E2B(R3) standards and relevant regional variations.

DATES: The first public meeting will be held on January 25, 2019, from
9 a.m. to 4 p.m. The second public meeting will be held on July 17,
2019, from 9 a.m. to 4 p.m. The third public meeting will be held on
February 19, 2020 from 9 a.m. to 4 p.m. Submit either electronic or
written comments on these public meetings by February 25, 2019, for the
first public meeting; by August 16, 2019, for the second public
meeting, and by March 20, 2020, for the third public meeting. See the
SUPPLEMENTARY INFORMATION section for registration dates and
information.

ADDRESSES: Each public meeting will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great
Room (Rm. 1503, Section A), Silver Spring, MD 20993-0002. Entrance for
the public meeting participants (non-FDA employees) is through Building
1, where routine security check procedures will be performed. For
parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/default.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. For timely consideration, we
request that electronic comments be submitted before or within 30 days
after each public meeting (i.e., comments submitted by or before
February 25, 2019, for the first public meeting; August 16, 2019, for
the second public meeting; and March 20, 2020, for the third public
meeting. The https://www.regulations.gov electronic filing system will
accept comments until 11:59 p.m. Eastern Time at the end of February
25, 2019; August 16, 2019; and March 20, 2020, after the first, second,
and the third meeting, respectively. Comments received by mail/hand

delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

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-N-4002 for ``Electronic Submission of Adverse Event Reports to
FAERS Using ICH E2B(R3) Standards.'' Received comments, those filed in
a timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Suranjan De, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4307, Silver Spring, MD 20993-0002, 240-
402-0498, email: [email protected]; or Judith Richardson, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7309A, Silver Spring, MD 20993-0002,
240-402-6473, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is committed to achieve the long-term goal of improving the
predictability and consistency of the electronic submission process and
enhancing transparency and accountability of FDA information
technology-related activities. FDA participated in the development of
ICH E2B guideline \1\ pertaining to the submission of adverse event
reports to the FAERS system: ``Implementation Guide for Electronic
Transmission of Individual Case Safety Reports (ICSRs) E2B(R3) Data
Elements and Message Specification.'' FDA plans to incorporate ICH
E2B(R3) recommended standards into the requirements for the electronic
submission of adverse event reports to FAERS tentatively by April 2020.
Consistent with the Prescription Drug User Fee Act (PDUFA) VI
commitments, FDA is organizing several public meetings to allow
industry the opportunity to provide feedback and/or participate in user
acceptance testing in advance of the Agency's planned implementation of
ICH E2B(R3) data standards. FDA's performance goals and procedures
under the PDUFA program for the years 2018 to 2022 are outlined in the
commitment letter available at: https://www.fda.gov/forindustry/userfees/prescriptiondruguserfee/ucm446608.htm.
---------------------------------------------------------------------------

    \1\ The ICH E2B(R3) IG guideline (http://estri.ich.org/e2br3/index.htm) provides technical and business specifications for the
harmonized, core set of ICH data elements.
---------------------------------------------------------------------------

II. Topics for Discussion at the Public Meetings

    FDA will present its plan to incorporate ICH E2B(R3) recommended
standards into the requirements for the electronic submission of
adverse event reports to FAERS. The meetings will include a general
discussion of CDER's and CBER's plans to revise the FDA Regional
Implementation Specifications for premarketing and postmarketing
adverse event reporting. The goal of this revision is to enhance the
quality of adverse event reports received by the Agency by
incorporating ICH E2B(R3) recommendations into FDA Regional
Implementation Specifications. The information exchange at the meetings
will enhance the pharmaceutical industry's knowledge of the processes
needed to implement ICH E2B(R3) into their systems. In addition, the
comments provided by participating stakeholders will inform CDER's and
CBER's plans for the implementation of ICH E2B(R3) for drugs,
biologics, and drug/biologic-led combination products.
    During the public meetings, FDA intends to discuss: (1) E2B(R3)
Regional (U.S.) Data Elements; (2) Usage of Data Standards in E2B(R3);
(3) Submission paths for premarket and postmarket ICSRs; (4) Data
Migration Exceptions; and (5) FDA Regional Implementation
Specifications for ICH E2B(R3) Implementation. One or more of the

above topics may be discussed in each meeting. FDA will consider all
comments made at these public meetings or received through the docket
(see ADDRESSES).

