[Federal Register: December 28, 2009 (Volume 74, Number 247)]
[Notices]
[Page 68646-68648]
[DOCID:fr28de09-100]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61202; File No. SR-Phlx-2009-103]

Self-Regulatory Organizations; NASDAQ OMX PHLX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Codify
Certain Provisions of the Options Listing Procedures Plan Into Phlx's
Rules

December 18, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 \2\ thereunder, notice is hereby given
that on December 7, 2009, NASDAQ OMX PHLX, Inc. (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change 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 change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is filing with the Commission a proposal to amend its
Rule 1012 (Series of Options Open for Trading) by adding Commentary .10
to apply uniform objective standards to the range of options series
exercise (or strike) prices available for trading on the Exchange. The
Exchange is also amending Options Floor Procedure Advice F-22 (Intra-
Day Addition of Strike Prices) (``OFPA'' or ``Advice'') to add a cross-
reference to Commentary .10 to Rule 1012.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqomxphlx.cchwallstreet.com/NASDAQOMXPHLX/
Filings/, at the principal office of the Exchange, 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 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposal is to implement in Phlx rules,
specifically Commentary .10 to Rule 1012, changes that were recently
made to the Plan for the Purpose of Developing and Implementing
Procedures Designated to Facilitate the Listing and Trading of
Standardized Options Submitted Pursuant to Section 11A(a)(3)(B) of the
Securities Exchange Act of 1934, also known as the Options Listing
Procedures Plan (``OLPP''), in Amendment No. 3 thereto.\3\; and to
cross-reference Commentary .10 to Rule 1012 in OFPA F-22. The proposed
rule change in Commentary .10 incorporates uniform objective standards
to the range of options series exercise (or strike) prices available
for trading on the Exchange, as a quote mitigation strategy intended to
reduce the overall number of option series available for trading, which
will in turn lessen the rate of increase in quote traffic (``range
limitations'' or ``range limitation strategy'').\4\
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    \3\ See Securities Exchange Act Release No. 60531 (August 19,
2009), 74 FR 43173 (August 26, 2009)(order approving Amendment No. 3
to the OLPP, which would apply uniform objective standards to the
range of options series exercise or strike prices available for
trading on exchanges that are sponsors of OLPP). The sponsors of
OLPP include Phlx, Chicago Board Options Exchange, Incorporated;
International Stock Exchange LLC; NASDAQ OMX BX, Inc.; The NASDAQ
Stock Market LLC; NYSE Amex, LLC; and NYSE Arca, Inc. (together
known as the ``Plan Sponsor Exchanges''). The OLPP is a national
market system plan that, among other things, sets forth procedures
governing the listing of new options series and replaces and
supersedes the Joint-Exchange Options Plan (``JEOP''). See
Securities Exchange Act Release No. 44521 (July 6, 2009), 66 FR
36809 (July 13, 2001)(order approving OLPP). See also Securities
Exchange Act Release No. 29698 (September 17, 1991), 56 FR 48954
(September 25, 1991)(order approving JEOP).
    \4\ The Exchange expects that other Plan Sponsor Exchanges will
file similar rule change proposals implementing range limitations in
their rules to mitigate quotes. See, for example, Securities
Exchange Act Release No. 60995 (November 13, 2009), 74 FR 60008
(November 19, 2009)(SR-CBOE-2009-084)(notice of filing and immediate
effectiveness).
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    Rule 1012 currently indicates what series of option contracts may
be open for trading after a particular class of options has been
approved for trading on the Exchange. This proposal adds Commentary .10
to Rule 1012 that applies certain ``range limitations'' to

the addition of new series for options classes overlying equity
securities, Exchange Traded Fund Shares (``ETFs''), or Trust Issued
Receipts (``TIRs'').
    As proposed in Commentary .10, if the price of the underlying
security is less than or equal to $20, the Exchange would not list new
option series with an exercise price more than 100 percent above or
below the price of the underlying security.\5\ If the price of the
underlying security is greater than $20, the Exchange would not list
new option series with an exercise price more than 50 percent above or
below the price of the underlying security. The proposal provides for
an objective basis upon which the underlying prices for the price range
limitations described above shall be determined, specifically in regard
to intra-day add-on series and next-day series additions, new
expiration months and for option series to be added as a result of pre-
market trading.
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    \5\ This restriction would not prohibit the listing of at least
three options series per expiration month in an option class.
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    The proposal also allows the Exchange to designate up to five
underlying securities to which, instead of the aforementioned 50
percent restriction, a 100 percent restriction would apply. These
designations would be made on an annual basis and cannot be removed
during the calendar year unless the option class is delisted by the
Exchange, in which case the Exchange may designate another class to
replace the delisted class. If a designated class is delisted by the
Exchange but continues to trade on at least one other exchange, any
additional series for the class which are added from that point forward
would again be subject to the proposed exercise price range
limitations, unless the class is subsequently designated by another
exchange. The proposal also provides a procedure for the Exchange to
request, if conditions warrant, additional case-by-case exceptions even
when it has already so designated five underlying securities.
    In addition, the Exchange may request, on a case-by-case basis, an
exemption when it desires to list a series from the 100 percent range
limitation. This procedure would enable the Exchange to list options
series with strike prices that are more than 100 percent above or below
the price of an underlying security, if unanimously agreed upon by all
exchanges that list options overlying the security.\6\
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    \6\ Application of any of the aforementioned exceptions and/or
exemptions to the strike price range limitations for an underlying
security would be available to all exchanges listing options on such
security.
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    The Exchange notes that the proposal would not restrict its ability
to list options series in two situations. First, the Exchange would not
be restricted from listing options series that have been properly
listed by another exchange. And second, the proposal expressly
eliminates the applicability of range limitations with regard to the
listing of $1 strike prices in option classes participating in the $1
Strike Program, and the listing of series of FLEX options.\7\
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    \7\ For the $1 Strike Program, see Commentary .05 to Rule 1012.
For FLEX Options, see Rule 1079.
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    The Exchange believes that the proposed rule change implementing
range limitation strategies for equity, ETF, and TIR options should be
beneficial in reducing quote traffic on the Exchange and in the options
industry.\8\
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    \8\ The Exchange's belief regarding reduction of quote traffic
in the options industry is based, as discussed previously, on the
expectation that other options exchanges will file similar rule
change proposals. According to a recent study, if all options
exchanges implement range limitations of the type proposed herein,
the options industry would expect an approximate four percent
reduction in the number of series traded, with only a nominal
reduction in trading volume. See Securities Exchange Act Release No.
60531 (August 19, 2009), 74 FR 43173 (August 26, 2009) (order
approving Amendment No. 3 to the OLPP).
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2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act \9\ in general, and furthers the objectives of Section
6(b)(5) of the Act \10\ in particular, in that it is designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in facilitating transactions in
securities, and to remove impediments to and perfect the mechanisms of
a free and open market and a national market system. The Exchange
believes that codifying certain range limitation provisions of the
OLPP, as amended, serves to foster investor protection.
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    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
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B. Self-Regulatory Organization's Statement on Burden on Competition

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

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

    No written comments were either solicited or received.

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

    The Exchange believes that the foregoing proposed rule change may
take effect upon filing with the Commission pursuant to Section
19(b)(3)(A) \11\ of the Act and Rule 19b-4(f)(6)(iii) thereunder \12\
because the foregoing proposed rule change does not: (i) Significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative prior
to 30 days from the date on which it was filed, or such shorter time as
the Commission may designate.\13\
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    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6)(iii).
    \13\ 17 CFR 240.19b-4(f)(6)(iii). In addition, Rule 19b-
4(f)(6)(iii) requires the Exchange to give the Commission written
notice of the Exchange's intent to file the proposed rule change
along with a brief description and the text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. The Exchange has satisfied the pre-filing requirement.
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Phlx-2009-103 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-Phlx-2009-103. 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 the filing also will be available for
inspection and copying at the principal office of the self-regulatory
organization. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
Phlx-2009-103 and should be submitted on or before January 19, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
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    \14\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-30600 Filed 12-24-09; 8:45 am]

BILLING CODE 8011-01-P


Combustion Only  # of Units, ( Capacity) SCR Only  # of Units, ( Capacity) SNCR Only  # of Units, ( Capacity) Combustion & SNCR  # of Units, ( Capacity)

28 4.05 18 ( 2.62 GW) 0 0 2 ( 0.3 GW) 11 ( 1.78 GW)

Combustion Only  # of Units, ( Capacity) SCR & Combusion  # of Units, ( Capacity) SNCR Only  # of Units, ( Capacity) Combustion & SNCR  # of Units, ( Capacity)

47 4.73 6 ( 0.623 GW) 1 ( 0.06 GW) 1 ( 0.163 GW) 0 0 Total Unit Capacity ( GW) SO2 Controls  # of Units, ( Capacity) BART Eligible Coal fired Units Nox Controls # Units  non CAIR, Unit Capacity < 200 MW BART Eligible Oil Gas fired Units # Units  non CAIR, Unit Capacity < 200 MW Total Unit Capacity ( GW) Nox Controls SO2 Controls  # of Units, ( Capacity) 9 ( 1.39 GW)

0 Both Nox and SO2 Controls  # of Units, ( Capacity)

Both Nox and SO2 Controls  # of Units, ( Capacity)


[Federal Register Volume 87, Number 228 (Tuesday, November 29, 2022)]
[Notices]
[Pages 73295-73296]
[FR Doc No: 2022-25988]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD22-10-000]

Reliability Technical Conference; Notice Inviting Post-Technical
Conference Comments

    On Thursday, November 10, 2022, the Federal Energy Regulatory
Commission (Commission) convened its annual Commissioner-led
Reliability Technical Conference to discuss policy issues related to
the reliability of the Bulk-Power System.
    All interested persons are invited to file post-technical
conference comments to address issues raised during the technical
conference identified in the Supplemental Notice of Technical
Conference issued on November 3, 2022. For reference, the questions
included in the Supplemental Notice are included below. Commenters need
not answer all of the questions, but are encouraged to organize
responses using the numbering and order in the below questions.
Commenters are also invited to reference material previously filed in
this docket but are encouraged to avoid repetition or replication of
their previous comments. Comments must be submitted on or before 60
days from the date of this Notice.

