[Federal Register: December 23, 2005 (Volume 70, Number 246)]
[Proposed Rules]
[Page 76224-76228]
[DOCID:fr23de05-22]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0322; FRL-7751-3]

Benzaldehyde, Captafol, Hexaconazole, Paraformaldehyde, Sodium
dimethyldithiocarbamate, and Tetradifon; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to revoke specific tolerances and tolerance
exemptions for residues of the insecticides paraformaldehyde and
tetradifon; fungicides captafol, hexaconazole, and sodium
dimethyldithiocarbamate; and bee repellant benzaldehyde. EPA canceled
food use registrations or deleted food uses from registrations
following requests for voluntary cancellation or use deletion by the
registrants, or non-payment of registration maintenance fees. Also,
stakeholders have withdrawn their support for import tolerances for
captafol and hexaconazole. EPA expects to determine whether any
individuals or groups want to support these tolerances. The regulatory
actions proposed in this document contribute toward the Agency's
tolerance reassessment requirements under the Federal Food, Drug, and
Cosmetic Act (FFDCA) section 408(q), as amended by the Food Quality
Protection Act (FQPA) of 1996. By law, EPA is required by August 2006
to reassess the tolerances that were in existence on August 2, 1996.
The regulatory actions proposed in this document pertain to the
proposed revocation of 39 tolerances and tolerance exemptions of which
38 would be counted as tolerance reassessments toward the August 2006
review deadline.

DATES: Comments must be received on or before February 21, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0322, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/.

Follow the on-line instructions for submitting comments.
     Agency Web Site: EDOCKET, EPA's electronic public docket
and comment system was replaced on November 25, 2005, by an enhanced
federal-wide electronic docket management and comment system located at
http://www.regulations.gov/. Follow the on-line instructions.

     E-mail: Comments may be sent by e-mail to
<EMAIL_ADDRESS>Attention: Docket ID Number EPA-HQ-OPP-2005-0322.

     Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001, Attention: Docket ID Number EPA-HQ-OPP-2005-0322.
     Hand Delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID Number EPA-HQ-OPP-2005-0322. Such
deliveries are only accepted during the Docket's normal hours of
operation, and

special arrangements should be made for deliveries of boxed
information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0322. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.epa.gov/edocket/, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through EDOCKET,
regulations.gov, or e-mail. The EPA EDOCKET and the regulations.gov
websites are ``anonymous access'' systems, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through EDOCKET or regulations.gov, your e-mail address
will be automatically captured and included as part of the comment that
is placed in the public docket and made available on the Internet. If
you submit an electronic comment, EPA recommends that you include your
name and other contact information in the body of your comment and with
any disk or CD ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit EDOCKET on-line or see the Federal Register of May 31,
2002 (67 FR 38102) (FRL-7181-7).
    Docket: All documents in the docket are listed in the EDOCKET index
at http://www.epa.gov/edocket/. Although listed in the index, some

information is not publicly available, i.e., 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 electronically in EDOCKET or in hard
copy at the Public Information and Records Integrity Branch (PIRIB),
Rm. 119, Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This
Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave, NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; e-mail
<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 Unit II.A. 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 and Other
Related Information?

    In addition to using EDOCKET(http://www.epa.gov/edocket/), you may

access this Federal Register document electronically through the EPA
Internet under the ``Federal Register'' listings athttp://www.epa.gov/fedrgstr/.
 A frequently updated electronic version of 40 CFR part 180

is available at E-CFR Beta Site Two athttp://www.gpoaccess.gov/ecfr/.

C. What Should I Consider as I Prepare My Comments for EPA?

    1.Submitting CBI. Do not submit this information to EPA through
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM
as CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the rulemaking by docket ID number and other
identifying information (subject heading, Federal Register date, and
page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

D. What Can I do if I Wish the Agency to Maintain a Tolerance That the
Agency Proposes to Revoke?

    This proposed rule provides a comment period of 60 days for any
person to state an interest in retaining a tolerance proposed for
revocation. If EPA receives a comment within the 60-day period to that
effect, EPA will not proceed to revoke the tolerance immediately.
However, EPA will take steps to ensure the submission of any needed
supporting data and will issue an order in the Federal Register under
FFDCA section 408(f) if needed. The order would specify data needed and
the time frames for its submission, and would require that within 90
days some person or persons notify EPA that they will submit the data.
If the data are not submitted as required in the order, EPA will take
appropriate action under FFDCA.

    EPA issues a final rule after considering comments that are
submitted in response to this proposed rule. In addition to submitting
comments in response to this proposal, you may also submit an objection
at the time of the final rule. If you fail to file an objection to the
final rule within the time period specified, you will have waived the
right to raise any issues resolved in the final rule. After the
specified time, issues resolved in the final rule cannot be raised
again in any subsequent proceedings.

II. Background

A. What Action is the Agency Taking?

    EPA is proposing to revoke certain specific tolerances and
tolerance exemptions for residues of the insecticides paraformaldehyde
and tetradifon; fungicides captafol, hexaconazole, and sodium
dimethyldithiocarbamate; and bee repellant benzaldehyde because these
specific tolerances and tolerance exemptions correspond to uses which
are no longer current or registered under FIFRA in the United States,
or no longer supported as import tolerances. It is EPA's general
practice to propose revocation of those tolerances for residues of
pesticide active ingredients on crop uses for which there are no active
registrations under FIFRA, unless any person in comments on the
proposal indicates a need for the tolerance to cover residues in or on
imported commodities or domestic commodities legally treated.
    1. Benzaldehyde. The last active registration for use of
benzaldehyde as a bee repellant in the harvesting of honey was canceled
in 1991 due to non-payment of the maintenance fee, and therefore the
tolerance exemption is no longer needed. EPA is proposing to revoke the
tolerance exemption in 40 CFR 180.1229 for residues of benzaldehyde
when used as a bee repellant in the harvesting of honey.
    2. Captafol. The Republic of Indonesia's Indonesian Ministry of
Agriculture had commented to a proposed rule to revoke tolerances for
captafol and several other pesticides, published in the Federal
Register of June 9, 1993 (58 FR 32320)(FRL-4183-6). The commenter had
stated that the use of captafol was being reevaluated in that country,
might undergo a phase out, and requested that EPA not revoke the onion,
potato, and tomato tolerances in 40 CFR 180.267. In the Federal
Register of July 21, 1999 (64 FR 39049)(FRL-6092-7), EPA published a
final rule in which it revoked specific captafol tolerances and
responded to the 1993 comment received from the Republic of Indonesia
by stating that the Agency would not take final action on the three
tolerances in 40 CFR 180.267 for residues of captafol on onion, potato,
and tomato at that time. In April 2005, EPA determined that captafol
has not been registered in Indonesia since 1998. Also, the Indonesian
Ministry of Agriculture verified that it no longer has a continuing
interest in the three captafol tolerances for importation purposes.
Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.267
for residues of the fungicide captafol in or on onion, potato, and
tomato.
    3. Hexaconazole. There have been no active U.S. registrations for
hexaconazole on banana since 1992. Recently, Syngenta has informed EPA
that it has voluntarily chosen to no longer support the hexaconazole
tolerance on banana for the purpose of importation. Consequently, the
tolerance is no longer needed. Therefore, EPA is proposing to revoke
the tolerance in 40 CFR 180.488 for residues of the fungicide
hexaconazole in or on banana.
    4. Paraformaldehyde. The last active registration for
paraformaldehyde use as an insecticide for the soil treatment of sugar
beets was canceled in 1989 due to non-payment of the maintenance fee,
and therefore the tolerance exemptions are no longer needed. EPA is
proposing to revoke the tolerance exemptions in 40 CFR 180.1024 for
residues of the insecticide paraformaldehyde in or on beet, sugar,
roots and beet, sugar, tops, when applied to the soil not later than
planting.
    5. Sodium dimethyldithiocarbamate. The last active registration for
use of sodium dimethyldithiocarbamate on melons was canceled in 1993
due to non-payment of the maintenance fee, and therefore the tolerance
is no longer needed. EPA is proposing to revoke the tolerance in 40 CFR
180.152 for residues of the fungicide sodium dimethyldithiocarbamate,
calculated as zinc ethylenebisdithiocarbamate, in or on melon.
    6. Tetradifon. The last tetradifon registrations were canceled in
1990 due to non-payment of maintenance fees. Uniroyal Chemical Company
(which later became part of Crompton Corporation) had commented to a
proposed revocation of tetradifon tolerances published in the Federal
Register of August 1, 2001 (66 FR 39705)(FRL-6786-4). Uniroyal noted
that it had submitted certain studies to EPA in 1998 and 1996, and
requested that EPA not revoke any of the tetradifon tolerances in 40
CFR 180.174. In the Federal Register of January 24, 2003 (68 FR
3425)(FRL-7187-3), EPA published a final rule and responded to
Uniroyal's comment by stating that the Agency would not take final
action on the tetradifon tolerances in 40 CFR 180.174 at that time.
During follow-up communication, EPA received a letter from Crompton
Corporation (now Chemtura Corporation) that it no longer supports
retention of the tolerances for tetradifon. Therefore, EPA is proposing
to revoke all the tolerances in 40 CFR 180.174 for residues of the
insecticide tetradifon in or on apple; apricot; cherry; citron, citrus;
crabapples; cucumber; fig; fig, dried fruit; grapefruit; grape; hop,
dried; hop, vine; lemon; lime; meat; melon; milk; nectarine; orange,
sweet; peach; pear; peppermint; plum, prune, fresh; pumpkin; quince;
spearmint, tops; strawberry; tangerine; tea, dried; tomato; and winter
squash.

