[Federal Register Volume 77, Number 201 (Wednesday, October 17, 2012)]
[Notices]
[Page 63839]
[FR Doc No: 2012-25503]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Oncologic Drugs Advisory Committee; Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The meeting of the Oncologic Drugs Advisory Committee Meeting
scheduled for November 8, 2012, is canceled. This cancellation applies
to both the morning session and afternoon session of the meeting. This
meeting was announced in the Federal Register of September 20, 2012 (77
FR 58399). The issues for which the FDA was seeking the scientific
input of the committee have been resolved.

FOR FURTHER INFORMATION CONTACT: Caleb Briggs, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area), and follow the prompts to the desired center or
product area. Please call the Information Line for up-to-date
information on this meeting.

    Dated: October 12, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-25503 Filed 10-16-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Rules and Regulations]
[Page 43575]
[FR Doc No: 2011-18169]

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

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-1285; Airspace Docket No. 10-AEA-27]

Amendment of Class E Airspace; Staunton, VA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E surface airspace extending upward
from 700 feet above the surface at Shenandoah Valley Regional Airport,
Staunton, VA. The Bridgewater Non-Directional Beacon (NDB) has been
decommissioned and new Standard Instrument Approach Procedures have
been developed for the airport. This action enhances the safety and
airspace management of Instrument Flight Rules (IFR) operations at the
airport.

DATES: Effective 0901 UTC, October 20, 2011. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.9 and publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On March 18, 2011, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace at Shenandoah
Valley Regional Airport, Staunton, VA (76 FR 14822) Docket No. FAA-
2010-1285.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received. Class E airspace designations are published in
paragraph 6005 of FAA Order 7400.9U dated August 18, 2010, and
effective September 15, 2010, which is incorporated by reference in 14
CFR part 71.1. The Class E airspace designations listed in this
document will be published subsequently in the Order.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 amends Class E airspace extending upward from 700 feet above
the surface to support new SIAPs developed at Shenandoah Valley
Regional Airport, Staunton, VA. Airspace reconfiguration is necessary
due to the decommissioning of the Bridgewater NDB and cancellation of
the NDB approach.
    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, is
non-controversial and unlikely to result in adverse or negative
comments. 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. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace at Staunton, VA.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.9U, Airspace Designations and Reporting
Points, dated August 18, 2010, effective September 15, 2010, is amended
as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AEA VA E5 Staunton, VA [Amended]

Shenandoah Valley Regional Airport, VA
    (Lat. 38[deg]15'50'' N., long. 78[deg]53'47'' W.)
Bridgewater Air Park, VA
    (Lat 38[deg] 22'00''; N., long 78[deg] 57'37'' W.)

That airspace extending upward from 700 feet above the surface
within a 7.6-mile radius of the Shenandoah Valley Regional Airport
and within 4 miles either side of the 218[deg] bearing from the
airport extending from the 7.6-mile radius to16.4 miles southwest of
the airport and within 4 miles either side of the 038[deg] bearing
from the airport extending from the 7.6-mile radius to 13.5 miles
northeast of the airport and within a 8.3-mile radius of the
Bridgewater Air Park and within 1.5 miles either side of the
338[deg] bearing from the airport extending from the 8.3-mile radius
to 10 miles northwest of the airport.

    Issued in College Park, Georgia, on July 11, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-18169 Filed 7-20-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 7, 2006 (Volume 71, Number 173)]
[Notices]
[Page 52785-52786]
[DOCID:fr07se06-39]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RR06-3-000]

North American Electric Reliability Council; North American
Electric Reliability Corporation; Notice of Filing

August 25, 2006.
    Take notice that on August 23, 2006, North American Electric
Reliability Corporation submitted for filing pursuant to Commission's
Regulations 18 CFR 39.4 its initial business plan and budget as the
electric reliability organization for the year ending December 31,
2007.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for 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
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on September 13, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-14768 Filed 9-6-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 7, 2008 (Volume 73, Number 89)]
[Notices]
[Page 25795-25805]
[DOCID:fr07my08-136]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-8916; 34-57766/May 2, 2008]

Order Making Fiscal Year 2009 Annual Adjustments to the Fee Rates
Applicable Under Section 6(b) of the Securities Act of 1933 and
Sections 13(e), 14(g), 31(b), and 31(c) of the Securities Exchange Act
of 1934

I. Background

    The Commission collects fees under various provisions of the
securities laws. Section 6(b) of the Securities Act of 1933
(``Securities Act'') requires the Commission to collect fees from
issuers on the registration of securities.\1\ Section 13(e) of the
Securities Exchange Act of 1934 (``Exchange Act'') requires the
Commission to collect fees on specified repurchases of securities.\2\
Section 14(g) of the Exchange Act requires the Commission to collect
fees on proxy solicitations and statements in corporate control
transactions.\3\ Finally, Sections 31(b) and (c) of the Exchange Act
require national securities exchanges and national securities
associations, respectively, to pay fees to the Commission on
transactions in specified securities.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 77f(b).
    \2\ 15 U.S.C. 78m(e).
    \3\ 15 U.S.C. 78n(g).
    \4\ 15 U.S.C. 78ee(b) and (c). In addition, Section 31(d) of the
Exchange Act requires the Commission to collect assessments from
national securities exchanges and national securities associations
for round turn transactions on security futures. 15 U.S.C. 78ee(d).
---------------------------------------------------------------------------

    The Investor and Capital Markets Fee Relief Act (``Fee Relief
Act'') \5\ amended Section 6(b) of the Securities Act and Sections
13(e), 14(g), and 31 of the Exchange Act to require the Commission to
make annual adjustments to the fee rates applicable under these
sections for each of the fiscal years 2003 through 2011, and one final
adjustment to fix the fee rates under these sections for fiscal year
2012 and beyond.\6\
---------------------------------------------------------------------------

    \5\ Pub. L. 107-123, 115 Stat. 2390 (2002).
    \6\ See 15 U.S.C. 77f(b)(5), 77f(b)(6), 78m(e)(5), 78m(e)(6),
78n(g)(5), 78n(g)(6), 78ee(j)(1), and 78ee(j)(3). Section 31(j)(2)
of the Exchange Act, 15 U.S.C. 78ee(j)(2), also requires the
Commission, in specified circumstances, to make a mid-year
adjustment to the fee rates under Sections 31(b) and (c) of the
Exchange Act in fiscal years 2002 through 2011.
---------------------------------------------------------------------------

II. Fiscal Year 2009 Annual Adjustment to the Fee Rates Applicable
Under Section 6(b) of the Securities Act and Sections 13(e) and 14(g)
of the Exchange Act

