H 2 Evaluation of the Chronic Data Available for Freshwater Species Following is a species by species discussion of each chronic test on copper evaluated for this document. Also presented are the results of regression analysis and probability distribution analysis of each dataset that was from an acceptable chronic test and contained sufficient acceptable data. For each such dataset, this appendix contains a figure that presents the data and regression/ probability distribution line.

Brachionus calyciflorus. The chronic toxicity of copper was ascertained in 4 day renewal tests conducted at regular intervals throughout the life of the freshwater rotifer, B. calyciflorus ( Janssen et al. 1994). The goal of this study was to develop and examine the use of this rotifer as a viable test organism. The effect of copper on the age specific survivorship and fertility of B. calyciflorus was determined, but no individual replicate data were provided and only three copper concentrations were tested, which precludes these data from further regression analysis. Chronic limits based on the intrinsic rate of natural increase were 2.5

g/ L total copper ( NOAEC) and 5.0

g/ L total copper ( LOAEC). The chronic value determined via traditional hypothesis testing is 3.54

g/ L total copper ( Table 2a).

Campeloma decisum. Adult C. campeloma were exposed to five concentrations of total copper and a control ( Lake Superior water) under flow through conditions in two 6 week studies conducted by Arthur and Leonard ( 1970). Adult survival in the two separate chronic copper toxicity test trials was markedly reduced in the two highest copper concentrations, 14.8 and 28.0

g/ L, respectively. The authors reported that growth, as determined from cast exoskeleton, was not measurable for this test species, although the authors did observe that the adult snails would not consume food at the two highest copper concentrations. Control survival was 80 percent or greater. Chronic values of 10.88

g/ L total copper were obtained for survival based on the geometric mean of the NOAEC and LOAEC of 8.0 and 14.8

g/ L, respectively, in both tests. The corresponding EC20s were 8.73 and 10.94

g/ L ( Table 2a).

Ceriodaphnia dubia. The chronic toxicity of copper to C. dubia was determined in ambient river water collected upstream of known point source discharges of domestic and industrial wastes as part of a water effect ratio study ( Carlson et al. 1986). In this study, survival and young production of C. dubia were assessed using a 7 day life cycle test. Organisms were not affected at total copper concentrations ranging from 3 to 12

g/ L ( 5 to 10

g/ L dissolved copper). There was a 62.7 percent reduction in survival and 97 percent reduction in the mean number of young produced per female at 32

g/ L total copper ( 27

g/ L dissolved copper). No daphnids survived to produce young at 91

g/ L total copper. Control survival during the study was 80 percent, which included one male. The chronic value EC20 selected for C. dubia in this study, 9.17

g/ L derived from a nonlinear regression evaluation, was based on mean number of young produced ( reproduction).

The effects of water hardness on the chronic toxicity of copper to C. dubia were assessed by Belanger et al. ( 1989) using 7 day life cycle tests. C. dubia 2 to 8 hours old were exposed to copper in ambient surface water from the New and Clinch Rivers, Virginia. Mean water hardness levels were 179 and 94 mg/ L as CaCO3, respectively. Test water was renewed on days 3 and 5. The corresponding chronic values for reproduction based on the NOAEC and LOAEC approach were 7.9 and < 19.3

g/ L dissolved copper, respectively. The EC20 value for number of young ( neonates) produced in Clinch River water ( water hardness of 94 mg/ L as CaCO3) was 19.36

g/ L dissolved copper. The EC20 for young produced in New River water was not calculated. The chronic values were converted to total copper using the freshwater conversion factor for copper 0.96 ( e. g., 7.897/ 0.96). The resulting total chronic values for the New and Clinch rivers are 8.23 and 20.17

g/ L, respectively.

Copper was one of 12 toxicants examined by Oris et al. ( 1991) in their comparisons between a 4 day survival and reproduction toxicity test utilizing C. dubia and a standard 7 day life cycle test for the H 3 species. The reported 7 day chronic values for survival and reproduction ( mean total young per living female) in two tests based on the traditional hypothesis testing techniques were 24.5 and 34.6

g/ L total copper. Comparable point estimates for these 7 day tests could not be calculated using regression analysis.

Daphnia magna. Blaylock et al. ( 1985) reported the average numbers of young produced for six broods of D. magna in a 14 day chronic exposure to copper. A significant reduction was observed in the mean number of young per female at a concentration of 30

g/ L total copper, the highest copper concentration tested. At this concentration, young were not produced at brood intervals 5 and 6. Reproduction was not affected at 10

g/ L total copper. The chronic value determined for this study ( 17.32

g/ L total copper) was based on the geometric mean of the NOAEC, 10

g/ L, and LOAEC, 30

g/ L.

Van Leeuwen et al. ( 1988) conducted a standard 21 day life cycle test with D. magna. The water hardness was 225 mg/ L as CaCO3. Carapace length was significantly reduced at 36.8

g/ L total copper, although survival was 100 percent at this concentration. Carapace length was not affected at 12.6

g/ L total copper. No daphnids survived at 110

g/ L concentration. The highest concentration not significantly different from the control for survival was 36.8

g/ L. The lowest concentration significantly different from the control based on survival was 110

g/ L, resulting in a chronic value of 63.6

g/ L for survival. The chronic value based on carapace length was 21.50

g/ L. The 21 day EC10 as reported by the author was 5.9

g/ L total copper.

Chronic ( 21 day) renewal toxicity tests were conducted using D. magna to determine the relationship between water hardness ( nominal values of 50, 100, and 200 mg/ L as CaCO3, respectively) and the toxicity of total copper ( Chapman et al. unpublished manuscript). All test daphnids were < 1 day old at the start of the tests. The dilution water was well water from the Western Fish Toxicology Station ( WFTS), Corvallis, Oregon. Test endpoints were reproduction ( total and live young produced per female) and adult survival. The survival of control animals was 100 percent at nominal water hardness levels of 50 and 200 mg/ L as CaCO3, and 80 percent at a hardness of 100 mg/ L as CaCO3. The chronic values for total young produced per female ( fecundity) based on the geometric mean of the NOAEC and LOAEC were 13.63, 29.33, and 9.53

g/ L at the nominal hardness levels of 50, 100, and 200 mg/ L as CaCO3, respectively. The corresponding EC20 values for reproduction calculated using nonlinear regression analysis were 12.58, 19.89, and 6.06

g/ L total copper. The chronic toxicity of copper to D. magna was somewhat ameliorated from an increase in water hardness from 50 to 100 mg/ L as CaCO3, but slightly increased from 100 to 200 mg/ L as CaCO3.

Daphnia pulex. Winner ( 1985) evaluated the effects of water hardness and humic acid on the chronic toxicity ( 42 day) of copper to D. pulex. Contrary to the expectation that sublethal endpoints are more sensitive indicators of chronic toxicity, reproduction was not a sensitive indicator of copper stress in this species. Water hardness also had little effect on the chronic toxicity of copper ( similar to D. magna trends), but humic acid significantly reduced chronic toxicity of copper when added to the varying water types. The survival chronic values based on the NOAEC and LOAEC values for the three low to no humic acid studies were 4.90, 7.07, and 12.25

g/ L total copper at hardnesses of 57.5, 115, and 230 ( 0.15 mg/ L HA)

g/ L as CaCO3, respectively. The EC20 values calculated for the low and high hardness studies using nonlinear regression techniques were 2.83 and 9.16

g/ L at hardness values of 57.5 and 230 ( 0.15 mg/ L HA)

g/ L as CaCO3, respectively.

