[Federal Register: March 18, 2010 (Volume 75, Number 52)]
[Rules and Regulations]
[Page 12977-12979]
[DOCID:fr18mr10-11]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 30714; Amdt. No. 3364]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This establishes, amends, suspends, or revokes Standard
Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums
and Obstacle Departure Procedures for operations at certain airports.
These regulatory actions are needed because of the adoption of new or
revised criteria, or because of changes occurring in the National
Airspace System, such as the commissioning of new navigational
facilities, adding new obstacles, or changing air traffic requirements.
These changes are designed to provide safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective March 18, 2010. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of March 18, 2010.

ADDRESSES: Availability of matters incorporated by reference in the
amendment is as follows:

For Examination

    1. FAA Rules Docket, FAA Headquarters Building, 800 Independence
Avenue, SW., Washington, DC 20591;
    2. The FAA Regional Office of the region in which the affected
airport is located;
    3. The National Flight Procedures Office, 6500 South MacArthur
Blvd., Oklahoma City, OK 73169 or
    4. The National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_
federal_regulations/ibr_locations.html.
    Availability--All SIAPs and Takeoff Minimums and ODPs are available
online free of charge. Visit http://www.nfdc.faa.gov to register.
Additionally, individual SIAP and Takeoff Minimums and ODP copies may
be obtained from:
    1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building,
800 Independence Avenue, SW., Washington, DC 20591; or
    2. The FAA Regional Office of the region in which the affected
airport is located.

FOR FURTHER INFORMATION CONTACT: Harry J. Hodges, Flight Procedure
Standards Branch (AFS-420), Flight Technologies and Programs Divisions,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd. Oklahoma City,
OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14 of the Code of
Federal Regulations, Part 97 (14 CFR part 97), by establishing,
amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS.
The complete regulators description of each SIAP and its associated
Takeoff Minimums or ODP for an identified airport is listed on FAA form
documents which are incorporated by reference in this amendment under 5
U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA
Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when
required by an entry on 8260-15A.
    The large number of SIAPs, Takeoff Minimums and ODPs, in addition
to their complex nature and the need for a special format make
publication in the Federal Register expensive and impractical.
Furthermore, airmen do not use the regulatory text of the SIAPs,
Takeoff Minimums or ODPs, but instead refer to their depiction on
charts printed by publishers of aeronautical materials. The advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP, Takeoff Minimums and ODP listed on
FAA forms is unnecessary. This amendment provides the affected CFR
sections and specifies the types of SIAPs and the effective dates of
the, associated Takeoff Minimums and ODPs. This amendment also
identifies the airport and its location, the procedure, and the
amendment number.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP, Takeoff Minimums and ODP as contained in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flight safety relating directly to published aeronautical charts. The
circumstances which created the need for some SIAP and Takeoff Minimums
and ODP amendments may require making them effective in less than 30
days. For the remaining SIAPS and Takeoff Minimums and ODPS, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPS contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPS and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. Because of
the close and immediate relationship between these SIAPs, Takeoff
Minimums and ODPs, and safety in air commerce, I find that notice and
public procedures before adopting these SIAPS, Takeoff Minimums and
ODPs are impracticable and contrary to the public interest and, where
applicable, that good cause exists for making some SIAPs effective in
less than 30 days.

Conclusion

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore--(1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air traffic control, Airports, Incorporation by reference, and
Navigation (air).

    Issued in Washington, DC, on March 5, 2010.
John M. Allen,
Director, Flight Standards Service.

Adoption of the Amendment

0
Accordingly, pursuant to the authority delegated to me, Title 14, Code
of Federal Regulations, Part 97 (14 CFR part 97) is amended by
establishing, amending, suspending, or revoking Standard Instrument
Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure
Procedures effective at 0902 UTC on the dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120,
44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:

Effective 8 APR 2010

Auburn, CA, Auburn Muni, Takeoff Minimums and Obstacle DP, Amdt 1
Columbia, CA, Columbia, GPS RWY 35, Orig, CANCELLED
Columbia, CA, Columbia, RNAV (GPS) RWY 35, Orig
Lakeport, CA, Lampson Field, Takeoff Minimums and Obstacle DP, Amdt
1
Mammoth Lakes, CA, Mammoth Yosemite, RNAV (GPS) RWY 27, Amdt 1
Shafter, CA, Shafter-Minter Field, RNAV (GPS) RWY 12, Orig
Shafter, CA, Shafter-Minter Field, VOR-A, Orig
Shafter, CA, Shafter-Minter Field, VOR OR GPS RWY 30, Orig,
CANCELLED
Panama City, FL, Northwest Florida-Panama City Intl, ILS OR LOC/DME
RWY 16, Orig
Panama City, FL, Northwest Florida-Panama City Intl, RNAV (GPS) RWY
16, Orig
Panama City, FL, Northwest Florida-Panama City Intl, RNAV (GPS) RWY
34, Orig
Panama City, FL, Northwest Florida-Panama City Intl, Takeoff
Minimums and Obstacle DP, Orig
Tampa, FL, Tampa Intl, Takeoff Minimums and Obstacle DP, Amdt 8
Winder, GA, Barrow County, ILS OR LOC RWY 31, Orig
Winder, GA, Barrow County, LOC RWY 31, Amdt 8C, CANCELLED
Winder, GA, Barrow County, RNAV (GPS) RWY 13, Amdt 1
Winder, GA, Barrow County, RNAV (GPS) RWY 23, Orig
Winder, GA, Barrow County, RNAV (GPS) RWY 31, Amdt 1
Winder, GA, Barrow County, VOR/DME RNAV OR GPS RWY 23, Orig-C,
CANCELLED
Belle Plaine, IA, Belle Plaine Muni, NDB RWY 36, Orig-A, CANCELLED
Knoxville, IA, Knoxville Muni, GPS RWY 15, Orig, CANCELLED
Knoxville, IA, Knoxville Muni, GPS RWY 33, Orig, CANCELLED
Knoxville, IA, Knoxville Muni, RNAV (GPS) RWY 15, Orig
Knoxville, IA, Knoxville Muni, RNAV (GPS) RWY 33, Orig
Knoxville, IA, Knoxville Muni, Takeoff Minimums and Obstacle DP,
Orig
Mapleton, IA, James G Whiting Memorial Field, GPS RWY 2, Orig,
CANCELLED
Mapleton, IA, James G Whiting Memorial Field, GPS RWY 20, Orig,
CANCELLED
Mapleton, IA, James G Whiting Memorial Field, RNAV (GPS) RWY 2, Orig
Mapleton, IA, James G Whiting Memorial Field, RNAV (GPS) RWY 20,
Orig
Carbondale/Murphysboro, IL, Southern Illinois, RNAV (GPS) RWY 18L,
Orig
Joliet, IL, Joliet Rgnl, Takeoff Minimums and Obstacle DP, Amdt 4
Fort Wayne, IN, Fort Wayne Intl, RNAV (GPS) RWY 14, Amdt 1
Fort Wayne, IN, Fort Wayne Intl, RNAV (GPS) RWY 32, Amdt 1
Muncie, IN, Delaware County-Johnson Field, RNAV (GPS) RWY 20, Orig
Muncie, IN, Delaware County-Johnson Field, VOR RWY 20, Amdt 14
Covington, KY, Cincinnati/Northern Kentucky Intl, Takeoff Minimums
and Obstacle DP, Amdt 1
Mount Sterling, KY, Mt Sterling-Montgomery County, Takeoff Minimums
and Obstacle DP, Amdt 1
Hammond, LA, Hammond Northshore Rgnl, Takeoff Minimums and Obstacle
DP, Amdt 1
Sanford, ME, Sanford Rgnl, RNAV (GPS) RWY 32, Orig
Marquette, MI, Sawyer Intl, Takeoff Minimums and Obstacle DP, Orig
Bemidji, MN, Bemidji Rgnl, ILS OR LOC RWY 31, Amdt 5
Bemidji, MN, Bemidji Rgnl, ILS OR LOC/DME RWY 25, Amdt 1
Bemidji, MN, Bemidji Rgnl, VOR/DME RWY 13, Orig
Bemidji, MN, Bemidji Rgnl, VOR/DME RWY 31, Orig
Cameron, MO, Cameron Memorial, NDB RWY 35, Amdt 3
Cameron, MO, Cameron Memorial, RNAV (GPS) RWY 17, Amdt 1
Cameron, MO, Cameron Memorial, RNAV (GPS) RWY 35, Amdt 1
Cameron, MO, Cameron Memorial, Takeoff Minimums and Obstacle DP,
Orig
Jackson, MS, Hawkins Field, ILS OR LOC RWY 16, Amdt 5
Jackson, MS, Hawkins Field, RNAV (GPS) RWY 16, Amdt 1
Jackson, MS, Hawkins Field, RNAV (GPS) RWY 34, Amdt 1
Oak Island, NC, Brunswick County, RNAV (GPS) RWY 5, Amdt 1
Bassett, NE, Rock County, NDB RWY 31, Amdt 4
Bassett, NE, Rock County, RNAV (GPS) RWY 13, Amdt 1
Bassett, NE, Rock County, RNAV (GPS) RWY 31, Amdt 1
Bassett, NE, Rock County, Takeoff Minimums and Obstacle DP, Amdt 2
Rome, NY, Griffiss Intl, Takeoff Minimums and Obstacle DP, Amdt 1
Cincinnati, OH, Cincinnati Muni Airport-Lunken Field, Takeoff
Minimums and Obstacle DP, Amdt 14
Oklahoma City, OK, Clarence E Page Muni, RNAV (GPS) RWY 35L, Amdt 2A
Collegeville, PA, Perkiomen Valley, RNAV (GPS) RWY 9, Amdt 1,
CANCELLED
Collegeville, PA, Perkiomen Valley, RNAV (GPS) RWY 27, Orig,
CANCELLED
Collegeville, PA, Perkiomen Valley, RNAV (GPS)-B, Orig
Collegeville, PA, Perkiomen Valley, RNAV (GPS)-C, Orig
Mount Pleasant, SC, Mt Pleasant Rgnl-Faison Field, RNAV (GPS) RWY
17, Orig
Mount Pleasant, SC, Mt Pleasant Rgnl-Faison Field, RNAV (GPS) RWY
35, Orig
Chattanooga, TN, Lovell Field, Takeoff Minimums and Obstacle DP,
Amdt 11
Abilene, TX, Abilene Rgnl, RNAV (GPS) RWY 17L, Amdt 1
Abilene, TX, Abilene Rgnl, RNAV (GPS) RWY 35R, Amdt 1
Albany, TX, Albany Muni Airport, RNAV (GPS) RWY 17, Orig
Albany, TX, Albany Muni Airport, RNAV (GPS) RWY 35, Orig
Albany, TX, Albany Muni Airport, Takeoff Minimums and Obstacle DP,
Orig
Carrizo Springs, TX, Dimmit County, GPS RWY 31, Orig, CANCELLED
Carrizo Springs, TX, Dimmit County, RNAV (GPS) RWY 31, Orig
El Paso, TX, El Paso Intl, GPS RWY 4, Orig-B, CANCELLED
El Paso, TX, El Paso Intl, RNAV (GPS) RWY 4, Orig
Henderson, TX, Rusk County, Takeoff Minimums and Obstacle DP, Amdt 2
Huntsville, TX, Huntsville Muni, RNAV (GPS) RWY 18, Orig-A
Danville, VA, Danville Rgnl, ILS OR LOC RWY 2, Amdt 4
Danville, VA, Danville Rgnl, Takeoff Minimums and Obstacle DP, Amdt
1
Danville, VA, Danville Rgnl, VOR RWY 2, Amdt 14
Danville, VA, Danville Rgnl, VOR RWY 20, Amdt 2
Richmond, VA, Chesterfield County, RNAV (GPS) RWY 15, Amdt 1
Wise, VA, Lonesome Pine LOC/DME RWY 24, Orig
Rhinelander, WI, Rhinelander-Oneida County, ILS OR LOC RWY 9, Amdt 8
Rhinelander, WI, Rhinelander-Oneida County, RNAV (GPS) RWY 9, Amdt 1
Rhinelander, WI, Rhinelander-Oneida County, RNAV (GPS) RWY 15, Amdt
1
Rhinelander, WI, Rhinelander-Oneida County, RNAV (GPS) RWY 27, Amdt
1
Rhinelander, WI, Rhinelander-Oneida County, RNAV (GPS) RWY 33, Amdt
1
Rhinelander, WI, Rhinelander-Oneida County, RNAV (GPS) Z RWY 27,
Orig, CANCELLED
West Bend, WI, West Bend Muni, NDB OR GPS RWY 31, Amdt 10A,
CANCELLED
West Bend, WI, West Bend Muni, RNAV (GPS) RWY 6, Orig
West Bend, WI, West Bend Muni, RNAV (GPS) RWY 13, Orig
West Bend, WI, West Bend Muni, RNAV (GPS) RWY 24, Orig
West Bend, WI, West Bend Muni, RNAV (GPS) RWY 31, Orig

