[Federal Register Volume 86, Number 65 (Wednesday, April 7, 2021)]
[Notices]
[Pages 18049-18051]
[FR Doc No: 2021-07107]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC21-7-000]

Commission Information Collection Activities (FERC-598); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection FERC-598 (Self-Certification for Entities
Seeking Exempt Wholesale Generator or Foreign Utility Company Status).

DATES: Comments on the collection of information are due May 7, 2021.

ADDRESSES: Send written comments on FERC-598 to the Office of
Management and Budget (OMB) through www.reginfo.gov/public/do/PRAMain,
Attention: Federal Energy Regulatory Commission Desk Officer. Please
identify the OMB control number (1902-0166) in the subject line. Your
comments should be sent within 30 days of publication of this notice in
the Federal Register.
    Please submit copies of your comments to the Commission (identified
by Docket No. IC21-7-000) by any of the following methods:
     eFiling at Commission's Website: http://www.ferc.gov/docs-filing/efiling.asp.
     U.S. Postal Service Mail: Persons unable to file
electronically may mail similar pleadings to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
     Effective July 1, 2020, delivery of filings other than by
eFiling or the U.S. Postal Service should be delivered to Federal
Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville, Maryland
20852.
    Instructions:
    OMB submissions must be formatted and filed in accordance with
submission guidelines at www.reginfo.gov/public/do/PRAMain; Using the
search function under the ``Currently Under Review field,'' select
Federal Energy Regulatory Commission; click ``submit'' and select
``comment'' to the right of the subject collection.
    FERC submissions must be formatted and filed in accordance with
submission guidelines at: http://www.ferc.gov. For user assistance,
contact FERC Online Support by email at<EMAIL_ADDRESS>or
by phone at:<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>and telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-598, Self-Certification for Entities Seeking Exempt
Wholesale Generator or Foreign Utility Company Status.
    OMB Control No.: 1902-0166.
    Type of Request: Three-year renewal of FERC-598.
    Abstract: Under 42 U.S.C. 16452(a), public-utility holding
companies and their associates must maintain, and make available to the
Commission, certain books, accounts, memoranda, and other records. The
pertinent records are those that the Commission has determined: (1) Are
relevant to costs incurred by a public-utility company that is an
associate company of such holding company; and (2) are necessary or
appropriate for the protection of utility customers with respect to
jurisdictional rates.
    Public-utility holding companies and their associates may seek
exemption from this requirement. The pertinent statutory and regulatory
provisions, 42 U.S.C. 16454 and 18 CFR 366.7, authorize such entities
to file with the Commission a notice of self-certification
demonstrating that their public-utility companies are ``exempt
wholesale generators'' (EWGs) or ``foreign utility companies'' (FUCOs).
If the Commission takes no action on a good-faith self-certification
filing within 60 days after the date of filing, the applicant is exempt
from the requirements of 42 U.S.C. 16452(a).
    An EWG is defined as ``any person engaged directly, or indirectly
through one or more affiliates . . . and exclusively in the business of
owning or operating, or both owning and operating, all or part of one
or more eligible facilities and selling electric energy at wholesale.''
\1\ A FUCO is defined as ``any company that owns or operates facilities
that are not located in any state and that are used for the generation,
transmission, or distribution of electric energy for sale or the
distribution at retail of natural or manufactured gas for heat, light,
or power, if such company: (1) derives no part of its income, directly
or indirectly, from the generation, transmission, or distribution of
electric energy for sale or the distribution at retail of natural or
manufactured gas for heat, light, or power, within the United States;
and (2) [n]either the company nor any of its subsidiary companies is a
public-utility company operating in the United States.'' \2\
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    \1\ 18 CFR 366.1.
    \2\ Id.
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    In the case of EWGs, the person filing a notice of self-
certification must also file a copy of the notice of self-certification
with the state regulatory authority of the state in which the facility
is located. In addition, that person must represent to the Commission
in its submission that it has filed a copy of the notice with the
appropriate state regulatory authority.\3\
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    \3\ 18 CFR 366.7(a).
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    In accordance with OMB requirements,\4\ the Commission issued and
published a 60-day notice inviting public comments. The Commission
issued the 60-day Notice on October 30, 2020, and published it in the
Federal Register on November 5, 2020.\5\ The Commission received no
comments in response.
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    \4\ 5 CFR 1320.8(d).
    \5\ 85 FR 70604.
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    Type of Respondents: EWGs and FUCOs.
    Estimate of Annual Burden: \6\ The Commission estimates the total
annual burden and cost \7\ for this information collection as follows:
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    \6\ ``Burden'' is the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. For further
explanation of what is included in the information collection
burden, refer to 5 CFR 1320.3.
    \7\ The Commission staff thinks that the average respondent for
this collection is similarly situated to the Commission, in terms of
salary plus benefits. Based upon FERC's FY 2020 annual full-time
equivalent average of $172,329 (for salary plus benefits), the
average hourly cost is $83 per hour.

                 FERC-598 (Self-Certification for Entities Seeking Exempt Wholesale Generator Status or Foreign Utility Company Status)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                   Total number                                                                           Average cost
Number of respondents  (EWGs and  Annual  number   of responses    Average burden hrs. and cost ($)    Total annual burden hours and     per respondent
             FUCOs)                of  responses    (column A x              per response              total annual cost (column C x     ($) (column E /
                                  per respondent     column B)                                                   column D)                  column 1)
(A)                                          (B)             (C)  (D)..............................  (E)..............................               (F)
--------------------------------------------------------------------------------------------------------------------------------------------------------
250.............................               1             250  6 hrs.; $498.....................  1,500 hrs.; $124,500.............              $498
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: March 23, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-07107 Filed 4-6-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 174 (Tuesday, September 9, 2014)]
[Notices]
[Page 53508]
[FR Doc No: 2014-21445]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: License
Requirements for Operation of a Launch Site

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The information to be collected includes data required for
performing launch site location analysis. The launch site license is
valid for a period of 5 years. Respondents are licensees authorized to
operate sites.