Clistoronia magnifica. The effects of copper on the lifecycle of the caddisfly, C. magnifica, were examined in Nebeker et al. ( 1984b). The test included continuous exposure of first generation aquatic larvae and pupae through to a third generation of larvae. A significant reduction in adult emergence occurred at 13.0

g/ L total copper from first generation larvae. No observed adverse effect to adult emergence occurred at 8.3

g/ L total copper. Percent larval survival was close to the control value of 80 H 4 percent. The chronic value based on hypothesis testing was 10.39

g/ L total copper. The corresponding EC20 value for adult emergence was 7.67

g/ L total copper.

Oncorhynchus mykiss. The growth and survival of developing O. mykiss embryos continuously and intermittently exposed to copper for up to 85 days post fertilization was examined by Seim et al. ( 1984). Results only from the continuous exposure study are considered here for deriving a chronic value. A flow through apparatus was used to deliver six concentrations and a control ( untreated well water; average of 3

g/ L copper) to a single incubation chamber. Continuous copper exposure of steelhead embryos in the incubation chambers was begun 6 days post fertilization. At 7 weeks post fertilization, when all control fish had hatched and reached swim up stage, subsamples of approximately 100 alevins were transferred to aquaria and the same exposure pattern continued. Dissolved oxygen remained near saturation throughout the study. Water hardness averaged 120 mg/ L as CaCO3. Survival of steelhead embryos and alevins exposed continuously to total copper concentrations in the range of 3 ( controls) to 30

g/ L was greater than 90 percent or greater. Survival was reduced at 57

g/ L and completely inhibited at 121

g/ L. A similar effect on survival was observed for embryos and alevins exposed to a mean of 51 ( peak 263) and 109 ( peak 465)

g/ L of copper in the intermittent exposure, respectively. The adverse effect of continuous copper exposure on growth ( measured on a dry weight basis) was observed at concentrations as low as 30

g/ L. ( There was a 30 percent reduction in growth during the intermittent exposure at 16

g/ L.) The chronic limits for survival of embryos and alevin steelhead trout exposed continuously to copper were 16 and 31

g/ L, respectively ( geometric mean = 22.27

g/ L). The EC20 for biomass for the continuous exposure was 27.77

g/ L.

Besser et al. ( 2001) conducted an ELS toxicity test with copper and the rainbow trout, O. mykiss, starting with eyed embryos and continuing for 30 days after the fish reached the swim up stage. The total test period was 58 days. The test was conducted in ASTM moderately hard reconstituted water with a hardness of approximately 160 to 180 mg/ L as CaCO3. Twenty five eyed embryos were held in each of four replicate egg cups at each concentration. Survival was monitored daily. At the end of the test, surviving fish in each replicate chamber were weighed ( dry weight). Dry weights were used to determine growth and biomass of surviving fish. The no observed effect concentrations ( NOECs) for survival and biomass were both 12

g/ L and the lowest observed effect concentrations ( LOECs) for survival and biomass was also the same for both endpoints, 22

g/ L. The chronic values for biomass and survival based on the geometric mean of the NOEC and LOEC were 16.25

g/ L. The corresponding EC20 for biomass was 20.32

g/ L.

Oncorhynchus tshawytscha. The draft manuscript prepared by Chapman ( 1975/ 1982) provides the results from a 4 month egg through fry partial chronic test conducted to determine the effects of copper on survival and growth of O. tshawytscha. Continuous exposure occurred from several hours post fertilization through hatch, swim up, and feeding fry stages. The test was terminated after 14 weeks post hatch. The dilution water was WFTS well water. Because of the influence of the nearby Willamette River on the hardness of this well water, reverse osmosis water was mixed periodically with ambient well water to attain a consistent hardness. The typical hardness of this well water was approximately 23 mg/ L as CaCO3. Control survival exceeded 90 percent for the test. The measured total copper concentrations during the test were 1.2 ( control), 7.4, 9.4, 11.7, 15.5, and 20.2

g/ L, respectively. Copper adversely affected survival at 11.7

g/ L copper and higher, and growth was reduced at all copper concentrations tested compared with the growth of control fish. The chronic limits for copper in this study were estimated to be less than 7.4

g/ L. The EC20 value estimated for biomass is 5.92

g/ L total copper based on a logistic nonlinear regression model.

Salmo trutta. McKim et al. ( 1978) examined the survival and growth ( expressed as standing crop) of embryo larval and early juvenile brown trout to copper. The most sensitive exposure was with embryos H 5 exposed for 72 days. The NOAEC and LOAEC, as obtained from the figure, were 20.8 and 43.8

g/ L total copper, respectively. Data were not available to calculate point estimates at the 20 percent effect level using regression analysis. The chronic value selected for this species was 29.91

g/ L total copper ( geometric mean of 20.8 and 43.8

g/ L total copper).

Salvelinus fontinalis. Sauter et al. ( 1976) examined the effects of copper on selected freshwater fish species at different hardness levels ( softwater at 37.5 mg/ L as CaCO3; hardwater at 187 mg/ L as CaCO3) during a series of partial life cycle ( PLC) tests. The species tested were brook trout ( Salvelinus fontinalis), channel catfish ( Ictalurus punctatus), and walleye ( Stizostedion vitreum). Because of the poor embryo and larval survival of control animals ( in all cases less than 70 percent), results from tests with channel catfish and walleye were not included in Table 2a. One of the replicate control chambers from the PLC tests conducted with brook trout in hard water also exhibited poor hatchability ( 48 percent) and survival ( 58 percent) between 31 and 60 days of exposure. Therefore, the data for brook trout in hard water were not included in the subsequent EC20 ( regression) analysis either.

The softwater test with brook trout was conducted using untreated well water with an average water hardness of 35 mg/ L as CaCO3. This PLC exposure consisted of six copper concentrations and a control. Hatchability was determined by examining randomly selected groups of 100 eggs from each replicate exposure tank. Growth and survival of fry were determined by impartially reducing the total sample size to 50 fry per tank and assessing their progress over 30 day intervals up to 60 days post hatch. The chronic limits based on the growth ( wet weight and total length) of larval brook trout after 60 days of exposure to copper in soft water were < 5 and 5

g/ L. The resultant chronic value for soft water based on hypothesis testing was < 5

g/ L. The corresponding EC20 values based on total length, wet weight, and biomass ( the product of wet weight and survival) for brook trout in the soft water exposures after 60 days were not amenable to nonlinear regression analysis.

McKim et al. ( 1978) examined survival and growth ( expressed as standing crop) of embryo larval and early juvenile brook trout exposed to copper. The embryo exposure was for 16 days, and the larvalearly juveniles exposure lasted 60 days. The NOAEC and LOAEC were 22.3 and 43.5

g/ L total copper, respectively. Data were not available to calculate point estimates at the 20 percent effect level using regression analysis. The chronic value for this species was 31.15

g/ L total copper ( geometric mean of 22.3 and 43.5

g/ L total copper).

