[Federal Register Volume 80, Number 159 (Tuesday, August 18, 2015)]
[Notices]
[Pages 50014-50015]
[FR Doc No: 2015-20316]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-2853]

Electronic Study Data Submission; Data Standards; Support for
Study Data Tabulation Model Implementation Guide Version 3.2

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Center for Biologics Evaluation and Research (CBER) and
the Center for Drug Evaluation and Research (CDER) are announcing
support for the 3.2 version (see section II. Exceptions) of Clinical
Data Interchange Standards Consortium (CDISC) Study Data Tabulation
Model Implementation Guide (SDTM IG 3.2), an update to the FDA Data
Standards Catalog (Catalog), and availability of validation rules for
the 3.2 version. SDTM IG 3.2 has been available from CDISC since
December 2013. FDA is encouraging sponsors and applicants to use SDTM
IG 3.2 (see section II. Exceptions) in investigational study data
provided in regulatory submissions to CBER and to CDER.

FOR FURTHER INFORMATION CONTACT: Ron Fitzmartin, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring,

MD 20993-002,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On December 17, 2014, FDA published a final guidance for industry
entitled ``Providing Regulatory Submissions in Electronic Format--
Standardized Study Data'' (eStudy Data) posted on FDA's Study Data
Standards Resources Web page at http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm. The eStudy Data guidance
implements the electronic submission requirements of section 745A(a) of
the FD&C Act (21 U.S.C. 379k-1) for study data contained in new drug
applications (NDAs), abbreviated new drug applications (ANDAs),
biologics license applications (BLAs), and investigational new drug
applications (INDs) to CBER or CDER by specifying the format for
electronic submissions. The initial timetable for the implementation of
electronic submission requirements for study data is December 17, 2016
(24 months after issuance of final guidance for NDAs, BLAs, ANDAs, and
36 months for INDs). The eStudy Data guidance states that a Federal
Register notice will specify the transition date for all version
updates (with the month and day for the transition date corresponding
to March 15).
    The transition date for support (see section II. Exceptions) of the
3.2 version of CDISC STDM IG is March 15, 2017. Although SDTM IG
version 3.2 is supported as of this Federal Register notice and
sponsors or applicants are encouraged to begin using it, the new
version will only be required in submissions for studies that start
after March 15, 2018. The Catalog will list March 15, 2018, as the
``date requirement begins.'' When multiple versions of an FDA-supported
standard are listed in the Catalog, sponsors or applicants can select a
version to use.

II. Exceptions

    The following SDTM IG 3.2 domains have not completed testing and
acceptance and are not supported at this time: Death Details and
Exposure as Collected. The therapeutic area (TA) standards (http://www.cdisc.org/) that are included in SDTM IG 3.2 have not completed
testing and acceptance and are not supported at this time. The specific
domain and the TA standard are listed in the table that follows:

------------------------------------------------------------------------
        SDTM IG 3.2 Domain                      TA User guide
------------------------------------------------------------------------
1. Healthcare Encounters..........  Cardiovascular Studies, 1.0;
                                     Polycystic Kidney Disease, 1.0;
                                     Asthma, 1.0.
2. Microscopic Findings...........  Tuberculosis, 1.0; Parkinson's, 1.0.
3. Morphology.....................  Cardiovascular Studies, 1.0;
                                     Parkinson's, 1.0; Polycystic Kidney
                                     Disease, 1.0; Alzheimer's, 1.0;
                                     Multiple Sclerosis, 1.0.
4. Procedures.....................  Cardiovascular Studies, 1.0;
                                     Polycystic Kidney Disease, 1.0;
                                     Alzheimer's, 1.0.
5. Reproductive System............  Polycystic Kidney Disease, 1.0.
6. Disease Response...............  Tuberculosis, 1.0.
7. Skin Response..................  Asthma, 1.0.
------------------------------------------------------------------------

    Sponsors and applicants with questions on how to implement the FDA-
supported study data standards should contact and work with FDA
technical staff. For questions, contact CDER at<EMAIL_ADDRESS>or CBER at<EMAIL_ADDRESS>
III. Comments

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

IV. Electronic Access

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

    Dated: August 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20316 Filed 8-17-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 23 (Thursday, February 3, 2022)]
[Notices]
[Pages 6194-6195]
[FR Doc No: 2022-02257]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4525-DR; Docket ID FEMA-2022-0001]

Utah; Amendment No. 8 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Utah (FEMA-4525-DR), dated April 4, 2020, and related
determinations.

