[Federal Register: April 3, 2008 (Volume 73, Number 65)]
[Notices]
[Page 18320-18321]
[DOCID:fr03ap08-98]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms and Recordkeeping Requirements; Agency Information
Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.), this notice announces that the Information
Collection Request (ICR) abstracted below has been forwarded to the
Office of Management and Budget (OMB) for review and comment. The ICR
describes the nature of the information collections and their expected
burden. The Federal Register Notice with a 60-day comment period was
published on January 9, 2008, Vol. 73, No. 6, Pages 1666-1667.

DATES: Comments must be submitted on or before May 5, 2008

FOR FURTHER INFORMATION CONTACT: Susan Ryan at the National Highway
Traffic Safety Administration, Office of Regional Operations and
Program Delivery (NTI-200),<PHONE_NUMBER>, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

SUPPLEMENTARY INFORMATION:

National Highway Traffic Safety Administration

    Title: Highway Safety Program Cost Summary and 23 CFR Part 1345,
Occupant Protection Incentive Grant, Section 405.
    OMB Numbers: 2127-0003; 2127-0600.
    Type of Request: Extension to a previously approved collection of
information.
    Abstract: The Highway Safety Plan identifies state's traffic safety
problems and describes the program and projects to address those
problems. In order to account for funds expended, States are required
to submit a HS-217 Highway Safety Program Cost Summary. The Program
Cost Summary is completed to reflect the state's proposed allocations
of funds (including carry-forward funds)

by program area, based on the projects and activities identified in the
Highway Safety Plan.
    An occupant protection incentive grant (Section 405) is available
to states that can demonstrate compliance with at least four of six
criteria. Demonstration of compliance requires submission of copies of
relevant seat belt and child passenger protection statutes, plan and/or
reports on statewide seatbelt enforcement and child seat education
programs and possible some traffic court records.
    Affected Public: For the Highway Cost Summary the public is the 50
states, District of Columbia, Puerto Rico, U.S. Territories, and Tribal
Government. For the Section 405 grant program the public is the 50
states, the District of Columbia, Puerto Rico, American Samoa, Guam,
Northern Marianas and the Virgin Islands.
    Estimated Total Annual Burden: 570 and 780 respectively.
    Address: Send comments, within 30 days, to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725-17th Street, NW., Washington, DC 20503, Attention: NHTSA Desk
Officer.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Departments estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology. A comment to OMB is most effective if OMB
receives it within 30 days of publication.

John F. Oates,
Acting Associate Administrator for Regional Operations and Program
Delivery.
 [FR Doc. E8-6856 Filed 4-2-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Pages 87781-87782]
[FR Doc No: 2023-27858]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-4596]

Determination That MEPHYTON (Phytonadione) Tablets, 5 Milligrams,
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that MEPHYTON (phytonadione) tablets, 5 milligrams (mg),
were not withdrawn from sale for reasons of safety or effectiveness.
This determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
this drug product, and it will allow FDA to continue to approve ANDAs
that refer to the product as long as they meet relevant legal and
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 5236, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    MEPHYTON (phytonadione) tablets, 5 mg, are the subject of NDA
010104, held by Bausch Health Americas, Inc., and initially approved in
1955. MEPHYTON is a vitamin K replacement indicated for the treatment
of adults with the following coagulation disorders, which are due to
faulty formation of factors II, VII, IX and X when caused by vitamin K
deficiency or interference with vitamin K activity:

 Anticoagulant-induced prothrombin deficiency caused by
coumarin or indanedione derivatives
 Hypoprothrombinemia secondary to antibacterial therapy
 Hypoprothrombinemia secondary to factors limiting absorption
or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula,
sprue, ulcerative colitis, celiac disease, intestinal resection, cystic
fibrosis of the pancreas, and regional enteritis
 Other drug-induced hypoprothrombinemia where it is

definitively shown that the result is due to interference with vitamin
K metabolism, e.g., salicylates

    MEPHYTON (phytonadione) tablets, 5 mg, are currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
    Lachman Consults submitted a citizen petition dated October 17,
2023 (Docket No. FDA-2023-P-4596), under 21 CFR 10.30, requesting that
the Agency determine whether MEPHYTON (phytonadione) tablets, 5 mg,
were withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that MEPHYTON (phytonadione) tablets, 5 mg, were
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that MEPHYTON
(phytonadione) tablets, 5 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of MEPHYTON (phytonadione) tablets, 5 mg,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have found no
information that would indicate that this drug product was withdrawn
from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list MEPHYTON
(phytonadione) tablets, 5 mg, in the ``Discontinued Drug Product List''
section of the Orange Book. The ``Discontinued Drug Product List''
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27858 Filed 12-18-23; 8:45 am]
BILLING CODE 4164-01-P


EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY

NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL
REGISTER

EPA Biopesticides and Pollution Prevention Division contact: Shannon
Borges<PHONE_NUMBER>)

LidoChem, Inc.

20 Village Court

Hazlet, NJ  07730

Petition Number: _______________

EPA has received a pesticide petition [Petition Number:
____________________] from LidoChem, Inc. (hereinafter “LidoChem”),
20 Village Court; Hazlet, NJ 07730 (submitted by RegWest Company, LLC:
8203 West 20th St., Suite A; Greeley, CO 80634-4696) requesting,
pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

To establish an exemption from the requirement of a tolerance for:

Microbial pesticide:  Bacillus amyloliquefaciens strain PTA-4838

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

LidoChem Petition Summary

	Petition Number: _______________

Product Name and Proposed Use Practices

The microbial pest control product, Bacillus amyloliquefaciens strain
PTA-4838, powder formulation is a chitinase-, protease- and
lipase-producing soil bacterium that is efficacious as a biocontrol
agent against certain pathogenic fungi, nematodes and to help establish
a vigorous root system, resulting in more uniform foliage and overall
enhanced plant health.

Commercial/Agricultural Uses

Varnimo WSP may be applied alone, in combination and/or rotation with
chemical fungicides as a tool for integrated disease management in
bushes, crops, herbs, spices, ornamentals, shrubs, trees (forest and
shade), turf, vegetables and vines. It offers a valuable tool for the
management of chemical pesticides’ resistance through its multiple and
unique modes of action.

