[Federal Register Volume 85, Number 44 (Thursday, March 5, 2020)]
[Rules and Regulations]
[Pages 12867-12870]
[FR Doc No: 2020-04175]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31299; Amdt. No. 3894]

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 rule amends, suspends, or removes 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 for the 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 5, 2020. 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 5, 2020.

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

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Navigation Products, 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, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104,
Oklahoma City, OK 73169. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.
The complete regulatory description of each SIAP is listed on the
appropriate FAA Form 8260, as modified by the National Flight Data
Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated
by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20.
The large number of SIAPs, their complex nature, and the need for a
special format make their verbatim publication in the Federal Register
expensive and impractical. Further, airmen do not use the regulatory
text of

the SIAPs, but refer to their graphic depiction on charts printed by
publishers of aeronautical materials. Thus, the advantages of
incorporation by reference are realized and publication of the complete
description of each SIAP contained on FAA form documents is
unnecessary.
    This amendment provides the affected CFR sections, and specifies
the SIAPs and Takeoff Minimums and ODPs with their applicable effective
dates. This amendment also identifies the airport and its location, the
procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on the
criteria contained in the U.S. Standard for Terminal Instrument
Procedures (TERPS). In developing these changes to SIAPs and Takeoff
Minimums and ODPs, the TERPS criteria were applied only to specific
conditions existing at the affected airports. All SIAP amendments in
this rule have been previously issued by the FAA in a FDC NOTAM as an
emergency action of immediate flight safety relating directly to
published aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    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 procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    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,
Navigation (air).

    Issued in Washington, DC, on February 21, 2020.
Rick Domingo,
Executive Director, Flight Standards Service.

Adoption Of The Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, (14 CFR part 97), is amended by
amending Standard Instrument Approach Procedures and Takeoff Minimums
and ODPs, effective at 0901 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(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

----------------------------------------------------------------------------------------------------------------
      AIRAC date          State         City             Airport        FDC No.      FDC date        Subject
----------------------------------------------------------------------------------------------------------------
26-Mar-20.............  NC        Greensboro......  Piedmont Triad         9/2114      1/17/20  This NOTAM,
                                                     Intl.                                       published in
                                                                                Docket No.
                                                                                31297, Amdt No.
                                                                                3892, TL 20-07
                                                                                (85 FR 10270;
                                                                                February 24,
                                                                                2020), is
                                                                                hereby
                                                                                rescinded in
                                                                                its entirety.
26-Mar-20.............  ME        Sanford.........  Sanford Seacoast       0/0536       2/4/20  RNAV (GPS) RWY
                                                     Rgnl.                                       25, Orig-B.
26-Mar-20.............  ME        Sanford.........  Sanford Seacoast       0/0537       2/4/20  RNAV (GPS) RWY
                                                     Rgnl.                                       32, Orig-A.
26-Mar-20.............  ME        Sanford.........  Sanford Seacoast       0/0538       2/4/20  RNAV (GPS) RWY
                                                     Rgnl.                                       7, Orig-C.
26-Mar-20.............  ME        Sanford.........  Sanford Seacoast       0/0539       2/4/20  VOR RWY 25, Amdt
                                                     Rgnl.                                       14B.
26-Mar-20.............  TX        Angleton/Lake     Texas Gulf Coast       0/0544       2/4/20  RNAV (GPS) RWY
                                   Jackson.          Rgnl.                                       17, Amdt 2A.
26-Mar-20.............  TX        Angleton/Lake     Texas Gulf Coast       0/0545       2/4/20  RNAV (GPS) RWY
                                   Jackson.          Rgnl.                                       35, Amdt 2A.
26-Mar-20.............  OK        Tulsa...........  Richard Lloyd          0/0581       2/4/20  VOR/DME-A, Amdt
                                                     Jones Jr.                                   7A.
26-Mar-20.............  ND        Grand Forks.....  Grand Forks Intl       0/2419      2/11/20  RNAV (GPS) RWY
                                                                                35L, Orig-B.
26-Mar-20.............  OK        Okmulgee........  Okmulgee Rgnl...       0/3051      2/11/20  RNAV (GPS) RWY
                                                                                36, Orig.
26-Mar-20.............  OK        Okmulgee........  Okmulgee Rgnl...       0/3052      2/11/20  ILS OR LOC RWY
                                                                                18, Amdt 1B.