    Section 6(b)(5) of the Securities Act requires the Commission to
make an annual adjustment to the fee rate applicable under Section 6(b)
of the Securities Act in each of the fiscal years 2003 through 2011.\7\
In those same fiscal years, Sections 13(e)(5) and 14(g)(5) of the
Exchange Act require the Commission to adjust the fee rates under
Sections 13(e) and 14(g) to a rate that is equal to the rate that is
applicable under Section 6(b). In other words, the annual adjustment to
the fee rate under Section 6(b) of the Securities Act also sets the
annual adjustment to the fee rates under Sections 13(e) and 14(g) of
the Exchange Act.
---------------------------------------------------------------------------

    \7\ The annual adjustments are designed to adjust the fee rate
in a given fiscal year so that, when applied to the aggregate
maximum offering price at which securities are proposed to be
offered for the fiscal year, it is reasonably likely to produce
total fee collections under Section 6(b) equal to the ``target
offsetting collection amount'' specified in Section 6(b)(11)(A) for
that fiscal year.
---------------------------------------------------------------------------

    Section 6(b)(5) sets forth the method for determining the annual
adjustment to the fee rate under Section 6(b) for fiscal year 2009.
Specifically, the Commission must adjust the fee rate under Section
6(b) to a ``rate that, when applied to the baseline estimate of the
aggregate maximum offering prices for [fiscal year 2009], is reasonably
likely to produce aggregate fee collections under [Section 6(b)] that
are equal to the target offsetting collection amount for [fiscal year
2009].'' That is, the adjusted rate is determined by dividing the
``target offsetting collection amount'' for fiscal year 2009 by the
``baseline estimate of the aggregate maximum offering prices'' for
fiscal year 2009.
    Section 6(b)(11)(A) specifies that the ``target offsetting
collection amount'' for fiscal year 2009 is $284,000,000.\8\ Section
6(b)(11)(B) defines the ``baseline estimate of the aggregate maximum
offering price'' for fiscal year 2009 as ``the baseline estimate of the
aggregate maximum offering price at which securities are proposed to be
offered pursuant to registration statements filed with the Commission
during [fiscal year 2009] as determined by the Commission, after
consultation with the Congressional Budget Office and the Office of
Management and Budget * * *.''
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    \8\ Congress determined the target offsetting collection amounts
by applying reduced fee rates to the CBO's January 2001 projections
of the aggregate maximum offering prices for fiscal years 2002
through 2011. In any fiscal year through fiscal year 2011, the
annual adjustment mechanism will result in additional fee rate
reductions if the CBO's January 2001 projection of the aggregate
maximum offering prices for the fiscal year proves to be too low,
and fee rate increases if the CBO's January 2001 projection of the
aggregate maximum offering prices for the fiscal year proves to be
too high.
---------------------------------------------------------------------------

    To make the baseline estimate of the aggregate maximum offering
price for fiscal year 2009, the Commission is using the same
methodology it developed in consultation with the Congressional Budget
Office (``CBO'') and Office of Management and Budget (``OMB'') to
project aggregate offering price for purposes of the fiscal year 2008
annual adjustment. Using this methodology, the Commission determines
the ``baseline estimate of the aggregate maximum offering price'' for
fiscal year 2009 to be $5,091,289,629,574.\9\ Based on this estimate,
the Commission calculates the fee rate for fiscal 2009 to be $55.80 per
million. This adjusted fee rate applies to Section 6(b) of the
Securities Act, as well as to Sections 13(e) and 14(g) of the Exchange
Act.
---------------------------------------------------------------------------

    \9\ Appendix A explains how we determined the ``baseline
estimate of the aggregate maximum offering price'' for fiscal year
2009 using our methodology, and then shows the purely arithmetical
process of calculating the fiscal year 2009 annual adjustment based
on that estimate. The appendix includes the data used by the
Commission in making its ``baseline estimate of the aggregate
maximum offering price'' for fiscal year 2009.
---------------------------------------------------------------------------

III. Fiscal Year 2009 Annual Adjustment to the Fee Rates Applicable
Under Sections 31(b) and (c) of the Exchange Act

    Section 31(b) of the Exchange Act requires each national securities
exchange to pay the Commission a fee at a rate, as adjusted by our
order pursuant to Section 31(j)(2),\10\ which currently is $5.60 per
million of the aggregate dollar amount of sales of specified securities
transacted on the exchange. Similarly, Section 31(c) requires each
national securities association to pay the Commission a fee at the same
adjusted rate on the aggregate dollar amount of sales of specified
securities transacted by or through any member of the association
otherwise than on an exchange. Section 31(j)(1) requires the Commission
to make annual adjustments to the fee rates applicable under Sections
31(b) and (c) for each of the fiscal years 2003 through 2011.\11\
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    \10\ Order Making Fiscal 2008 Mid-Year Adjustment to the Fee
Rates Applicable Under Sections 31(b) and (c) of the Securities
Exchange Act of 1934, Rel. No. 34-57407 (February 29, 2008), 73 FR
12228 (March 6, 2008).
    \11\ The annual adjustments, as well as the mid-year adjustments
required in specified circumstances under Section 31(j)(2) in fiscal
years 2002 through 2011, are designed to adjust the fee rates in a
given fiscal year so that, when applied to the aggregate dollar
volume of sales for the fiscal year, they are reasonably likely to
produce total fee collections under Section 31 equal to the ``target
offsetting collection amount'' specified in Section 31(l)(1) for
that fiscal year.
---------------------------------------------------------------------------

    Section 31(j)(1) specifies the method for determining the annual
adjustment

for fiscal year 2009. Specifically, the Commission must adjust the
rates under Sections 31(b) and (c) to a ``uniform adjusted rate that,
when applied to the baseline estimate of the aggregate dollar amount of
sales for [fiscal year 2009], is reasonably likely to produce aggregate
fee collections under [Section 31] (including assessments collected
under [Section 31(d)]) that are equal to the target offsetting
collection amount for [fiscal year 2009].''
    Section 31(l)(1) specifies that the ``target offsetting collection
amount'' for fiscal year 2009 is $1,023,000,000.\12\ Section 31(l)(2)
defines the ``baseline estimate of the aggregate dollar amount of
sales'' as ``the baseline estimate of the aggregate dollar amount of
sales of securities * * * to be transacted on each national securities
exchange and by or through any member of each national securities
association (otherwise than on a national securities exchange) during
[fiscal year 2009] as determined by the Commission, after consultation
with the Congressional Budget Office and the Office of Management and
Budget * * *.''
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    \12\ Congress determined the target offsetting collection
amounts by applying reduced fee rates to the CBO's January 2001
projections of dollar volume for fiscal years 2002 through 2011. In
any fiscal year through fiscal year 2011, the annual and, in
specified circumstances, mid-year adjustment mechanisms will result
in additional fee rate reductions if the CBO's January 2001
projection of dollar volume for the fiscal year proves to be too
low, and fee rate increases if the CBO's January 2001 projection of
dollar volume for the fiscal year proves to be too high.
---------------------------------------------------------------------------