DATES: Written comments should be submitted by November 10, 2014.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0644.
    Title: License Requirements for Operation of a Launch Site.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The data requested for a license application to operate
a commercial launch site are required by 49 U.S.C. Subtitle IX, 701--
Commercial Space Launch Activities, 49 U.S.C. 70101-70119 (1994). The
information is needed in order to demonstrate to the FAA Office of
Commercial Space Transportation (FAA/AST) that the proposed activity
meets applicable public safety, national security, and foreign policy
interest of the United States.
    Respondents: Approximately 1 applicant.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 2,322 hours.
    Estimated Total Annual Burden: 4,644 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, ASP-110, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on September 3, 2014.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, ASP-110.
[FR Doc. 2014-21445 Filed 9-8-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 134 (Wednesday, July 13, 2011)]
[Rules and Regulations]
[Pages 41135-41138]
[FR Doc No: 2011-17391]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0327; FRL-8878-4]

2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with 2-
propenoic acid and sodium 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonate (1:1), peroxydisulfuric acid ([HO)S(O)2]202) sodium
salt (1:2)-initiated; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 2-Propenoic acid, 2-methyl-,
phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1),
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated (also
known here as: ``the Polymer''); when used as an inert ingredient in a
pesticide chemical formulation under 40 CFR 180.960. Akzo Nobel Surface
Chemistry LLC, 909 Mueller Avenue, Chattanooga, TN 37406 submitted a
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA),
requesting an exemption from the requirement of a tolerance. This
regulation eliminates the need to establish a maximum permissible level
for residues of ``the Polymer'' on food or feed commodities.

DATES: This regulation is effective July 13, 2011. Objections and
requests for hearings must be received on or before September 12, 2011,
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-2011-0327. All documents in the
docket are listed in the docket index available at http://www.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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket Facility telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Mark Dow, 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. 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 get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. 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-2011-0327 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 12, 2011. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    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. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0327, 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 Facility'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 20, 2011 (76 FR 22069) (FRL-8869-
7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (PP 1E7834) filed
by Akzo Nobel Surface Chemistry LLC, 909 Mueller Avenue, Chattanooga,
TN 37406. The petition requested that 40 CFR 180.960 be amended by
establishing an exemption from the requirement of a tolerance for
residues of 2-Propenoic acid, 2-methyl-,phenylmethyl ester, polymer
with 2-propenoic acid and sodium 2-methyl-2-[(1-oxo-2-propen-1-
yl)amino]-1-propanesulfonate (1:1), peroxydisulfuric acid
([HO)S(O)2]202) sodium salt (1:2)-

initiated (CASRN 1246766-57-3). That notice included a summary of the
petition prepared by the petitioner and solicited comments on the
petitioner's request. The Agency did not receive any comments. 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 exemption 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 use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of 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 * * *'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), 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. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d). 2-Propenoic acid, 2-methyl-
,phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1),
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated
conforms to the definition of a polymer given in 40 CFR 723.250(b) and
meets the following criteria that are used to identify low-risk
polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's number average MW is greater than 1,000 and less
than 10,000 daltons. The polymer contains less than 10% oligomeric
material below MW 500 and less than 25% oligomeric material below MW
1,000, and the polymer does not contain any reactive functional groups.
    Thus, ``the Polymer'' meets the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on its conformance to
the criteria in this unit, no mammalian toxicity is anticipated from
dietary, inhalation, or dermal exposure to ``the Polymer''.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that 2-Propenoic acid, 2-methyl-,
phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1),
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated could
be present in all raw and processed agricultural commodities and
drinking water, and that non-occupational non-dietary exposure was
possible. The number average MW of ``the Polymer'' is 1,000 daltons.
Generally, a polymer of this size would be poorly absorbed through the
intact gastrointestinal tract or through intact human skin. Since ``the
Polymer'' conform to the criteria that identify a low-risk polymer,
there are no concerns for risks associated with any potential exposure
scenarios that are reasonably foreseeable. The Agency has determined
that a tolerance is not necessary to protect the public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    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.''
    EPA has not found ``the Polymer'' to share a common mechanism of
toxicity with any other substances, and ``the Polymer'' does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
``the Polymer'' does not have 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 EPA's Web site at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and

children. Due to the expected low toxicity of ``the Polymer'', EPA has
not used a safety factor analysis to assess the risk. For the same
reasons the additional tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of 2-Propenoic acid, 2-methyl-,
phenylmethyl ester, polymer with 2-propenoic acid and sodium 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1),
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated.

VIII. Other Considerations

A. Analytical Enforcement Methodology

    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 Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for ``the Polymer''.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 2-Propenoic acid,
2-methyl-, phenylmethyl ester, polymer with 2-propenoic acid and sodium
2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonate (1:1),
peroxydisulfuric acid ([HO)S(O)2]202) sodium salt (1:2)-initiated from
the requirement of a tolerance will be safe.

X. 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 rules 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, entitled 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 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).
    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, or otherwise have any unique
impacts on local governments. 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 9, 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) (Pub. L.
104-4).
    Although this action does not 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), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population.

