ATTACHMENT A UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES Elliot Gordon, PhD, DABT Makhteshim Agan of North America Inc. 551 Fifth Avenue, Suite 1100 New York, NY 10176 Subject: Third Party Review for Reclassification of Captan's Carcinogenicity Dear Dr. Gordon:

Thank your for meeting with us on July 22, 2003. This letter is a follow up to that meeting, to provide you with more formal comments on your proposed process for conducting a third party review of the cancer classification for captan. As stated at the meeting, we will not formally approve your protocol, but rather will provide you with comments intended to make the process more balanced and objective. We believe that addressing our comments will allow your process to deliver a third party product at the level of quality necessary for presentation to the Agency's Scientific Advisory Panel ( SAP). All of the comments below were discussed at the July 22nd meeting, however, I am including them here for your records.

1. Schedule. The process should allow enough time for both EPA and the SAP reviews. EPA will require at least 4 to 6 weeks and the SAP will require an additional 6 to 8 weeks for review. Based on the peer review schedule and the needs of the EPA and SAP, it does not appear possible to address the captan reclassification issue at the December meeting. If the third party report on captan is ready with sufficient lead time, the Agency will try to include it in an SAP meeting in Spring 2004.

2. Public Notification. EPA believes that public involvement will contribute to creating a credible end product. As you are aware, EPA has revamped many of its processes to increase the opportunity for public participation and involvement. Suggestions for improved public involvement in the captan process include:   Individually notifying organizations such as the Natural Resources Defense Council, Farmworker Justice Fund, and other interested parties involved in the captan reregistration eligibility decision ( RED) of the proposed process and meetings   Distribute press releases and other announcements of the process to more diverse groups and organizations ( the current list is restricted to scientists)   Ensure that any web postings are placed in a prominent internet location that can be easily accessed by the public, without needing a direct link   Providing adequate opportunity for public comments before and during meetings   Including and announcing a phone link at the meetings for anyone who might want to listen in from a remote location 3. Transparency of Process. EPA believes that a transparent process will contribute to creating a credible end product. EPA has revamped many of its processes to be more transparent, which we believe leads to a higher quality final product that is more defensible. Following some or all of the Office of Pesticide Programs' existing processes will enhance the credibility of the end product. Suggestions for improved transparency of the process include:   Publicize criteria that were used to evaluate potential organizations to serve as third parties, including other organizations that may have been considered, and the rationale for selecting the proposed third party   Publicize criteria that were used to select panel members, and the rationale for making final selections 4. Conflict of Interest Issues. The process should be portrayed as a " third party" review, rather than an " independent" review. Do not hesitate to acknowledge that the registrant is paying for the third party review being conducted by TERA. All potential, actual or perceived conflicts of interest for both the third party and panel members should be open and made freely available to the public.

5. Panel. Expertise of the panel should be broad enough to adequately cover all scientific areas of interest. EPA is concerned that the proposed panel is composed largely from members of industry or related groups. The lack of representatives from environmental organizations and academia could lead to the end product being less credible than you desire. At the July 22nd meeting, you mentioned that holding the meeting in September makes it more difficult to recruit academics. If necessary, perhaps you should consider rescheduling the meeting a bit later in the fall to accommodate these potential members. A diverse panel enhances the credibility of the end product. Moreover, all views of the review panel members should be reflected in the final report, including any dissenting views.

6. Data provided to panel. All of the data should be provided to panel members and be the main source of information for the peer review. Dissemination of an overview document is not sufficient for the review panel to make an informed decision. Ultimately, all of the data will also need to be provided to the SAP. EPA also believes that a presentation to the panel by the registrant could undermine the credibility of your process. The data should speak for themselves. We also advise you to carefully word all documents, including the protocol, to ensure no value laden language is included ( for example, the protocol states that public comments during meetings will be " restricted in time such that panel deliberations are not adversely affected").

Although these comments are advisory, I strongly encourage you to incorporate them into your process, as they will significantly enhance the credibility of the end product. I also want to thank you for your efforts in furthering this project and if you have any questions, please contact Michael Goodis at 703 308 8157 or Susan Jennings at 706 355 8574.

Sincerely,

Betty Shackleford, Acting Director Special Review and Reregistration Division Office of Pesticide Programs


[Federal Register: July 9, 2009 (Volume 74, Number 130)]
[Notices]
[Page 32901-32902]
[DOCID:fr09jy09-45]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 739-022]

Appalachian Power Company; Notice of Application Tendered for
Filing With the Commission and Establishing Procedural Schedule for
Licensing and Deadline for Submission of Final Amendments