Salvelinus namaycush. McKim et al. ( 1978) examined the survival and growth ( expressed as standing crop) of embryo larval and early juvenile lake trout exposed to copper. The embryo exposure was for 27 days, and the larval early juveniles exposure lasted 66 days. The NOAEC and LOAEC were 22.0 and 43.5

g/ L total copper, respectively. Data were not available to calculate point estimates at the 20 percent effect level using regression analysis. The chronic value for this species was 30.94

g/ L total copper ( geometric mean of 22.0 and 43.5

g/ L total copper).

Esox lucius. McKim et al. ( 1978) examined the survival and growth ( expressed as standing crop) of embryo larval and early juvenile northern pike exposed to copper. The embryo exposure was for 6 days, and the larval early juveniles exposure lasted 34 days. The NOAEC and LOAEC were 34.9 and 104.4

g/ L total copper, respectively. The authors attributed the higher tolerance of E. lucius to copper to the very short embryonic exposure period compared with salmonids and white sucker, Catostomus commersoni. Data were not available to calculate point estimates at the 20 percent effect level using regression analysis. The chronic value for this species was 60.36

g/ L total copper ( geometric mean of 34.9 and 104.4

g/ L total copper). H 6 Pimephales notatus. An experimental design similar to that described by Mount and Stephan ( 1967) and Mount ( 1968) was used to examine the chronic effect of copper on the bluntnose minnow, P. notatus ( Horning and Neiheisel 1979). Measured total copper concentrations were 4.3 ( control), 18.0, 29.9, 44.1, 71.8, and 119.4

g/ L, respectively. The experimental dilution water was a mixture of spring water and demineralized City of Cincinnati tap water. Dissolved oxygen was kept at 5.9 mg/ L or greater throughout the test. Total water hardness ranged from 172 to 230 mg/ L as CaCO3. The test was initiated with 22 6 week old fry. The fish were later separated according to sex and thinned to a sex ratio of 5 males and 10 females per duplicated test chamber. Growth ( total length) was significantly reduced in parental and first ( F1) generation P. notatus after 60 days of exposure to the highest concentration of copper tested ( 119.4

g/ L). Survival of parental P. notatus exposed to this same high test concentration was also lower ( 87 percent) at the end of the test compared with the other concentrations ( range of 93 to 100 percent). Copper at concentrations of 18

g/ L and greater significantly reduced the number of eggs produced per female. The number of females available to reproduce was generally the same up to about 29.9

g/ L of copper. The chronic limits were based on an NOAEC and LOAEC of < 18 and 18

g/ L for number of eggs produced per female. An EC20 was not estimated by nonlinear regression; nevertheless, in this case an EC20 is likely to be substantially below 18 µ g/ L.

Pimephales promelas. The results from a 30 day ELS toxicity test to determine the chronic toxicity of copper to P. promelas using dilution water from Lake Superior ( hardness ranging from 40 to 50 mg/ L as CaCO3) was included in Table 2a from a manuscript prepared by Lind et al. in 1978. In this experiment, five test concentrations and a control were supplied by a continuous flow diluter. The exposure began with embryos 1 day post fertilization. Pooled results from fish dosed in replicate exposure chambers were given for mean percentage embryo survival to hatch, mean percentage fish survival after hatch, and mean fish wet weight after 30 days. The percentage of embryo survival to hatch was not affected by total copper concentrations as high as 52.1

g/ L total copper. Survival after hatch, however, was compromised at 26.2

g/ L, and mean wet weight of juvenile fathead minnows was significantly reduced at 13.1

g/ L of copper. The estimated EC20 value for biomass was 9.376

g/ L total copper.

Catastomus commersoni. McKim et al. ( 1978) examined the survival and growth ( expressed as standing crop) of embryo larval and early juvenile white sucker exposed to copper. The embryo exposure was for 13 days, and the larval early juvenile exposure lasted 27 days. The NOAEC and LOAEC were 12.9 and 33.8

g/ L total copper, respectively. The resulting chronic value based on hypothesis testing for this species was 20.88

g/ L total copper ( geometric mean of 12.9 and 33.8

g/ L total copper).

Lepomis macrochirus. Results from a 22 month copper life cycle toxicity test with bluegill ( L. macrochirus) were reported by Benoit ( 1975). The study included a 90 day embryo larval survival and growth component. The tests were conducted at the U. S. EPA National Water Quality Laboratory in Duluth, Minnesota, using Lake Superior water as the dilution water ( average water hardness = 45 mg/ L as CaCO3). The test was initiated in December 1969 with 2 year old juvenile L. macrochirus. In May 1971, the fish were sexed and randomly reduced to three males and seven females per tank. Spawning commenced on 10 June 1971. The 90 day embryo larval exposure was initiated when 12 lots of 50 newly hatched larvae from one of the two control groups were randomly selected and transferred to duplicate grow out chambers at 1 of 6 total copper concentrations: 3 ( control), 12, 21, 40, 77, and 162

g/ L, respectively. In the 22 month juvenile through adult exposure, survival, growth, and reproduction were unaffected at 77

g/ L of copper and below. No spawning occurred at 162

g/ L. Embryo hatchability and survival of 4 dayold larvae at 77

g/ L did not differ significantly from those of controls. However, after 90 days of exposure, survival of larval L. macrochirus at 40 and 77

g/ L was significantly lower than for controls, and no larvae survived at 162

g/ L. Growth remained unaffected at 77

g/ L. Based on the 90 day survival of bluegill larvae, the chronic limits were estimated to be 21 and 40

g/ L ( geometric mean = 28.98

g/ L). The corresponding EC20 for embryo larval survival was 27.15

g/ L. H 7 H 8 Log Cu ( ug/ L ) Fracti on Surv iv al 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 0 .2 .4 .6 .8 1.0 1.2 Log Cu ( ug/ L ) Fracti on Surv iv al 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 0 .2 .4 .6 .8 1.0 1.2 Log Cu ( ug/ L ) Y oung per Female .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 2.0 2.2 2.4 0 5 10 15 20 Campeloma decisum ( Test 1), Life cycle, Arthur and Leonard 1970 Campeloma decisum ( Test 2), Life cycle, Arthur and Leonard 1970 Ceriodaphnia dubia ( Clinch River), Life cycle, Belanger et al. 1989 EC20 = 8.73

g/ L EC20 = 10.94

g/ L EC20 = 19.36

g/ L H 9 Log Cu ( ug/ L ) Biomass 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 0 200 400 600 800 1000 1200 1400 Log Cu ( ug/ L ) Young per Original Female 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 2.0 2.2 0 2 4 6 8 10 12 14 16 Log Cu ( ug/ L ) Fracti on Surv iv al .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 2.0 2.2 2.4 0 .2 .4 .6 .8 1.0 1.2 Lepomis macrochirus, Early Life stage, Benoit 1975 Oncorhynchus mykiss, Early Life Stage, Besser et al. 2001 Ceriodaphnia dubia, Life cycle, Carlson et al. 1986 EC20 = 27.15

g/ L EC20 = 20.32

g/ L EC20 = 9.17

g/ L H 10 Log Cu ( ug/ L ) Young per Original Female 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 2.0 0 50 100 150 200 250 300 Log Cu ( ug/ L ) Young per Original Female 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 2.0 2.2 0 50 100 150 200 Log Cu ( ug/ L ) Young per Original Female 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 0 50 100 150 200 250 Daphnia magna ( Hardness 104), Life cycle, Chapman et al. Manuscript Daphnia magna ( Hardness 211), Life cycle, Chapman et al. Manuscript Daphnia magna ( Hardness 51), Life cycle, Chapman et al. Manuscript EC20 = 19.89

