In a developmental toxicity (MRID No. 43709032), CGA 219417 technical (99 5%a.i., Lot# P9t2004) was administered in 3% aqueous corn starch suspension to 19 inseminated female rabbits (Russian Chbb:HM, SPF)/dose by gavage at dose levels of 0,5; 30; 150, or 400 mg/kg/day from days 7 through 19 of gestation. Mean maternal body weight gain (p <0.01) and food consumption (not significant) decreased, mainly during the first week of treatment in the 400 mg/kg/day group. Mean body weight gain was 622% less than controls (p <0.01) in this group between days 7 and 13 of gestation. The maternal LOAEL is 400 mg/kg/day, based on decreased body weight gain. The maternal NOAEL is 150 mg/kg/day. Fetuses at the 400 mg/kg/day dose exhibited indications of an increased incidence of a 13th rib (not significant). Although there were indications of developmental delays in fetal skeletons, such as poor or absent ossification of the sternebrae and metacarpals at all dose levels, only the extra rib is likely to be compound related. Uni- or bilateral hyperflexion of the carpal joint at the 400 and 150 mg/kg/day doses (not significant) was not associated with the skeletal changes. The fetal developmental LOAEL is 400 mg/kg/day based on a slight increase of litters showing extra (13th) ribs. The fetal developmental NOAEL is 150 mg/kg/day.  The developmental toxicity study in the rabbit is classified acceptable (guideline) and satisfies the guideline requirement for a developmental toxicity study (OPPTS 870.3700; §83-3 (b)) in rabbit.

A.4.3	Reproductive Toxicity

	870.3800 Reproduction and Fertility Effects  -  Rat MRID 43709034

In a two-generation reproduction study (MRID No. 43709034), Tif:RAIf rats (30 rats/sex/dose), with one litter per generation received CGA219417 (99.5 % a.i., Batch No. P912004) in the diet at doses of 0, 10, 100, 1000 or 4000 ppm (actual intake, males: 0, 0.7, 6.7, 68 or 273; females: 0, 0.8, 8.2, 81 or 326 mg/kg/day) for a 10 week pre-mating period.  Signs of toxicity at 4000 ppm consisted of lower body weights (12.5%) in the F0 females after the pre-mating period. Increased liver weight in 1000 (marginal) and 4000 ppm males and females was not supported by histopathological findings. Although these were considered treatment related, they were considered to be non-adverse. The LOAEL for maternal systemic toxicity is 4000 ppm (about 326 mg/kg/day) based on lower body weights in the F0 females during the pre-mating period. The NOAEL for maternal systemic toxicity was 1000 ppm (about 81 mg/kg/day). HIARC determined that premating body weight gain (not absolute body weight) should be used as the basis of the NOAEL.  Signs of reproductive toxicity included significantly lower F1 and F2 pup weights in the high-dose group during lactation, which continued to be lower than controls post-weaning and after the pre-mating period (examination in F1 generation only). The LOAEL for reproductive/developmental toxicity is 4000 ppm (about 326 mg/kg/day) based on decreased pup weights (F1 and F2). The NOAEL for reproductive toxicity is 1000 ppm (about 81 mg/kg/day).
The two-generation reproduction study in the rat is classified acceptable (guideline) and satisfies the guideline requirement for a two-generation reproduction study (OPPTS 870.3800; §83-4) in rat.

A.4.4	Chronic Toxicity

        870.4100a (870.4300) Combined Chronic Toxicity/Carcinogenicity  -  Rat MRIDs 43737602, 44429401, 44417902

In a 24-month chronic toxicity/oncogenicity study (MRID No: 43737602, 44429401,44417902), Tif:RAIf rats (50 rats/sex/dose - carcinogenicity portion, plus 20/sex/dose laboratory investigations) were fed diets containing 0, 5, 75, 1000 or 2000 ppm (actual concentrations: males 0, 0.177, 2.7, 35.6 or 73.6 mg/kg/day; females  0, 0.204, 3.22, 41.2 or 87.1 mg/kg/day) CGA 219417(99.2-99.6% a.i. Batch No. P 912006). An additional 10/sex/dose were fed test diets for 12 months (interim sacrifice). Survival was slightly lower in males at 2000 ppm relative to control and other dose groups (54, 50, 50, 49, and 44%, from controls to high dose). Toxicologically significant findings included increased liver weights in high-dose males (10.7%) and a dose-related increase in the incidence of spongiosis hepatis in the liver of 1000 and 2000 ppm males (5, 5, 3, 17 and 23 %, controls to high dose). For chronic toxicity, the NOAEL was 75 ppm (2.7 mg/kg/day) and the LOAEL was 1000 ppm (35.6 mg/kg/day) based on degenerative liver lesions (spongiosis hepatis) in males. This chronic carcinogenicity study in the rat is acceptable (guideline).

      870.4100b Chronic Toxicity - Dog  MRID 43709030

A 1-year study (MRID 43709030) was carried out in Beagle dogs where animals (4/sex/dose) were fed diets containing 0,25,250,2500 or 15,000 ppm (actual concentrations: males -0, 0.72, 6.87, 65.63 or 449.25; females -0, 0.76, 6.80, 67.99 or 446.37 mg/kg/day) CGA 219417 (99.6% a.i., Batch No. P 912006).

There was no effect on mortality, hematological, or clinical chemistry parameters, and no clinical signs of systemic toxicity. Throughout the first half of the study, lower bodyweight gains (31-38% less) (attributable primarily to 2/4 of each sex) and decreased food consumption were apparent in high-dose males and females; with reduced food efficiency in high dose males and females in the latter part of the study. The LOEL is 15,000 ppm (males - 449.25, females 446.37 mg/kg/day) based on lower bodyweight gains and decreased food consumption and food efficiency. The NOAEL is 2500 ppm (males - 65.63, females - 67.99 mg/kg/day).  This study is classified as acceptable (guideline) and satisfied the guideline requirement for a chronic oral dog study (870.4100b).