July 1, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 739-022.
    c. Date Filed: June 29, 2009.
    d. Applicant: Appalachian Power Company.
    e. Name of Project: Claytor Project.
    f. Location: On the New River in Pulaski County, Virginia. The
project does not affect Federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791 (a)-825(r).
    h. Applicant Contact: Ms. Teresa Rogers, Reservoir Superintendent,
Appalachian Power Company, 40 Franklin Road, Roanoke, VA 24011, (540)
985-2441<EMAIL_ADDRESS>    i. FERC Contact: John Smith,<PHONE_NUMBER> or<EMAIL_ADDRESS>    j. This application is not ready for environmental analysis at this
time.
    k. The Project Description: The Claytor Project consists of: (1) A
1,142-foot-long, 137-foot-high concrete gravity dam; (2) a 4,472-acre
reservoir with a storage capacity of 225,000 acre-feet at normal pool
elevation 1,846.0 feet National Geodetic Vertical Datum (NGVD); (3)
four 16-foot-diameter penstocks; (4) a powerhouse integral with the dam
containing four generating units with a combined capacity of 75
megawatts; (5) a 1,000-foot-long transmission line; and (6) switching
and appurtenant equipment.
    The applicant proposes to expand its current levelized flow mode
whereby releases from the project approximate inflows to the project
over a 24-hour period from April 15 through October 15 to April 1
through November 30. Reservoir levels would continue to be maintained
between 1,845 feet NGVD and 1,846 feet NGVD and a minimum average
hourly flow of 750 cubic feet per second (cfs), or inflow, whichever is
less, would be provided downstream of the project. The applicant would
also modify the current period for peaking operations from October 16
through April 14 to December 1 through March 31 and increase its
minimum average hourly downstream flow from 750 cfs to 1,000 cfs, or
inflow, whichever is less. During this period, the applicant would
extend the time to ramp down during peaking operations from 15 minutes
to 30 minutes but continue to bring units on line in 15-minute
intervals to meet system demands. Reservoir levels would be maintained
between 1,844 feet NGVD and 1,846 feet NGVD. In addition, the applicant
would eliminate the current winter drawdown to protect aquatic
resources including state-listed mussel populations. For recreation
purposes, the applicant is proposing to provide weekend releases of
1,000 cfs when inflow falls below 1,000 cfs but is above 800 cfs and
would provide recreation releases for the annual squirt boat
competition each May.
    l. Locations of the Application: A copy of the application is
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, contact FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. Procedural Schedule: The application will be processed according
to the following Hydro Licensing Schedule. Revisions to the schedule
may be made as appropriate.

------------------------------------------------------------------------
              Milestone                           Target date
------------------------------------------------------------------------
Notice of Acceptance/Notice of Ready  September 27, 2009.
 for Environmental Analysis (when
 FERC approved studies are complete).

Filing of recommendations,            November 26, 2009.
 preliminary terms and conditions,
 and fishway prescriptions.
Commission issues Draft EA..........  July 9, 2010.
Comments on Draft EA................  August 8, 2010.
Filing Modified Terms and Conditions  October 7, 2010.
Commission Issues Final EA..........  January 5, 2011.
------------------------------------------------------------------------

    o. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of the notice
of ready for environmental analysis.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-16158 Filed 7-8-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 23, 2009 (Volume 74, Number 54)]
[Notices]
[Page 12167-12169]
[DOCID:fr23mr09-96]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59579; File No. SR-NASDAQ-2006-056]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Order
Approving Proposed Rule Change as Modified by Amendment No. 2 Thereto
To Establish Nasdaq Custom Data Feeds

March 13, 2009.
    On December 12, 2006, The NASDAQ Stock Market LLC (``Nasdaq'')
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
establish a data filtration service called Nasdaq Custom Data Feeds
(``Service''). The Service would permit entities to request and receive
customized data feeds containing data elements from Nasdaq's current
data feeds. The proposed rule change was published in the Federal
Register on December 27, 2006.\3\ On March 9, 2009, Nasdaq filed
Amendment No. 1 to the proposed rule change. On March 10, 2009, Nasdaq
filed Amendment No. 2 to the proposed rule change.\4\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 54959 (December 18,
2006), 71 FR 77842 (``Notice'').
    \4\ Amendment No. 2 replaced Amendment No. 1, which was
withdrawn. In Amendment No. 2, Nasdaq proposed to re-number the new
rule from Rule 7038 to Rule 7047, as rule number 7038 has since been
used for a subsequent rule. Nasdaq also clarified that the Service
will only be available with respect to data feeds that contain non-
core market data. Nasdaq also listed the current data feeds which
can be customized through the Service. Because Amendment No. 2 is
technical in nature, it is not subject to notice and comment.
---------------------------------------------------------------------------

    The Commission received one comment on the proposal from the
Securities Industry and Financial Markets Association (``SIFMA'').\5\
SIFMA believes that the proposed rule change does not meet the
requirements of the Act because ``there is no cost-based analysis or
justification for the service in the release.'' \6\ SIFMA also asserts
that the proposed rule change ``raises problems regarding how the
proposed fee was calculated.'' \7\ Finally, SIFMA questions if
competitors will be disadvantaged by the proposal as Nasdaq will have
processed the raw data into a customized data feed when the data is
released, and if a commercial service should be provided by Nasdaq or
if it should instead ``be offered by an affiliate on the condition that
the terms under which that affiliate receives the underlying market
data are offered to other vendors so as to assure competition and
prevent commercial conflicts of interest.'' \8\
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    \5\ See letter from Melissa MacGregor, Assistant Vice President
and Assistant General Counsel, SIFMA, to Nancy M. Morris, Secretary,
Commission, dated January 17, 2007.
    \6\ Id. at 1.
    \7\ Id.
    \8\ Id. at 2.
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    The Commission has reviewed carefully the proposed rule change and
finds that the proposed rule change is consistent with the requirements
of the Act and the rules and regulations thereunder applicable to a
national securities exchange \9\ and, in particular, Section 6(b)(4) of
the Act,\10\ which requires, among other things, that Nasdaq's rules
provide for the equitable allocation of reasonable dues, fees and other
charges among members and