g/ L EC20 = 6.06

g/ L EC20 = 12.58

g/ L H 11 Log Cu ( ug/ L ) Fraction Adult Emergence 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 2.0 2.2 0 .1 .2 .3 .4 .5 .6 .7 .8 .9 EC20 = 7.67

g/ L Log Cu ( ug/ L ) Biomass .2 .4 .6 .8 1.0 1.2 1.4 1.6 0 .1 .2 .3 .4 .5 .6 .7 .8 .9 1.0 Log Cu ( ug/ L ) Biomass 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 2.0 0 20 40 60 80 100 120 140 Oncorhynchus tshawytscha, Early Life Stage, Chapman 1975 & 1982 Pimephales promelas, Early Life stage, Lind et al. 1978 Clistoronia magnifica, Life cycle, Nebeker et al. 1984a EC20 = 5.92

g/ L EC20 = 9.38

g/ L H 12 Log Cu ( ug/ L ) Biomass .2 .4 .6 .8 1.0 1.2 1.4 1.6 1.8 2.0 0 20 40 60 80 100 120 140 160 180 Log Cu ( ug/ L ) Fracti on Surv iv al 0 .2 .4 .6 .8 1.0 1.2 1.4 1.6 0 .2 .4 .6 .8 1.0 1.2 Log Cu ( ug/ L ) Fracti on Surv iv al  1.0 . 5 0 .5 1.0 1.5 0 .2 .4 .6 .8 1.0 1.2 Oncorhynchus mykiss, Early Life stage, Seim et al. 1984 Daphnia pulex ( Hardness 230 HA 0.15), Life cycle, Winner 1985 Daphnia pulex ( Hardness 57), Life cycle, Winner 1985 EC20 = 27.77

g/ L EC20 = 9.16

g/ L EC20 = 2.83

g/ L


[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Pages 18626-18627]
[FR Doc No: 2018-08923]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2017-0290]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 51 individuals from the
prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs)
against persons with insulin-treated diabetes mellitus (ITDM) from
operating a commercial motor vehicle (CMV) in interstate commerce. The
exemptions enable these individuals with ITDM to operate CMVs in
interstate commerce.

DATES: The exemptions were applicable on March 17, 2018. The exemptions
expire on March 17, 2020.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER>, [email protected], FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
e.t., Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., e.t., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to http://www.regulations.gov, as described in
the system of records notice (DOT/ALL-14 FDMS), which can be reviewed
at http://www.dot.gov/privacy.

II. Background

    On February 14, 2018, FMCSA published a notice announcing receipt
of applications from 51 individuals requesting an exemption from
diabetes requirement in 49 CFR 391.41(b)(3) and requested comments from
the public (83 FR 6704). The public comment period ended on March 16,
2017, and one comment was received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).
    The physical qualification standard for drivers regarding diabetes
found in 49 CFR 391.41(b)(3) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control.

III. Discussion of Comments

    FMCSA received one comment in this proceeding. Vicky Johnson stated
that the Minnesota Driver and Vehicle Services (DVS) has no objections
in granting exemptions to the following Minnesota drivers: Deavan T.
Jones, Sandra K. Kostka, and Todd D. Rue.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes standard in 49 CFR 391.41(b)(3) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. The exemption allows the applicants
to operate CMVs in interstate commerce.
    The Agency's decision regarding these exemption applications is
based on the program eligibility criteria and an individualized
assessment of information submitted by each applicant. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the February 14, 2018, Federal
Register notice (83 FR 6704) and will not be repeated in this notice.
    These 51 applicants have had ITDM over a range of 1 to 41 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (two
or more) severe hypoglycemic episodes in the past five years. In each
case, an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document

and includes the following: (1) Each driver must submit a quarterly
monitoring checklist completed by the treating endocrinologist as well
as an annual checklist with a comprehensive medical evaluation; (2)
each driver must report within two business days of occurrence, all
episodes of severe hypoglycemia, significant complications, or
inability to manage diabetes; also, any involvement in an accident or
any other adverse event in a CMV or personal vehicle, whether or not it
is related to an episode of hypoglycemia; (3) each driver must provide
a copy of the ophthalmologist's or optometrist's report to the Medical
Examiner at the time of the annual medical examination; and (4) each
driver must provide a copy of the annual medical certification to the
employer for retention in the driver's qualification file, or keeping a
copy in his/her driver's qualification file if he/she is self-employed.
The driver must also have a copy of the exemption when driving, for
presentation to a duly authorized Federal, State, or local enforcement
official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 51 exemption applications, FMCSA
exempts the following drivers from the diabetes requirement in 49 CFR
391.41(b)(10), subject to the requirements cited above:

Carl W. Anderson (PA)
Thomas J. Anderson (CA)
Jorge A. Barra-Del Valle (UT)
Jeffery L. Bennett (IL)
William T. Bookamer, Jr. (TN)
Ronnie J. Boyd (TN)
Travis R. Breakiron (PA)
Corey D. Calvert (WI)
Jon Conley (OH)
Kiva J. Coppage (MO)
Peter F. Cox (MA)
Kerry P. Daniels (WA)
Joshua M. Dekker (MI)
Miguel A. Disla (VA)
Jon R. Easterla (IL)
Andrew W. Erickson (WY)
Martie L. Eubanks (MO)
Dwight G. Farnworth (ID)
John A. Gott (MD)
Ian C. Hall (MI)
Carl L. Harville, Jr. (VA)
Terry L. Helderman (IL)
James M. Hershey (WA)
Glee D. Jacobs (KS)
Thomas V. Johnson (IN)
Deavan T. Jones (MN)
Bryant C. Kongsted (MD)
Sandra K. Kostka (MN)
Geoffrey A. Kusman (IL)
Chadwick L. Lekwa (IA)
Craig W. Lockwood (WI)
Joseph A. Malone (CA)
Chance P. Masterson (OR)
Harold W. Meade (VA)
Korey E. Molina (VA)
Steven G. Ojala (WA)
Kathy L. Pospichal (WI)
Robert S. Reyes (CA)
Robert D. Risk (IN)
David L. Robson (IA)
Todd D. Rue (MN)
Luis A. Saavedra (TX)
Timothy S. Smith (NC)
Michael E. Smyth (ID)
Dennis N. Spake (VA)
Vincent F. Strafford (NC)
Frederick W. Stevens (OH)
Jason E. Stocker (VT)
Thomas L. Tallon (WA)
Michael L. Vanalstine (OH)
Ralph O. Weathers (IN)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for two years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136(e) and 31315.

    Issued on: April 18, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-08923 Filed 4-26-18; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: March 19, 2010 (Volume 75, Number 53)]
[Notices]
[Page 13332-13333]
[DOCID:fr19mr10-126]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety; Notice of Application for
Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: List of applications for modification of special permits.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR Part 107,
Subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the applications described herein. This
notice is abbreviated to expedite docketing and public notice. Because
the sections affected, modes of transportation, and the nature of
application have been shown in earlier Federal Register publications,
they are not repeated here. Requests for modification of special
permits (e.g. to provide for additional hazardous materials, packaging
design changes, additional mode of transportation, etc.) are described
in footnotes to the application number. Application numbers with the
suffix ``M'' denote a modification request. These applications have
been separated from the new application for special permits to
facilitate processing.

