Analysis of impact of Evansville Urban Area on Dubois County PM 2.5 Concentrations S ummary The Jasper, Indiana monitoring site, in Dubois County, currently has a design value exceeding the PM2.5 National Ambient Air Quality Standard ( NAAQS). Jasper is located approximately 45 miles northeast of Evansville. Because the Evansville ( Vanderburgh County) design value from 2001  2003 also exceeded the NAAQS, that area is also being considered for nonattainment designation. However, it appears that 2004 data will drive the design value below the NAAQS in Vanderburgh County. Discussions have recently centered around whether or not EPA should proceed with a nonattainment designation of Vanderburgh County ( and other Evansville Urban Area counties) because of its possible impact on the Dubois County monitor value.

The Dubois County monitor is one of three non urban PM2.5 sites operated by IDEM in southwest Indiana. Additional sites are in Knox and Spencer Counties. In addition, there is an Interagency Monitoring of Protected Visual Environments ( IMPROVE) site operated at Livonia in Washington County. The site in Spencer County is in Dale, approximately 15 miles due south of Jasper, almost on the southern Dubois County border. There is a map of the monitoring locations on the following page.

The Dubois County site has consistently averaged higher than any other non urban sites in southwest Indiana. Table 1 shows these differences from 2001  2003.

Table 1 Design values for southwestern Indiana PM2.5 sites County 2001 2002 2003 Dubois 16.54 16.34 15.72 Knox 13.39 14.20 13.96 Spencer 14.52 14.06 14.63 Livonia 13.30 12.26 12.30 In attempting to determine why Dubois County has had higher values, several analyses have been performed. Regionally, there are significant amounts of emissions from large utilities in southwestern Indiana, as well as utilities in southern Illinois and Kentucky. There are a significant number of wood furniture manufacturers located in the Jasper area. Many of these burn scrap wood in boilers. Emissions from these sources are not large annually, but wood is generally burned when supplies accumulate. These sources could impact the monitoring site on certain days, but this has not been clearly established. Emissions from heavy duty diesel trucks and other traffic along US 231, a major north south highway which passes several hundred yards west of the site, may also be impacting monitored values, but data to quantify such an impact are not available. Therefore, an analysis of meteorological data and monitoring values at nearby sites was performed.

The following conclusions about Dubois County data were reached based upon this analysis:

1. Average wind directions for the 2002  2003 time period were primarily from the south and southwest.

2. Background levels at the other sites were all 12  14 ug/ m3 for an annual average.

3. Wind directions from days with high PM2.5 values at Dubois County are seldom from Vanderburgh County. An analysis of wind direction on days with the highest values, e. g. over 20 ug/ m3, at the Jasper site in Dubois County showed that the wind direction seldom was from the south or southwest ( origin of Vanderburgh County). 4. On days with high values at Dubois County, the other sites are usually high also. This analysis also showed that generally when one non urban site in southwest Indiana was over 20 ug/ m3, the others were also. On these days, these sites were seldom impacted by an air mass that moved over the Evansville area. On days in which Evansville was directly upwind of Dubois County, the Dubois values were relatively the same as the other sites not impacted by Evansville. For the Dubois County site, the mass for the days with values above 20 ug/ m3 contributed about 3 ug/ m3 to the annual average.

5. PM2.5 values for this area are greatly impacted by regional transport. Speciated data are not available from sites operated by IDEM. However, the Livonia IMPROVE site and others in the general area show that sulfate is the predominate portion of the sample, followed by organic carbon. This indicates emissions from regional transport sources, such as utilities, is a major contributor to concentrations in the area. For Vanderburgh County, SO2 emissions for the past three years have averaged less than 40 tons per year. Reducing these emissions to zero would likely have little to no impact on Dubois County.

Gibson Pike Dubois Spencer Warrick Vanderburgh LIVONIA 200 W. 6TH ST FIRE STATION # 17 SW PURDUE AG FARM UNIV OF EVANSVILLE DAVID TURNHAM SCHOOL CIVIC CENTER COURTS BLDG Legend County PM 2.5 Monitor Southwest Indiana PM2.5 Monitors 0 9 18 4.5 Miles Detailed Analysis Data Used for Analysis Information was gathered through the Indiana climate page on the Purdue Applied Meteorology Group   Department of Agronomy website http:// shadow. agry. purdue. edu/ sc. hly geog. html. Southern Purdue Agricultural Research Center in Dubois, Dubois County was selected.