The proposed uses are as follows:

Varnimo WSP, as a fungicide and nematode suppressant, may be used on all
crops, ornamentals and turf at the rate of 3-32 ounces of product in a
minimum of 25 gallons of water (drench and drip applications) and the
same dilution  applied per acre (foliar application).

Varnimo WSP, as a plant growth promoter, may be used in the following
methods:

Transplants (including plugs): Apply Varnimo WSP to transplants by
dipping or drenching, making sure the root system is thoroughly soaked.
For dipping, follow the instructions for "Cutting and Root Dips" before
planting transplants into soil medium. For drenching, first plant the
transplants into soil medium and then follow instructions for
"Drenching".

Drenching:  Apply Varnimo WSP to seedlings or to newly rooted cuttings.
Drench plants with Varnimo WSP’s suspension making sure the root
system is thoroughly soaked, allowing Varnimo WSP to work into the root
zone.

Cutting and Root Dips: Stir suspension for several minutes to ensure
complete mixture and to eliminate clumps. Place rootstock in the
suspension for 5-10 minutes, allowing time for Varnimo WSP to penetrate
the root zone. For ornamentals, apply at least one follow-up drench
treatment 2-3 weeks following initial treatment.

Tree Injection: Refer to manufacturers’ instructions for individual
tree injection methods/devices.

New Turf Grow-Ins: Optimal results are obtained by making the first
application 2-7 days prior to seeding, sprigging, laying sod or at the
time of seeding, sprigging or sodding. Maintain soil moisture until
seeds, sprigs or sod are installed.

Cool Season and Warm Season Turf: Optimal results are obtained by making
the first application before the first flush of roots.

Hydroponics: Prepare a stock solution by adding 0.25–0.75 ounces of
Varnimo WSP, for every 50 feet of irrigation tubing, in one gallon of
water. Stir product for several minutes to ensure complete suspension.
Add solution to circulating water system and circulate through 3 to 5
watering cycles before clearing the system. For best results, make 2 or
3 weekly applications.

Soil Incorporation: Mix Varnimo WSP into soil or soilless growing media
at a rate of 0.5-2 ounces per cubic yard. Thoroughly mix media, using
mechanical mixing equipment, to ensure uniform distribution of the
product. Incorporated into soil, Varnimo WSP may be raked into growing
beds prior to planting.

Residential Uses

Varnimo WSP is a fungicide used for suppression of fungal plant diseases
on home garden plants, lawn and other turfgrass areas.  Application
methods are limited to drench and spray (4-8 ounces of product to 10
gallons of water with 1 gallon per every 10 square feet).

Varnimo WSP is a Plant Growth Promoter used for enhancing root
development and crop production on bushes, crops, herbs, spices,
ornamentals, shrubs, trees (forest and shade), turf, vegetables and
vines.  Varnimo WSP helps establish a vigorous root system, which often
results in more uniform foliage and overall enhanced plant health. Apply
Varnimo WSP to field soil, to planting substrate, to solid absorbent
soil amendments and directly on propagation material.

Commercial/Agricultural Seed Treatment Uses

Varnimo ST is a biological seed treatment that provides early-season
protection against listed plant parasitic nematodes and helps to
establish a vigorous root system resulting in greater yields, more
uniform foliage and overall enhanced plant health. Varnimo ST is applied
as a water-based suspension of adequate volume to uniformly distribute
the product over the seed surface area. The volume of suspension varies
according to seed type and whether companion seed treatments are used.
Application rates, depending upon the type of seed, range from 0.01 to
0.09 ounce per 100 pounds of seed; 0.02 to 0.12 ounce per 140,000
soybean seeds; and 0.01 to 0.03 ounce per 100,000 sugar beet seeds.

Product Identity/Chemistry

Identity of the pesticide and corresponding residues.

Bacillus amyloliquefaciens strain PTA-4838 is a gram-positive,
nonpathogenic and harmless bacterium, and is ubiquitous in the
environment; it may be isolated from the air, streams, soils and oceans
and a variety of plants.

Bacillus amyloliquefaciens strain PTA-4838 has been described as
irregular, beige, crateriform with undulate margin. Bacillus
amyloliquefaciens are gram-positive rods with peritrichous flagella
allowing motility. The cells often appear as long chains unlike many
other Bacillus species that form as single cells. The optimal
temperature for cellular growth is between 30-40°C. Similar to other
Bacillus species, Bacillus amyloliquefaciens forms endosphores allowing
survival for a long period of time. Endospores appear centrally in the
cells which do not have a swollen appearance.

The culture is deposited in the American Type Culture Collection’s
(“ATCC”) Patent Collection and identified as “New strain of
Bacillus, APM-1 (ATCC® PTA-4838TM).

Bacillus amyloliquefaciens strain PTA-4838 is not considered to be a
human pathogen. Bacillus subtilis species, including Bacillus subtilis
variety amyloliquefaciens PTA-4838, produce proteolytic enzymes and are
widely used as additives in laundry detergents. Bacillus
amyloliquefaciens is used in broiler feed to improve poultry
productivity by its actions at different levels.

Magnitude of residues at the time of harvest and method used to
determine the residue.

Bacillus amyloliquefaciens strain PTA-4838 is ubiquitous in the
environment, especially in soils and agricultural environments all over
the world. As a result, dietary exposure to background levels of the
naturally-occurring microbe may already be occurring and will likely
continue to occur. Because of its ubiquitous presence in the
environment, no increase in exposure to Bacillus amyloliquefaciens
strain PTA-4838 resulting from the proposed pesticidal uses, when
compared to existing exposure to background levels of Bacillus
amyloliquefaciens strain PTA-4838, is expected to occur.

Any potentially occurring residual deposits on crops will not harm
humans because the strain shows no toxicity, infectivity or
pathogenicity in appropriate tests.

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

The acute toxicity studies discussed in Section C of this document are
sufficient to show that there are no foreseeable human or domestic
health hazards likely to arise from the use of the product as proposed.
LidoChem is requesting an exemption from the requirement for a tolerance
for any residues remaining in/on all agricultural commodities. Since
enforcement of residue levels would not be needed, an enforcement
analytical method is not required.