    Comments, identified by docket number, may be filed electronically
or paper-filed. Electronic filing through https://www.ferc.gov is
preferred. Documents must be filed in acceptable native applications
and print-to -PDF, but not in scanned or picture format. Instructions
are available on the Commission's website: http://www.ferc.gov/docs-filing/efiling.asp.
    Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, submissions sent via
the U.S. Postal Service must be addressed to: Federal Energy Regulatory
Commission, Office of the Secretary, 888 First Street NE, Washington,
DC 20426. Submissions sent via any other carrier must be addressed to:
Federal Energy Regulatory Commission, Office of the Secretary, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    For more information about this Notice, please contact:

Lodie White (Technical Information), Office of Energy Reliability,
(202) 502-8453, [email protected]
Leigh Anne Faugust (Legal Information), Office of General Counsel,
(202) 502-6396, [email protected]

    Dated: November 22, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-25988 Filed 11-28-22; 8:45 am]
BILLING CODE 6717-01-P


Frederick J. Neri, Jr. Plant Manager Calpine Parlin Cogeneration Facility 970 Washington Road Parlin, NJ 08859 Re: Calpine Parlin, Inc. Request for Alternative NSPS Subpart Db Opacity Monitoring Requirement Dear Mr. Neri:

The U. S. Environmental Protection Agency ( EPA) has reviewed your letter dated April 11, 2001, requesting an Alternative Monitoring Procedure with respect to Continuous Opacity Monitoring ( COMS) requirements for its auxiliary boilers that are subject to NSPS Subpart Db. The basis for your request is that Calpine Parlin's auxiliary boilers are affected by the opacity standard provided in 40 CFR § 60.43 ( b), only when firing kerosene, and would not be subject to the opacity monitoring requirements when firing natural gas.

EPA concurs with Calpine Parlin that an opacity monitor is not required when only natural gas is fired. However, when firing kerosene the facility is still subject to the opacity standard as provided in 40 CFR § 60.43 ( b) ( f). Since historical data shows that boiler operations when burning kerosene are limited, 40 CFR § 60.13 ( i) ( 2) allows EPA to approve alternative opacity monitoring requirements for sources that are " infrequently operated".

EPA will allow Calpine Parlin to use visual determination of opacity during the firing of kerosene in the auxiliary boilers ( 40 CFR § 60, Appendix A, Method 9) provided that it complies with the following conditions:

A. Two certified smoke readers will be on the operating staff of Calpine Parlin, Inc.

B. At least one certified smoke reader will be present at the facility when an auxiliary boiler is required to operate on kerosene.

C. A six minute reading will be taken at the beginning of every hour that an auxiliary boiler is operating on kerosene. If the six minute reading exhibits an average of 20% opacity or greater, then readings will continue at six minute intervals until a six minute reading exhibits an opacity average of less than 20%. Opacity readings during night time hours are exempt.

D. A six minute reading will be taken during the first six minutes of boiler start up on kerosene. If the six minute reading exhibits an average of 20% opacity or greater, then readings will continue at six minute intervals until a six minute reading exhibits an opacity average of less than 20%. Opacity readings during night time hours are exempt. E. Certification records of smoke readers, and all smoke readings taken shall be kept on site for at least five years.

F. Records of the reasons for operating the auxiliary boilers when firing kerosene, the times of operation, the amount of kerosene used, and fuel analysis shall be kept onsite for at least five years.

G. All records pertinent to this Alternative Opacity Monitoring Procedure shall be kept on site for a period of five years, and be available for inspection by personnel of Federal, State, and Local pollution control agencies.

H. Should Calpine Parlin, Inc. opt to use the continuous monitoring system required by 40 CFR § 60.48b ( a), it shall provide EPA with notice 60 days in advance.

Any deviations from the above conditions would constitute a violation of the NSPS. If you have any questions regarding this letter, please contact Marina Castro at 212 637 3516.

Sincerely,

Kenneth Eng, Chief Air Compliance Branch


additional or different challenges in coming into compliance with the
amendments than larger entities. As result, small funds will have an
additional six months to come into compliance with the final rules
relative to larger entities.
    We do not believe that clarifying, consolidating, or simplifying
the compliance requirements under the final amendments for small funds,
beyond that already required for all funds, would permit us to achieve
our stated objectives. Again, this approach would raise investor
protection concerns for investors in small funds and, as discussed
above, the final amendments apply most of the rule's requirements and
corresponding compliance burdens--only to certain fund names that are
required to adopt an 80% investment policy.
    The costs associated with the final amendments will vary depending
on the fund's particular circumstances, and thus the amendments may
result in different burdens on funds' resources. In particular, we
expect that a fund that has a name that will be required to adopt an
80% investment policy under the final amendments will have higher costs
than those that do not. Thus, to the extent a fund that is a small
entity has a name that will not require the fund to adopt an 80%
investment policy under the final amendments, we believe it will incur
relatively low compliance costs. Further, some funds with names that
will be newly subject to the 80% investment policy requirement may
already have adopted an investment policy that requires them to invest
80% or more of the value of their assets in investments consistent with
the name, or otherwise may already have investments that reflect the
name's focus totaling 80% or more of the value of the fund's assets.
These funds will not have to bear the burden of adjusting their
portfolios or changing their name, and the burden of adopting an
investment policy consistent with the names rule's requirements also
could be relatively lower for these funds. However, we believe that it
is appropriate for the costs associated with the final amendments to
correlate with the costs of ensuring that the fund's name reflects its
investments (and thus the expectations fostered with investors), as
opposed to adjusting these costs to account for a fund's size, in light
of how the final amendments are designed to further our investor
protection objectives.
    Finally, with respect to the use of performance rather than design
standards, the final amendments generally use performance standards for
all funds subject to the amendments, regardless of size. We believe
that providing funds with the flexibility permitted in the final
amendments with respect to designing 80% investment policies is
appropriate because of the fact-specific nature of the investment focus
of funds.

Statutory Authority

    The Commission is adopting the amendments to rule 35d-1 under the
authority set forth in sections 8, 30, 31, 34, 35, 38, 59, and 64 of
the Investment Company Act of 1940 [15 U.S.C. 80a-8, 80a-29, 80a-30,
80a-33, 80a-34, 80a-37, 80a-58, and 80a-63]. The Commission is adopting
amendments to Form N-1A, Form N-2, Form N-8B-2, Form S-6, and Form N-
PORT under the authority set forth in sections 8, 30, 35, and 38 of the
Investment Company Act

of 1940 [15 U.S.C. 80a-8, 80a-18, 80a-34, and 80a-37], sections 5, 6,
7, 8, 10, and 19 of the Securities Act of 1933 [15 U.S.C. 77e, 77f,
77g(a), 77h, 77j, and 77s(a)], and sections 10, 13, 15, 23, and 35A of
the Exchange Act [15 U.S.C. 78j, 78m, 78o, 78w, and 78ll]. The
Commission is adopting amendments to rules 11 and 405 of Regulation S-T
under the authority set forth in section 23 of the Exchange Act [15
U.S.C. 78w]. The Commission is adopting amendments to rules 485 and 497
under the authority set forth in sections 10 and 19 of the Securities
Act [15 U.S.C. 77j and 77s].

List of Subjects

17 CFR Part 230

    Investment companies, Reporting and recordkeeping requirements,
Securities.

17 CFR Part 232

    Administrative practice and procedure, Reporting and recordkeeping
requirements, Securities.

17 CFR Part 239

    Reporting and recordkeeping requirements, Securities.

17 CFR Parts 270 and 274

    Investment companies, Reporting and recordkeeping requirements,
Securities.

Text of Rule and Form Amendments

    For the reasons set out in the preamble, title 17, chapter II of
the Code of Federal Regulations is amended as follows:

PART 230--GENERAL RULES AND REGULATIONS, SECURITIES ACT OF 1933

0
1. The authority citation for part 230 continues to read, in part, as
follows:

    Authority: 15 U.S.C. 77b, 77b note, 77c, 77d, 77f, 77g, 77h,
77j, 77r, 77s, 77z-3, 77sss, 78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o-
7 note, 78t, 78w, 78ll(d), 78mm, 80a-8, 80a-24, 80a-28, 80a-29, 80a-
30, and 80a-37, and Pub. L. 112-106, sec. 201(a), sec. 401, 126
Stat. 313 (2012), unless otherwise noted.
* * * * *
    Sections 230.400 to 230.499 issued under secs. 6, 8, 10, 19, 48
Stat. 78, 79, 81, and 85, as amended (15 U.S.C. 77f, 77h, 77j, 77s).
* * * * *

0
2. Amend Sec.  230.485 by revising paragraph (c)(3) to read as follows:

Sec.  230.485  Effective date of post-effective amendments filed by
certain registered investment companies.

* * * * *
    (c) * * *
    (3) A registrant's ability to file a post-effective amendment,
other than an amendment filed solely for purposes of submitting an
Interactive Data File, under paragraph (b) of this section is
automatically suspended if a registrant fails to submit any Interactive
Data File (as defined in Sec.  232.11 of this chapter) required by the
registration form on which the registrant is filing the post-effective
amendment. A suspension under this paragraph (c)(3) shall become
effective at such time as the registrant fails to submit an Interactive
Data File as required by the relevant registration form. Any such
suspension, so long as it is in effect, shall apply to any post-
effective amendment that is filed after the suspension becomes
effective, but shall not apply to any post-effective amendment that was
filed before the suspension became effective. Any suspension shall
apply only to the ability to file a post-effective amendment pursuant
to paragraph (b) of this section and shall not otherwise affect any
post-effective amendment. Any suspension under this paragraph (c)(3)
shall terminate as soon as a registrant has submitted the Interactive
Data File required by the relevant registration form.
* * * * *

0
3. Amend Sec.  230.497 by revising paragraphs (b), (c), (d), and (e) to
read as follows:

Sec.  230.497  Filing of investment company prospectuses--number of
copies.