B. What is the Agency's Authority for Taking This Action?

    A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by the FQPA of 1996, Public Law 104-170, authorizes the
establishment of tolerances, exemptions from tolerance requirements,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of the FFDCA, 21 U.S.C. 342(a).
Such food may not be distributed in interstate commerce (21 U.S.C.
331(a)). For a food-use pesticide to be sold and distributed, the
pesticide must not only have appropriate tolerances under the FFDCA,
but also must be registered under FIFRA (7 U.S.C. 136 et seq.). Food-
use pesticides not registered in the United States must have tolerances
in order for commodities treated with those pesticides to be imported
into the United States.
    EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances

even when corresponding domestic uses are canceled if the tolerances,
which EPA refers to as ``import tolerances,'' are necessary to allow
importation into the United States of food containing such pesticide
residues. However, where there are no imported commodities that require
these import tolerances, the Agency believes it is appropriate to
revoke tolerances for unregistered pesticides in order to prevent
potential misuse.
    Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under section 408 of the FFDCA, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may be more difficult for others to obtain needed
tolerances or to register needed new uses. To avoid potential trade
restrictions, the Agency is proposing to revoke tolerances for residues
on crops uses for which FIFRA registrations no longer exist, unless
someone expresses a need for such tolerances. Through this proposed
rule, the Agency is inviting individuals who need these import
tolerances to identify themselves and the tolerances that are needed to
cover imported commodities.
    Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.

C. When do These Actions Become Effective?

    EPA is proposing that revocation of these tolerances and tolerance
exemptions become effective on the date of publication of the final
rule in the Federal Register because their associated uses have been
canceled for several years. The Agency believes that treated
commodities have had sufficient time for passage through the channels
of trade. However, if EPA is presented with information that existing
stocks would still be available and that information is verified, the
Agency will consider extending the expiration date of the tolerance. If
you have comments regarding existing stocks and whether the effective
date allows sufficient time for treated commodities to clear the
channels of trade, please submit comments as described under
SUPPLEMENTARY INFORMATION.
    Any commodities listed in this proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this section, any residues of these
pesticides in or on such food shall not render the food adulterated so
long as it is shown to the satisfaction of the Food and Drug
Administration that: (1) The residue is present as the result of an
application or use of the pesticide at a time and in a manner that was
lawful under FIFRA, and (2) the residue does not exceed the level that
was authorized at the time of the application or use to be present on
the food under a tolerance or exemption from tolerance. Evidence to
show that food was lawfully treated may include records that verify the
dates when the pesticide was applied to such food.

D. What Is the Contribution to Tolerance Reassessment?

    By law, EPA is required by August 2006 to reassess the tolerances
in existence on August 2, 1996. As of December 8, 2005, EPA has
reassessed over 7,820 tolerances. This document proposes to revoke a
total of 39 tolerances and tolerance exemptions of which 38 would be
counted as tolerance reassessments toward the August 2006 review
deadline of FFDCA section 408(q), as amended by FQPA in 1996.

III. Are The Proposed Actions Consistent With International
Obligations?

    The tolerance revocations in this proposal are not discriminatory
and are designed to ensure that both domestically-produced and imported
foods meet the food safety standard established by the FFDCA. The same
food safety standards apply to domestically produced and imported
foods.
    EPA is working to ensure that the U.S. tolerance reassessment
program under FQPA does not disrupt international trade. EPA considers
Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in
reassessing them. MRLs are established by the Codex Committee on
Pesticide Residues, a committee within the Codex Alimentarius
Commission, an international organization formed to promote the
coordination of international food standards. It is EPA's policy to
harmonize U.S. tolerances with Codex MRLs to the extent possible,
provided that the MRLs achieve the level of protection required under
FFDCA. EPA's effort to harmonize with Codex MRLs is summarized in the
tolerance reassessment section of individual Reregistration Eligibility
Decision documents. EPA has developed guidance concerning submissions
for import tolerance support (65 FR 35069, June 1, 2000) (FRL-6559-3).
This guidance will be made available to interested persons. Electronic
copies are available on the internet at http://www.epa.gov/. On the

Home Page select ``Laws, Regulations, and Dockets,'' then select
``Regulations and Proposed Rules'' and then look up the entry for this
document under ``Federal Register--Environmental Documents.'' You can
also go directly to the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/
.

IV. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revoke specific
tolerances and tolerance exemptions established under FFDCA section
408. The Office of Management and Budget (OMB) has exempted this type
of action (i.e., tolerance revocation for which extraordinary
circumstances do not exist) from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this proposed rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this proposed
rule is not subject to Executive Order 13211, entitled Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This proposed rule
does not contain any information collections subject to OMB approval
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or
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). Nor does it require any special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any other
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). 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). Pursuant to the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency previously assessed whether
revocations of tolerances might significantly impact a substantial
number of small entities and concluded that, as a general matter, these
actions do not impose a significant economic impact on a substantial
number of small entities. This analysis was published on December 17,
1997 (62 FR 66020), and was provided to the Chief Counsel for Advocacy
of the Small Business Administration. Taking into account this
analysis, and available information concerning the pesticides listed in
this proposed rule, the Agency hereby certifies that this proposed
action will not have a significant negative economic impact on a
substantial number of small entities. Specifically, as per the 1997
notice, EPA has reviewed its available data on imports and foreign
pesticide usage and concludes that there is a reasonable international
supply of food not treated with canceled pesticides. Furthermore, for
the pesticide named in this proposed rule, the Agency knows of no
extraordinary circumstances that exist as to the present proposal that
would change the EPA's previous analysis. Any comments about the
Agency's determination should be submitted to the EPA along with
comments on the proposal, and will be addressed prior to issuing a
final rule. In addition, the Agency has determined that this action
will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.