Mammalian Toxicological Profile

LidoChem conducted and submitted the required toxicology studies to
support its petition for an exemption from the requirement of a
tolerance and associated registration. Toxicology data submitted in
support of the exemption from the requirement of a tolerance for
Bacillus amyloliquefaciens strain PTA-4838 included studies on the
technical form and formulated product as follows:

Acute Toxicity and/or Pathogenicity

Varnimo® Technical

OCSPP Guideline 885.3050: The acute oral toxicity/pathology of Varnimo
Technical was evaluated when administered to rats by gavage in a single
high dose exposure and given an adequate post-exposure observation
period. The only observed general health finding was one male (17-M) in
Group IV – MCPA with a slight decrease in activity on Day 0. There
were no other abnormal general health findings. There were no observed
abnormalities during necropsy. The test substance appeared to clear
completely from brain and kidneys by Day 7, from the blood by Day 14 and
from the cecum by Day 21. The lungs, spleen, liver and mesenteric lymph
nodes (“MLN”) showed patterns of clearance through Day 21. There
were no indications of infectivity or pathogenicity by the test
substance. Varnimo Technical was determined to be non-toxic to rats when
administered by oral gavage in a single dose of 3.5 x 108 CFU/rat.

OCSPP Guideline Number 885.3150: The pulmonary toxicity, infectivity and
pathogenicity of Varnimo Technical were evaluated when administered to
rats at a single high dose exposure and an adequate post-exposure
observation period. There were no abnormal general health observations.
There were no observed abnormalities during necropsy. The test organism
was considered completely clear from the blood and cecum by Day 7;
considered completely clear from the kidneys and MLN by Day 14;
considered completely cleared from the brain, lungs and spleen by Day
21; and was present in the liver on Day 14 in one out of six animals,
but was clear on Day 21. Varnimo Technical was determined to be
non-toxic to rats when administered by tracheal injection in a single
dose of 3.1 x 109 CFU/g or 3.1 x 108 CFU/rat.

OCSPP Guideline Number 885.3200: Varnimo Technical was evaluated to
assess the acute intravenous toxicity and infectivity using a single
high dose exposure and an adequate post-exposure observation period. No
abnormalities were seen during daily observations or at necropsy. There
was no mortality in any group during the study. The test organism had
cleared completely from the Group III (MPCA) blood by Day 3 and from the
brain and the cecum by Day 7. The test organism showed a pattern of
clearance from the Group III lungs, liver, spleen and MLN. Varnimo
Technical was determined to be non-toxic to rats when injected
intravenously at a dose of 2.7 x 108 CFU/mL or 2.7 x 107 CFU/rat.

Varnimo® WSP

OCSPP Guideline Number 870.1100: Varnimo WSP was evaluated for acute
oral toxicity potential in female albino rats when administered as a
gavage dose at 5000 mg/kg. No mortality occurred during the study. There
were no clinical signs of toxicity during the study. Animals exhibited
weekly weight gain during the study. Gross necropsy conducted at
termination revealed no observable abnormalities. The acute oral LD50
was determined to be greater than 5000 mg/kg.

OCSPP Guideline Number 870.1200: Varnimo WSP was evaluated for dermal
toxicity potential and relative skin irritancy when a single dose
moistened with 0.5 mL of deionized (“DI”) water/g test substance, at
5050 mg/kg, was applied to the intact skin of albino rats. No mortality
occurred during the study. There were no clinical signs of toxicity at
any time throughout the study. Signs of dermal irritation included
erythema, atonia, desquamation and alopecia on Days 7-14. Animals
exhibited weekly weight gain, except for one that failed to gain weight
between Days 0 and 7. Gross necropsy conducted at study termination
revealed no observable abnormalities. The LD50 was determined to be
greater than 5050 mg/kg.

OCSPP Guideline Number 870.1300: Varnimo WSP was evaluated for acute
inhalation toxicity potential in albino rats. Pre-study trial assays
were conducted to determine if aerosolizing the test substance into the
exposure chamber would produce an acceptable concentration of at least 2
mg/L with mass median aerodynamic diameter (“MMAD”) between 1 and 4
μm. Prior to aerosolization in some assays, the test substance was
heat-dried and/or ground. An aerosol was generated using a Venturi
Aspirator connected to a 500 L exposure chamber. No attempt resulted in
an appropriate exposure concentration with an appropriate correspond
MMAD. Due to the nature of the test substance, an exposure concentration
could not be achieved that would provide meaningful acute inhalation
toxicity data. Based on the laboratory report, LidoChem submitted a
waiver request for this data requirement.

OCSPP Guideline Number 870.2400: An acute eye irritation study was
conducted on three albino rabbits using Varnimo WSP. The test substance,
100 mg, was placed into the conjunctival sac of the right eye of each
animal selected for testing. All treated eyes were washed with room
temperature deionized (“DI”) water for one minute immediately after
recording the 24-hour observation. There were no positive effects
exhibited in any eyes after treatment. The test substance is rated
non-irritating.

OCSPP Guideline Number 870.2500: A primary dermal irritation study was
conducted on three albino rabbits using Varnimo WSP. There was one
intact test site per animal. Each test site was treated with 500 mg of
Varnimo WSP moistened with 0.5 mL of deionized (“DI”) water and
covered with semi-permeable dressing. Test substance was maintained in
contact with the skin for 4 hours. Observations for dermal irritation
and defects were made at 1, 24, 48 and 72 hours after removal of the
dressings. Based on 0.2 PII, the test substance is rated slightly
irritating. Based on scores at only the 72-hour observation, the test
substance is assigned Toxicity Category IV. The death of one animal on
Day 3 of the study is considered unrelated to administration of the test
substance.

Aggregate Exposure

Dietary exposure

 Food

Bacillus amyloliquefaciens strain PTA-4838 is ubiquitous in the
environment, especially in soils and agricultural environments. As a
result, dietary exposure to background levels of the naturally-occurring
microbe may already be occurring and will likely continue to occur.
Because of its ubiquitous presence in the environment, no increase in
exposure to Bacillus amyloliquefaciens strain PTA-4838, resulting from
the proposed pesticidal uses, is expected when compare to existing
exposure to background levels of Bacillus amyloliquefaciens strain
PTA-4838.

As previously discussed, dietary exposure to the naturally-occurring
microbe may already be occurring and will likely continue to occur.
Notably, similar Bacillus subtilis strains are used internationally in
the production of food-grade products and in fermented foods in Japan
and Thailand. Reports in the literature implicating Bacillus subtilis
sp. in food-borne illness do not describe any pathogen or toxin
production, but rather simple spoilage from Bacillus subtilis growth in
dough. Such low-quality dough would not be suitable for bread production
by commercial bakeries, therefore this particular food exposure scenario
is unlikely and the human risk negligible.