A.4.5	Carcinogenicity

870.4200a Carcinogenicity/Chronic Study  -  Mice MRID 43709031

An 18-month oncogenicity study was carried out in Tif:MAGf(SPF) albino mice where animals (50 mice/sex/dose - carcinogenicity portion, plus 10/sex/dose - hematology) were fed diets containing 0, 10, 150, 2000 or 5000 ppm (actual concentrations: males - 0, 1.15, 16.1, 212.4 or 630; females - 0, 1.08, 14.7, 196.3 or 558.1 mg/kg/day) of CGA 219417 (99.0-99.5% a.i., Batch No. P912006). There was no effect on mortality, or hematology parameters, and no clinical signs of toxicity. Treatment-related effects included lower bodyweight and bodyweight gain (males - 10%, females - 27%) at 5000 ppm, reduced food efficiency and increased relative liver weights (16%) in high-dose males and females, and a dose-related, increase in minimal to marked pancreatic acinar cell hyperplasia in 2000 and 5000 ppm males (8, 8, 10, 16, 28% incidence, from control to high dose). The LOAEL is 2000 ppm (males - 212.4 mg/kg/day) based on a dose-related increase in the incidence of focal, and multifocal hyperplasia of the exocrine pancreas in. males. The NOAEL was 150 ppm (males - 16.1 mg/kg/day). This study was tested to adequate levels based on signs of toxicity in males at 2000 ppm and female at 5000 ppm. This chronic carcinogenicity study in the mouse is acceptable/guideline.

A.4.6	Mutagenicity

	Gene Mutation
Guideline # 870.5100 Bacterial assay
MRID 43709037
Acceptable/Guideline
Guideline #870.5300, In vitro mammalian cell gene mutation test
MRID 43709036
Acceptable Guideline

Not mutagenic

Not mutagenic in the presence or absence of S9-activation up to cytotoxic concentrations (96.0 ug/mL with S9) (24 ug/mL without S9).

	Cytogenetics
Guideline # 870.5375,
Cytogenetics/In vitro Chromosomal Aberration
MRID 43709038
Acceptable Guideline

Guideline #870.5395
Cytogenetics/In vivo bone marrow micronucleus MRID 43709039
Acceptable Guideline
cyprodinil gave negative results up to cytotoxic concentrations

negative

A.4.7	Neurotoxicity

	870.6100 Delayed Neurotoxicity Study  -  Hen - NA

	870.6200a  Acute Neurotoxicity Screening Battery MRID 48304202

In an acute neurotoxicity study in mice (MRID 48304202) CGA 219417 technical (batch #: P.012011 a light beige powder with a purity of 99.2%) was administered to rats to assess the potential acute neurotoxicity and to estimate the NOAEL of exposure of the test compound, a fungicide, when administered by gavage.  The test article was administered by gavage as single oral dose of 0, 200, 600, and 2000 mg/kg to a total of 80 Sprague-Dawley-derived rats (10 males, and 10 females, per dose group).  Mortality, clinical signs, body weight, and food consumption were monitored throughout the study. A 'Functional Observational Battery'
(FOB) was performed pretest, at the time of peak effect (2 hours post-dose, and on test days 8 and 15. At necropsy, animals were sacrificed by in situ perfusion. The brain, spinal cord, peripheral nerves and eyes were collected, prepared for histological evaluation and 5 animals per sex each of the control and top-dose group (experimental group I) examined microscopically.  Two animals of group 3 died spontaneously. The male, found dead on test day 2, was most likely miss-intubated. For the female, which was found dead on test day 18, the cause of death could not be identified. Body weight gain and food consumption were not affected by treatment. Observations and functional tests conducted as part of the FOB showed relevant changes at the time of peak effect only. In females of group 3 and 4 reduced activity, hunched posture, piloerection, and increased responsiveness to sensory stimuli were observed with hunched posture seen also in few group 2 females. In females of group 3 and 4, signs lasted up to test day 4 and were considered to indicate toxicity. A dose related decrease in body temperature was observed, being minimal in animals of group 2.  Changes in motor activity parameters were limited to the time of peak effect. In group 4 males and in females of group 3 and 4 horizontal and vertical activity parameters were reduced.  Macroscopic and microscopic examination of the multiple areas of the central and peripheral nervous system, the eyes, optic nerves, and skeletal muscle of the male and female, control and high-dose animals of experimental group I didn't reveal any treatment-related neuropathic changes.  Based on these data it was concluded that CGA 219417 tech., when administered to rats at a single oral dose of 200, 600 or 2000 mg/kg, induced a dose-related hypothermia. Due to its full reversibility in all dose groups, the slightly reduced body temperature in low-dose animals was not considered as adverse.  A dose of 200 mg/kg thus represented the NOAEL for this study. The LOAEL was deemed to be 600 mg/kg and greater induced signs of toxicity at the time of peak effect which disappeared within a few days as well.  In the absence of any permanent or delayed functional changes and of neuropathic changes in the central and peripheral nervous system, CGA 219417 tech was considered not to be neurotoxic up to the near lethal dose of 2000 mg/kg.

	870.6200b Subchronic Neurotoxicity Screening Battery MRID 45906101

In a subchronic neurotoxicity study (MRID 45906101) CGA 219417 technical (99.2% a.i., batch #: P. 012011) was administered to 10 Tif: RAIf Sprague-Dawley derived albino rats/sex/group at dose levels of 0, 80, 800, or 8000 ppm (equivalent to 0, 5.8, 54.5, and 601 mg/kg bw/day in males and 0, 6.3, 58.7, and 631 mg/kg bw/day in females) for 90 consecutive days.  Neurobehavioral assessment (functional observational battery and motor activity testing) was performed in 10 animals/sex/group pre-exposure and at weeks 4, 8, and 13. At study termination, 10 animals/sex/group were euthanized and perfused in situ for neuropathological examination.  Of the perfused animals, 5/sex/group of the control and high-dose groups were subjected to histopathological evaluation of brain and peripheral nervous system tissues.  In addition, the liver, kidneys, thyroid gland, and pituitary were collected from all animals and examined microscopically.