List of Subjects in 40 CFR Part 180

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

    Dated: December 13, 2005.
James Jones,
Director, Office of Pesticide Programs.
    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 180--[AMENDED]

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

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

Sec. Sec.  180.152, 180.174, 180.267, 180.488, 180.1024 and
180.1229  [Removed]

    2. Sections 180.152, 180.174, 180.267, 180.488, 180.1024 and
180.1229 are removed.
[FR Doc. E5-7693 Filed 12-22-05; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 38 (Tuesday, February 28, 2017)]
[Notices]
[Page 12150]
[FR Doc No: 2017-03928]

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SECURITIES AND EXCHANGE COMMISSION

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, March
2, 2017 at 11 a.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), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit
consideration of the scheduled matter at the closed meeting.
    Acting Chairman Piwowar, as duty officer, voted to consider the
items listed for the closed meeting in closed session.
    The subject matter of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Adjudicatory matters;
    Resolution of litigation claims; 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 Brent J. Fields from
the Office of the Secretary at<PHONE_NUMBER>.

    Dated: February 23, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-03928 Filed 2-24-17; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 136 (Wednesday, July 15, 2020)]
[Notices]
[Pages 42882-42883]
[FR Doc No: 2020-15248]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1984-N-0259 (formerly 84N-0167)]

Vasodilan Injection and Tablets Containing Isoxsuprine
Hydrochloride; Final Decision on Proposal To Withdraw Approval of New
Drug Application; Availability of Final Decision

AGENCY: Food and Drug Administration; Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing that the Initial Decision of the Administrative Law Judge
(ALJ), that Vasodilan containing Isoxsuprine Hydrochloride had not been
shown to be supported by substantial evidence consisting of adequate
and well-controlled studies to be effective for treating symptoms
relating to senile dementia of the Alzheimer type (SDAT) and multiple
infarct dementia and peripheral vascular disease, is the final decision
of the Commissioner of Food and Drugs (the Commissioner).

DATES: This notice is applicable July 15, 2020.

ADDRESSES: For access to the docket, 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 between 9 a.m. and 4 p.m., Monday through Friday. Publicly
available submissions may be seen in the docket.

FOR FURTHER INFORMATION CONTACT:  Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Several parties to the hearing, including
the new drug application (NDA) holder and identical, related, or
similar (IRS) product manufacturers, filed exceptions to the ALJ's
Initial Decision. FDA recently requested that the current owner of the
NDA and successors-in-interest to IRS product manufacturers who
submitted timely exceptions to the ALJ's Initial Decision affirm,
within a specific timeframe, their interest in pursuing their appeals
of the ALJ's Initial Decision. FDA did not receive any responses within
the specified timeframe. Accordingly, FDA now deems those exceptions as
withdrawn. Consequently, the proceeding is in the same procedural
position as if no exceptions to the ALJ's Initial Decision had been
filed. Therefore, the ALJ's Initial Decision has become the final
decision of the Commissioner by operation of law.

I. Background

    In 1962, the Federal Food, Drug, and Cosmetic Act (FD&C Act) was
amended by the Drug Amendments Act of 1962, and these amendments
provided that new drugs could no longer be approved unless both safety
and efficacy had been established for them. As amended, the FD&C Act
also required FDA to evaluate drugs approved as safe between 1938 and
1962 to determine whether such drugs were effective and to withdraw
approval for any NDA where there was not substantial evidence of the
drug's effectiveness. The person contesting the withdrawal of the
approval had the burden of coming forward with evidence of
effectiveness for the drug. FDA's review of these pre-1962 drugs is
known as the Drug Efficacy Study Implementation program.
    In a notice published in the Federal Register of July 11, 1972 (37
FR 13565, available at https://www.govinfo.gov/content/pkg/FR-1972-07-11/pdf/FR-1972-07-11.pdf), after receiving reports from the National
Academy of Sciences/National Research Council, Drug Efficacy Study
Group, FDA stated that Vasodilan Injection and Tablets containing
Isoxsuprine Hydrochloride lacked substantial evidence of effectiveness
for several indications. In a notice published in the Federal Register
of May 25, 1979 (44 FR 30443, available at https://www.govinfo.gov/content/pkg/FR-1979-05-25/pdf/FR-1979-05-25.pdf), the Director of the
Bureau of Drugs (now the Center for Drug Evaluation and Research),
after reviewing all the data previously submitted, concluded that
Vasodilan lacks substantial evidence of effectiveness for its labeled
indications, and proposed to withdraw approval of the NDA and issued a
notice of opportunity for hearing on a proposal to withdraw approval of
Vasodilan.
    Mead Johnson, the NDA holder of Vasodilan (NDA 11-832) submitted
data intended to support the effectiveness of Vasodilan for other
indications, including: (1) Relief of symptoms associated with SDAT
and/or multiple infarct dementia; (2) relief of symptoms associated
with peripheral vascular disease of arteriosclerosis obliterans,
thromboangiitis obliterans, and Raynaund's disease; and (3) relief of
symptoms of uterine motility, including premature labor, dysmenorrhea,
and threatened abortion.
    Mead Johnson and multiple IRS product manufacturers responded to
the notice of opportunity for a hearing and submitted requests for a
hearing. By notice published in the Federal Register on September 28,
1984 (49 FR 38363, available at https://www.govinfo.gov/content/pkg/FR-1984-09-28/pdf/FR-1984-09-28.pdf), the Commissioner granted a hearing;
however, the Commissioner only granted a hearing concerning the use of
Vasodilan in treating symptoms related to: (1) SDAT or multiple infarct
dementia and (2) peripheral vascular disease. Although Mead Johnson
requested a hearing on the issue of Vasodilan's effectiveness in
relieving symptoms of uterine motility, including premature labor,
dysmenorrhea, and threatened abortion, Mead Johnson later abandoned
this indication and consented to withdrawal of Vasodilan's approval for
it (see id.). Following the submission of written testimony and
documentary evidence, an ALJ, Daniel J. Davidson, conducted a hearing
and issued his Initial Decision on August 20, 1986. The ALJ found that
the effectiveness of Vasodilan had not been shown to be supported by
substantial evidence and, as a result, ordered that the approval of the
NDA be withdrawn. Mead Johnson and certain IRS product manufacturers
timely appealed the ALJ's Initial Decision by filing exceptions with
the Commissioner under 21 CFR 12.125.
    Separately, by notice published in the Federal Register of February
11, 2009 (74 FR 6896), FDA withdrew approval of Vasodilan. The current
NDA holder and successor to Mead Johnson, Apothecon, c/o Bristol-Myers
Squibb Co. (BMS), had requested that FDA withdraw approval of the
application because the drug product was no longer marketed;
additionally, BMS waived its opportunity for a hearing on the
withdrawal.
    On November 9, 2017, FDA sent letters to BMS and the successors-in-

interest to the IRS product manufacturers who submitted timely
exceptions, to determine whether the companies remained interested in
pursuing their appeals of the ALJ's Initial Decision. FDA informed the
companies that, if they did not respond and affirm their desire to
pursue their appeals by January 8, 2018, the Office of the Commissioner
would conclude that the companies no longer wish to pursue the appeal
of the ALJ's Initial Decision and will proceed as if the appeals have
been withdrawn. The Office of the Commissioner did not receive a
response from any of the companies by the given date; therefore, the
Commissioner now deems the exceptions withdrawn.