XI. 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 rule in the Federal
Register. This 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: June 27, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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 Sec.  180.960, the table is amended by adding alphabetically the
following polymers to read as follows:

Sec.  180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
              Polymer                              CAS No.
------------------------------------------------------------------------

                              * * * * * * *
2-Propenoic acid, 2-methyl-,         CASRN 1246766-57-3
 phenylmethyl ester, polymer with 2-
 propenoic acid and sodium 2-methyl-
 2-[(1-oxo-2-propen-1-yl)amino]-1-
 propanesulfonate (1:1),
 peroxydisulfuric acid
 ([HO)S(O)2]202) sodium salt (1:2)-
 initiated minimum number average
 molecular weight > 1,000 Daltons;
 maximum number average molecular
 weight 10,000 Daltons.

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2011-17391 Filed 7-12-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 215 (Wednesday, November 8, 2017)]
[Notices]
[Pages 51823-51824]
[FR Doc No: 2017-24269]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

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

    Docket Numbers: ER17-2246-001.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2017-11-02_Compliance filing-
implementation of regional cost allocation for TMEP to be effective 10/
4/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5160.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER17-2400-002.
    Applicants: SP Butler Solar, LLC.
    Description: Tariff Amendment: SP Butler Solar MBR Tariff Amendment
Filing to be effective 9/1/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5204.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER17-2401-002.
    Applicants: SP Decatur Parkway Solar, LLC.
    Description: Tariff Amendment: SP Decatur Parkway Solar MBR Tariff
Amendment Filing to be effective 9/1/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5205.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER17-2403-002.
    Applicants: SP Pawpaw Solar, LLC.
    Description: Tariff Amendment: SP Pawpaw Solar MBR Tariff Amendment
Filing to be effective 9/1/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5206.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER17-2404-002.
    Applicants: SP Sandhills Solar, LLC.
    Description: Tariff Amendment: SP Sandhills Solar MBR Tariff
Amendment Filing to be effective 9/1/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5207.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-230-000.
    Applicants: Gilroy Energy Center, LLC.
    Description: Baseline eTariff Filing: Gilroy RMR Agreement Filing
to be effective 1/1/2018.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5142.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-231-000.
    Applicants: American Transmission Systems, Incorporated, PJM
Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: ATSI submits Engineering and
Construction Services Agreement SA No. 4714 to be effective 1/2/2018.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5146.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-232-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Tariff Clean-Up Filing to
Remove Rejected Tariff Language to be effective 7/15/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5162.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-233-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEP TX-LCRA Interconnection
Agreement Second Amend & Restated to be effective 10/3/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5210.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-234-000.
    Applicants: GSP Newington LLC.
    Description: Baseline eTariff Filing: Newington MBR Filing to be
effective 12/28/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5234.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-235-000.
    Applicants: AEP Texas Inc.
    Description: Sec.  205(d) Rate Filing: AEP TX-Bruenning's Breeze
Wind Interconnection Agreement Second Amend & Restated to be effective
10/12/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5236.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-236-000.
    Applicants: GSP Merrimack LLC.
    Description: Baseline eTariff Filing: Merrimack MBR Filing to be
effective 12/28/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5237.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-237-000.
    Applicants: GSP White Lake LLC.
    Description: Baseline eTariff Filing: White Lake MBR Filing to be
effective 12/28/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5240.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-238-000.
    Applicants: GSP Schiller LLC.
    Description: Baseline eTariff Filing: Schiller MBR Filing to be
effective 12/28/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5241.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-239-000.
    Applicants: GSP Lost Nation LLC.
    Description: Baseline eTariff Filing: Lost Nation MBR Filing to be
effective 12/28/2017.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5243.
    Comments Due: 5 p.m. ET 11/24/17.

    Docket Numbers: ER18-240-000.
    Applicants: Metcalf Energy Center, LLC.
    Description: Baseline eTariff Filing: Metcalf RMR Agreement Filing
to be effective 1/1/2018.
    Filed Date: 11/2/17.
    Accession Number: 20171102-5246.
    Comments Due: 5 p.m. ET 11/24/17.

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

    Dated: November 2, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-24269 Filed 11-7-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 73 (Thursday, April 16, 2015)]
[Notices]
[Page 20515]
[FR Doc No: 2015-08698]

=======================================================================
-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74704; File No. SR-NYSEMKT-2014-86]

Self-Regulatory Organizations; NYSE MKT LLC.; Notice of
Designation of Longer Period for Commission Action on Proceedings to
Determine Whether to Approve or Disapprove Proposed Rule Change to
Remove the Exchange's Quote Mitigation Plan as Provided by Exchange
Rule 970.1NY

April 10, 2015.