West Bend, WI, West Bend Muni, VOR/DME RNAV OR GPS RWY 13, Amdt 5A,
CANCELLED

[FR Doc. 2010-5286 Filed 3-17-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: May 2, 2006 (Volume 71, Number 84)]
[Notices]
[Page 25867-25875]
[DOCID:fr02my06-104]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53715; File No. SR-MSRB-2006-03]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing of Proposed Rule Change Consisting of
Interpretive Guidance on Customer Protection Obligations of Brokers,
Dealers and Municipal Securities Dealers Relating to the Marketing of
529 College Savings Plans

April 25, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on March 31, 2006, the Municipal Securities Rulemaking Board (``MSRB''
or ``Board'') 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 substantially
prepared by the MSRB. 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 MSRB is filing with the Commission a proposed rule change
consisting of interpretive guidance on customer protection obligations
of brokers, dealers and municipal securities dealers (``dealers'')
relating to the marketing of 529 college savings plans. The MSRB
proposes an effective date for the proposed rule change of 60 calendar
days after Commission approval. The text of the proposed rule change is
available on the MSRB's Web site (http://www.msrb.org), at the MSRB's

principal office, 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 MSRB 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 MSRB has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

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

1. Purpose
    In a May 14, 2002 notice (the ``2002 Notice''), the MSRB
interpreted Rule G-17, on fair dealing, to require dealers selling out-
of-state 529 college savings plan interests to customers to disclose at
or prior to the sale to the customer (the ``time of trade'') that,
depending upon the laws of the customer's home state, favorable state
tax treatment for investing in a 529 college savings plan may be
limited to investments made in a 529 college savings plan offered by
the customer's home state.\3\ In addition, the MSRB provided guidance
in the 2002 Notice on the application of Rule G-19, on suitability of
recommendations and transactions, and other customer protection rules
in the context of 529 college savings plan transactions.
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    \3\ See Rule G-21 Interpretation--Application of Fair Practice
and Advertising Rules to Municipal Fund Securities, May 14, 2002,
reprinted in MSRB Rule Book.
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    The proposed rule change broadens the existing time-of-trade
disclosure obligation with respect to the marketing of out-of-state 529
college savings plans. Under the proposed rule change, dealers selling
out-of-state 529 college savings plan interests are required to
disclose to the customer, at or prior to the time of trade, that: (i)
Depending on the laws of the home state of the customer or designated
beneficiary, favorable state tax treatment or other benefits offered by
such home state may be available only if the customer invests in the
home state's 529 college savings plan; (ii) state-based benefits should
be one of many appropriately weighted factors to be considered in
making an investment decision; and (iii) the customer should consult
with his or her financial, tax or other adviser about how such state-
based benefits would apply to the customer's specific circumstances and
may wish to contact his or her home state or any other 529 college
savings plan to learn more about their features. Guidance is provided
as to the manner of delivering this revised out-of-state disclosure to
ensure that such information is noted by the customer, and dealers are
reminded that all disclosures made to customers, regardless of whether
they are made pursuant to a regulatory mandate, must not be false or
misleading.
    The proposed rule change further reminds dealers that providing
disclosures to customers does not relieve them of their suitability
duties--including their obligation to consider the customer's financial
status, tax status and investment objectives--arising in connection
with recommended transactions. The proposed rule change describes
certain basic suitability principles applicable to recommended
transactions in 529 college savings plans, advising dealers to consider
whether a recommendation is consistent with the customer's tax status
and any federal or state tax-related investment objectives of the
customer. The proposed rule change emphasizes that any dealer that
recommends a transaction must undertake an active suitability process
involving a meaningful analysis that takes into consideration
information about the customer and the security. Dealers are further
advised that suitability determinations should be based on the various
appropriately weighted factors that are relevant in any particular set
of facts and circumstances. Finally, the proposed rule change reaffirms
existing guidance from the 2002 Notice on other customer protection
obligations applicable to dealer sales practices in the 529 college
savings plan market.
2. Statutory Basis
    The MSRB believes that the proposed rule change is consistent with
Section 15B(b)(2)(C) of the Act,\4\ which provides that the MSRB's
rules shall:
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    \4\ 15 U.S.C. 78o-4(b)(2)(C).

be 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
regulating, clearing, settling, processing information with respect
to, and facilitating transactions in municipal securities, to remove
impediments to and perfect the mechanism of a free and open market
in municipal securities, and, in general, to protect investors and
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the public interest.

The MSRB believes that the proposed rule change is consistent with the
Act because it will further investor protection by strengthening and
clarifying dealers' customer protection obligations relating to the
marketing of 529 college savings plans, including but not limited to
the duty to provide important disclosures to customers investing in
out-of-state 529 college

savings plans and to undertake active suitability analyses for
recommended transactions based on appropriately weighted factors.

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

    The MSRB does not believe that the proposed rule change will result
in any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act since it would apply equally to
all dealers.