    To make the baseline estimate of the aggregate dollar amount of
sales for fiscal year 2009, the Commission is using the same
methodology it developed in consultation with the CBO and OMB to
project dollar volume for purposes of prior fee adjustments.\13\ Using
this methodology, the Commission calculates the baseline estimate of
the aggregate dollar amount of sales for fiscal year 2009 to be
$113,703,210,464,919. Based on this estimate, and an estimated
collection of $18,755 in assessments on security futures transactions
under Section 31(d) in fiscal year 2009, the uniform adjusted rate for
fiscal year 2009 is $9.30 per million.\14\
---------------------------------------------------------------------------

    \13\ Appendix B explains how we determined the ``baseline
estimate of the aggregate dollar amount of sales'' for fiscal year
2009 using our methodology, and then shows the purely arithmetical
process of calculating the fiscal year 2009 annual adjustment based
on that estimate. The appendix also includes the data used by the
Commission in making its ``baseline estimate of the aggregate dollar
amount of sales'' for fiscal year 2009.
    \14\ The calculation of the adjusted fee rate assumes that the
current fee rate of $5.60 per million will apply through October 31,
2008, due to the operation of the effective date provision contained
in Section 31(j)(4)(A) of the Exchange Act.
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IV. Effective Dates of the Annual Adjustments

    Section 6(b)(8)(A) of the Securities Act provides that the fiscal
year 2009 annual adjustment to the fee rate applicable under Section
6(b) of the Securities Act shall take effect on the later of October 1,
2008, or five days after the date on which a regular appropriation to
the Commission for fiscal year 2009 is enacted.\15\ Sections
13(e)(8)(A) and 14(g)(8)(A) of the Exchange Act provide for the same
effective date for the annual adjustments to the fee rates applicable
under Sections 13(e) and 14(g) of the Exchange Act.\16\
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    \15\ 15 U.S.C. 77f(b)(8)(A).
    \16\ 15 U.S.C. 78m(e)(8)(A) and 78n(g)(8)(A).
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    Section 31(j)(4)(A) of the Exchange Act provides that the fiscal
year 2009 annual adjustments to the fee rates applicable under Sections
31(b) and (c) of the Exchange Act shall take effect on the later of
October 1, 2008, or 30 days after the date on which a regular
appropriation to the Commission for fiscal year 2009 is enacted.

V. Conclusion

    Accordingly, pursuant to Section 6(b) of the Securities Act and
Sections 13(e), 14(g), and 31 of the Exchange Act,\17\
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    \17\ 15 U.S.C. 77f(b), 78m(e), 78n(g), and 78ee(j).
---------------------------------------------------------------------------

    It is hereby ordered that the fee rates applicable under Section
6(b) of the Securities Act and Sections 13(e) and 14(g) of the Exchange
Act shall be $55.80 per million effective on the later of October 1,
2008, or five days after the date on which a regular appropriation to
the Commission for fiscal year 2009 is enacted; and
    It is further ordered that the fee rates applicable under Sections
31(b) and (c) of the Exchange Act shall be $9.30 per million effective
on the later of October 1, 2008, or 30 days after the date on which a
regular appropriation to the Commission for fiscal year 2009 is
enacted.

    By the Commission.
Nancy M. Morris,
Secretary.

Appendix A

    With the passage of the Investor and Capital Markets Relief Act,
Congress has, among other things, established a target amount of monies
to be collected from fees charged to issuers based on the value of
their registrations. This appendix provides the formula for determining
such fees, which the Commission adjusts annually. Congress has mandated
that the Commission determine these fees based on the ``aggregate
maximum offering prices,'' which measures the aggregate dollar amount
of securities registered with the Commission over the course of the
year. In order to maximize the likelihood that the amount of monies
targeted by Congress will be collected, the fee rate must be set to
reflect projected aggregate maximum offering prices. As a percentage,
the fee rate equals the ratio of the target amounts of monies to the
projected aggregate maximum offering prices.
    For 2009, the Commission has estimated the aggregate maximum
offering prices by projecting forward the trend established in the
previous decade. More specifically, an ARIMA model was used to forecast
the value of the aggregate maximum offering prices for months
subsequent to March 2008, the last month for which the Commission has
data on the aggregate maximum offering prices.
    The following sections describe this process in detail.

A. Baseline Estimate of the Aggregate Maximum Offering Prices for
Fiscal Year 2009

    First, calculate the aggregate maximum offering prices (AMOP) for
each month in the sample (March 1998-March 2008). Next, calculate the
percentage change in the AMOP from month to month.
    Model the monthly percentage change in AMOP as a first order moving
average process. The moving average approach allows one to model the
effect that an exceptionally high (or low) observation of AMOP tends to
be followed by a more ``typical'' value of AMOP.
    Use the estimated moving average model to forecast the monthly
percent change in AMOP. These percent changes can then be applied to
obtain forecasts of the total dollar value of registrations. The
following is a more formal (mathematical) description of the procedure:
    1. Begin with the monthly data for AMOP. The sample spans ten
years, from March 1998 to March 2008.
    2. Divide each month's AMOP (column C) by the number of trading
days in that month (column B) to obtain the average daily AMOP (AAMOP,
column D).
    3. For each month t, the natural logarithm of AAMOP is reported in
column E.
    4. Calculate the change in log(AAMOP) from the previous month as
[Delta]t = log (AAMOPt)-log(AAMOPt-1).
This approximates the percentage change.
    5. Estimate the first order moving average model
[Delta]t = [alpha] + [beta]et-1 + et,
where

et denotes the forecast error for month t. The forecast
error is simply the difference between the one-month ahead forecast and
the actual realization of [Delta]t. The forecast error is
expressed as et = [Delta]t-[alpha]-
[beta]et-1. The model can be estimated using standard
commercially available software such as SAS or Eviews. Using least
squares, the estimated parameter values are [alpha] = 0.00154 and
[beta] = -0.87424.
    6. For the month of April 2008 forecast [Delta]t=4/08 =
[alpha] + [beta]et = 3/08. For all subsequent months,
forecast [Delta]t = [alpha].
    7. Calculate forecasts of log(AAMOP). For example, the forecast of
log(AAMOP) for June 2008 is given by FLAAMOPt = 6/08 =
log(AAMOPt = 3/08) + [Delta]t=4/08
+[Delta]t = 5/08 + [Delta]t = 6/08.
    8. Under the assumption that et is normally distributed,
the n-step ahead forecast of AAMOP is given by exp(FLAAMOPt
+ [sigma]n2/2), where [sigma]n denotes
the standard error of the n-step ahead forecast.
    9. For June 2008, this gives a forecast AAMOP of $19.7 Billion
(Column I), and a forecast AMOP of $414.1 Billion (Column J).
    10. Iterate this process through September 2009 to obtain a
baseline estimate of the aggregate maximum offering prices for fiscal
year 2009 of $5,091,289,629,574.