I. Introduction

    On October 2, 2014, NYSE MKT LLC (``NYSE MKT'' or ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ a proposed rule change to
remove the Exchange's quote mitigation plan as provided by NYSE MKT
Rule 970.1NY. The proposed rule change was published for comment in the
Federal Register on October 21, 2014.\3\ On December 2, 2014, the
Commission extended the time period in which to either approve the
proposal, disapprove the proposal, or to institute proceedings to
determine whether to approve or disapprove the proposal, to January 19,
2015.\4\ On January 16, 2015, the Commission instituted proceedings to
determine whether to approve or disapprove the proposal.\5\ The
Commission received 2 comment letters in further support of the
proposal from NYSE MKT.\6\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 73367 (October 15,
2014), 79 FR 63009 (``Notice'').
    \4\ See Securities Exchange Act Release No. 73718 (December 2,
2014), 79 FR 72748 (December 8, 2014).
    \5\ See Securities Exchange Act Release No. 74087 (January 16,
2015), 80 FR 3697 (January 23, 2015) (``Order Instituting
Proceedings'').
    \6\ See letters to Elizabeth M. Murphy, Secretary, Commission,
from Elizabeth King, Secretary & General Counsel, Exchange, dated
January 8, 2015 and February 27, 2015.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \7\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change.\8\ The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination.\9\ The
proposed rule change was published for notice and comment in the
Federal Register on October 21, 2014. April 19, 2015, is 180 days from
that date, and June 18, 2015, is 240 days from that date.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(2).
    \8\ 15 U.S.C. 78s(b)(2)(B)(ii)(I).
    \9\ 15 U.S.C. 78s(b)(2)(B)(ii)(II).
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposal,
and the issues raised in NYSE MKT's comment letters.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\10\ designates June 18, 2015 as the date by which the Commission
shall either approve or disapprove the proposed rule change (File No.
SR-NYSEMKT-2014-86).
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-08698 Filed 4-15-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 81, Number 202 (Wednesday, October 19, 2016)]
[Notices]
[Pages 72151-72152]
[FR Doc No: 2016-25230]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2016-0194]

Agency Information Collection Activities; Renewal of a Currently-
Approved Information Collection: Licensing Applications for Motor
Carrier Operating Authority

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

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FMCSA
announces its plan to submit the Information Collection Request (ICR)
described below to the Office of Management and Budget (OMB) for review
and approval. The FMCSA requests approval to renew an ICR titled,
``Licensing Applications for Motor Carrier Operating Authority,'' that
is used by for-hire motor carriers of regulated commodities, motor
passenger carriers, freight forwarders, property brokers, and certain
Mexico-domiciled motor carriers to register their operations with the
FMCSA.

DATES: We must receive your comments on or before November 18, 2016.
OMB must receive your comments by this date in order to act quickly on
the ICR.

ADDRESSES: All comments should reference Federal Docket Management
System (FDMS) Docket Number FMCSA-2016-0194. Interested persons are
invited to submit written comments on the proposed information
collection to the Office of Information and Regulatory Affairs, Office
of Management and Budget. Comments should be addressed to the attention
of the Desk Officer, Department of Transportation/Federal Motor Carrier
Safety Administration, and sent via electronic mail to
<EMAIL_ADDRESS>or faxed to<PHONE_NUMBER>, or mailed to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, Docket Library, Room 10102, 725 17th Street NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Mr. Jeffrey Secrist, Office of
Registration and Safety Information, Department of Transportation,
Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue
SE., Washington, DC 20590-0001. Telephone Number:<PHONE_NUMBER>; Email
Address<EMAIL_ADDRESS>Office hours are from 8:00 a.m. to 5:00
p.m., E.T.,

Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:
    Title: Licensing Applications for Motor Carrier Operating
Authority.
    OMB Control Number: 2126-0016.
    Type of Request: Renewal of a currently approved collection.
    Respondents: Motor carriers, motor passenger carriers, freight
forwarders, brokers, and certain Mexico-domiciled motor carriers.
    Estimated Number of Respondents and Responses: 37,240 respondents
[(37,216 respondents and responses for Year 1) + (12 respondents and
responses for Year 2) + (12 respondents and responses for Year 3)].
    Estimated Time per Response: 2 hours for forms OP-1, OP-1(P), OP-
1(FF) and 4 hours for forms OP-1(MX), OP-1(NNA).
    Expiration Date: October 31, 2016.
    Frequency of Response: Other (as needed).
    Estimated Total Annual Burden: 24,853 hours [74,464 hours for Year
1 + 48 hours for Year 2 + 48 hours for Year 3 = 74,560 hours/3 year
approval for ICR = 24,853 estimated average number of annual burden
hours].
    Background: The FMCSA registers for-hire motor carriers of
regulated commodities, motor passenger carriers, freight forwarders,
property brokers, and certain for-hire Mexico-domiciled motor carriers
under 49 U.S.C. 13902(c). These motor carriers may conduct
transportation services in the United States only if they are
registered with the FMCSA. Each registration is effective from the date
specified and remains in effect for such period as the Secretary of
Transportation (Secretary) determines by regulations. The ICC
Termination Act of 1995 (ICCTA), Public Law 104-88, 109 Stat. 803
(December 29, 1995), transferred this registration authority from the
former Interstate Commerce Commission (ICC) to the Secretary who
subsequently delegated the registration function to the Federal Highway
Administration (FHWA) (FMCSA's predecessor agency), then to the FMCSA
at the time that agency was created.
    On March 19, 2002, the FMCSA published an interim final rule (IFR)
at 67 FR 12702 which proposed to amend 49 CFR part 365 and revise Form
OP-1(MX). Under the amended regulations, Mexico-domiciled long-haul
motor carriers seeking to operate within the United States beyond the
commercial border zones, including carriers that previously filed
pending Form OP-1(MX) applications, would be required to submit the
revised Form OP-1(MX). Under the revised Form OP-1(MX), the FMCSA would
collect more detailed information on an applicant motor carrier's size,
operations and history than could be collected previously by using the
existing form.
    The Final Rule titled, ``Unified Registration System,'' (78 FR
52608) dated August 23, 2013, implemented statutory provisions for an
on-line registration system required by ICCTA and the Safe,
Accountable, Flexible, Efficient Transportation Equity Act: A Legacy
for Users, 2005 (SAFETEA-LU). The URS streamlines the registration
process and serves as a clearinghouse and repository of information on,
and identification of, motor carriers, brokers, freight forwarders,
intermodal equipment providers (IEPs), hazardous materials safety
permit (HMSP) applicants, and cargo tank facilities required to
register with FMCSA. This ICR previously covered registration
requirements for non-exempt for-hire carriers, freight forwarders, and
property brokers. Under the URS, all forms in this ICR, except the OP-1
(MX), were folded into the Form MCSA-1 under the OMB Control Number
2126-0051 titled, ``FMCSA Registration/Updates,'' ICR on October 23,
2015. The Form OP-1(MX) would be retained for the small number of
Mexico-domiciled carriers that seek authority to operate beyond the
United States municipalities on the United States-Mexico border and
their commercial zones because they are not included within the scope
of the URS rule.
    The Final Rule titled, ``Unified Registration System,'' (80 FR
63695) dated October 21, 2015, changed the effective and compliance
dates of the 2013 URS Final Rule from October 23, 2015, to September
30, 2016, in order to allow FMCSA additional time to complete the
information technology (IT) systems work required to fully implement
that rule. An additional delay was published on July 28, 2016 (81 FR
49553), stating the URS Final Rule will come into effect on January 14,
2017, however the full compliance date is April 14, 2017. This ICR
revision will restore the Forms OP-1, OP-1(P), OP-1(FF), and OP-1(NNA)
under control number 2126-0016, until the scheduled URS full compliance
date of April 14, 2017, because these forms are still needed to support
registration processes for entities subject to FMCSA's regulations that
enforce these motor carriers to update their registration for operating
authority, or add additional authorities with FMCSA, in order to
conduct for-hire interstate transportation services of passengers, or
regulated commodities, in the United States. After April 14, 2017, all
forms in this ICR, except the OP-1(MX), will be folded into the online
Form MCSA-1 under the OMB Control Number 2126-0051 titled, ``FMCSA
Registration/Updates.''
    Public Comments Invited: No comments were received from the public
in response to the 60-day Federal Register (81 FR 53539), issued on
August 12, 2016. You are asked to comment on any aspect of this
information collection, including: (1) Whether the proposed collection
is necessary for the performance of FMCSA's functions; (2) the accuracy
of the estimated burden; (3) ways for FMCSA to enhance the quality,
usefulness, and clarity of the collected information; and (4) ways that
the burden could be minimized without reducing the quality of the
collected information.