II. Conclusion and Order

    Given that the exceptions have been deemed withdrawn, this
proceeding is now in the same procedural posture as if no exceptions
had ever been filed. When parties do not file exceptions to the ALJ's
Initial Decision, and the Commissioner does not file a notice of
review, the ALJ's Initial Decision becomes the final decision of the
Commissioner (see 21 CFR 12.120(e)). FDA will publish a notice in the
Federal Register when an initial decision becomes the final decision of
the Commissioner without appeal to or review by the Commissioner (see
21 CFR 12.120(f)).
    Pursuant to the findings in the ALJ's Initial Decision, under
section 505(e) of the FD&C Act (21 U.S.C. 355(e)), there is a lack of
substantial evidence that Vasodilan will have the effect it purports or
is represented to have under the conditions of use prescribed,
recommended, or suggested in its labeling for: (1) SDAT or multiple
infarct dementia and (2) peripheral vascular disease. Distribution of
products subject to the Initial Decision in interstate commerce without
an approved application is prohibited and subject to regulatory action
(see, e.g., sections 505(a) and 301(d) of the FD&C Act (21 U.S.C.
355(a) and 331(d)).
    The full text of the ALJ's Initial Decision may be seen at Dockets
Management Staff (see ADDRESSES).

    Dated: July 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15248 Filed 7-14-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 7, 2006 (Volume 71, Number 151)]
[Notices]
[Page 44691-44694]
[DOCID:fr07au06-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2101-074]

Sacramento Municipal Utility District; Notice of Application and
Applicant-Prepared EA Accepted for Filing, Soliciting Motions To
Intervene and Protests, and Soliciting Comments, and Final
Recommendations, Terms and Conditions, and Prescriptions

July 28, 2006.
    Take notice that the following hydroelectric application and
applicant-prepared environmental assessment has been filed with the
Commission and is available for public inspection.
    a. Type of Application: New--Major Modified License.
    b. Project No.: 2101.
    c. Date Filed: July 15, 2005.
    d. Applicant: Sacramento Municipal Utility District.
    e. Name of Project: Upper American River Project.
    f. Location: On the Rubicon River, Silver Creek, and South Fork of
the American River near Placerville, California. The project affects
6,375 acres of Federal land administered by the El Dorado National
Forest and 54 acres of Federal land administered by the Bureau of Land
Management.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: David Hanson, Project Manager, Sacramento
Municipal Utility District, 6301 S Street, Sacramento, California
95817-1899. Phone:<PHONE_NUMBER> or e-mail<EMAIL_ADDRESS>

    i. FERC Contact: Jim Fargo at<PHONE_NUMBER>, or e-mail:
<EMAIL_ADDRESS>
    j. Deadline for filing motions to intervene and protests, comments,
and final recommendations, terms and conditions, and prescriptions is
60 days from the issuance date of this notice; reply comments are due
105 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor 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.
    Motions to intervene and protests, comments, recommendations, terms
and conditions, and prescriptions may be filed electronically via the
Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the ``e-

Filing'' link.
    k. This application has been accepted for filing.
    l. Description of project: The project is located on the west slope
of the Sierra Nevada Mountain Range, in El Dorado and Sacramento
counties. The proposed project would be comprised of eight
developments; seven of which are existing developments (Loon Lake,
Robbs Peak, Jones Fork, Union Valley, Jaybird, Camino, and Slab Creek/
White Rock) constructed by SMUD from 1959 through 1985 under the
initial FERC license, and one of which would be a new pumped storage
development (Iowa Hill) proposed by SMUD to be constructed by 2015.
Nearly all of the land surrounding the project reservoirs within the
FERC Project Boundary is owned by the United States and administered by
the Forest Service as part of the Eldorado National Forest (ENF). There
are also several project-related recreation facilities, which are owned
and operated by the ENF, at Loon Lake, Gerle Creek, Union Valley, and
Ice House reservoirs. These recreation facilities are not project
features.
     Loon Lake Development--(1) Rubicon Dam--A 36-foot-high by
644-foot-long, concrete gravity main diversion dam located on the
Rubicon River, and a concrete gravity auxiliary dam that is 29-foot-
high by 553-foot-long. These structures create the Rubicon Reservoir;
(2) Rockbound Tunnel--A 0.2-mile-long, 13-foot-diameter unlined
horseshoe tunnel that diverts water from Rubicon Reservoir to Buck
Island Reservoir via Rockbound Lake (a non-project facility) located on
Highland Creek; (3) Buck Island Dam--A concrete gravity diversion dam
located on the Little Rubicon River that is 23-feet-high by 293-feet-
long, and a 15-foot-high by 244-foot-long concrete gravity auxiliary
dam. These structures create Buck Island Reservoir; (4) Buck-Loon
Tunnel--A 1.6-mile-long, 13-foot-diameter unlined modified horseshoe
tunnel that diverts water from Buck Island Reservoir to Loon Lake
Reservoir; (5) Loon Lake Dam--A rockfill dam on Gerle Creek that is
0.4-mile-long by 108-feet-high, with a 250-foot-long side channel
spillway on the right bank, and a 910-foot-long by 95-foot-high
rockfill auxiliary dam, and an earthfill dike. These create Loon Lake
Reservoir; (6) Loon Lake Penstock--A 0.3-mile-long, 14-foot-diameter
concrete-lined horseshoe tunnel; 10-foot-diameter concrete lined
vertical shaft; and 8.5-foot-diameter steel lined tunnel that extends
from Loon Lake Reservoir to Loon Lake Powerhouse; (7) Loon Lake
Powerhouse--An underground powerhouse, located over 1,100 feet below
the surface of the Loon Lake Reservoir, consisting of one turbine with
a rated capacity of 70,479 kW at best gate opening and one generator
rated at 85,215 kW, with powerhouse maximum capability of 82,000 kW;
(8) Loon Lake Tailrace Tunnel--A 3.8-mile-long, 18-foot diameter
unlined horseshoe tunnel that runs from Loon Lake Powerhouse and
discharges into Gerle Creek Reservoir; and (9) Transmission Lines--Two
69 kV overhead transmission lines: one extending to the Robbs Peak
switchyard via the 7.9-mile-long Loon Lake-Robbs Peak Transmission
Line, and the other extending to the Union Valley Switchyard via the
12.4-mile-long Loon Lake-Union Valley Transmission Line.
     Robbs Peak Development--(1) Gerle Creek Dam--A 58-foot-
high, 444-foot-long concrete gravity overflow structure located on
Gerle Creek, upstream of its confluence with SFRR, incorporating the
intake of Gerle Creek Canal in its left abutment, creating Gerle Creek
Reservoir; (2) Gerle Creek Canal--An above ground canal, 22-foot-wide
and 19-foot-deep, extending 1.9 miles from Gerle Creek Reservoir to
Robbs Peak Reservoir. It is partially lined with gunite; (3) Robbs Peak
Dam--A 44-foot-high, 320-foot-long concrete gravity overflow structure,
with 12 steel bulkhead gates, all 6.2-foot-high, on the spillway crest,
located on the SFRR upstream of its confluence with Gerle Creek, that
forms Robbs Peak Reservoir; (4) Robbs Peak Tunnel--A 3.2-mile-long, 13-
foot-diameter unlined horseshoe and 10-foot-diameter lined diversion
tunnel from Robbs Peak Reservoir to Robbs Peak Penstock; (5) Robbs Peak
Penstock--A 9.75-to 8.5-foot-diameter, 0.4-mile-long steel penstock
from Robbs Peak Tunnel to Robbs Peak Powerhouse; (6) Robbs Peak
Powerhouse--Located on the northeast shore of Union Valley Reservoir,
equipped with one turbine that has a rated capacity at best gate
opening of 28,125 kW, and one generator rated at 29,700 kW, with
maximum capability of 29,000 kW; and (7) Robbs Peak-Union Valley
Transmission Line--A 6.8-mile-long, 69 kV overhead line that connects
the Robbs Peak switchyard to the Union Valley switchyard.
     Jones Fork Development--(1) Ice House Dam--A rockfill dam
located on the South Fork Silver Creek, 0.3-mile-long and 150-foot-
high, incorporating a concrete ogee spillway with radial gates, and two
auxiliary earthfill dikes; these create the Ice House Reservoir; (2)
Jones Fork Tunnel--A 0.3-mile-long, 8-foot-diameter horseshoe concrete-
and steel-lined tunnel from Ice House Reservoir to the Jones Fork
Penstock; (3) Jones Fork Penstock--A 1.6-mile-long, 6-foot-diameter
steel and concrete penstock from Jones Fork Tunnel to the Jones Fork
Powerhouse; (4) Jones Fork Powerhouse--Contains a turbine with a rated
capacity at best gate opening of 10,400 kW, and one generator rated at
11,495 kW, located on the southeast shore of Union Valley Reservoir;
with maximum capability of 11,500 kW; and (5) Jones Fork-Union Valley
Transmission Line--A 69 kV, 4.0-mile-long overhead transmission line
from the Jones Fork switchyard to the Union Valley switchyard.
     Union Valley Development--(1) Union Valley Dam--An
earthfill dam located on Silver Creek, 0.3-mile-long and 453-feet-high,
incorporating a concrete ogee spillway with radial gates, creating
Union Valley Reservoir; (2) Union Valley Tunnel--A 268-foot-long, 11-
foot-diameter concrete-lined tunnel with an approximately 10-foot-
diameter steel penstock in part of the tunnel and connecting Union
Valley Reservoir with Union Valley Powerhouse; (3) Union Valley
Penstock--A 0.3-mile-long, 10-foot-diameter steel penstock that conveys
water from the outlet of the Union Valley Tunnel to the Union