DATES: Comments must be received on or before April 5, 2010.
    Address Comments to: Record Center, Pipeline and Hazardous
Materials, Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.

    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Copies of the applications are
available for inspection in the Records Center, East Building, PHH-30,
1200 New Jersey Avenue, Southeast, Washington, DC, or at http://
regulations.gov.
    This notice of receipt of applications for modification of special
permit is published in accordance with Part 107 of the Federal
hazardous materials transportation law (49 U.S.C. 5 117(b); 49 CFR
1.53(b)).

    Issued in Washington, DC, on March 11, 2010.
Delmer F. Billings,
Director, Office of Hazardous Materials, Special Permits and Approvals.

----------------------------------------------------------------------------------------------------------------
                                                                      Regulation(s)         Nature of special
   Application No.          Docket No.             Applicant             affected            permits thereof
----------------------------------------------------------------------------------------------------------------
                                          Modification Special Permits
----------------------------------------------------------------------------------------------------------------
8815-M..............  ......................  Florex Explosives,   49 CFR 173.62......  To modify the special
                                               Inc., Crystal                             permit by adding an
                                               River, FL.                                additional Division
                                                                                1.5D explosive.
8826-M..............  ......................  Phoenix Air Group,   49 CFR 172.101;      To modify the special to
                                               Inc.,                172.204(c)(3);       reflect the current
                                               Cartersville, GA.    173.27;              statutes and
                                                                    175.30(a)(1);        regulations changes.
                                                                    175.320(b).
9880-M..............  ......................  G.E. Reuter-Stokes,  49 CFR 173.302;      To modify the special
                                               Inc., Twinsburg,     175.3; Part 172      permit to authorize one
                                               OH.                  Subpart E and F.     drop test instead of 5
                                                                                drop tests every 24
                                                                                months and in section
                                                                                8.e. add ``e.e.
                                                                                radiation sensor''
                                                                                after ``Each packaging
                                                                                manufactured''.
10049-M.............  ......................  Martin Transport,    49 CFR 173.318;      To modify the special
                                               Inc., Kilgore, TX.   173.338; 173.320;    permit to authorize in
                                                                    177.840.             Section 7.2.b to state
                                                                                Design temperature is -
                                                                                320 Deg. F for inner
                                                                                tank.
10869-M.............  ......................  Norris Cylinder      49 CFR 173.301(b);   To modify the special
                                               Company, Longview,   173.302(a)(5);       permit to authorize a
                                               TX.                  173.304(a); 175.3.   new 4130 Modified Cr-Mo
                                                                                steel chemistry;
                                                                                removed the K1C test;
                                                                                replace the one-per-
                                                                                heat flawed cylinder
                                                                                pressure test with a
                                                                                one-per-lot burst test;
                                                                                and add 3 new drawings
                                                                                for pressure 4500,
                                                                                5000, and 6000 psi with
                                                                                the new steel
                                                                                chemistry.
11489-M.............  ......................  TRW, Washington, MI  49 CFR 172.320;      To modify the special
                                                                    173.56(b).           permit to authorize an
                                                                                additional Division
                                                                                1.4C explosive article.
11911-M.............  ......................  Transfer Flow,       49 CFR 178.700 thru  To modify the special
                                               Inc., Chico, CA.     178.819.             permit to authorize new
                                                                                part numbers for tank
                                                                                drawings; to add
                                                                                several new refueling
                                                                                systems; to add two new
                                                                                fuel caps; and to add
                                                                                several new fuel tanks
                                                                                to the special permit.
13998-M.............  ......................  3AL Testing Corp.,   49 CFR 172.203(a);   To modify the special
                                               Denver, CO.          172.302a(b)(2),      permit to authorize the
                                                                    (4)(5);              use of tare weight to
                                                                    180.205(f)(g);       identify DOT 3A/3AA
                                                                    180.209(a),          cylinders.
                                                                    (b)(1)(iv).
14206-M.............  ......................  Digital Wave         49 CFR 180.205.....  To modify the special
                                               Corporation,                              Corporation permit to
                                               Englewood, CO.                            authorize the use of
                                                                                tare weight to identify
                                                                                DOT 3A/3AA cylinders.
14808-M.............  ......................  Amtrol, Inc., West   49 CFR 178.51(b),    To modify the special
                                               Warwick, RI.         (f)(1) and (2) and   permit to authorize
                                                                    (g).                 removal of paragraph
                                                                                7(d)(2) under
                                                                                Operational Controls.
14926-M.............  ......................  Lynden Air Cargo,    49 CFR 173.302(f)..  To modify the special
                                               Anchorage, AK.                            permit to authorize the
                                                                                removal of the
                                                                                restriction of Human
                                                                                Health care and
                                                                                Veterinary services
                                                                                from the special
                                                                                permit.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-5897 Filed 3-18-10; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register: January 27, 2009 (Volume 74, Number 16)]
[Notices]
[Page 4793-4796]
[DOCID:fr27ja09-72]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59267; File No. SR-FINRA-2009-003]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change To Implement Technical Changes to the Code of
Arbitration Procedure for Customer Disputes and Industry Disputes

January 16, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a
National Association of Securities Dealers, Inc. (``NASD''))

filed with the Securities and Exchange Commission (``SEC'' or
``Commission'') on January 8, 2009, the proposed rule change as
described in Items I and II below, which Items have been prepared by
FINRA Dispute Resolution. FINRA has designated the proposed rule change
as constituting a ``non-controversial'' rule change under paragraph
(f)(6) of Rule 19b-4 under the Act,\3\ which renders the proposal
effective upon receipt of this filing by the Commission. 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\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    FINRA is proposing to amend the Code of Arbitration Procedure for
Customer Disputes (``Customer Code'') and the Code of Arbitration
Procedure for Industry Disputes (``Industry Code'') to insert rule
language from the Code of Arbitration Procedure (``old Code'') that was
inadvertently omitted when the Customer Code and Industry Code were
adopted, to correct inaccurate cross-references, and typographical
errors. The text of the proposed rule change is available on FINRA's
Web site at http://www.finra.org, at the principal office of FINRA, 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, FINRA 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 these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    On January 24, 2007, the SEC approved a proposal to amend the old
Code by simplifying the language, codifying current dispute resolution
practices, and implementing several substantive changes to dispute
resolution rules.\4\ The proposal reorganized the old Code into three
separate procedural codes: the Customer Code, the Industry Code, and
the NASD Code of Mediation Procedure (``Mediation Code'').\5\ The
Customer, Industry and Mediation Codes (the ``new Codes'') replace the
old Code in its entirety.\6\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 55158 (January 24,
2007); 72 FR 4574 (January 31, 2007) (File Nos. SR-NASD-2003-158 and
SR-NASD-2004-011).
    \5\ The SEC approved the Mediation Code on October 31, 2005. See
Securities Exchange Act Release No. 52705 (Oct. 31, 2005); 70 FR
67525 (November 7, 2005) (File No. SR-NASD-2004-013). It became
effective on January 30, 2006. See Notice to Members 05-85 (December
2005).
    \6\ The Customer and Industry Codes became effective on April
16, 2007. See Notice to Members 07-07 (February 2007).
---------------------------------------------------------------------------

    Since the new Codes became effective, FINRA has found some
inaccurate cross-references, typographical errors, inadvertent
omissions, and rule language that could be improved to better convey
FINRA's intent or to clarify current practice regarding those rules.
FINRA is, therefore, proposing several technical, non-substantive
amendments to the Customer and Industry Codes that would correct
inaccurate cross-references and typographical errors, insert rule
language that was inadvertently omitted, codify current practice
concerning the administration of existing rules, and make certain
clarifying changes. FINRA will discuss the proposed changes in the
order that they appear in the new Codes, beginning with the proposed
amendments to the Customer Code.