III. Participating in the Public Meeting

    Registration: To register for the public meetings, please visit the
following website to register: https://fdae2br3.eventbrite.com by
December 20, 2018, for the first meeting, June 14, 2019, for the second
meeting, and January 17, 2020, for the third meeting. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, telephone, and method of attendance (in-
person or web conference).
    Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending the public
meetings must register by 11:59 p.m. Eastern Time on December 20, 2018,
for the first meeting, June 14, 2019, for the second meeting, and
January 17, 2020, for the third meeting. Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting/public workshop
will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Chenoa Conley,<PHONE_NUMBER>, email: [email protected],
at least 7 days before each meeting.
    Request for Oral Presentations: During online registration you may
indicate if you wish to present during the public comment session. All
requests to make oral presentations must be received by the close of
registration at 11:59 p.m. Eastern Time on December 20, 2018, for the
first meeting, June 14, 2019, for the second meeting, and January 17,
2020, for the third meeting. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin and will select and notify participants by 11:59 p.m. Eastern
Time on January 4, 2019, for the first meeting, June 26, 2019, for the
second meeting, and January 30, 2020, for the third meeting. FDA will
notify registered presenters of their scheduled presentation time. If
selected for presentation, any presentation materials must be emailed
to [email protected] no later than 11:59 p.m. Eastern Time on January
18, 2019, for the first meeting, July 10, 2019, for the second meeting,
and February 12, 2020, for the third meeting. Persons registered to
speak should check in before the meeting and are encouraged to arrive
early to ensure their designated order of presentation. Participants
who are not present when called may not be permitted to speak at a
later time. No commercial or promotional material will be permitted to
be presented or distributed at the public meeting. An agenda will be
made available at least 3 days before each public meeting at https://www.fda.gov/Drugs/NewsEvents/ucm621215.htm.
    Streaming Webcast of the Public Meetings and Video of the Public
Meetings: These public meetings will also be webcast; the URL will be
posted at https://www.fda.gov/Drugs/NewsEvents/ucm621215.htm at least 1
day before each meeting. A video record of the public workshops will be
available at the same website address for 1 year.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program,
visit https://www.adobe.com/go/connectpro_overview. FDA has verified
the website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm115894.htm.

    Dated: November 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25063 Filed 11-15-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Proposed Rules]
[Pages 77611-77613]
[FR Doc No: 2013-29938]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 25

[Docket No. FAA-2013-1001; Notice No. 25-13-35-SC]

Special Conditions: Airbus, A350-900 Series Airplane; High Speed
Protection System

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed special conditions.

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SUMMARY: This action proposes special conditions for Airbus A350-900
series airplanes. These airplanes will have a novel or unusual design
feature when compared to the state of technology envisioned in the
airworthiness standards for transport category airplanes. These design
features include a high-speed protection system. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for this design feature. These proposed special conditions
contain the additional safety standards that the Administrator
considers necessary to establish a level of safety equivalent to that
established by the existing airworthiness standards.

DATES: We must receive your comments by February 7, 2014.

ADDRESSES: Send comments identified by docket number FAA-2013-1001
using any of the following methods:
     Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending
your comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 8 a.m. and 5 p.m.,
Monday through Friday, except federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov/, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov/.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov/ at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except federal holidays.

FOR FURTHER INFORMATION CONTACT: Todd Martin, FAA, Airframe/Cabin
Safety, ANM-115, Transport Airplane Directorate, Aircraft Certification
Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone
(425) 227-1178; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data. We ask
that you send us two copies of written comments.