B. Using the Forecasts From A to Calculate the New Fee Rate

    1. Using the data from Table A, estimate the aggregate maximum
offering prices between 10/1/08 and 9/30/09 to be $5,091,289,629,574.
    2. The rate necessary to collect the target $284,000,000 in fee
revenues set by Congress is then calculated as: $284,000,000 /
$5,091,289,629,574 = 0.00005578.
    3. Round the result to the seventh decimal point, yielding a rate
of .0000558 (or $55.80 per million).

[GRAPHIC] [TIFF OMITTED] TN07MY08.060

[GRAPHIC] [TIFF OMITTED] TN07MY08.061

[GRAPHIC] [TIFF OMITTED] TN07MY08.062

[GRAPHIC] [TIFF OMITTED] TN07MY08.063

BILLING CODE 8010-01-C

Appendix B

    With the passage of the Investor and Capital Markets Relief Act,
Congress has, among other things, established a target amount of monies
to be collected from fees charged to investors based on the value of
their transactions. This appendix provides the formula for determining
such fees, which the Commission adjusts annually, and may

adjust semi-annually.\18\ In order to maximize the likelihood that the
amount of monies targeted by Congress will be collected, the fee rate
must be set to reflect projected dollar transaction volume on the
securities exchanges and certain over-the-counter markets over the
course of the year. As a percentage, the fee rate equals the ratio of
the target amounts of monies to the projected dollar transaction
volume.
---------------------------------------------------------------------------

    \18\ Congress requires that the Commission make a mid-year
adjustment to the fee rate if four months into the fiscal year it
determines that its forecasts of aggregate dollar volume are
reasonably likely to be off by 10% or more.
---------------------------------------------------------------------------

    For 2009, the Commission has estimated dollar transaction volume by
projecting forward the trend established in the previous decade. More
specifically, dollar transaction volume was forecasted for months
subsequent to March 2008, the last month for which the Commission has
data on transaction volume.
    The following sections describe this process in detail.

A. Baseline Estimate of the Aggregate Dollar Amount of Sales for Fiscal
Year 2009

    First, calculate the average daily dollar amount of sales (ADS) for
each month in the sample (March 1998-March 2008). The monthly aggregate
dollar amount of sales (exchange plus certain over-the-counter markets)
is presented in column C of Table B.
    Next, calculate the change in the natural logarithm of ADS from
month to month. The average monthly percentage growth of ADS over the
entire sample is 0.015 and the standard deviation is 0.126. Assuming
the monthly percentage change in ADS follows a random walk, calculating
the expected monthly percentage growth rate for the full sample is
straightforward. The expected monthly percentage growth rate of ADS is
2.3%.
    Now, use the expected monthly percentage growth rate to forecast
total dollar volume. For example, one can use the ADS for March 2008
($338,395,058,873) to forecast ADS for April 2008 ($346,177,695,873=
$338,395,058,873 x 1.023).\19\ Multiply by the number of trading days
in April 2008 (22) to obtain a forecast of the total dollar volume for
the month ($7,615,909,309,196). Repeat the method to generate forecasts
for subsequent months.
---------------------------------------------------------------------------

    \19\ The value 1.023 has been rounded. All computations are done
with the unrounded value.
---------------------------------------------------------------------------

    The forecasts for total dollar volume are in column G of Table B.
The following is a more formal (mathematical) description of the
procedure:
    1. Divide each month's total dollar volume (column C) by the number
of trading days in that month (column B) to obtain the average daily
dollar volume (ADS, column D).
    2. For each month t, calculate the change in ADS from the previous
month as [Delta]t = log (ADSt/ADSt-1),
where log (x) denotes the natural logarithm of x.
    3. Calculate the mean and standard deviation of the series
{[Delta]1, [Delta]2, . . . ,
[Delta]120{time} . These are given by [mu] = 0.015 and
[sigma] = 0.126, respectively.
    4. Assume that the natural logarithm of ADS follows a random walk,
so that [Delta]s and [Delta]t are statistically
independent for any two months s and t.
    5. Under the assumption that [Delta]t is normally
distributed, the expected value of ADSt/ADSt-1 is
given by exp ([mu] + [sigma]2/2), or on average
ADSt = 1.023 x ADSt-1.
    6. For April 2008, this gives a forecast ADS of 1.023 x
$338,395,058,873 = $346,177,695,873. Multiply this figure by the 22
trading days in April 2008 to obtain a total dollar volume forecast of
$7,615,909,309,196.
    7. For May 2008, multiply the April 2008 ADS forecast by 1.023 to
obtain a forecast ADS of $354,139,323,188. Multiply this figure by the
21 trading days in May 2008 to obtain a total dollar volume forecast of
$7,436,925,786,952.
    8. Repeat this procedure for subsequent months.

B. Using the Forecasts from A to Calculate the New Fee Rate

    1. Use Table B to estimate fees collected for the period 10/1/08
through 10/31/08. The projected aggregate dollar amount of sales for
this period is $9,125,934,321,266. Projected fee collections at the
current fee rate of 0.0000056 are $51,105,232.
    2. Estimate the amount of assessments on securities futures
products collected during 10/1/08 and 9/30/09 to be $18,755 by
projecting a 2.3% monthly increase from a base of $1,173 in March 2008.
    3. Subtract the amounts $51,105,232 and $18,755 from the target
offsetting collection amount set by Congress of $1,023,000,000 leaving
$971,876,013 to be collected on dollar volume for the period 11/1/08
through 9/30/09.
    4. Use Table B to estimate dollar volume for the period 11/1/08
through 9/30/09. The estimate is $104,577,276,143,653. Finally, compute
the fee rate required to produce the additional $971,876,013 in
revenue. This rate is $971,876,013 divided by $104,577,276,143,653 or
0.0000092934.
    5. Round the result to the seventh decimal point, yielding a rate
of .0000093 (or $9.30 per million).