26-Mar-20.............  OK        Okmulgee........  Okmulgee Rgnl...       0/3053      2/11/20  RNAV (GPS) RWY
                                                                                18, Amdt 1.
26-Mar-20.............  OK        Okmulgee........  Okmulgee Rgnl...       0/3056      2/11/20  VOR-A, Amdt 1.
26-Mar-20.............  MN        Staples.........  Staples Muni....       0/3087      2/11/20  NDB RWY 14, Amdt
                                                                                3A.
26-Mar-20.............  MI        Hastings........  Hastings........       0/3088      2/11/20  VOR RWY 12, Orig-
                                                                                G.
26-Mar-20.............  TX        Granbury........  Granbury Rgnl...       0/3089      2/11/20  VOR/DME RWY 14,
                                                                                Amdt 1A.
26-Mar-20.............  VA        Charlottesville.  Charlottesville-       0/3090      2/11/20  RNAV (GPS) Y RWY
                                                     Albemarle.                                  21, Amdt 2B.
26-Mar-20.............  MO        Fredericktown...  A Paul Vance           0/3093      2/11/20  VOR/DME RWY 1,
                                                     Fredericktown                               Amdt 3A.
                                                     Rgnl.
26-Mar-20.............  MO        Fredericktown...  A Paul Vance           0/3094      2/11/20  VOR RWY 19, Amdt
                                                     Fredericktown                               1B.
                                                     Rgnl.
26-Mar-20.............  VA        Hot Springs.....  Ingalls Field...       0/3317      2/14/20  RNAV (GPS) RWY
                                                                                25, Orig.
26-Mar-20.............  VA        Hot Springs.....  Ingalls Field...       0/3318      2/14/20  RNAV (GPS) RWY
                                                                                7, Orig.
26-Mar-20.............  TX        Dallas-Fort       Dallas-Fort            0/3356      2/12/20  ILS OR LOC RWY
                                   Worth.            Worth Intl.                                 17R, Amdt 23C.
26-Mar-20.............  NM        Deming..........  Deming Muni.....       0/3465      1/16/20  VOR RWY 26, Amdt
                                                                                10A.
26-Mar-20.............  NE        York............  York Muni.......       0/3638      1/17/20  RNAV (GPS) RWY
                                                                                35, Amdt 1.
26-Mar-20.............  MN        Minneapolis.....  Airlake.........       0/3905      2/12/20  VOR RWY 12, Amdt
                                                                                3.
26-Mar-20.............  WI        Appleton........  Appleton Intl...       0/3911      2/12/20  RNAV (GPS) RWY
                                                                                12, Amdt 1A.
26-Mar-20.............  WI        Appleton........  Appleton Intl...       0/3912      2/12/20  RNAV (GPS) RWY
                                                                                3, Amdt 1A.
26-Mar-20.............  WI        Appleton........  Appleton Intl...       0/3916      2/12/20  RNAV (GPS) RWY
                                                                                21, Amdt 2A.
26-Mar-20.............  NC        Greensboro......  Piedmont Triad         0/4152      2/12/20  ILS OR LOC RWY
                                                     Intl.                                       23L, Amdt 9C.
26-Mar-20.............  MI        Saginaw.........  Saginaw County H       0/4286      2/12/20  RNAV (GPS) RWY
                                                     W Browne.                                   10, Amdt 1.
26-Mar-20.............  PA        Washington......  Washington             0/4320      2/13/20  ILS OR LOC RWY
                                                     County.                                     27, Amdt 1B.
26-Mar-20.............  OH        Millersburg.....  Holmes County...       0/4324      2/12/20  RNAV (GPS) RWY
                                                                                9, Orig-A.
26-Mar-20.............  OH        Millersburg.....  Holmes County...       0/4342      2/12/20  RNAV (GPS) RWY
                                                                                27, Orig-A.
26-Mar-20.............  FL        Orlando.........  Orlando Sanford        0/4707      2/13/20  ILS OR LOC RWY
                                                     Intl.                                       9R, Amdt 1B.
26-Mar-20.............  GA        Atlanta.........  Hartsfield--Jack       0/6301      1/27/20  ILS OR LOC RWY
                                                     son Atlanta                                 9L, Amdt 10B.
                                                     Intl.
26-Mar-20.............  GA        Atlanta.........  Hartsfield--Jack       0/6306      1/27/20  RNAV (GPS) PRM
                                                     son Atlanta                                 RWY 9L
                                                     Intl.                                       (SIMULTANEOUS
                                                                                CLOSE
                                                                                PARALLEL), Orig-
                                                                                D.
26-Mar-20.............  GA        Atlanta.........  Hartsfield--Jack       0/6315      1/27/20  RNAV (GPS) RWY
                                                     son Atlanta                                 09L, Amdt 4C.
                                                     Intl.
26-Mar-20.............  GA        Atlanta.........  Hartsfield--Jack       0/6317      1/27/20  ILS PRM RWY 9L
                                                     son Atlanta                                 (SIMULTANEOUS
                                                     Intl.                                       CLOSE
                                                                                PARALLEL), Amdt
                                                                                2.
26-Mar-20.............  WA        Seattle.........  Boeing Field/          0/6509       2/3/20  ILS OR LOC RWY
                                                     King County                                 14R, Amdt 31.
                                                     Intl.
26-Mar-20.............  MA        Worcester.......  Worcester Rgnl..       0/6960       2/7/20  VOR/DME RWY 33,
                                                                                Amdt 1B.
26-Mar-20.............  CA        Ontario.........  Ontario Intl....       0/7324       2/3/20  ILS OR LOC RWY
                                                                                26L, ILS RWY
                                                                                26L (CAT II),
                                                                                ILS RWY 26L
                                                                                (CAT III), Amdt
                                                                                8B.
26-Mar-20.............  OH        Youngstown/       Youngstown-            0/8835       2/6/20  ILS OR LOC RWY
                                   Warren.           Warren Rgnl.                                14, Amdt 8C.
26-Mar-20.............  OH        Youngstown/       Youngstown-            0/8836       2/6/20  ILS OR LOC RWY
                                   Warren.           Warren Rgnl.                                32, Amdt 27C.
26-Mar-20.............  OH        Youngstown/       Youngstown-            0/8837       2/6/20  NDB RWY 32, Amdt
                                   Warren.           Warren Rgnl.                                20C.
26-Mar-20.............  OH        Youngstown/       Youngstown-            0/8838       2/6/20  RNAV (GPS) RWY
                                   Warren.           Warren Rgnl.                                14, Orig-B.
26-Mar-20.............  OH        Youngstown/       Youngstown-            0/8839       2/6/20  RNAV (GPS) RWY
                                   Warren.           Warren Rgnl.                                32, Orig-D.
26-Mar-20.............  AL        Brewton.........  Brewton Muni....       0/8854      2/10/20  RNAV (GPS) RWY
                                                                                12, Orig-A.
26-Mar-20.............  AL        Brewton.........  Brewton Muni....       0/8855      2/10/20  RNAV (GPS) RWY
                                                                                30, Orig-A.
26-Mar-20.............  AL        Brewton.........  Brewton Muni....       0/8856      2/10/20  VOR/DME RWY 30,
                                                                                Amdt 8.

26-Mar-20.............  FL        Titusville......  Arthur Dunn Air        0/8867       2/6/20  RNAV (GPS)-A,
                                                     Park.                                       Orig-A.
26-Mar-20.............  FL        Titusville......  Arthur Dunn Air        0/8868       2/6/20  RNAV (GPS)-B,
                                                     Park.                                       Orig-A.
26-Mar-20.............  NY        New York........  John F Kennedy         0/8874       2/7/20  RNAV (RNP) Z RWY
                                                     Intl.                                       31R, Amdt 1A.
26-Mar-20.............  FL        Bonifay.........  Tri-County......       0/8877       2/6/20  RNAV (GPS) RWY
                                                                                19, Orig-B.
26-Mar-20.............  TX        Denton..........  Denton                 0/8892       2/6/20  RNAV (GPS) RWY
                                                     Enterprise.                                 36, Amdt 2B.
26-Mar-20.............  AZ        Tucson..........  Tucson Intl.....       0/8926       2/3/20  RNAV (GPS) RWY
                                                                                11R, Orig-C.
26-Mar-20.............  AZ        Tucson..........  Tucson Intl.....       0/9081       2/3/20  ILS OR LOC RWY
                                                                                11L, Amdt 14B.
26-Mar-20.............  OR        Grants Pass.....  Grants Pass.....       0/9185       2/7/20  RNAV (GPS)-A,
                                                                                Orig.
26-Mar-20.............  ND        Grand Forks.....  Grand Forks Intl       0/9985      2/11/20  VOR RWY 17R,
                                                                                Amdt 6A.
26-Mar-20.............  CA        Sacramento......  Sacramento             9/4931       2/6/20  ILS OR LOC RWY
                                                     Mather.                                     22L (SA CAT I),
                                                                                ILS RWY 22L (SA
                                                                                CAT II), Amdt
                                                                                7.
26-Mar-20.............  IN        Indianapolis....  Indianapolis           9/4955      1/28/20  ILS OR LOC RWY
                                                     Intl.                                       5R, ILS RWY 5R
                                                                                (SA CAT I), ILS
                                                                                RWY 5R (CAT
                                                                                II), ILS RWY 5R
                                                                                (CAT III), Amdt
                                                                                7.
26-Mar-20.............  IN        Indianapolis....  Indianapolis           9/4956      1/28/20  RNAV (RNP) Z RWY
                                                     Intl.                                       23L, Amdt 2.
26-Mar-20.............  IN        Columbus........  Columbus Muni...       9/9469      1/21/20  ILS OR LOC RWY
                                                                                23, Amdt 8.
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[FR Doc. 2020-04175 Filed 3-4-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Page 80924]
[FR Doc No: 2011-33074]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL01-88-010]

