[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Pages 34135-34136]
[FR Doc No: 2013-13383]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 19b-5 and Form PILOT; SEC File No. 270-448; OMB Control No.
3235-0507.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 19b-5 (17 CFR 240.19b-5)
and Form PILOT (17 CFR 249.821) under the Securities Exchange Act of
1934, as amended (``Act'') (15 U.S.C. 78a et seq.). The Commission
plans to submit this existing collection of information to the Office
of Management and Budget (``OMB'') for extension and approval.
    Rule 19b-5 provides a temporary exemption from the rule-filing
requirements of Section 19(b) of the Act (15 U.S.C. 78s(b)) to self-
regulatory organizations (``SROs'') wishing to establish and operate
pilot trading systems. Rule 19b-5 permits an SRO to

develop a pilot trading system and to begin operation of such system
shortly after submitting an initial report on Form PILOT to the
Commission. During operation of any such pilot trading system, the SRO
must submit quarterly reports of the system's operation to the
Commission, as well as timely amendments describing any material
changes to the system. After two years of operating such pilot trading
system under the exemption afforded by Rule 19b-5, the SRO must submit
a rule filing pursuant to Section 19(b)(2) of the Act (15 U.S.C.
78s(b)(2)) in order to obtain permanent approval of the pilot trading
system from the Commission.
    The collection of information is designed to allow the Commission
to maintain an accurate record of all new pilot trading systems
operated by SROs and to determine whether an SRO has properly availed
itself of the exemption afforded by Rule 19b-5, is operating a pilot
trading system in compliance with the Act, and is carrying out its
statutory oversight obligations under the Act.
    The respondents to the collection of information are national
securities exchanges and national securities associations.
    While there are 17 national securities exchanges and national
securities associations that may avail themselves of the exemption
under Rule 19b-5 and the use of Form PILOT, it is estimated that
approximately three respondents will file a total of 3 initial reports,
12 quarterly reports, and 6 amendments on Form PILOT per year, with an
estimated total annual response burden of 126 hours. At an average
hourly cost of $350.07, the estimated aggregate related cost of
compliance with Rule 19b-5 for all respondents is $44,109 per year (126
burden hours multiplied by $350.07/hour = $44,109).
    Written comments are invited on (a) whether the proposed collection
of information is necessary for the proper performance of the functions
of the Commission, including whether the information shall have
practical utility; (b) the accuracy of the Commission's estimates of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number.
    Please direct your written comments to: Thomas Bayer, Director/
Chief Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 6432 General Green Way, Alexandria, Virginia 22312 or
send an email to<EMAIL_ADDRESS>
    Dated: May 31, 2013.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-13383 Filed 6-5-13; 8:45 am]
BILLING CODE 8011-01-P


Reply to

Attn Of: 	OWW-131

MEMORANDUM

SUBJECT:	Endangered Species Act Considerations In Connection with EPA(s
Removal of the State of Washington’s Numeric Criteria for Marine
Copper and Cyanide, referenced in Washington Administrative Code
173-201A-040 Table 240(3) Toxic Substances Criteria, from the National
Toxics Rule

FROM:	Jannine Jennings

		Manager, Water Quality Standards Unit

TO:		The Record

Section 7(a)(2) of the Endangered Species Act (ESA) requires that
federal agencies, in consultation with the U.S. Fish and Wildlife
Service and/or the National Oceanic and Atmospheric Administration
Fisheries Service (the Services), ensure that actions they authorize,
fund, or carry out are not likely to jeopardize the continued existence
of federally-listed threatened or endangered species or result in the
destruction or adverse modification of designated critical habitat of
such species.    SEQ CHAPTER \h \r 1 Under relevant ESA implementing
regulations, consultation is required for actions that “may affect”
listed species or designated critical habitat and is not required where
the action has no effect on such species or critical habitat.  50 CFR
§ 402.14.  Upon initiation of consultation, Section 7(d) of the ESA
prohibits irreversible or irretrievable commitments of resources that
have the effect of foreclosing the formulation or implementation of
reasonable and prudent alternatives which would not violate Section
7(a)(2) of the ESA.

In 1997, the State of Washington submitted criteria for marine copper
(chronic) for EPA review under the Clean Water Act (CWA).  In addition,
in 2003, the State submitted a criterion for marine cyanide (chronic)
for EPA review.  EPA approved these criteria in 1998 and 2007,
respectively.  Prior to those approvals, EPA initiated consultation with
the Services under Section 7(a)(2) regarding EPA’s approval actions
and determined that approval of the State’s criteria prior to
conclusion, and subject to the outcome, of ESA consultation was
consistent with ESA Section 7(d).  EPA concluded that the approvals
subject to the outcome of ESA consultation did not constitute an
irreversible or irretrievable commitment of resources within the meaning
of Section 7(d) in that the Agency retained sufficient authority under
the CWA to implement alternatives that might be determined in the
consultation to be needed to comply with Section 7(a)(2).  In
particular, EPA retained the full range of options available under
Section 303(c) of the CWA for ensuring water quality standards are
environmentally protective.  EPA could, for example, work with the State
of Washington to ensure that it revises its standards as needed to
ensure protection of listed species, initiate rulemaking under Section
303(c)(4)(B) of the CWA to promulgate federal standards to supersede the
State’s standards or, in appropriate circumstances, change EPA’s
approval to a disapproval.  Moreover, EPA believed that the approval of
these standards would not result in any impacts of concern prior to
conclusion of ESA consultation.