[GRAPHIC] [TIFF OMITTED] TN07MY08.064

[GRAPHIC] [TIFF OMITTED] TN07MY08.065

[GRAPHIC] [TIFF OMITTED] TN07MY08.066

 [FR Doc. E8-10068 Filed 5-6-08; 8:45 am]

BILLING CODE 8010-01-C


FEB 18 2005 Dr. Ravinder S. Sidhu Regulatory Affairs Manager Monsanto Company 800 North Lindbergh Blvd. St. Louis, MO 63167 Dear Dr. Sidhu:

Subject: Your Application, Administrative Material, and Section G Dated July 28, 2004 to Test ZMIR39 x MON810 Combined Insecticidal Trait Stacked Corn Along with ZMIR39 and MON810 Corn. EPA Experimental Use Permit No. 524 EUP 96 Effective Dates: Plantings Through March 1, 2006 and Associated Activities Such as Collection of Field Data; Harvesting & Processing of Seed After Last Planting; Etc. Quantity Authorized: 60,457 lb seed ( 3.63 lb active ingredient)

On the basis of the information furnished by the applicant and the annexed program, this experimental use permit ( EUP) under § 5 of the Federal Insecticide, Fungicide, and Rodenticide Act is hereby amended/ extended to test ZMIR39 x MON810 combined insecticidal trait stacked corn hybrids along with ZMIR39 and MON810 corn hybrids; Bacillus thuringiensis Cry3Bb1 Protein and the genetic material necessary for its production ( vector ZMIR39) in corn [ ZMIR39] and Bacillus thuringiensis Cry1Ab delta endotoxin and the genetic material necessary for its production ( vector PV ZMCT01) in corn [ MON810]. Shipment and/ or use under this Permit is subject to the provisions of 40 CFR Part 172. Tolerance exemptions under 40 CFR 180.117[ 3]* and 180.1214 apply to these plant incorporated protectants in corn to be tested under this permit.

Prior to shipment and/ or use of the subject corn, you must consult with the pesticide regulatory officials and, if applicable, the biotechnology regulatory officials of the State( s) in which your experimental program will be conducted, and obtain a State permit or license if such is required. ( Note Hawaii's reporting requirement for genetically modified organisms under section 321 11.6 of the Hawaii revised statutes.) Issuance of this Federal permit does not negate the need for permission from individual States. Prior to initiating this experimental program in any State, you are to notify the lead Agency of the State( s) in which your experimental program will be conducted of the specific testing program ( when, where, how much, etc.). Failure to do so may result in revocation or modification of this EUP. You must comply with all requirements of the USDA/ APHIS as they apply to the proposed testing.

You must provide notice to the State pesticide regulatory Agency at least 72 hours before you begin to apply the experimental use product. You must also provide a copy of this authorization letter and stamped labels, as well as the non confidential portion of the Administrative Material and Section G dated July 28, 2004 to all cooperators, participants, and users prior to the initial pesticide application made in accordance with the EUP 2 amendment/ extension. The Agency is also notifying the relevant EPA Region( s), by sending them copies of this EUP.

Conditions under which the EUP is being issued are as follows.

1. The total amount of corn seed to be used will not exceed the quantity authorized by the EUP and its planting acres.

2. The permittee must immediately notify the Environmental Protection Agency of any findings from the experimental uses that have a bearing on safety ( i. e., reporting to the Agency of any adverse effects from the use of, or exposure to, the pesticide is required). The permittee will also keep records of production, distribution and performance, and, on request, make the records available to any authorized officer or employee of the Environmental Protection Agency.

3. You must provide a final report within180 days of the expiration of the permit. The final report must include all of the items set forth in 40 CFR § 172.8( b) and must include the following items.

  A state by state breakdown of acreage per protocol.   A state by state breakdown of locations per protocol.   A listing of experiments conducted within each protocol.   Average acreage per location for each experiment included within each protocol ( ideally this would be presented on a state by state basis).

4. Per 40 CFR § 17[ 2]*. 4( b)( v), you must provide the name and street address of all cooperators as soon as available and prior to planting.

5. The labeling submitted in connection with your application is acceptable and must be used for all shipments of seed subsequent to receiving this approval and be in possession of the user under this EUP amendment.

6. This experimental use permit is not a limited seed increase registration under § 3 of FIFRA and plantings solely for commercial seed increase are prohibited Based upon the submitted experimental program, the subject corn seed may be shipped for use under this permit to the following State( s) and be planted on the following acreage; provided that the protocol specific acreage is not exceeded, that the States agree to the trials, and all other requirements of the USDA/ APHIS have been met as they apply to the testing. We note that 3,023 acres of ZMIR39 containing seed are included.

States Acres AL 3.75 CA 268 CO 113.20 3 States cont. Acres cont.

HI 843.44 IA 737.75 IL 490.50 IN 272.25 KS 157.55 KY 35 MD 12 MI 73.60 MN 149.35 MO 108.25 MS 3.75 NC 2.40 ND 6.45 NE 382.10 NM 2.40 NY 12 OH 101.20 OK 4.00 PA 35.45 PR 245.93 SD 100.95 TN 40.35 TX 75 VA 2.40 WA 276 WI 127.85 Total 4682.87 4 Acreage Protocol Type ZMIR39 MON810 ZMIR39 x MON810 Border Rows Total Breeding and observation 410.65 159.00 297.20 175.32 1,042.17 Inbred seed increase production 808.50 97.30 396.50 158.05 1,460.35 Line per se, hybrid yield and herbicide tolerance trials 457.50 332.00 374.00 451.40 1,614.90 Insect efficacy trials 91.55 79.15 86.55 198.60 455.85 Product characterization and performance trials 1.00 1.00 1.00 1.00 4.00 Insect resistance management trials 5.20 2.60 5.20 2.60 15.60 Nontarget organisms and benefit trials 2.00 0.50 2.00 0.50 5.00 Seed treatment trials 2.00 0.50 2.00 0.50 5.00 Swine growth and feed efficiency trials 8.00 0 0 0 8.00 Dairy cattle feed efficiency trials 4.00 0 0 0 4.00 Beef cattle growth and feed efficiency trials 36.00 0 0 0 36.00 Cattle grazing feed efficiency trials 32.00 0 0 0 32.00 Total 1,858.4 672.05 1,164.45 987.97 4,682.87 We note that future EUP submissions should include the following information.