Proposed Non-Substantive Amendments to the Customer Code

Table of Contents
    FINRA proposes to amend the title that introduces Part IV of the
Table of Contents, by adding a comma after the word
``Disqualification,'' so that the title in the Table of Contents to the
Customer Code is the same as the title in the Customer Code.
Rule 12102--National Arbitration and Mediation Committee
    Rule 10102(a) of the old Code authorized the then--NASD Dispute
Resolution Board of Directors to appoint a National Arbitration and
Mediation Committee (the ``Committee''); and, under this rule, the
Committee was authorized to establish and maintain rosters of neutrals.
    When the old Code was reorganized into the Customer Code, the
Committee's authorization to establish and maintain neutral rosters was
inadvertently omitted from Rule 12102. Thus, FINRA proposes to amend
Rule 12102(b) to insert language similar to that in old Rule 10102(a),
which will authorize the Committee to establish and maintain rosters of
neutrals composed of persons from within and outside of the securities
industry. As the Committee currently works to establish and maintain
FINRA's arbitrator rosters, the amendment would not be a change to
current practice.
Rule 12206--Time Limits
    FINRA proposes to amend Rule 12206(d) to correct a proofreading
oversight by removing the word ``matter'' from the end of the sentence.
Under the new Codes, the term ``claim,'' not ``matter,'' is used when
referring to an allegation or request for relief.
Rule 12307--Deficient Claims
    In the Customer Code, FINRA codified its practice regarding
deficient claims, which had not been codified in the old Code. Under
Rule 12307, the deficient claims rule, FINRA lists the reasons that a
claim may be deficient, explains the process if a deficiency is not
corrected, and sets forth procedures for handling other pleadings that
may be deficient. Specifically, Rule 12307(b) provides that the
Director will not refund any filing fees paid by claimants when staff
closes a deficient case. FINRA proposes to amend Rule 12307(b) because
it does not reflect accurately its practice concerning refunding
certain fees paid by claimants when FINRA closes a deficient claim.
    When claimants filed a claim under the old Code, they submitted
their Statement of Claim along with two separate fees: A non-refundable
filing fee and a hearing session deposit.\7\ When FINRA staff closed a
deficient case, FINRA would retain the non-refundable filing fee and
refund the hearing session deposit to the claimants. Under the Customer
Code, FINRA combined the old Code filing fee and hearing session
deposit into one ``filing fee.'' \8\ However, FINRA did not change its
practice regarding refunds of a portion of the filing fee when it
closes a deficient case--FINRA continues to refund the refundable part
of the filing fee to claimants, while retaining the remaining portion.
Thus, FINRA believes the language in Rule 12307(b) does not reflect
accurately its practice and could be confusing to users of the forum.
Therefore, FINRA proposes to amend Rule 12307(b) to state that the
Director will close the case without

serving the claim, and will refund part of the filing fee in the amount
indicated in the schedule of fees. FINRA believes the amendment will
reflect accurately its practice concerning refunds when it closes a
deficient case and will minimize confusion concerning its fees.
---------------------------------------------------------------------------

    \7\ See Rule 10332(c) of the Code of Arbitration Procedure.
    \8\ See Rule 12900. A portion of the filing fee is refundable
under certain circumstances, Rule 12900(c).
---------------------------------------------------------------------------

Rule 12410--Removal of Arbitrator by Director
    Rule 12410 addresses removal of an arbitrator by the Director of
Arbitration. Specifically, Rule 12410(a)(1) states, in relevant part,
that ``the Director will grant a party's request to remove an
arbitrator if it is reasonable to infer, based on information known at
the time of the request, that the arbitrator is biased, lacks
impartiality, or has a direct or indirect interest in the outcome of
the arbitration. The interest or bias must be direct, definite, and
capable of reasonable demonstration, rather than remote or
speculative.'' \9\ FINRA believes the word ``direct'' in the second
sentence of the rule conflicts with the meaning of the first sentence,
in which an arbitrator may be challenged for having ``a direct or
indirect interest in the outcome of the arbitration.'' Thus, FINRA
proposes to remove ``direct'' from the second sentence of Rule
12410(a)(1) to eliminate the conflict in the rule language.
---------------------------------------------------------------------------

    \9\ See Rule 12410(a)(1).
---------------------------------------------------------------------------

Proposed Non-Substantive Amendments to the Industry Code \10\
---------------------------------------------------------------------------

    \10\ Most rules of the Customer and Industry Codes are
identical, except for panel composition, references to document
production lists that apply only in customer cases, and rules
relating to employment discrimination and injunctive relief that
apply only to industry claims. Wherever possible, the last three
digits of the rule numbers in the Customer and Industry Codes are
the same. Thus, the explanation for the proposed amendments in the
Customer Code also apply to the proposed amendments in the Industry
Code, except where indicated.
---------------------------------------------------------------------------

Table of Contents
    For an explanation of the proposed amendment, see the relevant
section under ``Proposed Non-Substantive Amendments to the Customer
Code'' above.
Rule 13102--National Arbitration and Mediation Committee
    For an explanation of the proposed amendment, see the relevant
section under ``Proposed Non-Substantive Amendments to the Customer
Code'' above.
Rule 13206--Time Limits
    For an explanation of the proposed amendment, see the relevant
section under ``Proposed Non-Substantive Amendments to the Customer
Code'' above.
Rule 13307--Deficient Claims
    For an explanation of the proposed amendment, see the relevant
section under ``Proposed Non-Substantive Amendments to the Customer
Code'' above.
Rule 13314--Combining Claims
    FINRA proposes to amend the erroneous cross-reference to Rule
13404(c) in Rule 13314. Rule 13314 states, in relevant part, that
before ranked arbitrator lists are due to the Director under Rule
13404(c), the Director may combine separate but related claims into one
arbitration. Rule 13404(c) instructs parties on the ranking procedures
in the forum. Rule 13404(d) governs when ranked lists must be returned
to the Director. Thus, the reference to Rule 13404(c) in Rule 13314 is
inaccurate and should be changed to Rule 13404(d).
Rule 13403--Generating and Sending Lists to the Parties
    FINRA proposes to amend the erroneous cross-reference to Rule
13404(c) in Rule 13403(c)(2). The relevant provision of Rule
13403(c)(2) states that when a party requests additional information,
the Director may, but is not required to, toll the time for parties to
return the ranked lists under Rule 13404(c). For the reason discussed
pertaining to the proposed amendment to Rule 13314, the reference to
Rule 13404(c) is inaccurate and should be changed to Rule 13404(d).
Rule 13410--Removal of Arbitrator by Director
    For an explanation of the proposed amendment, see the relevant
section under ``Proposed Non-Substantive Amendments to the Customer
Code'' above.
Rule 13804--Temporary Injunctive Orders; Requests for Permanent
Injunctive Relief
    FINRA proposes to correct a typographical error in Rule
13804(b)(3)(A)(ii). The relevant sentence of the rule states that ``the
Direct shall consolidate the parties'' rankings, and shall appoint
arbitrators based on the order of rankings on the consolidated list,
subject to the arbitrators' availability and disqualification.'' FINRA
proposes to change the word ``Direct'' to ``Director.''
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act, which requires, among other
things, that FINRA rules must be designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest.
    FINRA believes that the proposed rule change will assist in the
efficient administration of arbitrations by clarifying current
practices and by correcting inaccurate cross-references and
typographical errors. FINRA believes these technical, non-substantive
amendments will enhance the new Codes by making them easier to
understand and apply.