    We will file in the docket all comments we receive, as well as a
report summarizing each substantive public contact with FAA personnel
concerning these special conditions. You can inspect the docket before
and after the comment closing date. If you wish to review the docket in
person, go to the address in the ADDRESSES section of this preamble
between 7:30 a.m. and 4:00 p.m., Monday through Friday, except Federal
holidays.
    We will consider all comments we receive on or before the closing
date for comments. We will consider comments filed late if it is
possible to do so without incurring expense or delay. We may change
these special conditions based on the comments we receive.
    If you want us to acknowledge receipt of your comments on this
proposal, include with your comments a self-addressed, stamped postcard
on which you have written the docket number. We will stamp the date on
the postcard and mail it back to you.

Background

    On August 25, 2008, Airbus applied for a type certificate for their
new A350-900 series airplane. Later, Airbus requested and the FAA
approved an extension to the application for FAA type certification to
June 28, 2009. The A350-900 series has a conventional layout with twin
wing-mounted Rolls Royce Trent engines. It features a twin aisle 9-
abreast economy class layout, and accommodates side-by-side placement
of LD-3 containers in the cargo compartment. The basic A350-900 series
configuration accommodates 315 passengers in a standard two-class
arrangement. The design cruise speed is Mach 0.89 with a Maximum Take-
Off Weight of 591,000 lbs. Airbus proposes the A350-900 series to be
certified for extended operations (ETOPS) beyond 180 minutes at entry
into service for up to a 420 minute maximum diversion time.
    The A350-900, like Airbus A320, A330, A340 and A380 series
aircraft, has a high speed protection system that limits nose down
pilot authority at speeds above VC/MC, and
prevents the airplane from actually performing the maneuver required
under Sec.  25.335(b)(1). Special conditions are necessary to address
the Airbus A350-900 series high speed protection system. The proposed
special conditions identify various symmetric and non-symmetric
maneuvers that will ensure that an appropriate design dive speed,
VD/MD, is established.

Type Certification Basis

    Under Title 14, Code of Federal Regulations (14 CFR) 21.17, Airbus
must show that the A350-900 series meets the applicable provisions of
part 25, as amended by Amendments 25-1 through 25-129.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 25) do not contain adequate or
appropriate safety standards for the A350-900 series because of a novel
or unusual design feature, special conditions are prescribed under the
provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the A350-900 series must comply with the fuel vent and
exhaust emission requirements of 14 CFR part 34 and the noise
certification requirements of 14 CFR part 36 and the FAA must issue a
finding of regulatory adequacy under section 611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19,
under Sec.  11.38, and they become part of the type-certification basis
under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The Airbus A350-900 series will incorporate the following novel or
unusual design features:
    A high speed protection system that limits nose down pilot
authority at speeds above VC/MC, and prevents the
airplane from actually performing the maneuver required under Sec.
25.335(b)(1). The proposed special conditions identify various
symmetric and non-symmetric maneuvers that will ensure that an
appropriate design dive speed, VD/MD, is
established.

Discussion

    Section 25.335(b)(1) is an analytical envelope condition which was
originally adopted in Part 4b of the Civil Air Regulations in order to
provide an acceptable speed margin between design cruise speed and
design dive speed. Flutter clearance design speeds and airframe design
loads are impacted by the design dive speed. While the initial
condition for the upset specified in the rule is 1g level flight,
protection is afforded for other inadvertent overspeed conditions as
well. Section 25.335(b)(1) is intended as a conservative enveloping
condition for potential overspeed conditions, including non-symmetric
ones.
    To establish that potential overspeed conditions are enveloped, the
applicant should demonstrate that any reduced speed margin, based on
the high speed protection system in the A350-900 series, will not be
exceeded in inadvertent, or gust induced, upsets resulting in
initiation of the dive from non-symmetric attitudes; or that the
airplane is protected by the flight control laws from getting into non-
symmetric upset conditions. The proposed special conditions identify
various symmetric and non-symmetric maneuvers that will ensure than an
appropriate design dive speed, VD/MD, is
established.
    These special conditions are proposed in lieu of Sec.
25.335(b)(1). Section 25.335(b)(2), which also addresses the design
dive speed, is applied separately (Advisory Circular (AC) 25.335-1A
provides an acceptable means of compliance to Sec.  25.335(b)(2)). The
applicant should conduct a demonstration that includes a comprehensive
set of conditions, as described below.
    Paragraph (2) of the proposed special condition references AC 25-
7C, section 32.c.(3), included here for information.
    ``(3) Gust Upset. In the following three upset tests, the values of
displacement should be appropriate to the airplane type and should
depend upon airplane stability and inertia characteristics. The lower
and upper limits should be used for airplanes with low and high
maneuverability, respectively.
    (a) With the airplane trimmed in wings-level flight, simulate a
transient gust by rapidly rolling to the maximum bank angle appropriate
for the airplane, but not less than 45 degrees nor more than 60
degrees. The rudder and longitudinal control should be held fixed
during the time that the required bank is being attained. The rolling
velocity should be arrested at this bank angle. Following this, the
controls should be abandoned for a minimum of 3 seconds after
VMO/MMO or 10 seconds, whichever occurs first.
    (b) Perform a longitudinal upset from normal cruise. Airplane trim
is determined at VMO/MMO using power/thrust
required for level flight but with not more than maximum continuous
power/thrust. (If VMO/MMO cannot be reached in
level flight with maximum continuous power or thrust, then the airplane
should be trimmed at VMO/MMO in a descent.) This
is followed by a decrease in speed, after which a pitch