* * * * *
    (b) For unit investment trusts filing on Sec.  274.12 of this
chapter (Form N-8B-2) or Sec.  239.16 of this chapter (Form S-6),
within five days after the effective date of a registration statement
or the commencement of a public offering after the effective date of a
registration statement, whichever occurs later, 10 copies of each form
of prospectus used after the effective date in connection with such
offering shall be filed with the Commission in the exact form in which
it was used. A registrant must submit an Interactive Data File (as
defined in Sec.  232.11 of this chapter) if required by the form on
which it files its registration statement.
    (c) For investment companies filing on Sec. Sec.  239.15A and
274.11A of this chapter (Form N-1A), Sec. Sec.  239.17a and 274.11b of
this chapter (Form N-3), Sec. Sec.  239.17b and 274.11c of this chapter
(Form N-4), or Sec. Sec.  239.17c and 274.11d of this chapter (Form N-
6), within five days after the effective date of a registration
statement or the commencement of a public offering after the effective
date of a registration statement, whichever occurs later, 10 copies of
each form of prospectus and form of Statement of Additional Information
used after the effective date in connection with such offering shall be
filed with the Commission in the exact form in which it was used. A
registrant must submit an Interactive Data File (as defined in Sec.
232.11 of this chapter) if required by the form on which it files its
registration statement.
    (d) After the effective date of a registration statement no
prospectus which purports to comply with section 10 of the Act and
which varies from any form of prospectus filed pursuant to paragraph
(b) or (c) of this section shall be used until 10 copies thereof have
been filed with, or mailed for filing to, the Commission. A registrant
must submit an Interactive Data File (as defined in Sec.  232.11 of
this chapter) if required by the Form on which it files its
registration statement.
    (e) For investment companies filing on Form N-1A, Form N-3, Form N-
4, or Form N-6, after the effective date of a registration statement,
no prospectus that purports to comply with Section 10 of the Act (15
U.S.C. 77j) or Statement of Additional Information that varies from any
form of prospectus or form of Statement of Additional Information filed
pursuant to paragraph (c) of this section shall be used until five
copies thereof have been filed with, or mailed for filing to the
Commission. A registrant must submit an Interactive Data File (as
defined in Sec.  232.11 of this chapter) if required by the Form on
which it files its registration statement.
* * * * *

PART 232--REGULATION S-T--GENERAL RULES AND REGULATIONS FOR
ELECTRONIC FILINGS

0
4. The general authority citation for part 232 continues to read as
follows:

    Authority: 15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s(a), 77z-3,
77sss(a), 78c(b), 78l, 78m, 78n, 78o(d), 78w(a), 78ll, 80a-6(c),
80a-8, 80a-29, 80a-30, 80a-37, 80b-4, 80b-6a, 80b-10, 80b-11, 7201
et seq.; and 18 U.S.C. 1350, unless otherwise noted.
* * * * *

0
5. Amend Sec.  232.11 by revising the definition of ``Related Official
Filing'' to read as follows:

Sec.  232.11  Definition of terms used in this part.

* * * * *
    Related Official Filing. The term Related Official Filing means the
ASCII or HTML format part of the official filing with which all or part
of an Interactive Data File appears as an exhibit or, in the case of a
filing on Form N-1A (Sec. Sec.  239.15A and 274.11A of this chapter),
Form N-2 (Sec. Sec.  239.14 and 274.11a-1 of this chapter), Form N-3

(Sec. Sec.  239.17a and 274.11b of this chapter), Form N-4 (Sec. Sec.
239.17b and 274.11c of this chapter), Form N-6 (Sec. Sec.  239.17c and
274.11d of this chapter), Form N-8B-2 (Sec.  274.12 of this chapter),
Form S-6 (Sec.  239.16 of this chapter), and Form N-CSR (Sec.  274.128
of this chapter), and, to the extent required by Sec.  232.405 (Rule
405 of Regulation S-T) for a business development company as defined in
Section 2(a)(48) of the Investment Company Act of 1940 (15 U.S.C. 80a-
2(a)(48)), Form 10-K (Sec.  249.310 of this chapter), Form 10-Q (Sec.
249.308a of this chapter), and Form 8-K (Sec.  249.308 of this
chapter), the ASCII or HTML format part of an official filing that
contains the information to which an Interactive Data File corresponds.
* * * * *

0
6. Amend Sec.  232.405 by:
0
a. Revising the introductory text;
0
b. Revising paragraphs (a)(2), (a)(3)(i) introductory text, (a)(3)(ii),
and (a)(4);
0
c. Revising paragraphs (b)(1) introductory text, (b)(2) introductory
text, and (b)(2)(iv) and (v);
0
d. Adding paragraph (b)(2)(vi); and
0
e. Revising the last sentence in Note 1 to Sec.  232.405.
    The revision and addition read as follows.

Sec.  232.405  Interactive Data File submissions.

    This section applies to electronic filers that submit Interactive
Data Files. Section 229.601(b)(101) of this chapter (Item 601(b)(101)
of Regulation S-K), General Instruction F of Sec.  249.311 (Form 11-K),
paragraph (101) of Part II--Information Not Required to be Delivered to
Offerees or Purchasers of Sec.  239.40 of this chapter (Form F-10),
Sec.  240.13a-21 of this chapter (Rule 13a-21 under the Exchange Act),
paragraph 101 of the Instructions as to Exhibits of Sec.  249.220f of
this chapter (Form 20-F), paragraph B.(15) of the General Instructions
to Sec.  249.240f of this chapter (Form 40-F), paragraph C.(6) of the
General Instructions to Sec.  249.306 of this chapter (Form 6-K), Sec.
240.17Ad-27(d) of this chapter (Rule 17Ad-27(d) under the Exchange
Act), Note D.5 of Sec.  240.14a-101 of this chapter (Rule 14a-101 under
the Exchange Act), Item 1 of Sec.  240.14c-101 of this chapter (Rule
14c-101 under the Exchange Act), General Instruction I of Sec.  249.333
of this chapter (Form F-SR), General Instruction C.3.(g) of Sec. Sec.
239.15A and 274.11A of this chapter (Form N-1A), General Instruction I
of Sec. Sec.  239.14 and 274.11a-1 of this chapter (Form N-2), General
Instruction C.3.(h) of Sec. Sec.  239.17a and 274.11b of this chapter
(Form N-3), General Instruction C.3.(h) of Sec. Sec.  239.17b and
274.11c of this chapter (Form N-4), General Instruction C.3.(h) of
Sec. Sec.  239.17c and 274.11d of this chapter (Form N-6), General
Instruction 2.(l) of Sec.  274.12 of this chapter (Form N-8B-2),
General Instruction 5 of Sec.  239.16 of this chapter (Form S-6), and
General Instruction C.4 of Sec. Sec.  249.331 and 274.128 of this
chapter (Form N-CSR) specify when electronic filers are required or
permitted to submit an Interactive Data File (Sec.  232.11), as further
described in note 1 to this section. This section imposes content,
format, and submission requirements for an Interactive Data File, but
does not change the substantive content requirements for the financial
and other disclosures in the Related Official Filing (as defined in
Sec.  232.11 of this chapter).
    (a) * * *
    (2) Be submitted only by an electronic filer either required or
permitted to submit an Interactive Data File as specified by Item
601(b)(101) of Regulation S-K, General Instruction F of Sec.  249.311
(Form 11-K), paragraph (101) of Part II--Information Not Required to be
Delivered to Offerees or Purchasers of Sec.  239.40 of this chapter
(Form F-10), Sec.  240.13a-21 of this chapter (Rule 13a-21 under the
Exchange Act), paragraph 101 of the Instructions as to Exhibits of
Sec.  249.220f of this chapter (Form 20-F), paragraph B.(15) of the
General Instructions to Sec.  249.240f of this chapter (Form 40-F),
paragraph C.(6) of the General Instructions to Sec.  249.306 of this
chapter (Form 6-K), Rule 17Ad-27(d) under the Exchange Act, Note D.5 of
Rule 14a-101 under the Exchange Act), Item 1 of Rule 14c-101 under the
Exchange Act, General Instruction I to Sec.  249.333 of this chapter
(Form F-SR), General Instruction C.3.(g) of Sec. Sec.  239.15A and
274.11A of this chapter (Form N-1A), General Instruction I of
Sec. Sec.  239.14 and 274.11a-1 of this chapter (Form N-2), General
Instruction C.3.(h) of Sec. Sec.  239.17a and 274.11b of this chapter
(Form N-3), General Instruction C.3.(h) of Sec. Sec.  239.17b and
274.11c of this chapter (Form N-4), General Instruction C.3.(h) of
Sec. Sec.  239.17c and 274.11d of this chapter (Form N-6), General
Instruction 2.(l) of Sec.  274.12 of this chapter (Form N-8B-2),
General Instruction 5 of Sec.  239.16 of this chapter (Form S-6), or
General Instruction C.4 of Sec. Sec.  249.331 and 274.128 of this
chapter (Form N-CSR), as applicable;
    (3) * * *
    (i) If the electronic filer is not a management investment company
registered under the Investment Company Act of 1940 (15 U.S.C. 80a et
seq.), a separate account as defined in Section 2(a)(14) of the
Securities Act (15 U.S.C. 77b(a)(14)) registered under the Investment
Company Act of 1940, a business development company as defined in
Section 2(a)(48) of the Investment Company Act of 1940 (15 U.S.C. 80a-
2(a)(48)), a unit investment trust as defined in Section 4(2) of the
Investment Company Act of 1940 (15 U.S.C. 80a-4), or a clearing agency
that provides a central matching service, and is not within one of the
categories specified in paragraph (f)(1)(i) of this section, as partly
embedded into a filing with the remainder simultaneously submitted as
an exhibit to:
* * * * *
    (ii) If the electronic filer is a management investment company
registered under the Investment Company Act of 1940 (15 U.S.C. 80a et
seq.), a separate account (as defined in Section 2(a)(14) of the
Securities Act (15 U.S.C. 77b(a)(14)) registered under the Investment
Company Act of 1940, a business development company as defined in
Section 2(a)(48) of the Investment Company Act of 1940 (15 U.S.C. 80a-
2(a)(48)), a unit investment trust as defined in Section 4(2) of the
Investment Company Act of 1940 (15 U.S.C. 80a-4), or a clearing agency
that provides a central matching service, and is not within one of the
categories specified in paragraph (f)(1)(ii) of this section, as partly
embedded into a filing with the remainder simultaneously submitted as
an exhibit to a filing that contains the disclosure this section
requires to be tagged; and
    (4) Be submitted in accordance with the EDGAR Filer Manual and, as
applicable, Sec.  229.601(b)(101) of this chapter (Item 601(b)(101) of
Regulation S-K), General Instruction F of Sec.  249.311 of this chapter
(Form 11-K), paragraph (101) of Part II--Information Not Required to be
Delivered to Offerees or Purchasers of Sec.  239.40 of this chapter
(Form F-10), Sec.  240.13a-21 of this chapter (Rule 13a-21 under the
Exchange Act), paragraph 101 of the Instructions as to Exhibits of
Sec.  249.220f of this chapter (Form 20-F), paragraph B.(15) of the
General Instructions to Sec.  249.240f of this chapter (Form 40-F),
paragraph C.(6) of the General Instructions to Sec.  249.306 of this
chapter (Form 6-K), Rule 17Ad-27(d) under the Exchange Act, Note D.5 of
Rule 14a-101 under the Exchange Act, Item 1 of Rule 14c-101 under the
Exchange Act, General Instruction I to Sec.  249.333 of this chapter
(Form F-SR), General Instruction C.3.(g) of Sec. Sec.  239.15A and
274.11A of this chapter (Form N-1A), General Instruction I of
Sec. Sec.  239.14 and 274.11a-1 of this chapter (Form N-2), General
Instruction C.3.(h) of Sec. Sec.  239.17a and 274.11b of this chapter
(Form N-3), General Instruction C.3.(h) of Sec. Sec.  239.17b