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

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act, as amended.

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

    Written comments were neither solicited nor received by FINRA.

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

    FINRA has represented that the proposed rule change qualifies for
immediate effectiveness pursuant to Section 19(b)(3)(A) of the Act \11\
and Rule 19b-4(f)(6) thereunder \12\ because it: (i) Does not
significantly affect the protection of investors or the public
interest; (ii) does not impose any significant burden on competition;
and (iii) by its terms, does not become operative for 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.\13\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ In addition, Rule 19b-4(f)(6)(iii) requires a self-
regulatory organization to give the Commission written notice of its
intent to file the proposed rule change at least five business days
prior to the date of filing of the proposed rule change, or such
shorter time as designated by the Commission. FINRA has satisfied
this requirement.
---------------------------------------------------------------------------

    FINRA has requested that the Commission waive the 30-day operative
delay, so that the proposed rule change may become operative upon
filing. The Commission hereby grants FINRA's request.\14\ The
Commission believes that

waiving the 30-day operative delay is consistent with the protection of
investors and the public interest because it makes only technical
changes to FINRA's rules which should help to avoid confusion among
FINRA members and other market participants.
---------------------------------------------------------------------------

    \14\ For the purposes only of waiving the 30-day operative
delay, the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate 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.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2009-003 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-FINRA-2009-003. This
file number should be included on the subject line if e-mail 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 inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of FINRA.
    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 the File Number SR-FINRA-
2009-003 and should be submitted on or before February 17, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E9-1675 Filed 1-26-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Notices]
[Pages 63948-63950]
[FR Doc No: 2019-24974]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87513; File No. SR-NYSEAMER-2019-46]

Self-Regulatory Organizations; NYSE American LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Amend
Rule 7.31E To Delete Cross Orders

November 13, 2019.
    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 October 30, 2019, NYSE American LLC (``NYSE American'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II 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 Substance
of the Proposed Rule Change

    The Exchange proposes to amend Rule 7.31E (Orders and Modifiers) to
delete Cross Orders from its rules and make other conforming changes.
The proposed rule change is available on the Exchange's website 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 purpose of the proposed rule change is to amend the Exchange's
rules to delete Cross Orders.
    As defined in Rule 7.31E(g), a Cross Order is a two-sided order
with instructions to match the identified buy-side with the identified
sell-side at a specified price (the ``cross price''). The Exchange
offers one type of Cross Order, the Limit IOC Cross Order. As defined
in Rule 7.31E(g)(1), a Limit IOC Cross Order is a Cross Order that must
trade in full at its cross price, will not route, and will cancel at
the time of order entry if the cross price is not between the BBO or
would trade through the PBBO.
    Due to a lack of demand for Cross Orders, the Exchange proposes to
discontinue supporting Cross Orders. Specifically, in the last three
months, the Exchange has not received any Cross Orders. Accordingly,
the Exchange proposes to delete the definition of Cross Order from Rule
7.31E(g), as well as the references to Cross Orders in Rules
7.10E(e)(1), 7.11E(a)(5)(E), 7.16E(f)(5)(H), 7.18E(c)(5),
7.34E(c)(1)(B), 7.34E(c)(1)(C), 7.34E(c)(2)(C), and 7.35E(f)(2). The
Exchange proposes to designate Rules 7.31E(g), 7.11E(a)(5)(E), and
7.16E(f)(5)(H) as Reserved and proposes to revise Rules 7.10E(e)(1),
7.18E(c)(5), 7.34E(c)(1)(B), 7.34E(c)(1)(C), 7.34E(c)(2)(C), and
7.35E(f)(2) to delete the references to Cross Orders. Subject to
effectiveness of this proposed rule change, the Exchange will announce
the implementation date of these changes through a Trader Update, which
the Exchange anticipates will be in November 2019.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the requirements of Section 6(b) of the Act,\4\ in general, and Section
6(b)(5) of the Act,\5\ in particular, in that it is designed to remove
impediments to and perfect the mechanism of a free and open market, to
promote just and equitable principles of trade, and, in general, to
protect investors and the public interest. Specifically, the Exchange
believes that the proposed rule change would remove impediments to and
perfect the mechanisms of a free and open market by eliminating a
little-used order type and improving the clarity of the Exchange's
rules. The Exchange further believes that deleting an order type rarely
used by investors also removes impediments to and perfects the
mechanism of a free and open market by facilitating market
participants' navigation of the Exchange's rulebook and improving their
ability to understand the order types available for trading on the
Exchange. Moreover, the Exchange believes that the elimination of Cross
Orders will simplify order processing and reduce the burden on system
capacity, which the Exchange believes is consistent with promoting just
and equitable principles of trade, as well as the protection of
investors and the public interest.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b).
    \5\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. Specifically, the Exchange
believes that the proposed rule change would relieve a burden on
competition by making the Exchange's rules easier to navigate and
promoting regulatory clarity through the elimination of a seldom-used
order type.

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) of the Act \6\ and Rule 19b-4(f)(6) thereunder.\7\ 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.\8\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(3)(A).
    \7\ 17 CFR 240.19b-4(f)(6).
    \8\ In addition, Rule 19b-4(f)(6) requires the Exchange to give
the Commission written notice of the Exchange's intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the date
of filing of the proposed rule change, or such shorter time as
designated by the Commission. The Exchange has satisfied this
requirement.
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) \9\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b-4(f)(6)(iii),\10\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has asked
the Commission to waive the 30-day operative delay so that the proposal
may become operative immediately upon filing. The Exchange has
represented that this order type is rarely used and has not been used
in the last three months. The Commission believes that waiver of the
30-day operative delay period is consistent with the protection of
investors and the public interest and hereby waives the 30-day
operative delay and designates the proposed rule change operative upon
filing.\11\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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) \12\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(2)(B).

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

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-NYSEAMER-2019-46 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEAMER-2019-46. 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 website (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 website 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 the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-NYSEAMER-2019-46 and should be submitted
on or before December 10, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-24974 Filed 11-18-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: October 13, 2005 (Volume 70, Number 197)]
[Notices]
[Page 59790-59791]
[DOCID:fr13oc05-142]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-8623; 34-52575, File No. 265-23]

Advisory Committee on Smaller Public Companies

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Meeting of SEC Advisory Committee on Smaller Public
Companies.

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

    The Securities and Exchange Commission Advisory Committee on
Smaller Public Companies is providing notice that it will hold a public
meeting on Monday and Tuesday, October 24 & 25, 2005, in Multi-Purpose
Room L006 of the Commission's headquarters, 100 F Street, NE.,
Washington, DC 20549, beginning at 9 a.m. on each day. The meeting is
expected to last until approximately 4 p.m. on each day, with a lunch
break from approximately noon to 1 p.m. The meeting will be audio
webcast on the Commission's Web site at http://www.sec.gov.