DATES: This change occurred on January 7, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Nancy J.
Dragani, of FEMA is appointed to act as the Federal Coordinating
Officer for this disaster.
    This action terminates the appointment of Tammy L. Littrell as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance

(Presidentially Declared Disasters); 97.039, Hazard Mitigation
Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2022-02257 Filed 2-2-22; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 66 (Tuesday, April 7, 2015)]
[Notices]
[Pages 18664-18665]
[FR Doc No: 2015-07852]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: U.S. Securities and
Exchange Commission, Office of FOIA Services, 100 F Street NE.,
Washington, DC 20549-2736.

Extension: Rule 17f-2. SEC File No. 270-233, OMB Control No. 3235-
0223.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 350l et seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget for extension and approval.
    Rule 17f-2 (17 CFR 270.17f-2), entitled ``Custody of Investments by
Registered Management Investment Company,'' was adopted in 1940 under
section 17(f) of the Investment Company Act of 1940 (15 U.S.C. 80a-
17(f)) (the ``Act''), and was last amended

materially in 1947. Rule 17f-2 establishes safeguards for arrangements
in which a registered management investment company (``fund'') is
deemed to maintain custody of its own assets, such as when the fund
maintains its assets in a facility that provides safekeeping but not
custodial services.\1\ The rule includes several recordkeeping or
reporting requirements. The fund's directors must prepare a resolution
designating not more than five fund officers or responsible employees
who may have access to the fund's assets. The designated access persons
(two or more of whom must act jointly when handling fund assets) must
prepare a written notation providing certain information about each
deposit or withdrawal of fund assets, and must transmit the notation to
another officer or director designated by the directors. An independent
public accountant must verify the fund's assets three times each year,
and two of those examinations must be unscheduled.\2\
---------------------------------------------------------------------------

    \1\ The rule generally requires all assets to be deposited in
the safekeeping of a ``bank or other company whose functions and
physical facilities are supervised by Federal or State authority.''
The fund's securities must be physically segregated at all times
from the securities of any other person.
    \2\ The accountant must transmit to the Commission promptly
after each examination a certificate describing the examination on
Form N-17f-2. The third (scheduled) examination may coincide with
the annual verification required for every fund by section 30(g) of
the Act (15 U.S.C. 80a-29(g)).
---------------------------------------------------------------------------

    Rule 17f-2's requirement that directors designate access persons is
intended to ensure that directors evaluate the trustworthiness of
insiders who handle fund assets. The requirements that access persons
act jointly in handling fund assets, prepare a written notation of each
transaction, and transmit the notation to another designated person are
intended to reduce the risk of misappropriation of fund assets by
access persons, and to ensure that adequate records are prepared,
reviewed by a responsible third person, and available for examination
by the Commission. The requirement that auditors verify fund assets
without notice twice each year is intended to provide an additional
deterrent to the misappropriation of fund assets and to detect any
irregularities.
    The Commission staff estimates that each fund makes 974 responses
and spends an average of 252 hours annually in complying with the
rule's requirements.\3\ Commission staff estimates that on an annual
basis it takes: (i) 0.5 hours of fund accounting personnel at a total
cost of $99 to draft director resolutions; \4\ (ii) 0.5 hours of the
fund's board of directors at a total cost of $2200 to adopt the
resolution; \5\ (iii) 244 hours for the fund's accounting personnel at
a total cost of $63,797 to prepare written notations of transactions;
\6\ and (iv) 7 hours for the fund's accounting personnel at a total
cost of $1386 to assist the independent public accountants when they
perform verifications of fund assets.\7\ Commission staff estimates
that approximately 188 funds file Form N-17f-2 each year.\8\ Thus, the
total annual hour burden for rule 17f-2 is estimated to be 47,376
hours.\9\ Based on the total costs per fund listed above, the total
cost of rule 17f-2's collection of information requirements is
estimated to be approximately $12.7 million.\10\
---------------------------------------------------------------------------