    Issued under the authority delegated in 49 CFR 1.87 on: October
13, 2016.
G. Kelly Regal.
Associate Administrator for Office of Research and Information
Technology.
[FR Doc. 2016-25230 Filed 10-18-16; 8:45 am]
 BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56854-56856]
[FR Doc No: 2018-24762]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4461]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Study
Design Recommendations for Residue Studies in Honey for Establishing
Maximum Residue Levels and Withdrawal Periods; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry (GFI) #243 entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Study Design Recommendations for
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods''
(VICH GL56). This guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This VICH
guidance document is intended to provide study design recommendations
that will facilitate the universal acceptance of the generated residue
depletion data to fulfill the national/regional requirements in order
to establish appropriate Maximum Residue Limits (MRLs) or other safe
limits in honey following the treatment of honeybees with veterinary
drug products, or to justify withdrawal periods in honey for
registration or approval purposes, as applicable, when an MRL already
exists.

DATES: The announcement of the guidance is published in the Federal
Register on November 14, 2018.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-4461 for ``Studies to Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Species: Study Design
Recommendations for Residue Studies in Honey for Establishing MRLs and
Withdrawal Periods'' (VICH GL56). Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and

contact information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of final GFI #243 entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Study Design Recommendations for
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods''
(VICH GL56). In recent years, many important initiatives have been
undertaken by regulatory authorities and industry associations to
promote the international harmonization of regulatory requirements. FDA
has participated in efforts to enhance harmonization and is committed
to seeking scientifically based harmonized technical procedures for
pharmaceutical development. One of the goals of harmonization is to
identify, and then reduce, differences in technical requirements for
drug development among regulatory agencies in different countries.
    FDA has actively participated in the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use for several years to develop, with input from both regulatory and
industry representatives, harmonized technical requirements for the
registration or approval of pharmaceutical products for human use among
the European Union, Japan, and the United States. The VICH is a
parallel initiative for veterinary medicinal products. The VICH is
concerned with developing harmonized technical requirements for the
approval of veterinary medicinal products in the European Union, Japan,
and the United States, and includes input from both regulatory and
industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission and European Medicines Agency;
International Federation for Animal Health--Europe; FDA; the U.S.
Department of Agriculture; the U.S. Animal Health Institute; the
Japanese Ministry of Agriculture, Forestry, and Fisheries; and the
Japanese Veterinary Products Association. Six observers are eligible to
participate in the VICH Steering Committee: One representative from the
government of Australia/New Zealand, one representative from the
industry in Australia/New Zealand, one representative from the
government of Canada, one representative from the industry in Canada,
one representative from the government of South Africa, and one
representative from the industry in South Africa. The World
Organisation for Animal Health, the Associate Member, has one delegate.
The VICH Secretariat, which coordinates the preparation of
documentation, is provided by HealthforAnimals.
    In the Federal Register of January 5, 2017 (82 FR 1342), FDA
published the notice of availability for a draft guidance entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Study Design Recommendations for
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods''
(VICH GL56), giving interested persons until March 6, 2017, to comment
on the draft guidance. FDA received two comments on the draft guidance,
and those comments, as well as those received by other VICH member
regulatory agencies, were considered as the guidance was finalized. The
guidance announced in this notice finalizes the draft guidance dated
January 2017. The final guidance is a product of the Metabolism and
Residue Kinetics Expert Working Group of the VICH.
    This VICH guidance document is intended to provide study design
recommendations that will facilitate the universal acceptance of the
generated residue depletion data to fulfill the national/regional
requirements in order to establish appropriate MRLs or other safe
limits in honey following the treatment of honeybees with veterinary
drug products, or to justify withdrawal periods in honey for
registration or approval purposes, as applicable, when an MRL already
exists.