Louisiana Public Service Commission v. Entergy Services, Inc.;
Notice of Compliance Filing

    Take notice that on December 19, 2011, Entergy Services, Inc., as
agent on behalf of the Entergy Operating Companies submitted a
compliance filing, in accordance with the Commission's Order on Remand,
137 FERC ] 61,047 (2011).
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on January 9, 2012.

    Dated: December 20, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-33074 Filed 12-23-11; 8:45 am]
BILLING CODE 6717-01-P


Signed Rule text

Rules Text: FRL-5766.6-01-OLEM CAA RMP SCCAP Preamble and Rule NPRM 20220816_ADMIN Accompanying RIA: 5766.6 2050-AH22 CAA RMP SCCAP RIA NPRM 20220811_EO12866 Clean


[Federal Register: February 7, 2006 (Volume 71, Number 25)]
[Notices]
[Page 6300-6302]
[DOCID:fr07fe06-66]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53203; File No. SR-NASD-2006-016]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Establish a Mechanism for Handling Sub-Penny Orders in
Securities Listed on the New York Stock Exchange or the American Stock
Exchange

 January 31, 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 January 31, 2006, the National Association of Securities Dealers,
Inc. (``NASD''), through its subsidiary, The Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by Nasdaq. Nasdaq filed this
proposal pursuant to Section 19(b)(3)(A) of the Act \3\ and Rule 19b-
4(f)(6) thereunder,\4\ which renders the proposed rule change effective
immediately upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

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

    Nasdaq proposes to establish a mechanism for handling sub-penny
orders in securities listed on the New York Stock Exchange (``NYSE'')
or the American Stock Exchange (``Amex'') due to readiness issues at
those two exchanges and to make another minor adjustment in the related
rule language. The text of the proposed rule change is below. Proposed
new language is in italics; proposed deletions are in [brackets].\5\
---------------------------------------------------------------------------

    \5\ Changes are marked to the rule text that appears in the
electronic NASD Manual found at http://www.nasd.com. Prior to the date when

The NASDAQ Stock Market LLC (``NASDAQ LLC'') commences operations,
NASDAQ LLC will file a conforming change to the rules of NASDAQ LLC
approved in Securities Exchange Act Release No. 53128 (January 13,
2006), 71 FR 3550 (January 23, 2006).
---------------------------------------------------------------------------

* * * * *

6330. Obligations of CQS Market Makers

    (a) through (c) No change
    (d) Minimum Price Variation
    (1) No change
    (2) [When a quotation properly (not in violation of paragraph (1)
above) priced in an increment of less than $0.01 is routed for
execution via the ITS System to a market that does not accept
quotations in increments of less than $0.01, such a quotation is
rounded down (for bids) or up (for offers) to the nearest $0.01
increment.] A quotation for a security listed on the New York Stock
Exchange or the American Stock Exchange and properly (not in violation
of paragraph (1) above) priced in an increment of less than $0.01 will
be adjusted by the Nasdaq Market Center down (for bids) or up (for
offers) to the nearest $0.01 increment prior to display, execution or
routing. A quotation so adjusted will have no price priority over
equivalent quotations that did not require adjustment under this
paragraph.
* * * * *

4962. Minimum Quotation Increment

    The minimum quotation increment in the INET System for quotations
of $1.00 or above in Nasdaq-listed securities and in securities listed
on a national securities exchange shall be $0.01. The minimum quotation
increment in the INET System for quotations below $1.00 in Nasdaq-
listed securities and in securities listed on a national securities
exchange shall be $0.0001. However, if the Securities and Exchange
Commission (``SEC'') permits, with respect to any security, the
display, rank or acceptance of quotations priced at or above $1.00 per
share in an increment smaller than $0.01, then the minimum quotation
increment for such a security shall be the minimum permitted by the SEC
or $0.0001, whichever is greater.
* * * * *

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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
    On December 22, 2005, Nasdaq filed with the Commission a rule
change \6\ to align Nasdaq's rules on minimum pricing increments with
Rule 612 of the Commission's Regulation NMS.\7\ Consistent with Rule
612, the Nasdaq Market Center (``NMC'') and Nasdaq's BRUT and INET
facilities now accept quotes that are in increments ofleast $0.0001 if
these quotes are priced below $1.00 or if they are in securities
exempted by the Commission under Rule 612.\8\ Quotes priced above $1.00
will be accepted by the NMC, BRUT, and INET in increments of at least
$0.01 (unless they are in securities exempted by the Commission). These
principles apply equally to Nasdaq-listed securities and to securities
listed on other exchanges.
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 53017 (December 22,
2005), 70 FR 77225 (December 29, 2005). The rule change was
effective immediately upon filing, but not operational until January
31, 2006.
    \7\ 17 CFR 242.612.
    \8\ The present proposed rule change clarifies with respect to
INET that the minimum pricing increment will, in fact, be $0.0001,
as opposed to $0.001. This filing also includes an additional
conforming change to the INET rules, to clarify that any security
that receives the Commission's permission for sub-penny quoting
above $1.00 will be eligible for such quoting on INET.
---------------------------------------------------------------------------