attitude of 6-12 degrees nose down, as appropriate for the airplane
type, is attained using the same power/thrust and trim. The airplane is
permitted to accelerate until 3 seconds after VMO/
MMO. The force limits of Sec.  25.143(d) for short term
application apply.
    (c) Perform a two-axis upset, consisting of combined longitudinal
and lateral upsets. Perform the longitudinal upset, as in paragraph (b)
above, and when the pitch attitude is set, but before reaching
VMO/MMO, roll the airplane 15-25 degrees. The
established attitude should be maintained until 3 seconds after
VMO/MMO.''
    Paragraphs (3) and (4) of the proposed special condition indicate
that failures of the high speed protection system must be improbable
and must be annunciated to the pilots. If these two criteria are not
met, then the probability that the established dive speed will be
exceeded, and the resulting risk to the airplane, is too great. On the
other hand, if the high speed protection system is known to be
inoperative, then dispatch of the airplane could be acceptable under an
approved Minimum Equipment List (MEL) containing language similar to
paragraph (5). Dispatch under an MEL would require that appropriate
reduced operating speeds, VMO/MMO, are provided
in the airplane flight manual, and the cockpit display of those reduced
speeds, as well as the overspeed warning for exceeding those speeds,
are equivalent to that of the normal airplane with the high speed
protection system operative.
    We do not believe that application of the Interaction of Systems
and Structures special condition (reference A350 issue paper A-3) or
the European Aviation Safety Agency (EASA) Certification Specification
(CS) 25.302, is appropriate in this case, because design dive speed is,
in and of itself, part of the design criteria. Stability and control,
flight loads, and flutter evaluations all depend on the design dive
speed. Therefore, a single design dive speed should be established that
will not be exceeded taking into account the performance of the high
speed protection system, as well as its failure modes, failure
indications and accompanying flight manual instructions.

Applicability

    As discussed above, these special conditions apply to A350-900
series airplanes. Should Airbus apply at a later date for a change to
the type certificate to include another series incorporating the same
novel or unusual design feature, the special conditions would apply to
that series as well.

Conclusion

    This action affects only certain novel or unusual design features
on the Airbus A350-900 series airplanes. It is not a rule of general
applicability.

List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Proposed Special Conditions