    \3\ The 974 responses are: 1 (one) response to draft and adopt
the resolution and 973 notations. Estimates of the number of hours
are based on conversations with individuals in the fund industry.
The actual number of hours may vary significantly depending on
individual fund assets.
    \4\ This estimate is based on the following calculation: 0.5
(burden hours per fund) x $198 (senior accountant's hourly rate) =
$99. Unless otherwise indicated, the hourly wage figures used herein
are from the Securities Industry and Financial Markets Association's
Management & Professional Earnings in the Securities Industry 2013,
modified by Commission staff to account for an 1800-hour work-year
and multiplied by 5.35 to account for bonuses, firm size, employee
benefits and overhead.
    \5\ The estimate for the cost of board time as a whole is
derived from estimates made by the staff regarding typical board
size and compensation that is based on information received from
fund representatives and publicly available sources.
    \6\ Respondents estimated that each fund makes 974 responses on
an annual basis and spends a total of 0.25 hours per response. The
fund personnel involved are Accounts Payable Manager ($186 hourly
rate), Operations Manager ($334 hourly rate) and Accounting Manager
($265 hourly rate). The average hourly rate of these personnel is
$262. The estimated cost of preparing notations is based on the
following calculation: 974 x 0.25 x $262 = $63,797.
    \7\ This estimate is based on the following calculation: 7 x
$198 (senior accountant's hourly rate) = $1386.
    \8\ On average, each year approximately 188 funds filed Form N-
17f-2 with the Commission during calendar years 2011-2013.
    \9\ This estimate is based on the following calculation: 188
(funds) x 252 (total annual hourly burden per fund) = 47,376 hours
for rule. The annual burden for rule 17f-2 does not include time
spent preparing Form N-17f-2. The burden for Form N-17f-2 is
included in a separate collection of information.
    \10\ This estimate is based on the following calculation:
$67,482 (total annual cost per fund) x 188 funds = $12,686,616.
---------------------------------------------------------------------------

    The estimate of average burden hours is made solely for the
purposes of the Paperwork Reduction Act, and is not derived from a
comprehensive or even a representative survey or study of the costs of
Commission rules and forms. Complying with the collections of
information required by rule 17f-2 is mandatory for those funds that
maintain custody of their own assets. Responses will not be kept
confidential. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid control number.
    Written comments are invited on: (a) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information has practical
utility; (b) the accuracy of the Commission's estimate of the burden of
the collection of information; (c) ways to enhance the quality,
utility, and clarity of the information collected; and (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: April 1, 2015.
 Brent J. Fields,
Secretary.
[FR Doc. 2015-07852 Filed 4-6-15; 8:45 am]
BILLING CODE CODE 8011-01-P


[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69463-69464]
[FR Doc No: 2013-27764]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

Notice of Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
November 21, 2013 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Stein, as duty officer, voted to consider the items
listed for the Closed Meeting in a closed session.
    The subject matter of the Closed Meeting will be:
    Settlement of injunctive actions;
    institution and settlement of administrative proceedings; and
    other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

     Dated: November 14, 2013.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2013-27764 Filed 11-15-13; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Proposed Rules]
[Pages 57066-57068]
[FR Doc No: 2012-22897]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2010-0003; Internal Agency Docket No. FEMA-B-1095]

Proposed Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Proposed rule; correction.