    Under the present proposal, which is being made to accommodate the
NYSE and the Amex, the NMC will adjust all proper (i.e., priced under
$1.00 and in increments of not less than $0.0001) sub-penny quotes in
NYSE- and Amex-listed securities as soon as it receives them. Offers
will be adjusted upwards to the next whole cent, while bids will be
adjusted downward to the next whole cent. Sub-penny quotes that are
adjusted in this manner will be displayed, executed, or routed, as
otherwise applicable, at the adjusted price and will not be accorded
any price priority over the equivalent unadjusted whole-cent quotes.
The NMC will adjust all sub-penny quotes that it receives for NYSE and
Amex securities, regardless of whether such quotes are entered into the
NMC directly or routed from another trading venue (including when the
quotes are routed to the NMC from Nasdaq's BRUT or INET facilities).
    The ability of the NMC, BRUT, or INET to accept sub-penny quotes in
Nasdaq-, NYSE-, or Amex-listed securities is not affected by this
proposal. However, the ``accepted'' sub-penny quotes for NYSE-or Amex-
listed stocks will be adjusted before being displayed in the NMC or
routed via the ITS linkage from the NMC to the NYSE or the Amex.
    Nasdaq views the proposal described above as temporary because it
will, in most cases, deprive investors of the ability, envisioned in
Rule 612, to trade in sub-pennies those NYSE and Amex listed stocks
that are priced below $1.00. When Nasdaq determines that this approach
is no longer appropriate, it will change the rule described herein by
making an immediately effective filing with the Commission.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 15A of the Act,\9\ in general, and with
Section 15A(b)(6) of the Act,\10\ in particular, in that it is designed
to promote just and equitable principles of trade and to remove
impediments to, and perfect the mechanism of, a free and open market.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78o-3.
    \10\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

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

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

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

    Written comments were neither solicited nor received.

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

    Because the proposed rule change: (1) Does not significantly affect
the protection of investors or the public interest; (2) does not impose
any significant burden on competition; and (3) does not become
operative for 30 days after the date of the filing, or such shorter
time as the Commission may designate if consistent with the protection
of investors and the public interest, the proposed rule change has
become effective pursuant to Section 19(b)(3)(A) of the Act \11\ and
Rule 19b-4(f)(6) thereunder.\12\ The Commission hereby waives the 30-
day operative delay.\13\ The Commission has previously determined that,
for NMS stocks, quoting below $1.00 in sub-penny increments should be
permitted and codified that view in Rule 612(b) of Regulation NMS.\14\
The proposed rule change to clarify that the minimum pricing increment
for INET will be $0.0001 is consistent with Rule 612(b) and raises no
new regulatory issues. With regard to the Exchange's proposal to round
away all proper sub-penny quotes in NYSE- and Amex-listed securities
immediately upon receipt by the NMC, the Commission believes that such
rounding is non-controversial, as Rule 612 does not require that
accepted sub-penny quotes priced below $1.00 be displayed, executed, or
routed in sub-pennies. Therefore, the Commission believes that waiving
the 30-day operative delay is consistent with the protection of
investors and the public interest.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). Pursuant to Rule 19b-4(f)(6)(iii)
under the Act, the Exchange is required to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of the proposed rule change, at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Commission has determined to waive this requirement.
    \13\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
    \14\ See Securities Exchange Act Release No. 51808 (June 9,
2005), 70 FR 37496, 37555 (June 29, 2005).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, 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-NASD-2006-016 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-NASD-2006-016. 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
principal office of the NASD. 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-NASD-2006-016 and should be submitted on or before
February 28, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Nancy M. Morris,
Secretary.
 [FR Doc. E6-1614 Filed 2-6-06; 8:45 am]

BILLING CODE 8010-01-P


Discussion of Potential Costs and Benefits Associated with the Clearance and Clearance Testing Requirements for the Renovation, Repair, and Painting Program Final Rule
                                [RIN 2070-AJ57]
                                 July 15, 2011

	On May 6, 2010, EPA published a proposed rule entitled Lead; Clearance and Clearance Testing Requirements for the Lead, Renovation, Repair, and Painting Program (75 FR 25038).  The proposal included a number of proposed revisions to the 2008 Lead Renovation, Repair, and Painting Program (RRP) rule, which established accreditation, training, certification, and recordkeeping requirements as well as work practice standards for persons performing renovations for compensation in most pre-1978 housing and child-occupied facilities.  Specifically, EPA proposed requirements for dust wipe testing, clearance, allowing a certified renovator to collect a paint chip sample and send it to a recognized laboratory for analysis, minor changes to the training program accreditation application process, standards for e-learning in accredited training programs, minimum enforcement provisions for authorized state and tribal renovation programs, and minor revisions to the training and certification requirements for renovators.  The benefits of the proposed dust wipe testing and clearance provisions were not quantified, but EPA estimated that the annualized cost of the proposed dust wipe testing and clearance provisions would be $272 million with a 3% discount rate or $293 million with 7% rate.

	For the final rule, EPA has decided not to require dust wipe testing and clearance as proposed, and therefore the estimated costs of these proposed provisions will not be realized.  However, EPA is finalizing several of the other proposed revisions to the 2008 rule, including a provision allowing a certified renovator to collect a paint chip sample and send it to a recognized laboratory for analysis, minor changes to the training program accreditation application process, standards for e-learning in accredited training programs, minimum enforcement provisions for authorized state and tribal renovation programs, and minor revisions to the training and certification requirements for renovators.  EPA is also promulgating clarifications to the requirements for vertical containment on exterior renovation projects, the prohibited or restricted work practice provisions, and the requirements for high-efficiency particulate air (HEPA) vacuums.

	This document discusses the anticipated costs and benefits associated with the final rule.
In most cases, EPA is unable to quantify the incremental costs or benefits that could be expected from each revision.  Thus, this document contains a primarily qualitative assessment of the costs and benefits attributable to the final rule.  For the most part, EPA believes that the incremental costs attributable to this final rule are minimal.  The quantifiable costs attributable to this final rule, those related to the recordkeeping and reporting provisions for training providers, are estimated to be $355 per year.

	1. Clearance in lieu of cleaning verification.  The final rule retains a provision that allows renovation firms to skip the cleaning verification part of the mandatory cleaning protocol if another Federal, State, or local law or regulation, or the contract between the renovation firm and the property owner, requires the renovation firm to use qualified entities to perform dust wipe testing and requires the renovation firm to achieve clearance.