Graph 1 shows the wind rose from Dubois County for 2002. The wind blows most frequently from the south, south southwest, north northwest, south southeast, southwest and northwest.

Graph 1 Wind Rose Analysis for Dubois County for 2002 Graph 2 shows the wind rose from Dubois County for 2003. The wind blows most frequently from the southsouthwest south, south southeast, west northwest, northwest, southeast and north northwest.

Graph 2 Wind Rose Analysis for Dubois County for 2003 Analysis of data values 20 ug/ m3 and over An analysis was performed to determine if high values were associated with different wind directions. IDEM had made wind roses for 2002 and 2003 high days earlier, so these were used for the analysis. The days used for this analysis are in Table 2.

Table 2 2002 2003 Dubois Knox Spencer Livonia Wind Direction Dubois Knox Spencer Livonia Wind Direction 1/ 2/ 2002 21.6 13.2 20.2 NW  NE 1/ 30/ 2003 38.2 27.2 23.9 NE S 1/ 20/ 2002 20.6 15.6 18.6 15.2 SE S 2/ 26/ 2003 29.1 24.0 22.4 16.8 NE S 3/ 18/ 2002 23.9 18.0 18.3 N NE 3/ 1/ 2003 52.9 49.8 29.6 NW 6/ 4/ 2002 24.7 28.0 S SW 3/ 7/ 2003 18.1 21.6 11.5 SE SW 6/ 10/ 2002 21.9 21.9 18.9 SE S 3/ 13/ 2003 50.0 29.3 22.3 NW SE 6/ 19/ 2002 28.2 28.3 27.8 SE S 4/ 18/ 2003 30.2 28.3 23.5 SW NW 6/ 22/ 2002 31.6 38.6 32.0 E SE 6/ 17/ 2003 25.1 27.7 22.0 NW NE 6/ 25/ 2002 20.8 15.5 20.5 14.3 SE SW 6/ 23/ 2003 16.4 24.2 20.2 SE 7/ 1/ 2002 27.2 25.3 27.2 27.2 N* 6/ 29/ 2003 21.4 22.1 17.7 SE SW 7/ 4/ 2002 33.9 35.9 27.8 NE* 7/ 2/ 2003 21.4 34.4 24.7 18.2 NW 7/ 10/ 2002 22.0 19.9 18.0 NE* 7/ 5/ 2003 20.8 18.6 24.2 SW 7/ 13/ 2002 29.4 28.7 26.5 24.4 NE* 7/ 14/ 2003 22.0 25.7 22.9 22.1 SE 7/ 16/ 2002 43.1 43.8 33.7 SE* 7/ 20/ 2003 38.0 29.0 35.3 S SW 7/ 22/ 2002 23.5 23.9 7/ 26/ 2003 24.6 22.0 24.8 25.6 S SW 7/ 25/ 2002 20.3 21.4 25.3 15.7 NE SE* 8/ 1/ 2003 31.4 26.4 27.9 27.3 SW 7/ 31/ 2002 23.3 18.9 26.7 8/ 13/ 2003 38.0 33.9 34.6 37.2 NE SE 8/ 3/ 2002 45.6 SE* 8/ 16/ 2003 26.0 21.9 27.0 NW 8/ 12/ 2002 24.5 24.0 24.3 22.6 SE SE* 8/ 19/ 2003 24.4 22.7 24.0 N SE 8/ 21/ 2002 25.1 26.2 22.0 SE S 8/ 22/ 2003 25.7 25.7 22.1 S SW 8/ 27/ 2002 23.8 20.3 N NE 8/ 25/ 2003 31.6 27.8 31.0 31.6 SW 8/ 30/ 2002 25.5 22.3 19.9 NE E 8/ 28/ 2003 21.7 18.6 20.4 S SW 9/ 2/ 2002 21.3 21.1 SE SW 9/ 12/ 2003 39.5 37.9 38.1 32.2 SE 9/ 8/ 2002 36.3 31.0 SE SW 9/ 18/ 2003 20.5 19.7 20.0 21.2 NE 9/ 17/ 2002 27.8 24.7 28.4 22.0 SE 9/ 21/ 2003 20.8 17.4 22.8 NE SE 9/ 29/ 2002 21.7 25.2 20.6 19.9 E SE 10/ 9/ 2003 24.2 28.5 18.3 SE 11/ 28/ 2002 20.4 18.2 13.7 SW 11/ 11/ 2003 22.0 22.4 18.9 16.6 SW 12/ 7/ 2002 31.5 19.7 S SW 12/ 10/ 2002 25.0 21.5 16.2 NE * Wind directions taken from Evansville NWS site. See the attachments for a complete set of wind roses for Dubois and Evansville meteorological sites. Data from the two sites are comparable so Evansville data was substituted where Dubois County data was unavailable.