issuers and other persons using any facility or system which Nasdaq
operates or controls. The Commission also finds that the proposed rule
change is consistent with the requirements of Section 6(b)(5) of the
Act,\11\ which requires, among other things, that Nasdaq's rules not
unfairly discriminate between customers, issuers, brokers or dealers.
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    \9\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \10\ 15 U.S.C. 78f(b)(4).
    \11\ 15 U.S.C. 78f(b)(5).
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    The Commission finds that the proposed rule change is consistent
with these statutory standards. Use of the Service is optional, and the
fees associated with the Service will be imposed on all subscribers
equally, based on the level of service that is selected. The fees for
the Service are intended to approximate the average costs of
establishing and maintaining a customized feed.\12\
---------------------------------------------------------------------------

    \12\ See Notice at 77843.
---------------------------------------------------------------------------

    In addition, the proposal meets the criteria, formulated by the
Commission \13\ in connection with the petition filed by
NetCoalition,\14\ for approval of proposed rule changes concerning the
distribution of non-core market data.\15\ In its order issued in
connection with the NetCoalition petition, the Commission stated that
``reliance on competitive forces is the most appropriate and effective
means to assess whether terms for the distribution of non-core data are
equitable, fair and reasonable, and not unreasonably discriminatory.''
\16\ As such, the ``existence of significant competition provides a
substantial basis for finding that the terms of an exchange's fee
proposal are equitable, fair, reasonable, and not unreasonably or
unfairly discriminatory.'' \17\ If an exchange ``was subject to
significant competitive forces in setting the terms of a proposal,''
the proposal will be approved unless the Commission determines that
``there is a substantial countervailing basis to find that the terms
nevertheless fail to meet an applicable requirement of the Exchange Act
or the rules thereunder.'' \18\
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    \13\ See Securities Exchange Act Release No. 59039 (December 2,
2008), 73 FR 74770 (December 9, 2008) (SR-NYSEArca-2006-21).
    \14\ See Securities Exchange Act Release No. 55011 (December 27,
2006) (order granting petition for review of SR-NYSEArca-2006-21).
    \15\ The Commission's order distinguishes between core market
data, which is defined as ``the best-priced quotations and last sale
information of all markets in U.S.-listed equities that Commission
rules require to be consolidated and distributed to the public by a
single central processor,'' and non-core market data. See 73 FR at
74771. Because the Service, which provides customized data feeds
using data that is available through Nasdaq's current proprietary
data feeds, does not involve core market data, this proposed rule
change is properly categorized as a non-core market data proposal.
    \16\ Id. at 74781.
    \17\ Id. at 74781-82.
    \18\ Id. at 74781. In approving NYSEArca-2006-21, the Commission
found that the proposed rule change was consistent with Section
6(b)(4) of the Act, 15 U.S.C. 78f(b)(4). See 73 FR at 74779. The
Commission also found that the proposal was consistent with Section
6(b)(5) of the Act, 15 U.S.C. 78f(b)(5), Section 6(b)(8) of the Act,
15 U.S.C. 78f(b)(8), and Rule 603(a) of Regulation NMS, 17 CFR
242.603(a). See 73 FR at 74779. The Commission noted that the
presence of competitive forces guided its analysis under both
Section 6 of the Act and Rule 603 of Regulation NMS. Id.
---------------------------------------------------------------------------

    In its order approving NYSEArca-2006-21, the Commission also stated
that the terms of a proposed rule change to distribute market data for
which the exchange is the exclusive processor must provide for an
equitable allocation of fees under Section 6(b)(4) of the Act,\19\ not
be designed to permit unfair discrimination under Section 6(b)(5) of
the Act,\20\ be fair and reasonable under Rule 603(a)(1),\21\ and not
be unreasonably discriminatory under Rule 603(a)(2).\22\ If the
proposal involves non-core market data, an analysis of competitive
forces may be used, and that analysis will apply to findings under
Section 6 of the Act, and to findings under Rule 603.\23\
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    \19\ 15 U.S.C. 78f(b)(4).
    \20\ 15 U.S.C. 78f(b)(5).
    \21\ 17 CFR 242.603(a)(1).
    \22\ 17 CFR 242.603(a)(2). See 73 FR at 74782.
    \23\ See 73 FR at 74779.
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    The Service customizes the information that is available through
Nasdaq's current proprietary data feeds. These current data feeds serve
as an alternative to the Service, and potential subscribers to the
Service can determine if the Service provides a benefit over the
current data feeds that justifies its added cost. In addition, Nasdaq
has represented that there is significant competition in the
distribution of market data to broker-dealers and to other consumers,
and that it fully expects its competitors to quickly replicate the
Service.\24\ In that scenario, potential subscribers to the Service
would have the added option of selecting a customized product offered
by a competitor.
---------------------------------------------------------------------------

    \24\ See Notice at 77844.
---------------------------------------------------------------------------