and 274.11c of this chapter (Form N-4), General Instruction C.3.(h) of
Sec. Sec.  239.17c and 274.11d of this chapter (Form N-6); Instruction
2.(l) of Sec.  274.12 of this chapter (Form N-8B-2); General
Instruction 5 of Sec.  239.16 of this chapter (Form S-6); or General
Instruction C.4 of Sec. Sec.  249.331 and 274.128 of this chapter (Form
N-CSR).
    (b) * * *
    (1) If the electronic filer is not a management investment company
registered under the Investment Company Act of 1940 (15 U.S.C. 80a et
seq.), a separate account (as defined in Section 2(a)(14) of the
Securities Act (15 U.S.C. 77b(a)(14)) registered under the Investment
Company Act of 1940, a business development company as defined in
Section 2(a)(48) of the Investment Company Act of 1940 (15 U.S.C. 80a-
2(a)(48)), a unit investment trust as defined in Section 4(2) of the
Investment Company Act of 1940 (15 U.S.C. 80a-4), or a clearing agency
that provides a central matching service, an Interactive Data File must
consist of only a complete set of information for all periods required
to be presented in the corresponding data in the Related Official
Filing, no more and no less, from all of the following categories:
* * * * *
    (2) If the electronic filer is an open-end management investment
company registered under the Investment Company Act of 1940, a separate
account (as defined in section 2(a)(14) of the Securities Act)
registered under the Investment Company Act of 1940 (15 U.S.C. 80a et
seq.), a unit investment trust as defined in Section 4(2) of the
Investment Company Act of 1940 (15 U.S.C. 80a-4), or a clearing agency
that provides a central matching service, an Interactive Data File must
consist of only a complete set of information for all periods required
to be presented in the corresponding data in the Related Official
Filing, no more and no less, from the information set forth in:
* * * * *
    (iv) Items 2, 4, 5, 10, 11, and 18 of Sec. Sec.  239.17c and
274.11d of this chapter (Form N-6);
    (v) Any disclosure provided in response to Item 18 of Sec. Sec.
249.331 and 274.128 of this chapter (Form N-CSR), or
    (vi) Item 11 of Sec.  274.12 of this chapter (Form N-8B-2) pursuant
to Instruction 2, including to the extent required by Sec.  239.16 of
this chapter (Form S-6); as applicable.
* * * * *

    Note 1 to Sec.  232.405:
    * * * For an issuer that is a management investment company or
separate account registered under the Investment Company Act of 1940
(15 U.S.C. 80a et seq.), a business development company as defined
in Section 2(a)(48) of the Investment Company Act of 1940 (15 U.S.C.
80a-2(a)(48)), or a unit investment trust as defined in Section 4(2)
of the Investment Company Act of 1940 (15 U.S.C. 80a-4), General
Instruction C.3.(g) of Form N-1A (Sec. Sec.  239.15A and 274.11A of
this chapter), General Instruction I of Form N-2 (Sec. Sec.  239.14
and 274.11a-1 of this chapter), General Instruction C.3.(h) of Form
N-3 (Sec. Sec.  239.17a and 274.11b of this chapter), General
Instruction C.3.(h) of Form N-4 (Sec. Sec.  239.17b and 274.11c of
this chapter), General Instruction C.3.(h) of Form N-6 (Sec. Sec.
239.17c and 274.11d of this chapter), General Instruction 2.(l) of
Form N-8B-2 (Sec.  274.12 of this chapter), General Instruction 5 of
Form S-6 (Sec.  239.16 of this chapter), and General Instruction C.4
of Form N-CSR (Sec. Sec.  249.331 and 274.128 of this chapter), as
applicable, specifies the circumstances under which an Interactive
Data File must be submitted.

PART 239--FORMS PRESCRIBED UNDER THE SECURITIES ACT OF 1933

0
7. The general authority citation for part 239 continues to read as
follows:

    Authority: 15 U.S.C. 77c, 77f, 77g, 77h, 77j, 77s, 77z-2, 77z-3,
77sss, 78c, 78l, 78m, 78n, 78o(d), 78o-7 note, 78u-5, 78w(a), 78ll,
78mm, 80a-2(a), 80a-3, 80a-8, 80a-9, 80a-10, 80a13, 80a-24, 80a-26,
80a-29, 80a-30, 80a-37, and sec. 71003 and sec. 84001, Pub. L. 114-
94, 129 Stat. 1321, unless otherwise noted.
* * * * *

0
8. Amend Form S-6 (referenced in Sec. Sec.  239.16) by adding General
Instruction 5.

    Note: Form S-6 is attached as Appendix A to this document. Form
S-6 will not appear in the Code of Federal Regulations.

* * * * *

PART 270--RULES AND REGULATIONS, INVESTMENT COMPANY ACT OF 1940

0
9. The general authority citation for part 270 continues to read as
follows:

    Authority: 15 U.S.C. 80a-1 et seq., 80a-34(d), 80a-37, 80a-39,
and Pub. L. 111-203, sec. 939A, 124 Stat. 1376 (2010), unless
otherwise noted.
* * * * *

0
10. Section 270.35d-1 is revised to read as follows:

Sec.  270.35d-1   Investment company names.

    (a) Materially deceptive and misleading fund names. For purposes of
section 35(d) of the Act (15 U.S.C. 80a-34(d)), a materially deceptive
and misleading name of a fund includes:
    (1) Names suggesting guarantee or approval by the United States
Government. A name suggesting that the fund or the securities issued by
it are guaranteed, sponsored, recommended, or approved by the United
States Government or any United States Government agency or
instrumentality, including any name that uses the words ``guaranteed''
or ``insured'' or similar terms in conjunction with the words ``United
States'' or ``U.S. Government.''
    (2) Names suggesting an investment focus. A name that includes
terms suggesting that the fund focuses its investments in: a particular
type of investment or investments; a particular industry or group of
industries; particular countries or geographic regions; or investments
that have, or whose issuers have, particular characteristics (e.g., a
name with terms such as ``growth'' or ``value,'' or terms indicating
that the fund's investment decisions incorporate one or more
environmental, social, or governance factors), unless:
    (i) The fund has adopted a policy to invest, under normal
circumstances, at least 80% of the value of its assets in investments
in accordance with the investment focus that the fund's name suggests.
For a name suggesting that the fund focuses its investments in a
particular country or geographic region, investments that are in
accordance with the investment focus that the fund's name suggests are
investments that are tied economically to the particular country or
geographic region suggested by its name;
    (ii) The policy described in paragraph (a)(2)(i) of this section is
a fundamental policy, or the fund has adopted a policy to provide the
fund's shareholders with at least 60 days' prior notice of any change
in the policy described in paragraph (a)(2)(i) of this section, and any
change in the fund's name that accompanies the change, that meets the
provisions of paragraph (e) of this section; and
    (iii) Any terms used in the fund's name that suggest that the fund
focuses its investments as described in paragraph (a)(2)(i) of this
section are consistent with those terms' plain English meaning or
established industry use.
    (3) Tax-exempt funds. A name suggesting that the fund's
distributions are exempt from Federal income tax or from both Federal
and State income tax, unless:
    (i) The fund has adopted a fundamental policy:
    (A) To invest, under normal circumstances, at least 80% of the
value of its assets in investments the income from which is exempt, as
applicable,