PM2.5 data used for the Livonia site is from http:// vista. cira. colostate. edu/ improve/. This sampler uses a different protocol than the FRM sites, but results are similar. The Dubois, Knox, and Livonia sites operate on a 1 in 3 day schedule, while Spencer County is 1 in 6 days. Therefore, the analysis was done on a 1 in 6 day schedule so that data would be comparable. This analysis showed:  When Dubois County site was high, generally, so also were the other non urban sites, indicating a regional contribution to the samples  The days with values over 20 ug/ m3 contributed nearly 3 ug/ m3 to the annual average. This was calculated by the following method: 1. summing the values of the 28 days for 2002, sum = 744.5, 26 days for 2003 = 734 2. calculating the baseline of 15 ug/ m3 for those days; 28 x 15 = 420 for 2002, 26 x 15= 390 for 2003 3. subtracting the baseline from the sum of the values; 744.5  420 = 324.5, 734  390 = 344 4. dividing each by 122 sample days for an entire year; 324.5/ 122= 2.66 for 2002, 2.82 for 2003 When these values are removed from the 2001  2003 design value of 16.2 ug/ m3 for Dubois County, it can be seen that the value would be well below the NAAQS of 15 ug/ m3. While an impact from Vanderburgh County could be included in the background concentrations, clearly there is a regional component that needs to be examined. Available data does not show that high values are more likely to occur at the Jasper site when the air mass is from the Evansville area.

Speciation information No speciated data is available for Dubois County. However, it is available for Livonia and several other sites in the area. The map below shows the results. Sulfates are a major component of the sample in this area, impacted greatly by the regional transport of emissions from large utilities. In this area, most pie charts look similar. While Evansville emissions could impact Dubois County, the point source emissions from Vanderburgh County have averaged under 40 tons/ year from 2001  2003. See the attachments for the inventory spreadsheet. Reducing these emissions to zero will not likely solve the attainment problems in Dubois County. Several of the counties in the area have large utilities. Addressing their regional impact through the NOx SIP Call and the Clean Air Interstate Rule will provide a better means of achieving attainment in this area. Another source of emissions impacting the samples could be mobile source emissions. These emissions are also properly addressed by a regional process, which EPA has already started with heavy duty diesel engine and diesel fuel rules, for both on and off road vehicles.


Subject:	Meeting with Holcim Cement to Discuss Statistical Methods

Location:	U.S. Environmental Protection Agency, Research Triangle Park, NC

Date: 		June 9, 2010

Participants:

Holcim

Hector Ybanez, Holcim

Dr. William Mills, Mills Consulting

U.S. Environmental Protection Agency (EPA)

Keith Barnett, SPPD, OAQPS

Steve Silverman, OGC (by phone)

RTI International

Mike Laney

Roy Neulicht

Breda Munoz

Representatives of Holcim Cement met with EPA to discuss the use of the upper predictive limit (UPL) and the variability associated with mercury in coals as well as intra-quarry variability of mercury concentrations. Other topics included autocorrelation of  consecutive mercury emissions data,  appropriate methods for the analysis of both long-term and short-term THC CEMS data, accounting for THC emissions from coal mills, clinker production monitoring issues, and issues associated with kiln startup and shutdown.