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

    On June 10, 2004, the MSRB published for comment draft interpretive
guidance relating to, among other things, the disclosure obligations of
dealers selling out-of-state 529 college savings plans, strengthening
the out-of-state disclosures originally mandated in the 2002 Notice
(the ``2004 Proposal'').\5\ The MSRB received comments on the 2004
Proposal from eight commentators.\6\ After reviewing these comments,
considering the concerns of NASD and others regarding high levels of
out-of-state sales and consulting with Commission staff, the MSRB
published on May 19, 2005 a notice seeking further comment on a revised
version of the draft interpretive guidance (the ``2005 Proposal'').\7\
The 2005 Proposal included a discussion of existing resources and
challenges in connection with obtaining disclosure information in the
529 college savings plan marketplace and sought comment on the possible
substantial expansion of the disclosure and suitability obligations
described in the 2002 Notice. The MSRB received comments on the 2005
Proposal from 22 commentators.\8\
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    \5\ See MSRB Notice 2004-16 (June 10, 2004). The 2004 Proposal,
together with a related proposal (MSRB Notice 2004-17 (June 15,
2004)), represented a comprehensive initiative of the MSRB to
strengthen a broad range of customer protection obligations set out
in the 2002 Notice. Portions of the 2004 Proposal significantly
strengthening 529 college savings plan advertising requirements have
been adopted, with certain additional requirements and
modifications, by the MSRB and approved by the Commission. See
Exchange Act Release No. 51736 (May 24, 2005), 70 FR 31551 (June 1,
2005). See also Exchange Act Release No. 52289 (August 18, 2005), 70
FR 49699 (August 24, 2005). In addition, the strengthened customer
protection obligations with respect to 529 college savings plan
sales incentives proposed in the related June 15, 2004 proposal have
been adopted by the MSRB and approved by the Commission. See
Exchange Act Release No. 52555 (October 3, 2005), 70 FR 59106
(October 11, 2005). The current proposed rule change represents the
final stage of the MSRB's 2004 customer protection initiative.
    \6\ Letters from: Kenneth B. Roberts, Hawkins Delafield & Wood
LLP (``Hawkins''), to Ernesto A. Lanza, Senior Associate General
Counsel, MSRB, dated August 20, 2004; Mary L. Schapiro, Vice
Chairman, NASD, and President, Regulatory Policy and Oversight, to
Mr. Lanza, dated September 9, 2004; Tamara K. Salmon, Senior
Associate Counsel, Investment Company Institute (``ICI''), to Mr.
Lanza, dated September 10, 2004; David J. Pearlman, Chairman,
College Savings Foundation (``CSF''), to Mr. Lanza, dated September
13, 2004; Elizabeth L. Bordowitz, General Counsel, Finance Authority
of Maine (``FAME''), to Mr. Lanza, dated September 13, 2004; Diana
F. Cantor, Chair, College Savings Plan Network (``CSPN''), and
Executive Director, Virginia College Savings Plan, to Mr. Lanza,
dated September 15, 2004; Elizabeth Varley and Michael D. Udoff, Co-
Staff Advisers, Securities Industry Association (``SIA'') Ad Hoc 529
Plans Committee, to Mr. Lanza, dated September 15, 2004; and Raquel
Alexander, PhD, Assistant Professor, and LeAnn Luna, PhD, Assistant
Professor, University of North Carolina at Wilmington (``UNCW''), to
Mr. Lanza, dated September 15, 2004.
    \7\ See MSRB Notice 2005-28 (May 19, 2005).
    \8\ Letters from: Ms. Alexander, Assistant Professor of
Accounting, University of Kansas, and Ms. Luna, Assistant Professor
of Accounting, University of Tennessee (``Alexander & Luna''), to
Mr. Lanza, dated July 26, 2005; Judith A. Wilson, Compliance
Attorney, 1st Global Capital Corp. (``1st Global''), to Mr. Lanza,
dated July 28, 2005; Diana Scott, Senior Vice President & General
Manager, John Hancock Financial Services (``Hancock''), to Mr.
Lanza, dated July 28, 2005; John C. Heywood, Principal, Vanguard
Group, Inc. (``Vanguard''), to Mr. Lanza, dated July 28, 2005; Mr.
Pearlman, CSF, to Mr. Lanza, dated July 29, 2005 and February 13,
2006; Tim Berry, Chair, CSPN, and Indiana State Treasurer, to Mr.
Lanza, dated July 29, 2005; Ms. Salmon, ICI, to Mr. Lanza, dated
July 29, 2005; Jacqueline T. Williams, Executive Director, Ohio
Tuition Trust Authority (``Ohio TTA''), to Mr. Lanza and Ghassan
Hitti, Assistant General Counsel, MSRB, dated July 29, 2005; Ira D.
Hammerman, Senior Vice President & General Counsel, SIA, to Mr.
Lanza, dated July 29, 2005; Ms. Cantor, Executive Director, Virginia
College Savings Plan (``Virginia CSP''), to Mr. Lanza, dated July
29, 2005; John D. Perdue, Chairman, Board of Trustees of the West
Virginia College Prepaid Tuition and Savings Program, and State
Treasurer (``West Virginia''), to Mr. Lanza, dated July 29, 2005;
James F. Lynch, Associate Vice President for Finance, University of
Alaska (``University of Alaska''), to Mr. Lanza, dated July 29,
2005; Eileen M. Smiley, Vice President & Assistant Secretary, USAA
Investment Management Company (``USAA''), to Mr. Lanza, dated July
29, 2005; Ronald C. Long, Senior Vice President, Wachovia
Securities, LLC (``Wachovia''), to Mr. Lanza, dated July 29, 2005;
Michael L. Fitzgerald, State Treasurer of Iowa (``Iowa''), to Mr.
Lanza, received August 1, 2005; Henry H. Hopkins, Vice President,
Director & Chief Legal Counsel, T. Rowe Price Investment Services,
Inc. (``T. Rowe''), to Mr. Lanza, dated August 1, 2005; Thomas M.
Yacovino, Vice President, A.G. Edwards and Sons, Inc., (``AG
Edwards''), to Mr. Lanza, dated August 3, 2005; W. Daniel Ebersole,
Director, Georgia Office of Treasury and Fiscal Services
(``Georgia''), to Mr. Lanza, dated August 4, 2005; Nancy K. Kopp,
Treasurer, State of Maryland, and Chair, College Savings Plans of
Maryland (``CSP-Maryland''), to Mr. Lanza, dated August 10, 2005;
Mr. Pearlman, Senior Vice President and Deputy General Counsel,
Fidelity Investments (``Fidelity''), to Mr. Lanza, dated December 7,
2005; James W. Pasman, Senior Vice President & Managing Director,
PFPC Inc. (``PFPC''), to Mr. Lanza, dated December 12, 2005; and
Randall Edwards, President, National Association of State Treasurers
(``NAST''), and Oregon State Treasurer, to Amelia A.J. Bond, Chair,
MSRB, dated March 20, 2006.
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    The 2004 and 2005 Proposals, as well as the comments received on
these proposals, are discussed below. The MSRB has considered these
comments, together with important developments in the mechanisms for
ensuring the free and effective flow of information to the public about
all 529 college savings plans offered in the marketplace (discussed
below), in determining to file this proposed rule change.
    General. The 2004 Proposal proposed expanding the existing
obligation of dealers under the 2002 Notice to advise their out-of-
state 529 college savings plan customers of the potential loss of in-
state benefits. The 2004 Proposal did not address issues relating to
suitability. All commentators on the 2004 Proposal supported the
importance of ensuring some degree of disclosure to customers of the
existence of potential in-state benefits of 529 college savings plans
but some commentators suggested changes to the specific proposal.
    The 2005 Proposal covered a wider range of topics than the portion
of the 2004 Proposal relating to disclosure. The 2005 Proposal sought
to expand the time-of-trade disclosure obligation for out-of-state
sales proposed in the 2004 Proposal to include a requirement that
dealers identify for their out-of-state customers the specific tax and
other benefits that each of their respective home states offer and that
such customers would forego by investing in an out-of-state 529 college
savings plan (the ``special home state disclosure proposal''). More
broadly, the 2005 Proposal discussed general disclosure practices and
mechanisms in the 529 college savings plan market, including the
possible establishment of centralized information sources. Dealers were
reminded that disclosures made to customers do not relieve dealers of
their suitability duties--including their obligation to consider the
customer's financial status, tax status and investment objectives--
arising in connection with recommended transactions. The 2005 Proposal
discussed existing suitability standards as applied to recommendations
of 529 college savings plan transactions and proposed expanding such
standards to require dealers recommending out-of-state 529 college
savings plan investments to undertake a comparative suitability
analysis involving a comparison of the recommended out-of-state 529
college savings plan with the customer's home state 529 college savings
plan (the ``comparative suitability proposal''). Finally, the 2005
Proposal discussed other sales practice obligations under the MSRB's
fair

practice rule.\9\ Although some commentators supported the concept of
centralized information sources for the 529 college savings plan market
and the clarification of certain elements of existing basic disclosure
and suitability obligations, the vast majority of commentators opposed
any requirements to disclose specific in-state features foregone as a
result of an out-of-state investment or to undertake a comparative
suitability analysis.
---------------------------------------------------------------------------

    \9\ These provisions did not generate comments and have been
included in the proposed rule change with only minimal
modifications.
---------------------------------------------------------------------------

    The MSRB has determined to strengthen the existing time-of-trade
disclosure and basic suitability obligations as applied to transactions
in 529 college savings plans. However, in view of significant
developments toward the maturation of the disclosure dissemination
system for this market and with due regard to concerns expressed by the
commentators and in press reports regarding the potentially substantial
impact of the special home state disclosure and comparative suitability
proposals, the MSRB has determined at this time not to adopt these two
proposals pending further assessment of the efficacy of developments in
the disclosure infrastructure.