EPA is now removing the State of Washington from the National Toxics
Rule (NTR) for the marine copper (chronic) criteria which the State
submitted in 1997 and for the marine cyanide (chronic) criterion
submitted in 2003, which EPA approved in 1998 and 2007, respectively.
As described above, EPA is already consulting with the Services under
the ESA regarding EPA’s approvals of the State’s marine copper and
cyanide criteria and has concluded that approval of the State’s
criteria subject to the outcome of consultation is consistent with
Section 7(d) of the ESA.  EPA similarly believes that removal of the
State from the NTR, which will effectively leave the same State criteria
upon which EPA is already consulting in place as governing CWA water
quality standards, is consistent with ESA requirements.

EPA notes that the State’s general (i.e., non-site-specific) marine
cyanide criteria (chronic), which EPA approved 2007, are identical to
the marine cyanide criteria in the NTR (and are also identical to
EPA’s marine cyanide criteria guidance issued under CWA section
304(a)).  Thus, removal of the State from the NTR for these criteria
will leave identical approved State criteria in place and will have no
effect on listed species or designated critical habitat in any area of
the State not covered by separate site-specific marine cyanide criteria.
 As noted above, EPA is also consulting with the Services regarding
approval of these State criteria.

Removal of the State from the NTR will also leave in place the State’s
approved marine copper criteria (chronic) and marine cyanide criteria
for Puget Sound (an area for which – as part of the 1998 approval
action – EPA approved site-specific State criteria).  As described
above, EPA is already consulting on these State criteria, and EPA’s
1998 approval was expressly made subject to the outcome of that
consultation.  Removal of the State from the NTR for these criteria and
areas does not constitute an irreversible or irretrievable commitment of
resources that would foreclose either the formulation by the Services,
or the implementation by EPA, of any alternatives that might be
determined in the consultation to be needed to comply with Section
7(a)(2).  In removing Washington from the NTR for these criteria, EPA is
not limiting or altering its authority (described above) to take
appropriate action if the consultation identifies alternatives needed to
protect listed species and comply with Section 7(a)(2).

In addition, EPA continues to believe that the approved standards will
adequately protect listed species and designated critical habitat and
will not result in any impacts of concern following removal of the State
from the NTR and prior to conclusion of ESA consultation.   EPA’s
belief is based on the following: 1) the criteria and listed species of
concern have not changed since EPA’s previous evaluation completed
concurrent with the 1998 and 2007 actions; 2) the State criteria that
remain in place are consistent with EPA’s current 304(a) guidance; 3)
as part of other ongoing ESA consultations, EPA is evaluating potential
affects of these parameters on listed species using the most current
methodologies including a thorough literature search, use of surrogates
and models as needed, and consideration of multiple lines of evidence,
bioaccumulation and effects on prey species.  Findings to date do not
indicate any impacts of concern for those species which either reside in
or rely on Washington marine waters; and 4) the facilities most likely
to discharge cooper and cyanide in Washington marine waters are federal
facilities.  EPA retains NPDES permitting responsibility for these
facilities and, therefore, EPA will complete ESA consultation under ESA
Section 7(s)(2) on these permits prior to reissuance.  If any concerns
are surfaced at that time, they may be addressed in either the permit or
through reconsideration of EPA’s approval action.

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[Federal Register Volume 88, Number 4 (Friday, January 6, 2023)]
[Notices]
[Pages 1076-1077]
[FR Doc No: 2023-00015]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2474]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Designated New Animal
Drugs for Minor Use and Minor Species

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by February 6, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0605. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Reporting Associated With Designated New Animal Drugs for Minor Use and
Minor Species--21 CFR Part 516