[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Page 43840]
[FR Doc No: 2022-15720]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3509-042]

Little Falls Hydroelectric Associates, LP; Notice of Waiver
Period for Water Quality Certification Application

    On July 14, 2022, Little Falls Hydroelectric Associates, LP,
submitted to the Federal Energy Regulatory Commission (Commission) a
copy of its application for a Clean Water Act section 401(a)(1) water
quality certification filed with the New York State Department of
Environmental Conservation (New York DEC), in conjunction with the
above captioned project. Pursuant to 40 CFR 121.6 and section
[4.34(b)(5), 5.23(b), 153.4, or 157.22] of the Commission's
regulations,\1\ we hereby notify the New York DEC of the following:
---------------------------------------------------------------------------

    \1\ 18 CFR [4.34(b)(5)/5.23(b)/153.4/157.22].
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    Date of Receipt of the Certification Request: July 14, 2022.
    Reasonable Period of Time to Act on the Certification Request: July
14, 2023.
    If New York DEC fails or refuses to act on the water quality
certification request on or before the above date, then the agency
certifying authority is deemed waived pursuant to section 401(a)(1) of
the Clean Water Act, 33 U.S.C. 1341(a)(1).

    Dated: July 18, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-15720 Filed 7-21-22; 8:45 am]
BILLING CODE 6717-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES AND

TOXIC SUBSTANCES

MEMORANDUM

Date:  June 2, 2008

SUBJECT:	Denatonium Saccharide (PC code 129045). Revised Human Health
Risk Scoping Document in Support of Registration Review.  DP Barcode
D352579.

FROM:	Yan Donovan, Risk Assessor

		Health Effects Division (7509P)

		Office of Pesticide Programs

THRU:	Ray Kent, Branch Chief

		Susan Hummel, Senior Scientist

		Reregistration Action Branch 4

		Health Effects Division (7509P)

		Office of Pesticide Programs

TO:	Joy Schnackenbeck

		Chemical Review Manager

		Special Review and Reregistration Division (7508P)

		Office of Pesticide Programs

Executive Summary

Health Effects Division’s (HED) denatonium saccharide scoping team has
revised the revised human health risk assessment status update issued on
May 8, 2008.  Denatonium saccharide is registered as a repellent or
feeding depressant to reduce chewing and biting damage to outdoor
structures and surfaces by tree squirrels, dogs and cats.  Currently
there is only one active registered product (Ro-Pel).  No dietary,
residential, or aggregate risk assessment was conducted before.  The
Agency’s most recent documentation on denatonium saccharide was a memo
dated May 9, 1996, where it was concluded that acute oral, dermal, and
inhalation toxicities for the formulated product are all category IV.
Denatonium saccharide is not an eye or skin irritant (Category IV).  It
is not a skin sensitizer.   No subchronic or chronic toxicity studies
are available.  Denatonium saccharide and denatonium benzoate (Bitrex)
both share the same cation: denatonium, which is a quaternary ammonium
cation.  No subchronic or chronic toxicity studies are available on
denatonium benzoate either.  Based on acute toxicity studies on the
denatonium benzoate salt, the acute oral LD50 is category III, the acute
inhalation LC50 is II, but the acute dermal LD50 study is unacceptable.

HED’s denatonium saccharide scoping team concludes that since this is
a non-food use chemical, it is not subject to FQPA, therefore, no
aggregate risk assessment is needed for the Registration Review of
denatonium saccharide.  However, depending on the outcome of the
Agency’s drinking water exposure assessment, a dietary assessment
(drinking water exposure only) may be needed.  An ORE assessment may be
needed if denatonium saccharide is shown to be dermally absorbed.  As
for the data requirements, HED’s scoping team concludes that a dermal
absorption study on the denatonium saccharide active ingredient is
needed to determine if there is potential dermal exposure to residential
handlers.  A 90-day oral on rodent may be needed to assess chronic
dietary (water only) risk to denatonium saccharide.

Introduction

HED has evaluated the status of the human health assessment for
denatonium saccharide to determine whether sufficient data are available
and whether a new or updated human health risk assessment is needed to
support Registration Review.  HED has considered the most recent risk
assessments for denatonium saccharide, HED databases, the OPPIN
database, and a Google online search during the process of this scoping.
 For a complete listing of the references, see Reference Section at the
end of this memo.