Disclosure. General Time-of-Trade Disclosure Obligation and Established
Industry Sources

    Summary. The 2005 Proposal described dealers' obligations to make
time-of-trade disclosures of all material facts about a 529 college
savings plan investment they are selling to their customers that are
known to the dealer or that are reasonably accessible from established
industry sources.\10\ The 2005 Proposal included a discussion of
established industry sources for 529 college savings plan information
\11\ and requested comments on whether one or more centralized Web-
based sources of information should be established by the private
sector, industry associations or the MSRB. The 2005 Proposal noted that
such a resource would ideally provide on-site summary information
formatted to allow dealers and customers to make meaningful comparisons
of the material features of 529 college savings plans, together with
direct links to all 529 college savings plan official statements
(typically referred to as ``program disclosure documents'') and related
information. The types of material features summarized on such a site
might include (among other things) state tax treatment, other state-
based benefits, costs associated with investments and performance
information. The 2005 Proposal suggested that such a centralized Web
site could embed within its posted summary information direct
hyperlinks to the portions of the program disclosure document or other
529 college savings plan materials that provide more detailed
descriptions of the summarized information.\12\ The 2004 Proposal did
not address these issues.
---------------------------------------------------------------------------

    \10\ Established industry sources include the system of
nationally recognized municipal securities information repositories,
the MSRB's Municipal Securities Information Library[supreg] system
and Real-Time Transaction Reporting System, rating agency reports
and other sources of information relating to the municipal
securities transaction generally used by dealers that effect
transactions in the type of municipal securities at issue. See Rule
G-17 Interpretation--Interpretive Notice Regarding Rule G-17, on
Disclosure of Material Facts, March 20, 2002, published in MSRB Rule
Book.
    \11\ The MSRB noted that many of the traditional established
industry sources are designed specifically for debt securities, not
529 college savings plans, and that it viewed established industry
sources for 529 college savings plans as encompassing a broad
variety of information sources that professionals in this market can
and do use to obtain material information about these investments
and the state programs.
    \12\ The 2005 Proposal noted that the centralized Web site
could, for example, provide hyperlinks to Web sites, or other
contact information for sources, providing performance data current
to the most recent month-end, as required under Rule G-21(e)(ii)(C)
relating to 529 college savings plan advertisements containing
performance information.
---------------------------------------------------------------------------

    Comments. Two commentators on the 2005 Proposal supported the
establishment of a centralized Web site for summary 529 college savings
plan information with links to 529 college savings plan materials for
more detailed information.\13\ They stated that such a Web site would
allow dealers and customers to make meaningful comparisons of features
and reduce the complexity of gathering accurate, complete and timely
information. Alexander & Luna listed what they viewed as several
weaknesses of current third-party Web sites: (i) Information that is
frequently out-of-date, incomplete or inaccurate; (ii) comparison
information that is not universally available; (iii) information that
is ``summarized at a very high level;'' (iv) Web site tools that are
often over-simplified, which can distort results and ultimately provide
incorrect guidance; and (v) many current Web sites that require users
to pay for subscriptions in order to obtain basic information.
---------------------------------------------------------------------------

    \13\ 1st Global; Alexander & Luna.
---------------------------------------------------------------------------

    Many commentators opposed, or questioned the feasibility of,
establishing a centralized Web site.\14\ Some commentators expressed
concern that disparate features of 529 college savings plans make
presentation of parallel information nearly impossible and that
information presented in a summary manner may omit material information
or portray such information inaccurately.\15\ Some commentators
expressed concerns about potential liabilities for dealers that might
rely on summarized information obtained from any such centralized Web
site.\16\ Hancock stated that existing Web sites are adequate for the
marketplace.
---------------------------------------------------------------------------

    \14\ AG Edwards, CSF, CSPN (with the concurrence of CSP-
Maryland, Georgia, Iowa, Ohio TTA, University of Alaska, Virginia
CSP, West Virginia), Hancock, and USAA.
    \15\ CSF, CSPN, Hancock.
    \16\ Hancock, Vanguard.
---------------------------------------------------------------------------

    CSPN stated that the creation of an MSRB-sponsored Web site would
be contrary to the municipal securities exemption under federal
securities laws and that it is already working to address 529 college
savings plan disclosure concerns through its disclosure principles and
its own Web site. CSPN noted that it had recently developed Disclosure
Principles Statement No. 2 (``DP-2'') which, ``along with the
information available on the CSPN Web site will be the most effective
and appropriate approach to enhancing investor accessibility to
pertinent 529 Plan information.'' \17\ CSPN stated that DP-2 included
``an expanded locator concept, which will assist investors in finding
similar information in the offering materials prepared by various State
issuers, while still using only the materials authorized by that State
issuer.'' \18\
---------------------------------------------------------------------------

    \17\ DP-2 updated CSPN's Voluntary Disclosure Principles
Statement No. 1 (``DP-1''), which CSPN published in 2004 to provide
guidance to state programs in preparing their program disclosure
documents. See also NAST.
    \18\ CSP-Maryland, Georgia, Iowa, Ohio TTA, University of
Alaska, Virginia CSP and West Virginia supported CSPN's position.
---------------------------------------------------------------------------

    Although the 2004 Proposal did not address broader disclosure
issues in the 529 college savings plan market, two commentators on the
2004 Proposal made suggestions in this regard, stating that the MSRB
should put in place a broader set of disclosure requirements to
accompany the proposed disclosures described in the draft guidance.\19\
NASD suggested that the MSRB require standardized point-of-sale
disclosure of fees and compensation in a manner similar to the point-
of-sale disclosure requirements included by the Commission in its
proposed Exchange

Act Rule 15c2-3.\20\ UNCW described an academic study on factors
influencing investor choices of 529 college savings plans and concluded
that ``investors appear to be choosing high fee/broker sold funds
rather than the lower fee, direct investment options * * * [and] appear
to be ignoring state tax benefits.'' Stating that its study suggested
that investors may not have sufficient information in these areas, UNCW
supported mandating disclosure of not only state tax benefits but also
uniform disclosure of fees and performance for each 529 college savings
plan portfolio and for each underlying fund in such portfolio, as well
as the percentage of total investments that each underlying fund
represents with respect to such 529 college savings plan portfolio.
---------------------------------------------------------------------------

    \19\ NASD and UNCW.
    \20\ See Securities Act Release No. 8358 (January 29, 2004), 69
FR 6438 (February 10, 2004). See also Securities Act Release No.
8544 (February 28, 2005), 70 FR 10521 (March 4, 2005). The proposed
rulemaking by the Commission would apply to dealer sales of 529
college savings plan interests, in addition to sales of mutual funds
and variable annuities. The MSRB observes that NASD has provided
comments to the Commission on this proposal that are similar to
those provided to the MSRB. The MSRB also has provided comments to
the Commission in support of its point-of-sale disclosure proposal
(available at http://www.sec.gov/ rules/proposed/s70604/ s70604-629.pdf).

The MSRB has taken NASD's suggestions in this regard under
advisement pending final action by the Commission on proposed Rule
15c2-3.
---------------------------------------------------------------------------

    MSRB Response. Since publishing the 2005 Proposal, the MSRB has
engaged the 529 college savings plan industry and other federal
securities regulators in a dialogue regarding the 2005 Proposal. In
particular, the MSRB has emphasized that a crucial factor underlying
the special home state disclosure and comparative suitability proposals
for out-of-state sales was the difficulty that the average investor
faces in obtaining and understanding the key items of information
relevant in making an informed investment decision in the context of
the varied and complex national 529 college savings plan
marketplace.\21\
---------------------------------------------------------------------------

    \21\ Investor confusion has often been reported to result from
the large number of states offering valuable state tax or other
benefits for investing in-state and the fact that virtually every
plan has unique and sometimes complicated features not included in
most other plans. The difficulties that investors face finding and
understanding relevant information (in spite of the existence of a
handful of Web-based resources on 529 college savings plans), as
well as some recent steps toward improving the ability of investors
to understand their choices in the marketplace, have been detailed
by the press. See, e.g., Ross Kerber, ``Complaints Mounting over
College Savings Accounts,'' Boston Globe, February 14, 2006, at
http://www.boston.com/ business/personalfinance/articles/ 2006/02/14/

complaints-- mounting--over-- college--savings--accounts; John
Wasik, ``How to Find the Best 529 College Savings Programs,''
Bloomberg.com, February 13, 2006, at http://www.bloomberg.com/ apps/

news?pid=10000039& sid=aUh68emzUVEE&refer= columnist--wasik; Albert
B. Crenshaw, ``529 College Savings Plans and State of Confusion,''
Washington Post, February 12, 2006, at F8; Aleksandra Todorova,
``529 Plans Get Report Card,'' SmartMoney.com, February 10, 2006, at
http://www.smartmoney.com/ consumer/index.cfm?story=200602101; Jonathan

Clements, ``Choosing a 529 College-Savings Plan: When It Makes Sense
to Go Out of State,'' Wall Street Journal, January 4, 2006, at D1;
Michelle Singletary, ``Get the Straight Facts on Section 529,''
Washington Post, December 1, 2005, at D2; Ashlea Ebling, ``College
Savers Unite!'' Forbes.com, September 28, 2005, at http://www.forbes.com/

estateplanning/2005/09/27/ beltway-college-savings-cz--ae--
0928beltway.html.
---------------------------------------------------------------------------