    Nasdaq was subject to significant competitive forces in formulating
the terms of the Service--specifically, the availability to market
participants of alternatives to purchasing the Service. Because the
proposed Service involves the distribution of non-core market data, and
significant competitive forces are present, the Service is thus
consistent with Section 6(b)(4) \25\ and Section 6(b)(5) of the
Act,\26\ and with Rule 603(a).\27\ There is not a substantial
countervailing basis that would render the proposal inconsistent with
the Act or the rules thereunder.
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    \25\ 15 U.S.C. 78f(b)(4).
    \26\ 15 U.S.C. 78f(b)(5).
    \27\ 17 CFR 242.603(a).
---------------------------------------------------------------------------

    As described above, SIFMA submitted a comment letter in which it
asserted that Nasdaq did not include a cost-based analysis or
justification for the Service in its proposed rule change. SIFMA also
questioned whether competitors would be disadvantaged by the proposal,
and queried whether the Service should be offered through an affiliate
of Nasdaq, with Nasdaq offering the underlying data to its affiliate
and to other vendors on equal terms.
    With respect to the basis for the proposed fees for the Service,
Nasdaq has represented that those fees are intended to approximate the
average costs of establishing and maintaining a customized feed.
Moreover, the Commission has stated that proposed fees need not be
subject to a cost-based review in order to conclude that such fees are
fair and reasonable.\28\ Rather, the criteria for review should be
``appropriate to the circumstances,'' and the existence of competitive
forces is ``particularly appropriate'' when assessing a proposed
fee.\29\ As noted above, Nasdaq was subject to significant competitive
forces in formulating the terms of the Service. A cost-based review is
therefore not necessary here.
---------------------------------------------------------------------------

    \28\ See 73 FR at 74787.
    \29\ Id.
---------------------------------------------------------------------------

    With respect to SIFMA's proposal that the Service be offered
through an affiliate of Nasdaq, and that Nasdaq offer the underlying
data on equal terms to its affiliate and competitors alike, a similar
proposal was made in the context of SR-NYSEArca-2006-21.\30\ In its
order approving that rule change, the Commission found that such a
proposal was not necessary or appropriate, as NYSE Arca, Inc. was
subject to significant competitive forces in setting the terms of its
data product.\31\ Given the presence of significant competitive forces
here, SIFMA's proposal that Nasdaq offer the Service through an
affiliate, and provide Nasdaq and other vendors access to the
underlying data on equal terms, is also unnecessary.\32\
---------------------------------------------------------------------------

    \30\ See FR at 74775 (summarizing comments received on the
proposed rule change from, among others, SIFMA).
    \31\ Id. at 74787.
    \32\ In its filing, Nasdaq represented that it would make the
data delivered by the Service available at the same time that the
data is made available through Nasdaq's current data feeds. In
addition, Nasdaq stated that, due to factors such as bandwidth and
equipment capacity, a subscriber to the Service may receive the
current data feed before receiving its customized data feed. See
Notice at 77843.

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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\33\ that the proposed rule change (SR-NASDAQ-2006-056), as
modified by Amendment No. 2 be, and it hereby is, approved.
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    \33\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\34\
---------------------------------------------------------------------------

    \34\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-6146 Filed 3-20-09; 8:45 am]


[Federal Register: February 4, 2009 (Volume 74, Number 22)]
[Notices]
[Page 6077-6079]
[DOCID:fr04fe09-92]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59304; File No. SR-NYSEALTR-2009-02]

Self-Regulatory Organizations; Notice of Filing of Proposed Rule
Change by NYSE Alternext US LLC To Revise Its Listing Fees

January 27, 2009.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act''),\2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on January 8, 2009, NYSE Alternext US LLC (``NYSE
Alternext'' or the ``Exchange'') filed with the Securities and Exchange
Commission the proposed rule changes as described in Items I, II, and
III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule changes from interested persons.
---------------------------------------------------------------------------

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

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

    The Exchange proposes to revise its listing fees. The text of the
proposed rule change is available on the Exchange's Web site at (http:/
/www.nyse.com), at the Exchange's Office of the Secretary, and at the
Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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. NYSE Alternext 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
    Following the October 2008 acquisition by NYSE Euronext of NYSE
Alternext's predecessor entity, the American Stock Exchange, NYSE
Euronext management reexamined NYSE Alternext's listing fees in light
of the cost of providing services to listed companies on an ongoing
basis and the fees charged by competitor exchanges. In particular, the
Exchange notes that it is now providing listed companies with a suite
of services similar to services provided to listed companies by the New
York Stock Exchange (``NYSE''), which is also a subsidiary of NYSE
Euronext. These services, which the Exchange has either already begun
providing or will roll out in early 2009, include: A daily summary of
trading activity in a listed company's stock delivered at the end of
each trading day to the company's executives (``market focus
reports''); a summary of relevant market information delivered each
morning with analysis of what may happen in the equity markets that
day; access to NYSENet, which is a web-based system that provides
listed companies with easy access to detailed trading data updated
intraday on a real-