Denatonium saccharide and denatonium benzoate (Bitrex) both share the
same cation: denatonium, which is a quaternary ammonium cation.
Denatonium cation is the most bitter substance known to date - dilutions
of as little as 10 ppm are unbearably bitter to humans.  The salts are
often used as aversive agents to prevent accidental ingestion (Google
search-Wikipedia).   Denatonium saccharide is registered as a repellent
or feeding depressant to reduce chewing and biting damage to outdoor
structures and surfaces (such as bark of trees, fences, poles, decks,
planters, siding, garbage cans, and furniture) by tree squirrels, dogs
and cats.  Currently there is only one active registered product: Ro-Pel
Tree Squirrel, Vole, Dog, and Cat Repellent (EPA Reg. # 81117-1).   It
is a ready-to-use liquid formulation which contains 0.065% denatonium
saccharide and 0.035% thymol.  This scoping document is for the
denatonium saccharide active ingredient only.  All products containing
denatonium benzoate as an active ingredient have been cancelled.

Hazard Identification/Toxicology

No subchronic or chronic toxicity studies are available for denatonium
saccharide.   Acute oral, dermal, and inhalation toxicities are category
IV for the product formulation.  Denatonium saccharide is not an eye or
skin irritant (Category IV).  It is not a skin sensitizer (Agency memo
of 05/09/1996, C. Glasgow).  No subchronic or chronic toxicity studies
are available on denatonium benzoate either.  Based on acute toxicity
studies on the benzoate active ingredient, the acute oral LD50 is
category III, the acute inhalation LC50 is II, but the acute dermal LD50
study is unacceptable (HED memo of 10/23/2007, E. Reaves, TXR Nos.
0054508).

A screening search on OPP’s incident data system (IDS) indicated that
no incident has been reported for denatonium saccharide.

Conclusions: The HED registration review scoping team determined that a
dermal absorption study is needed to determine potential dermal exposure
to residential handlers.  Depending on the outcome of the Agency’s
drinking water exposure assessment, a 90-day oral study on rodent may be
needed to assess chronic dietary (drinking water only) risk to
denatonium saccharide.

Exposures

No dietary or residential exposure assessment was conducted previously.

Conclusions: There are no food uses for denatonium saccharide and
contamination of home grown produce from residential use of denatonium
saccharide is unlikely, so exposure from consumption of food is not
assessed.  Dietary exposure from drinking water is not known at this
time since the Environmental Fate and Effects Division (EFED) does not
have enough environmental fate data to make the determination yet.
Depending on the outcome of EFED’s drinking water assessment, a
chronic dietary assessment for drinking water exposure only may be
needed.  HED does not believe that there is acute dietary risk of
concern, because denatonium saccharide is such a bitter compound that it
is unlikely that human will accidentally consume enough to cause any
acute toxic effects.

Exposures to residential handlers during application can occur.
Denatonium saccharide is a ready-to-use liquid formulation which can be
applied using paintbrush or sprayer.  Dermal and inhalation exposures
can occur during application, especially dermal exposure. A residential
handler dermal assessment may be necessary if denatonium saccharide is
dermally absorbed.  HED does not believe that risk from inhalation
exposure will be of concern since this product is to be applied using
coarse spray or paint brush, and the % ai in the RTU liquid formulation
is very low (0.065%).

Aggregate

No aggregate risk assessment was conducted previously.

Conclusions:  HED’s scoping team concluded that since this is a
non-food use chemical, therefore, it is not subject to FQPA.  No
aggregate risk assessment is needed.

Occupational Exposure and Risk

No occupational risk assessment was conducted previously.

Conclusions: HED’s scoping team concludes that although there are
exposure scenarios to workers who apply the pesticide, no occupational
handler assessment is needed at this time, based on the low acute
toxicity of the formulation, the required personal protective equipment
stated on the product label, and the fact that no incidents have been
reported so far.

Data Requirements

A dermal absorption study on the saccharide active ingredient is needed.