    The MSRB has long been an advocate for the best possible disclosure
practices by the 529 college savings plan community, having previously
noted that investor protection concerns dictate that disclosure in this
market should be based on six basic characteristics: comprehensiveness,
understandability, comparability, universality, timeliness and
accessibility.\22\ However, the MSRB has no authority to mandate that
529 college savings plans make specific disclosures, including
disclosure of costs associated with investments in the plans,
descriptions of the state tax consequences of investing in their plans
or in out-of-state plans, or disclosure of performance under uniform
standards.\23\
---------------------------------------------------------------------------

    \22\ See Oversight Hearing on 529 College Savings Plans, Hearing
Before the Subcomm. on Financial Management, The Budget, and
International Security of the Senate Comm. on Governmental Affairs,
108th Cong. (Sept. 30, 2004) (testimony of Ernesto A. Lanza, Senior
Associate General Counsel, MSRB).
    \23\ When dealers market 529 college savings plans, the MSRB
requires time-of-trade disclosures of material information to
customers, including but not limited to disclosure of the possible
loss of state tax benefits if investing out-of-state. Proposed
Exchange Act Rule 15c2-3, if adopted, would mandate that point-of-
sale fee disclosures be made by dealers in a uniform manner.
Furthermore, the MSRB has adopted uniform requirements for the
calculation and presentation of up-to-date performance data in 529
college savings plan advertisements published by dealers that also
require that advertisements disclose the possible loss of state tax
benefits if investing out-of-state.
---------------------------------------------------------------------------

    The MSRB is of the view that a more comprehensive and user-friendly
system of established industry sources is needed in the 529 college
savings plan market. Such a system would be based on centralized Web
sites providing direct access to official issuer disclosure materials
for the entire universe of 529 college savings plan offerings, together
with understandable educational information and tools allowing for
side-by-side comparisons of different 529 college savings plans. It is
crucial for ensuring that dealers and other investment professionals
seeking to provide advice to their customers on their college savings
options are able to do so with a full view of the available
alternatives. In addition, this maturation of the disclosure
dissemination system for the 529 college savings plan market would be
particularly crucial to allowing customers to have direct access to the
types of information and other resources they need to make informed
investment decisions, thereby promoting investor confidence in their
own abilities to make such informed choices, whether with the advice of
an investment professional or as a self-directed investor.
    The MSRB understands that CSPN has undertaken to upgrade its
existing Web site to provide a comprehensive centralized Web-based
utility for the 529 college savings plan market.\24\ This CSPN utility
is expected to provide a combination of on-site and hyperlinked
resources, including summary information formatted to allow meaningful
comparisons of many of the material features of different 529 college
savings plans, together with direct links to all 529 college savings
plan program disclosure documents and related information as well as to
other sources providing tools designed for analyzing potential 529
college savings plan investments. The MSRB understands that the types
of material features to be disclosed through this utility include, but
are not limited to, state tax treatment and other state-based benefits,
costs associated with investments, types of underlying investments,
performance information and other important features that can vary
considerably from state to state, with hyperlinks embedded within such
summary information providing direct links to a full description of
such specific feature in the issuer's official program disclosure
document or other reliable sources. CSPN has also recently published
its DP-2, which updates its baseline disclosure standards designed to
assist the states in improving the quality and comparability of their
529 college savings plan disclosures in the program disclosure
document. In the 2005 Proposal, the MSRB had urged CSPN and the
individual 529 college savings plans to strive for the maximum possible
ease of access to, and uniformity of content in, the program disclosure
documents consistent with providing information that is complete,
understandable and not misleading. The MSRB views the upcoming
implementation of the CSPN Web site disclosure utility and the
development and universal adoption of DP-2 as significant steps toward
achieving the goals the MSRB had set out for the 529 college savings
plan market.
---------------------------------------------------------------------------

    \24\ NAST. CSPN is an affiliate of NAST.
---------------------------------------------------------------------------

    The CSPN utility will join other commercial, industry group and

regulator Web-based resources providing useful information for
individuals seeking to save for college expenses and for investment
professionals active in the 529 college savings plan market. Several
commercial ventures already provide, in summary and often tabular form,
some categories of information for all available 529 college savings
plans. Such information can include fees and expenses, minimum and
maximum investments, nature of the underlying investments, distribution
channels, and state tax treatment, as well as proprietary ratings based
on varying criteria. Much of this information is available at no cost,
with some sources making available, for a fee, premium or membership-
based services for professionals that provide greater detail or more
comprehensive analyses of the available information. Many of these
commercial Web sites have taken recent steps to augment and refine the
information they offer to the public, and the MSRB understands that
alternative pricing structures suitable for retail investors for access
to these premium services are being considered. In addition, the MSRB,
the Commission, NASD and the North American Securities Administrators
Association (``NASAA'') all provide general information about investing
in 529 college savings plans useful to individual investors and market
participants.\25\ NASD plans to introduce on its Web site in the near
future an improved expense analyzer for the 529 college savings plan
market using a live datafeed that should allow for more reliable
calculations and cost comparisons among different 529 college savings
plans. The CSPN utility is expected to serve as a central hub through
which investors can easily access many of these other Web-based
resources.
---------------------------------------------------------------------------

    \25\ The MSRB provides information for investors in 529 college
savings plans at http://www.msrb.org/msrb1/mfs/ruleinfo.asp. The Commission

also has published an investor-oriented introduction to 529 college
savings plans at http://www.sec.gov/investor/pubs/intro529.htm. NASD has

created a college savings center for investors at http://apps.nasd.com/investor_Information/Smart/529/000100.asp.
 NASAA, an

association of state securities regulators, has published (in
conjunction with CSPN and ICI) a brochure on understanding college
savings plans, available at http://www.nasaa.org/Investor_Education/3136.cfm
.

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

    The MSRB believes that improved disclosures can only be effective
if potential investors actually access such disclosures with sufficient
time to make use of the information in coming to an investment
decision. The MSRB urges dealers and other participants in the 529
college savings plan market to provide the investing public with easy
access to, and to affirmatively encourage the use of, this market-wide
information. The MSRB will monitor the 529 college savings plan market
closely with respect to the concerns it sought to address through the
2005 Proposal. The MSRB will be acutely sensitive to, and will consider
whether further rulemaking would be appropriate in the event of, any
significant failures in the further development of the disclosure
dissemination system or in the efficacy of this dissemination system to
address the MSRB's stated investor protection concerns.

Time-of-Trade Disclosure Obligation in Connection With Out-of-State
Sales.

    Summary. Currently, a dealer's time-of-trade disclosure obligation
under Rule G-17 requires the dealer, when selling an out-of-state 529
college savings plan interest to a customer, to disclose that,
depending upon the laws of the customer's home state, favorable state
tax treatment for investing in a 529 college savings plan may be
limited to investments made in a 529 college savings plan offered by
the customer's home state.\26\ The 2004 Proposal sought to broaden this
time-of-trade disclosure obligation to include reference to other
potential benefits (such as scholarships to in-state colleges, matching
grants into 529 college savings plan accounts, or reduced or waived
program fees, among other benefits), in addition to state tax benefits,
offered solely in connection with in-state investments.\27\
---------------------------------------------------------------------------

    \26\ The 2002 Notice also stated that such disclosure, coupled
with a suggestion that the customer consult a tax adviser about any
state tax consequences of the investment, would provide adequate
notice of the potential loss of in-state tax benefits.
    \27\ The 2004 Proposal would require the dealer to suggest that
the customer consult with a qualified adviser or contact his or her
home state's 529 college savings plan to learn more about any state
tax or other benefits that might be available in conjunction with an
investment in that state's 529 college savings plan.
---------------------------------------------------------------------------

    The 2005 Proposal retained the baseline time-of-trade disclosure
proposed in the 2004 Proposal, with a modification to include reference
to the designated beneficiary's home state in addition to that of the
customer. The 2005 Proposal also would add to the baseline time-of-
trade disclosure a requirement that the dealer advise the customer that
any state-based benefits offered with respect to a particular 529
college savings plan should be considered as one of many appropriately
weighted factors that should be considered by the customer in making
his or her investment decision. The dealer also would be required to
suggest that the customer consult with his or her financial, tax or
other adviser to learn more about how such home state features
(including any limitations) may apply to the customer's specific
circumstances, and that the customer also may wish to contact his or
her home state or any other 529 college savings plan to learn more
about any state-based benefits (and any limitations thereto) that might
be available in conjunction with an investment in that state's 529
college savings plan.
    In a significant expansion from the 2004 Proposal, the 2005
Proposal sought to impose the special home state disclosure proposal in
addition to the baseline time-of-trade disclosure described above.
Under this special home state disclosure proposal, a dealer would be
required to inquire of any out-of-state customer as to whether the
realization of state-based benefits was an important factor in the
customer's investment decision. If the customer were to answer
affirmatively, the dealer would be required to disclose (i) material
information available from established industry sources about state-
based benefits offered by the home state of the customer or designated
beneficiary for investing in its 529 college savings plan and (ii)
whether such state-based benefits are available in the case of an
investment in an out-of-state 529 college savings plan.
    Finally, the 2005 Proposal reminded dealers that the time-of-trade
disclosure obligation with respect to sales of out-of-state 529 college
savings plan interests is in addition to dealers' existing general
obligation under Rule G-17 to disclose to their customers at the time
of trade all material facts known by dealers about the 529 college
savings plan interests they are selling to the customers, as well as
material facts about such 529 college savings plan that are reasonably
accessible to the market through established industry sources. Further,
the 2005 Proposal reminded dealers that disclosures made to customers
as required under MSRB rules do not relieve dealers of their
suitability obligations--including the obligation to consider the
customer's financial status, tax status and investment objectives--if
they have recommended investments in 529 college savings plans.
    Comments. All commentators on the 2004 Proposal supported the
importance of ensuring disclosure to customers of the potential
existence of state-specific features of 529 college savings plans, with
many providing suggested modifications. CSF expressed concern about the
potential for over-emphasizing state variations in a way that may