II. Significance of Guidance

    This guidance, developed under the VICH process, is being issued
consistent with FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    The guidance represents the current thinking of FDA on ``Studies to
Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in
Food-Producing Species: Study Design Recommendations for Residue
Studies in Honey for Establishing MRLs and Withdrawal Periods'' (VICH
GL56). It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 have been approved under
OMB control number 0910-0032.

IV. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or
https://www.regulations.gov.

    Dated: November 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24762 Filed 11-13-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: June 18, 2007 (Volume 72, Number 116)]
[Notices]
[Page 33551-33553]
[DOCID:fr18jn07-93]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55893; File No. SR-NSX-2007-05]

Self-Regulatory Organizations; National Stock Exchange, Inc.;
Notice of Filing of Proposed Rule Change To Modify Chapter VII of the
Exchange's Rules Regarding Suspensions of an ETP Holder by Certain
Exchange Officers

June 11, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 9, 2007, National Stock Exchange, Inc. (``NSX'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. 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.
---------------------------------------------------------------------------

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

    The Exchange is proposing to modify Chapter VII of the Exchange's
rules to provide that the Chairman of the Exchange's Board of Directors
(``Chairman'') or the Exchange's Chief

Regulatory Officer, or their respective designees, would have the
authority to summarily suspend or place limitations or conditions on an
ETP Holder, or summarily suspend a person from access to Exchange
services in certain circumstances. That authority currently rests with
the Chairman or the Exchange's President. The text of the proposed rule
change is below. Proposed new language is in italics; proposed
deletions are enclosed in brackets.
RULES OF NATIONAL STOCK EXCHANGE, INC.
* * * * *
CHAPTER VII
Suspension by Chairman [or President] or Chief Regulatory Officer
Rule 7.1. Imposition of Suspension
    (a) An ETP Holder which fails or is unable to perform any of its
contracts, or is insolvent or is unable to meet the financial
responsibility requirements of the Exchange, shall immediately inform
the Secretary in writing of such fact. Upon receipt of said notice, or
whenever it shall appear to the Chairman of the Board or [President]
Chief Regulatory Officer, or their respective designees, (after such
verification and with such opportunity for comment by the ETP Holder as
the circumstances reasonably permit) that an ETP Holder has failed to
perform its contracts or is insolvent or is in such financial or
operational condition or is otherwise conducting its business in such
financial or operational condition or is otherwise conducting its
business in such a manner that it cannot be permitted to continue in
business with safety to its customers, creditors and other ETP Holders
of the Exchange, the Chairman or [President] Chief Regulatory Officer,
or their respective designees, may summarily suspend the ETP Holder or
may impose such conditions and restrictions upon the ETP Holder as are
reasonably necessary for the protection of investors, the Exchange, the
creditors and the customers of such ETP Holder.
    (b) No Change.
    (c) In the event of suspension of an ETP Holder, the Exchange shall
give prompt notice of such suspension to the ETP Holders of the
Exchange. Unless the Chairman or the Chief Regulatory Officer, or their
respective designees, [President] shall determine that lifting the
suspension without further proceedings is appropriate, such suspension
shall continue until the ETP Holder is reinstated as provided in Rule
7.3. of this Chapter.
    Rules 7.2.-7.5. No Change.
Rule 7.6. Summary Suspension of Exchange Services
    The Chairman [or President] of the Board or Chief Regulatory
Officer, or their respective designees, (after such verification with
such opportunity for comment as the circumstances reasonably permit)
may summarily limit or prohibit: (i) Any person from access to services
offered by the Exchange, if such person has been and is expelled or
suspended from any self-regulatory organization or barred or suspended
from being associated with an ETP Holder of any self-regulatory
organization or is in such financial or operating difficulty that the
Exchange determines that such person cannot be permitted to do business
with safety to investors, creditors, Exchange ETP Holders or the
Exchange; or (ii) a person who is not an ETP Holder from access to
services offered by the Exchange, if such person does not meet the
qualification requirements or other pre-requisites for such access and
if such person cannot be permitted to continue to have access with
safety to investors, creditors, ETP Holders and the Exchange. Any
person aggrieved by any such summary action may seek review under the
provisions of the Exchange Rules relating to adverse action.
    Rule 7.7. No Change.
* * * * *