Valley Powerhouse; (4) Union Valley Powerhouse--The powerhouse is
equipped with one turbine with a rated capacity at best gate opening of
40,074 kW, and one generator rated at 44,400 kW, located at the base of
Union Valley Dam; with maximum capability of 46,700 kW; and (5)
Transmission Lines--Two 230 kV overhead transmission lines, one to the
Camino switchyard via the 11.8-mile-long Union Valley-Camino
Transmission Line, and the other to the Jaybird switchyard via the 5.9-
mile-long Union Valley-Jaybird Transmission Line.
     Jaybird Development--(1) Junction Dam--A double curvature,
concrete overflow arch dam located on Silver Creek that is 525 feet
long and 168 feet high, creating Junction Reservoir; (2) Jaybird
Tunnel--An 11- to 14-foot-diameter modified horseshoe tunnel 4.4-mile-
long, connecting Junction Reservoir and the Jaybird Penstock; (3)
Jaybird Penstock--A 6- to 10-foot-diameter steel penstock with a surge
tank that is 0.5-mile-long, connecting Jaybird Tunnel and Jaybird
Powerhouse; (4) Jaybird Powerhouse--The powerhouse is equipped with two
Pelton turbines, one with a rated capacity of 61,607 kW and the other
61,574 kW at best gate opening, and two generators, each rated at
84,450 kW; with total powerhouse maximum capability of 144,000 kW; and
(5) Jaybird-White Rock Transmission Line--A 15.9-mile-long, 230 kV
overhead transmission line connecting the Jaybird and White Rock
switchyards.
     Camino Development--(1) Camino Dam--A concrete double
curvature arch dam located on Silver Creek that is 470-foot-long and
133-foot-high, and has three integral bulkhead gates. These structures
create Camino Reservoir; (2) Camino Tunnel--A 5-mile-long power tunnel
with a diameter ranging from 13 feet to 14 feet; and including a surge
tank that connects Camino Reservoir with the Camino Penstock; (3) Brush
Creek Dam--A double curvature arch dam located on Brush Creek, 213 feet
high and 780 feet long, creating Brush Creek Reservoir; (4) Brush Creek
Tunnel--An approximately 14-foot-diameter modified horseshoe tunnel
extending 0.8 mile from Brush Creek Reservoir to the lower end of
Camino Tunnel; (5) Camino Penstock--A 5-foot to 12-foot-diameter, 0.3-
mile-long above ground steel penstock connecting Camino Tunnel and
Camino Powerhouse; (7) Camino Powerhouse--The powerhouse is located on
the SFAR and is equipped with two turbines: One with a rated capacity
of 73,760 kW and the other with a rated capacity at best gate opening
of 70,769 kW with total powerhouse maximum capability of 150,000 kW.
The powerhouse is also equipped with two generators rated at 90,820 kW
each. Both generators are installed with secondary oil containment; and
(8) Transmission Lines--Two 230 kV overhead transmission lines
originate at the Camino Switchyard, one (Camino-Lake) is 31.7-mile-long
and connects to SMUD's Lake Substation and the other (Camino-White
Rock) is 10.0 miles long and connects to the White Rock Switchyard.
    Slab Creek/White Rock Development--(1) Slab Creek Dam--A double
curvature variable radius concrete arch dam that stretches across the
South Fork American River is 250 feet high and 817 feet long, with a
central uncontrolled overflow spillway. The structures create Slab
Creek Reservoir; (2) Slab Creek Penstock--A 40-foot-long, 24-inch-
diameter steel penstock that passes through the dam and connects Slab
Creek Reservoir with Slab Creek Powerhouse; (3) Slab Creek Powerhouse--
The powerhouse, which is located at the base of Slab Creek Dam and
utilizes minimum stream flow releases, has one turbine with a rated
capacity at best gate opening of 450 kW, and one generator rated at 485
kW, with a total powerhouse maximum capability of 400 kW; (4) White
Rock Tunnel--an approximately 20- to 24-foot-diameter modified
horseshoe tunnel 4.9-mile-long and has a surge shaft that connects Slab
Creek Reservoir with White Rock Penstock; (5) White Rock Penstock--A 9-
to 15-foot-diameter, 0.3-mile-long above-ground steel penstock that
connects White Rock Tunnel to White Rock Powerhouse; (6) White Rock
Powerhouse--The powerhouse is equipped with two turbines, one rated at
112,976 kW and the other at 120,000 kW at best gate opening, and two
generators, rated at 109,250 kW and 133,000 kW, with total powerhouse
maximum capability of 224,000 kW; and (7) Transmission Lines--There are
two 230 kV overhead transmission lines and one 12 kV distribution line.
The two transmission lines, both 21.8 miles in length, connect the
White Rock switchyard to SMUD's Folsom Junction. The 600-foot-long 12
kV Slab Creek tap line connects the Slab Creek Powerhouse to the
junction with Pacific Gas and Electric Company's 12-kV distribution
line.
    SMUD's Proposed Action includes the addition of the Iowa Hill
Development. The development would be composed of the following
features: (1) Iowa Hill Reservoir--A new off-stream, rock filled
earthen dike of varying height depending on natural terrain (maximum
height 280 feet) and 5,900 feet in circumference with a geotextile
liner on the reservoir floor and inside surface of the dike; (2) Iowa
Hill Tunnel--A new underground water conduit extending from Iowa Hill
Reservoir and connecting to Slab Creek Reservoir, and comprised of: a
1,120-foot-long, 19.02-foot-diameter, concrete-lined vertical shaft; a
1,110-foot-long, 19.02-foot-diameter concrete-lined high pressure
tunnel; a 250-foot-long, 15.74-foot-diameter, steel-lined high pressure
tunnel; a 150-foot-long, 12.45-foot-diameter, steel manifold; three
180-foot-long, 7.87-foot-diameter, steel penstocks; three 450-foot-
long, 12.46-foot-diameter draft tube extensions; a 150-foot-long,
17.22-foot-diameter steel manifold; and a 1,230-foot-long, 20-93-foot-
diameter, concrete-lined low pressure tunnel; (3) Iowa Hill
Powerhouse--A new underground powerhouse along the Iowa Hill Tunnel
that would include three variable speed turbines each with a nominal
rating of 133 MW, and a three generators each rated at 170 MW as a pump
motor. The powerhouse would have a maximum capability of 400 MW; (4)
Iowa Hill Switchyard--A new Iowa Hill Switchyard; and (5) Transmission
Line--A new 230 kV transmission line that would connect the Iowa Hill
Switchyard to the existing Camino-White Rock Transmission Line. SMUD
anticipates that from the time a new project license is issued by FERC
and accepted by SMUD, seven years would be required to complete the
engineering, procurement, and construction of the Iowa Hill
Development.
    In addition, as part of the License Application, SMUD proposes to
exclude from the project description and FERC Project Boundary certain
transmission line sections included in the current license and FERC
Project Boundary. The excluded sections are: (1) A 9.3-mile long
section of 230 kV line from Folsom Junction to Orangevale Substation;
(2) a 17.8-mile long section of 230 kV line from Folsom Junction to
Hedge Substation; and (3) a 1.9-mile long section of 230 kV line from
Folsom Junction to Lake Substation.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may 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 to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available