time basis; and eGovDirect.com, a secure web-based system enabling
companies to submit certifications to the Exchange electronically. To
recoup the cost of providing these services and, more generally, in
response to increased costs in its continuing service and regulatory
programs, the Exchange proposes to make a number of changes to its
listing fees.
    The Exchange proposes to amend its initial listing fees for common
stock or common stock equivalents. The initial listing fees set forth
in Section 140 of the Exchange's Company Guide for issuances of (i)
less than five million shares will be increased from $40,000 to
$50,000, (ii) five million to 10 million shares will be increased from
$50,000 to $55,000, (iii) 10,000,001 shares to 15 million shares will
be increased from $55,000 to $60,000 and (iv) in excess of 15 million
shares will be increased from $65,000 to $70,000. The Exchange
currently charges a nonrefundable $5,000 application fee in connection
with a company's initial listing on the Exchange. The Exchange proposes
to eliminate this application fee \4\ and notes that, as a consequence,
any company paying the increased initial listing fee in connection with
the listing of five million shares or more at the time of first listing
on the Exchange will not pay a higher aggregate fee to the Exchange as
the initial listing fee increase of $5,000 is offset by the elimination
of the application fee.\5\ The Exchange also notes that the proposed
minimum initial listing fee of $50,000 for up to five million shares is
the same as the Nasdaq Capital Market minimum fee for issuances of up
to 15 million shares, while the proposed maximum fee of $70,000 for
more than 15 million shares is less than the $75,000 maximum initial
listing fee charged by Nasdaq Capital Market for listing in excess of
15 million shares.\6\ As such, the Exchange believes that the proposed
amended initial listing fees are competitive with those of other
markets. In addition, the Exchange believes that it is appropriate to
charge companies different amounts based on the number of shares
listed, as the Exchange provides different levels of services to
companies based on their size. For example, only larger companies are
provided with the market focus reports described above.
---------------------------------------------------------------------------

    \4\ The Exchange proposes to make conforming changes to Section
144 of the Company guide to eliminate references to the application
processing fee.
    \5\ The Exchange notes that companies listing less than five
million shares at the time of initial listing will be charged an
initial listing fee that is $10,000 higher than is currently the
case, giving rise to a net fee increase of $5,000 after taking into
account the elimination of the application processing fee. In
addition, the Exchange notes that companies that have previously
listed a class of stock or warrants on the Exchange that are listing
an additional class of securities would not have been required to
pay the application processing fee in connection with the listing of
the second class.
    \6\ The initial listing fee for issuers listing less than five
million shares is increasing by $10,000, while the fees for the
other tiers are increasing by just $5,000. The Exchange believes
that this larger increase is necessary to cover the costs of
regulatory review and use of operational resources which are
essentially fixed in relation to any new listing regardless of the
company's size.
---------------------------------------------------------------------------

    The Exchange notes that it is extremely difficult to establish
listing fee schedules on the basis of market capitalization as stock
prices are inherently volatile. As a consequence, all of the major
national securities exchanges use the number of shares outstanding as a
proxy for a company's size in establishing fee schedules, as, much of
the time, the number of shares a company has outstanding provides a
reasonable guide as to its size.
    Section 140 provides for a $5,000 application processing fee
payable in connection with the initial listing of a class of bonds of
an issuer that does not have another class of securities listed on the
Exchange. The Exchange proposes to eliminate this fee.
    Section 140 currently provides that, in the case of non-U.S.
issuers listed on foreign stock exchanges, the fee, including the one-
time, non-refundable application-processing fee of $5,000, is $40,000.
The Exchange proposes to conform the initial listing fees charged to
non-U.S. companies to those charged to domestic companies. The Exchange
believes it is appropriate to charge these non-U.S. companies as much
as other companies as they receive the same level of service from the
Exchange and therefore are as costly to service on an ongoing basis as
any other company of similar size. Accordingly, the Exchange believes
that by charging non-U.S. companies the same fees as domestic companies
it will be providing for a more equitable allocation of reasonable
dues, fees and other charges among its members, issuers and other
persons using its facilities.
    Section 141 of the Company Guide currently provides that issuers
must pay a minimum annual fee of $27,500 if the issuer has 50 million
shares or less outstanding. If the issuer has from 50,000,001 to 75
million shares outstanding, the current annual fee is $32,500. If the
issuer has in excess of 75 million shares outstanding, the current
annual fee is $34,000. The Exchange proposes to retain the minimum
annual fee of $27,500 for issuers with 50 million shares or less
outstanding. Therefore, issuers with 50 million shares or less
outstanding will not be subject to any annual fee increase for 2009.
With effect from January 1, 2010, the Exchange proposes to increase the
annual fee for issuers that have between 50,000,001 and 75 million
shares outstanding from $32,500 to $36,500 and for issuers with in
excess of 75 million shares outstanding the annual fee will be raised
from $34,000 to $40,000. As of the date of approval of this rule
filing, issuers will be required to pay a supplemental annual fee equal
to the difference between the amount they would pay in 2009 based on
the current annual fee rates and the amount they would be required to
pay if the 2010 annual fee rates were in place on January 1, 2009. As
with initial listing fees, the Exchange notes that larger companies
receive more services from the Exchange and it is therefore justifiable
to charge them higher annual fees to recoup the related expenses. For
example, only larger companies are provided with the market focus
reports described above.
    Sections 140 and 146 of the Company Guide contain provisions that
grant the Board of Directors of the Exchange the discretion to defer,
waive or rebate all or any part of the initial listing fee payable in
connection with any listing of securities. Section 142(g) grants the
Board of Directors the same discretion to defer, waive or rebate all or
any part of the fees payable for the listing of additional shares. The
Exchange proposes to eliminate these provisions in Sections 140 and
142(g) and to eliminate Section 146 in its entirety. The Exchange has
not exercised this discretion recently and has concluded that it is no
longer relevant to its strategy going forward.
    The Exchange proposes to amend Section 142 of the Company Guide by
(i) increasing from $60,000 to $65,000 the maximum fee per issuer for
listing additional shares in a calendar year, which is the maximum
imposed by Nasdaq Capital Market and Nasdaq Global Market, and (ii)
increasing from $2,000 to $2,500 the fee charged in connection with a
company changing its name or ticker symbol, which is also the fee
charged by Nasdaq Capital Market and Nasdaq Global Market for changes
of this nature. The Exchange also proposes to amend Section 142 to
adopt a fee of $7,500 for technical original listings (``Technical
Original Listings'') and reverse stock splits. The Exchange will apply
the proposed $7,500 application fee for a Technical Original Listing if
the change in the company's status is technical in nature and the