    The agenda for the meeting includes consideration of proposals of
the Advisory Committee's four subcommittees on possible recommendations
for changes to the current securities regulatory system for smaller
companies. The public is invited to submit written statements for the
meeting.

DATES: Written statements should be received on or before October 17,
2005.

ADDRESSES: Written statements may be submitted by any of the following
methods:

Electronic Statements

     Use the Commission's Internet submission form (http://www.sec.gov/info/smallbus/acspc.shtml.
); or     Send an e-mail message to<EMAIL_ADDRESS>Please

include File Number 265-23 on the subject line; or

Paper Statements

     Send paper statements in triplicate to Jonathan G. Katz,
Committee Management Officer, Securities and Exchange Commission, 100 F
Street, NE., Washington, DC 20549-9303.
    All submissions should refer to File No. 265-23. This file number
should be included on the subject line if e-mail is used. To help us
process and review your statement more efficiently, please use only one
method. The Commission staff will post all statements on the Advisory
Committee's Web site (http://www.sec.gov./info/smallbus/acspc.shtml).

    Statements also will be available for public inspection and copying
in the Commission's Public Reference Room, 100 F Street, NE., Room
1580, Washington, DC 20549. All statements received will be posted
without change; we do not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly.

FOR FURTHER INFORMATION CONTACT: Kevin M. O'Neill, Special Counsel, at
(202) 551-3260, Office of Small Business Policy, Division of
Corporation Finance, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-3628.

SUPPLEMENTARY INFORMATION: In accordance with section 10(a) of the
Federal Advisory Committee Act, 5 U.S.C.-App. 1, Sec.  10(a), and the

regulations thereunder, Gerald J. Laporte, Designated Federal Officer
of the Committee, has ordered publication of this notice.

    Dated: October 7, 2005.
Jonathan G. Katz,
Committee Management Officer.
[FR Doc. 05-20569 Filed 10-7-05; 3:55 pm]

BILLING CODE 8010-01-P


[Federal Register: November 19, 2009 (Volume 74, Number 222)]
[Notices]
[Page 59986]
[DOCID:fr19no09-61]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Endocrinologic and Metabolic Drugs Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Endocrinologic and Metabolic Drugs Advisory
Committee.
    General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on January 12 and 13,
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: Paul Tran, 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,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>or FDA Advisory Committee Information Line,
1-800-741-8138<PHONE_NUMBER> in the Washington, DC area), code
3014512536. 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 January 12, 2010, the committee will discuss new drug
application (NDA) 21-348, ZAVESCA (miglustat), 100 milligram (mg)
capsules, by Actelion Pharmaceuticals, Ltd., proposed for the
treatment of progressive neurological manifestations (symptoms
related to the nervous system) in patients with Niemann-Pick Disease
(type C). On January 13, 2010, the committee will discuss NDA 22-
562, CARBGLU (carglumic acid), 200 mg tablets, by Orphan Europe
SARL, proposed for the treatment of hyperammonemia (elevated levels
of ammonia in the blood) in patients with N acetyl glutamate
synthetase (NAGS) deficiency, an inherited disorder that causes
ammonia to accumulate in the blood.
    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
December 28, 2009. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. on both days.
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
December 17, 2009. 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
December 18, 2009.
    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 Paul Tran 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: November 13, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27741 Filed 11-18-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 168 (Thursday, August 29, 2019)]
[Notices]
[Pages 45496-45497]
[FR Doc No: 2019-18715]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3092]

Placebos and Blinding in Randomized Controlled Cancer Clinical
Trials for Drug and Biological Products; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Placebos
and Blinding in Randomized Controlled Cancer Clinical Trials for Drug
and Biological Products.'' This guidance provides recommendations to
industry about using placebos and blinding in randomized controlled
clinical trials in development programs for drug or biological products
to treat hematologic malignancies and oncologic diseases regulated by
the Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER). This guidance finalizes the
draft guidance entitled ``Hematologic Malignancy and Oncologic Disease:
Considerations for Use of Placebos and Blinding in Randomized
Controlled Clinical Trials for Drug Product Development'' issued August
24, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on August 29, 2019.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-3092 for ``Placebos and Blinding in Randomized Controlled
Cancer Clinical Trials for Drug and Biological Products.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Placebos and Blinding in Randomized Controlled Cancer
Clinical Trials for Drug and Biological Products.'' This guidance
provides recommendations to industry about using placebos and blinding
in randomized controlled clinical trials in development programs for
drug or biological products to treat hematologic malignancies and
oncologic diseases regulated by CDER and CBER.
    This guidance finalizes the draft guidance entitled ``Hematologic
Malignancy and Oncologic Disease: Considerations for Use of Placebos
and Blinding in Randomized Controlled Clinical Trials for Drug Product
Development'' (August 24, 2018, 83 FR 42902). Changes made to the
guidance took into consideration comments received on the draft
guidance and include the following: (1) Clarifying that unblinding
should be limited to only the patient and the investigator, (2)
clarifying that the guidance does not address statistical approaches to
consider when unblinding data, (3) making minor wording changes
throughout the document for clarity, and (4) simplifying the guidance
title.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Placebos and Blinding in Randomized
Controlled Cancer Clinical Trials for Drug and Biological Products.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations. This
guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collection of information in 21 CFR part 312 (Investigational New Drug
Application) has been approved under OMB control number 0910-0014. The
collections of information in 21 CFR parts 50 and 56 (Protection of
Human Subjects: Informed Consent; Institutional Review Boards) have
been approved under OMB control number 0910-0755.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or https://www.regulations.gov.

    Dated: August 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18715 Filed 8-28-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 5, 2010 (Volume 75, Number 64)]
[Notices]
[Page 17137]
[DOCID:fr05ap10-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings No. 2

March 16, 2010.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP10-360-001.
    Applicants: Texas Gas Transmission, LLC.
    Description: Texas Gas Transmission, LLC submits Sub Original Sheet
No. 650 to FERC Gas Tariff, Third Revised Volume No. 1.
    Filed Date: 03/10/2010.
    Accession Number: 20100311-0011.
    Comment Date: 5 p.m. Eastern Time on Monday, March 22, 2010.

    Docket Numbers: RP09-185-002.
    Applicants: MoGas Pipeline LLC.
    Description: MoGas Pipeline, LLC submits Third Revised Sheet 58 et
al. to its FERC Gas Tariff, First Revised Volume 1.
    Filed Date: 03/09/2010.
    Accession Number: 20100310-0231.
    Comment Date: 5 p.m. Eastern Time on Monday, March 22, 2010.

    Docket Numbers: RP10-434-001.
    Applicants: Columbia Gas Transmission, LLC.
    Description: Columbia Gas Transmission, LLC submits Fifth Revised
Sheet 503.01 to its FERC Gas Tariff, Third Revised Volume 1, to be
effective 4/1/10.
    Filed Date: 03/09/2010.
    Accession Number: 20100310-0228.
    Comment Date: 5 p.m. Eastern Time on Monday, March 22, 2010.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing 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. Such protests
must be filed on or before 5 p.m. Eastern time on the specified comment
date. Anyone filing a protest must serve a copy of that document on all
the parties to the proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons
unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.,
Deputy Secretary
[FR Doc. 2010-7538 Filed 4-2-10; 8:45 am]
BILLING CODE 6717-01-P