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SUMMARY: On May 21, 2010, FEMA published in the Federal Register a
proposed rule that contained an erroneous table. This notice provides
corrections to that table, to be used in lieu of the information
published at 75 FR 28511. The table provided here represents the
flooding sources, location of referenced elevations, effective and
modified elevations, and communities affected for Muhlenberg County,
Kentucky and Incorporated Areas. Specifically, it addresses the
following flooding sources: Brier Creek (backwater effects from Green
River), Caney Creek, Caney Creek Tributary 27.1 (backwater effects from
Caney Creek), Caney Creek Tributary 31 (backwater effects from Caney
Creek), Canfield Branch (backwater effects from Green River), Cypress
Creek (backwater effects from Green River), Cypress Creek Tributary 1
(backwater effects from Green River), Green River, Irwin Creek
(backwater effects from Green River), Isaacs Creek (backwater effects
from Green River), Jacobs Creek (backwater effects from Green River),
Jacobs Creek Tributary 7 (backwater effects from Green River), Little
Cypress Creek, Little Cypress Creek Tributary 16 (backwater effects
from Little Cypress Creek), Little Cypress Creek Tributary 8 (backwater
effects from Little Cypress Creek), Log Creek (backwater effects from
Green River), Mud River (backwater effects from Green River), Muddy
Fork (backwater effects from Green River), Nelson Creek (backwater
effects from Green River), Opossum Run (backwater effects from Sandlick
Creek), Plum Creek (backwater effects from Green River), Plum Creek
Tributary 5 (backwater effects from Green River), Pond Creek (backwater
effects from Green River), Pond Creek (backwater effects from Sandlick
Creek), Pond Creek Tributary 29 (backwater effects from Green River),
Pond Creek Tributary 30 (backwater effects from Green River), Pond
River (backwater effects from Green River) and Sandlick Creek Tributary
2 (backwater effects from Sandlick Creek).

DATES: Comments are to be submitted on or before December 17, 2012.

ADDRESSES: You may submit comments, identified by Docket No. FEMA-B-
1095, to Luis Rodriguez, Chief, Engineering Management Branch, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER> or
(email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER> or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) publishes proposed determinations of Base (1% annual-chance)
Flood Elevations (BFEs) and modified BFEs for communities participating
in the National Flood Insurance Program (NFIP), in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed BFEs and modified BFEs, together with the floodplain
management criteria required by 44 CFR 60.3, are minimum requirements.
They should not be construed to mean that the community must change any
existing ordinances that are more stringent in their floodplain
management requirements. The community may at any time enact stricter
requirements of its own or pursuant to policies established by other
Federal, State, or regional entities. These proposed elevations are
used to meet the floodplain management requirements of the NFIP and
also are used to calculate the appropriate flood insurance premium
rates for new buildings built after these elevations are made final,
and for the contents in those buildings.

Corrections

    In the proposed rule published at 75 FR 28511, in the May 21, 2010,
issue of the Federal Register, FEMA published a table under the
authority of 44 CFR 67.4. The table, entitled ``Muhlenberg County,
Kentucky, and Incorporated Areas'' addressed the following flooding
sources: Brier Creek (backwater effects from Green River), Caney Creek,
Caney Creek Tributary 27.1 (backwater effects from Caney Creek), Caney
Creek Tributary 31 (backwater effects from Caney Creek), Canfield
Branch (backwater effects from Green River), Cypress Creek (backwater
effects from Green River), Cypress Creek Tributary 1 (backwater effects
from Green River), Green River, Irwin Creek (backwater effects from
Green River), Isaacs Creek (backwater effects from Green River), Jacobs
Creek (backwater effects from Green River), Jacobs Creek Tributary 7
(backwater effects from Green River), Little Cypress Creek, Little
Cypress Creek Tributary 16 (backwater effects from Little Cypress
Creek), Little Cypress Creek Tributary 8 (backwater effects from Little
Cypress Creek), Log Creek (backwater effects from Green River), Mud
River (backwater effects from Green River), Muddy Fork (backwater
effects from Green River), Nelson Creek (backwater effects from Green
River), Opossum Run (backwater effects from Sandlick Creek), Plum Creek
(backwater effects from Green River), Plum Creek Tributary 5 (backwater
effects from Green River), Pond Creek (backwater effects from Green
River), Pond Creek (backwater effects from Sandlick Creek), Pond Creek
Tributary 29 (backwater effects from Green River), Pond Creek Tributary
30 (backwater effects from Green River),

Pond River (backwater effects from Green River) and Sandlick Creek
Tributary 2 (backwater effects from Sandlick Creek). That table
contained inaccurate information as to the communities affected for the
flooding source the Green River. In this notice, FEMA is publishing a
table containing the accurate information, to address these prior
errors. The information provided below should be used in lieu of that
previously published.