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 Exchange 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 Exchange 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 Exchange is proposing to modify Chapter VII of the Exchange's
rules regarding suspensions of an ETP Holder by certain Exchange
officers. Specifically, the proposal provides that the Chairman or the
Chief Regulatory Officer, or their respective designees, would now have
the authority to summarily suspend or place limitations or conditions
on an ETP Holder under Rule 7.1, and lift suspensions pursuant to Rule
7.1(c) without further proceedings. The proposal also provides that the
Chairman or the Chief Regulatory Officer, or their respective
designees, shall also have the authority to summarily limit or suspend
Exchange services to certain persons under Rule 7.6. In both cases,
that authority currently rests with the Chairman or the President.
    The proposal also provides that in the event either the Chairman or
the Chief Regulatory Officer is not available, a person may be
designated to act in their place for purposes of Chapter VII. The
designee for the Chairman would be the Chairman of the Exchange's
Regulatory Oversight Committee (``ROC''), a member of the ROC, or
another comparable member of the Exchange's Board of Directors who is
an Independent Director,\3\ in that order of priority. The designee for
the Chief Regulatory Officer would be an officer in the Regulatory
Services Division of the Exchange. This provision would provide
continuity in the event the Chairman or the Chief Regulatory Officer is
unavailable.
---------------------------------------------------------------------------

    \3\ Section 1.1. I of the NSX By-Laws defines Independent
Director as a member of the Board that the Board has determined to
have no material relationship with the Exchange or any affiliate of
the Exchange, or any ETP Holder or any affiliate of any such ETP
Holder, other than as a member of the Board.
---------------------------------------------------------------------------

    This rule change proposal would impact who has authority to act
under Chapter VII but in no way changes the substantive provisions of
this Chapter VII.
2. Statutory Basis
    The proposed rule change is consistent with the Act and the rules
and regulations under the Act applicable to a national securities
exchange and, in particular, the requirements of Section 6(b) \4\ of
the Act. Specifically, the Exchange believes the proposed rule change
is consistent with the requirements of Section 6(b)(5) \5\ of the Act
that the rules of an exchange be designed to promote just and equitable
principles of trade, to prevent fraudulent and manipulative acts and
practices, and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. Sec.  78f(b).
    \5\ 15 U.S.C. Sec.  78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any inappropriate 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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission will:
    (A) By order approve such proposed rule change or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

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-NSX-2007-05 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-NSX-2007-05. This file
number should be included in 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. Copies of such
filing also will be available for inspection and copying at the
principal office of NSX. 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 the File
Number SR-NSX-2007-05 and should be submitted on or before July 9,
2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\6\
Nancy M. Morris,
Secretary.
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

 [FR Doc. E7-11627 Filed 6-15-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: August 26, 2010 (Volume 75, Number 165)]
[Rules and Regulations]
[Page 52465-52467]
[DOCID:fr26au10-13]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0502]
RIN 1625-AA00

Safety Zones; Swim Events Within the Sector New York Captain of
the Port Zone

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing five temporary safety zones
for swim events occurring on waters of the Hudson River, East River and
Long Island Sound. These temporary safety zones are necessary to
protect swimmers, spectators and vessels from the hazards associated
with the swim events. Persons and vessels are prohibited from entering
into, transiting through, or anchoring within the safety zones unless
authorized by the Captain of the Port New York or designated
representative.

DATES: This rule is effective in the CFR on August 26, 2010 through
11:59 p.m. on September 12, 2010. This rule is effective with actual
notice for purposes of enforcement beginning at 03:30 a.m. on July 24,
2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0502 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0526 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail LTJG Eunice James, Coast Guard Sector
New York Waterways Management Division;<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because publishing an NPRM is impractical as
the Coast Guard did not receive notification of the specific location
or planned dates for the events in sufficient time to issue an NPRM
without delaying this rule making. A delay or cancellation of the
events in order to allow for a notice and comment period is contrary to
the public interest in having these events occur on schedule. For the
same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good
cause exists for making this rule effective less than 30 days after
publication in the Federal Register. In addition to the reasons stated
above, this rule is intended to ensure the safety of the event
participants, spectators and other waterway users; thus any delay in
the rule's effective date would be impractical.

Basis and Purpose

    These temporary safety zones are necessary to ensure the safety of
participants, vessels and spectators from hazards associated with the
swimming events and the inherent nature of a large number of swimmers,
kayaks, and recreation vessels in the water. Swim events have the
potential to result in serious injuries or fatalities. These temporary
safety zones are intended to restrict vessels entering the area around
the participants to reduce the risk while the swimmers are in the
water.

Discussion of Rule

    Several organizations are sponsoring swimming events within the
waters of the Sector New York Captain of the Port Zone, including the
Hudson River, the East River and Long Island Sound. The swim events
consist of a large number of swimmers, and paddlers crossing the
navigable channels.
    These events pose significant risks to participants, spectators and
the boating public because of the large number of swimmers, kayakers,
and recreational vessels that are expected in the area of the event.
The temporary safety zones are necessary to ensure the safety of
participants, spectators and vessels from the hazards associated with
the swim events.

    This rule establishes the following temporary safety zones:
    (1) A 100-yard radius around the participants of the Swim Across
America swim event on the waters of Long Island Sound in the vicinity
of Glen Cove, NY and Larchmont, NY.
    (2) A 100-yard radius around the participants of Newburgh to Beacon
Swim event in the vicinity of Newburgh, NY.
    (3) A 100-yard radius around the participants of the Brooklyn
Bridge Swim, a swim event on the waters of the East River in the
vicinity of Brooklyn, NY.
    (4) A 100-yard radius around the participants of the Hudson River
Swim for Life, a swim event on the waters of the Hudson River in the
vicinity of Nyack, NY and Sleepy Hollow, NY.
    (5) A 100-yard radius around the participants of the Toughman Half
Triathlon, a swim event on the waters of the Hudson River in the
vicinity of Croton Point Park, NY.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    The Coast Guard's implementation of these temporary safety zones
will be of short duration and designed to minimize the impact on
navigable waters. These safety zones will be of limited duration, and
they cover only a small portion of the navigable waterways.
Furthermore, vessels may be authorized to transit the zones with
permission of the Captain of the Port New York or designated
representative.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities.
    This rule will affect the following entities, some of which may be
small entities: The owners and operators of vessels intending to
transit or anchor in the designated safety zone during the enforcement
period of the named swim events.
    The safety zones will not have a significant economic impact on a
substantial number of small entities for the following reasons: Vessel
traffic can safely transit around the zones. Before the effective
period, the Coast Guard will issue notice of the time and location of
each safety zone through the Local Notice to Mariners and Broadcast
Notice to Mariners.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or Tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children From Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have Tribal implications under Executive Order
13175, Consultation and Coordination With Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian Tribes, 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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not