An extensive literature search yielded no reliable reports of adverse
effects on non-target terrestrial plants. One on-line report identified
Bacillus amyloliquefaciens as infecting an onion in cold storage. The
temperature of the storage unit was 0-1°C. It has been established that
Bacillus amyloliquefaciens remains inactive at temperatures below 15°C
or above 50°C. Eight bacterial isolates were found all to infect
longitudinally-cut onions at 30°C. LidoChem concludes this report is
not reliable as the bacteria would have remained dormant during cold
storage and the isolation and identification of the Bacillus
amyloliquefaciens was incidental or incorrect.

The risk posed to adults, infants and children from food-related
exposure to Bacillus amyloliquefaciens strain PTA-4838 is minimal due to
the demonstrated lack of acute oral toxicity/pathogenicity associated
with the microbial pesticide. Based on the submitted data, there are no
dietary risks exceeding regulatory levels of concern.

Drinking water

Bacillus amyloliquefaciens strain PTA-4838 is ubiquitous in the
environment and exposure to the microbe through drinking water may
already be occurring and will likely continue to occur. While the
proposed and existing use sites do not include direct application to
aquatic environments, the intended use of Bacillus subtilis treatment of
growing crops or seed for the control of plant disease might result in
the potential for drift or runoff that might reach surface or ground
waters. Bacillus subtilis species are not recognized aquatic bacteria
and are not expected to grow in aquatic environments.  Municipal
drinking water treatment processes and deep water wells both further
reduce any such residues. Even if oral exposure to this ubiquitous
microbe should occur through drinking water, due to its demonstrated
lack of acute oral toxicity/pathogenicity, it is likely that no harm
will result from such exposure.

Non-dietary exposure

The pesticide uses of Bacillus amyloliquefaciens strain PTA-4838, as
proposed, do not increase in a significant way the potential for
non-dietary, non-occupational exposure to its residues for the general
population, including infants and children, because Bacillus
amyloliquefaciens strain PTA-4838 is naturally-occurring and ubiquitous
in the environment and because it is likely populations have been
previously exposed, and will likely continue to be exposed, to
background levels of the microbe. Neither such common human exposure to
Bacillus amyloliquefaciens strain PTA-4838 naturally present in soils,
waters and plants, nor exposures associated with similar Bacillus
subtilis strains used internationally in producing food-grade products
and fermented foods, have resulted in reports of infections in humans
(which consistently are reported only in otherwise-compromised
individuals) those reports are most notable for their rare and
exceptional nature.

We believe evaluation of the high-dose Tier 1 acute toxicity and
pathogenicity tests will result in the assignment of Toxicity Category
IV (least toxic) and determinations of not infective and not pathogenic
will be concluded for all exposure routes. No toxicological end points
of concern have been identified. There are no dietary endpoints that
exceed regulatory levels of concern. Any additional exposure to the
microbe resulting from residues attributable to Bacillus subtilis var.
amyloliquefaciens strain PTA-4838 pesticide use, will not result in
additional aggregate non-occupational risk from dermal and inhalation
exposures. Based solely on non-occupation exposure scenarios, regular
occupational exposures associated with this active ingredient pose
negligible risk.

Cumulative Effects

No mechanism of toxicity in mammals has been identified for Bacillus
amyloliquefaciens strain PTA-4838. Therefore, no cumulative effect with
other related organisms is anticipated, because the available data
demonstrate a lack of toxicity/pathogenicity potential for the active
ingredient, adverse dietary effects are unlikely.

Safety Determination

U.S. population

Based on the acute toxicity information discussed in 3.C., there is a
reasonable certainty that no harm will result to the United States
population from aggregate exposure to residues of Bacillus
amyloliquefaciens strain PTA-4838. See “2. Infants and Children” for
rationale support.

Infants and children

Based on the acute toxicity information discussed in 3.C., there is a
reasonable certainty that no harm will result to the United States
population, including infants and children, from aggregate exposure to
residues of Bacillus amyloliquefaciens strain PTA-4838. This includes
all anticipated dietary exposures and all other exposures for which
there is reliable information. This is based on the available data on
Bacillus subtilis species, including Bacillus amyloliquefaciens strain
PTA-4838, that demonstrate a lack of toxicity/pathogenicity potential.
There are no threshold effects of concern and therefore, the additional
tenfold margin of safety for infants and children is unnecessary. The
need to consider consumption patterns, special susceptibility and
cumulative effects is unnecessary when dealing with pesticides with no
demonstrated significant adverse effects.

Effects on the Immune and Endocrine Systems

Bacillus amyloliquefaciens strain PTA-4838 is a ubiquitous organism in
the environment that is non-toxic to mammals. To date, there is no
evidence to suggest that Bacillus amyloliquefaciens strain PTA-4838
affects the immune system, functions in a manner similar to any known
hormone, or that it acts as an endocrine disruptor. The submitted
toxicity/pathogenicity studies in rodents indicate that, following
several routes of exposure, the immune system is intact and able to
process and clear the active ingredient. Therefore, it is unlikely that
this organism will have estrogenic or endocrine effects.

Existing Tolerances

There are no existing tolerance exemptions or tolerances established for
Bacillus amyloliquefaciens strain PTA-4838.

International Tolerances

No Codex maximum residue level (“MRL”) exists for Bacillus
amyloliquefaciens strain PTA-4838.

 PAGE

 PAGE   6


Conforming alternate version means a Web page that allows a
corresponding non-conforming Web page on the primary Web site to be
included within the scope of conformance as long as it meets the WCAG
2.0 Level AA success criteria, is up-to-date and contains the same
information and functionality in the same language as the non-
conforming page. At least one of the following applies to a conforming
alternative version:
    (1) The conforming version can be reached from the non-conforming
page via an accessibility-supported mechanism; or
    (2) The non-conforming version can only be reached from the
conforming version; or
    (3) The non-conforming version can only be reached from a
conforming page that also provides a mechanism to reach the conforming
version.
* * * * *
    Flight-related services mean functions related to air travel
including, but not limited to, ticket purchase, rebooking cancelled
flights, seat selection, and obtaining boarding passes or bag tags.
* * * * *
    Primary (or Main) Web site means the Web site that is accessed upon
entering the uniform resource locator (e.g., www.carriername.com,
www.airline designator code.com) in an Internet browser from a standard
desktop or laptop computer where the carrier advertises or sells air
transportation to the public.
* * * * *
    Shared-use automated airport kiosk means a self-service transaction
machine that is jointly owned, controlled or leased by an airport
operator and carriers and/or an independent service provider and that
provides carrier software applications which enable customers to
independently access flight-related services.
* * * * *

Sec.  382.31  [Amended]

0
3. In Sec.  382.31, paragraph (c) is removed.