  Protocols to be conducted.   Experiments to be included within each protocol.   Estimated state by state breakdown of acreage per protocol.   Estimated state by state breakdown of locations per protocol.   Estimate of acreage and locations required for each experiment included within protocols ( ideally this would be presented on a state by state basis).   If an acreage increase is requested for one or more protocols, justification should be provided for those increases ( justification should be provided on a protocol by protocol basis).   Objective and brief description of each experiment included within protocols. Approximate number of hybrids/ inbreds/ isolines to be tested should also be included ( may be presented as average number of lines per location).   Clear explanation of acreage calculation, including a breakdown of EUP acreage designated for test plants, non test plants, and border rows included within experimental blocks.   It should be noted that EUP acreage designated for demonstration trials is generally considered inappropriate.

Sincerely,

/ s/

Janet L. Andersen, Ph. D., Director Biopesticides and Pollution Prevention Division ( 7511C) Enclosure * Typographical Correction


[Federal Register Volume 83, Number 208 (Friday, October 26, 2018)]
[Notices]
[Pages 54173-54174]
[FR Doc No: 2018-23461]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2017-0002-N-5]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), U.S. Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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

SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA) and its
implementing regulations, FRA seeks approval of the Information
Collection Request (ICR) abstracted below. Before submitting this ICR
to the Office of Management and Budget (OMB) for approval, FRA is
soliciting public comment on specific aspects of the activities
identified below.

DATES: Interested persons are invited to submit comments on or before
December 26, 2018.

ADDRESSES: Submit written comments on the information activities
described in this notice by mail to either Ms. Rachel Grice,
Engineering Psychologist, Office of Railroad Policy and Development,
Human Factors Division, RPD-34, FRA, 1200 New Jersey Avenue SE, Room
W36-429, Washington, DC 20590; or Ms. Kimberly Toone, Information
Collection Clearance Officer, Office of Information Technology, RAD-20,
FRA, 1200 New Jersey Avenue SE, Room W34-212, Washington, DC 20590.
Commenters requesting FRA to acknowledge receipt of their respective
comments must include a self-addressed stamped postcard stating,
``Comments on OMB Control Number 2130-XXXX,'' (the relevant OMB control
number for the ICR listed below) and should also include the title of
the ICR. Alternatively, comments may be faxed to<PHONE_NUMBER> or
(202) 493-6630, or emailed to [email protected] or
[email protected]. Please refer to the assigned OMB control number in
any correspondence submitted. FRA will summarize comments received in
response to this notice in a subsequent notice and include them in its
information collection submission to OMB for approval.

FOR FURTHER INFORMATION CONTACT: Rachel Grice, Engineering
Psychologist, Office of Research, Development, and Technology, Human
Factors Division, RPD-34, Federal Railroad Administration, 1200 New
Jersey Avenue SE, Room W36-429, Washington, DC 20590 (telephone: (202)
493-8005) or Ms. Kim Toone, Information Collection Clearance Officer,
Office of Information Technology, RAD-20, Federal Railroad
Administration, 1200 New Jersey Avenue SE, Room W34-212, Washington, DC
20590 (telephone:<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
provide 60-days' notice to the public to allow comment on information
collection activities before seeking OMB approval of the activities.
See 44 U.S.C. 3506, 3507; 5 CFR 1320.8 through 1320.12. Specifically,
FRA invites interested parties to comment on the following ICR
regarding: (1) Whether the information collection activities are
necessary for FRA to properly execute its functions, including whether
the activities will have practical utility; (2) the accuracy of FRA's
estimates of the burden of the information collection activities,
including the validity of the methodology and assumptions used to
determine the estimates; (3) ways for FRA to enhance the quality,
utility, and clarity of the information being collected; and (4) ways
for FRA to minimize the burden of information collection activities on
the public, including the use of automated collection techniques or
other forms of

information technology. See 44 U.S.C. 3506(c)(2)(A); 5 CFR
1320.8(d)(1).
    FRA believes that soliciting public comment will promote its
efforts to reduce the administrative and paperwork burdens associated
with the collection of information that Federal regulations require. In
summary, FRA reasons that comments received will advance three
objectives: (1) Reduce reporting burdens; (2) ensure organization of
information collection requirements in a ``user-friendly'' format to
improve the use of such information; and (3) allow an accurate
assessment of the resources expended to retrieve and produce
information requested. See 44 U.S.C. 3501.
    The summaries below describe the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: The Impact of Commute Times on the Fatigue and Safety of
Locomotive Engineers.
    OMB Control Number: 2130-NEW.
    Abstract: Time-on-task and time awake are two well-known factors
that contribute to fatigue. Time-on-task refers to the length of time a
person has been performing a task, whereas time awake refers to the
length of time since a person last slept. Both of these factors can
have a detrimental effect on performance, with the risk of adverse
safety events (e.g., crashes) increasing as the length of time that a
person performs a task or remains awake increases. These factors also
influence each other; that is, the negative effects of increasing time-
on-task may become evident sooner if the person has also been awake for
a long time. Drivers with longer commutes experience greater time awake
and time-on-task than drivers with shorter commutes. A growing body of
evidence from a number of industries (e.g., medical, mining, long-haul
trucking) suggests that commuting time has a detrimental impact on
driving performance, particularly when combined with night-time shift
work. However, the extent to which these factors impact the fatigue and
safety of locomotive engineers remains unknown.
    Type of Request: New information collection.
    Affected Public: Railroad Workers.
    Forms: FRA F 245.
    Respondent Universe: 35,000 locomotive engineers.
    Frequency of Submission: Single submission per person.
    Reporting Burden: The estimated total annual burden is 1,750 hours
across the 5,250 locomotive engineers (estimating a 15% response rate).
Each locomotive engineer completes a single online questionnaire and
the questionnaire is estimated to take 20 minutes.
    Total Estimated Annual Responses: 5,250 responses.
    Total Estimated Annual Burden: 1,750 hours.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

    Authority: 44 U.S.C. 3501-3520.

Juan D. Reyes III,
Chief Counsel.
[FR Doc. 2018-23461 Filed 10-25-18; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13933-13934]
[FR Doc No: 2019-06896]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0982]

Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Oncologic Drugs Advisory
Committee. The general function of the committee is to provide advice
and recommendations to FDA on regulatory issues. The meeting will be
open to the public. FDA is establishing a docket for public comment on
this document.