shareholders of the original company receive or retain a share-for-
share interest in the new company without any change in their equity
position or rights. For example, a change in a company's state of
incorporation or a reincorporation or formation of a holding company
that replaces a listed company would be considered a Technical Original
Listing.\7\ The $7,500 application fee will also apply to a reverse
stock split. The Technical Original Listing fee will replace the
current $5,000 fee for ``substitution listings'' set forth in Section
142(d). The Technical Original Listing fee is intended to apply only to
those events that would have previously been subject to the
substitution listing fee. The Exchange has changed the fee's name and
provided more detail as to when it is applicable in order to better
inform companies as to when it is applicable and to conform to the
comparable rule of the NYSE.\8\ Nasdaq Capital Market and Nasdaq Global
Market have a fee set at the same $7,500 level for ``substitution
listing events,'' which is applicable in the same circumstances as the
Technical Original Listing fee.\9\ The Exchange believes that the
increases in the various fees charged under Section 142 referenced in
this paragraph are justified by the increasing cost of providing
services to companies and in particular the cost of the Exchange's
utilization of staff operational resources in making changes required
by the events giving rise to the applicable fees. The Exchange also
notes that the increased fees are set at the same level as those of
Nasdaq Capital Market and Nasdaq Global Market and are therefore
reasonable in light of the charges imposed by competitor exchanges. The
Exchange is amending the language of Section 142 to state that the fees
in that section apply to non-U.S. companies. As the fees in Section 142
have always applied to non-U.S. companies, this amendment is simply a
clarification and not a substantive change.
---------------------------------------------------------------------------

    \7\ Minor technical amendments are being made to Rule 142(e) to
reflect the fact that reincorporations will be explicitly included
in the categories of events subject to the proposed Technical
Original Listing fee.
    \8\ See Section 902.03 of the NYSE Listed Company Manual.
    \9\ See Nasdaq Marketplace Rules 4510(f) (for the Nasdaq Global
Market fee) and 4520(e) (for the Nasdaq Capital Market fee).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 \10\ of the Act in general and Section
6(b)(4) of the Act \11\ in particular, in that it is designed to
provide for the equitable allocation of reasonable dues, fees and other
charges among its members and other persons using its facilities. The
Exchange believes that the proposal does not constitute an inequitable
allocation of dues, fees and other charges as the proposed fees are set
at levels that are competitive with those already in place at Nasdaq
Capital Market and Nasdaq Global Market and, to the extent different
levels of fees are charged to companies of different sizes, the
differential fees are reasonable in light of the different levels of
service devoted to companies based on their size. Accordingly, the
Exchange believes that the proposal provides for an equitable
allocation of reasonable dues, fees and other charges among its
members, issuers and other persons using its facilities.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f.
    \11\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purpose 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 self-regulatory organization consents, the Commission will:
    (A) By order approve the 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-NYSEALTR-2009-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSEALTR-2009-02. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/
rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing will also be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File No. SR-NYSEALTR-2009-02 and should be
submitted on or before February 25, 2009.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-2250 Filed 2-3-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 132 (Monday, July 11, 2011)]
[Notices]
[Page 40722]
[FR Doc No: 2011-17250]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER11-3941-000]

Granite Reliable Power, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Granite Reliable Power, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is July 21, 2011.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 1, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-17250 Filed 7-8-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 68 (Monday, April 9, 2012)]
[Notices]
[Pages 21123-21125]
[FR Doc No: 2012-8463]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66731; File No. SR-NSCC-2012-02]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Order Approving Proposed Rule Change To Enhance Its
Margining Methodology as Applied to Municipal and Corporate Bonds

April 4, 2012.