0
4. Section 382.43 is amended by revising the section heading and adding
paragraphs (c) through (e) to read as follows:

Sec.  382.43  Must information and reservation services of carriers be
accessible to individuals with visual, hearing, and other disabilities?

* * * * *
    (c) If you are a U.S. or foreign air carrier that operates at least
one aircraft having a designed seating capacity of more than 60
passengers and owns or controls a primary Web site that markets
passenger air transportation, or a tour (i.e., a combination of air
transportation and ground or cruise accommodations), or tour component
(e.g., a hotel stay) that must be purchased with air transportation,
you must ensure the public-facing Web pages on your primary Web site
are accessible to individuals with disabilities as provided in
paragraphs (c)(1) through (4) of this section. Only Web sites that
market air transportation to the general public in the United States
must be accessible to individuals with disabilities. The following are
among the characteristics of a primary Web site that markets to the
general public in the U.S.: the content can be viewed in English, the
site advertises or sells flights operating to, from, or within the
United States, and the site displays fares in U.S. dollars.
    (1) Your primary Web site must conform to all Success Criteria and
all Conformance Requirements from the World Wide Web Consortium (W3C)
Recommendation 11 December 2008, Web site Content Accessibility
Guidelines (WCAG) 2.0 for Level AA as follows:
    (i) Web pages associated with obtaining the following core air
travel services and information that are offered on your primary Web
site are conformant by December 12, 2015:
    (A) Booking or changing a reservation, including all flight
amenities;
    (B) Checking in for a flight;
    (C) Accessing a personal travel itinerary;
    (D) Accessing the status of a flight;
    (E) Accessing a personal frequent flyer account;
    (F) Accessing flight schedules; and
    (G) Accessing carrier contact information.
    (ii) All remaining Web pages on your primary Web site are
conformant by December 12, 2016.
    (2) Your primary Web site must be tested in consultation with
individuals with disabilities or members of disability organization(s)
who use or want to use carrier Web sites to research or book air
transportation in order to obtain their feedback on the Web site's
accessibility and usability before the dates specified in paragraph
(c)(1) of this section. Collectively, such individuals must be able to
provide feedback on the usability of the Web site by individuals with
visual, auditory, tactile, and cognitive disabilities. Consultation is
required to ensure that your Web site is usable by individuals with
disabilities by the date specified in paragraph (c)(1).
    (3) You are permitted to use a Level AA conforming alternate
version only when conforming a public-facing Web page to all WCAG 2.0
Level AA success criteria would constitute an undue burden or
fundamentally alter the information or functionality provided by that
page.
    (4) You must assist prospective passengers who indicate that they
are unable to use your Web site due to a disability and contact you
through other channels (e.g., by telephone or at the ticket counter) as
follows:
    (i) Disclose Web-based discount fares to the passenger if his or
her itinerary qualifies for the discounted fare.
    (ii) Provide Web-based amenities to the passenger, such as waiving
any fee applicable to making a reservation or purchasing a ticket using
a method other than your Web site (e.g., by telephone), unless the fee
applies to other customers purchasing the same fare online.
    (d) As a carrier covered under paragraph (c) of this section, you
must provide a mechanism on your primary

Web site for persons with disabilities to request disability
accommodation services for future flights, including but not limited to
wheelchair assistance, seating accommodation, escort assistance for a
visually impaired passenger, and stowage of an assistive device no
later than December 12, 2015. You may require individuals who request
accommodations using this mechanism to provide contact information
(e.g., name, daytime phone, evening phone, and email address) for
follow-up by your customer service department or medical desk.
    (e) As a carrier covered under paragraph (c) of this section, you
must provide a disclaimer activated when a user clicks a link on your
primary Web site to an external Web site or to third-party software
informing the user that the Web site or software may not follow the
same accessibility policies no later than December 12, 2016.

0
5. Section 382.57 is revised to read as follows:

Sec.  382.57  What accessibility requirements apply to automated
airport kiosks?