DATES: The meeting will be held on May 14, 2019, from 8 a.m. to 5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2019-N-0982. The docket will close on May 13,
2019. Submit either electronic or written comments on this public
meeting by May 13, 2019. Please note that late, untimely filed comments
will not be considered. The https://www.regulations.gov electronic
filing system will accept comments until 11:59 p.m. Eastern Time at the
end of May 13, 2019. Comments received by mail/hand delivery/courier
(for written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.
    Comments received on or before April 30, 2019, will be provided to
the committee. Comments received after that date will be taken into
consideration by FDA.
    You may submit comments 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-2019-N-0982 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS

CONFIDENTIAL INFORMATION.'' FDA 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
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
the information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email: [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: During the morning session, the committee will discuss new
drug application (NDA) 211810 for pexidartinib capsule, submitted by
Daiichi Sankyo, Inc. The proposed indication (use) for this product is
for the treatment of adult patients with symptomatic tenosynovial giant
cell tumor, also referred to as giant cell tumor of the tendon sheath
or pigmented villonodular synovitis, which is associated with severe
morbidity or functional limitations, and which is not amenable to
improvement with surgery.
    During the afternoon session, the committee will discuss NDA 212166
for quizartinib tablets, submitted by Daiichi Sankyo, Inc. The proposed
indication (use) for this product is for the treatment of adults with
relapsed or refractory acute myeloid leukemia, which is FLT3-ITD
positive, as detected by an FDA-approved test.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the docket (see
ADDRESSES) on or before April 30, 2019, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
April 22, 2019. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by April 23, 2019.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Jennifer Shepherd (see FOR FURTHER INFORMATION CONTACT) at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-06896 Filed 4-5-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 44 (Monday, March 7, 2022)]
[Notices]
[Page 12759]
[FR Doc No: 2022-04763]

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

Federal Railroad Administration

[Docket Number FRA-2022-0017]

Petition for Modification of Standards and Alternate Compliance

    Under part 232 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on February 8, 2022, the
HeritageRail Alliance (HRA) (co-sponsored jointly by the Railroad
Passenger Car Alliance (RPCA)) petitioned the Federal Railroad
Administration (FRA) for a modification of standards and alternate
compliance in accordance with 49 CFR 232.307, Modification of brake
test procedures, pertaining to the Federal railroad safety regulations
contained at 49 CFR 232.717, Freight and passenger train car brakes.
FRA assigned the petition Docket Number FRA-2022-0017.
    Specifically, HRA/RPCA requests a modification of standards and
alternative compliance pursuant to 49 CFR 232.717(d) using HRA
Recommended Practice RP-001-21, which includes proposed alternate
compliance methods to fulfill the requirements of Sec.  232.717,
Freight and passenger train car brakes.\1\ HRA states that many
tourist/museum operations employ obsolete equipment types that are not
subject to current Association of American Railroads (AAR) Interchange
Rules, nor any other currently published maintenance standard, and that
in recent years the maintenance of railroad mechanical systems has
moved away from prescribed periodic attention to performance based
systems, and that the assurance of safety is achieved by employing more
frequent periodic testing (primarily single car tests) to detect
degradation of performance. Railroads have also identified
opportunities to extend service intervals through application of newer
materials, and as tourist and excursion equipment is often used
infrequently, extended service periods may be warranted. The
Recommended Practice includes justification of the reduction of
cleaning, oiling, testing, and stenciling periods (an activity that in
itself can degrade the performance and service life of the equipment),
and provides documentation guides on the operating history to assure
compliance with the conditions of the extension.
---------------------------------------------------------------------------

    \1\ To view the Recommended Practice, see https://www.regulations.gov/document/FRA-2022-0017-0001.
_____________________________________-

    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by May 6, 2022 will be considered by FRA
before final action is taken. Pursuant to Sec.  232.307(d), if no
comment objecting to the requested modification is received during the
60-day comment period, or if FRA does not issue a written objection to
the requested modification, the modification will become effective May
23, 2022.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), the U.S. Department of Transportation (DOT)
solicits comments from the public to better inform its processes. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of
regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2022-04763 Filed 3-4-22; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 83, Number 242 (Tuesday, December 18, 2018)]
[Notices]
[Pages 64925-64927]
[FR Doc No: 2018-27338]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2018-0368]

Hours of Service of Drivers: North Shore Environmental
Construction, Inc.; Application for Exemption

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

ACTION: Notice of application for exemption; request for comments.

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SUMMARY: FMCSA announces that it has received an application from North
Shore Environmental Construction, Inc. (North Shore) for exemption from
the hours-of-service (HOS) regulations for drivers engaged in providing
direct assistance in environmental emergencies or potential
environmental emergencies. The applicants request a five-year exemption
from the ``14-hour rule'' for their drivers engaged in responding to
environmental emergencies. FMCSA requests public comment on this
application for exemption.

DATES: Comments must be received on or before January 17, 2019.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2018-0368 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. See the
Public Participation and Request for Comments section below for further
information.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
     Fax: 1-202-493-2251.
    Each submission must include the Agency name and the docket number
for this notice. Note that DOT posts all comments received without
change to www.regulations.gov, including any personal information
included in a comment. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line FDMS is available 24 hours each
day, 365 days each year.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Mr. Richard Clemente, FMCSA Driver and
Carrier Operations Division; Telephone:<PHONE_NUMBER>; Email:
<EMAIL_ADDRESS>If you have questions on viewing or submitting material
to the docket, contact Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
I. Public Participation and Request for Comments

    FMCSA encourages you to participate by submitting comments and
related materials.

Submitting Comments

    If you submit a comment, please include the docket number for this
notice (FMCSA-2018-0368), indicate the specific section of this
document to which the comment applies, and provide a reason for
suggestions or recommendations. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so the Agency can contact you if it has questions
regarding your submission.
    To submit your comment online, go to www.regulations.gov and put
the docket number, ``FMCSA-2018-0368'' in the ``Keyword'' box, and
click ``Search.'' When the new screen appears, click on ``Comment
Now!'' button and type your comment into the text box in the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit. If you submit your
comments by mail or hand delivery, submit them in an unbound format, no
larger than 8\1/2\ by 11 inches, suitable for copying and electronic
filing. If you submit comments by mail and would like to know that they
reached the facility, please enclose a stamped, self-addressed postcard
or envelope. FMCSA will consider all comments and material received
during the comment period and may grant or not grant this application
based on your comments.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must also provide an opportunity for public comment on the
request.
    The Agency reviews safety analyses and public comments submitted,
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reasons for denying or granting the application
and, if granted, the name of the person or class of persons receiving
the exemption, and the regulatory provision from which the exemption is
granted. The notice must also specify the effective period (up to 5
years) and explain the terms and conditions of the exemption. The
exemption may be renewed (49 CFR 381.300(b)).