for inspection and reproduction at the address in item h above.
    n. 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.
    All filings must (1) Bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or ``PRESCRIPTIONS;''
(2) set forth in the heading the name of the applicant and the project
number of the application to which the filing responds; (3) furnish the
name, address, and telephone number of the person protesting or
intervening; and (4) otherwise comply with the requirements of 18 CFR
385.2001 through 385.2005. All comments, recommendations, terms and
conditions or prescriptions must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may
obtain copies of the application directly from the applicant. A copy of
any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. A copy of all other filings in reference to this
application must be accompanied by proof of service on all persons
listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
    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,
contact FERC Online Support.
    o. Procedural schedule: The application will be processed according
to the following Hydro Licensing Schedule. Revisions to the schedule
will be made if the Commission determines it necessary to do so:

------------------------------------------------------------------------
                Milestone                          Tentative date
------------------------------------------------------------------------
Notice of the availability of the draft    March 2007.
 EIS.
Notice of the availability of the final    August 2007.
 EIS.
Ready for Commission's decision on the     October 2007.
 application.
------------------------------------------------------------------------

Magalie R. Salas,
Secretary.
 [FR Doc. E6-12718 Filed 8-4-06; 8:45 am]

BILLING CODE 6450-01-P


[Federal Register: April 7, 2008 (Volume 73, Number 67)]
[Notices]
[Page 18836-18838]
[DOCID:fr07ap08-108]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57592; File No. SR-NYSE-2008-23]

Self-Regulatory Organizations; New York Stock Exchange, LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to NYSE Rule 104.10 To Extend the Duration of the Pilot
Program Applicable to Conditional Transactions in All Securities to
June 30, 2008

April 1, 2008.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on March 27, 2008, the New York Stock Exchange, LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the NYSE. The
NYSE has designated the proposed rule change as a ``non-controversial''
rule change pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule
19b-4(f)(6) thereunder,\4\ which renders the proposed rule change
effective upon filing with the Commission. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    The NYSE is proposing to amend NYSE Rule 104.10 to extend the
duration of the pilot program applicable to Conditional Transactions as
defined in Rule 104.10(6)(i) in all securities to June 30, 2008. The
text of the proposed rule change is available at NYSE, at http://
www.nyse.com, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the NYSE included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The NYSE has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    The NYSE is proposing to amend NYSE Rule 104.10 to extend the
duration of the pilot program applicable to Conditional Transactions as
defined in Rule 104.10(6)(i) in all securities for an additional three
months until June 30, 2008.
    On October 26, 2007, the Commission approved the ability of NYSE
specialists to effect Conditional Transactions pursuant to NYSE Rule
104.10(6) in all securities traded on the NYSE to operate as a pilot
through March 31, 2008 (the ``Conditional Transaction Pilot'').\5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 56711 (October 26,
2007), 72 FR 62504 (November 5, 2007) (SR-NYSE-2007-83).
---------------------------------------------------------------------------

    (a) Current Conditional Transaction Pilot
    Conditional Transactions are specialists' transactions that
establish or increase a position and reach across the market to trade
as the contra-side to the Exchange published bid or offer. Under the
current Conditional Transaction Pilot, NYSE specialists are allowed to
effect Conditional Transactions in all securities traded on the NYSE
until March 31, 2008.
    When a specialist effects a Conditional Transaction he or she has
obligations to re-enter the market on the opposite side from which the
specialist effected his or her Conditional Transaction pursuant to the
rule. Specifically, pursuant to NYSE Rule 104.10(6)(ii) ``appropriate''
re-entry means ``re-entry on the opposite side of the market at or
before the price participation point or the `PPP.' '' \6\ Depending on
the type of Conditional Transaction, a specialist's obligation to re-
enter may be immediate or subject to the same re-entry conditions of
Non-Conditional Transactions.\7\ Conditional