    (a) As a carrier, you must comply with the following requirements
with respect to any automated airport kiosk you own, lease, or control
at a U.S. airport with 10,000 or more enplanements per year.
    (1) You must ensure that all automated airport kiosks installed on
or after December 12, 2016, are models that meet the design
specifications set forth in paragraph (c) of this section until at
least 25 percent of automated kiosks provided in each location at the
airport (i.e., each cluster of kiosks and all stand-alone kiosks at the
airport) meets this specification.
    (2) You must ensure that at least 25 percent of automated kiosks
you own, lease, or control in each location at a U.S. airport meet the
design specifications in paragraph (c) of this section by December 12,
2022.
    (3) When the kiosks provided in a location at the airport perform
more than one function (e.g., print boarding passes/bag tags, accept
payment for flight amenities such as seating upgrades/meals/WiFi
access, rebook tickets, etc.), you must ensure that the accessible
kiosks provide all the same functions as the inaccessible kiosks in
that location.
    (4) You must ensure that a passenger with a disability who requests
an accessible automated kiosk is given priority access to any available
accessible kiosk you own, lease, or control in that location at the
airport.
    (5) You must ensure that each automated airport kiosk that meets
the design specifications in paragraph (c) of this section is:
    (i) Visually and tactilely identifiable to users as accessible
(e.g., an international symbol of accessibility affixed to the front of
the device).
    (ii) Maintained in proper working condition.
    (b) As a carrier, you must comply with the following requirements
for any shared-use automated airport kiosks you jointly own, lease, or
control at a U.S. airport with 10,000 or more enplanements per year.
    (1) You must ensure that all shared-use automated airport kiosks
you jointly own, lease, or control installed on or after December 12,
2016, meet the design specifications in paragraph (c) of this section
until at least 25 percent of automated kiosks provided in each location
at the airport (i.e., each cluster of kiosks and all stand-alone kiosks
at an airport) meet this specification.
    (2) You must ensure that at least 25 percent of shared-use
automated kiosks you own, lease, or control in each location at the
airport meet the design specifications in paragraph (c) of this section
by December 12, 2022.
    (3) When shared-use automated kiosks provided in a location at the
airport perform more than one function (e.g., print boarding passes/bag
tags, accept payment for flight amenities such as seating upgrades/
meals/WiFi access, rebook tickets, etc.), you must ensure that the
accessible kiosks provide all the same functions as the inaccessible
kiosks in that location.
    (4) You must ensure that each automated airport kiosk that meets
the design specifications set forth in paragraph (c) of this section
is:
    (i) Visually and tactilely identifiable to users as accessible
(e.g., an international symbol of accessibility affixed to the front of
the device; and
    (ii) Maintained in proper working condition.
    (5) As a carrier, you are jointly and severally liable with airport
operators and/or other participating carriers for ensuring that shared-
use automated airport kiosks are compliant with the requirements of
paragraphs (b) and (c) of this section.
    (c) You must ensure that the automated airport kiosks provided in
accordance with this section conform to the following technical
accessibility standards with respect to their physical design and the
functions they perform:
    (1) Self contained. Except for personal headsets and audio loops,
automated kiosks must be operable without requiring the user to attach
assistive technology.
    (2) Clear floor or ground space. A clear floor or ground space
complying with section 305 of the U.S. Department of Justice's 2010 ADA
Standards for Accessible Design, 28 CFR 35.104 (defining the ``2010
Standards'' for title II as the requirements set forth in appendices B
and D to 36 CFR part 1191 and the requirements contained in 28 CFR
35.151) (hereinafter 2010 ADA Standards) must be provided.
    (3) Operable parts. Operable parts must comply with section 309 of
the 2010 ADA Standards, and the following requirements:
    (i) Identification. Operable parts must be tactilely discernible
without activation;
    (ii) Timing. Where a timed response is required, the user must be
alerted visually and by touch or sound and must be given the
opportunity to indicate that more time is required;
    (iii) Status indicators. Status indicators, including all locking
or toggle controls or keys (e.g., Caps Lock and Num Lock keys), must be
discernible visually and by touch or sound; and
    (iv) Color. Color coding must not be used as the only means of
conveying information, indicating an action, prompting a response, or
distinguishing a visual element.
    (4) Privacy. Automated airport kiosks must provide the opportunity
for the same degree of privacy of input and output available to all
individuals. However, if an option is provided to blank the screen in
the speech output mode, the screen must blank when activated by the
user, not automatically.
    (5) Output. Automated airport kiosks must comply with paragraphs
(c)(5)(i) through (iv) of this section.
    (i) Speech output enabled. Automated airport kiosks must provide an
option for speech output. Operating instructions and orientation,
visible transaction prompts, user input verification, error messages,
and all other visual information for full use must be accessible to and
independently usable by individuals with vision impairments. Speech
output must be delivered through a mechanism that is readily available
to all users, including but not limited to, an industry standard
connector or a telephone handset. Speech output must be recorded or
digitized human, or synthesized. Speech output must be coordinated with
information displayed on the screen. Speech output must comply with
paragraphs (c)(5)(i)(A) through (F) of this section.
    (A) When asterisks or other masking characters are used to
represent personal identification numbers or other

visual output that is not displayed for security purposes, the masking
characters must be spoken (``*'' spoken as ``asterisk'') rather than
presented as beep tones or speech representing the concealed
information.
    (B) Advertisements and other similar information are not required
to be audible unless they convey information that can be used in the
transaction being conducted.
    (C) Speech for any single function must be automatically
interrupted when a transaction is selected or navigation controls are
used. Speech must be capable of being repeated and paused by the user.
    (D) Where receipts, tickets, or other outputs are provided as a
result of a transaction, speech output must include all information
necessary to complete or verify the transaction, except that--
    (1) Automated airport kiosk location, date and time of transaction,
customer account numbers, and the kiosk identifier are not required to
be audible;
    (2) Information that duplicates information available on-screen and
already presented audibly is not required to be repeated; and
    (3) Printed copies of a carrier's contract of carriage, applicable
fare rules, itineraries and other similar supplemental information that
may be included with a boarding pass are not required to be audible.
    (ii) Volume control. Automated kiosks must provide volume control
complying with paragraphs (c)(5)(ii)(A) and (B) of this section.
    (A) Private listening. Where speech required by paragraph (c)(5)(i)
of this section is delivered through a mechanism for private listening,
the automated kiosk must provide a means for the user to control the
volume. A function must be provided to automatically reset the volume
to the default level after every use.
    (B) Speaker volume. Where sound is delivered through speakers on
the automated kiosk, incremental volume control must be provided with
output amplification up to a level of at least 65 dB SPL. Where the
ambient noise level of the environment is above 45 dB SPL, a volume
gain of at least 20 dB above the ambient level must be user selectable.
A function must be provided to automatically reset the volume to the
default level after every use.
    (iii) Captioning. Multimedia content that contains speech or other
audio information necessary for the comprehension of the content must
be open or closed captioned. Advertisements and other similar
information are not required to be captioned unless they convey
information that can be used in the transaction being conducted.
    (iv) Tickets and boarding passes. Where tickets or boarding passes
are provided, tickets and boarding passes must have an orientation that
is tactilely discernible if orientation is important to further use of
the ticket or boarding pass.
    (6) Input. Input devices must comply with paragraphs (c)(6)(i)
through (iv) of this section.
    (i) Input controls. At least one input control that is tactilely
discernible without activation must be provided for each function.
Where provided, key surfaces not on active areas of display screens,
must be raised above surrounding surfaces. Where touch or membrane keys
are the only method of input, each must be tactilely discernible from
surrounding surfaces and adjacent keys.
    (ii) Alphabetic keys. Alphabetic keys must be arranged in a QWERTY
keyboard layout. The ``F'' and ``J'' keys must be tactilely distinct
from the other keys.
    (iii) Numeric keys. Numeric keys must be arranged in a 12-key
ascending or descending keypad layout or must be arranged in a row
above the alphabetic keys on a QWERTY keyboard. The ``5'' key must be
tactilely distinct from the other keys.
    (iv) Function keys. Function keys must comply with paragraphs
(c)(6)(iv)(A) and (B) of this section.
    (A) Contrast. Function keys must contrast visually from background
surfaces. Characters and symbols on key surfaces must contrast visually
from key surfaces. Visual contrast must be either light-on-dark or
dark-on-light. However, tactile symbols required by (c)(6)(iv)(B) are
not required to comply with (c)(6)(iv)(A) of this section.
    (B) Tactile symbols. Function key surfaces must have tactile
symbols as follows: Enter or Proceed key: raised circle; Clear or
Correct key: raised left arrow; Cancel key: raised letter ex; Add Value
key: raised plus sign; Decrease Value key: raised minus sign.
    (7) Display screen. The display screen must comply with paragraphs
(c)(7)(i) and (ii) of this section.
    (i) Visibility. The display screen must be visible from a point
located 40 inches (1015 mm) above the center of the clear floor space
in front of the automated kiosk.
    (ii) Characters. Characters displayed on the screen must be in a
sans serif font. Characters must be 3/16 inch (4.8 mm) high minimum
based on the uppercase letter ``I.'' Characters must contrast with
their background with a minimum luminosity contrast ratio of 3:1.
    (8) Braille instructions. Braille instructions for initiating the
speech mode must be provided. Braille must comply with section 703.3 of
the 2010 ADA Standards.
    (9) Biometrics. Biometrics must not be the only means for user
identification or control, unless at least two biometric options that
use different biological characteristics are provided.
    (d) You must provide equivalent service upon request to passengers
with a disability who cannot readily use your automated airport kiosks
(e.g., by directing a passenger who is blind to an accessible automated
kiosk, assisting a passenger in using an inaccessible automated kiosk,
assisting a passenger who due to his or her disability cannot use an
accessible automated kiosk by allowing the passenger to come to the
front of the line at the check-in counter).