	Elimination of this provision could result in some additional cost for renovations that must achieve clearance.  EPA's "Electrostatic Cloth and Wet Cloth Field Study in Residential Housing" showed that cleaning verification should take approximately 5 minutes per cloth for each pass, and each cloth may be used for up to 40 square feet of uncarpeted floor, countertop, or windowsill space.  EPA estimated, as part of the 2008 final RRP rule economic analysis, that the material cost for each disposable cloth is $0.46 and that handles are $13.60 apiece.  EPA assumed that these handles can be used for approximately 1,000 events.  Using the interior event sizes and other calculations used in the 2008 RRP rule economic analysis, cleaning verification would cost from approximately $5.15 for a small bathroom remodel involving an uncarpeted work area of 48 square feet, to $30.92 for a large window replacement project in multi-unit target housing (likely to be the largest project for which clearance would be required by the Department of Housing and Urban Development (HUD) and for which EPA has estimated costs).  EPA is unable to estimate how many renovations covered by the RRP rule would also have to be cleared under another statute, regulation, or ordinance, or the renovation contract.

 	It is likely that completing the entire RRP cleaning protocol will increase the probability that clearance, where required, will be achieved on the first attempt, thus eliminating the burden of additional clearance attempts.

	2. Paint chip sampling option.  EPA is finalizing the proposed option allowing certified renovators to collect paint chip samples from painted components that will be disturbed by a renovation and submit those samples to an NLLAP-recognized entity for analysis.  This revision is beneficial, in that it provides certified renovators with another option for determining whether painted components contain lead-based paint.  This revision adds no costs, because no certified renovators are required to use this option.

	3. Additional materials required with training provider application.  The final rule requires training providers to submit copies of the qualifications of their training manager and principal instructor along with their applications for accreditation.  Training providers are already required to obtain and retain these materials, the final rule merely requires them to be sent to EPA along with the application.  EPA estimates that these materials will consist of a 1-page resume and, possibly, a copy of a diploma, course completion certificate, or transcript.  For a training provider with one training manager and one principal instructor, this will mean an additional 2-4 photocopies.  In the draft Information Collection Request Supporting Statement accompanying the proposed rule, EPA estimated that each photocopy costs $0.09, for a total of $0.36 per accreditation or reaccreditation application.  An application for reaccreditation must be submitted every 4 years in order to maintain accreditation.  EPA has estimated that approximately 170 training providers would become accredited to offer renovation training.  Thus, the annualized cost of this requirement is approximately $15.

	This amendment is beneficial because, when EPA reviews applications for accreditation, it is common for the Agency to request this documentation from training providers in order to verify that the training program manager and principal instructor(s) have the proper qualifications.  Requesting this information takes time and can delay the review of an application.  Having training providers submit this information upfront with the application will avoid such delays.

	The final rule also requires training providers who use course materials approved by an authorized State or Tribal RRP program to submit them to EPA along with their application.  Previously, training providers who used EPA, State or Tribal course materials could merely certify that they were using such materials, and not submit them for review.  However, given the diversity of the State and Tribal programs that EPA expects to authorize in the coming years, it could be very difficult for EPA to determine, without reviewing the actual materials, whether the proposed course would be suitable for the Federal RRP program.

	Submitting State or Tribal course materials could involve a significant number of photocopies and additional mailing costs.  Using the example of the EPA model course materials, the instructor and student manuals for the renovator course consist of 434 and 312 pages respectively.  Using EPA's estimated cost per photocopy of $0.09, it would cost $67.14 to photocopy these two manuals.  However, EPA does not know how many training providers would want to use State or Tribal course materials rather than EPA's model course materials.  EPA has not received any applications for accreditation from renovation training providers who wish to use course materials from any of the 10 currently-authorized States.  EPA believes that the most likely scenario would be a training provider who is accredited in an authorized State who would like to provide training in an adjacent non-authorized State.

	4. Role of principal instructor.  The final rule contains regulatory text intended to clarify the role of the principal instructor in providing training.  The regulation, at 40 CFR 745.227(c)(3), previously stated that principal instructors are responsible for the organization of their courses and oversight of the teaching of all course material.  The regulations also define "principal instructor" as "the individual who has the primary responsibility for organizing and teaching a particular course."  Nonetheless, the rule also allows training program managers to designate experts in a particular field (e.g., doctors or lawyers) as guest instructors, on an as needed basis, to teach discrete portions of the course.  EPA interprets these provisions to require a principal instructor to be present and primarily responsible for teaching the course, although guest instructors may be used to teach some portion(s) of the course.  Principal instructors are also responsible for the quality of the instruction delivered by the guest instructors.  To ensure that the regulation is clear on this point, EPA is amending the regulation to state that principal instructors are primarily responsible for teaching the course materials and must be present to provide instruction (or oversight of portions of the course taught by guest instructors) for the courses for which they have been designated the principal instructor.  No costs are associated with this amendment, because it is merely a clarification of an existing EPA regulatory interpretation.  The amendment is beneficial because it should reduce confusion about the role of the principal instructor.

	5. Amendments to accreditation applications.  EPA has interpreted the training provider accreditation regulations to require accredited training providers to submit amended applications whenever there is a change to the information provided in the training provider's most recent application for accreditation or re-accreditation, including information regarding the training manager and any principal instructor(s) teaching courses offered by the training provider.  However, the regulations have not previously specified a time limit for submitting such amendments.  The final rule requires providers to submit amendments within 90 days of the date a change occurs to information in each provider's most recent application.  If a training provider does not do so, it must stop providing training until the accreditation application is amended.   This amendment is unlikely to add additional costs, because EPA believes that training providers have generally been updating their information in a timely manner.  EPA is also revising the regulation to specifically state that no fee will be charged for accreditation application amendments.

	The final rule also gives EPA a 30-day period to approve or disapprove amendments involving a new training manager, any new or additional principal instructors, or any new permanent training location.  A training provider may not offer training under a new training manager or a new principal instructor, or training at a new permanent training location until 30 days after the date that EPA receives an amended accreditation application.  This 30-day time period will give EPA sufficient time to check the qualifications of the training manager(s) or principal instructor(s) before the training manager begins managing or the principal instructor begins teaching a course.  This 30-day time period also gives EPA sufficient time to verify the suitability of a new permanent training location by visiting the location.  While this specific revision may add some burden for training providers, EPA believes that most training providers plan far enough ahead so that the 30-day period will not delay training course delivery.