There were no treatment related effects on mortality, clinical signs, or gross or histological neuropathology.  FOB and motor activity testing revealed no treatment related effects up to the highest dose tested (8000 ppm).  In high-dose animals, absolute body weight was significantly or slightly less than the controls throughout the study due to reduced weight gain by the treated animals.  Cumulative weight gain by the high-dose groups was significantly less than that of the control groups during weeks 1-6 and 8 for males and weeks 1, 4, and 11-13 for females.  The most pronounced effect on weight gain was during the first week of the study when high-dose males and females gained 59% and 38%, respectively, of the control levels.  Overall weight gain by the high-dose males and females was 87% and 79%, respectively, of the controls.  Food consumption by the high-dose animals was reduced only at week 1 to 89% and 77% of controls for males and females, respectively.  In the high-dose group, absolute and relative liver weights were increased in both sexes (126-138% and 121-125% of controls for males and females, respectively).  Absolute and relative kidney weights were elevated in high-dose females (112-118% of controls).

Microscopic examination revealed an increase in the incidence, but not in severity, at the high dose of lesions in the liver, kidney, and thyroid.  Hepatocellular hypertrophy in the liver was observed in 5/10 high-dose males compared with 1/10 controls and in 5/10 high-dose females compared with 0/10 controls; this is an adaptive response.  Tubular lesions or tubular casts were seen in the kidneys of 4/10 high-dose males and 5-7/10 high-dose females vs 0-2/10 animals in the control groups.  Hypertrophy of the follicular epithelial cells in the thyroid gland occurred in 5/10 high-dose males and 4/10 high-dose females compared with only 1/10 control males.

Based on the results of this 90-day subchronic oral neurotoxicity study, the neurotoxicity LOAEL for CGA 219417 technical in male and female rats was not identified, while the NOAEL is 8000 ppm (601 mg/kg bw/d in males; 631 mg/kg bw/d in females).

The systemic toxicity LOAEL for CGA 219417 technical in male and female rats is 8000 ppm (601 mg/kg bw/d in males and 631 mg/kg bw/d in females) based on decreased body weight gain, tubular casts in the kidneys, and thyroid follicular cell hypertrophy.  The NOAEL is 800 ppm (54.5 mg/kg bw/d in males and 58.7 mg/kg bw/d in females).

The study is classified as Acceptable/Guideline and satisfies the guideline requirement for a subchronic neurotoxicity study in rats (870.6200b).

A.4.8	Metabolism

      870.7485	Metabolism  -  Rat

Study 1

In a metabolism study ( MRID 43709040), single oral doses (0.5 or 100 mg/kg bw) of phenyl or pyrimidyl-radiolabelled CGA-219417 (purity  98%) were administered to Tif:RAIf(SPF) rats, with one low-dose group receiving unlabeled CGA 219417 (purity  99%) for 2 weeks prior to treatment with radiolabelled compound.  Absorption was very rapid (tcmax= 0.3 hours) with rapid clearance (tcmax/2=1.2 hours).  A minimum of 75% of the administered dose was absorbed.  A biphasic first order kinetics was observed for radioactivity depletion, with a duration of 0.3-1.2 hours for the first phase, and 27-65 hours for the second phase.  Excretion was rapid and almost complete, with urine as the principle route of excretion (48-68%), and >90% of the administered dose detected in the urine and feces within 48 hours.  Tissue residues declined rapidly, with the highest concentrations ( 1.8 ppm) found in kidneys, liver, lungs, spleen, thyroid, whole blood, and carcass.  The urine, fecal, and bile metabolite patterns were complex, with 8, 8 and 9 defined metabolite fractions, respectively.  Unchanged parent compound was detected in feces extract only.  Excretion, distribution and metabolite profiles were essentially independent of dose level, pretreatment, and type of label, although there were some quantitative differences sex-dependent qualitative differences in two urinary metabolite fractions.

This study is classified as acceptable (guideline) and when taken together with study (MRID 43709041) satisfies the guideline requirement for a metabolism study in rats (85-1).

Study 2

Excreta (Group D1 and D2) and bile (Group G1) from radiolabelled CGA 219417-treated Tif:RAIf(SPF) rats of a previous ACME  study (MRID 43709040) were used to characterize, isolate and identify CGA 219417 metabolites (MRID 43709041).  Eleven metabolites were isolated from urine, feces and bile, and the metabolic pathways in the rat were proposed.  All urinary and biliary metabolites (with the exception of 7U) were conjugated with glucuronic acid or sulfonated, and excreted.  CGA 219417 was almost completely metabolized by hydroxylation of the phenyl ring (position 4) or pyrimidine ring (position 5), followed by conjugation.  An alternative pathway involved oxidation of the phenyl ring followed by glucuronic acid conjugation.  A quantitative sex difference was observed with respect to sulfonation of the major metabolite that formed 6U.  The monosulfate metabolite (1U) was predominant in females, whereas equal amounts of mono- and disulfate (6U) conjugates were noted in males.  Most of the significant metabolites in feces were exocons of biliary metabolites (2U, 3U, 1G).  These were assumed to be deconjugated in the intestines, partially reabsorbed into the general circulation, conjugated again, and eliminated renally.  The major metabolic pathways of CGA 219417 were not significantly influenced by the dose, treatment regimen, or sex of the animal.

This study is classified as acceptable (guideline) and when taken together with study (MRID 43709040) satisfies the guideline requirement for a metabolism study in rats (85-1).