III. Request for Exemption

    North Shore Environmental Construction, Inc. (North Shore) seeks an
exemption from the ``14-hour rule'' [Sec.  395.3(a)(2)] for its drivers
engaged in responding to environmental emergencies. North Shore employs
12 commercial driver's license (CDL) holders, and its total number of
commercial motor vehicles (CMVs) is 15. North Shore is a member of the
Spill Control Association of America. In responding to emergency
incidents, North Shore's technicians work alongside a mix of both
private industry and public agencies, and their work often has a direct
impact on protection of both public safety and the environment. North
Shore advises that it is contractually required to provide direct
assistance to responsible parties who are experiencing environmental
emergencies or potential environmental emergencies. North Shore defines
an environmental emergency as a sudden threat to the public health or
the well-being of the environment, arising from the release or
potential release of oil, radioactive materials, or hazardous chemicals
into the air, land, or water. North Shore's employees are hybrid
driver/operator/technicians, so the total on-duty time can be a
challenge, especially after normal work hours. Other job duties include
industrial maintenance, spill response, sampling, lab packing and waste
management. With the current driver shortage, obtaining qualified
drivers with these additional skills and experience has become
problematic.
    North Shore is requesting relief from 49 CFR 395.3(a)(2), commonly
known as the ``14-hour rule.'' North Shore states that the hours-of-
service (HOS) rules have always been an issue for emergency response
companies. The national shortage of drivers, and in its case, drivers
with specialized safety and environmental training, has been worsening
over the last few years, making this a critical issue. North Shore is
requesting this exemption to allow the company to respond to a release
or threat of a release of oil and other hazardous materials. North
Shore is requesting relief from this regulation with the following
conditions:
     On-duty period will not exceed 4.5 additional hours for
initial response;
     Any driver who exceeds the 14-hour period would in no case
exceed a total of 8 hours drive time;
     Drivers would not exceed 70 hours on duty in 8 days;
     Drivers would be required to take 10 hours off duty,
subsequent to the duty day; and
     All activities would be subject to the electronic logging
device rule.
    According to North Shore, there would be a significant challenge in
responding to environmental emergencies if the exemption was not
granted. The initial response hours are the most critical in an
environmental emergency and the ability to quickly respond is vital.
North Shore believes that a tightly managed exemption actually provides
a risk averse situation by discouraging potentially unmanaged risk
taking. If the exemption is not granted, there could be a disruption of
nation/regional commerce activities, including power restoration
activities and protection of interstate commerce and infrastructure.
Granting the exemption would mitigate public transportation
disruptions, much as tow trucks do when moving wrecked or disabled
vehicles under 49 CFR 390.23(a)(ii)(3).

IV. Method To Ensure an Equivalent or Greater Level of Safety

    North Shore believes that the proposed relief, and the parameters
in which their drivers operate, would continue to provide the highest
level of safety and compliance, while carefully responding to incidents
that threaten public safety and the environment. Safety is always the
primary objective and guiding principle of all of North Shore's
business activities as demonstrated by the following:
     North Shore has specific policies on ``fatigue and
transportation management.''
     Health and safety is paramount for all operations dealing
with environmental emergencies and would remain the case when utilizing
the exemption.
     Drivers who utilize this exemption may come back into
compliance and restart the computation of maximum driving time only
after 10 hours off duty which starts at the end of their extended hours
period.
     The exemption would not exempt drivers or the company from
the requirements relating to the CDL, drug/alcohol testing, hazardous
materials, size and weight, or State/Federal registration and tax
requirements.

     North Shore understands the concepts of risk management
and mitigation.
     North Shore maintains a multitude of safety, security,
annual medical surveillance, and training plans, as well as
comprehensive drug and alcohol programs compliant with multiple DOT
departments.
     North Shore has vigorous preventative maintenance programs
specific to the equipment they own and operate.
    North Shore believes an equivalent level of safety will be achieved
if their drivers are exempt from the requirements as described in this
notice. The requested exemption is for 5 years. A copy of the
application for exemption is available for review in the docket for
this notice.

    Issued on: December 7, 2018.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2018-27338 Filed 12-17-18; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register: October 20, 2009 (Volume 74, Number 201)]
[Notices]
[Page 53732]
[DOCID:fr20oc09-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2413-112]

Georgia Power Company; Notice of Application for Amendment of
License and Soliciting Comments, Motions To Intervene, and Protests

October 13, 2009.
    a. Type of Application: Non-project use of project lands and
waters.
    b. Project Number: 2413-112.
    c. Date Filed: June 23, 2009.
    d. Applicant: Georgia Power Company.
    e. Name of Project: Wallace Dam Hydroelectric Project.
    f. Location: The project is located on the Oconee River in Putnam,
Morgan, Oconee, Oglethorpe, Greene, and Hancock Counties, Georgia, and
occupies Federal lands administered by the U.S. Forest Service. The
proposed action would occur in Greene County.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a) 825(r)
and 799 and 801.
    h. Applicant Contact: Mr. Herbie N. Johnson, Lake Resources
Manager, 125 Wallace Dam Road, NE., Eatonton, GA 21024, telephone:
(706) 485-8704 ext. 5.
    i. FERC Contact: Any questions on this notice should be addressed
to Christopher Yeakel at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments and or motions: November 13, 2009.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervener files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the Applicant specified in the particular application.
    k. Description of Request: Georgia Power Company (licensee)
proposes to permit the Linger Longer Development Company (permittee) to
construct six community boat docks with 5 double slips each, access
walkways, and a pedestrian bridge for use by residents of Hall's
Crossing development. The proposed facilities would impact a total of
2.02 acres of project lands and would be constructed along 2,180 linear
feet of shoreline. In addition, rip-rap would be installed along the
shoreline at each dock location, and fish attractors would be placed
beneath each dock to enhance fish habitat. In developing the
application, the licensee consulted with the U.S. Fish and Wildlife
Service, Georgia State Historic Preservation Officer, and Georgia
Department of Natural Resources--Wildlife Resources Division.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field (p-2413) to access the document. You
may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3372 or e-mail<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``RECOMMENDATIONS FOR TERMS AND CONDITIONS'',
``PROTEST'', or ``MOTION TO INTERVENE'', as applicable, and the Project
Number of the particular application to which the filing refers (p-
2413-112).
    p. Agency Comments--Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov
under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-25098 Filed 10-19-09; 8:45 am]

BILLING CODE 6717-01-P