detract from more fundamental considerations in making an investment
decision. Two commentators stated that not every difference in state
treatment ultimately will be a benefit to the investor, particularly in
view of potential recapture of state tax benefits or other restrictions
that some states impose under certain circumstances.\28\ These
commentators suggested that the best course would be to remind
investors to carefully review the program disclosure documents of their
home state programs and to consult their own advisors before investing,
with one commentator stating that it would be inappropriate to suggest
to investors that they seek help from their home state programs because
it is unclear whether the programs can provide complete information
regarding such consequences and because some states may seek to
persuade investors to make an investment in their program rather than
to impart disinterested information.\29\ Two other commentators stated
that the proposed disclosure should reflect that some benefits may be
dependent on the designated beneficiary's home state (rather than or in
addition to the home state of the investor).\30\
---------------------------------------------------------------------------

    \28\ CSF and SIA.
    \29\ CSF. However, Hawkins disagreed, stating that with respect
to non-tax state benefits, customers should be directed to the
specific state program for more information.
    \30\ CSPN and FAME.
---------------------------------------------------------------------------

    Most commentators on the 2005 Proposal accepted the modified
baseline time-of-trade disclosure. However, most commentators strongly
opposed the newly proposed special home state disclosure proposal
requiring disclosure of specific in-state features that an out-of-state
investor may forego,\31\ with no commentator expressing support for
this proposal. Several commentators argued that the specific
disclosures under the special home state disclosure proposal would
inevitably result in state-based benefits being given disproportionate
weight as compared to the many other important factors to be considered
in making an investment decision.\32\ In addition, commentators
observed that, without a reliable source of market-wide information,
dealers would be required to undertake substantial effort (with
concomitant expenditure of resources) to understand and track the
details of constantly changing state law treatment of all 529 college
savings plans.\33\ Two commentators warned that requiring dealers to
make specific disclosures about 529 college savings plans they do not
offer could result in potential liability.\34\ SIA stated that the
special home state disclosure proposal would have the counter-intuitive
result of compromising a dealer's ability to develop in-depth expertise
regarding the range of investment products it is reasonably capable of
servicing. Wachovia expressed concern that this requirement would have
the potential to paralyze investors with an overabundance of
information.
---------------------------------------------------------------------------

    \31\ AG Edwards, CSF, CSP-Maryland, CSPN, Georgia, ICI, Iowa,
Ohio TTA, SIA, T. Rowe, University of Alaska, USAA, Vanguard,
Virginia CSP, Wachovia and West Virginia.
    \32\ AG Edwards, CSF, ICI and Vanguard.
    \33\ Hancock, ICI, SIA, T. Rowe, USAA, Vanguard and Wachovia.
    \34\ Hancock and ICI.
---------------------------------------------------------------------------

    The University of Alaska stated that it did not wish to have its
program features explained by dealers who are not authorized to market
its 529 college savings plan, with other commentators echoing the
concern that dealers would often be required to disclose information
about a security they do not offer and about which they may not have
sufficient expertise.\35\ CSF observed that the burden this requirement
would place on the 529 college savings plan market does not exist for
any other type of security. Two commentators suggested that the MSRB
await final action by the Commission on its point-of-sale disclosure
proposal before finalizing any significant changes in 529 college
savings plan disclosure requirements.\36\
---------------------------------------------------------------------------

    \35\ ICI and Vanguard.
    \36\ USAA and Wachovia.
---------------------------------------------------------------------------

    MSRB Response. The MSRB continues to believe that it is important
that investors are informed that they may be foregoing state tax and
other benefits offered by their home states by investing in out-of-
state 529 college savings plans. At the same time, the MSRB agrees that
there is a potential for over-emphasizing the importance of a
particular state's beneficial state tax treatment of an investment in
its 529 college savings plan, such as where a state offers a tax
benefit that ultimately is relatively small in value compared to the
financial impact that a marginally higher expense figure may have or
under a variety of other circumstances. As a result, the MSRB has
adopted the revised out-of-state disclosure obligation, which retains
the baseline time-of-trade disclosure as modified in the 2005 Proposal.
The MSRB believes that this time-of-trade disclosure in connection with
out-of-state sales of 529 college savings plans, as embodied in the
revised out-of-state disclosure obligation, achieves the appropriate
balance between providing for the disclosure to customers of material
information about the potential loss of state tax or other benefits
relevant to their investment decision in 529 college savings plans
without imposing a significant burden on dealers and other 529 college
savings plan market participants that could possibly result in an over-
simplification of the complexity of state law factors or an over-
emphasis of state law factors as compared to other relevant investment
factors. The MSRB has also retained the reminders in the 2005 Proposal
to the effect that these disclosures do not obviate other disclosure
requirements or suitability obligations arising as a result of a
recommendation.
    The MSRB has determined not to retain the proposal to expand the
time-of-trade disclosure obligation to include disclosures of specific
state tax and other state-based features of the investor's home state
as set out in the special home state disclosure proposal. The MSRB has
based this determination in large measure on the potential adverse
impact of this proposal and the significant steps currently in process
toward improvements in the 529 college savings plan disclosure system.

Fulfilling the Revised Out-of-State Disclosure Obligation Through the
Program Disclosure Document.

    Summary. The 2004 Proposal would have clarified that dealers could
meet their baseline time-of-trade disclosure obligation with respect to
potentially foregone in-state benefits through the issuer's program
disclosure document so long as the program disclosure document is
provided to the customer at or prior to the time of trade. The 2004
Proposal also would have strengthened the minimum standards for
prominence in the program disclosure document in order to meet the
baseline time-of-trade disclosure obligation. Thus, to meet this
obligation through the program disclosure document, the disclosure must
appear in a manner that is reasonably likely to be noted by an
investor. A presentation of this disclosure in the program disclosure
document in close proximity and with equal prominence to the first
presentation of information regarding other federal or state tax-
related consequences of investing in the 529 college savings plan, and
in close proximity and with equal prominence to each other presentation
of information regarding state tax-related consequences of investing in
the 529 college savings plan, would be deemed to satisfy this
requirement. The 2005 Proposal modified this presentation standard to
provide for equal prominence with the principal (rather than first)
presentation of substantive information regarding

other federal or state tax-related consequences of investing in the 529
plan, and the inclusion of a reference to this disclosure (rather than
restating such disclosure in full) in close proximity and with equal
prominence to each other presentation of information regarding state
tax-related consequences of investing in the 529 plan. Neither proposal
required that such disclosure be made through the program disclosure
document, noting that the MSRB does not have the authority to mandate
the inclusion of any particular item of information in the issuer's
disclosure document. Both proposals provided that dealers would be
required to separately make such disclosure if the program disclosure
document did not include the information in the manner prescribed.
    Comments. Two commentators expressed concern that the 2004 Proposal
would effectively establish requirements for what information must be
included in the program disclosure document.\37\ They noted that the
MSRB does not have authority to directly impose such requirements. CSF
stated that the MSRB should not establish specific requirements for how
such disclosure should appear in the program disclosure document, while
two other commentators suggested limiting some of the presentation
requirements described in the 2004 Proposal.\38\ SIA stated that the
requirement that the information appearing in the program disclosure
document must appear in a manner ``reasonably likely to be noted by an
investor'' would place dealers in the position to question the judgment
of the state issuers and suggested that there should be a presumption
that the placement and adequacy of the disclosure in the program
disclosure document is reasonable.
---------------------------------------------------------------------------

    \37\ CSPN and FAME. These commentators, as well as Hawkins,
noted that CSPN's DP-1 already contained language on this topic.
    \38\ Hawkins and ICI.
---------------------------------------------------------------------------

    CSPN also expressed concern with respect to the reformulation of
this language in the 2005 Proposal, stating that dealers would have to
determine whether the issuer has satisfactorily made such disclosures,
potentially calling into question the issuer's determination to include
or omit particular information.\39\ CSPN stated that this would create
a constant second-guessing aspect as to the validity of offering
materials created and distributed by state issuers. SIA stated that
this provision would likely lead dealers to create their own disclosure
documents for use in marketing 529 college savings plans, conflicting
with most distribution agreements and program disclosure documents.
---------------------------------------------------------------------------

    \39\ CSP-Maryland, Georgia, Iowa, Ohio TTA, University of
Alaska, Virginia CSP and West Virginia supported CSPN's position.
---------------------------------------------------------------------------