A 90-day oral study on rodent may be needed.

References

Bibliography for Denatonium saccharide and Denatonium benzoate (OPPIN
database);

Agency memo of 05/09/1996, C. Glasgow, “EPA File Symbol/EPA Reg. No.:
45735-2/RoPel Animal, Rodent and Bird Repellant”;

HED memo of 10/23/2007, E. Reaves, TXR Nos. 0054508, “RED-0350-26839:
Denatonium benzoate/Bitrex”.  D340792;

Google online search- Denatonium- Wikipedia;

Google on line search- Denatonium saccharide- ChemBlink.

DCI Table

Guideline Number: 870.7600

Study Title:  Dermal Penetration Study

Rationale for Requiring the Data

The use pattern of this product results in potential dermal exposure to
handlers.

Practical Utility of the Data

How will the data be used?

To determine how much, if any, the saccharide is absorbed through the
skin.

How could the data impact the Agency's future decision-making?

The result of this data will affect whether or not EAP needs to do a
dermal exposure assessment for residential handlers.  If EPA does not
have this data, then 100% absorption will needed to be assumed, and a
repeated dose dermal study will be required to assess handler dermal
exposure.

Guideline Number: 870.3100

Study Title:  90-day Oral Study on Rodent

Rationale for Requiring the Data

This study is required for non-food use pesticides if oral exposure
could occur.  The 90-day rat oral study is required for hazard
characterization (possibly endpoint selection) and dose-setting for the
chronic/carcinogenicity study (40 CRF parts 9 and 158, subpart F).  In
the case of denatonium saccharide, the scoping conclusions indicated
that there may be dietary exposure from drinking water; therefore, it is
recommended that a 90-day study be conducted to assess chronic dietary
risk.

Practical Utility of the Data

How will the data be used?

The results of this study will be used to characterize the hazard of
denatonium saccharide and serve as the base for chronic dietary endpoint
selection.

How could the data impact the Agency's future decision-making?

The result of this data may affect the Agency’s decision to continue
to grant the existing use of denatonium saccharide with or without risk
mitigations.

Page   PAGE  4  of   NUMPAGES  6


[Federal Register Volume 82, Number 29 (Tuesday, February 14, 2017)]
[Notices]
[Page 10611]
[FR Doc No: 2017-02932]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79992; File No. 265-29]

Equity Market Structure Advisory Committee

AGENCY: Securities and Exchange Commission.

ACTION: Notice of Federal Advisory Committee Renewal.

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

SUMMARY: The Securities and Exchange Commission is publishing this
notice to announce that the Chair of the Commission, with the
concurrence of the other Commissioners, has approved the renewal of the
Securities and Exchange Commission Equity Market Structure Advisory
Committee.

FOR FURTHER INFORMATION CONTACT: Molly Kim, Assistant Director,
Division of Trading and Markets, Securities and Exchange Commission,
100 F Street NE., Washington, DC 20549,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In accordance with the requirements of the
Federal Advisory Committee Act, 5 U.S.C.--App., the Commission is
publishing this notice that the Chair of the Commission, with the
concurrence of the other Commissioners, has approved the renewal of the
Securities and Exchange Commission Equity Market Structure Advisory
Committee (the ``Committee''). The Chair of the Commission affirms that
the renewal of the Committee is necessary and in the public interest.
    The Committee's objective is to provide the Commission with diverse
perspectives on the structure and operations of the U.S. equities
markets, as well as advice and recommendations on matters related to
equity market structure.
    No more than seventeen voting members will be appointed to the
Committee, representing a cross-section of those directly affected by,
interested in, and/or qualified to provide advice to the Commission on
matters related to equity market structure. The Committee's membership
will continue to be balanced fairly in terms of points of view
represented and functions to be performed.
    The Charter provides that the duties of the Committee are to be
solely advisory. The Commission alone will make any determinations of
actions to be taken and policies to be expressed with respect to
matters within the Commission's jurisdiction as to which the Committee
provides advice or makes recommendations. The Committee will meet at
such intervals as are necessary to carry out its functions. The charter
contemplates that the full Committee will meet two times. Meetings of
subgroups or subcommittees of the full Committee may occur more
frequently.
    The Committee will terminate six months from the date it is renewed
or such earlier date as determined by the Commission unless, before the
expiration of that time period, it is renewed in accordance with the
Federal Advisory Committee Act. A copy of the charter for the Committee
has been filed with the Chair of the Commission, the Committee on
Banking, Housing, and Urban Affairs of the United States Senate, the
Committee on Financial Services of the United States House of
Representatives, the Committee Management Secretariat of the General
Services Administration, and the Library of Congress. It also has been
posted on the Commission's Web site at www.sec.gov.