PART 399--STATEMENTS OF GENERAL POLICY [AMENDED]

0
4. The authority citation for part 399 is revised to read as follows:

    Authority: 49 U.S.C. 41712

0
5. Section 399.80 is amended by revising the introductory text, adding
reserved paragraphs (o) through (r), and adding paragraph (s) to read
as follows:

Sec.  399.80  Unfair and deceptive practices of ticket agents.

    It is the policy of the Department to regard as an unfair or
deceptive practice or unfair method of competition the practices
enumerated in paragraphs (a) through (m) of this section by a ticket
agent of any size and the practice enumerated in paragraph (s) by a
ticket agent that sells air transportation online and is not considered
a small business under the Small Business Administration's size
standards set forth in 13 CFR 121.201:
* * * * *
    (o)-(r) [Reserved]
    (s) Failing to disclose and offer Web-based discount fares on or
after June 10, 2014, to prospective passengers who contact the agent
through other channels (e.g., by telephone or in the agent's place of
business) and indicate they are unable to use the agent's Web site due
to a disability.

Title 49--Transportation

PART 27--NONDISCRIMINATION ON THE BASIS OF DISABILITY IN PROGRAMS
OR ACTIVITIES RECEIVING FEDERAL FINANCIAL ASSISTANCE

0
6. The authority citation for part 27 continues to read as follows:

    Authority:  Sec. 504 of the Rehabilitation Act of 1973, as
amended (29 U.S.C. 794); sec. 16(a) and (d) of the Federal Transit
Act of 1964, as amended (49 U.S.C. 5310(a) and (f); sec. 165(b) of
the Federal-Aid Highway Act of 1973, as amended (23 U.S.C. 142 nt.).

0
7. Section 27.71 is amended by adding reserved paragraphs (h) and (i)
and paragraphs (j) and (k) to read as follows:

Sec.  27.71  Airport facilities.