I. Introduction

    On February 1, 2012, the National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change SR-NSCC-2012-02 pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'').\1\
The proposed rule change was published for comment in the Federal
Register on February 22, 2012.\2\ The Commission received no comment
letters. For the reasons discussed below,

the Commission is granting approval of the proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Securities Exchange Act Release No. 34-66398 (February 15,
2012), 77 FR 10589 (February 22, 2012).
---------------------------------------------------------------------------

II. Description

    This rule change will enhance NSCC's margining methodology as it
applies to municipal and corporate bonds

Proposal Overview

    A primary objective of NSCC's clearing fund (``Clearing Fund'') is
to have on deposit from each applicable member assets sufficient to
satisfy losses that may otherwise be incurred by NSCC as the result of
the default of the member and the resultant close out of that member's
unsettled positions under NSCC's trade guaranty. Each member's Clearing
Fund required deposit is calculated daily pursuant to a formula set
forth in Procedure XV of NSCC's Rules, which formula is designed to
provide sufficient funds to cover this risk of loss. The Clearing Fund
formula accounts for a variety of risk factors through the application
of a number of components, each described in Procedure XV.\3\
---------------------------------------------------------------------------

    \3\ In addition to those described in this filing, Clearing Fund
components also include (i) a mark-to-market component that takes
into account the difference between the contract price and market
price for the net position of each security in a member's portfolio
through settlement; (ii) the Market Maker Domination component
(``MMDOM'') is charged to Market Makers or firms that clear for
them; (iii) a ``special charge'' in view of price fluctuations in or
volatility or lack of liquidity of any security; (iv) an additional
charge between 5-10% of a member's outstanding fail positions; (v) a
``specified activity charge'' for transactions scheduled to settle
on a shortened settlement cycle (i.e., less than T+3 or T+3 for
``as-of'' transactions); (vi) an additional charge that NSCC may
require of members on surveillance status; and (vii) an ``Excess
Capital Premium'' that takes into account the degree to which a
member's collateral requirement compares to the member's excess net
capital by applying a charge if a member's Required Deposit minus
amounts applied from the charges described in (ii) and (iii) above
is above its required capital.
---------------------------------------------------------------------------

    The volatility component or ``VaR'' is a core component of this
formula and is designed to calculate the amount of money that may be
lost on a portfolio over a given period of time and that is assumed
would be necessary to liquidate the portfolio within a given level of
confidence. Pursuant to Procedure XV, NSCC may exclude from this
calculation net unsettled positions in classes of securities such as
illiquid municipal or corporate bonds, whose volatility is amenable to
generally accepted statistical analysis only in a complex manner. The
volatility charge for such positions is determined by multiplying the
absolute value of the positions by a predetermined percentage
(``haircut''), which shall not be less than 2%.
    In connection with its ongoing review of the adequacy and
appropriateness of its margining methodologies, NSCC is amending
Procedure XV of its Rules so that NSCC will apply this haircut-based
margining methodology at a rate of no less than 2% as is currently
permitted by Procedure XV to all municipal and corporate bonds
processed through NSCC. The proposed rule change will make clear that
to the extent NSCC deems appropriate NSCC may apply this haircut to any
of the municipal and corporate bonds that it processes. As NSCC
continues its ongoing review of the adequacy of its margining
methodology in achieving the desired coverage, the proposed rule change
will allow NSCC to apply a margin requirement to these instruments that
it deems appropriate.
    NSCC reviews its risk management processes against applicable
regulatory and industry standards, including, but not limited to: (i)
The Recommendations for Central Counterparties (``Recommendations'') of
the Committee on Payment and Settlement Systems and the Technical
Committee of the International Organization of Securities Commissions
(``IOSCO'') and (ii) the securities laws and rulemaking promulgated by
the Commission. In conformance with Recommendations 3 and 4 of the
IOSCO Recommendations and with the Commission rules proposed under the
Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010,
specifically proposed Rule 17Ad-22(b)(1) addressing measurement and
management of credit exposures, this proposed rule change will assist
NSCC in its continuous efforts to ensure the reliability of its
margining methodology and will limit NSCC's exposures to losses by
allowing NSCC to apply a margin requirement to the corporate and
municipal bonds it clears that captures the risk characteristics, which
are asset class specific, of these instruments, including historical
price volatility, market liquidity, and idiosyncratic risk.

Implementation Timeframe

    Members will be advised of the implementation date through issuance
of an NSCC Important Notice.

Proposed Rule Changes

    In order to make clear that to the extent NSCC deems appropriate it
may apply a haircut-based margining methodology to all municipal and
corporate bonds processed at NSCC, NSCC is amending Sections
I(A)(1)(a)(ii) and I(A)(2)(a)(ii) of Procedure XV, as marked on Exhibit
5 to the proposed rule filing, by removing the qualifier ``illiquid''
before ``municipal or corporate bonds.'' No other changes to the Rules
are contemplated by this proposed rule change.

III. Discussion

    Section 17A(b)(3)(F) of the Act \4\ requires, among other things,
that the rules of a clearing agency be designed, to assure the
safeguarding of securities and funds which are in the custody or
control of such clearing agency or for which it is responsible and in
general to protect investors and the public interest.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    As a central counterparty, NSCC occupies an important role in the
securities settlement system by interposing itself between
counterparties to financial transactions, thereby reducing the risk
faced by members and contributing to global financial stability. The
effectiveness of a central counterparty's risk controls and the
adequacy of its financial resources are critical to achieving these
risk-reducing goals. Because the proposed rule change will assist NSCC
in its continuous efforts to ensure the reliability of its margining
methodology and will limit NSCC's exposures to losses by allowing it to
apply a margin requirement to corporate and municipal bonds cleared at
NSCC that better addresses the risk characteristics of these
instruments, the proposed rule change should help assure the
safeguarding of securities and funds which are in the custody or
control of NSCC or for which it is responsible, and in general, protect
investors and the public interest and therefore is consistent with the
requirements of Section 17A(b)(3)(F) of the Act. The proposed rule
change is not inconsistent with the existing rules of NSCC, including
any other rules proposed to be amended.