    Accordingly, the Federal Aviation Administration (FAA) proposes the
following special conditions as part of the type certification basis
for Airbus A350-900 series airplanes.
    (1) In lieu of compliance with Sec.  25.335(b)(1), if the flight
control system includes functions that act automatically to initiate
recovery before the end of the 20 second period specified in Sec.
25.335(b)(1), VD/MD must be determined from the
greater of the speeds resulting from conditions (a) and (b) below. The
speed increase occurring in these maneuvers may be calculated, if
reliable or conservative aerodynamic data are used.
    (a) From an initial condition of stabilized flight at
VC/MC, the airplane is upset so as to take up a
new flight path 7.5 degrees below the initial path. Control
application, up to full authority, is made to try and maintain this new
flight path. Twenty seconds after initiating the upset, manual recovery
is made at a load factor of 1.5 g (0.5 acceleration increment), or such
greater load factor that is automatically applied by the system with
the pilot's pitch control set to neutral. Power, as specified in Sec.
25.175(b)(1)(iv), is assumed until recovery is initiated, at which time
power reduction and the use of pilot controlled drag devices may be
used.
    (b) From a speed below VC/MC, with power to
maintain stabilized level flight at this speed, the airplane is upset
so as to accelerate through VC/MC at a flight
path 15 degrees below the initial path (or at the steepest nose down
attitude that the system will permit with full control authority if
less than 15 degrees). The pilot's controls may be in the neutral
position after reaching VC/MC and before recovery
is initiated. Recovery may be initiated three seconds after operation
of the high speed warning system by application of a load of 1.5g (0.5
acceleration increment), or such greater load factor that is
automatically applied by the system with the pilot's pitch control
neutral. Power may be reduced simultaneously. All other means of
decelerating the airplane, the use of which is authorized up to the
highest speed reached in the maneuver, may be used. The interval
between successive pilot actions must not be less than one second.
    (2) The applicant must also demonstrate that the speed margin,
established as above, will not be exceeded in inadvertent, or gust
induced, upsets resulting in initiation of the dive from non-symmetric
attitudes, unless the airplane is protected by the flight control laws
from getting into non-symmetric upset conditions. The upset maneuvers
described in AC 25-7C, Chapter 2, Section 8, Paragraph 32c.(3)(a) and
(c), may be used to comply with this requirement.
    (3) Detected loss of the high speed protection function must be
less than 10-3 per flight hour.
    (4) Failures of the system must be annunciated to the pilots. The
Operating Limitations Section of the Airplane Flight Manual must
contain instructions that reduce the maximum operating speeds,
Vmax/Mmax, to a value that maintains a speed
margin between these speeds and VD/MD that is
consistent with showing compliance to Sec.  25.335(b) without the
benefit of the high speed protection system.
    (5) Dispatch of the airplane with the high speed protection system
inoperative is prohibited except under an approved Minimum Equipment
List (MEL) that requires Airplane Flight Manual instructions to
indicate reduced maximum operating speeds, as described in paragraph
(4). In addition, the cockpit display of the reduced operating speeds,
as well as the overspeed warning for exceeding those speeds, must be
equivalent to that of the normal airplane with the high speed
protection system operative. Also, it must be shown that no additional
hazards are introduced with the high speed protection system
inoperative.

    Issued in Renton, Washington, on November 16, 2013.
Jeffrey E. Duven,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-29938 Filed 12-23-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Notices]
[Pages 15794-15795]
[FR Doc No: 2020-05769]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0020 OMB No. 1660-0125]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; FEMA Preparedness Grants: Homeland Security
Grant Program (HSGP)

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice and request for comments.

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SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use, this notice seeks comments concerning the
HSGP.

DATES: Comments must be submitted on or before April 20, 2020.

ADDRESSES: Submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the Desk
Officer for the Department of Homeland Security, Federal Emergency
Management Agency, and sent via electronic mail to
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Requests for additional information or
copies of the information collection should be made to Director,
Information Management Division, 500 C Street SW, Washington, DC 20472,
email address<EMAIL_ADDRESS>or
Laila Ouhamou, Acting Branch Chief, Program Development and Support
Branch, Grant Programs Directorate, FEMA,<PHONE_NUMBER>. You may contact
the FEMA Information Management Division for copies of the proposed
collection of information at email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposed information collection
previously published in the Federal Register on November 27, 2019, at
84 FR 65402 with a 60-day public comment period. One comment was
submitted for the docket ID, but it was unrelated to this information
collection. The purpose of this notice is to notify the public that
FEMA will submit the information collection abstracted below to the
Office of Management and Budget for review and clearance.