----------------------------------------------------------------------------------------------------------------
                                                                     * Elevation in feet
                                                                     (NGVD)  + Elevation
                                                                       in feet  (NAVD)
                                                                      Depth in
         Flooding source(s)              Location of referenced      feet  above ground    Communities affected
                                               elevation**          [caret] Elevation in
                                                                        meters  (MSL)
                                                                   ----------------------
                                                                    Effective   Modified
----------------------------------------------------------------------------------------------------------------
                               Muhlenberg County, Kentucky, and Incorporated Areas
----------------------------------------------------------------------------------------------------------------
Brier Creek (backwater effects from   From the confluence with           None       +389  Unincorporated Areas
 Green River).                         Pond River to approximately                         of Muhlenberg County.
                                       1,390 feet downstream of
                                       Phillips Town Road.
Caney Creek.........................  Approximately 0.5 mile             None       +413  City of Greenville,
                                       upstream of North Main                              Unincorporated Areas
                                       Street.                                             of Muhlenberg County.
                                      At the Caney Creek Tributary       None       +423
                                       27 confluence.
Caney Creek Tributary 27.1            From the Caney Creek               None       +424  City of Greenville,
 (backwater effects from Caney         confluence to approximately                         Unincorporated Areas
 Creek).                               0.7 mile upstream of the                            of Muhlenberg County.
                                       Caney Creek confluence.
Caney Creek Tributary 31 (backwater   From the Caney Creek               None       +413  Unincorporated Areas
 effects from Caney Creek).            confluence to approximately                         of Muhlenberg County.
                                       0.6 mile upstream of the
                                       Caney Creek confluence.
Canfield Branch (backwater effects    From the Mud River                 None       +404  Unincorporated Areas
 from Green River).                    confluence to approximately                         of Muhlenberg County.
                                       340 feet upstream of Forest
                                       Oak Church Road.
Cypress Creek (backwater effects      From approximately 0.6 mile        None       +393  Unincorporated Areas
 from Green River).                    downstream of KY-175 to                             of Muhlenberg County.
                                       approximately 0.7 mile
                                       upstream of KY-81.
Cypress Creek Tributary 1 (backwater  From the Cypress Creek             None       +393  Unincorporated Areas
 effects from Green River).            confluence to approximately                         of Muhlenberg County.
                                       0.8 mile upstream of
                                       Coffman Schoolhouse Road.
Green River.........................  At the confluence with Mud         +394       +393  City of South
                                       River.                                              Carrollton,
                                                                                Unincorporated Areas
                                                                                of Muhlenberg County.
                                      Approximately 2.6 miles            +403       +404
                                       upstream of CSX Railroad.
Irwin Creek (backwater effects from   From the Isaacs Creek              None       +389  Unincorporated Areas
 Green River).                         confluence to approximately                         of Muhlenberg County.
                                       2,000 feet upstream of the
                                       Isaacs Creek confluence.
Isaacs Creek (backwater effects from  From the Green River               None       +389  Unincorporated Areas
 Green River).                         confluence to approximately                         of Muhlenberg County.
                                       1,035 feet upstream of the
                                       Irwin Creek confluence.
Jacobs Creek (backwater effects from  From the Green River               None       +402  Unincorporated Areas
 Green River).                         confluence to approximately                         of Muhlenberg County.
                                       2.0 miles upstream of
                                       Riverside Road.
Jacobs Creek Tributary 7 (backwater   From the Jacobs Creek              None       +402  Unincorporated Areas
 effects from Green River).            confluence to approximately                         of Muhlenberg County.
                                       370 feet upstream of
                                       Riverside Road.
Little Cypress Creek................  Approximately 190 feet             None       +405  Unincorporated Areas
                                       upstream of West Whitmer                            of Muhlenberg County,
                                       Street.                                             City of Central City.
                                      Just upstream of Front             None       +408
                                       Street.
Little Cypress Creek Tributary 16     From the Little Cypress            None       +405  City of Central City,
 (backwater effects from Little        Creek confluence to                                 Unincorporated Areas
 Cypress Creek).                       approximately 2,507 feet                            of Muhlenberg County.
                                       upstream of the Little
                                       Cypress Creek confluence.
Little Cypress Creek Tributary 8      From the Little Cypress            None       +422  Unincorporated Areas
 (backwater effects from Little        Creek confluence to                                 of Muhlenberg County.
 Cypress Creek).                       approximately 1,100 feet
                                       upstream of the Little
                                       Cypress Creek confluence.
Log Creek (backwater effects from     From the Pond River                None       +389  Unincorporated Areas
 Green River).                         confluence to approximately                         of Muhlenberg County.
                                       3,900 feet upstream of
                                       Millport Sacramento Road.
Mud River (backwater effects from     From the Green River               None       +404  Unincorporated Areas
 Green River).                         confluence to approximately                         of Muhlenberg County.
                                       535 feet upstream of the
                                       Canfield Branch confluence.
Muddy Fork (backwater effects from    From the Cypress Creek             None       +393  Unincorporated Areas
 Green River).                         confluence to approximately                         of Muhlenberg County.
                                       0.8 mile upstream of the
                                       Cypress Creek confluence.
Nelson Creek (backwater effects from  From the Green River               None       +398  Unincorporated Areas
 Green River).                         confluence to approximately                         of Muhlenberg County.
                                       0.4 mile upstream of Green
                                       River Haul Road.
Opossum Run (backwater effects from   From the Sandlick Creek            None       +430  Unincorporated Areas
 Sandlick Creek).                      confluence to approximately                         of Muhlenberg County.
                                       1,175 feet upstream of
                                       Opossum Lane.
Plum Creek (backwater effects from    From the Pond Creek                None       +401  City of Drakesboro,
 Green River).                         confluence to approximately                         Unincorporated Areas
                                       300 feet downstream of the                          of Muhlenberg County.
                                       Plum Creek Tributary 4
                                       confluence.
Plum Creek Tributary 5 (backwater     From the Plum Creek                None       +401  Unincorporated Areas
 effects from Green River).            confluence to approximately                         of Muhlenberg County.
                                       0.65 mile upstream of the
                                       Plum Creek confluence.