    By the Commission.

    Dated: February 9, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-02932 Filed 2-13-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 159 (Thursday, August 16, 2012)]
[Notices]
[Pages 49449-49450]
[FR Doc No: 2012-19852]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Food and Drug Administration Clinical Trial Requirements,
Compliance, and Good Clinical Practice; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

    The Food and Drug Administration (FDA), Office of Regulatory
Affairs (ORA), Dallas District Office, in co-sponsorship with the
Society of Clinical Research Associates (SoCRA) is announcing a public
workshop. The public workshop on FDA's clinical trial requirements is
designed to aid the clinical research professional's understanding of
the mission, responsibilities, and authority of FDA and to facilitate
interaction with FDA representatives. The program will focus on the
relationships among FDA and clinical trial staff, investigators, and
institutional review boards (IRBs). Individual FDA representatives will
discuss the informed consent process and informed consent documents;
regulations relating to drugs, devices, and biologics; as well as
inspections of clinical investigators, IRBs, and research sponsors.
    Date and Time: The public workshop will be held on March 6 and 7,
2013, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Sheraton Dallas
Hotel, 400 North Olive St., Dallas, TX 75201,<PHONE_NUMBER>.
    Attendees are responsible for their own accommodations. Please
mention SoCRA to receive the hotel room rate of $145 plus applicable
taxes (available until February 3, 2013, or until the SoCRA room block
is filled).
    Contact: David Arvelo, Office of Regulatory Affairs, Food and Drug
Administration, Southwest Regional Office, 4040 North Central
Expressway, Suite 900, Dallas, TX 75204,<PHONE_NUMBER>, Fax: 214-253-
4970, email<EMAIL_ADDRESS>or SoCRA, 530 West Butler Ave.,
Suite 109, Chalfont, PA 18914,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>Web site: http://www.SoCRA.org.
    Registration: The registration fee covers the cost of actual
expenses, including refreshments, lunch, materials, and speaker
expenses. Seats are limited; please submit your registration as soon as
possible. Workshop space will be filled in order of receipt of
registration. Those accepted into the workshop will receive
confirmation. The cost of registration is as follows:

SoCRA member, $575.00
SoCRA nonmember (includes membership), $650.00
Federal Government SoCRA member, $450.00
Federal Government SoCRA nonmember, $525.00
FDA Employee, Fee Waived

    If you need special accommodations due to a disability, please
contact SoCRA (see Contact) at least 21 days in advance.
    Extended periods of question and answer and discussion have been
included in the program schedule. SoCRA designates this educational
activity for a maximum of 13.3 Continuing Education (CE) credits for
SoCRA CE and Nurse continuing nursing education (CNE). SoCRA designates
this educational activity for a maximum of 13.3 American Medical
Association Physicians Recognition Award Category 1
Credit(s)TM. Physicians should claim credit commensurate
with the extent of their participation. SoCRA is accredited by the
Accreditation Council for Continuing Medical Education to provide
continuing medical education for physicians. SoCRA is an approved
provider of CNE by the Pennsylvania State Nurses Association (PSNA), an
accredited approver by the American Nurses Credentialing Center's
Commission on Accreditation (ANCC). ANCC/PSNA Provider Reference
Number: 205-3-A-09.
    Registration Instructions: To register, please submit a
registration form with your name, affiliation, mailing address, phone,
fax number, and email, along

with a check or money order payable to ``SoCRA''. Mail to: SoCRA (see
Contact for address). To register via the Internet, go to http://www.socra.org/html/FDA_Conference.htm. (FDA has verified the Web site
address, but we are not responsible for any subsequent changes to the
Web site after this document is published in the Federal Register.)
    Payment by major credit card is accepted (Visa/MasterCard/AMEX
only). For more information on the meeting registration, or for
questions on the workshop, contact SoCRA (see Contact).