Collection of Information

    Title: FEMA Preparedness Grants: Homeland Security Grant Program
(HSGP).
    Type of Information Collection: Revision of a currently approved
information collection
    OMB Number: 1660-0125
    FEMA Forms: FEMA Form 089-1, HSGP Investment Justification (SHSP
and UASI); FEMA Form 089-16, OPSG Operations Order Report; FEMA Form
089-20, OPSG Inventory of Operation Orders.
    Abstract: The HSGP is an important tool among a comprehensive set
of measures to help strengthen the Nation against risks associated with
potential terrorist attacks. DHS/FEMA uses the information to evaluate
applicants' familiarity with the national preparedness architecture and
identify how elements of this architecture have been incorporated into
regional/State/local planning, operations, and investments.
    The HSGP is a primary funding mechanism for building and sustaining
national preparedness capabilities. The

HSGP is comprised of three separate grant programs: The SHSP, the UASI,
and OPSG. Together, these grants fund a range of preparedness
activities, including planning, organization, equipment purchase,
training, exercises, and management and administration costs.
    Affected Public: State, Local or Tribal Government.
    Estimated Number of Respondents: 2,209.
    Estimated Number of Responses: 548,327.
    Estimated Total Annual Burden Hours: 867,016.
    Estimated Total Annual Respondent Cost: $65,797,844.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $1,426,953.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Maile Arthur,
Acting Records Management Branch Chief, Office of the Chief
Administrative Officer, Mission Support, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 2020-05769 Filed 3-18-20; 8:45 am]
 BILLING CODE 9111-19-P


[Federal Register Volume 78, Number 50 (Thursday, March 14, 2013)]
[Notices]
[Pages 16332-16334]
[FR Doc No: 2013-05883]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69081; File No. SR-NYSEMKT-2013-16]

Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Amending Rules
Governing Order Format and System Entry Requirements

March 8, 2013.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on March 5, 2013, NYSE MKT LLC (the ``Exchange'' or ``NYSE
MKT'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    The Exchange proposes to amend rules governing Order Format and
System Entry Requirements. The text of the proposed rule change is
available on the Exchange's Web site at www.nyse.com, at the principal
office of the Exchange, and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Exchange Rule 955NY(c) by revising
the requirements for entering an order into the Electronic Order
Capture System (``EOC''). In addition, the Exchange proposes to delete
all references pertaining to the Electronic Tablet, a decommissioned
Exchange order entry mechanism.
Order Format and System Entry Requirements
    EOC is the Exchange's floor-based electronic audit trail and order
tracking system that provides an accurate time-sequenced record of all
orders and transactions entered and executed on the floor of the
Exchange. EOC records the receipt of an order and documents the life of
the order through the process of execution, partial execution, or
cancellation. This system includes the electronic communications
interface between booth terminals and the Floor Broker work stations
and hand held applications. The EOC is designed to fulfill one of the
undertakings contained in the Commission's Order Instituting Public
Administrative Proceedings Pursuant to Sections 19(h)(1) of the
Securities Exchange Act of 1934, Making Findings and Imposing Remedial
Sanctions (``Order'').\4\ Specifically, the EOC is intended to respond
to Section IV.B.e.(v) of the Order, which requires, among other things,
that the Exchange incorporate into its audit trail all non-electronic
orders such that the audit trail provides an accurate, time-sequenced
record of electronic and other orders, quotations and transactions,
beginning with the receipt of the order and documenting the life of the
order through the process of execution, partial execution, or
cancellation.
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    \4\ See Securities Exchange Act Release No. 43268 (September 11,
2000) and Administrative Proceeding File No. 3-10282.
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    In order to comply with the terms of Rule 955NY(c), and thus be in
compliance with the Order, Floor Brokers and employees of floor
brokerage firms (collectively ''Floor Brokers'') upon receiving an
order for execution on the Exchange must immediately, prior to
representation in the trading crowd, record the details of the order
into EOC. This process, commonly referred to the ``systemization'' of
an order, creates an accurate time-sequenced record of orders on the
Exchange.
    The Exchange has prescribed certain data elements that must be
entered into the EOC before an order may be represented in the Trading
Crowd. These data elements, as contained in Rule 956NY--Record of
Orders, include: (1) Clearing Member Trade Agreement (``CMTA'')
information,\5\ and the name of the clearing ATP Holder; (2) options
symbol, expiration month, exercise price and type of options; (3) side
of the market and order type; \6\ (4) quantity of options; (5) limit or
stop price or special conditions; (6) opening or closing transaction;
(7) time in force; (8) account origin code; \7\ and (9) whether the
order was solicited or unsolicited. The Exchange may, from time to
time, also require additional information if needed. The remaining data
elements prescribed in Rule 956NY are to be recorded as the events
occur and/or during trade reporting procedures.
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    \5\ The CMTA process allows an OTP Holder or OTP Firm [sic] to
enter a trade that is subsequently settled into the account of a
different Broker Dealer at the Options Clearing Corporation.
    \6\ Order type is also referred to as the origin code (i.e.
Customer, Firm or Market Maker).
    \7\ See supra note 6.
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    The Exchange now proposes to incorporate into the text of Rule
955NY(c) specific data elements required for the proper systemization
of an order. The Exchange proposes that in order to meet the
requirements for the proper systemization of an order Floor Brokers
will be required to enter into the EOC: (i) The option symbol; (ii) the
expiration date of the option; \8\ (iii) the exercise price; (iv) buy
or sell with applicable limit or stop price or special instructions;
(v) call or put; (vi) the quantity of contracts; (vii) the name of the
clearing ATP Holder; and (viii) such other information as may be
required by the Exchange from time to time. Any additional information
with respect to the order, including those data elements found in Rule
956NY that pursuant to this proposal will no longer be required at the
time of systemization, shall be recorded contemporaneously upon receipt
which may occur after the representation and execution of the order.
The proposed order entry requirements for the EOC are consistent with
the order format requirements of Rule 955NY(b). Thus, adopting the
order format requirements of Rule 955NY(b) for the EOC and
incorporating them into Rule 955NY(c) will serve to align Exchange
Rules on order entry requirements. In addition, the Exchange notes that
the proposed order entry requirements necessary for the systemization
of an order for the EOC are substantially similar to those prescribed
by the Chicago Board