A.4.9	Immunotoxicity

	870.7800	Immunotoxicity  -  Mice  MRID 48304203

In an immunotoxicity study (MRID 48304203), the test substance cyprodinil was offered ad libitum in the diet of Crl:DC1 (ICR) female mice, for 28 consecutive days to three groups (Groups 2-4) at dietary concentrations of 500, 2000, and 5000 ppm, respectively.  Mice in Group 5 were administered the positive control substance, cyclophosphamide (CPS), via IP (50 mg/kg/day) for four consecutive days (study days 24-27).  The vehicle and positive control groups (Groups 1 and 5, respectively) were offered a basal diet on a comparable regimen as the cyprodinil-treated groups.  In addition, all mice were immunized with sheep red blood cells (sRBC) on study day 24.  All animals were euthanized on day 28.  Mortality and morbidity were observed twice daily in all animals, while clinical exams were performed once a day.  More detailed physical exams were performed once a week and the day of necropsy.  Single animal body weights were recorded two times a week and food consumption was recorded weekly.  Complete necropsies were conducted on all animals.  Organs (liver, spleen, and thymus) were collected and weighed at scheduled necropsy.  Spleens were analyzed by ImmunoTox(R),Inc . for IgM antibody forming cells directed towards the sRBC determination.  Test substances were 0, 103.8, 468.3, and 1245.3mg/kg/day or 0, 500, 2000, and 5000ppm, respectively, for the entire 4-week study.  All animals survived to necropsy.  There were no test substance-related clinical observations, no effects on body-weight, food consumption, no macroscopic findings.  There were no cyprodinil-related effects on absolute, adjusted, or relative spleen or thymus weights; no effects on specific activity or total activity of splenic IgM antibody-forming cells to the T cell-dependent antigen sRBC.  Effects did include higher mean absolute, relative to body weight, and adjusted liver weights noted in the 5000ppm cyprodinil-treated group were consistent with previous studies assessing cyprodinil at similar exposure levels.  Noted for the positive control (CPS) were lower mean absolute and adjusted spleen and thymus weights when compared to vehicle control group.  All effects seen with the CPS were consistent with the known immunosuppressant effects and also validated the appropriateness of the AFC assay.  No mention of a NK cell activity assay was performed.  It is unclear why this test was not performed and no justification was noted in the study write-up.

Based on the study, treatment of female Crl:CD-1(ICR) mice with cyprodinil given on a continued basis in the diet for 28 sequential days resulted in no apparent suppression of the humoral component of the immune system.  The NOEL for the suppression of the immune response in female CD-1 mice given cyprodinil was 5000ppm (1245.3mg/kg/day).  The only effect attributed to cyprodinil treatment was higher mean absolute, relative to body weight, and adjusted liver weights also for the 5000ppm group.

APPENDIX B.  Chemical Names And Structures Of Metabolites

B.1 	Chemical Names and Structures

Table B.1 Cyprodinil and Metabolites Names and Structures
Chemical Name/Code
                              Chemical Structure
Cyprodinil (CGA-219417)

4-cyclopropyl-6-methyl-N-phenyl-2-pyrimidinamine

                               \s \* MERGEFORMAT

CGA-232449

6-cyclopropyl-2-(phenylamino)-4-pyrimidinemethanol

                               \s \* MERGEFORMAT

CGA-304075

4-[(4-cyclopropyl-6-methyl-2-2-pyrimidinyl)amino]-phenol

                               \s \* MERGEFORMAT

CGA-304076

                               \s \* MERGEFORMAT

NOA-413167

                               \s \* MERGEFORMAT

CGA-249287

4-cyclopropyl-6-methyl-2-pyrimidinamine

                               \s \* MERGEFORMAT

NOA-422054

4-cyclopropyl-6-hydroxymethyl-2-pyrimidinamine

                               \s \* MERGEFORMAT

CGA-263208

phenylguanidine

                               \s \* MERGEFORMAT

APPENDIX C. Physical/Chemical Properties

Table C.1 Physicochemical Properties of Technical Grade of Cyprodinil.
Parameter
                                     Value
Reference
Melting point/range
75.9 [0]C
                        DP# 345970, W. Cutchin, 6/4/08
pH
9.5 at 25 [0]C (1% aqueous dispersion)

Density
1.21 g/cm[3] at 20[0]C

Water solubility (mg/L at 25 C)
16 at pH 7.6, 20 at pH 5, 13 at pH 7, 5 at pH 9

Solvent solubility (g/L at 25 C)
ethanol-160, acetone-610, toluene-460,
n-octanol-160, n-hexane-30

Vapor pressure
3.8 x 10[-6] mm Hg at 25 [0]C

Dissociation constant, pKa
4.44 at 20 [0]C

Octanol/water partition coefficient, Log(KOW) at 25 C
3.9 at pH 5, 4.0 at pH 7,  4.0 at pH 9

UV/visible absorption spectrum
(molar absorption coefficients for the absorbance maximum)
29,200 L/mol∙cm at 270.8 nm (neutral)
29,200 L/mol∙cm at 251.6 nm (acidic)
29,200 L/mol∙cm at 316.8 nm (acidic)
28,400 L/mol∙cm at 270.8 nm (basic)

APPENDIX D.  Studies Reviewed for Ethical Conduct

The PHED Task Force, 1995.  The Pesticide Handlers Exposure Database, Version 1.1.  Task Force members Health Canada, U.S. Environmental Protection Agency, and the National Agricultural Chemicals Association, released February, 1995.

Agricultural Re-entry Task Force (ARTF) data base (SOP #3.1)


[Federal Register Volume 81, Number 83 (Friday, April 29, 2016)]
[Notices]
[Pages 25679-25680]
[FR Doc No: 2016-10025]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1160]

Center for Biologics Evaluation and Research eSubmitter Program
for Electronic Submission of Postmarketing Adverse Event Reports for
Human Vaccine Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency), Center for
Biologics Evaluation and Research (CBER) is announcing the availability
of a Vaccine Adverse Event Reporting System (VAERS) eSubmitter program
for the electronic submission of postmarketing individual case safety
reports (ICSRs) and ICSR attachments of adverse events for human
vaccine products (VAERS eSubmitter program). The VAERS eSubmitter
program is a free software program for voluntary use that is intended
to help persons subject to mandatory postmarketing requirements for
vaccines including applicants, manufacturers, packagers, and
distributors to electronically submit ICSRs and ICSR attachments as
required by the final rule titled ``Postmarketing Safety Reports for
Human Drug and Biological Products; Electronic Submission
Requirements.'' The VAERS eSubmitter program creates a simple and
efficient mechanism for the secure electronic submission of
postmarketing ICSRs and ICSR attachments into the VAERS database
without the need for an internal database that is compatible with the
International Conference on Harmonisation (ICH)-based direct database
to database submission system.