SUPPLEMENTARY INFORMATION: The public conference helps fulfill the
Department of Health and Human Services' and FDA's important mission to
protect the public health. The workshop will provide those engaged in
FDA-regulated (human) clinical trials with information on a number of
topics concerning FDA requirements related to informed consent,
clinical investigation requirements, IRB inspections, electronic record
requirements, and investigator initiated research. Topics for
discussion include the following: (1) What FDA Expects in a
Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--Science,
Regulation, Error, and Safety; (3) Part 11 Compliance--Electronic
Signatures; (4) Informed Consent Regulations; (5) IRB Regulations and
FDA Inspections; (6) Keeping Informed and Working Together; (7) FDA
Conduct of Clinical Investigator Inspections; (8) Meetings With FDA:
Why, When, and How; (9) Investigator Initiated Research; (10) Medical
Device Aspects of Clinical Research; (11) Working With FDA's Center for
Biologics Evaluation and Research; (12) The Inspection Is Over--What
Happens Next? Possible FDA Compliance Actions; (13) Ethical Issues in
Subject Enrollment; (14) Medical Device Aspects of Clinical Research;
and (15) Are We There Yet? An Overview of the FDA Good Clinical
Practice Program.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The public workshop helps to achieve objectives set
forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C.
393), which includes working closely with stakeholders and maximizing
the availability and clarity of information to stakeholders and the
public. The public workshop also is consistent with the Small Business
Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) as
outreach activities by Government Agencies to small businesses.

    Dated: August 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19852 Filed 8-15-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Notices]
[Pages 49932-49933]
[FR Doc No: 2018-21519]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1175]

Atopic Dermatitis: Timing of Pediatric Studies During Development
of Systemic Drugs; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Atopic
Dermatitis: Timing of Pediatric Studies During Development of Systemic
Drugs.'' This guidance addresses FDA's current thinking about the
relevant age groups to study and how early in drug development
applicants should incorporate pediatric patients for development of
systemic drugs for atopic dermatitis (AD). This guidance finalizes the
draft guidance of the same name issued on April 9, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on October 3, 2018.

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-1175 for ``Atopic Dermatitis: Timing of Pediatric Studies
During Development of Systemic Drugs.'' 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. 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: Dawn Williams, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5168, Silver Spring, MD 20993-0002, 301-
796-5376; 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 ``Atopic Dermatitis: Timing of Pediatric Studies During
Development of Systemic Drugs.'' This guidance addresses FDA's current
thinking about the relevant age groups to study and how early in drug

development applicants should incorporate pediatric patients for
development of systemic drugs for AD. This guidance has only minor
editorial changes and finalizes the draft guidance of the same name
issued on April 9, 2018 (83 FR 15157) to which no comments were
received.
    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 ``Atopic Dermatitis: Timing of Pediatric
Studies During Development of Systemic Drugs.'' 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
collections of information related to the burden on the submission of
new drug applications in 21 CFR 314.50(d)(7), including pediatric use
information, have been approved under OMB control number 0910-0001. The
collections of information related to the burden on the submission of
investigational new drug applications in Sec.  312.47(b)(1)(iv) (21 CFR
312.47(b)(1)(iv)), including plans for pediatric studies, have been
approved under OMB control number 0910-0014. The collections of
information related to the burden for requesting meetings with FDA
about drug development programs in Sec. Sec.  312.47 and 312.82 have
been approved under OMB control number 0910-0429. The collections of
information related to the burden on the submission of information
about expedited review programs for serious conditions and the guidance
for industry entitled ``Expedited Programs for Serious Conditions--
Drugs and Biologics'' (available at<EMAIL_ADDRESS>have
been approved under OMB control number 0910-0765. The collections of
information referenced in this guidance that are related to the burden
on the submission of biologics license applications covered under 21
CFR part 601, including pediatric use information, have been approved
under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: September 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21519 Filed 10-2-18; 8:45 am]
 BILLING CODE 4164-01-P