Options Exchange (``CBOE'') pursuant to CBOE Rule 6.24(a)(2).\9\
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    \8\ In order to accommodate Quarterly Options Series and Short
Term Option Series, the Exchange proposes to require the actual
expiration date of an option, and not just the expiration month, as
presently required.
    \9\ See CBOE Rule 6.24(a)(2). See also Securities Exchange Act
Release No. 50996 (January 7, 2005), 70 FR 2436 (Jan. 13, 2005) (SR-
CBOE-2004-77).
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    Pursuant to the proposed rule change, Floor Brokers will be
required to enter much of the same information when systematizing an
order as is presently required, with the exception of the CMTA
information, opening/closing designation, the order type or account
origin code, the time in force, and whether the order was solicited or
unsolicited. Floor Brokers have told the Exchange that generally these
are the last bits of information given to them when receiving an order
and that waiting to receive this information and enter it into EOC can
delay the representation and execution of an order. In today's trading
environment of rapidly moving markets and the need to execute an order
and hedge a trade in real or near real time, even a slight delay can
prove to be detrimental to the handling of an order. Because the CMTA
information, the opening/closing designation, the account origin code,
the time if force and whether an order was solicited or unsolicited are
not contractual terms of a trade itself nor are they required data
elements pursuant to the Exchange's order format requirements, the
Exchange does not believe this information needs to be entered into the
EOC prior to an order being represented in the Trading Crowd, but may
be entered contemporaneously upon the receipt of such information, even
if that occurs after the order had been represented and executed in the
Trading Crowd.
    The Exchange notes that proposed rule changes mentioned above
relate only to the system entry requirements for floor based orders and
do not amend or revise rules governing the record of orders (Rule
956NY). Floor Brokers must continue to maintain proper order records,
including order information presently required for the proper
systemization of an order that will no longer be required for that
purpose pursuant to this proposal. In addition, the Exchange notes that
this proposal does not amend or revise rules governing trade reporting
duties (Rule 957NY).
The Electronic Tablet
    The Electronic Tablet was an order entry system which would record
orders in a hand written format that in turn could be transmitted to a
Floor Broker's EOC workstation for representation in the Trading Crowd.
The Electronic Tablet provided an alternative to the order entry
functionality of the EOC while providing for an accurate time-sequenced
record of orders on the Exchange. Floor Brokers could hand write order
information into the Electronic Tablet upon receipt of an order, route
the order to EOC and then manually key into EOC additional order and
transaction information for reporting and clearing purposes.
    The Electronic Tablet was designed to expedite the entry of orders
into EOC. Due to ongoing enhancements to the functionality of the EOC
system since its introduction, the Electronic Tablet was used
increasingly less often and eventually became obsolete. The Electronic
Tablet was fully decommissioned by the Exchange in 2009. Because Floor
Brokers may satisfy all order entry requirements by entering an order
directly into EOC, the Exchange has no plans to utilize the Electronic
Tablet functionality going forward. Accordingly, the Exchange proposes
to delete references to the Electronic Tablet found in its Rules.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Securities Exchange Act of 1934 (the ``Act''),\10\ in general, and
furthers the objectives of Section 6(b)(5),\11\ in particular, in that
it is designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities, and to remove impediments to and perfect
the mechanism of a free and open market and a national market system.
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    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
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    The proposed changes to order entry requirements for the EOC is
designed to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in facilitating
transactions in securities by ensuring that the terms of an order
continue to be properly systematized prior to the order being
represented in the Trading Crowd. The Exchange notes that changes are
consistent with the order systemization requirements in the Order which
requires, among other things, that the Exchange incorporate into its
audit trail all non-electronic orders such that the audit trail
provides an accurate, time-sequenced record of electronic and other
orders, quotations and transactions, beginning with the receipt of the
order and documenting the life of the order through the process of
execution, partial execution, or cancellation. The Exchange believes
that aligning the order entry requirements for the EOC with the
Exchange's order format requirements will further promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in facilitating transactions in securities on the
Exchange. Reducing the burden on Floor Brokers to enter order
information prior to representation will promote just and equitable
principles of trade and remove impediments to and perfect the mechanism
of a free and open market by reducing the delay in representation and
execution of an order on the Exchange. The proposal is also designed to
prevent fraudulent and manipulative acts and practices, by ensuring
that the Exchange is able to meet its obligation to create and maintain
a time-sequenced record of orders, quotations and transactions on the
Exchange. In addition, the deletion of rule references pertaining to a
decommissioned order entry system will help protect investors and the
public interest by reducing potential confusion that may result from
having obsolete or out-dated rules in the Exchange's rulebook.
Furthermore, the proposal removes impediments to and perfects the
mechanism of a free and open market and a national market system by
allowing for more timely executions of open-outcry orders.