FOR FURTHER INFORMATION CONTACT: Bioinformatics Support Staff, Office
of Review Management, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of the VAERS eSubmitter program
for the electronic submissions of postmarketing ICSRs and ICSR
attachments of adverse events for human vaccine products. The VAERS
eSubmitter program is available for voluntary use by applicants and
others required to report postmarketing adverse events, as described
above, to submit an initial or follow-up ICSR document for human
vaccine products. The eSubmitter application software, which can be
downloaded free of charge, assists users in the preparation of
submissions that contain the minimum elements necessary for FDA to
perform a comprehensive review.
    The eSubmitter ICSR template for vaccines is designed to ensure
that those submitting postmarketing ICSRs and ICSR attachments include
necessary information in these regulatory submissions. It is also
designed to guide users of the system as they complete the ICSR file
creation and submission process. The VAERS eSubmitter program will help
to improve the consistency, quality, and completeness of ICSR
submissions and make the submission and review process more user-
friendly for those required to report postmarketing adverse events for
human vaccine products.
    FDA published in the Federal Register of June 10, 2014 (79 FR
33072), a final rule titled ``Postmarketing Safety Reports for Human
Drug and Biological Products; Electronic Submission Requirements,''
which requires, in part, that applicants and other adverse event
reporters submit postmarketing ICSRs and ICSR attachments to CBER in an
electronic format that the Agency can process, review, and archive. The
final rule became effective June 10, 2015. Postmarketing ICSRs and ICSR
attachments sent to CBER for human vaccines are processed into the
VAERS database. As discussed in the preamble to the final rule and in
CBER's final guidance for industry ``Providing Submissions in
Electronic Format--Postmarketing Safety Reports for Vaccines,'' dated
August 2015 (August 2015 Guidance), FDA is providing two voluntary
options for electronic submission of ICSRs and ICSR attachments into
VAERS: (1) Direct database to database submission through the
Electronic Submissions Gateway (ESG), and (2) submission of safety
reports through the VAERS eSubmitter program as described on the CBER
eSubmitter Web page (available at: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm191387.htm). Applicants and others required to report

postmarketing adverse events can choose either option to electronically
submit ICSRs and ICSR attachments to VAERS.
    The ICSR eSubmitter software is a government-issued software
provided in support of the Government Paperwork Elimination Act of 1998
(44 U.S.C. 3504). As users of the eSubmitter software, applicants and
others required to report postmarketing adverse events are not required
to perform their own file validation process. The purpose of the ICSR
eSubmitter template is to facilitate the electronic submission of
postmarketing vaccine safety reports using internationally adopted data
standards to enhance regulatory review, exchange and dissemination of
vaccine safety information. Applicants and others who choose to use the
eSubmitter program for required postmarketing reporting of adverse
events for human vaccine products must first download the eSubmitter
software and then manually enter information into the ICSR template
form to create each electronic ICSR or ICSR attachment for submission
to FDA through the ESG for uploading to the VAERS database. Further
information on submitting ICSRs and ICSR attachments using eSubmitter
is included in the August 2015 Guidance (available at: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/default.htm), and on the CBER eSubmitter Web page referenced above.

    Dated: April 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10025 Filed 4-28-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 124 (Friday, June 27, 2014)]
[Notices]
[Page 36529]
[FR Doc No: 2014-15036]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1155]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Food Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Food Labeling Regulations'' has
been approved by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On December 31, 2013, the Agency submitted a
proposed collection of information entitled ``Food Labeling
Regulations'' to OMB for review and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. OMB has now approved the information
collection and has assigned OMB control number 0910-0381. The approval
expires on June 30, 2017. A copy of the supporting statement for this
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: June 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15036 Filed 6-26-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 4, 2006 (Volume 71, Number 232)]
[Notices]
[Page 70375-70376]
[DOCID:fr04de06-48]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

November 27, 2006.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC07-24-000.
    Applicants: Endeavor Power Partners, LLC; Osceola Windpower, LLC.
    Description: Endeavor Power Partners, LLC and Osceola Windpower,
LLC submit a joint application for authorization to dispose of
jurisdictional facilities to acquire an existing Generation Facility.
    Filed Date: 11/17/2006.
    Accession Number: 20061122-0125.
    Comment Date: 5 p.m. Eastern Time on Friday, December 8, 2006.

    Take notice that the Commission received the following electric
rate filings

    Docket Numbers: ER06-615-003.
    Applicants: California Independent System Operator Corporation.
    Description: California Independent System Operator Corp submits a
compliance filing pursuant to the Commission's 9/21/06 Order.
    Filed Date: 11/20/2006.
    Accession Number: 20061122-0123.
    Comment Date: 5 p.m. Eastern Time on Monday, December 11, 2006.

    Docket Numbers: ER06-729-003.
    Applicants: Southwest Power Pool, Inc.
    Description: Southwest Power Pool, Inc submits a compliance filing
to the Commission's 10/19/06 Order.
    Filed Date: 11/20/2006.
    Accession Number: 20061122-0193.
    Comment Date: 5 p.m. Eastern Time on Monday, December 11, 2006.

    Docket Numbers: ER06-869-001.
    Applicants: Consolidated Edison Company of New York.
    Description: Consolidated Edison Co of New York, Inc submits
amendments to its Electric Tariff Rate Schedules 96 and 92 in
compliance with the Commission's 5/15/06 letter order.
    Filed Date: 11/20/2006.
    Accession Number: 20061121-0273.
    Comment Date: 5 p.m. Eastern Time on Monday, December 11, 2006.

    Docket Numbers: ER06-1308-003.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator
submits a second errata to its 11/6/06 compliance filing, revisions to
Schedules 10-C, 16-A and 17-A of its OAT&EM Tariff.
    Filed Date: 11/21/2006.
    Accession Number: 20061124-0079.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 12, 2006.

    Docket Numbers: ER06-1537-001.
    Applicants: Public Service Company of New Mexico.
    Description: Public Service Company of New Mexico submits notices
of cancellation of Rate Schedules 149 and 121 in compliance with the
Commission's 11/15/06 letter order.
    Filed Date: 11/20/2006.
    Accession Number: 20061122-0185.
    Comment Date: 5 p.m. Eastern Time on Monday, December 11, 2006.