      In further reviewing this proposed provision, EPA has decided that additional flexibility would be beneficial for training providers.  If the training provider wishes to use a training manager or principal instructor who has already been reviewed by EPA as part of a successful application for training provider accreditation under 40 CFR 745.225, whether for that training provider or another, the training provider may do so on an interim basis without delay.  EPA will also allow training providers to use new permanent training locations on an interim basis for 30 days.  If, during that 30 days, EPA determines that the location is not adequate, the training provider must stop using that location upon written notice from EPA.

	6. Hands-on training topics.  40 CFR 745.225 includes requirements and procedures that training programs must follow to become accredited in order to provide instruction in lead-based paint courses.  Minimum requirements for training curricula are found in this section, which lists course topics that must be included in the different training courses with an indication of the topics that require hands-on instruction.  However, EPA inadvertently omitted indicating which course topics required hands-on training for the renovator and dust sampling technician disciplines.  Accordingly, the final rule identifies the topics for which hands-on training is required in renovator and dust sampling technician courses.  EPA believes that this amendment adds no costs, because the EPA model courses include hands-on training in these topics and most training providers are using the EPA model courses to deliver training.  However, EPA has received some questions on this issue, so this revision should reduce potential confusion about which topics must be covered in the hands-on training.

	The final rule also adds a sentence to 40 CFR 745.225(e)(2) stating that refresher courses for all disciplines except project designer must include a hands-on component.  This does not add any costs, because it is a restatement of EPA policy.

	7. Minimum e-learning course requirements and recordkeeping.  The final rule adds minimum requirements for e-learning courses and associated recordkeeping.  These requirements include:
      * A unique identifier for each student
      * Tracking each student's course log-ins, launches, progress, and completion, and maintaining these records
      * At least 16 periodic knowledge checks per course, which must be successfully completed before the student can continue through the course.
      * A test of at least 20 questions at the end of the electronic learning portion of the course, of which 80% must be answered correctly by the student for successful completion of the electronic learning portion of the course.
      * An electronic learning course completion certificate which can be saved or printed by the student, but which cannot be immediately and easily edited by the student.

	While the final rule imposes additional substantive requirements and recordkeeping on training providers who wish to provide e-learning courses, e-learning is optional and not required for any training provider.  In addition, EPA believes that the recordkeeping requirements for e-learning courses are comparable to, and no more burdensome than, the ordinary recordkeeping already required for courses provided in traditional formats.  This revision is beneficial because it enumerates the important elements of e-learning that EPA is already using as it evaluates applications for e-learning course accreditation.

	8. Recordkeeping periods for renovation training providers.  The final rule requires providers of renovator and dust sampling technician courses to keep student training records for 5 years.  Previously, training providers were required to keep training records for 3 years and 6 months.  This length of time was chosen because of the length of individual certification periods for lead-based paint activities, which can be as long as 3 years and 6 months including interim certification.  However, the renovator and dust sampling technician certification periods are 5 years, with no interim certification.  In order to ensure that the training records from the previous training course are available for certified renovators and dust sampling technicians taking refresher courses, EPA is increasing the general recordkeeping period applicable to these disciplines to 5 years.  In addition, because EPA has already extended the certification period for any certified renovator who was trained before April 22, 2010 to July 1, 2015, EPA is requiring training records from those courses to be kept until July 1, 2015 as well.  This revision is beneficial, in that it ensures that training records from the previous course would always be available for renovators and dust sampling technicians taking refresher courses.

	EPA can estimate the increased cost attributable to this revision.  EPA's economic analysis for the 2008 RRP rule estimated that a total of 170 training providers would become accredited for renovator training, and 56 renovator courses per training provider would be needed to train the renovators required for the first year that the RRP rule was effective.  EPA's economic analysis for the Opt-Out and Recordkeeping Final Rule estimated that no new training providers would become accredited, and a total of 30 additional renovator courses per existing training provider would be needed to train the additional renovators required during the first year after the Opt-Out Rule took effect.  According to these analyses, a total of 20 renovator courses would be needed per training provider during subsequent years.  These analyses also estimated that 1 page of records would be kept for each notification provided, including pre-course notifications, re-notifications, and post-course notifications.  Each course would require a pre-notification before the course began, giving general information on the training provider and the time and place for the course, and a post-notification after the course, which would include general information on the provider and information on successful trainees and their photographs.  EPA estimated that 12 percent of courses would also require a re-notification due to changes in date, time, or location.  Thus, during the first year, 86 courses would have been provided by each training provider, resulting in 182 notifications that would have to be kept for an additional 2 years, approximately, depending upon when the course was actually given.  Additional years would add 20 courses per year per training provider, resulting in 42 notifications that would have to be kept for an additional 18 months.  In its economic analysis for the Opt-Out Rule, EPA estimated the recordkeeping costs per notification would total $0.24.  Pro-rating this amount for 5 years results in an estimated recordkeeping cost of $0.34 per notification.  Thus, recordkeeping costs for the 86 courses given per training provider in the first year would total $61.88 instead of $43.68.  The recordkeeping costs for the 20 courses given per training provider in subsequent years would total $6.80 instead of $4.80.  These estimates cover the entire 5 year period during which the records would have to be kept.  Therefore, the costs of this provision are estimated to be $340 per year.

	9. Trainee photographs.  The final rule also includes certain minimum standards for the trainee photographs that must appear on renovator and dust sampling technician course completion certificates.  Accredited training programs are required to issue a course completion certificate for each person who passes a training course.  A variety of information is required to be on the certificate including the name of the course, the name and address of the student, and contact information for the training program.  Course certificates for renovators or dust sampling technicians must include a photograph of the student, but the regulation does not include size requirements or other specifications for the photograph.  Since publishing the RRP rule, the Agency has been asked if there is a minimum size for the photograph.  EPA believes that it would be beneficial to have minimum standards for the photograph in order to ensure that the person in the photograph is recognizable.  Therefore, the final rule requires the photographs on course completion certificates to be an accurate and recognizable image of the trainee and at least one square inch in size.  This revision is not likely to add any costs, because EPA believes that training providers are already complying with these standards.  The revision is beneficial because it should reduce potential confusion over the standards for trainee photographs.

	10. State and Tribal programs.  The final rule establishes certain minimum standards for authorized State and Tribal lead-based paint enforcement programs.  These standards include a minimum penalty authority of $5,000 per violation per day, a requirement that the State or Tribe be able to sue to obtain penalties, and a requirement that the burden of proof and degree of knowledge or intent of the respondent be no greater than it is for EPA under the Toxic Substances Control Act (TSCA).  The final rule also includes several clarifications on required elements of authorized State and Tribal renovation programs, such as requirements for dust sampling technician training and on-the-job training.  These revisions are beneficial because they ensure that State and Tribal programs have adequate enforcement mechanisms and reduce potential confusion about what such programs must include.  These revisions impose no costs, because States and Tribes are not required to develop renovation and other lead-based paint programs, nor are they required to obtain EPA authorization for these programs.  EPA will continue to implement the lead-based paint programs, including renovation programs, in unauthorized States and Tribal areas.