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \5\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\6\ that the proposed rule change (File No. SR-NSCC-2012-02) be,
and hereby is, approved.\7\
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78s(b)(2).
    \7\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).
    \8\ 17 CFR 200.30-3(a)(12).

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

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\8\
Kevin O'Neill,
Deputy Secretary.
[FR Doc. 2012-8463 Filed 4-6-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35655-35657]
[FR Doc No: 2018-16027]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6380]

Clarification of Orphan Designation of Drugs and Biologics for
Pediatric Subpopulations of Common Diseases; 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 entitled
``Clarification of Orphan Designation of Drugs and Biologics for
Pediatric Subpopulations of Common Diseases.'' FDA does not expect to
grant any additional orphan-drug designation to drugs for pediatric
subpopulations of common diseases (i.e., diseases or conditions with an
overall prevalence of 200,000 or greater). This will help resolve an
unintended loophole in the Pediatric Research Equity Act (PREA) orphan
exemption process where a sponsor holding a pediatric-subpopulation
designation can submit a marketing application for use of its drug

in the non-orphan adult population of that disease, get a pediatric-
subpopulation designation for the pediatric subset of the disease, and,
due to this designation, be exempt from conducting the pediatric
studies normally required under PREA when seeking approval of the adult
indication.

DATES: The announcement of the guidance is published in the Federal
Register on July 27, 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-2017-D-6380 for ``Clarification of Orphan Designation of Drugs and
Biologics for Pediatric Subpopulations of Common Diseases.'' 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 this guidance to the
Office of Orphan Products Development, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5295,
Silver Spring, MD 20993. 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: Aaron Friedman, Office of Orphan
Products Development, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5209, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Clarification of Orphan Designation of Drugs and Biologics
for Pediatric Subpopulations of Common Diseases.'' In the Federal
Register of December 20, 2017 (82 FR 60402), FDA published a notice of
availability for the draft guidance entitled ``Clarification of Orphan
Designation of Drugs and Biologics for Pediatric Subpopulations of
Common Diseases,'' announcing that FDA does not expect to grant any
additional orphan drug designation to drugs for pediatric
subpopulations of common diseases (i.e., diseases or conditions with an
overall prevalence of over 200,000 in the United States). In the
Federal Register of January 12, 2018 (83 FR 1619), FDA announced that
it was extending the comment period for this draft guidance for an
additional 30 days. FDA received several comments on the draft guidance
and those comments were considered as the guidance was finalized. The
guidance announced in this notice finalizes the draft guidance dated
December 2017. FDA does not expect to grant any additional orphan-drug
designation to drugs for pediatric subpopulations of common diseases
(i.e., diseases or conditions with an overall prevalence of 200,000 or
greater). This will help resolve an unintended loophole in the
Pediatric Research Equity Act (PREA) orphan exemption process where a
sponsor holding a pediatric-subpopulation designation can submit a
marketing application for use of its drug in the non-orphan adult
population of that disease, get a pediatric-subpopulation designation
for the pediatric subset of the disease, and, due to this designation,
be exempt from conducting the pediatric studies normally required under
PREA when seeking approval of the adult indication.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on orphan designation of drugs and biologics
for pediatric subpopulations of common diseases. 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.

II. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Orphan or https://www.regulations.gov.

    Dated: July 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16027 Filed 7-26-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Notices]
[Page 35117]
[FR Doc No: 2021-14099]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4602-DR; Docket ID FEMA-2021-0001]

Virginia; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the Commonwealth of Virginia (FEMA-4602-DR), dated May 10,
2021, and related determinations.

DATES: The declaration was issued May 10, 2021.

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

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated May 10, 2021, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the damage in certain areas of the
Commonwealth of Virginia resulting from severe winter storms during
the period of February 11 to February 13, 2021, is of sufficient
severity and magnitude to warrant a major disaster declaration under
the Robert T. Stafford Disaster Relief and Emergency Assistance Act,
42 U.S.C. 5121 et seq. (the ``Stafford Act'').
    Therefore, I declare that such a major disaster exists in the
Commonwealth of Virginia.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the Commonwealth.
Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Kevin I. Snyder, of FEMA is
appointed to act as the Federal Coordinating Officer for this major
disaster.
    The following areas of the Commonwealth of Virginia have been
designated as adversely affected by this major disaster:

    Amelia, Appomattox, Bedford, Brunswick, Campbell, Caroline,
Charlotte, Cumberland, Dinwiddie, Essex, Floyd, Franklin, Goochland,
Greensville, Halifax, King and Queen, King William, Lancaster,
Louisa, Lunenburg, Mecklenburg, Middlesex, New Kent, Northumberland,
Nottoway, Patrick, Pittsylvania, Powhatan, Prince Edward, Prince
George, and Richmond Counties for Public Assistance.
    All areas within the Commonwealth of Virginia are eligible for
assistance under the Hazard Mitigation Grant Program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-14099 Filed 6-30-21; 8:45 am]
BILLING CODE 9111-23-P