    Docket Numbers: ER07-235-000.
    Applicants: Midwest Independent Transmission System Operator, Inc.
    Description: Midwest Independent Transmission System Operator, Inc
submits proposed designation of an additional Narrow Constrained Area.
    Filed Date: 11/20/2006.
    Accession Number: 20061122-0192.
    Comment Date: 5 p.m. Eastern Time on Monday, December 11, 2006.

    Docket Numbers: ER07-236-000.
    Applicants: Carolina Power and Light Company.
    Description: California Power and Light Company submits an
amendment to its Large Generator Interconnection Agreement filed on 2/
1/06.
    Filed Date: 11/20/2006.
    Accession Number: 20061122-0190.
    Comment Date: 5 p.m. Eastern Time on Monday, December 11, 2006.

    Docket Numbers: ER07-237-000; EC05-104-002.
    Applicants: Monogahela Power Company; Allegheny Energy, Inc.; The
Potomac Edison Company; Allegheny Energy Supply Company, LLC.
    Description: Monogahela Power Company et al. submit a Motion to
amend application for authorization of disposition of jurisdictional
assets and filing of related jurisdictional contract, Power Sales
Agreement.
    Filed Date: 11/17/2006.
    Accession Number: 20061122-0191.
    Comment Date: 5 p.m. Eastern Time on Friday, December 8, 2006.

    Docket Numbers: ER07-239-000.
    Applicants: BG Energy Merchants, LLC.
    Description: BG Energy Merchants, LLC submits a petition for
acceptance of Initial Rate Tariff, Waivers and Blanket Authority.
    Filed Date: 11/21/2006.
    Accession Number: 20061124-0086.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 12, 2006.

    Docket Numbers: ER07-240-000.
    Applicants: Twin Buttes Wind LLC.
    Description: Twin Buttes Wind LLC submits an application for
market-based rate authority under Section 205 of the Federal Power Act
and request for waivers and pre-approvals.
    Filed Date: 11/21/2006.
    Accession Number: 20061124-0087.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 12, 2006.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,

interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov.
 To facilitate electronic service, persons with Internet

access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also 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>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-20466 Filed 12-1-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Rules and Regulations]
[Pages 17483-17486]
[FR Doc No: 2018-08138]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31189; Amdt. No. 3796]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective April 20, 2018. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of April 20, 2018.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169, or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedure
Standards Branch (AFS-420) Flight Technologies and Procedures Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082 Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained on FAA form documents is
unnecessary.
    This amendment provides the affected CFR sections, and specifies
the SIAPs and Takeoff Minimums and ODPs with their applicable effective
dates. This amendment also identifies the airport and its location, the
procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on April 6, 2018.
John S. Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, (14 CFR part 97), is amended by
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, effective at 0901 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Sec. Sec.  97.23, 97.25, 97.27, 97.29 97.31, 97.33, 97.35  [Amended]

    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
        AIRAC date            State             City               Airport          FDC No.      FDC date                      Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
24-May-18................  IA           Denison............  Denison Muni.......       7/0823      3/29/18  RNAV (GPS) RWY 30, Amdt 1.
24-May-18................  NY           Akron..............  Akron..............       7/3460      3/22/18  RNAV (GPS) RWY 25, Amdt 2C.
24-May-18................  NC           Lincolnton.........  Lincolnton-Lincoln        7/7043      3/29/18  RNAV (GPS) RWY 23, Amdt 1.
                                                              County Rgnl.
24-May-18................  NC           Lincolnton.........  Lincolnton-Lincoln        7/7045      3/29/18  ILS Y OR LOC Y RWY 23, Orig-A.
                                                              County Rgnl.
24-May-18................  NC           Lincolnton.........  Lincolnton-Lincoln        7/7046      3/29/18  ILS Z OR LOC Z RWY 23, Orig-A.
                                                              County Rgnl.
24-May-18................  NC           Lincolnton.........  Lincolnton-Lincoln        7/7074      3/29/18  RNAV (GPS) RWY 5, Amdt 1B.
                                                              County Rgnl.
24-May-18................  MS           Greenville.........  Greenville Mid-           7/8318      3/22/18  RNAV (GPS) RWY 36L, Orig-B.
                                                              Delta.
24-May-18................  AL           Huntsville.........  Huntsville Intl-          8/0247      3/29/18  ILS OR LOC RWY 18L, Amdt 4D.
                                                              Carl T Jones Field.
24-May-18................  NY           Akron..............  Akron..............       8/0745      3/22/18  RNAV (GPS) RWY 7, Amdt 2C.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1011      3/26/18  ILS OR LOC RWY 5, Amdt 38A.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1029      3/26/18  ILS OR LOC RWY 18C, Amdt 10D.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1045      3/26/18  ILS OR LOC RWY 18L, Amdt 9.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1065      3/26/18  ILS OR LOC RWY 18R, Amdt 1.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1082      3/26/18  ILS OR LOC RWY 23, Amdt 3C.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1084      3/26/18  ILS OR LOC RWY 36C, Amdt 16C.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1088      3/26/18  ILS OR LOC RWY 36L, Amdt 1.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1217      3/26/18  ILS OR LOC RWY 36R, Amdt 12.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1219      3/26/18  RNAV (RNP) Z RWY 5, Orig-A.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1275      3/26/18  RNAV (RNP) Z RWY 18C, Orig-C.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1276      3/26/18  RNAV (RNP) Z RWY 36C, Orig-D.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1279      3/26/18  RNAV (GPS) Y RWY 5, Amdt 3B.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1282      3/26/18  RNAV (GPS) Y RWY 18C, Amdt 3D.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1283      3/26/18  RNAV (GPS) Y RWY 18L, Amdt 4.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1286      3/26/18  RNAV (GPS) Y RWY 23, Amdt 1A.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1313      3/26/18  RNAV (GPS) Y RWY 36L, Amdt 1A.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1321      3/26/18  RNAV (GPS) Y RWY 36R, Amdt 4A.
                                                              Intl.
24-May-18................  NC           Charlotte..........  Charlotte/Douglas         8/1339      3/26/18  RNAV (GPS) Y RWY 36C, Amdt 3C.
                                                              Intl.
24-May-18................  OR           Pendleton..........  Eastern Oregon Rgnl       8/1743      3/22/18  RNAV (GPS) RWY 25, Orig-A.
                                                              at Pendleton.
24-May-18................  CA           Santa Rosa.........  Charles M Schulz-         8/1748      3/22/18  RNAV (GPS) RWY 32, Amdt 1C.
                                                              Sonoma County.
24-May-18................  MI           Grand Haven........  Grand Haven               8/1755      3/22/18  RNAV (GPS) RWY 27, Orig.
                                                              Memorial Airpark.
24-May-18................  NJ           Toms River.........  Ocean County.......       8/2519      3/22/18  Takeoff Minimums and Obstacle DP, Amdt 1A.
24-May-18................  VT           West Dover.........  Deerfield Valley          8/2942      3/22/18  RNAV (GPS) RWY 1, Orig-A.
                                                              Rgnl.
24-May-18................  IL           Chicago/Lake In The  Lake In The Hills..       8/2943      3/22/18  VOR RWY 26, Amdt 4.
                                         Hills.
24-May-18................  IA           Cedar Rapids.......  The Eastern Iowa...       8/2956      3/29/18  ILS OR LOC RWY 9, Amdt 18C.
24-May-18................  IA           Cedar Rapids.......  The Eastern Iowa...       8/2958      3/29/18  ILS OR LOC RWY 27, Amdt 6F.
24-May-18................  NE           Lincoln............  Lincoln............       8/2959      3/29/18  ILS OR LOC RWY 36, Amdt 11I.
24-May-18................  GA           Augusta............  Augusta Rgnl at           8/2961      3/22/18  ILS OR LOC RWY 17, Amdt 9A.
                                                              Bush Field.
24-May-18................  TX           Amarillo...........  Rick Husband              8/2967      3/29/18  VOR/DME RWY 13, Orig.
                                                              Amarillo Intl.
24-May-18................  KS           Eureka.............  Lt William M              8/3244      3/22/18  RNAV (GPS) RWY 18, Orig-A.
                                                              Milliken.
24-May-18................  KS           Eureka.............  Lt William M              8/3259      3/22/18  VOR/DME RWY 18, Amdt 2B.
                                                              Milliken.
24-May-18................  AL           Oneonta............  Robbins Field......       8/3747      3/29/18  Takeoff Minimums and Obstacle DP, Orig.