Transactions are subject to a specialist's overall negative
obligation.\8\
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    \6\ NYSE Rule 104.10(6)(iii)(a) provides that the PPP identifies
the price at or before which a specialist is expected to re-enter
the market after effecting a Conditional Transaction. PPPs are only
minimum guidelines and compliance with them does not guarantee that
a specialist is meeting its obligations. The Exchange issued
guidance regarding PPPs in January 2007. See NYSE Member Education
Bulletin 2007-1 (January 18, 2007).
    \7\ NYSE Rule 104.10(6)(iii)(c) provides that immediate re-entry
is required after the following Conditional Transactions:
    As a condition of operating the Conditional Transaction Pilot,
the Exchange committed to providing the Commission with data related
to specialist executions of Conditional Transactions. The data
includes the daily Consolidated Tape volume in shares, daily number
of trades; daily high-low volatility in basis points and daily close
price in dollars.
    (I) A purchase that (1) reaches across the market to trade with
an Exchange published offer that is above the last differently
priced trade on the Exchange and above the last differently priced
published offer on the Exchange, (2) is 10,000 shares or more or has
a market value of $200,000 or more, and (3) exceeds 50% of the
published offer size.
    (II) A sale that (1) reaches across the market to trade with an
Exchange published bid that is below the last differently priced
trade on the Exchange and below the last differently priced
published bid on the Exchange, (2) is 10,000 shares or more or has a
market value of $200,000 or more, and (3) exceeds 50% of the
published bid size. (Emphasis added.)
    Moreover, pursuant to current NYSE Rule 104.10(6)(iv)
Conditional Transactions that involve (a) a specialist's purchase
from the Exchange published offer that is priced above the last
differently-priced trade on the Exchange or above the last
differently-priced published offer on the Exchange and (b) a
specialist's sale to the Exchange published bid that is priced below
the last differently-priced trade on the Exchange or below the last
differently-priced published bid on the Exchange are subject to the
re-entry requirements for Non-Conditional Transactions pursuant to
Rule 104.10(5)(i)(a)(II)(c), which provides:
    Re-entry Obligation Following Non-Conditional Transactions--The
specialist's obligation to maintain a fair and orderly market may
require re-entry on the opposite side of the market trend after
effecting one or more Non-Conditional Transactions. Such re-entry
transactions should be commensurate with the size of the Non-
Conditional Transactions and the immediate and anticipated needs of
the market.
    \8\ The negative obligation, which is part of NYSE Rule 104,
requires that specialists restrict their dealings so far as
practicable to those reasonably necessary to permit the specialists
to maintain a fair and orderly market. Specifically, NYSE Rule
104(a) provides:
    No specialist shall effect on the Exchange purchases or sales of
any security in which such specialist is registered, for any account
in which he, his member organization or any other member, allied
member, or approved person, (unless an exemption with respect to
such approved person is in effect pursuant to Rule 98) in such
organization or officer or employee thereof is directly or
indirectly interested, unless such dealings are reasonably necessary
to permit such specialist to maintain a fair and orderly market, or
to act as an odd-lot dealer in such security.
---------------------------------------------------------------------------

    The Exchange continues to calculate the specialist's profit on
round-trip Hit Bid and Take Offer (``HB/TO'') executions. This is
accomplished by measuring the specialist's profit on HB/TO activity by
taking the round-trip trading profits for all HB/TO trades where the
specialist executes an offsetting trade within 30 seconds. In cases
where the volume of the offsetting execution is less than the size of
the HB/TO execution, the calculation will only include profits realized
within the 30-second window.
    The Exchange continues to calculate the quote-based specialist re-
entry ratio. Each re-entry price level is categorized and reported
separately. In addition, the Exchange continues to provide the
Commission with data related to the average realized spread on
specialist HB/TO executions. These calculations are done using the same
formula as SEC Rule 605. Specifically, the average realized spread is a
share-weighted average of realized spreads. For specialist buys, it is
double the amount of difference between the execution price and the
midpoint of the consolidated best bid and offer five minutes after the
time of HB/TO execution. For specialist sells, it is double the amount
of difference between the midpoint of the consolidated best bid and
offer five minutes after the time of HB/TO execution and the execution
price.
    The Exchange has provided the Commission's Division of Trading and
Markets and the Office of Economic Analysis with statistics related to
market quality, specialist trading activity, and sample statistics for
the months of November and December 2007. The Exchange represents it
will provide the relevant statistics for January and February 2008 no
later than March 28, 2008. Commencing with the relevant statistics for
the month of March 2008, the Exchange represents that it will provide
all the aforementioned information to the Commission on or before the
15th of the calendar month directly following the data month. The
Exchange represents it will maintain average measures for each stock-
day during a particular month in order to provide such information to
the Commission upon request.
    Furthermore, NYSE Regulation, Inc. (``NYSER'') believes that it has
appropriate surveillance procedures in place to surveil for compliance
with the negative obligations of specialists. NYSER monitors, using a
pattern and practice and/or outlier approach, specialist activity that
appears to cause or exacerbate excessive price movement in the market
(since such transactions would appear to be in violation of a
specialist's negative obligation). In this connection, NYSER continues
to surveil for specialist compliance with the PPP re-entry
requirements, and based on its reviews of surveillance data to date,
has not identified significant compliance issues. The Division of
Market Surveillance of NYSER also monitors specialist trading to
cushion such price movements.
    (b) Conclusion
    The Exchange believes that an extension of the current Conditional
Transaction Pilot program will continue to provide NYSE specialists
with the flexibility to compete and to efficiently and systematically
trade and quote in their securities as well as equip them to fluidly
manage their risk.
    In view of the above, the NYSE believes it is appropriate to extend
the operation of the Conditional Transaction Pilot program for an
additional three months until June 30, 2008.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the requirement under Section 6(b)(5) \9\ of the Act that an
Exchange have rules that are designed to promote just and equitable
principles of trade, to remove impediments to and perfect the mechanism
of a free and open market and a national market system, and, in
general, to protect investors and the public interest. The proposed
rule change also is designed to support the principles of Section
11A(a)(1) \10\ in that it seeks to assure economically efficient
execution of securities transactions. The Exchange believes that
extending the operation of the Conditional Transaction Pilot will
provide specialists with the required flexibility to compete, thus
adding value to the Exchange market by encouraging specialists to
continue to commit capital. Ultimately, the Exchange believes that the
Conditional Transaction Pilot benefits the marketplace by allowing
specialists to manage their risk and, therefore, gives them the ability
to increase the liquidity they provide at prices outside the best bid
and offer, as well as to meet their obligation to bridge temporary gaps
in supply and demand, thereby dampening volatility.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78f(b)(5).
    \10\ 15 U.S.C. 78k-1(a)(1).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the foregoing proposed rule change: (1) Does not
significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) by its terms does not become operative for 30 days after the
date of this filing, or such shorter time as the Commission may
designate if consistent with the protection of investors and the public
interest, the proposed rule change has become effective pursuant to
Section 19(b)(3)(A) \11\ of the Act and Rule 19b-4(f)(6)
thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally may
not become operative prior to 30 days after the date of filing.
However, Rule 19b-4(f)(6)(iii) permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. The NYSE requests that the
Commission waive the 5-day pre-filing notice requirement and the 30-day
operative delay, as specified in Rule 19b-4(f)(6)(iii),\13\ which would
make the rule change effective and operative upon filing. The
Commission believes that waiving the 5-day pre-filing notice and

the 30-day operative delay is consistent with the protection of
investors and the public interest because such waiver would allow the
Conditional Transaction Pilot to continue without interruption through
June 30, 2008 and provide the Exchange and the Commission additional
time to evaluate the pilot.\14\ Accordingly, the Commission designates
that the proposed rule change effective and operative upon filing with
the Commission.
---------------------------------------------------------------------------

    \13\ 17 CFR 240.19b-4(f)(6)(iii).
    \14\ For purposes only of waiving the operative delay for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2008-23 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2008-23. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the NYSE. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2008-23 and should be
submitted on or before April 28, 2008.

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

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E8-7114 Filed 4-4-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 75, Number 127 (Friday, July 2, 2010)]
[Notices]
[Pages 38602-38603]
[FR Doc No: 2010-16180]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-1999-5578; FMCSA-1999-6480; FMCSA-2001-11426; FMCSA-
2003-14223; FMCSA-2003-16564; FMCSA-2004-17195; FMCSA-2006-24015;
FMCSA-2006-24783; FMCSA-2008-0021]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of renewal of exemptions; request for comments.