from Federal income tax or from both Federal and State income tax; or
    (B) To invest, under normal circumstances, its assets so that at
least 80% of the income that it distributes will be exempt, as
applicable, from Federal income tax or from both Federal and State
income tax; and
    (ii) Any terms used in the fund's name that suggest that the fund
invests its assets as described in paragraph (a)(3)(i) of this section
are consistent with those terms' plain English meaning or established
industry use.
    (b) Operation of policies and related recordkeeping. (1) The
requirements of paragraph (a)(2)(i) and (a)(3)(i) of this section apply
at the time a fund invests its assets, provided that:
    (i) The fund must review its portfolio investments' inclusion in
the fund's 80% basket, as defined in paragraph (g) of this section, at
least quarterly. If, subsequent to an investment, the fund identifies
that the requirements of paragraph (a)(2)(i) or (a)(3)(i) of this
section, as applicable, are no longer met, the fund must make future
investments in a manner that will bring the fund into compliance with
those paragraphs as soon as reasonably practicable, and in all
circumstances within 90 consecutive days of the fund's identification
that those requirements are no longer met;
    (ii) If the fund departs from the requirements of paragraph
(a)(2)(i) or (a)(3)(i) of this section, as applicable, in other-than-
normal circumstances, the fund must come back into compliance with the
requirements of those paragraphs within 90 consecutive days, measured
from the time of the initial departure; and
    (iii) A fund may temporarily invest less than 80% of the value of
its assets in accordance with the fund's investment focus as otherwise
required by paragraph (a)(2)(i) or (a)(3)(i) of this section, as
applicable, to reposition or liquidate the fund's assets in connection
with a reorganization, to launch the fund, or when notice of a change
in a fund's policy as described in paragraph (a)(2)(ii) of this section
has been provided to fund shareholders.
    (2) For the purpose of determining the fund's compliance with an
investment policy adopted under paragraph (a)(2)(i) or (a)(3)(i)(A) of
this section, in addition to any derivatives instrument that the fund
includes in its 80% basket because the derivatives instrument provides
investment exposure to investments suggested by the fund's name, a fund
may include in its 80% basket a derivatives instrument that provides
investment exposure to one or more of the market risk factors
associated with the investment focus that the fund's name suggests.
    (3) A fund must maintain written records documenting its compliance
under paragraphs (a) and (b) of this section, as applicable. A fund
must maintain written records, at the time a fund invests its assets,
documenting: whether the investment the fund makes is included in the
fund's 80% basket and, if so, the basis for including such investment
in the fund's 80% basket; and the value of the fund's 80% basket, as a
percentage of the value of the fund's assets. A fund must maintain
written records documenting its review of its portfolio investments'
inclusion in the fund's 80% basket, as described in paragraph (b)(1)(i)
of this section, including whether each investment is included in the
fund's 80% basket and the basis for including such investment in the
80% basket. If during the review of portfolio investments' inclusion in
the fund's 80% basket or otherwise, the fund identifies that the
requirements of paragraph (a)(2)(i) or (a)(3)(i) of this section, as
applicable, are no longer met, the fund must maintain written records
documenting: the date this was identified; and the reason for any
departure from the policies described in paragraphs (a)(2)(i) and
(a)(3)(i) of this section. If the fund departs from the requirements of
paragraph (a)(2)(i) or (a)(3)(i) of this section, as applicable, in
other-than-normal circumstances as described in paragraph (b)(1)(ii) of
this section, or as described in paragraph (b)(1)(iii) of this section,
the fund must keep records documenting: the date of any departure from
the policies described in paragraphs (a)(2)(i) and (a)(3)(i) of this
section; and the reason for any such departure (including why the fund
determined that circumstances are other-than-normal). A fund must
maintain records of any notice sent to the fund's shareholders pursuant
to paragraph (d) of this section. Written records documenting the
fund's compliance under paragraphs (a) and (b) of this section must be
maintained for a period of not less than six years following the
creation of each required record (or, in the case of notices, following
the date the notice was sent), the first two years in an easily
accessible place.
    (c) Effect of compliance with policy adopted under paragraph
(a)(2)(i) or (a)(3)(i). A fund name may be materially deceptive or
misleading under section 35(d) of the Act even if the fund adopts and
implements a policy under paragraph (a)(2)(i) or (a)(3)(i) of this
section and otherwise complies with the requirements of paragraph
(a)(2) or (a)(3) of this section, as applicable.
    (d) Notice. A policy to provide a fund's shareholders with notice
of a change in a fund's policy as described in paragraph (a)(2)(ii) of
this section must provide that:
    (1) The notice will be provided in plain English separately from
any other documents (provided, however, that if the notice is delivered
in paper form, it may be provided in the same envelope as other written
documents);
    (2) The notice will contain the following prominent statement, or
similar clear and understandable statement, in bold-face type:
``Important Notice Regarding Change in Investment Policy [and Name]'',
provided that:
    (i) If the notice is provided in paper form, the statement also
will appear on the envelope in which the notice is delivered; and
    (ii) If the notice is provided electronically, the statement also
will appear on the subject line of the email communication that
includes the notice or an equivalent indication of the subject of the
communication in other forms of electronic media; and
    (3) The notice must describe, as applicable, the fund's policy
adopted under paragraph (a)(2)(i) of this section, the nature of the
change to the policy, the fund's old and new names, and the effective
date of any policy and/or name changes.
    (e) Unit investment trusts. The requirements of paragraphs
(a)(2)(i), (a)(3)(i), and (b)(3) of this section shall apply to any
unit investment trust (as defined in section 4(2) of the Act (15 U.S.C.
80a-4(2)) only at the time of initial deposit of portfolio securities.
    (f) Unlisted registered closed-end funds and business development
companies. Notwithstanding the requirements of paragraph (a)(2)(ii) of
this section, if the fund is a closed-end company or business
development company, and the fund does not have shares that are listed
on a national securities exchange, any policy adopted pursuant to
paragraph (a)(2) of this section can be changed only if authorized by
the vote of the majority of the outstanding voting securities of such
fund unless:
    (1) The fund conducts a tender or repurchase offer to allow
shareholders to redeem shares, in accordance with all applicable
Commission rules, in advance of any change in such policy;
    (2) The fund provides the fund's shareholders with at least 60
days' prior notice of any change in such policy in advance of the
tender or repurchase offer described in paragraph (f)(1) of this
section;

    (3) The tender or repurchase offer described in paragraph (f)(1) of
this section is not oversubscribed; and
    (4) In the event of a tender offer, the fund purchases shares at
their net asset value.
    (g) Definitions. For purposes of this section:
    Assets means net assets, plus the amount of any borrowings for
investment purposes. In determining the value of a fund's assets for
purposes of this section, a fund must value each derivatives instrument
using the instrument's notional amount (which must be converted to 10-
year bond equivalents for interest rate derivatives and delta adjusted
for options contracts) and must value each physical short position
using the value of the asset sold short. The fund may reduce the value
of its assets by excluding any cash and cash equivalents, and U.S.
Treasury securities with remaining maturities of one year or less, up
to the notional amount of the derivatives instrument(s) and the value
of asset(s) sold short, and also exclude any closed-out derivatives
positions if those positions result in no credit or market exposure to
the fund. A fund must exclude from this calculation derivatives
instruments used to hedge currency risks associated with one or more
specific foreign-currency-denominated equity or fixed-income
investments held by the fund, provided that such currency derivatives
are entered into and maintained by the fund for hedging purposes and
that the notional amounts of such derivatives do not exceed the value
of the hedged investments (or the par value thereof, in the case of
fixed-income investments) by more than 10 percent.
    Derivatives instrument means any swap, security-based swap, futures
contract, forward contract, option, any combination of the foregoing,
or any similar instrument.
    Eighty percent (80%) basket means investments that are invested in
accordance with the investment focus that the fund's name suggests (or
as described in paragraph (a)(3)(i) of this section).
    Fund means a registered investment company or a business
development company, including any separate series thereof.
    Fundamental policy means a policy that a fund adopts under section
8(b)(3) of the Act (15 U.S.C. 80a-8(b)(3)) or, in the case of a
business development company, a policy that is changeable only if
authorized by the vote of a majority of the outstanding voting
securities of the fund.
    Launch means a period, not to exceed 180 consecutive days, starting
from the date the fund commences operations.
    Oversubscribed means shareholders have tendered or requested
repurchase of a greater number of shares than the fund has offered to
purchase in accordance with applicable Commission rules.

PART 274--FORMS PRESCRIBED UNDER THE INVESTMENT COMPANY ACT OF 1940

0
11. The authority for part 274 continues to read as follows:

    Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78l, 78m,
78n, 78o(d), 80a-8, 80a-24, 80a-26, 80a-29, and 80a-37 unless
otherwise noted.

0
12. Amend Form N-1A (referenced in Sec. Sec.  239.15A and 274.11A) by
revising paragraph (a)(1) of Item 4 and adding new instruction 8 to
paragraph (b)(1) of Item 9.

    Note: Form N-1A is attached as Appendix B to this document. Form
N-1A will not appear in the Code of Federal Regulations.

0
13. Amend Form N-2 (referenced in Sec. Sec.  239.14 and 274.11a-1) by
revising Item 8.

    Note: Form N-2 is attached as Appendix C to this document. Form
N-2 will not appear in the Code of Federal Regulations.

0
14. Amend Form N-8B-2 (referenced in Sec.  274.12) by adding new
General Instruction 2.(l) and by revising the Instruction to Item 11.

    Note: Form N-8B-2 is attached as Appendix D to this document.
Form N-8B-2 will not appear in the Code of Federal Regulations.

0
15. Amend Form N-PORT (referenced in Sec.  274.150) by revising General
Instruction A, Part B, and Part C.