    MSRB Response. The MSRB reaffirms its view that it has no authority
to mandate the inclusion of any particular items in the issuer's
program disclosure document. As noted in both the 2004 and 2005
Proposals, disclosure through the program disclosure document in the
manner described by the MSRB is not the sole manner in which a dealer
may fulfill the revised out-of-state disclosure obligation. Just as a
dealer could meet this disclosure obligation through a separate
communication, it stands to reason that a disclosure made through the
program disclosure document in a manner that is reasonably likely to be
noted by an investor could also be used by a dealer to fulfill this
duty. Thus, the MSRB has provided in the proposed rule change that, if
the issuer has not included the information in the program disclosure
document in the manner described, inclusion in the program disclosure
document in another manner may nonetheless fulfill the dealer's out-of-
state disclosure obligation so long as disclosure in such other manner
is reasonably likely to be noted by an investor.\40\
---------------------------------------------------------------------------

    \40\ Some commentators stated that certain portions of the 2005
Proposal might not be consistent with the notion that the issuer's
program disclosure document serves as ``the fundamental, stand-alone
disclosure'' for the offering of its securities. See, e.g., AG
Edwards. The MSRB believes that dealers generally may view the
issuer's program disclosure document as the definitive source from
which to obtain information about the securities they are selling to
their customers. The requirement that a dealer make the revised out-
of-state disclosure separately if such disclosure is not included in
the program disclosure document in a manner reasonably likely to be
noted by an investor is not intended to imply otherwise, consistent
with prior Commission guidance regarding the obligations of
underwriters and other dealers in connection with municipal issuers'
disclosure materials under the federal securities laws. See Exchange
Act Release No. 26100 (September 22, 1988), 53 FR 37778 (Section
III--Municipal Underwriter Responsibilities), as modified by
Exchange Act Release No. 26985 (June 28, 1989), 54 FR 28799 (Section
III--Interpretation of Underwriter Responsibilities), and as
reaffirmed by Exchange Act Release No. 33741 (March 9, 1994), 59 FR
12748 (Section V--Interpretive Guidance with Respect to Obligations
of Municipal Securities Dealers).
---------------------------------------------------------------------------

General Suitability Obligations

    Summary. The 2005 Proposal reaffirmed the guidance originally
provided in the 2002 Notice regarding general suitability standards
under Rule G-19 for recommended transactions in 529 college savings
plans. The 2005 Proposal added reminders to dealers to the effect that
their suitability obligation requires a meaningful analysis that
establishes the reasonable grounds for believing that the
recommendation is suitable and that they must have and enforce written
supervisory procedures reasonably designed to ensure compliance with
this obligation for every recommended transaction. The 2004 Proposal
did not address suitability issues.
    Comments. No commentator opposed the 2005 Proposal's discussion of
general suitability standards.
    MSRB Response. The MSRB has retained this discussion of general
suitability standards.

Comparative Suitability Obligation for Out-of-State Sales

    Summary. The 2005 Proposal would require a dealer to undertake a
comparative suitability analysis if the dealer has recommended an out-
of-state 529 college savings plan transaction to a customer who has
indicated that one of his or her investment objectives is realization
of state-based benefits, as contemplated under the special home state
disclosure proposal. This would involve the consideration of the state-
based benefits available from the customer's home state 529 college
savings plan in a comparative analysis with the out-of-state 529
college savings plan being offered. Any such state-based benefits
offered with respect to a particular 529 college savings plan would be
considered as one of many appropriately weighted factors that have an
ultimate bearing on the relative strengths of a particular investment,
and the existence of state-based benefits would not create a
presumption that investment in the home state 529 college savings plan
is necessarily superior to an out-of-state 529 college savings plan. If
a dealer were to conclude that an investment in the home state 529
college savings plan would be superior to an investment in the offered
out-of-state 529 college savings plan under every reasonable scenario,
then the dealer would be obligated to inform the customer of this
determination and would be permitted to effect a transaction in the
offered out-of-state 529 college savings plan only if the customer has
directed to do so after this suitability determination has been
disclosed and if the out-of-state 529 college savings plan would,
without regard to the comparative analysis with the home state 529
college savings plan, be suitable for the customer under traditional
suitability standards. The 2004 Proposal did not contain comparable
language.
    Comments. Most commentators strongly opposed the comparative

suitability proposal,\41\ although two commentators conceded that,
depending on the facts and circumstances, the availability of in-state
benefits may be one of many appropriate factors to consider in making a
suitability determination under traditional suitability standards.\42\
Three commentators stated that there has been no evidence of abuse in
the offering of out-of-state 529 college savings plans to justify these
new requirements, observing that no enforcement actions have been
taken.\43\ Several commentators observed that federal securities
regulation has never been premised on the concept that a dealer is
obligated to determine the most suitable investment of a particular
type for any customer and that the comparative suitability proposal is
inconsistent with the application of the suitability rule to every
other product sold by dealers.\44\ Two commentators stated that
comparisons are highly disfavored by NASD rules.\45\ The University of
Alaska noted that one result of a more stringent suitability obligation
for recommendations of 529 college savings plan transactions might be
that dealers would place their clients in other investment vehicles
that do not carry such regulatory risk.
---------------------------------------------------------------------------

    \41\ AG Edwards, CSF, CSP-Maryland, CSPN, Fidelity, Georgia,
Hancock, ICI, Iowa, NAST, Ohio TTA, PFPC, SIA, T. Rowe, University
of Alaska, USAA, Virginia CSP, Wachovia and West Virginia. No
commentator expressed support for the comparative suitability
proposal.
    \42\ AG Edwards and Hancock.
    \43\ CSF, ICI and USAA. NASD subsequently announced on October
26, 2005 that it had reached a settlement agreement with Ameriprise
Financial Services, Inc., in connection with the failure of the firm
to establish and maintain supervisory systems and procedures
reasonably designed to achieve compliance with suitability
obligations relating to recommended transactions in 529 college
savings plans. See http://www.nasd.com/ web/idcplg?IdcService= SS--GET--

PAGE& ssDocName=NASDW--015319. This settlement agreement appears to
have been the basis for concern expressed by Fidelity and PFPC that
NASD may be incorporating the comparative suitability proposal into
its enforcement posture prior to its final approval. The MSRB
understands that NASD did not intend certain language included in
the settlement agreement to imply that the comparative suitability
proposal is currently in effect.
    \44\ CSF, Fidelity, Hancock, PFPC, SIA, University of Alaska and
USAA.
    \45\ CSF and SIA.
---------------------------------------------------------------------------

    Many commentators viewed the comparative suitability proposal as
effectively requiring dealers to become fully familiar with the terms
of all 529 college savings plans before offering any particular 529
college savings plan.\46\ These commentators argued that this
extraordinary burden is unprecedented and is likely to significantly
discourage the marketing of 529 college savings plans. NAST agreed,
emphasizing that the comparative suitability proposal would have
substantially increased the burden on the states themselves. Wachovia
suggested that the MSRB undertake a cost-benefit analysis before
adopting the comparative suitability proposal, while USAA stated that
the incremental costs associated with meeting this standard would cause
firms to reevaluate whether offering 529 college savings plans
continues to make sense or to pass the incremental costs on to
investors. AG Edwards argued that it is untenable to require a dealer
to inform a client that one 529 college savings plan is unequivocally
superior to another. Two other commentators stated that they are
receiving anecdotal evidence that some selling dealers are withdrawing
from the 529 college savings plan market in response to this proposal
and to recent NASD enforcement activity.\47\ CSF noted that one
potential result may be that some customers who are accustomed to
relying on their financial advisors and who otherwise might invest in
suitable 529 college savings plans may ultimately never make such an
investment.
---------------------------------------------------------------------------

    \46\ CSPN (with the concurrence of CSP-Maryland, Georgia, Iowa,
Ohio TTA, University of Alaska, Virginia CSP, West Virginia),
Hancock, ICI, T. Rowe Price and Wachovia.
    \47\ Fidelity and PFPC. Concerns regarding the negative impact
of the comparative suitability proposal have also been detailed in
press reports. See Charles Paikert, ``MSRB to Decide on
Controversial 529 Proposals,'' Investment News, February 13, 2006,
at 2; Terry Savage, ``Political Issues Put the Hurt on College
Savings,'' The Street, February 10, 2006, at http://www.thestreet.com/

funds/investing/10267688.html; Jilian Mincer, ``Sales of 529 College
Savings Plans Fell in '05 Amid Scrutiny,'' Wall Street Journal,
February 9, 2006, at D2; Jilian Mincer, ``Disclosure Proposals for
529s Risk a Broker Backlash,'' Wall Street Journal, January 3, 2006,
at D2; Lauren Barack, ``Will Reform Drive Brokers From 529 Sales?''
Registered Rep, November 1, 2005, at http://www.registeredrep.com/ mag/

finance--reform-- drive--brokers.
---------------------------------------------------------------------------

    SIA expressed concern that the comparison contemplated by the
proposal would be difficult to implement from a practical standpoint.
ICI agreed, identifying a number of specific practical concerns. Some
commentators stated that the comparative suitability proposal would
place inordinate focus on state benefits while effectively ignoring the
many other reasons why an investor might choose to invest in an out-of-
state 529 college savings plan.\48\ Other commentators predicted that
the potential liabilities that would arise under the comparative
suitability proposal would result in many dealers limiting their sales
solely to the in-state 529 college savings plan, regardless of its
advantage or disadvantage.\49\ CSF requested that the MSRB defer action
on the comparative suitability proposal pending implementation of the
planned CSPN Web site enhancement.
---------------------------------------------------------------------------

    \48\ ICI, Hancock and Wachovia.
    \49\ AG Edwards, Fidelity and PFPC.
---------------------------------------------------------------------------

    MSRB Response. The MSRB has determined not to retain the
comparative suitability proposal, based in large measure on the
potential adverse impact of this proposal and the significant steps
currently in process toward dramatic improvements in the 529 college
savings plan disclosure system. However, the MSRB agrees with those
commentators that noted that the availability of in-state benefits may
be one of many appropriate factors to consider in making a suitability
determination under traditional suitability standards, depending on all
the facts and circumstances. Thus, the MSRB has added guidance to this
effect in the proposed rule change, in conjunction with additional
guidance to the effect that dealers should consider whether a
recommendation is consistent with the customer's tax status and any
customer investment objectives materially related to federal or state
tax consequences of an investment.