 	11. Vertical containment.  The final rule includes several provisions designed to clarify when vertical containment must be used and ensure that renovation firms consider all of the appropriate factors when designing containment systems for exterior projects.  Specifically, the final rule requires vertical containment or equivalent extra precautions in containing the work area to be used whenever a renovation project is being performed within 10 feet of the property line.  This requirement will help to ensure that neighboring properties are not contaminated by exterior renovations.  The final rule also adds a definition of "containment" that provides additional guidance on what vertical containment or equivalent extra precautions in containing the work area consists of and what should generally be considered when designing containment systems.

	In EPA's economic analysis for the 2008 RRP rule, EPA addressed those situations where the renovation firm must take extra precautions to effectively contain dust and debris, including work areas in close proximity to other buildings, work areas that abut a property line, and windy conditions.  The 2008 economic analysis specifically notes that it is sometimes necessary to erect a system of vertical containment to prevent paint dust and debris from contaminating the ground or any object beyond the work area.  To account for these situations, EPA estimated that approximately 2% of exterior jobs would use exterior containment, and the incremental cost of vertical containment varies from $330 per wall to $1,640 per wall, depending on the size of the job.  Adding together the costs for 2% of the exterior jobs covered by the 2008 RRP rule and 2% of the exterior jobs covered by the 2010 Opt-out rule results in an annualized cost of approximately $118 million for vertical containment that EPA has already accounted for.  Thus, EPA has already accounted for the additional costs incurred for using vertical containment systems on renovations performed within 10 feet of the property line.

	In addition, at the request of several members of the regulated community, EPA is revising the interior and exterior containment provisions to permit renovation firms to establish vertical containment closer than the mandatory minimum floor or ground containment distance.  If a firm chooses this option, the firm need not extend the floor or ground containment beyond the vertical containment unless it is necessary to contain dust and debris.  This additional flexibility, particularly in situations where obstacles make it difficult to cover the floor or ground for the necessary distance, is likely to make it easier for renovation firms to comply with the rule.

	12. Prohibited and restricted practice clarifications.  The final rule contains a number of minor revisions to the language on prohibited and restricted renovation practices, and adds a definition of "painted surfaces" to further clarify when practices are prohibited or restricted.  Specifically, the final rule clarifies that the prohibitions and restrictions on renovation practices, such as the prohibition on open flame burning or torching, apply to all painted surfaces, not just surfaces where the presence of lead-based paint has been confirmed.  The definition of "painted surface" additionally clarifies that term means component surfaces that contain paint or other surface coatings.  The final rule also clarifies that the restriction on the use of machines that remove paint through high speed operation applies anywhere painted surfaces are being disturbed by such machines, the restriction is not limited to situations where all of the paint is removed by such machines.  Lastly, the final rule clarifies what EPA meant by HEPA exhaust control.  These revisions clarify existing requirements and reflect established EPA interpretations.  Therefore, these revisions do not impose additional costs.

	13. HEPA vacuum operation and maintenance.  The final rule adds a requirement that high-efficiency particulate air (HEPA) vacuums be operated and maintained in accordance with the manufacturer's recommendations, including filter change intervals.  HEPA vacuums are already mandatory for the specialized cleaning protocol required by the RRP rule.  While this revision may add some additional costs in the form of more frequent filter changes, EPA believes that most renovation firms are already operating and maintaining their HEPA vacuums in accordance with the manufacturer's instructions.  EPA is unable to estimate how many renovation firms are not doing so, and might thereby incur additional costs to comply with this new requirement.

	14. On-the-job training.  The final rule clarifies that the certified renovator assigned to the renovation must only provide on-the-job training to other renovation workers (who have not had certified renovator training) in the RRP-required work practices that the renovation workers will be performing.  This is a stakeholder-requested clarification of the existing RRP rule requirements and does not add any costs.

	15. Grandfathering cut-off date.  The effective date of the final rule will be the last date that individuals may take advantage of the "grandfathering" provisions of the RRP rule.  Under the 2008 RRP rule, individuals who successfully complete an accredited abatement worker or supervisor course, and individuals who successfully complete the HUD, EPA, or the joint EPA/HUD model renovation training courses may take an accredited refresher renovation training course in lieu of the initial renovation training to become a certified renovator.  In addition, individuals who have successfully completed an accredited lead-based paint inspector or risk assessor course, but are not currently certified in the discipline, may take an accredited refresher dust sampling technician course in lieu of the initial training to become a certified dust sampling technician.

	While this restriction is likely to impose some burdens on individuals wishing to become certified renovators or dust sampling technicians, EPA is unable to estimate the extent of these burdens.  EPA does not have information on the availability of pre-RRP lead-safe work practices courses, nor can EPA estimate how many previously-trained individuals would choose to become renovators after the effective date of the rule.

Provision
                            Proposed Cost Estimates
                                 (Annualized)
                             Final Cost Estimates
                                 (Annualized)
Dust Wipe Testing & Clearance
                             $272,000,000 (3%)[1]
                              293,000,000 (7%)[1]
                                      $0
                              Provision Excluded
                                From Final Rule
Elimination of Clearance in lieu of Cleaning Verification
                                 Not Estimated
                                 Not Estimated
Paint Chip Sampling Option
                                 Not Estimated
                                      $0
Additional Application Materials
                                 Not Estimated
                                   $15[2,3]
Role of Principal Instructor
                                 Not Estimated
                                      $0
Application Amendments
                                 Not Estimated
                                 Not Estimated
Hands-on Training
                                 Not Estimated
                                      $0
E-learning
                                 Not Estimated
                                 Not Estimated
Recordkeeping
                                 Not Estimated
                                   $340[2,3]
Photographs
                                 Not Estimated
                                 Not Estimated
State and Tribal Enforcement
                                 Not Estimated
                                 Not Estimated
Vertical Containment
                                 Not Estimated
                                 Not Estimated
Prohibited/Restricted Practices
                                 Not Estimated
                                      $0
HEPA vacuums
                                 Not Estimated
                                 Not Estimated
On-the-job Training
                                 Not Estimated
                                      $0
Grandfathering
                                 Not Estimated
                                 Not Estimated
TOTAL:
                             $272,000,000 (3%)[1]
                               293,000,000 (7%)[1]
                                   $355[2,3]
[1]Economic Analysis of the Proposed Dust Testing and Clearance Amendments to the TSCA Lead Renovation, Repair, and Painting Program for Target Housing and Child-Occupied Facilities, April 2010.  (http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2005-0049-1110)
[2]Economic Analysis for the TSCA Lead Renovation, Repair and Painting Program Final Rule for Target Housing and Child-Occupied Facilities, April 2008. (http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2005-0049-0916)
[3]Economic Analysis for the TSCA Lead Renovation, Repair, and Painting Program Opt-out and Recordkeeping Final Rule for Target Housing and Child-Occupied Facilities, April 2010. (http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2005-0049-1135)