Pond Creek (backwater effects from    From the Green River               None       +401  Unincorporated Areas
 Green River).                         confluence to approximately                         of Muhlenberg County.
                                       1,280 feet upstream of I-
                                       431.
Pond Creek (backwater effects from    From the Sandlick Creek            +422       +421  Unincorporated Areas
 Sandlick Creek).                      confluence to just                                  of Muhlenberg County.
                                       downstream of Johnson Road.
Pond Creek Tributary 29 (Backwater    From the Pond Creek                None       +401  Unincorporated Areas
 effects from Green River).            confluence to approximately                         of Muhlenberg County.
                                       1,000 feet upstream of KY-
                                       2107.
Pond Creek Tributary 30 (backwater    From the Pond Creek                None       +401  Unincorporated Areas
 effects from Green River).            confluence to approximately                         of Muhlenberg County.
                                       1.4 miles upstream of the
                                       Pond Creek confluence.
Pond River (backwater effects from    From the Green River               None       +389  Unincorporated Areas
 Green River).                         confluence to approximately                         of Muhlenberg County.
                                       1.0 mile upstream of KY-70.
Sandlick Creek Tributary 2            From the Sandlick Creek            None       +449  Unincorporated Areas
 (backwater effects from Sandlick      confluence to approximately                         of Muhlenberg County.
 Creek).                               1,600 feet upstream of the
                                       Sandlick Creek confluence.
----------------------------------------------------------------------------------------------------------------
* National Geodetic Vertical Datum.
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

** BFEs to be changed include the listed downstream and upstream BFEs, and include BFEs located on the stream
 reach between the referenced locations above. Please refer to the revised Flood Insurance Rate Map located at
 the community map repository (see below) for exact locations of all BFEs to be changed.

Send comments to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation
 Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472.
                                                    ADDRESSES
City of Central City
Maps are available for inspection at City Hall, 214 North 1st Street, Central City, KY 42330.
City of Drakesboro
Maps are available for inspection at City Hall, 212 West Mose Rager Boulevard, Drakesboro, KY 42337.
City of Greenville
Maps are available for inspection at City Hall, 118 Court Street, Greenville, KY 42345.
City of South Carrollton
Maps are available for inspection at City Hall, 10515 U.S. Route 431, South Carrollton, KY 42374.
                                    Unincorporated Areas of Muhlenberg County
Maps are available for inspection at the Muhlenberg County Judicial Building, 136 South Main Street, Greenville,
 KY 42345.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: August 23, 2012.
Sandra K. Knight,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2012-22897 Filed 9-14-12; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: February 20, 2008 (Volume 73, Number 34)]
[Rules and Regulations]
[Page 9214-9217]
[DOCID:fr20fe08-19]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0306; FRL-8347-8]