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

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

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml
); or

     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2006-03 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.
    All submissions should refer to File Number SR-MSRB-2006-03. 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. Copies of such
filing also will be available for inspection and copying at the MSRB's
offices. 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-
MSRB-2006-03 and should be submitted on or before May 23, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\50\
---------------------------------------------------------------------------

    \50\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
[FR Doc. E6-6555 Filed 5-1-06; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 104 (Tuesday, May 31, 2016)]
[Notices]
[Pages 34355-34356]
[FR Doc No: 2016-12656]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Sequencing Quality Control II; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Sequencing Quality Control II.'' The purpose of the
public workshop is to define the scope of project and study designs,
and solicit participation of DNA sequencing community and stakeholders
for data generation, management, analysis, and interpretation.

DATES: The public workshop will be held on September 13 and 14, 2016,
from 8 a.m. to 5 p.m. See the SUPPLEMENTARY INFORMATION section for
registration date and information.

ADDRESSES: The public workshop will be held at Wilson Hall, Bldg. 1,
National Institutes of Health (NIH), 31 Center Dr., Bethesda, MD 20892.
Entrance for the public workshop participants (non-NIH employees) is
through the NIH Gateway Center where routine security check procedures
will be performed. For parking and security information, please refer
to https://www.nih.gov/about-nih/visitor-information/campus-access-security.

FOR FURTHER INFORMATION CONTACT: Weida Tong, National Center for
Toxicological Research (NCTR), Food and Drug Administration, 3900 NCTR
Rd., Jefferson, AR 72079,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA's Critical Path Initiative (http://www.fda.gov/oc/initiatives/criticalpath/) identifies pharmacogenomics
as a key opportunity in advancing medical product development and
personalized medicine. FDA has issued the ``Guidance for Industry:
Pharmacogenomic Data Submissions'' (http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm079849.pdf) to
facilitate scientific progress in the field of pharmacogenomic data
integration in drug development and medical diagnostics. Microarrays
represent a core technology in

pharmacogenomics and toxicogenomics; however, next-generation
sequencing technologies promise to provide some unique advantages in
DNA and RNA analyses and are expected to be adopted by the
pharmaceutical and medical industries for advancing personalized
nutrition and medicine.
    Starting in 2005, FDA initiated an open project, MicroArray Quality
Control (MAQC), which has gone through three phases. MAQC-I focused on
the technical aspects of microarray-based gene expression measurements,
the MAQC-II focused on validation of microarray-based predictive
models, and MAQC-III, which is also called the Sequencing Quality
Control (SEQC), focused on assessing the performance of whole
transcriptome sequencing (RNA-seq).
    The Sequencing Quality Control Phase 2 (SEQC-II) is a natural
extension of the SEQC project with emphasis on DNA-Seq for various
applications. The SEQC-II project, with broad participation from
scientists and reviewers within FDA and collaborators across the
public, academic, and private sectors, is expected to help prepare FDA
for the next wave of submission of genomic data generated from the
next-generation sequencing technologies.
    Registration: Mail, fax, or email your registration information
(including name, title, firm name, address, telephone, and fax numbers)
to the contact person by August 31, 2016. FDA will email a confirmation
to those who have registered. There is no registration fee for the
public workshop. Early registration is recommended because seating is
limited. No registration on the day of the public workshop will be
provided.
    If you need special accommodations due to a disability, please
contact Weida Tong (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance.

    Dated: May 24, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-12656 Filed 5-27-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: March 29, 2006 (Volume 71, Number 60)]
[Notices]
[Page 15730-15731]
[DOCID:fr29mr06-76]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0227; FRL-7770-6]

Acetochlor; Tolerance Reassessment Decision

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's Report on Food
Quality Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision (TRED) for the chloroacetanilide pesticide
acetochlor. The Agency's risk assessments and other related supporting
documents also are available in the acetochlor docket. Through the
tolerance reassessment program, EPA is ensuring that all pesticides
meet current health and food safety standards. This decision is being
released concurrent with the Notice of Availability of the cumulative
risk assessment for the chloroacetanilide pesticides which include
acetochlor and alachlor. See EPA-HQ-OPP-2006-0202 in the Notice section
of this issue of the Federal Register.

FOR FURTHER INFORMATION CONTACT: Felicia Fort, Special Review and
Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
Docket identification number (ID) [EPA-HQ-OPP-2005-0227; FRL-7770-6].
Publicly available docket materials are available either electronically
at http://www.regulations.gov or in hard copy at the Public Information

and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall 2,
1801 S. Bell St., Arlington, VA. This Docket Facility is open from 8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
Docket telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.

II. Background

A. What Action is the Agency Taking?

    EPA has assessed risks associated with use of the chloroacetanilide
pesticide acetochlor, and reached a tolerance reassessment and risk
management decision reassessing 12 existing tolerances or legal residue
limits for acetochlor. Acetochlor, 2-chloro-N-(ethoxymethyl)-N-(2-
ethyl-6-methylphenyl)acetamide, is a preemergence herbicide used for
the control of weeds and is registered for use on field corn and
popcorn. Corn fields treated with acetochlor may later be rotated to
grain sorghum (milo), soybeans, wheat, and tobacco, according to the
currently registered use pattern. Corn and the rotational crops listed
above were considered in the risk assessment supporting the acetochlor
TRED. There are no risks of concern associated with the use of
acetochlor. The Agency is now issuing a Report on Food Quality
Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision for acetochlor, known as a TRED, as well as related
technical support documents.
    EPA must review tolerances and tolerance exemptions that were in
effect when FQPA was enacted in August 1996, to ensure that these
existing pesticide residue limits for food and feed commodities meet
the safety standard established by the new law. Tolerances are
considered reassessed once the safety finding has been made or a
revocation occurs. EPA has reviewed and made the requisite safety
finding for the acetochlor tolerances included in this notice.
    The acetochlor TRED presents the Agency's tolerance reassessment
conclusions for acetochlor alone; however, section 408(b)(2)(D)(v) of
the Federal Food, Drug and Cosmetic Act (FFDCA) directs the Agency also
to consider available information on the cumulative risk from
substances sharing a common mechanism of toxicity. Because the
chloroacetanilides pesticides share a common mechanism of toxicity, due
to their ability to cause nasal turbinate tumors, the Agency evaluated
the cumulative risk posed by this group before making its final
tolerance reassessment decision on the chloroacetanilide pesticide,
acetochlor. EPA has determined that the cumulative risk associated with
chloroacetanilide pesticides, which include acetochlor and alachlor, is
below the Agency's level of concern. Therefore, the 12 tolerances
established for residues of

acetochlor in/on raw agricultural commodities are now considered
reassessed as safe under section 408(q) of FFDCA, as amended by FQPA.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004, (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, EPA is tailoring its public participation process to be
commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
Due to its uses, risks, and other factors, acetochlor was reviewed
through the modified 4-Phase public participation process. Through this
process, EPA worked extensively with stakeholders and the public to
reach the regulatory decisions for acetochlor.
    The tolerance reassessment program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public. Few substantive
comments were received during the earlier comment period for this
pesticide, and all issues related to this pesticide were resolved
through consultations with stakeholders. The Agency therefore is
issuing the acetochlor TRED without a comment period. However, the
Agency is concurrently issuing the cumulative risk assessment for the
chloroacetanilide group of pesticides, which includes acetochlor and
alachlor, for public comment (see EPA-HQ-OPP-2006-0202 in the Notice
section of this issue of the Federal Register).

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

    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006. A tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2), respectively, if ``the
Administrator determines the pesticide chemical residue is safe'',
i.e., ``that there is a reasonable certainty that no harm will result
from aggregate exposure to the pesticide chemical residue, including
all anticipated dietary exposures and all other exposures for which
there is reliable information.'' 21 U.S.C.
Sec. 346a(b)(2)(A),(c)(2)(A). In making this safety finding, FFDCA
requires the Administrator to consider, among other factors,
``available information concerning the cumulative effects of such
residues and other substances that have a common mechanism of toxicity
. . . .'' 21 U.S.C. Sec. 346a(b)(2)(D)(v), (c)(2)(B).
    Section 4(g)(2) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) as amended, requires the Administrator to make
``a determination as to the eligibility for reregistration (i) for all
active ingredients subject to reregistration under this section for
which tolerances or exemptions from tolerances are required under the
Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), not later
than the last date for tolerance reassessment established under section
408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C))....''

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: March 21, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-4503 Filed 3-28-06; 8:45 am]

BILLING CODE 6560-50-S