    Note: Form N-PORT is attached as Appendix E to this document.
Form N-PORT will not appear in the Code of Federal Regulations.

    By the Commission.

    Dated: September 20, 2023.
Vanessa A. Countryman,
Secretary.

    Note: The following appendices will not appear in the Code of
Federal Regulations.

Appendix A--Form S-6

Form S-6

* * * * *

General Instructions

* * * * *

Instruction 5. Interactive Data

    (a) An Interactive Data File (as defined in Sec.  232.11 of this
chapter) is required to be submitted to the Commission in the manner
provided by Sec.  232.405 of this chapter (Rule 405 of Regulation S-
T) for any registration statement or post-effective amendment
thereto filed on Form S-6 that includes or amends information
provided in response to Instruction 2 to Item 11 of Form N-8B-2 (as
provided on this Form pursuant to Instruction 1(a) of the
Instructions as to the Prospectus of this Form).
    (1) Except as required by paragraph (a)(2), the Interactive Data
File must be submitted as an amendment to the registration statement
to which the Interactive Data File relates. The amendment must be
submitted on or before the date the registration statement or post-
effective amendment that contains the related information becomes
effective.
    (2) In the case of a post-effective amendment to a registration
statement filed pursuant to paragraphs (b)(1)(i), (ii), (v), or
(vii) of Sec.  230.485 of this chapter (Rule 485 under the
Securities Act), the Interactive Data File must be submitted either
with the filing, or as an amendment to the registration statement to
which the Interactive Data Filing relates that is submitted on or
before the date the post-effective amendment that contains the
related information becomes effective.
    (b) An Interactive Data File is required to be submitted to the
Commission in the manner provided by Rule 405 of Regulation S-T for
any form of prospectus filed pursuant to paragraphs (b) or (d) of
Rule 497 under the Securities Act that includes information provided
in response to Instruction 2 to Item 11 of Form N-8B-2 (as provided
on this Form pursuant to Instruction 1(a) of the Instructions as to
the Prospectus of this Form) that varies from the registration
statement. The Interactive Data File must be submitted with the
filing made pursuant to Rule 497.
    (c) All interactive data must be submitted in accordance with
the specifications in the EDGAR Filer Manual.
* * * * *

Appendix B--Form N-1A

Form N-1A

* * * * *

Item 4. Risk/Return Summary: Investments, Risks, and Performance

    Include the following information, in plain English under rule
421(d) under the Securities Act, in the order and subject matter
indicated:
    (a) Principal Investment Strategies of the Fund.
    (1) Based on the information given in response to Item 9(b),
summarize how the Fund intends to achieve its investment objectives
by identifying the Fund's principal investment strategies (including
the type or types of securities in which the Fund invests or will
invest principally) and any policy to concentrate in securities of
issuers in a particular industry or group of industries.
    Instruction: If the Fund is subject to paragraph (a)(2)(i) or
(a)(3)(i) of rule 35d-1 [17 CFR 270.35d-1], the Fund's disclosure
provided in response to Item 4(a)(1) must summarize the definitions
of the terms used

in its name, including the specific criteria the Fund uses to select
the investments the term describes, if any. For purposes of this
instruction, ``terms'' means any word or phrase used in a Fund's
name, other than any trade name of the Fund or its adviser, related
to the Fund's investment focus or strategies.
* * * * *

Item 9. Investment Objectives, Principal Investment Strategies, Related
Risks, and Disclosure of Portfolio Holdings

* * * * *
    (b) * * * Instructions
* * * * *
    8. If the Fund is subject to paragraph (a)(2)(i) or (a)(3)(i) of
rule 35d-1 [17 CFR 270.35d-1], the Fund's disclosure provided in
response to Item 9(b)(1) must include the definitions of the terms
used in its name, including the specific criteria the Fund uses to
select the investments the term describes, if any. For purposes of
this instruction, ``terms'' means any word or phrase used in a
Fund's name, other than any trade name of the Fund or its adviser,
related to the Fund's investment focus or strategies.

Appendix C--Form N-2

Form N-2

* * * * *

Part A--Information Required in a Prospectus

* * * * *

Item 8. General Description of the Registrant

* * * * *
    2. * * *
    b. * * *

Instructions

    1. Concentration, for purposes of this Item, is deemed 25
percent or more of the value of the Registrant's total assets
invested or proposed to be invested in a particular industry or
group of industries. The policy on concentration should not be
inconsistent with the Registrant's name.
    2. If the Fund is subject to paragraph (a)(2)(i) or (a)(3)(i) of
rule 35d-1 [17 CFR 270.35d-1], the Fund's disclosure provided in
response to Item 8(2)(b)(2) must include definitions of the terms
used in its name, including the specific criteria the Fund uses to
select the investments the term describes, if any. For purposes of
this instruction, ``terms'' means any word or phrase used in a
Fund's name, other than any trade name of the Fund or its adviser,
related to the Fund's investment focus or strategies.
* * * * *

Appendix D--Form N-8B-2

Form N-8B-2

* * * * *

General Instructions for Form N-8B-2

* * * * *

2. Preparation and Filing of Registration Statement

(l) Interactive Data

    (1) An Interactive Data File as defined in rule 11 of Regulation
S-T [17 CFR 232.11] is required to be submitted to the Commission in
the manner provided by rule 405 of Regulation S-T [17 CFR 232.405]
for any registration statement on Form N-8B-2 that includes
information provided in response to Item 11 pursuant to Instruction
2 of that Item. The Interactive Data File must be submitted with the
filing to which it relates on the date such filing becomes
effective.
    (2) All interactive data must be submitted in accordance with
the specifications in the EDGAR Filer Manual.
* * * * *

II. General Description of the Trust and Securities of the Trust

* * * * *

Information Concerning the Securities Underlying the Trust's
Securities

* * * * *
    Instructions:
    1. The registrant need disclose information only with respect to
an issuer that derived more than 15% of its gross revenues from the
business of a broker, a dealer, an underwriter, or an investment
adviser during its most recent fiscal year. If the registrant has
issued more than one class or series of securities, the requested
information must be disclosed for the class or series that has
securities that are being registered.
    2. If the trust is subject to paragraph (a)(2)(i) or (a)(3)(i)
of rule 35d-1 [17 CFR 270.35d-1], the trust's disclosure provided in
response to item 11 must include definitions of the terms used in
its name, including the specific criteria used to select the
investments the term describes, if any. For purposes of this
instruction, ``terms'' means any word or phrase used in a trust's
name, other than any trade name of the trust or its depositor,
related to the trust's investment focus.
* * * * *

Appendix E--Form N-PORT

Form N-PORT

* * * * *

General Instructions

A. Rule as To Use of Form N-PORT

    Form N-PORT is the reporting form that is to be used for monthly
reports of Funds other than money market funds and SBICs under
section 30(b) of the Act, as required by rule 30b1-9 under the Act
(17 CFR 270.30b1-9). Funds must report information quarterly about
their portfolios and each of their portfolio holdings as of the last
business day, or last calendar day, of each month, other than the
information reported in Items B.9 and C.2.e, which Funds must report
quarterly about their portfolios and each of their portfolio
holdings as of the last business day, or calendar day, of the third
month of the quarter. A registered investment company that has filed
a registration statement with the Commission registering its
securities for the first time under the Securities Act of 1933 is
relieved of this reporting obligation with respect to any reporting
period or portion thereof prior to the date on which that
registration statement becomes effective or is withdrawn.
    Reports on Form N-PORT must disclose portfolio information as
calculated by the fund for the reporting period's ending net asset
value (commonly, and as permitted by rule 2a-4, the first business
day following the trade date). A Fund must maintain in its records
the information that is required to be included on Form N-PORT no
later than 30 days after the end of each month, other than the
information reported in Items B.9 and C.2.e which is required to be
maintained no later than 30 days after the end of each quarter. Such
information shall be treated as a record under section 31(a)(1) of
the Act and rule 31a-1(b) thereunder subject to the requirements of
rule 31a-2(a)(2). Reports on Form N-PORT for each month in each
fiscal quarter of a fund must be filed with the Commission no later
than 60 days after the end of such fiscal quarter. If the due date
falls on a weekend or holiday, the filing deadline will be the next
business day.
    A Fund may file an amendment to a previously filed report at any
time, including an amendment to correct a mistake or error in a
previously filed report. A Fund that files an amendment to a
previously filed report must provide information in response to all
items of Form N-PORT, regardless of why the amendment is filed.
* * * * *

Part B: Information About the Fund

* * * * *
    Item B.9 Investment Company Act Names Rule Investment Policy. If
the Fund is required to adopt a policy as described in rule 35d-
1(a)(2)(i) or (a)(3)(i) [17 CFR 270.35d-1(a)(2)(i) or (3)(i)],
provide the following:
    a. The definitions of the terms used in the Fund's name,
including the specific criteria the Fund uses to select the
investments the term describes, if any; and
    b. The value of the Fund's 80% basket, as defined in rule 35d-
1(g)(1), as a percentage of the value of the Fund's assets.
    Instruction to Item B.9:
    Consistent with rule 35d-1(g)(2), if the Fund uses a derivatives
instrument's notional amount (which must be converted to 10-year
bond equivalents for interest rate derivatives and delta adjusted
for options contracts) and/or values a physical short position using
the value of the asset sold short, for purposes of determining the
fund's compliance with an investment policy adopted under rule 35d-
1(a)(2)(i) or (a)(3)(i)(A), the percentage that the Fund reports in
response to Item B.9.b must reflect the use of notional amounts with
certain adjustments (and/or the value of the asset sold short) as
set forth above. This percentage also must reflect any reduction of
the value of the Fund's assets resulting from, as applicable, the
fund's exclusion of cash and cash equivalents and U.S. Treasury
securities with remaining maturities of one year or less, closed-out
derivatives positions,

and currency derivatives instruments, each as provided in rule 35d-
1(g)(2).
* * * * *