Vitamin E, d-alpha tocopherol, dl-alpha tocopherol, d-alpha
tocopheryl acetate, and dl-alpha tocopheryl acetate; Inert Ingredients;
Exemption from the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance under 40 CFR 180.910 for residues of vitamin E (CAS Reg.
No. 1406-18-4), d-alpha tocopherol (CAS Reg. No. 9-02-9), dl-alpha
tocopherol (CAS Reg. No.10191-41-0), d-alpha tocopheryl acetate (CAS
Reg. No. 58-95-7), and dl-alpha tocopheryl acetate (CAS Reg. No. 7695-
91-2) in or on raw agricultural commodities when applied or used as
inert ingredients in pesticide formulations. Because these five
substances are chemically-similar, for the sake of simplicity,
discussion of vitamin E in this rule (unless otherwise noted) can be
considered to be vitamin E per se and/or one of the two alcohols (d-
alpha tocopherol, dl-alpha tocopherol) or two acetates (d-alpha
tocopheryl acetate, dl-alpha tocopheryl acetate). BASF Corporation
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act, as amended by the Food Quality Protection Act of 1996, requesting
an exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of vitamin E.

DATES: This regulation is effective February 20, 2008. Objections and
requests for hearings must be received on or before April 21, 2008, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0306. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced

Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the Office

of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kathleen Martin, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide

for readers regarding entities likely to be affected by this action.
Other types of entities not listed in this unit could also be affected.
The North American Industrial Classification System (NAICS) codes have
been provided to assist you and others in determining whether this
action might apply to certain entities. To determine whether you or
your business may be affected by this action, you should carefully
examine the applicability provisions in 40 CFR 152. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, as amended by FQPA, any person may
file an objection to any aspect of this regulation and may also request
a hearing on those objections. The EPA procedural regulations which
govern the submission of objections and requests for hearings appear in
40 CFR part 178. You must file your objection or request a hearing on
this regulation in accordance with the instructions provided in 40 CFR
part 178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2005-0306 in the subject line on the first page of
your submission. All requests must be in writing, and must be mailed or
delivered to the Hearing Clerk on or before April 21, 2008.
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0306, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of April 4, 2007 (72 FR 16352) (FRL-8119-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 5E6996) by BASF Corporation, PO Box 13528; Research
Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be
amended by establishing an exemption from the requirement of a
tolerance for residues of d-alpha tocopherol, d-alpha tocopheryl
acetate, dl-alpha tocopherol acetate, dl-alpha tocopheryl, and/or
vitamin E. That notice included a summary of the petition prepared by
the petitioner BASF Corporation. Please note that the April 4, 2007
notice amended a previous Notice of Filing for that petition; it was
published on January 18, 2006 (71 FR 2925) and was limited to a single
substance, alpha-tocopherol (CAS Reg. No. 10191-41-0). BASF asked to
amend the petition because it was too narrowly defined: ``Alpha-
tocopherol is known to be the most biologically active form of Vitamin
E. However, the ester of alpha-tocopherol (alpha-tocopheryl acetate) is
also a common source of Vitamin E. Alpha-tocopheryl acetate is
converted to alpha-tocopherol in the body upon ingestion. For purposes
of this rule, BASF requests that the acetate and alcohol forms of
Vitamin E be viewed as equivalent substances and that the existing
petition 5E6996 be amended to include the closely related Vitamin E
substances.'' Between the two notices, one comment was received in
response to the notices of filing; it was addressed.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical
residue....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. The following
provides a brief summary of the risk assessment and conclusions for the
Agency's review of vitamin E. The full decision document for this
action is available on EPA's Electronic Docket at http://www.regulations.gov/
 under docket number EPA-HQ-OPP-2005-0306.

III. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. The nature of the toxic effects caused by vitamin
E is discussed in this unit.
    In brief, the Agency reviewed the available information on vitamin
E submitted by the petitioner as well as additional information
available to EPA in two international, peer-reviewed evaluations of
vitamin E. The toxicity database is sufficient. In summary, vitamin E
has low acute oral toxicity. Alpha-tocopherol has an lethal dose

(LD)50 greater than 2,000 milligrams/kilograms bodyweight
(mg/kg bw) in mice, rats, and rabbits. In subchronic toxicity testing
vitamin E appears to elicit systemic toxicity to rats only at high
doses, with the target organs being the liver and blood. Vitamin E has
not been shown to be neurotoxic, mutagenic, or carcinogenic. Finally,
no developmental and reproductive effects have been shown.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to
consider available information concerning exposures from the pesticide
residue in food and all other non-occupational exposures, including
drinking water from groundwater or surface water and exposure through
pesticide use in gardens, lawns, or buildings (residential and other
indoor uses).
    EPA does not have information available to assess the potential for
exposure to vitamin E in consumer products. Nevertheless, given vitamin
E's known role in human physiology and its presence in various foods
such as nuts and vegetable oils, it is unlikely that residential
exposures of concern would result from the use of vitamin E in
nonpesticide products and as an ingredient in pesticide. Therefore, no
further aggregate assessment is necessary.

Dietary Exposure

    1. Food. EPA estimated dietary exposures for use of vitamin E as an
inert ingredient using Dietary Exposure Evaluation Model (DEEM\TM\), a
generic screening model that assumes that the inert ingredient is used
on all commodities and that 100 percent of crops are treated with the
inert ingredient. Generic chronic exposure for the overall U.S.
population was estimated at 0.12 mg/kg/day.
    2. Drinking water exposure. Surface water concentration of vitamin
E was estimated at 0.065 parts per billion (ppb); EPA's Pesticide Root
Zone Model - Exposure Analysis Modeling System (PRZM-EXAMS) model was
used. Groundwater concentration was estimated at 0.0015 ppb using EPA's
screening concentration in groundwater (SCI-GROW) model.

V. Cumulative Effects

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to vitamin E (CAS Reg. Nos.
1406-18-4; 59-02-9; 10191-41-0; 58-95-7; and 7695-91-2) and any other
substances and, this material does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that vitamin E (CAS
Reg. Nos. 1406-18-4; 59-02-9; 10191-41-0; 58-95-7; and 7695-91-2) has a
common mechanism of toxicity with other substances. For information
regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA's Office of
Pesticide Programs (OPP) concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.

VI. Determination of Safety for U.S. Population, Infants and Children

    Based on the information in this preamble, EPA concludes that there
is a reasonable certainty of no harm from aggregate exposure to
residues. Accordingly, EPA finds that exempting from the requirement of
a tolerance will be safe.

VII. Other Considerations

A. Analytical Method(s)

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Tolerances

    The Agency is not aware of any country requiring a tolerance for
vitamin E (CAS Reg. No. 1406-18-4), d-alpha tocopherol (CAS Reg. No. 9-
02-9), dl-alpha tocopherol (CAS Reg. No.10191-41-0), d-alpha tocopheryl
acetate (CAS Reg. No. 58-95-7), or dl-alpha tocopheryl acetate (CAS
Reg. No. 7695-91-2), nor have any CODEX Maximum Residue Levels (MRLs)
been established for any food crops at this time.

VIII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section

12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

IX. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: February 6, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In section 180.910 the table is amended by adding alphabetically the
following inert ingredients to read as follows:

Sec.  180.910  Inert ingredients used pre-harvest and post-harvest;
exemptions from the requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                              * * * * * * *
d-Alpha tocopherol (CAS Reg. No.  None                Safener
 9-02-9.
d-Alpha tocopheryl acetate (CAS   None                Safener
 Reg. No. 58-95-7).
dl-Alpha tocopherol (CAS Reg.     None                Safener
 No.10191-41-0).
dl-Alpha tocopheryl acetate (CAS  None                Safener
 Reg. No. 7695-91-2).
                              * * * * * * *
Vitamin E (CAS Reg. No. 1406-18-  None                Safener
 4).
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. E8-3127 Filed 2-19-08; 8:45 am]

BILLING CODE 6560-50-S