require a Statement of Energy Effects under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, the Coast
Guard did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded under figure 2-1, paragraph
(34)(g), of the Instruction as this rule involves establishing safety
zones. An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety navigation (water), Reporting and
recordkeeping requirements, Security measures, and Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; Pub. L. 107-295, 116 Stat. 2064;
Department of Homeland Security Delegation No. 0170.1.

0
2. Add a new temporary safety zones Sec.  165.T01-0502 to read as
follows:

Sec.  165.T01-0502  Safety Zones; Swim Events within the Sector New
York Captain of the Port Zone.

    (a) Location. The following swim events include safety zones as
described herein:
    (1) Swim Across America 2010 LIS Swim, Glen Cove, NY to Larchmont,
NY.
    (i) All waters of Long Island Sound, from surface to bottom, within
100-yard radius around the swimmers swimming from Morgan Park Beach,
Glen Cove, NY to Larchmont Shore Club, Larchmont, NY.
    (ii) Effective Date. This rule will be effective from 5:30 a.m.
through 10:30 p.m. on July 24, 2010 and August 14, 2010.
    (2) Newburgh to Beacon Swim, Newburgh, NY to Beacon, NY.
    (i) All waters of the Hudson River from surface to bottom, within a
100-yard radius around the swimmers swimming from the waterfront at
Newburgh, NY to the waterfront at Beacon, NY.
    (ii) Effective Date. This rule will be effective from 11:30 a.m. to
1:30 p.m. on July 31, 2010.
    (3) Brooklyn Bridge Swim, Brooklyn, NY.
    (i) All waters of the East River from surface to bottom, within a
100-yard radius around the swimmers swimming in the waters of the East
River from Brooklyn Bridge Park to East River Park, Brooklyn.
    (ii) Effective Date. This rule will be effective from 11:45 a.m. to
1:30 p.m. on September 11, 2010.
    (4) Hudson River Swim for Life, Nyack, NY to Sleepy Hollow, NY.
    (i) All waters of the Hudson River from surface to bottom, within a
100-yard radius around the swimmers swimming from Nyack, NY to
Kingsland Point Park, Sleepy Hollow, NY.
    (ii) Effective Date. This rule will be effective from 9 a.m. to
12:30 p.m. on September 12, 2010.
    (5) Toughman Half Iron Triathlon, Hudson River, Croton Point Park,
NY.
    (i) All waters of the Hudson River from surface to bottom, within a
100-yard radius around the swimmers swimming in the vicinity of
Haverstraw Bay, Croton Point Park, Westchester County, NY.
    (ii) Effective Date. This rule will be effective from 6 a.m. to 10
a.m. on September 12, 2010.
    (b) Definitions. The following definition applies to this section:
Designated representative means any commissioned, warrant and petty
officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, State, and Federal law enforcement vessels that
have been authorized to act on behalf of the Captain of the Port New
York.
    (c) Regulations. In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transit through or anchoring
within the safety zones is prohibited unless authorized by the Captain
of the Port New York or a designated representative. Persons desiring
to transit within any of the safety zones established in this section
may contact the Captain of the Port at telephone number<PHONE_NUMBER> or
via on-scene patrol personnel on VHF channel 16 to seek authorization.
    If permission is granted, all persons and vessels must comply with
the instructions of the Captain of the Port New York or the designated
representative.
    (d) Enforcement period. This section will be enforced from 3:30
a.m. to 11:59 p.m. on various dates from July 24 to September 12, 2010.

    Dated: July 22, 2010.
G.P. Hitchen,
Captain, U.S. Coast Guard, Acting, Captain of the Port New York.
[FR Doc. 2010-21311 Filed 8-25-10; 8:45 am]
BILLING CODE 9110-04-P


"O'Hare, Andy"<EMAIL_ADDRESS>09/26/2006 09:24 AM	To
Keith Barnett/RTP/USEPA/US@EPA
cc

bcc

Subject
Mercury/Fly Ash

		Keith,

		As we have discussed previously, the cement industry has been discussing
various policy approaches for addressing the mercury/fly ash issue.  After
much discussion, the industry yesterday agreed on the language below.

		Please review and call to discuss at your convenience.

		Regards,
		Andy O’Hare

		The language is as follows:
		“Fly ash from utility boilers that is impacted by the use of activated
carbon injection for mercury capture will not be used as an alternative
raw material source in the manufacturing of portland cement clinker if it
will result in an increase of mercury input to the process, unless the
plant desiring to use the fly ash is already subject to a mercury standard
(either an emission or input limitation).”

		Andrew T. O'Hare, CAE
		Portland Cement Association
		500 New Jersey Avenue, NW
		7th Floor
		Washington, DC  20001
		Ph:<PHONE_NUMBER>
		Fx:<PHONE_NUMBER>
		Cell:<PHONE_NUMBER>
		e-mail<EMAIL_ADDRESS>