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SUMMARY: FMCSA announces its decision to renew the exemptions from the
vision requirement in the Federal Motor Carrier Safety Regulations for
13 individuals. FMCSA has statutory authority to exempt individuals
from the vision requirement if the exemptions granted will not
compromise safety. The Agency has concluded that granting these
exemption renewals will provide a level of safety that is equivalent
to, or greater than, the level of safety maintained without the
exemptions for these commercial motor vehicle (CMV) drivers.

DATES: This decision is effective August 1, 2010. Comments must be
received on or before August 2, 2010.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket ID FMCSA-1999-5578; FMCSA-1999-6480;
FMCSA-2001-11426; FMCSA-2003-14223; FMCSA-2003-16564; FMCSA-2004-17195;
FMCSA-2006-24015; FMCSA-2006-24783; FMCSA-2008-0021, using any of the
following methods.
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     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., Washington, DC between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket number for this Notice. Note that DOT posts all comments
received without change to http://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 http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The FDMS is available 24 hours each day, 365 days
each year. If you want acknowledgment that we received your comments,
please include a self-addressed, stamped envelope or postcard or print
the acknowledgement page that appears after submitting comments on-
line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review the DOT's complete Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19476). This information is
also available at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Mary D. Gunnels, Director, Medical
Programs,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA, Department of
Transportation, 1200 New Jersey Avenue, SE., Room W64-224, Washington,
DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m. Monday through
Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may renew an exemption
from the vision requirements in 49 CFR 391.41(b)(10), which applies to
drivers of CMVs in interstate commerce, for a two-year period if it
finds ``such exemption would likely achieve a level of safety that is
equivalent to, or greater than, the level that would be achieved absent
such exemption.'' The procedures for requesting an exemption (including
renewals) are set out in 49 CFR part 381.

Exemption Decision

    This Notice addresses 13 individuals who have requested renewal of
their exemptions in accordance with FMCSA procedures. FMCSA has
evaluated these 13 applications for renewal on their merits and decided
to extend each exemption for a renewable two-year period. They are:
Manuel A. Almeida
Ronald B. Brown
Thomas L. Corey
Lawrence M. Daley
Brian G. Hagen
Alfred G. Jeffus
Christopher P. Lefler
Michael G. Martin
Charles R. Murphy
Willard L. Riggle
Robert H. Rogers
Jose M. Suarez
Barney J. Wade
    The exemptions are extended subject to the following conditions:
(1) That each individual has a physical examination every year (a) by
an ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in 49 CFR 391.41(b)(10), and
(b) by a medical examiner who attests that the individual is otherwise
physically qualified under 49 CFR 391.41; (2) that each individual
provides a copy of the ophthalmologist's or optometrist's report to the
medical examiner at the time of the annual medical examination; and (3)
that each individual provide a copy of the annual medical certification
to the employer for retention in the driver's qualification file and
retains a copy of the certification on his/her person while driving for
presentation to a duly authorized Federal, State, or local enforcement
official. Each exemption will be valid for two years unless rescinded
earlier by FMCSA. The exemption will be rescinded if: (1) The person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
before it was granted; or (3) continuation of the exemption would not
be consistent with the goals and objectives of 49 U.S.C. 31136(e) and
31315.

Basis for Renewing Exemptions

    Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no
longer than two years from its approval date and may be renewed upon
application for additional two year periods. In accordance with 49
U.S.C. 31136(e) and 31315, each of the 13 applicants has satisfied the
entry conditions for obtaining an exemption from the vision
requirements (64 FR 27027; 64 FR

51568; 64 FR 68195; 65 FR 20251; 67 FR 38311; 69 FR 26221; 71 FR 27033;
73 FR 52451; 69 FR 26921; 73 FR 28186; 67 FR 17102; 69 FR 17267; 71 FR
26601; 73 FR 27017; 67 FR 10471; 67 FR 19798; 69 FR 19611; 71 FR 19604;
73 FR 27014; 68 FR 10301; 68 FR 19596; 70 FR 74102; 73 FR 52451; 68 FR
74699; 69 FR 10503; 71 FR 16410; 73 FR 28188; 69 FR 17263; 69 FR 31447;
71 FR 43556; 73 FR 52451; 73 FR 36954; 71 FR 14566; 71 FR 30227; 73 FR
27014; 73 FR 52451; 71 FR 32183; 71 FR 41310; 73 FR 15567; 73 FR
27015). Each of these 13 applicants has requested renewal of the
exemption and has submitted evidence showing that the vision in the
better eye continues to meet the standard specified at 49 CFR
391.41(b)(10) and that the vision impairment is stable. In addition, a
review of each record of safety while driving with the respective
vision deficiencies over the past two years indicates each applicant
continues to meet the vision exemption standards. These factors provide
an adequate basis for predicting each driver's ability to continue to
drive safely in interstate commerce. Therefore, FMCSA concludes that
extending the exemption for each renewal applicant for a period of two
years is likely to achieve a level of safety equal to that existing
without the exemption.

Request for Comments

    FMCSA will review comments received at any time concerning a
particular driver's safety record and determine if the continuation of
the exemption is consistent with the requirements at 49 U.S.C. 31136(e)
and 31315. However, FMCSA requests that interested parties with
specific data concerning the safety records of these drivers submit
comments by August 2, 2010.
    FMCSA believes that the requirements for a renewal of an exemption
under 49 U.S.C. 31136(e) and 31315 can be satisfied by initially
granting the renewal and then requesting and evaluating, if needed,
subsequent comments submitted by interested parties. As indicated
above, the Agency previously published Notices of final disposition
announcing its decision to exempt these 13 individuals from the vision
requirement in 49 CFR 391.41(b)(10). The final decision to grant an
exemption to each of these individuals was made on the merits of each
case and made only after careful consideration of the comments received
to its Notices of applications. The Notices of applications stated in
detail the qualifications, experience, and medical condition of each
applicant for an exemption from the vision requirements. That
information is available by consulting the above cited Federal Register
publications.
    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315, FMCSA will take immediate steps to revoke the
exemption of a driver.

    Issued on: June 28, 2010.
Larry W. Minor,
Associate Administrator for Policy and Program Development.
[FR Doc. 2010-16180 Filed 7-1-10; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 87, Number 205 (Tuesday, October 25, 2022)]
[Notices]
[Page 64508]
[FR Doc No: 2022-23155]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4673-DR; Docket ID FEMA-2022-0001]

Florida; 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 Florida (FEMA-4673-DR), dated September 29, 2022, and
related determinations.

DATES: This amendment was issued October 11, 2022.

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 notice of a major disaster declaration
for the State of Florida is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of September 29, 2022.

    Brevard, Hendry, and Monroe Counties for Individual Assistance
(already designated Public Assistance).
    Okeechobee County for Individual Assistance (already designated
for emergency protective measures [Category B], including direct
federal assistance, under the Public Assistance program).
    Glades and Okeechobee Counties for debris removal [Category A]
and permanent work [Categories C-G] (already designated for
emergency protective measures [Category B], including direct federal
assistance, under the Public Assistance program).

    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. 2022-23155 Filed 10-24-22; 8:45 am]
BILLING CODE 9111-23-P