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed rule change is
designed to enable NYSE Amex Options to align the order format
requirements of the Exchange with those of a competing options
exchange. The proposal would allow Floor Brokers on the Exchange to be
afforded the ability to transact business under the similar
requirements as brokers on a competing exchange. The Exchange believes
that the proposal will reduce the burden on Floor Brokers by
coordinating order entry requirements on different exchanges. By
reducing Floor Brokers burden on order entry compliance, the Exchange
believes the proposal will improve the competitiveness of Exchange
Floor Brokers and also promote competition for orderflow among market
participants and the options exchanges.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has filed the proposed rule change pursuant to Section
19(b)(3)(A)(iii) of the Act \12\ and Rule 19b-4(f)(6) thereunder.\13\
Because the proposed rule change does not: (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative prior to
30 days from the date on which it was filed, or such shorter time as
the Commission may designate, if consistent with the protection of
investors and the public interest, the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \14\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\15\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \14\ 17 CFR 240.19b-4(f)(6).
    \15\ 17 CFR 240.19b-4(f)(6)(iii).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \16\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \16\ 15 U.S.C. 78s(b)(2)(B).
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IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSEMKT-2013-16 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSEMKT-2013-16. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSEMKT-2013-16, and should
be submitted on or before April 4, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-05883 Filed 3-13-13; 8:45 am]
BILLING CODE 8011-01-P