OMB Control Number 0910-0605--Extension

    The Federal Food, Drug, and Cosmetic Act authorizes FDA to
implement regulatory procedures intended to make more medications
legally available to veterinarians and animal owners for the treatment
of minor animal species as well as uncommon diseases in major animal
species (21 U.S.C. 360ccc). This statutory authority provides
incentives designed to help pharmaceutical companies overcome the
financial burdens they face in providing limited-demand animal drugs.
These incentives are only available to sponsors who have had their
drugs designated by FDA under section 573 of the Minor Use and Minor
Species Animal Health Act of 2004 (Pub. L. 108-282) (MUMS Act). Minor
use drugs are drugs for use in major species (cattle, horses, swine,
chickens, turkeys, dogs, and cats) that are needed for diseases that
occur in only a small number of animals either because they occur
infrequently or in limited geographic areas. Minor species are all
animals other than the major species, for example, zoo animals,
ornamental fish, parrots, ferrets, and guinea pigs. Some animals of
agricultural importance are also minor species. These include animals
such as sheep, goats, catfish, and honeybees.
    MUMS-drug designation is completely optional for drug sponsors. The
associated reporting only applies to those sponsors who request and are
subsequently granted MUMS-drug designation status. Our regulations in
21 CFR part 516 specify the criteria and procedures for requesting
MUMS-drug designation as well as the annual reporting requirements for
MUMS designees. Sponsors use FDA's ``eSubmitter'' system to fill out a
series of system generated screens to submit their request and annual
report electronically. To access the ``eSubmitter'' system, sponsors
will use a previously established account. Additional information about
this system is available on our website at: https://www.fda.gov/industry/fda-esubmitter.
    Description of Respondents: The respondents to this information
collection are pharmaceutical companies that sponsor new animal drugs.
    In the Federal Register of August 1, 2022 (87 FR 46961), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
    21 CFR section; activity         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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516.20; content and format of                  5               2              10              16             160
 MUMS-drug designation request..
516.26; requirements for                       3               1               3               2               6
 amending MUMS-drug designation.
516.27; change in sponsorship of               1               1               1               1               1
 MUMS-drug designation..........
516.29; termination of MUMS-drug               2               1               2               1               2
 designation....................
516.30; requirements of annual                26               2              52               2             104
 reports from sponsor(s) of MUMS-
 designated drugs...............
516.36; consequences for                       1               1               1               3               3
 insufficient quantities of MUMS-
 designated drugs...............
                                 -------------------------------------------------------------------------------
  Total.........................  ..............  ..............  ..............  ..............             276
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The information collection reflects an overall adjustment decrease
of 88 responses and 1,086 burden hours. Upon further review since
publication of the 60-day notice, we determined that the number of
respondents for new designation requests decreased (from 15 to 5
respondents) due to changes in industry, while the number of
respondents for annual reports increased (from 15 to 26 respondents),
due to an increase in the number of sponsors holding active MUMS
designations since the last renewal of this collection. We also
decreased the

number of responses per respondent for both the new designation request
and the annual report (from five to two), based on our experience over
the last 3 years.

    Dated: January 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00015 Filed 1-5-23; 8:45 am]
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[Federal Register: February 21, 2007 (Volume 72, Number 34)]
[Proposed Rules]
[Page 7842]
[DOCID:fr21fe07-11]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 52 and 70

[EPA-R07-OAR-2006-0803; FRL-8278-7]

Approval and Promulgation of Implementation Plans and Operating
Permits Program; State of Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve a revision to the Missouri State
Implementation Plan (SIP) and Operating Permits Program. The revisions
clarify the rule and streamline processes without negatively impacting
air quality. This revision will ensure consistency between the state
and the federally-approved rules.

DATES: Comments on this proposed action must be received in writing by
March 23, 2007.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2006-0803 by one of the following methods:
    1. http://www.regulations.gov: Follow the on-line instructions for

submitting comments.
    2. E-mail<EMAIL_ADDRESS>    3. Mail: Amy Algoe-Eakin, Environmental Protection Agency, Air
Planning and Development Branch, 901 North 5th Street, Kansas City,
Kansas 66101.
    4. Hand Delivery or Courier: Deliver your comments to: Amy Algoe-
Eakin, Environmental Protection Agency, Air Planning and Development
Branch, 901 North 5th Street, Kansas City, Kansas 66101. Such
deliveries are only accepted during the Regional Office's normal hours
of operation. The Regional Office's official hours of business are
Monday through Friday, 8 a.m. to 4:30 p.m., excluding legal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Amy Algoe-Eakin at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's SIP revision and Title V
revision as a direct final rule without prior proposal because the
Agency views this as a noncontroversial revision amendment and
anticipates no relevant adverse comments to this action. A detailed
rationale for the approval is set forth in the direct final rule. If no
relevant adverse comments are received in response to this action, no
further activity is contemplated in relation to this action. If EPA
receives relevant adverse comments, the direct final rule will be
withdrawn and all public comments received will be addressed in a
subsequent final rule based on this proposed action. EPA will not
institute a second comment period on this action. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on part of this rule
and if that part can be severed from the remainder of the rule, EPA may
adopt as final those parts of the rule that are not the subject of an
adverse comment. For additional information, see the direct final rule
which is located in the rules section of this Federal Register.

    Dated: February 9, 2007.
John B. Askew,
Regional Administrator, Region 7.
 [FR Doc. E7-2807 Filed 2-20-07; 8:45 am]

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