24-May-18................  WI           Clintonville.......  Clintonville Muni..       8/3775      3/22/18  Takeoff Minimums and Obstacle DP, Amdt 2.
24-May-18................  PA           Philadelphia.......  Philadelphia Intl..       8/4432      3/22/18  RNAV (GPS) RWY 27L, Amdt 3A.
24-May-18................  IN           Griffith...........  Griffith-                 8/4530      3/22/18  RNAV (GPS) RWY 8, Orig.
                                                              Merrillville.
24-May-18................  IN           Griffith...........  Griffith-                 8/4532      3/22/18  VOR RWY 8, Amdt 8A.
                                                              Merrillville.
24-May-18................  IN           Griffith...........  Griffith-                 8/4534      3/22/18  RNAV (GPS) RWY 26, Orig.
                                                              Merrillville.
24-May-18................  RI           Newport............  Newport State......       8/4781      3/29/18  VOR/DME RWY 16, Amdt 1B.
24-May-18................  RI           Newport............  Newport State......       8/4782      3/29/18  RNAV (GPS) RWY 16, Orig-B.
24-May-18................  IA           Denison............  Denison Muni.......       8/4938      3/29/18  RNAV (GPS) RWY 12, Amdt 1.
24-May-18................  KS           Concordia..........  Blosser Muni.......       8/6132      3/29/18  Takeoff Minimums and Obstacle DP, Amdt 1.
24-May-18................  ID           Salmon.............  Lemhi County.......       8/6800      3/29/18  RNAV (GPS)-D, Amdt 2.
24-May-18................  MI           Sturgis............  Kirsch Muni........       8/6813      3/29/18  NDB RWY 18, Amdt 5D.
24-May-18................  NJ           Teterboro..........  Teterboro..........       8/8120      3/22/18  RNAV (GPS) Y RWY 19, Orig.
24-May-18................  CT           Windsor Locks......  Bradley Intl.......       8/8445      3/23/18  Takeoff Minimums and Obstacle DP, Amdt 3.
24-May-18................  TN           Memphis............  Memphis Intl.......       8/9753      3/29/18  RNAV (GPS) Z RWY 18R, Amdt 2E.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2018-08138 Filed 4-19-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28275-28276]
[FR Doc No: 2015-11846]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1377]

Electronic Study Data Submission; Data Standards; Study Data
Standardization Plan Recommendations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of draft recommendations for preparing a Study Data
Standardization Plan (Standardization Plan). The Standardization Plan
is referenced in the Study Data Technical Conformance Guide (Guide).
The Guide supplements the guidance for industry ``Providing Regulatory
Submissions in Electronic Format--Standardized Study Data'' and
provides specifications, recommendations, and general considerations on
submitting standardized study data using FDA-supported data standards.
The Guide recommends that, for clinical and nonclinical studies,
sponsors include a plan that describes the submission of standardized
study data to FDA. The proposed recommendations describe the
information that should be included in the Standardization Plan. The
proposed recommendations for creating a Standardization Plan are posted
on FDA's Study Data Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.

DATES: Although you can comment on these recommendations at any time,
to ensure that the Agency considers your comments, please submit either
electronic or written comments by July 2, 2015.

ADDRESSES: Submit written requests for single copies of the
recommendations to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 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.
    Submit electronic comments to http://www.regulations.gov. Submit

written comments to the Division of Dockets Management (HFA-305), Food
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852. See the SUPPLEMENTARY INFORMATION section for electronic access
to the draft recommendations for preparing the Standardization Plan.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993-002, 301-
796-5333, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of draft recommendations for
preparing the Standardization Plan. The Standardization Plan is
referenced in the Guide. The Guide supplements the guidance for
industry ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data'' and provides specifications, recommendations,
and general considerations on submitting standardized study data using
FDA-supported data standards; it is posted on FDA's Study Data
Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm.
    The Guide recommends that, for clinical and nonclinical studies,
sponsors include a plan that describes the submission of standardized
study data to FDA. The Standardization Plan will assist FDA in
identifying potential data standardization issues early in the
development program (e.g., pre-investigational new drug application
stage). The draft recommendations describe the information that should
be included in the Standardization Plan. The recommendations include,
but are not limited to, the following: (1) General sponsor information,
(2) product information, (3) list of completed studies and standards,
and (4) list of planned studies and standards.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the proposed
recommendations at either http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm or http://www.regulations.gov.