* * * * *
    (h) [Reserved]
    (i) [Reserved]
    (j) Shared-use automated airport kiosks. This paragraph applies to
U.S. airports with 10,000 or more annual enplanements.
    (1) Airport operators that jointly own, lease, or control automated
airport kiosks with carriers at U.S. airports must ensure that all
shared-use automated kiosks installed on or after December 12, 2016
meet the design specifications set forth in paragraph (k) of this
section until at least 25 percent of kiosks provided in each location
at the airport (i.e., each cluster of kiosks and all stand-alone kiosks
at the airport) meet this specification.
    (2) Airport operators must ensure that at least 25 percent of
shared-use automated airport kiosks they jointly own, lease, or control
with carriers in each location at the airport meet the design
specifications in paragraph (k) of this section by December 12, 2022.
    (3) When shared-use kiosks provided in a location at the airport
perform more than one function (e.g., print boarding passes/bag tags,
accept payment for flight amenities such as seating upgrades/meals/WiFi
access, rebook tickets, etc.), the accessible kiosks must provide all
the same functions as the inaccessible kiosks in that location.
    (4) Each shared-use automated kiosk that meets the design
specifications in paragraph (k) of this section must be visually and
tactilely identifiable to users as accessible (e.g., an international
symbol of accessibility affixed to the front of the device) and
maintained in proper working condition.
    (5) Airport operators are jointly and severally liable with
carriers for ensuring that shared-use automated airport kiosks are
compliant with the requirements of paragraphs (j) and (k) of this
section.
    (k) Shared-use automated airport kiosks provided in accordance with
paragraph (j) of this section must conform to the following technical
accessibility standards with respect to their physical design and the
functions they perform:
    (1) Self contained. Except for personal headsets and audio loops,
automated kiosks must be operable without requiring the user to attach
assistive technology.
    (2) Clear floor or ground space. A clear floor or ground space
complying with section 305 of the U.S. Department of Justice's 2010 ADA
Standards for Accessible Design, 28 CFR 35.104 (defining the ``2010
Standards'' for title II as the requirements set forth in appendices B
and D to 36 CFR part 1191 and the requirements contained in 28 CFR
35.151) (hereinafter 2010 ADA Standards) must be provided.
    (3) Operable parts. Operable parts must comply with section 309 of
the 2010 ADA Standards, and the following requirements:
    (i) Identification. Operable parts must be tactilely discernible
without activation;
    (ii) Timing. Where a timed response is required, the user must be
alerted visually and by touch or sound and must be given the
opportunity to indicate that more time is required;
    (iii) Status indicators. Status indicators, including all locking
or toggle controls or keys (e.g., Caps Lock and Num Lock keys), must be
discernible visually and by touch or sound; and
    (iv) Color. Color coding must not be used as the only means of
conveying information, indicating an action, prompting a response, or
distinguishing a visual element.
    (4) Privacy. Automated airport kiosks must provide the opportunity
for the same degree of privacy of input and output available to all
individuals. However, if an option is provided to blank the screen in
the speech output mode, the screen must blank when activated by the
user, not automatically.
    (5) Output. Automated airport kiosks must comply with paragraphs
(k)(5)(i) through (iv) of this section.
    (i) Speech output enabled. Automated airport kiosks must provide an
option for speech output. Operating instructions and orientation,
visible transaction prompts, user input verification, error messages,
and all other visual information for full use must be accessible to and
independently usable by individuals with vision impairments. Speech
output must be delivered through a mechanism that is readily available
to all users, including but not limited to, an industry standard
connector or a telephone handset. Speech output must be recorded or
digitized human, or synthesized. Speech output must be coordinated with
information displayed on the screen. Speech output must comply with
paragraphs (k)(5)(i)(A) through (D) of this section.
    (A) When asterisks or other masking characters are used to
represent personal identification numbers or other visual output that
is not displayed for security purposes, the masking characters must be
spoken (``*'' spoken as ``asterisk'') rather than presented as beep
tones or speech representing the concealed information.
    (B) Advertisements and other similar information are not required
to be audible unless they convey information that can be used in the
transaction being conducted.
    (C) Speech for any single function must be automatically
interrupted when a transaction is selected or navigation controls are
used. Speech must be capable of being repeated and paused by the user.
    (D) Where receipts, tickets, or other outputs are provided as a
result of a transaction, speech output must include all information
necessary to complete or verify the transaction, except that -
    (1) Automated airport kiosk location, date and time of transaction,
customer account numbers, and the kiosk identifier are not required to
be audible;
    (2) Information that duplicates information available on-screen and
already presented audibly is not required to be repeated; and
    (3) Printed copies of a carrier's contract of carriage, applicable
fare rules, itineraries and other similar supplemental information that
may be included with a boarding pass are not required to be audible.
    (ii) Volume control. Automated kiosks must provide volume control
complying with paragraphs (k)(5)(ii)(A) and (B) of this section.
    (A) Private listening. Where speech required by paragraph (k)(5)(i)
is delivered through a mechanism for private listening, the automated
kiosk must provide a means for the user to control the volume. A
function must be provided to automatically reset the volume to the
default level after every use.
    (B) Speaker volume. Where sound is delivered through speakers on
the automated kiosk, incremental volume control must be provided with
output amplification up to a level of at least 65 dB SPL. Where the
ambient noise level of the environment is above 45 dB SPL, a volume
gain of at least 20 dB above

the ambient level must be user selectable. A function must be provided
to automatically reset the volume to the default level after every use.
    (iii) Captioning. Multimedia content that contains speech or other
audio information necessary for the comprehension of the content must
be open or closed captioned.
    Advertisements and other similar information are not required to be
captioned unless they convey information that can be used in the
transaction being conducted.
    (iv) Tickets and boarding passes. Where tickets or boarding passes
are provided, tickets and boarding passes must have an orientation that
is tactilely discernible if orientation is important to further use of
the ticket or boarding pass.
    (6) Input. Input devices must comply with paragraphs (k)(6)(i)
through (iv) of this section.
    (i) Input controls. At least one input control that is tactilely
discernible without activation must be provided for each function.
Where provided, key surfaces not on active areas of display screens,
must be raised above surrounding surfaces. Where touch or membrane keys
are the only method of input, each must be tactilely discernible from
surrounding surfaces and adjacent keys.
    (ii) Alphabetic keys. Alphabetic keys must be arranged in a QWERTY
keyboard layout. The ``F'' and ``J'' keys must be tactilely distinct
from the other keys.
    (iii) Numeric keys. Numeric keys must be arranged in a 12-key
ascending or descending keypad layout or must be arranged in a row
above the alphabetic keys on a QWERTY keyboard. The ``5'' key must be
tactilely distinct from the other keys.
    (iv) Function keys. Function keys must comply with paragraphs
(k)(6)(iv)(A) and (B) of this section.
    (A) Contrast. Function keys must contrast visually from background
surfaces. Characters and symbols on key surfaces must contrast visually
from key surfaces. Visual contrast must be either light-on-dark or
dark-on-light. However, tactile symbols required by (k)(6)(iv)(B) are
not required to comply with paragraph (k)(6)(iv)(A) of this section.
    (B) Tactile symbols. Function key surfaces must have tactile
symbols as follows: Enter or Proceed key: raised circle; Clear or
Correct key: raised left arrow; Cancel key: raised letter ex; Add Value
key: raised plus sign; Decrease Value key: raised minus sign.
    (7) Display screen. The display screen must comply with paragraphs
(k)(7)(i) and (ii) of this section.
    (i) Visibility. The display screen must be visible from a point
located 40 inches (1015 mm) above the center of the clear floor space
in front of the automated kiosk.
    (ii) Characters. Characters displayed on the screen must be in a
sans serif font. Characters must be 3/16 inch (4.8 mm) high minimum
based on the uppercase letter ``I.'' Characters must contrast with
their background with a minimum luminosity contrast ratio of 3:1.
    (8) Braille instructions. Braille instructions for initiating the
speech mode must be provided. Braille must comply with section 703.3 of
the 2010 ADA Standards.
    (9) Biometrics. Biometrics must not be the only means for user
identification or control, unless at least two biometric options that
use different biological characteristics are provided.

[FR Doc. 2013-26749 Filed 11-7-13; 4:15 pm]
BILLING CODE 4910-9X-P


[Federal Register Volume 84, Number 118 (Wednesday, June 19, 2019)]
[Notices]
[Page 28548]
[FR Doc No: 2019-12965]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ID-8709-000]

Henley, Greg; Notice of Filing

    Take notice that on June 13, 2019, Greg Henley filed an application
for authorization to hold interlocking positions, pursuant to section
305(b) of the Federal Power Act, 16 U.S.C. 825d(b), and Part 45 of the
Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR
part 45 (2019).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the website that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on July 5, 2019.

    Dated: June 13, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-12965 Filed 6-18-19; 8:45 am]
BILLING CODE 6717-01-P