Part C: Schedule of Portfolio Investments

* * * * *
    Item C.2. Amount of each investment.
* * * * *
    e. If the Fund is required to adopt a policy as described in
rule 35d-1(a)(2)(i) or (a)(3)(i) [17 CFR 270.35d-1(a)(2)(i) or
(3)(i)], is the investment included in the Fund's 80% basket, as
defined in rule 35d-1(g), as applicable? [Y/N]
* * * * *
[FR Doc. 2023-20793 Filed 10-10-23; 8:45 am]
BILLING CODE 8011-01-P


collection sites for whom we perform testing.  As others
have described the samples are flown in or driven into
these three laboratory sites on a daily basis.  The
three sites work together to develop standard protocols
for validation, for procedures, and for training.  So

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we're all using very common procedures.
Next slide, please.  Going through the list
of questions as far as routine product release and
surveying our sites, of the 56 sites for whom we do
testing, 55 claimed to routinely release products based
on both serology and NAT results.  However, 11 of the 43
sites that surveyed that responded to the question said
they did have a policy for exception release based on
serology.  So I think the definition here is unclear as
to how many sites are really releasing all the time
based on NAT results and it occurs that it's less than
the 55 of the 56.
We did have sites that did -- that are in
Phase II that reported some significant product lost
during implementation.  Twelve of 43 sites that we
surveyed reported some significant losses, primarily in
platelet pheresis products during the first stages of
implementation, when turnaround times were very long.
Next slide.  Turnaround times vary.  They
obviously differ from one lab to another.  We have a
range of anywhere from 12 to 18 hours and these are
means for test result.  In other words, time into the
lab and time out and then turnaround time from the time
of collection until the time of release of the products

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is anywhere -- ranges from 20 to 36 hours.
Recipient follow-up is in progress.  I told
you earlier that we do have six cases, six field cases.
Of those, we have two cases where we haven't formed the
recipients of the other donors.  It is not appropriate
to do so, so this is in progress.  As far as donor
follow-up goes, of the NAT reactives that we have for
which we have not been able to confirm by
discriminatory, we have about a little over half of the
donors who have returned for follow-up.
Next slide.  As far as just identifying
issues that our hospitals have made us aware of, during
the implementation, although we do feel like the
implementation went very smoothly.  The blood centers
and hospitals for whom we provide laboratory services
were extremely concerned about the delay and product
release for a period of time.  Product loss, the
shortened expiration dates on platelets, as well as the
mixed inventory that Kay mentioned, donor deferral and,
obviously, the increase in cost.
Next slide.  The laboratories as everyone
mentioned, are extremely concerned about the lack of
automation.  The difficulty in adhering to current good
manufacturing practices with the difficulties in process

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control with these manual systems.
It was also very difficult in the learning
curve for the new technology.  We're not familiar with
molecular technology in blood centers and this was
something that we had to overcome.  The logistics of
centralized testing was something new.  Many of the
laboratories who are doing testing for others, this had
been their first experience with doing so.  And then the
complexities of pool testing.
The next couple of slides I just want to
elaborate a little bit on.  The issue that I talked
about this morning which is the issue of false positives
which causes a concern for us because these now are
people who are deferred, blood donors who are deferred
and we have almost 300 of these in our system.
As you can see from this curve, this is a
curve by month, the number of false positive incidents
that we have had within our laboratory and you can see
there's a spike and obviously this represents a learning
curve of the test and we are coming down in the number
of false positives that we're seeing.  But obviously, we
need to resolve this issue.  It has donor impact.  It
has product impact.  It has cost impact.  And we are
working very closely with Chiron and Gen-Probe and the

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other laboratories to try to evaluate what's causing
these.
Next slide.  We found in looking at the
relative position of these samples in the test system
itself that 99 percent of these are caused by some
positional effect within the test system, so in 47 of
the cases, there was a seropositive right next door to
that positive sample.  In 15 cases, there was a
seropositive sample either in front of or behind in the
actual test system.  Within the TTU, which is the
testing unit, there were 33 and then there were 20 just
randomly within that run.  So I think that we know the
reason for the false positives and we are working very
carefully to try to reduce this number.
And
then lastly, I'll address the issue of availability.
All of the Chiron Gen-Probe centers are accepting
testing from both hospitals.  Of the 56 sites that we
test for, 12 of those sites are hospital transfusion
services.  So I'll close with that.
Thank you.
(Applause.)
DR. MIED:  Thank you, Sally.  We also have
Michael Strong for America's Blood Centers.
DR. STRONG:  I also will address the

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questions that have been posed to us by the FDA.  In
terms of markers tested, the Roche sites are currently
in transition to HIV.  The majority of those sites will
be up by the end of this month and we have the two final
sites that will up by the middle of January.
In terms of Phase I to Phase II transition,
our recent survey demonstrated that we have a majority
in Phase II for HCV.  We are just beginning the
transition to HIV with two laboratories that are up.
This is the time line for transition to Phase II by the
laboratories that reported.  There are still a
significant number of labs that haven't determined when
they will, in fact, be in Phase II.
Next.  In terms of recipient follow-up, so
far the ten confirmed donors that we have been all first
time donors, so there have been no follow-ups to be done
on those.  And all of the products have been controls
where there have been no release of positive products.
In terms of turnaround time, I mentioned
this morning that we have a turnaround time of about 10
to 14 hours for the test.  In terms of platelet release
with a couple of exceptions, the majority of our
laboratories are able to release product within 24 hours
with the exception of those where we have a positive

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pool and resolution testing has to take place.  In that
case, worse case seems to be about 72 hours.
Next.  In terms of automation, our current
system employs the Hamilton 1 AT Plus Pipetter.  The
COBAS sample core analyzer which has quite a lot of
field experience now in Europe and elsewhere in the
world, the new AmpliScreen data system which -- data
management system which is currently being implemented
in the majority of the Roche testing sites with a couple
of exceptions is version 1 and the second version is to
be implemented shortly.
In terms of desired automation, clearly for
us automated sample preparation would be a huge
improvement.  Currently, it's all done manually on these
pools and that's been a problem initially with failed
internal controls.  And of course, we also, we'd like to
see software upgrades that would allow us to make this
an integrated system from sample in to data out to
connect with all of the different information systems
that we currently employ in these different
laboratories.  There are a multiplicity of different
software systems.
Next.  In terms of test availability, once
again I showed this slide this morning.  We have the 13

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sites distributed geographically throughout the country.
That was one of the selection criteria by ABC for
determining test sites.  And you can see from the
connections here with the colored dots where the
collection centers are relative to a test setter.  To
pick our heartland representative here in Kansas City,
you can see they have samples coming from Ohio in the
central part of the U.S. and, of course, the further
away, the more challenging in the turnaround time and
platelet release.
Next.  Now finally, I do want to give
credit to all of the laboratories that are involved in
this process.  It's been a tremendous effort to
coordinate all of these programs.  The cooperation with
Roche has been very good and it's been a real challenge
to do that.  But to give you some idea of where we stand
relative to leadership and it's been about a year since
that cold night when we first started, we also would
like to just show you what the leadership has been like,
and also to redefine window cases.
(Laughter.)
We have been all over the map.
(Laughter.)
Thank you.

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(Applause.)
DR. MIED:  Thank you, Michael, I think.
(Laughter.)
Next we have Chris Healey, speaking on
behalf of ABRA.
MR. HEALEY:  Thanks, Paul.  As you may
know, ABRA is the trade association and standard setting
organization for the source plasma collection industry
and just let me just echo what Celso said that we're
proud to be part of the NAT success story.  Although
ABRA members and plasma collectors, in general, haven't
been involved in the process of pursuing INDs for NAT,
they nevertheless play an important role in fulfilling
the IND requirements.  First, collection centers are
responsible for ensuring that adequate informed consent
is obtained from each donor whose plasma will be tested
under an IND.  This is no small task when one considers
that a single collection center may supply two or more
fractionators with INDs that mandate the use of varying
informed consent forms.
The same hypothetical center may also
supply a non-U.S. fractionated for whom no informed
consent is required because NAT may not be -- because
NAT may not be considered an investigational test in

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that country.
The second way in which plasma collection
centers contribute to the success of NAT is by managing
the look back process.  Collection centers are charged
with the responsibility of identifying prior donations
from donors that have a positive test result by either
serology or NAT.  Because the time frames for obtaining
test results vary by test, this process becomes more
complex with the addition of each new test and NAT is no
exception.
The complexity of the look back process is
confounded even further by the growing list of events
for which look backs are required.  From the perspective
of source plasma collectors, look backs and informed
consent represent the greatest challenges in terms of
NAT implementation.  However, they also represent the
greatest opportunities.  ABRA believes that a
substantial effort should be undertaken to standardize
informed consent forms for NAT.  This would simplify the
process for collectors, fractionators and regulators
alike without in any way impacting source plasma safety
or compromising the donor's right to know.
Further, this would permit source plasma
intermediates to move more freely between and among

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fractionators and to meet market demands in a more
timely basis.
Second, in light of the resulting reduction
in window periods occasioned by NAT, FDA should begin
reconsidering the look back, the current look back
periods.  Such periods currently range from six months
and, in the words of Buzz Lightyear, to infinity and
beyond.  But with the advent of NAT and the industry 60-
day voluntary hold, the question becomes what is an
appropriate look back period?
A third implementation issue for the source
plasma collectors is how NAT has impacted the
administration of the ABRA viral marker rate standard.
For those of you who don't know this past year ABRA
implemented a revised viral marker rate standard that
sets cut off limits and action levels based on the
number of confirmed viral market positive donors at each
center.  Centers that exceed the standard for a single
review period of six months must take corrective action
and those that exceed it for two periods lose their QPP
certification.
This standard was developed using industry-
wide data that were collected just as NAT for HCV came
into full implementation.  In terms of implementing this