    Dated: May 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11846 Filed 5-15-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Notices]
[Pages 22990-22991]
[FR Doc No: 2015-09551]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC15-104-000.
    Applicants: Tilton Energy, LLC, Rocky Road Power, LLC.
    Description: Supplement to March 27, 2015 Application for Approval
Pursuant to Section 203 of the FPA of Tilton Energy LLC and Rocky Road
Power, LLC.
    Filed Date: 4/17/15.
    Accession Number: 20150417-5386.
    Comments Due: 5 p.m. ET 4/24/15.

    Docket Numbers: EC15-125-000.
    Applicants: Blue Sky West, LLC.
    Description: Application for Authorization Under Section 203 of the
Federal Power Act and Request for Waivers, Confidential Treatment,
Expedited Action and Shortened Comment Period of Blue Sky West, LLC.
    Filed Date: 4/17/15.
    Accession Number: 20150417-5358.
    Comments Due: 5 p.m. ET 5/8/15.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER15-960-000.
    Applicants: CPV Biomass Holdings, LLC.
    Description: Second Supplement to February 2, 2015 CPV Biomass
Holdings, LLC tariff filing.
    Filed Date: 4/17/15.
    Accession Number: 20150417-5276.
    Comments Due: 5 p.m. ET 4/24/15.

    Docket Numbers: ER15-994-001.

    Applicants: PJM Interconnection, L.L.C.
    Description: Annual Compliance Report Regarding Operating Penalties
of PJM Interconnection, L.L.C.
    Filed Date: 4/17/15.
    Accession Number: 20150417-5387.
    Comments Due: 5 p.m. ET 5/8/15.

    Docket Numbers: ER15-1530-000.
    Applicants: New England Power Company.
    Description: Section 205(d) rate filing per 35.13(a)(2)(iii):
Amendment to REMVEC II Agreement and Request for Waiver of Notice
Requirement to be effective 4/30/2015.
    Filed Date: 4/17/15.
    Accession Number: 20150417-5343.
    Comments Due: 5 p.m. ET 5/8/15.

    Docket Numbers: ER15-1531-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Compliance filing per 35: Distribution of Penalty
Revenues for Non-Firm PTP to be effective 4/17/2015.
    Filed Date: 4/20/15.
    Accession Number: 20150420-5001.
    Comments Due: 5 p.m. ET 5/11/15.

    Docket Numbers: ER15-1532-000.
    Applicants: Southern California Edison Company.
    Description: Tariff Withdrawal per 35.15: Notices of Cancellation
SGIA and Distribution Serv Agmt Greenpower Williams LLC to be effective
6/20/2015.
    Filed Date: 4/20/15.
    Accession Number: 20150420-5005.
    Comments Due: 5 p.m. ET 5/11/15.

    Docket Numbers: ER15-1533-000.
    Applicants: DTE Electric Company.
    Description: Notice of Cancellation of Electric Rate Schedule FERC
No. 23 of DTE Electric Company.
    Filed Date: 4/17/15.
    Accession Number: 20150417-5355.
    Comments Due: 5 p.m. ET 5/8/15.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES15-17-000.
    Applicants: PJM Interconnection, L.L.C., PJM Settlement, Inc.
    Description: Application of PJM Interconnection, L.L.C. and PJM
Settlement, Inc. Under Section 204 of the Federal Power Act for an
Order Authorizing Issuances of Securities and Approving Guranty.
    Filed Date: 4/17/15.
    Accession Number: 20150417-5356.
    Comments Due: 5 p.m. ET 5/8/15.

    Docket Numbers: ES15-18-000.
    Applicants: MDU Resources Group, Inc.
    Description: Application to issue securities and authorization to
engage in methods of issuance other than competitive bidding and
negotiated offers for 401(k) retirement plan of MDU Resources Group,
Inc.
    Filed Date: 4/17/15.
    Accession Number: 20150417-5388.
    Comments Due: 5 p.m. ET 5/8/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 20, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-09551 Filed 4-23-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 213 (Tuesday, November 4, 2014)]
[Notices]
[Pages 65408-65409]
[FR Doc No: 2014-26143]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0312]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Extralabel Drug Use in Animals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the reporting requirements
associated with extralabel drug use in animals.

DATES: Submit electronic or written comments on the collection of
information by January 5, 2015.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information''is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Extralabel Drug Use in Animals--21 CFR 530 (OMB Control Number--0910-
0325)--Extension

    The Animal Medicinal Drug Use Clarification Act of 1994 allows a
veterinarian to prescribe the extralabel use of approved new animal
drugs. Also, it permits FDA, if it finds that there is a reasonable
probability that the extralabel use of an animal drug may present a
risk to the public health, to establish a safe level for a residue from
the extralabel use of the drug, and to require the development of an
analytical method for the detection of residues above that established
safe level. Although to date we have not established a safe level for a
residue from the extralabel use of any new animal drug and, therefore,
have not required the development of analytical methodology, we believe
that there may be instances when analytical methodology will be
required. We are, therefore, estimating the reporting burden based on
two methods being required annually. The requirement to establish an
analytical method may be fulfilled by any interested person. We believe
that the sponsor of the drug will be willing to develop the method in
most cases. Alternatively, FDA, the sponsor, and perhaps a third party
may cooperatively arrange for method development. The respondents may
be sponsors of new animal drugs, State, or Federal Agencies, academia,
or individuals.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
         21 CFR section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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530.22(b).......................               2               1               2           4,160           8,320
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: October 29, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-26143 Filed 11-3-14; 8:45 am]
BILLING CODE 4164-01-P