[Federal Register Volume 77, Number 127 (Monday, July 2, 2012)]
[Notices]
[Pages 39245-39246]
[FR Doc No: 2012-16156]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0063]

Sami Arshak Yanikian: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Sami Arshak Yanikian for 10 years from providing services in any
capacity to a person that has an approved or pending drug product
application. FDA bases this order on a finding that Mr. Yanikian was
convicted of two counts of introducing unapproved new drugs into
interstate commerce, which relates to the development or approval,
including the process for development or approval, of drug products and
to the regulation of drug products under the FD&C Act. In addition, the
type of conduct that served as the basis for Mr. Yanikian's convictions
undermine the process for the regulation of drugs. Mr. Yanikian was
given notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. Mr. Yanikian
failed to respond. Mr. Yanikian's failure to respond constitutes a
waiver of his right to a hearing concerning this action.

DATES: This order is effective July 2, 2012.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Office of Regulatory
Affairs, Food and Drug Administration, 12420 Parklawn Dr., Rockville,
MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the development or approval, including the
process for development or approval, of any drug product or otherwise
relating to the regulation of drug products under the FD&C Act, and if
FDA finds that the type of conduct that served as the basis for the
conviction undermines the process for the regulation of drugs.
    On June 29, 2011, Mr. Yanikian was found guilty of two counts of
introduction of an unapproved drug in interstate commerce, in violation
of sections 301(d), 505(a), and 303(a)(1) of the FD&C Act (21 U.S.C.
331(d), 355(a), 333(a)(1)) and of aiding and abetting, in violation of
18 U.S.C. 2(b), and the U.S. District Court for the Central District of
California entered judgment against Mr. Yanikian for the misdemeanor
offenses of introduction of an unapproved drug in interstate commerce
and aiding and abetting.
    The FDA's finding that debarment is appropriate is based on the
misdemeanor convictions referenced herein. The factual basis for the
conviction is as follows: On March 17, 2005, FDA sent Mr. Yanikian a
warning letter regarding his marketing and sale of Novel natural
formulation for atrial fibrillation, Super Nasal Drops, and Sams No
Tinnitus Formulation. The warning letter described the claims Mr.
Yanikian's Web site was making pertaining to these products and
informed him that his claims caused the products to be ``drugs'' as
defined by the FD&C Act because they were intended to cure, mitigate,
treat, or prevent disease. Mr. Yanikian was informed that his products
were ``new drugs'' and that a new drug could not be introduced or
delivered for introduction into interstate commerce unless an FDA-
approved application was in effect for it. The

warning letter additionally noted that none of the products described
had an approved application and that their introduction or delivery for
introduction into interstate commerce violated section 301(d) of the
FD&C Act. Mr. Yanikian was advised to immediately correct the
violations.
    In response, on April 11, 2005, Mr. Yanikian wrote a reply letter
to FDA in which he stated that the products were mailed for sale
outside the United States to hospitals that deal with natural health
products. He further noted that his products were not intended for sale
as over-the-counter or for single individuals in the United States
until they were approved by FDA.
    Despite knowing that he was not allowed to sell these unapproved
new drugs in the United States without FDA approval, and despite his
repeated representations to FDA that he was not selling his products to
customers in the United States, Mr. Yanikian subsequently sold his
unapproved new drug products to an undercover agent in November 2005,
and again in November 2006, in violation of sections 301(d), 505(a),
and 303(a)(1) of the FD&C Act and 18 U.S.C. 2(b).
    As a result of his conviction, on April 3, 2012, FDA sent Mr.
Yanikian a notice by certified mail proposing to debar him for 10 years
from providing services in any capacity to a person that has an
approved or pending drug product application. FDA subsequently
confirmed that Mr. Yanikian personally received the notice on April 11,
2012. The proposal was based on a finding, under section
306(b)(2)(B)(i)(I) of the FD&C Act that Mr. Yanikian was convicted of
two counts of a misdemeanor under Federal law. In the notice, FDA found
that the conduct underlying these Federal misdemeanor convictions
relates to the development or approval, including the process for
development or approval, of drug products and relates to the regulation
of drug products under the FD&C Act and undermines the process for the
regulation of drugs because the introduction and causing the
introduction of unapproved new drugs into interstate commerce are
prohibited by the FD&C Act. The proposal also offered Mr. Yanikian an
opportunity to request a hearing, providing him 30 days from the date
of receipt of the letter in which to file the request, and advised him
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Mr. Yanikian failed to respond within the timeframe prescribed
by regulation, and has therefore waived his opportunity for a hearing
and waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act
under authority delegated to him (Staff Manual Guide 1410.35), finds
that Sami Arshak Yanikian has been convicted of two counts of a
misdemeanor under Federal law for conduct relating to the development
or approval, including the process for development or approval, of drug
products and relating to the regulation of drug products under the FD&C
Act, and that the type of conduct that served as a basis for the
conviction undermines the process for the regulation of drugs.
    As a result of the foregoing finding, Mr. Yanikian is debarred for
10 years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES), (see sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 321(dd))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Mr. Yanikian, in any capacity during Mr.
Yanikian's debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Yanikian
provides services in any capacity to a person with an approved or
pending drug product application during his period of debarment he will
be subject to civil money penalties (section 307(a)(7) of the FD&C
Act). In addition, FDA will not accept or review any abbreviated new
drug applications submitted by or with the assistance of Mr. Yanikian
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Mr. Yanikian for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2012-N-0063 and sent to the Division of Dockets Management (see
ADDRESSES). All such submissions are to be filed in four copies. The
public availability of information in these submissions is governed by
21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 15, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-16156 Filed 6-29-12; 8:45 am]
BILLING CODE 4160-01-P