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standard, NAT has added an unanticipated level of
complexity.  The NAT data must be aggregated by
collection center and reconciled with each center's
serology data.  The fact that different laboratories
perform serology and NAT makes this process even more
arduous.  Today, the viral marker rate standard has been
fully implemented and the first formal six month review
period will come to a close at the end of December, this
month.  ABRA is confident that the NAT results will be
fully integrated into this process.
In closing, I'd like to reiterate that the
source plasma industry is proud to be part of the NAT
implementation process and we look forward to an
on-going dialogue regarding our proposals for informed
consent and reconsidering look backs.  Thanks.
(Applause.)
DR. MIED:  Thank you, Chris.  And I believe
as our final speaker for this session we have a
representative of IPPIA.
MR. HEALEY:  I think that the
representative will be available to respond to any of
these questions to be appropriated.
DR. MIED:  Okay.
DR. JACOBS:  Okay, we've got a period of

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time to discuss some of the questions and Joe's going to
show you on the overhead.  I think as you look at the
implementation questions, you'll see that many of these
were covered by our speakers.  We'd like to go through
them briefly and see if we have additional comments on
them.  And we want to assure you that we've been
listening carefully to the various specific comments
that were directed to FDA about suggestions for how we
are continuing to implement those and some specific ones
were made by Dr. Bianco, by Kay Gregory and just now by
Mr. Healey.
So looking at the first implementation
question, it seems as those most people have talked
about the timing from Phase I to Phase II.  It seems
though from the data from Dr. Strong that we're not sure
about full implementation of HIV and I wonder if the
different groups could comment specifically on what they
think the time line will be for full implementation of
HIV and at the same time, do they want to say anything
else about the shelf life of platelets in Phase II.
We could start here.  Sue or -- did you
want to respond to that on full implementation of HIV in
Phase II?
DR. STRONG:  Okay, I'll start.  Since I've

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raised this ugly specter.  I think the big problem for
the Roche sites is software.  The dreaded V word, as we
say, validation.
Because we have a multiplicity of systems
and people are trying to automate as best they can in
order to eliminate errors from manual data transfer and
to make the implementation easier, they have put off
going to Phase II for HIV for the very reasons just
mentioned.  Platelets are a significant problem.
Also, to some extent, transportation and
turnaround time for samples in and out for some centers
has been a problem, so I think to be conservative,
people have tried to do it in a fashion that doesn't
overly extend the availability of blood components.
Obviously, some places have been able to do
that more quickly than others and my guess would be that
we will probably have everybody in Phase II within about
six months.  That's my best guess.
DR. CAGLIOTI:  I'll just comment on the
Chiron Gen-Probe.  I think you've seen the data.
There's a very high percentage of those that are within
our IND that are in Phase II.  However, many of them
have these exception rules.  I think to be 100 percent
Phase II, I think it will mean that we'll have a license

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test available from the FDA.  So I believe that we won't
be in 100 percent Phase II product release until we do
have a license test of some sort because there are some
organizations that just feel like they cannot get their
platelets released in a timely manner due to all the
complexities of the testing.
DR. GAMMON:  I just want to make a comment
that AIBC is currently 100 percent in Phase II.  We felt
that it was necessary to do and we were able to do that
from the start.  Thank you.
DR. STRAMER:  Speaking for the Red Cross, a
little bit larger volume in comparison to AIBC.  We've
been testing in one laboratory and as I've shown you
from the number of samples arriving per day, the
formidable challenge for us is having additional sites
to perform testing.  We are currently in process to
bring up the second facility, very close to our first
facility in order to split our testing into two and
hopefully that will decrease our turnaround time,
perhaps by half.  What we need to do is clearly define
what our turnaround time needs to be for labile
components to make sure they're available for our
consignees and then to go through the process of
training and all of our procedures.  So we hope that

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will happen shortly after the beginning of the year, but
I cannot tell you a specific date because we need to
have a specific target and then we need our plans for
implementation.
DR. JACOBS:  Thank you.
DR. MIED:  I'd like to go back just a
moment to the question of platelet release and direct my
question to Richard Gammon and perhaps also Sue Stramer.
Richard, you mentioned that automation
problems with -- when you have those problems with the
TECAN or the L.A. Block or you have invalid tests or
errors which, taken all together, may not be that
infrequent and you need to go back and recreate those in
process and master pools.
First of all, a logistical question.  Are
the samples that went into that master pool somehow
sequestered so that they can easily be brought back out
again to create new in-process and master pool and
secondly, if you do have an automation problem or an
error or an invalid test, is that it for platelet
release because now you're talking about getting into
second day and maybe the third day.  Under Phase II.
DR. GAMMON:  Right.  Well, a couple of
things.  We haven't, to my knowledge, we haven't

189
S A G  CORP.S A G  CORP.
202/797-2525
Washington, D.C.
Fax: 202/797-2525
released anything.  We have not released anything
without being fully NAT tested.  If there is a problem
and we do do -- we have two runs a day, sometimes three
runs, morning, afternoon and sometimes evening.  So if
there would be a problem or a loss of a run or a run
would have to be redone it could be done later on that
day or the first thing the next morning.  So to my
knowledge we have not released any components without


[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4226-4227]
[FR Doc No: 2022-01586]

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DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration

ENVIRONMENTAL PROTECTION AGENCY

Coastal Nonpoint Pollution Control Program: Proposal To Find That
Louisiana Has Satisfied All Conditions of Approval Placed on Its
Coastal Nonpoint Pollution Control Program

AGENCY: National Oceanic and Atmospheric Administration, U.S.
Department of Commerce, and U.S. Environmental Protection Agency.

ACTION: Notice of proposed finding; request for comments.

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SUMMARY: The National Oceanic and Atmospheric Administration (NOAA) and
the U.S. Environmental Protection Agency (EPA) (hereafter, ``the
agencies'') invite public comment on the agencies' proposed finding
that Louisiana has satisfied all conditions the agencies established as
part of their 1998 approval of the State's coastal nonpoint pollution
control program (coastal nonpoint program). The Coastal Zone Act
Reauthorization Amendments (CZARA) direct states and territories with
coastal zone management programs previously approved under Section 306
of the Coastal Zone Management Act to develop and implement coastal
nonpoint programs, which must be submitted to the Federal agencies for
approval. Prior to making such a finding, NOAA and the EPA invite
public input on the Federal agencies' rationale for this proposed
finding.

DATES: Individuals or organizations wishing to submit comments on the
proposed findings document should do so by February 28, 2022.

ADDRESSES: Comments may be submitted by:
     Electronic Submission: Submit all electronic public
comments via the Federal eRulemaking Portal. Go to www.regulations.gov,
enter NOAA-NOS-2020-0100 in the Search box, click the ``Comment'' icon,
complete the required fields, and enter or attach your comments.
     Mail: Submit written comments to Joelle Gore, Chief,
Stewardship Division (N/OCM6), Office for Coastal Management, NOS,
NOAA, 1305 East-West Highway, Silver Spring, Maryland 20910; phone
(240) 533-0813; ATTN: Louisiana Coastal Nonpoint Program.
    Instructions: All comments received are a part of the public record
and will generally be posted for public viewing on www.regulations.gov
without change. All personally identifiable information (for example,
name, address, etc.), confidential business information, or otherwise
sensitive information submitted voluntarily by the commenter will be
publicly accessible. NOAA and EPA will accept anonymous comments (enter
``N/A'' in the required fields if you wish to remain anonymous).
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The
agencies will generally not consider comments or comment contents
located outside of the primary submission (i.e., on the web, cloud, or
other file sharing system).

FOR FURTHER INFORMATION CONTACT: Copies of the proposed findings
document may be found on www.regulations.gov (search NOAA-NOS-2020-
0100) and NOAA's Coastal Nonpoint Pollution Control Program website at
https://coast.noaa.gov/czm/pollutioncontrol/. Additional background
information on the State's program may be obtained upon request from:
Allison Castellan, Stewardship Division (N/OCM6), Office for Coastal
Management, NOS, NOAA, 1305 East-West Highway, Silver Spring, Maryland
20910, phone<PHONE_NUMBER>, email: [email protected]; or
Patty Taylor, U.S. EPA Region 6, EPA Region 6 Main Office, 1201 Elm
Street, Suite 500, Dallas, Texas 75270, phone:<PHONE_NUMBER>, email:
[email protected].

SUPPLEMENTARY INFORMATION: Section 6217(a) of the Coastal Zone Act
Reauthorization Amendments (CZARA), 16 U.S.C. Section 1455b(a),
requires that each state (or territory) with a coastal zone management
program previously approved under Section 306 of the Coastal Zone
Management Act must prepare and submit to the agencies a coastal
nonpoint pollution control program for approval. Because Louisiana
administers a federally approved coastal zone management program,
Louisiana submitted its program updates to the agencies for approval in
1997. The agencies provided public notice of and invited public comment
on their proposal to approve, subject to specific conditions, the
Louisiana program (62 FR 38520). The agencies approved the program by
letter dated June 30, 1998, subject to the conditions specified at that
time (63 FR 37094). The agencies now propose to find, and invite public
comment on the proposed findings, that Louisiana has fully satisfied
the conditions associated with the earlier approval.
    The proposed findings document for Louisiana's program is available
at www.regulations.gov (search for NOAA-NOS-2020-0100) and information
on the Coastal Nonpoint Program in general is available on the NOAA
website at https://coast.noaa.gov/czm/pollutioncontrol/.

Nicole R. LeBoeuf,
Assistant Administrator for Ocean Services, Environmental Protection
Agency.
Radhika Fox,
Assistant Administrator, Office of Water, National Oceanic and
Atmospheric Administration.
[FR Doc. 2022-01586 Filed 1-26-22; 8:45 am]
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